In a robust clinical program consisting of three randomized, placebo-controlled studies and a two-year open label safety study, GOCOVRI demonstrated a durable reduction in dyskinesia and secondarily in OFF time in people with Parkinson’s disease. Specifically, the pooled data analysis (placebo adjusted) from the two positive Phase 3 pivotal trials of GOCOVRI demonstrates:
ADS-4101 in Development for the Treatment of Partial Onset Seizures in Patients with Epilepsy
Epilepsy affects an estimated three million Americans, of which approximately 60% have partial onset seizures. Of those people with partial onset seizures, about 30% to 40% of patients have poor seizure control with current anti-epilepsy drugs. There are limited data on the temporal distribution of seizures over the 24-hour day; however, published studies suggest that seizures occur in a diurnal pattern, characterized by a peak between 11 a.m. and 5 p.m. and lowest between 11 p.m. and 5 a.m. Thus,
We have completed two Phase 1 studies of ADS-4101 in healthy volunteers. The Phase 1a study showed that a single 400 mg dose of ADS-4101 was better tolerated compared to the equivalent dose of VIMPAT immediate release tablets. The data also demonstrated that ADS-4101 exhibited the desired pharmacokinetic properties, namely a reduced rate of initial rise and delayed time to maximum drug concentration appropriate for bedtime dosing. In addition, a multi-dose Phase 1b study demonstrated that a 600 mg dose of ADS-4101, taken once-nightly, provided a 1.5 to 2.5-fold increase in average lacosamide concentrations throughout the day compared to the maximum approved daily dose of 400 mg, taken as 200 mg twice-daily (BID), of VIMPAT immediate release tablets in healthy volunteers, with comparable tolerability.
In November 2012, we granted Allergan an exclusive license, with right to sublicense, to certain of our intellectual property rights relating to human therapeutics containing memantine in the United States. In connection with these rights, Allergan markets and sells NamzaricNAMZARIC and NamendaNAMENDA XR for the treatment of moderate to severe
dementia related to Alzheimer’s disease. Pursuant to the agreement, Allergan made an upfront payment of $65.0 million. We earned and received additional cash payments totaling $95.0 million upon achievement by Allergan of certain development and regulatory milestones. Under the agreement, external costs incurred related to the prosecution and litigation of intellectual property rights are reimbursable.
ADS-4101 is currently covered by U.S. and PCTex-U.S. patent applications containing method and composition claims relating to their pharmacokinetic profile and dosing of antiepileptic agents. On January 25, 2021, a Notice of Allowance was received in U.S. Patent Application No. 15/396,161, and on February 18, 2021, a Notice of Allowance was received in U.S. Patent Application No. 15/863,746. Both of these applications are expected to issue as patents within the first half of 2021. Patents issuing from these applications, if issued, will expire at least as late as 2036. These patent applications are wholly owned by us and are not subject to any license agreements.
We commenced the full commercial launch of GOCOVRI in January 2018. In connectionTo drive awareness and adoption of GOCOVRI by movement disorder centers, specialists and other neurologists for their Parkinson’s disease patients with this launch,OFF and dyskinesia, we deployeddeploy a field sales forceteam of approximately 60 experienced neurology account specialists plus six regional business directors. specialists. This team is equipped with compelling educational materials demonstrating the benefit and safety profile of GOCOVRI for appropriate patients. Also, to facilitate patient access to, and physician experience with, GOCOVRI, we have both in-
We sell GOCOVRI to a specialty pharmacy and certain limited specialty distributors, which we collectively refer to as our customers. For the yearyears ended December 31, 2018,2020 and 2019, our largest customer, Alliance Rx Walgreens Prime, or AllianceRx, was responsible for approximately 99%95% and 98% of our product revenue.revenue, respectively. We have a product purchase agreement with Walgreen Co., acting on behalf of itself and its specialty pharmacy affiliates, including AllianceRx, through which AllianceRx purchases its supply of GOCOVRI. The agreement provides that AllianceRx has the nonexclusive right to purchase GOCOVRI from us or our authorized distributors solely to dispense to patients in the United States and Puerto Rico, and that AllianceRx will purchase GOCOVRI only from us or our authorized distributors. There are no minimum purchase requirements under the product purchase agreement. We do not believe the loss of this customer would significantly impact the ability to distribute our product as we believe alternative distributors are available.
Our industry is highly competitive and subject to rapid and significant technological change. While we believe that our development experience and scientific knowledge provide us with competitive advantages, we may face competition from large pharmaceutical and biotechnology companies, smaller pharmaceutical and biotechnology
companies, specialty pharmaceutical companies, generic drug companies, academic institutions, government agencies and research institutions, and others.
Many of our competitors may have significantly greater financial, technical, and human resources than we have. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Our commercial opportunity could be reduced or eliminated if our competitors develop or market products or other novel technologies that are more effective, safer, or less costly than any that will be commercialized by us. Our success will be based in part on our ability to identify, develop, and manage a portfolio of drugs that are safer, more efficacious, and/or more cost-effective than alternative therapies.
The commercialization of new pharmaceutical products is highly competitive, and we face substantial competition with respect to GOCOVRI. For example, although GOCOVRI is the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, and, as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes, we face competition from various branded and generic drugs approved for the treatment of Parkinson’s disease that physicians either have historically used or may use in an attempt to manage dyskinesia. Competition may arise from all versions of levodopa (Sinemet(SINEMET (Merck & Co., Inc.), ParcopaPARCOPA (Schwartz Pharma), Rytary (Impax)RYTARY (Amneal Pharmaceuticals, Inc.), DuopaDUOPA (AbbVie), InbrijaINBRIJA (Acorda)); dopamine agonists (subcutaneous(APOKYN subcutaneous apomorphine, RequipREQUIP XL (GlaxoSmithKline plc), MirapexMIRAPEX and MirapexMIRAPEX ER (Boehringer Ingelheim Pharmaceuticals Inc.), NeuproNEUPRO Patch (UCB SA/NV), KYNMOBI (Sunovion)); MAOB inhibitors (selegiline (Somerset Pharmaceuticals, Inc.), AzilectAZILECT (Teva Pharmaceuticals Industries, Ltd.), XadagoXADAGO (Newron Pharmaceuticals S.p.A.)); adenosine receptor antagonist (NOURIANZ (Kyowa Kirin, Inc.)); COMT inhibitors
We will also face competition from investigational drugs in late stage development for the treatment of Parkinson’s disease, if approved, including product candidates from Mitsubishi Tanabe, Bial-Portela CSA, Genervon Biopharmaceuticals, and Pharma Two B, Neurocrine, and Sunovion.B. GOCOVRI may also face competition from drugs currently in development for dyskinesia in Parkinson’s disease or for Parkinson’s disease from a number of pharmaceutical companies, such as Novartis, Avanir Pharmaceuticals, Neurolixis, Amarantus BioScience, Addex Pharma, and Neurim Pharmaceuticals Ltd.
Many of our competitors, including a number of large pharmaceutical companies that compete directly with us, have significantly greater financial resources commercializing approved products than we do. Also, many of our competitors are large pharmaceutical companies that will have a greater ability to reduce prices for their competing drugs in an effort to gain market share and undermine the value proposition that we might otherwise be able to offer to payers.
release coatings. Our products are made in a fluidized bed coating machine in sequential steps. Once the extended or modified release coating is applied, the coated pellets are tested to ensure that the desired dissolution rate is achieved. These coatings are relatively thin, and susceptible to changes in raw materials, temperature, humidity, and other manufacturing process parameters.
Our third-party manufacturers, their facilities, and all lots of drug substance and drug products used commercially or in our clinical trials are required to be in compliance with current Good Manufacturing Practices, or cGMP. The cGMP regulations include requirements relating to organization of personnel, buildings and facilities, equipment, control of components and drug product containers and closures, production and process controls, packaging and labeling controls, holding and distribution, laboratory controls, records and reports, and returned or salvaged products. The manufacturing facilities for our products must meet cGMP requirements and FDA satisfaction before any product is approved and we can manufacture commercial products. Our third-party manufacturers are also subject to periodic inspections of facilities by the FDA and other authorities, including procedures and operations used in the testing and manufacture of our products to assess our compliance with applicable regulations. Failure to comply with statutory and regulatory requirements subjects a manufacturer to possible legal or regulatory action, including warning letters, the seizure or recall of products, injunctions, consent decrees placing significant restrictions on or suspending manufacturing operations, and civil and criminal penalties. These actions could have a material impact on the availability of our products.
The FDA and comparable regulatory agencies in state and local jurisdictions and in foreign countries impose substantial requirements upon the clinical development, manufacture and marketing of pharmaceutical products. These agencies and other federal, state, and local entities regulate research and development activities and the testing, manufacture, quality control, safety, effectiveness, labeling, storage, recordkeeping, tracking, approval, import, export, advertising, and promotion of our products.
The process required by the FDA before product candidates may be marketed in the United States generally involves the following:
The testing and approval process requires substantial time, effort, and financial resources. Prior to commencing the first clinical trial with a product candidate, we must submit an IND to the FDA. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises safety concerns or questions about the conduct of the clinical trial by imposing a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Submission of an IND may not result in FDA
authorization to commence a clinical trial. A separate submission to the existing IND must be made for each successive
clinical trial conducted during product development. Further, an independent institutional review board for each medical center proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical trial commences at that center. Regulatory authorities or an institutional review board or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. Some studies also include a data safety monitoring board, which receives special access to unblinded data during the clinical trial and may halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration of efficacy.
In general, for purposes of NDA approval, human clinical trials are typically conducted in three sequential phases that may overlap.
The FDA may require, or companies may pursue, additional clinical trials after a product is approved. These so-called Phase 4 studies may be made a condition to be satisfied after approval. The results of Phase 4 studies can confirm the effectiveness of a product candidate and can provide important safety information.
Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the product candidate, as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, must develop methods for testing the identity, strength, quality and purity of the final product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.
The Federal Food, Drug, and Cosmetic Act (“FDCA”) provides two pathways for the approval of new drugs through an NDA. An NDA under Section 505(b)(1) of the FDCA is a comprehensive application to support approval of a product candidate that includes, among other things, data and information to demonstrate that the proposed drug is safe and effective for its proposed uses, that production methods are adequate to ensure its identity, strength, quality, and
purity of the drug, and that proposed labeling is appropriate and contains all necessary information. A 505(b)(1) NDA contains results of the full set of preclinical and clinical studies conducted by or on behalf of the applicant to characterize and evaluate the product candidate.
Section 505(b)(2) of the FDCA provides an alternate regulatory pathway to obtain FDA approval for new or improved formulations or new uses of previously approved drug products. Specifically, Section 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. The applicant may rely to some extent upon the FDA’s findings of safety and effectiveness for an approved product that acts as the reference listed drug (“RLD”), and submit its own product-specific data-which may include data from preclinical or clinical studies conducted by or on behalf of the applicant-to address differences between the product candidate and the RLD. GOCOVRI and our current and anticipated product candidates based upon ADS-5102 are or will be based on already approved active pharmaceutical ingredients (“API”), rather than new chemical entities, and a formulation that has been evaluated in Phase 1 studies. Accordingly, we expect to be able to rely on information from previously conducted studies involving our ADS-5102 formulation in our clinical development plans and our NDA submissions. For product candidates that involve novel fixed-dose combinations of existing drugs or for studies of an existing product or product candidate in a new indication, we expect that we will generally be able to initiate Phase 2/3 studies without conducting any new non-clinical or Phase 1 studies. In those instances where our product candidate includes previously unapproved API, we will need to conduct certain non-clinical and Phase 1 studies to investigate the safety and pharmacokinetic profile of the product candidate prior to conducting Phase 2/3 studies.
The submission of an NDA under either Section 505(b)(1) or Section 505(b)(2) generally requires payment of a substantial user fee to the FDA. The FDA reviews applications to determine, among other things, whether a product is
safe and effective for its intended use and whether the manufacturing controls are adequate to assure and preserve the product’s identity, strength, quality, and purity. For some NDAs, the FDA may convene an advisory committee to seek insights and recommendations on issues relevant to approval of the application. Although the FDA is not bound by the recommendation of an advisory committee, the agency usually follows such recommendations. Although the FDA did not do so upon the approval of GOCOVRI, theThe FDA may determine that a Risk Evaluation and Mitigation Strategy (“REMS”) is necessary to ensure that the benefits of a new product outweigh its risks, and such REMS can be imposed either at the time of approval or subsequent to a product’s marketing. A REMS may include various elements, ranging from a medication guide or patient package insert to limitations on who may prescribe or dispense the drug, depending on what the FDA considers necessary for the safe use of the drug. Under the Pediatric Research Equity Act, certain applications for approval must include an assessment, generally based on clinical study data, of the safety and effectiveness of the subject drug or biological product in relevant pediatric populations. Before approving an NDA, the FDA will inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications.
Once the NDA submission has been accepted for filing, which occurs, if at all, within 60 days after submission of the NDA, the FDA’s goal for a non-priority review of an NDA is ten months from submission for Section 505(b)(2) applications,based upon goals set under annual user fee guidance, although the review process can be and often is significantly extended by FDA requests for additional information, studies, or clarification. Upon completion of its review, the FDA will respond to the applicant by approving the application or issuing a Complete Response letter. A Complete Response letter outlines deficiencies in the NDA and may request additional information, including additional preclinical or clinical data. Even if an applicant submits this additional information, the FDA may determine that the NDA still does not meet the standards for approval. Data from clinical trials are not always conclusive and the FDA may interpret data differently than the sponsor. The timing of approval, if any, of any NDA we submit will depend on when the FDA determines that the NDA satisfies all requirements for approval. Also, even if the FDA approves an NDA, such approval may entail limitations on the uses or conditions for which such product may be marketed, or the FDA may require Phase 4 post-marketing studies to monitor the safety or efficacy of the product, and may further limit the marketing of the product based on the results of these post-marketing studies. The FDA may withdraw approval of an NDA if the sponsor does not comply with extensive post-marketing regulatory requirements (as described below) or if problems occur after the product reaches the marketplace.
The Hatch-Waxman Act also provides periods of regulatory exclusivity for products that would serve as RLDs for an ANDA or 505(b)(2) application. If a product is a new chemical entity, or NCE-generally meaning that the active moiety has never before been approved in any drug-there is a period of five years from the product’s approval during which the FDA may not accept for filing any ANDA or 505(b)(2) application for a drug with the same active moiety. An ANDA or 505(b)(2) application may be submitted after four years, however, if the sponsor makes a Paragraph IV certification challenging a listed patent. Because of relevant statutory and regulatory provisions, as well as the time it takes for the FDA to review and approve an application, five-year NCE exclusivity usually effectively means an ANDA or 505(b)(2) application is not approved for a period well beyond five years after approval of the RLD.
The Orphan Drug Act provides incentives for the development of drugs intended to treat rare diseases or conditions, which generally are diseases or conditions affecting less than 200,000 individuals in the United States. If a sponsor demonstrates that a drug or biologic is intended to treat a rare disease or condition and meets other qualifying criteria, the FDA grants orphan drug designation to the product for that use. The benefits of orphan drug designation include research and development tax credits and exemption from user fees. In general, a drug that is approved for the orphan drug designated indication is granted seven years of orphan drug exclusivity, and during that period, the FDA generally may not approve any other application for the same product for the same indication, although there are exceptions, most notably when the later product is shown to be clinically superior to the product with exclusivity. GOCOVRI has been granted orphan drug exclusivity until August 24, 2024 for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy with or without concomitant dopaminergic medications.
Any drug products we manufacture, market, or distribute pursuant to FDA approvals are subject to continuing regulation by the FDA. For example, drug manufacturers and their subcontractors must register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by regulatory authorities, including by the FDA for compliance with cGMP, which imposes significant manufacturing-related requirements. We cannot be certain that we or our present or future suppliers will be able to comply with the cGMP regulations and other regulatory requirements imposed by the FDA or other regulatory authorities. If we or our present or future suppliers are not able to comply with FDA requirements, for example, the FDA may take enforcement action, including, but not limited to, halting our clinical trials, requiring us to recall a product from distribution, or seeking to withdraw approval of an NDA or other necessary licenses.
The FDA closely regulates the marketing and promotion of drugs. A company’s promotional claims about the safety and efficacy of its drug products must be consistent with FDA-approved labeling, truthful, and non-misleading. Failure to comply with these requirements can result in adverse publicity, warning or untitled letters, corrective advertising, and potential civil and criminal penalties. Physicians may legally prescribe approved drugs for uses that are not described in the product’s labeling and that differ from those tested by us and approved by the FDA. Such “off-label” use is common in some areas of medicine and reflects physicians’ professional judgment that such use is an appropriate treatment option for patients under certain circumstances. The FDA does not regulate physicians’ practice of medicine, but the FDA does restrict manufacturers’ communications about their drug products, including communications about unapproved uses of approved products. However, a manufacturer that is found to have promoted off-label use of its product may be subject to significant liability, including administrative, civil and criminal sanctions.
In addition to these post-marketing requirements, companies that manufacture or distribute drug products or that hold approved NDAs must comply with numerous other post-marketing regulatory requirements, including submitting annual reports, reporting information about adverse drug experiences, and maintaining certain records.
The extensive laws and regulations that apply to the research, development, manufacture, quality control, safety, effectiveness, approval, labeling, storage, record keeping, reporting, distribution, import, export, advertising, and promotion of drug products and product candidates in the United States are subject to change, and it is difficult to foresee whether, how, and when such changes may affect our business.
Our business activities, including but not limited to, research, sales, promotion, distribution, medical education, and other activities following product approval will be subject to regulation by numerous regulatory and law enforcement authorities in the United States in addition to the FDA, including potentially the Department of Justice, the Department of Health and Human Services and its various divisions, including the Centers for Medicare and Medicaid Services, and state and local governments. Our business activities must comply with numerous healthcare laws, including but not limited to, the federal Anti-Kickback Statute, the False Claims Act, the Veterans Health Care Act, and similar state laws.
The federal Anti-Kickback Statute prohibits, among other things, any person or entity from knowingly and willfully offering, paying, soliciting, or receiving any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or in return for purchasing, leasing, ordering, or arranging for the purchase, lease, or order of any item
or service reimbursable under Medicare, Medicaid, or other federal healthcare programs. The term remuneration has been interpreted broadly to include anything of value. Liability under the Anti-Kickback Statute may be established without a person or entity having actual knowledge of the statute or specific intent to violate it. In addition, the government may assert that a claim including items or services resulting from a violation of the Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution. We seek to comply with these exceptions and safe harbors whenever possible, but the exceptions and safe harbors are drawn narrowly, and our business practices may be subject to scrutiny if they do not qualify for an exception or safe harbor or if there is no exception or safe harbor available. Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances.
The federal civil False Claims Act prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, a false claim for payment to, or approval by, the federal government or knowingly making, using, or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government. The False Claims Act also permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the statute and to share in any monetary recovery. Many pharmaceutical and other healthcare companies have been investigated or subject to lawsuits by whistleblowers and have reached substantial financial settlements with the federal government under the False Claims Act for a variety of alleged improper marketing activities.activities, among other things. Pharmaceutical and other healthcare companies also are subject to other federal false claim laws, including federal criminal healthcare fraud and false statement statutes that extend to non-government health benefit programs.
We and our business activities are subject to the civil monetary penalties statute, which imposes penalties against any person or entity who, among other things, is determined to have presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent.
The majority of states also have statutes or regulations similar to the federal Anti-Kickback Statute and federal False Claims Act, which apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payer. These includeAdditionally, there are state laws that require pharmaceutical companies to report expenses relating to the marketing and promotion of pharmaceutical products and to report gifts and payments to individual physicians in the states;states, restrict when pharmaceutical companies may provide meals to prescribers or engage
In addition, we may be subject to data privacy and security regulations by both the federal government and the states in which we conduct our business. The legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing focus on privacy and data protection issues which may affect our business. Numerous federal and state laws and regulations, including state security breach notification laws, state health information privacy laws and federal and state consumer protection laws, govern the collection, use, disclosure, and protection of personal information. Failure to comply with such laws and regulations could result in government enforcement actions and create liability for us (including the imposition of significant penalties), private litigation and/or adverse publicity that negatively affects our business. In addition, healthcare providers who prescribe our products and research institutions we collaborate with are subject to privacy and security requirements under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic
and Clinical Health Act (“HITECH”). HIPAA and its implementing regulations impose certain requirements on covered entities, including certain healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity and their subcontractors that use, disclose, access, or otherwise process individually identifiable protected health information, relating to the privacy, security and transmission of individually identifiable health information. Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to business associates-independentassociates, which are independent contractors or agents of covered entities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity. HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions. In addition, state laws govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
In order to be eligible to have our products paid for with federal funds under the Medicaid and Medicare Part B programs and purchased by certain federal agencies and grantees, we will have to comply with the Veterans Health Care Act of 1992 (“VHCA”). The VHCA requires manufacturers to offer their covered drugs (biologics and single source and innovator multiple source drugs) for sale to certain federal agencies, including but not limited to, the Department of Veterans Affairs (“VA”), on a Federal Supply Schedule contract, at a price no higher than the statutory Federal Ceiling Price (“FCP”). The FCP is based on the non-federal average manufacturer price, or Non-FAMP, which we will have to calculate and report to the VA on a quarterly and annual basis. In addition, the Federal Supply Schedule contract requires compliance with applicable federal procurement laws.
Depending on the circumstances, failure to comply with these laws can result in penalties, including significant criminal, civil, and/or administrative criminal penalties, damages, fines, disgorgement, exclusion of products from reimbursement under government programs, “qui tam” actions brought by individual whistleblowers in the name of the government, individual imprisonment, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, refusal to allow us to enter into supply contracts, including government contracts, reputational harm, diminished profits, and future earnings, and the curtailment or restructuring of our operations, any of which could adversely affect our business.
The United States and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals designed to change the healthcare system in ways that could affect our ability to sell our products profitably. Among policy makers and payers in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives.
For example, in March 2010, the Patient Protection and Affordable Care Act (“PPACA”) was passed, which has substantially changed how health care is financed by both governmental and private insurers, and has significantly impacted the U.S. pharmaceutical industry. The PPACA, among other things, revised the methodology by which rebates owed by manufacturers to the state and federal government for covered outpatient drugs under the Medicaid Drug Rebate Program (“MDRP”) are calculated, increased the minimum Medicaid rebates owed by most manufacturers under the MDRP, extended the MDRP to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations, subjected manufacturers to new annual fees and taxes for certain branded prescription drugs, provided incentives to programs that increase the federal government’s comparative effectiveness research, and provided for a Medicare Part D coverage gap discount program, in which manufacturers must now agree to offer 50%70% point-of-sale discounts off negotiated prices of applicable branded drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D.
There has been heightened governmental scrutiny recently over pharmaceutical pricing practices in light of the rising cost of prescription drugs and biologics. Such scrutiny has resulted in several recent Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. At the federal level, the Trump Administration’s budget proposal for fiscal
We expect that the PPACA, as currently enacted or as it may be amended in the future, and other healthcare reform measures that may be adopted in the future, could have a material adverse effect on our industry generally and on our ability to maintain or increase sales of any of our product candidates that we successfully commercialize. There have also been proposals to impose federal rebates on Medicare Part D drugs, requiring federally-mandated rebates on all drugs dispensed to Medicare Part D enrollees or on only those drugs dispensed to certain groups of lower income beneficiaries. If any of these proposals are adopted, they could result in us owing additional rebates, which could have a negative impact on revenues from sales of any of our product candidates that we successfully commercialize. Further, it is possible that additional government action is taken in response to the COVID-19 pandemic.
Our ability to commercialize our product candidates successfully, and to attract commercialization partners for our products, will depend in significant part on the availability of adequate financial coverage and reimbursement from third-party payers, including, in the U.S., governmental payers such as the Medicare and Medicaid programs, managed care organizations, and private health insurers. We intend to participate in and then will have certain price reporting and other obligations to the Medicaid Drug Rebate program and other governmental pricing programs. These obligations are discussed in greater detail under the heading “If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs that we may join if we successfully commercialize any of our product candidates,in the United States, we could be subject to additional reimbursement requirements, penalties,fines, sanctions and fines,exposure under other laws which could have a material adverse effect on our business, financial condition, results of operations and growth prospects”financial condition” in Part 1, Item 1A. Risk Factors, of this Annual Report on Form 10-K. Political, economic, and regulatory influences are subjecting the healthcare industry in the U.S. to fundamental changes. There have been, and we expect there will continue to be, legislative and regulatory proposals to change the healthcare system in ways that could
impact our ability to sell any of our product candidates that we successfully commercialize profitably. We expect to experience pricing pressure in the U.S. in connection with the sale of our products due to managed healthcare, the increasing influence of health maintenance organizations, additional legislative proposals to curb healthcare costs, and negative publicity regarding pricing and price increases generally, which could limit the prices that we charge for any of our product candidates that we successfully commercialize, limit our commercial opportunity, and/or negatively impact revenues from sales of our products. We anticipate that the U.S.
Congress, state legislatures, and the private sector will continue to consider and may adopt healthcare policies intended to curb rising healthcare costs, particularly given the current atmosphere of mounting criticism of prescription costs in the U.S. These cost containment measures include controls on government-funded reimbursement for drugs; new or increased requirements to pay prescription drug rebates to government health care programs; pharmaceutical cost transparency bills that aim to require drug companies to justify their prices; controls on healthcare providers; challenges to the pricing of drugs or limits or prohibitions on reimbursement for specific products through other means; requirements to try less expensive products or generics before a more expensive branded product; changes in drug importation laws; expansion of use of managed care systems in which healthcare providers contract to provide comprehensive healthcare for a fixed cost per person; and public funding for cost effectiveness research, which may be used by government and private third-party payers to make coverage and payment decisions. For example, much attention has been paid to legislation proposing federal rebates on Medicare Part D and Medicare Advantage utilization for drugs issued to certain groups of lower income beneficiaries and the desire to change the provisions that treat these dual-eligible patients differently from traditional Medicare patients. Any such changes could have a negative impact on revenues from sales of any of our product candidates that we successfully commercialize.
Coverage, reimbursement, and formulary placement decisions are being negotiated on a plan by plan basis for GOCOVRI for the treatment of dyskinesia in Parkinson’s disease.disease and, as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes. Coverage, reimbursements, and placement decisions for products are based on many factors including the coverage, reimbursement, and placement of already marketed branded drugs for the same or similar indications, the safety and efficacy of the product, availability of generics for similar indications, and the clinical need for the product. Within the Medicare program, as self-administered drugs, GOCOVRI would be reimbursed under the expanded prescription drug benefit, known as Medicare Part D. This program is a voluntary Medicare benefit administered by private plans that operate under contracts with the federal government. These Part D plans negotiate discounts with drug manufacturers, which are passed on to each of the plan’s enrollees. Historically, Part D beneficiaries have been exposed to significant out-of-pocket costs after they surpass an annual coverage limit and until they reach a catastrophic coverage threshold. However, changes made by recent legislation will reduce this patient coverage gap, known as the “donut hole”, by transitioning patient responsibility in that coverage range from 100% in 2010 to only 25% in 2019.currently. To help achieve this reduction, since 2011, pharmaceutical manufacturers are required to pay quarterly discounts of 50% off the negotiated price of branded drugs issued to Medicare Part D patients in the donut hole, and such quarterly discounts have increased to 70% on January 1, 2019. In 2020, drug manufacturers have been responsible for a larger share of total drug costs due to an increase to the catastrophic coverage threshold. Such increase will also result in a higher out-of-pocket costs paid by Part D beneficiaries.
If a drug product is reimbursed by Medicare or Medicaid, pricing and rebate programs must comply with the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, as applicable, as well as with the Medicaid rebate requirements of the Omnibus Budget Reconciliation Act of 1990, or the OBRA, and the Veterans Health Care Act of 1992, or the VHCA, each as amended. Among other things, the OBRA requires drug manufacturers to pay rebates on prescription drugs to state Medicaid programs and empowers states to negotiate rebates on pharmaceutical prices, which may result in prices for our future products that will likely be lower than the prices we might otherwise obtain. If products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements apply.
Third-party payers decide which drugs they will pay for and establish reimbursement and co-pay levels. Third-party payers are increasingly challenging the prices charged for medical products and services and examining their cost effectiveness, in addition to their safety and efficacy. Even with studies, any of our product candidates that we successfully commercialize may be considered less safe, less effective, or less cost-effective than other products, and third-party payers may not provide coverage and reimbursement for any of our product candidates that we commercialize, in whole or in part. The process for determining whether a payer will provide coverage for a product may be separate from the process for setting the price or reimbursement rate that the payer will pay for the product once coverage is approved. Third-party payers may limit coverage to specific products on an approved list, or formulary, which might not include all of the approved products for a particular indication. For example, third-party payers have started to require discounts and/or exclusivity arrangements with some drug manufacturers in exchange for including a
specific product on their formularies. Any such requirements could have a negative impact on revenues from sales of our products.
Payers also are increasingly considering new metrics as the basis for reimbursement rates, such as average sales price, average manufacturer price, and actual acquisition cost. Payers may also impose price protection or inflation protection in their contracts with manufacturers to limit the manufacturer’s ability to increase prices. The existing data for reimbursement based on these metrics is relatively limited, although certain states have begun to survey acquisition cost data for the purpose of setting Medicaid reimbursement rates. Both Medicare and Medicaid are administered by CMS. CMS surveys and publishes retail community pharmacy acquisition cost information in the form of National Average Drug Acquisition Cost files to provide state Medicaid agencies with a basis of comparison for their own reimbursement and pricing methodologies and rates. It is difficult to project the impact of these evolving reimbursement mechanics on the willingness of payers to cover our products.
The Foreign Corrupt Practices Act (“FCPA”) prohibits any U.S. individual or business from paying, offering, or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party, or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to comply with accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations.
We make available, free of charge on our corporate website, copies of our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, Proxy Statements, and all amendments to these reports, as soon as reasonably practicable after such material is electronically filed with or furnished to the Securities and Exchange Commission pursuant to Section 13(a) or 15(d) of the Securities Exchange Act. We also show detail about stock trading by corporate insiders by providing access to SEC Forms 3, 4 and 5. Our common stock is traded on the Nasdaq Stock Market under the symbol “ADMS”.
Item 1A. Risk Factors
We have identified the following risks and uncertainties that may have a material adverse effect on our business, financial condition, results of operations, and future growth prospects. Our business could be harmed by any of these risks. The risks and uncertainties described below are not the only ones we face. The trading price of our common stock could decline due to any of these risks, and you may lose all or part of your investment.In assessing these risks, you should also refer to the other information contained in this Annual Report on Form 10-K, including our consolidated financial statements and related notes.
Risks related to the COVID-19 pandemic
The outbreak of the novel Coronavirus (“COVID-19”) has negatively impacted our business, including the commercialization strategy and sales of GOCOVRI® (amantadine) extended release capsules.
The outbreak of the novel Coronavirus (“COVID-19”), which is understood to have begun in December 2019, continues to grow both within the U.S. and globally. The World Health Organization has declared the outbreak of COVID-19 to be a pandemic, and the U.S. federal government has declared it a national emergency. Efforts to contain the spread of COVID-19 have intensified and the U.S. has implemented severe travel restrictions, enforced social distancing, shelter-in-place orders and delays or cancellations of physician visits. These circumstances have negatively impacted our business and the commercialization strategy of GOCOVRI, including a fluid environment in which office practices are changing frequently including healthcare providers temporarily closing their offices or restricting patient visits, patients postponing visits to healthcare provider facilities, and depending on the local environment, limiting the ability of our sales force to travel and meet with healthcare providers and resulting in sales and marketing being conducted in a mix of virtual and live interactions. In particular, we have observed an impact in our new prescription rate, which we attribute to the effects of the restrictive actions taken.
We have implemented a work-from-home policy for all our employees, including allowing for flexible work schedules. The effects of our work-from-home policy may negatively impact productivity and disrupt our business.
These disruptions in our operations have negatively impacted, and we expect will continue to negatively impact, our business, operating results and financial condition. The COVID-19 pandemic continues to rapidly evolve. The ultimate cumulative impact of the COVID-19 pandemic on our business operations, the duration and severity of which will depend on future developments, is highly uncertain and cannot be predicted with confidence. We will continue to monitor the situation closely. The COVID-19 pandemic may also exacerbate a number of the risks discussed below.
Risks related to the commercialization of GOCOVRITM® (amantadine) extended release capsules (formerly ADS-5102)
Our success depends heavily on the success of GOCOVRI for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.medications, and as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes. To the extent GOCOVRI is not commercially successful, our business, financial condition and results of operations will be materially harmed.
We have invested and continue to invest a significant portion of our efforts and financial resources in the development, approval and commercialization of GOCOVRI for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.medications, and as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes. The success of GOCOVRI will depend on numerous factors, including:
•GOCOVRI’s efficacy and safety profile;
•our success in the marketing, sales, and distribution of GOCOVRI;GOCOVRI, especially in light of the COVID-19 pandemic;
successfully establishing•the duration of the COVID-19 pandemic, the stay-at-home restrictions and maintaining commercial manufacturingaccess of our staff to clinics to be able to interact with third parties;healthcare providers;
•acceptance of GOCOVRI by physicians, hospital administrators, patients, third-party payers, and others in the healthcare community;
•coverage and adequate reimbursement of GOCOVRI by third-party payers;
•willingness and ability of patients to pay out of pocket for GOCOVRI;
•successfully establishing and maintaining commercial manufacturing with third parties;
•effectively competing with other approved or used medicines and future compounds in development;
•continued demonstration of an acceptable safety profile of GOCOVRI following approval;GOCOVRI; and
•obtaining, maintaining, enforcing, and defending intellectual property rights and claims.
If we doare not achievesuccessful in addressing these issues, or one or more of these factors in a timely manner or at all,negatively affect us, we could experience significant delays or an inability to further commercialize GOCOVRI, which would materially harm our business.
GOCOVRI may fail to achieve the degree of market acceptance by physicians, patients, healthcare payers, and others in the medical community we are targeting, which would negatively impact our business.
GOCOVRI may fail to gain sufficient market acceptance by physicians, hospital administrators, patients, third-party payers, and others in the healthcare community. The degree of market acceptance of GOCOVRI will depend on a number of factors, including:
its efficacy, duration of response, and potential advantages compared to alternative treatments;
the prevalence and severity of any side effects;
the acceptability of the price of GOCOVRI relative to other treatments;
the willingness of physicians to change their current treatment practices;
its convenience and ease of administration compared to alternative treatments;
the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
the effectiveness of our marketing, promotion, selling, and distribution support; and
the availability of third-party payer coverage and adequate reimbursement.
The failure of GOCOVRI to achieve market acceptance would negatively impact our business.
If we are unable to recruit and retain experienced commercialqualified personnel and third-party distributors, our business will be substantially harmed.
Competition for biotechnology and pharmaceutical employees, sales personnel and other key personnel is intense. We have limitedexperienced and may in the future experience difficulty attracting and retaining qualified candidates to fill open positions and may be required to expend significant financial resources in marketing, sellingour employee recruitment and distributing pharmaceutical products. With respect to GOCOVRI in particular, it is the first and only drug approved by the U.S. Food and Drug Administration, or FDA, for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications and we have only been marketing and distributing it for just over a year. Therefore, none of the members of our commercial team, including our sales force, has ever promoted GOCOVRI prior to its launch in January 2018, and we are continuing to refine our promotional capabilities as well as our distribution and reimbursement capabilities, all of which are necessary to successfully commercialize GOCOVRI. In addition, weretention efforts. We are required to expend significant time and resources to market, sell, and distribute GOCOVRI to neurologists and movement disorder specialists in a credible, persuasive, and compliant manner consistent with applicable laws. Our business could be harmed if we are unable to recruit, employ, appropriately train, and retain experienced sales professionals to successfully execute our commercialization strategies and tactics, including educating potential customers about the benefits and risks of GOCOVRI and its proper administration.
Moreover, there is no guarantee that the strategies, tactics and marketing messages, or the distribution and reimbursement capabilities that we have established will be successful. Specifically, for distribution of GOCOVRI, we are heavily dependent on third-party logistics, pharmacy and distribution partners. If they are unable to perform effectively, including due to the impact of the COVID-19 pandemic on their operations, or if they do not provide efficient distribution of the medicine to patients, our business will suffer.
Failure to successfully obtain coverage and reimbursement for GOCOVRI in the United States, or the availability of coverage and reimbursement only at limited levels, would diminish our ability to generate product revenue.
Our ability to commercialize GOCOVRI successfully in the United States will depend in part on the extent to which we obtain and maintain coverage and reimbursement for GOCOVRI becomes available from third-party payers, including government health administration authorities, such as those that administer the Medicare and Medicaid programs, and private health insurers. Patients who are prescribed medicine for the treatment of their conditions generally rely on third-party payers to reimburse all or part of the costs associated with their prescription drugs. Coverage and reimbursement discussions are currently ongoing with payers. Coverage and adequate reimbursement from both governmental healthcare programs, such as Medicare and Medicaid, and commercial payers are critical to GOCOVRI’s commercial success.success since they ensure patients have affordable access to the drug. Coverage and reimbursement decisions may depend upon clinical and economic standards that disfavor newer drug products when more established or cheaper therapeutic alternatives are already available or subsequently become available. For example, even though other versions of amantadine are not approved for dyskinesia, some payers have asked physicians if patients have had prior experience with such versions or required that physicians actually prescribe such versions prior to providing reimbursement foraccess to GOCOVRI.
Coverage For some patients, coverage and reimbursement may not be available for GOCOVRI. GOCOVRI, or the patient’s out of pocket cost may be unaffordable.
Even if we obtain coverage for GOCOVRI, the resulting reimbursement rateslevel of coverage might not be adequate or may require co-payments or co-insurance payments that patients find unacceptably high. Coverage and reimbursement determinations by third-party payers willcan impact the demand for GOCOVRI and therefore our revenues. Patients may choose not to use GOCOVRI if coverage is not provided or reimbursementthe payer’s determined out of pocket cost for the patient is inadequate to cover a significant portion of its cost.unaffordable for the patient. If coverage and reimbursement are not available or are available only to limited levels we may not be able to successfully commercialize GOCOVRI.
As with any approved medicine for a particular indication, there may be significant delays in obtaining final coverage and reimbursement decisions for GOCOVRI or changes in coverage and reimbursement decisions over time. Third-party payers are increasingly challengingmaking the price and reviewing the cost-effectiveness of medical drug products, in addition to questioning their safety and efficacy.
Net prices for products mayunaffordable to patients, our business could be reduced by mandatory discounts or rebates required by government healthcare programs, such as the federal 340B Drug Pricing Program, or by private third-party payers and could also be adversely affected by any future relaxation of laws that currently restrict imports of products from countries where they may be sold at lower prices than in the United States. In the United States, private third-party payers often rely upon Medicare coverage and reimbursement policies and payment limitations in setting their own coverage and reimbursement policies.harmed.
Our inability to promptly obtain and maintain coverage and adequate reimbursement rates from both government-funded and private third-party payers for GOCOVRI could have a material adverse effect on our operating results, and our overall financial condition.
We face substantial competition in the commercialization of GOCOVRI.
The commercialization of pharmaceutical products is highly competitive and we face substantial competition with respect to GOCOVRI. For example, although GOCOVRI is the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, and as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes, we face competition from various branded and generic drugs approved for the treatment of Parkinson’s disease that physicians either have historically used or may use in an attempt to manage dyskinesia. If approved, we will also face competition from investigational drugs in late stagelate-stage development for the treatment of Parkinson’s disease, and may also face competition from drugs currently in development for dyskinesia in Parkinson’s disease or for Parkinson’s disease from a number of pharmaceutical companies.
Many of our competitors, including a number of large pharmaceutical companies that compete directly with us, have significantly greater financial resources commercializing approved products than we do. Also, many of our competitors are large pharmaceutical companies that will have a greater ability to reduce prices for their competing drugs in an effort to gain market share and undermine the value proposition that we might otherwise be able to offer to payers.
If manufacturers obtain approval for generic versions of GOCOVRI, or of products with which we compete, our business may suffer.
Under the U.S. Food, Drug and Cosmetic Act, or FDCA, the FDA can approve an Abbreviated New Drug Application, or ANDA, for a generic version of a branded drug without the ANDA applicant undertaking the clinical testing necessary to obtain approval to market a new drug. Generally, in place of such clinical studies, an ANDA applicant usually needs only to submit data demonstrating that its product has the same active ingredient(s), strength, dosage form, route of administration and that it is bioequivalent to the branded product. We have received a notice of an ANDA submitted to the FDA requesting permission to manufacture and market a generic version of GOCOVRI, and we are currently in litigation with that ANDA filer.
The FDCA requires that an applicant for approval of a generic form of a branded drug certify either that its generic product does not infringe any of the patents listed by the owner of the branded drug in the Orange Book or that those patents are not enforceable. This process is known as a paragraph IV challenge. Upon notice of a paragraph IV challenge, a patent owner has 45 days to bring a patent infringement suit in federal district court against the company seeking ANDA approval of a product covered by one of the owner’s patents. If this type of suit is commenced, the FDCA provides a 30-month stay on the FDA’s approval of the competitor’s application. If the litigation is resolved in favor of the ANDA applicant or the challenged patent expires during the 30-month stay period, the stay is lifted and the FDA may thereafter approve the application based on the standards for approval of ANDAs. Once an ANDA is approved by the FDA, the generic manufacturer may market and sell the generic form of the branded drug in competition with the branded medicine.
The ANDA process can result in generic competition if the patents at issue are not upheld or if the generic competitor is found not to infringe the owner’s patents. If this were to occur with respect to GOCOVRI or products with which it competes, our business would be materially harmed. Furthermore, even if ultimately successful, ANDA litigation can take several years and is generally time-consuming and costly. Such litigation has been commenced by us to enforce certain patents related to GOCOVRI. See Litigation and Other Legal Proceedings in “Note 8 - Commitments and Contingencies” in the accompanying “Notes to Consolidated Financial Statements” in this Annual Report for more information.
Unforeseen safety issues could emerge with GOCOVRI that could require us to change the prescribing information to add warnings, limit use of the product, and/or result in litigation. Any of these events could have a negative impact on our business.
Discovery of unforeseen safety problems or increased focus on a known problem could impact our ability to commercialize GOCOVRI and could result in restrictions on its permissible uses, including withdrawal of the medicine from the market.
If we or others identify additional undesirable side effects caused by GOCOVRI after approval:
•regulatory authorities may require the addition of labeling statements, specific warnings, contraindications, or field alerts to physicians and pharmacies;
•regulatory authorities may withdraw their approval of the product and require us to take our approved drugs off the market;
•we may be required to change the way the product is administered, conduct additional clinical trials, change the labeling of the product, or implement a Risk Evaluation and Mitigation Strategy, or REMS;
•we may have limitations on how we promote our drugs;
•third-party payers may limit coverage or reimbursement for GOCOVRI;
•sales of GOCOVRI may decrease significantly;
•we may be subject to litigation or product liability claims; and
•our reputation may suffer.
Any of these events could prevent us from achieving or maintaining market acceptance of GOCOVRI and could substantially increase our commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenue from its sale.
Further, GOCOVRI may also be affected by the safety and tolerability of its parent drug or drugs with similar mechanisms of action. Although amantadine, which is a component of GOCOVRI, has been used in patients for many years, newly observed toxicitiesproblems identified with other approved amantadine products or worsening of known toxicities in preclinical studies or in subjectsamantadine products being studied in clinical studies receiving amantadine, or reconsideration of known toxicities of compounds in the setting of new indications,trials could result in increased regulatory scrutiny of our products and product candidates.
In addition, problems with approved products marketed by third parties that utilize the same therapeutic target and/or that belong to the same therapeutic class as amantadine could adversely affect the commercialization of GOCOVRI.
If a safety issue emerges post-approval, we may become subject to costly product liability litigation by our customers, their patients or payers. Product liability claims could divert management’s attention from our core business, be expensive to defend, and result in sizable damage awards against us that may not be covered by insurance. If we cannot successfully defend ourselves against claims that GOCOVRI caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:
decreased demand for any product candidates or products that we may develop;
the inability to commercialize any products that we may develop;
injury to our reputation and significant negative media attention;
withdrawal of patients from clinical studies or cancellation of studies;
significant costs to defend the related litigation;
substantial monetary awards to patients; and
loss of revenue.
We currently hold $15.0 million in product liability insurance coverage, which may not be adequate to cover all liabilities that we may incur. Insurance coverage is increasingly expensive. We may not be able to obtain insurance coverage at a reasonable cost or in amounts adequate to satisfy any liability or associated costs that may arise in the future. These events could harm our business and results of operations and cause our stock price to decline.
The marketing and promotionIf manufacturers obtain approval for generic versions of GOCOVRI, must be limitedor of products with which we compete, our business may suffer.
Under the U.S. Food, Drug and Cosmetic Act, or FDCA, the FDA can approve an Abbreviated New Drug Application, or ANDA, for a generic version of a branded drug without the ANDA applicant undertaking the clinical testing necessary to obtain approval to market a new drug. Generally, in place of such clinical studies, an ANDA applicant usually needs only to submit data demonstrating that its product has the same active ingredient(s), strength, dosage form, route of administration and that it is bioequivalent to the approved indicationbranded product. We have recently settled an ANDA litigation with a generic filer. See Litigation and Other Legal Proceedings in “Note 9 - Commitments and Contingencies” in the accompanying “Notes to Consolidated Financial Statements” in this Annual Report for usemore information. However, other filers could submit an ANDA to the FDA requesting permission to manufacture and the information and clinical data included in or consistent with the approved prescribing information. If we want to expand the marketing and promotionmarket another generic version of GOCOVRI, beyondwhich could result in our expending significant time and incurring significant expenses in challenging the approved indicationsubmissions.Further, if one or with information not consistent withmore of these filers is successful, the approved prescribing information, we will need to obtain additional regulatory approvals, which may not be granted.
With the August 2017 approvalintroduction of a generic version of GOCOVRI for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, we currently are permitted to market or promote it, consistent with the information and data in its approved prescribing information, only for the treatment of dyskinesia and not for other uses. We are developing GOCOVRI for at least one additional indication, treatment of walking impairment in patients with multiple sclerosis, and potentially others. To market and promote GOCOVRI for these additional indications, we will need to conduct additional clinical trials that will likely be time-consuming and expensive to obtain regulatory approval for such uses. Additionally,could harm our current marketing and promotional efforts will be limited to the use of information included in or deemed to be consistent with the approved prescribing information for GOCOVRI for the treatment of dyskinesia, including the clinical databusiness and results reflected in the prescribing information. To use information not consistent with the approved prescribing information will require additional regulatory approvals. of operations and cause our stock price to decline.
If we are found to have improperly promoted unapproved uses of GOCOVRI, or if physicians misuse it, we may be subject to restrictions on the sale or marketing of GOCOVRI and significant fines, penalties, sanctions and product liability claims, and our image and reputation within the industry and marketplace could be harmed.
The FDA and other regulatory agencies, including regulatory authorities outside the United States, strictly regulate the marketing and promotional claims that are made about drug products, such as GOCOVRI. In particular, promotion of a product must be consistent with its labeling approved by the FDA or by regulatory agencies in other countries. For example, in the case of GOCOVRI, for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, and as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes, we cannot prevent physicians from prescribing GOCOVRI for indications or uses that are inconsistent with the approved label.label based on the physician’s professional medical judgment. If, however, we are found to have promoted such unapproved uses prior to the FDA’s approval for an additional indication, we may, among other consequences, receive untitled or warning letters and become subject to significant liability, which would materially harm our business. Both the U.S. federal government and foreign regulatory authorities have levied significant civil and criminal fines against companies and individuals for alleged improper promotion and have entered into settlement agreements with pharmaceutical companies to limit inappropriate promotional activities. If we become the target of such an investigation or prosecution based on our marketing and promotional practices, we could face similar sanctions, which would materially harm our business. In addition, management’s attention could be diverted from our business operations, significant legal expenses could be incurred, and our reputation could be damaged.
Physicians prescribing of our products for unapproved uses may also subject us to product liability claims, to the extent such uses lead to adverse events, side effects, or injury. Product liability claims could divert management’s attention from our core business, be expensive to defend, and result in sizable damage awards against us that may not be covered by insurance. Furthermore, the use of our products for indications other than those approved by the FDA or regulatory authorities outside the United States may not effectively treat such conditions, which could harm our reputation in the marketplace among physicians and patients. Any of these events could harm our business and results of operations and cause our stock price to decline.
If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs in the United States, we could be subject to additional reimbursement requirements, fines, sanctions and exposure under other laws which could have a material adverse effect on our business, results of operations and financial condition.
We participate in the Medicaid Drug Rebate Program, as administered by the Centers for Medicare and Medicaid Services, or CMS, and other federal and state government pricing programs in the United States, and we may participate in additional government pricing programs in the future. These programs generally require us to pay rebates or otherwise provide discounts to government payers in connection with drugs that are dispensed to beneficiaries/recipients of these programs. In some cases, such as with the Medicaid Drug Rebate Program, the rebates are based on pricing that we report on a monthly and quarterly basis to the government agencies that administer the programs. Pricing requirements and rebate/discount calculations are complex, vary among products and programs, and are often subject to interpretation by governmental or regulatory agencies and the courts. The requirements of these programs, including, by way of example, their respective terms and scope, change frequently. Responding to current and future changes may increase our costs, and the complexity of compliance will be time consuming. Invoicing for rebates is provided in arrears, and there is frequently a time lag of up to several months between the sales to which rebate notices relate and our receipt of those notices, which further complicates our ability to accurately estimate and accrue for rebates related to the Medicaid program as implemented by individual states. Thus, there can be no assurance that we will be able to identify all factors that may cause our discount and rebate payment obligations to vary from period to period, and our actual results may differ significantly from our estimated allowances for discounts and rebates. Changes in estimates and assumptions may have a material adverse effect on our business, results of operations and financial condition.
In addition, the Office of Inspector General of the Department of Health and Human Services and other Congressional enforcement and administrative bodies have increased their focus on pricing requirements for products, including, but not limited to the methodologies used by manufacturers to calculate average manufacturer price, or AMP, and best price, or BP, for compliance with reporting requirements under the Medicaid Drug Rebate Program. We are liable for errors associated with our submission of pricing data and for any overcharging of government payers. For example, failure to submit monthly/quarterly AMP and BP data on a timely basis could result in significant civil monetary penalties for each day the submission is late beyond the due date. Failure to make necessary disclosures and/or to identify overpayments could result in allegations against us under the Federal False Claims Act and other laws and regulations. Any required refunds to the U.S. government or responding to a government investigation or enforcement action would be expensive and time consuming and could have a material adverse effect on our business, results of operations and financial condition. In addition, in the event that CMS were to terminate our rebate agreement, no federal payments would be available under Medicaid or Medicare for our covered outpatient drugs.
GOCOVRI is complex to manufacture, and manufacturing disruptions may occur that could cause us to experience disruptions in the supply of GOCOVRI.
GOCOVRI is a high-dose, extended release amantadine, specifically designed to be taken once-daily at bedtime that deliversto provide an initial lag, then a slow rise in amantadine concentration during the night, and high levels of amantadine in the morning upon waking andthat gradually fall throughout the day.day into the evening. The manufacture of extended release versions of drugs is more complex than the manufacture of the immediate release versions of drugs. Notwithstanding the fact that we have validated our process, manufacturing disruptions may occur.occur, including disruptions related to the impact or
uncertainties of the duration of the COVID-19 pandemic. Such problems may prevent the production of lots that meet the specifications required for sale of the product and may be difficult and expensive to resolve. Although we have an adequate supply of GOCOVRI to address patient needs into mid-2022 and have not observed disruptions in our supply chain to date as a result of COVID-19, there is no guarantee that we will not experience interruption of, or delays in receiving, supply due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems in the future. If any such issues were to arise with respect to GOCOVRI, our business, financial results, or stock price could be adversely affected.
If we are unable to maintain orphan exclusivity for GOCOVRI for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, our business may be substantially harmed.
Under the Orphan Drug Act, the FDA may designate a drug product as an orphan drug if it is a drug or biologic intended to treat a rare disease or condition. Generally, if a drug product with an orphan drug designation receives the first marketing approval for the indication for which it has such designation, the drug product is entitled to a period of marketing exclusivity, which may preclude the FDA from approving another marketing application for the same drug product for the same therapeutic indication. The applicable period of exclusivity is seven years in the United States.When GOCOVRI received orphan designation for the treatment of levodopa-induced dyskinesia in 2015. When it was
approved for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, GOCOVRI earned seven years of orphan drug exclusivity.
Although we have obtained marketing approvalexclusivity under the Orphan Drug Act for GOCOVRI for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy,this use. Even so, the FDA could still subsequently approve the same drug with the same active moiety for the same conditionindication if the FDA concludes that the later drug is safer or more effective or makes a major contribution to patient care, or if we are unable to assure that sufficient quantities of medicine are available to meet patient needs. If we are unable to maintain orphan drug exclusivity for GOCOVRI for the treatment of dyskinesia, our business wouldmay be substantially harmed.
Risks related to the commercialization of GOCOVRI will be substantially the same for OSMOLEX ER® (amantadine) extended release tablets. We rely on a single supplier of OSMOLEX ER, and if that supplier is unable to supply OSMOLEX ER, or is unable to supply OSMOLEX ER in sufficient quantities, we may not be able to meet demand for OSMOLEX ER which could impair our investment in OSMOLEX ER.
We obtained the global rights to sell OSMOLEX ER on January 4, 2021, and began selling product through select specialty pharmacies and distributors. We have entered into a supply agreement with Osmotica Pharmaceutical US LLC (“Osmotica”), a subsidiary of Osmotica Pharmaceuticals plc, in which Osmotica will be the sole manufacturer of OSMOLEX ER. If Osmotica is unable to supply sufficient quantities of OSMOLEX ER to meet market demand, we may be unable to realize on our investment in OSMOLEX ER, which could have an adverse effect on our financial results and condition.
We have just begun to market OSMOLEX ER, and are subject to the same commercialization and regulatory risks regarding OSMOLEX ER as we have with respect to the commercialization and regulatory compliance for GOCOVRI.
We have just begun to market OSMOLEX ER, and we are subject to the same commercialization and post-approval regulatory risks with respect to OSMOLEX ER as we have with respect to the commercialization and regulatory compliance for GOCOVRI. Further, although our commercial team has experience with the marketing and sale of GOCOVRI, it has only begun to market and sell OSMOLEX ER, and we may encounter unexpected difficulties in marketing and selling OSMOLEX ER.
Risks related to ourclinical development of potential future product candidates in clinical development
Our success depends on the timely clinical development, approval and successful commercialization of our product candidates. If we are unableresume development of ADS-4101, or seek to do any of these with ourdevelop additional product candidates that we may develop or ifacquire, we experience significant delays in doing so, our business will be materially harmed.face regulatory and development risks.
WeAlthough we have invested a significant portion of our efforts and financial resources intoplaced the development and potential commercialization of our product candidates, including ADS-5102program for the treatment of walking impairment in patients with multiple sclerosis, and potentially other indications, as well as ADS-4101 (lacosamide) modified release capsules for the treatment of partial onset seizures in epilepsy. Our abilitypatients with epilepsy on hold, if we determine to generate product revenue will depend heavily on the successfulresume development regulatory approval, and commercialization of our product candidates. The success of ourADS-4101, or develop or acquire other potential product candidates will depend on numerous factors, including:
successfully completing the development program for our product candidates in a timely manner;
receiving marketing approval for our product candidates from the FDA in a timely manner;
successfully establishing and maintaining commercial manufacturing with third parties;
commercializing our product candidates, if approved, including marketing, sales, and distribution of the product independently or in partnership with another company;
acceptance by the medical community and patients of the approved product;
coverage and adequate reimbursement of our product candidates by third-party payers;
willingness and ability of patientsseek to pay out of pocket for our product candidates;
effectively competing with other approved or used medicines and future compounds in development;
continued demonstration of an acceptable safety profile of the approved products following approval; and
obtaining, maintaining, enforcing, and defending intellectual property rights and claims.
Ifdevelop them, we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize our product candidates, which would materially harm our business.
We will face risks in the development of ADS-5102 (GOCOVRI) for additional indications, ADS-4101regulatory and other product candidates.
development risks. There are risks associated with pursuing clinical trials in other indications for ADS-5102 (GOCOVRI), ADS-4101 and otherpotential future product candidates, as we may experience numerous unforeseen events during, or as a result, of clinical studies that could harm our ability to commercialize such products and candidates or to receive regulatory approval, including that:
•clinical studies may produce negative or inconclusive results or raise significant safety concerns, and we may decide, or regulators may require us, to conduct additional clinical studies or abandon product development programs;
•even if clinical studies demonstrate statistically significant efficacy and acceptable safety, the FDA or similar authorities outside the United States may not consider the results of our studies to be sufficient for approval;approval or we may not receive approval in a timely manner, especially in light of the COVID-19 pandemic;
•our clinical sites and clinical investigators may fail to comply with, or inconsistently apply, the trial protocols, regulatory requirements including Good Clinical Practices, contractual obligations, and the rating assessments;
•our third-party vendors, including our Contract Research Organizations, or CROs, and contract manufacturing organizations, or CMOs, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;
•we might have to suspend or terminate clinical studies for various reasons, including a finding that our product candidatesproducts have unanticipated serious side effects or other unexpected characteristics or that the patients are being exposed to unacceptable health risks;
•regulators or institutional review boards may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements;
•the supply or quality of ADS-5102, ADS-4101, or other materials necessary to conduct clinical studies may be insufficient or inadequate; andinadequate, especially in light of the COVID-19 pandemic;
•our new product discovery or research program may not be successful or warrant clinical development.development;
With respect•we may be unable to successfully complete the development program in a timely manner, especially in light of additional indicationsthe COVID-19 pandemic;
•we may be unsuccessful commercializing our products, if approved, including marketing, sales, and distribution of the product independently or in partnership with another company;
•we may fail to gain acceptance by the medical community and patients of the approved product;
•we may be unable to obtain coverage and adequate reimbursement by third-party payers;
•patients may be unwilling or unable to pay out of pocket for GOCOVRI, although the products;
•we may be unable to effectively compete with other approved or used medicines and future compounds in development;
•we may be unable to continue demonstration of an acceptable safety profile of amantadine, the active pharmaceutical ingredient in GOCOVRI, is already characterized in the approved label for amantadine (i.e., Symmetrel®)following approval; and in the GOCOVRI clinical trial data in the dyskinesia population, there can
•we may be no assurance that our clinical development program for ADS-5102 (GOCOVRI) for multiple sclerosis walking impairment or future studies in other indications will not reveal additional safety or tolerability issues that could leadunable to changes in the GOCOVRI prescribing information. In such an event, our ability to commercialize GOCOVRI for dyskinesia and/or expand our business could be compromised.obtain, maintain, enforce, and defend intellectual property rights and claims.
If we are forced to delay or abandon development of our product candidates,products, especially in light of the COVID-19 pandemic, our business, results of operations, and financial condition will be materially and adversely harmed.
We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidatesproducts or indications that may be more profitable or for which there is a greater likelihood of success.
Because we have limited financial and managerial resources, we have chosenmay choose to focus on research programs and product candidatesproducts for specific indications. As a result, we may forego or delay pursuit of opportunities with our product candidatescandidate or other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our investment in current and future research and development programs and product candidates for specific indications may not yield any commercially viable products for us or future partners. For example, we discontinued the development of ADS-5102 for the treatment of walking impairment in patients with multiple sclerosis in June 2020 following a comprehensive evaluation of the INROADS Phase 3 data, including evaluating the ongoing, open label extension study, and engaging with the FDA, the revised product profile and potential path to submission.
If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing, or other royalty arrangements in cases in which it would have been advantageous for us to retain sole development and commercialization rights.
FailureWe may in the future seek to gain approval of or successfully commercializeacquire additional product candidates, which may subject us to additional risks and expense.
In the future, in seeking to diversify our product candidates in the United States could substantially harm our business.
Ourcandidate portfolio we may seek to identify and acquire or in-license novel product candidates. We may fail to identify and acquire or in-license product candidates, will face including for reasons discussed in these risk factors, and also:
•the same or similar challenges in obtaining FDA approvalprocess by which we identify and in commercialization as GOCOVRI, as outlined above, including but not limited to market acceptance by physicians and patients and coverage and reimbursement by third party payers.
Failure to obtain regulatory approvals in foreign jurisdictions would prevent us from marketing our products internationally.
We may decide to seek marketing authorizations on our own or with a partner to commercialize GOCOVRI, ADS-4101, and other futureacquire product candidates outside of the United States. To market our future products in the European Union, or EU, and many other foreign jurisdictions, we must obtain separate regulatory approvals. Specifically, in the EU, medicinal products can only be commercialized after obtaining a Marketing Authorization, or MA.
Before granting an MA, the European Medicines Agency, or EMA, or the competent authorities of the member states of the EU make an assessment of the risk-benefit balance of the product on the basis of a Common Technical Document including, among other information, scientific criteria concerning its quality, safety, and efficacy.
Similar to the United States, both MA holders and manufacturers of medicinal products are subject to comprehensive regulatory oversight by the EMA and the competent authorities of the individual EU member states both before and after grant of the manufacturing and Marketing Authorizations. This includes control of compliance with current good manufacturing practices, or cGMP, rules, which govern quality control of the manufacturing process and require documentation policies and procedures. We and our third-party manufacturers are required to ensure that all of our processes, methods, and equipment are compliant with cGMP. Failure by us or by any of our third-party partners, including suppliers, manufacturers, and distributors, to comply with EU laws and the related national laws of individual EU member states governing the conduct of clinical trials, manufacturing approval, marketing authorization of medicinal products, both before and after grant of marketing authorization, and marketing of such products following grant of authorization may result in administrative, civil, or criminal penalties. These penalties could include delays in or refusal to authorize the conduct of clinical trials or to grant Marketing Authorization, product withdrawals and recalls, product seizures, suspension, or variation of the marketing authorization, total or partial suspension of production, distribution, manufacturing, or clinical trials, operating restrictions, injunctions, suspension of licenses, fines, and criminal penalties.
We have had limited interactions with foreign regulatory authorities. The approval procedures vary among countries and can involve additional clinical testing, and the time required to obtain approval may differ from and be longer than that required to obtain FDA approval. Clinical studies conducted in one country may not be accepted by regulatory authorities insuccessful;
•the competition to acquire or in-license promising product candidates is fierce and many of our competitors are large, multinational pharmaceutical, biotechnology and medical device companies with considerably more financial, development and commercialization resources and experience than we have;
•potential product candidates may, upon further study during or after the acquisition process, fail to demonstrate clinical efficacy, be shown to have harmful side effects or other countries. Approval by the FDA does not ensurecharacteristics that indicate that they are unlikely to be products that will receive marketing approval by regulatory authorities in other countries,or achieve market acceptance; and approval by one or more foreign regulatory authorities does not ensure approval by regulatory authorities in other foreign countries or by the FDA. However, a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in others. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval as well as additional, different risks.
There is no assurance that we will be able to obtain marketing authorizations in foreign countries on a timely basis, if at all. We•potential product candidates may not be able to file for foreign regulatory approvals, and eveneffective in treating their targeted diseases.
In addition, if we filedo acquire additional product candidates and they prove to be unsuccessful, we maywill have spent significant amounts of resources in acquiring and pursuing these product candidates and not receive necessary approvals to commercializeany return on our products in any market. If we are unable to obtain non-U.S. regulatory approval to market ourinvestments. Further, time and resources spent searching for, identifying, acquiring, and developing potential product candidates in other countries, we ormay distract management’s attention from our potential partners may not be able to achieve the financial results we project and our stock price could decline.existing business.
Risks related to our reliance on third parties
We rely on third-party contract manufacturing organizations to manufacture, serializesupply, and supply GOCOVRI and our product candidates.distribute GOCOVRI. If one of our suppliers or manufacturersthese organizations fails to perform adequately or fulfill our needs, we may be required to incur significant costs and devote significant efforts to find new suppliers third-party vendors and/or manufacturers and qualify them. We may also face delays in the development, commercialization and supply of GOCOVRI and our product candidates.GOCOVRI.
We currently have limited experience in, and we do not own facilities for clinical and commercial manufacturing of GOCOVRI or our product candidates, and we rely upon third-party contract manufacturing organizations to manufacture, serialize and supply drug product for our clinical studies and to meet commercial demand. The manufacture of pharmaceutical products in compliance with the FDA’s cGMP requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls.
Manufacturers of pharmaceutical products oftenIf our manufacturers were to encounter difficulties in production, including difficulties with production costs and yields, quality control, including stability of the product candidateGOCOVRI and quality assurance testing, shortages of qualified personnel, as well as complianceespecially in light of the COVID-19 pandemic, or fail to comply with strictly enforced cGMP requirements, other federal and state regulatory requirements, and foreign regulations. If our manufacturers were to encounter any of these difficulties or otherwise fail to comply with their obligations to us or under applicable regulations, our commercial supply of GOCOVRI or product candidates in our clinical trials could be jeopardized. We have little control over our manufacturers’ operations or their compliance with applicable regulations and standards. Any delay or interruption in the supply of clinical study materials or commercial product could cause delays in our clinical programs, harm our ability to gain approval from regulatory authorities, and potentially disrupt patient access to our approved products. These events would substantially harm our business, reputation and stock price.
We also rely on a single specialty pharmacy to distribute and provide access to GOCOVRI for the vast majority of our patients. Accordingly, this specialty pharmacy is our largest customer representing approximately 95% of our product revenue. If this specialty pharmacy fails to perform, it could materially harm our business.
All third-party manufacturers of our products product candidates and ingredients thereof must comply with cGMP requirements enforced by the FDA through its facilities inspection program. These requirements include, among other things, quality control, quality assurance, and the maintenance of records and documentation. Manufacturers of our products and product candidates may be unable to comply with these cGMP requirements and with other FDA, state and foreign regulatory requirements. The FDA or similar foreign regulatory agencies may also implement new standards at any time or change their interpretation and enforcement of existing standards for manufacture, packaging, or testing of products. We have little control over our manufacturers’ compliance with these regulations and standards. A failure to comply with these requirements may result in fines and civil penalties, suspension of production, suspension or delay in product approval, product seizure or recall, or withdrawal of product approval. If the safety of any product supplied is compromised due to our manufacturers’
failure to adhere to applicable laws or for other reasons, we may not be able to obtain regulatory approval for or successfully commercialize our products or product candidates and we may be held liable for any injuries sustained as a result. Any of these factors could cause a delay of clinical studies, regulatory submissions, approvals, commercialization or supply of our products, or product candidates, entail higher costs, impair our reputation, and potentially disrupt patient access or our approved products.
We rely on a single sourcesingle-source third-party contract manufacturing organization for the manufacture and supply ofour drug substancesproduct for GOCOVRI and our other product candidates.GOCOVRI.
Although weWe have supply agreements with two drug substance suppliers only one is currently manufacturing at commercial scales required for GOCOVRI. In addition,and we also currently rely on a single drug product manufacturer for GOCOVRI and our other product candidates.GOCOVRI. We continue to seek additional long-term supply agreements with suppliers and supplier qualifications. A failure of our single source manufacturer or drug substance suppliersuppliers or single-source drug product manufacturer for GOCOVRI, or our failure to qualify at least one other drug product manufacturer organization on a timely basis, especially in light of the current COVID-19 pandemic, and validate the manufacturing process employed at that manufacturer or supplier could delay or harm commercialization of GOCOVRI or our product candidates.GOCOVRI. Although we believe alternative sources of supply exist, the number of third-party suppliers with the necessary manufacturing and regulatory expertise and facilities is limited and it could be expensive and take a significant amount of time to arrange and negotiate acceptable long-term contracts and obtain regulatory approvals and qualifications, which would adversely affect our business. New suppliers of any product candidatedrug substance would be required to be qualified under applicable regulatory requirements including demonstration of bioequivalence of the product made at the new supplier, and would need to have sufficient rights under applicable intellectual property laws to the method of manufacturing the product candidate.product. Obtaining the necessary FDA approvals or other qualifications under applicable regulatory requirements and ensuring non-infringement of third-party intellectual property rights could result in a significant interruption of supply and could require the new manufacturer to bear significant additional costs, which may be passed on to us. Qualifying and negotiating long-term contracts with manufacturers and providers of packaging services is a lengthy process. If at any time, one or more of our qualified contract manufacturing organizations were not able to manufacture our drug substance or drug product or provide the requisite services, our business and financial condition would be materially adversely affected.
We rely on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of these trials.
We do not independently conduct clinical studies of our product candidates.products. Instead, we rely on third parties, such as CROs, clinical data management organizations, medical institutions, and clinical investigators to perform this function. Our reliance on these third parties for clinical development activities reduces our control over these activities, but does not relieve us of our responsibilities. For example, the FDA requires us to comply with standards, commonly referred to as Good Clinical Practice, for conducting, recording, and reporting the results of clinical studies to assure that
data and reported results are credible and accurate and that the rights, integrity, and confidentiality of patients in clinical studies are protected, even though we are not in control of these processes. These third parties may also have relationships with other entities, some of which may be our competitors. If these third parties do not successfully carry out their contractual duties, meet expected deadlines, or conduct our clinical studies in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, regulatory approvals for our product candidatesproducts and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates.products.
We also rely on other third parties to store and distribute supplies for our clinical studies. Any performance failure on the part of our existing or future distributors could delay clinical development or regulatory approval of our product candidatesproducts or commercialization of our products, producing additional losses and depriving us of potential product revenue.
In our existing or any future potential collaborations or partnerships, we will likely not be able to control all aspects of the development andcommercialization ofour products or product candidates. This lack ofcontrolcould subject us to additional risks that could harm our business.
Collaborations or license agreements involving our current or future products or product candidates are subject to numerous risks, which may include that:
partners have significant discretion in determining the efforts and resources that they will apply to collaborations;
partners may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical study results, changes in their strategic focus due to the acquisition of competitive products, availability of funding, or other external factors, such as a business combination that diverts resources or creates competing priorities;
partners may delay clinical studies, provide insufficient funding for a clinical study program, stop a clinical study, abandon a product candidate, repeat or conduct new clinical studies, or require a new formulation of a product candidate for clinical testing;
partners could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates;
a partner with marketing, manufacturing, and distribution rights to one or more products may not commit sufficient resources to or otherwise not perform satisfactorily in carrying out these activities;
we could grant exclusive rights to our partners that would prevent us from collaborating with others;
partners may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability;
partners may not aggressively or adequately pursue litigation against ANDA filers or may settle such litigation on unfavorable terms, as they may have different economic interests than ours, and such decisions could negatively impact any royalties we may receive under our license agreements;
disputes may arise between us and a partner that causes the delay or termination of the research, development, or commercialization of our current or future products or that results in costly litigation or arbitration that diverts management attention and resources;
agreements may be terminated, sometimes at-will, without penalty, and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable current or future products;
partners may own or co-own intellectual property covering our products that results from our collaborating with them, and in such cases, we would not have the exclusive right to commercialize such intellectual property; and
a partner’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings.
Risks related to government regulation
Changes in healthcare law and implementing regulations, including government restrictions on pricing and reimbursement, as well as healthcare policy and other healthcare payer cost-containment initiatives and current societal pressures regarding pharmaceutical product pricing, may negatively impact our ability to generate revenues from or could limit or prevent our product candidates’products’ commercial success.
In the United States, there have been and we expect there will continue to be a number of legislative and regulatory changes to the healthcare system that could affect our future revenue and profitability and the future revenue and profitability of our potential customers. Federal and state lawmakers regularly propose and, at times, enact
legislation that would result in significant changes to the healthcare system, some of which are intended to contain or reduce the costs of medical products and services. For example, in March 2010, the Patient Protection and Affordable Care Act (“PPACA”) was passed, which has substantially changed how healthcare is financed by both governmental and private insurers, and has significantly impacted the U.S. pharmaceutical industry. Details of healthcare regulations, including changes under the PPACA, are discussed in the business heading “Other healthcare regulations” in Part I, Item 1, of this Annual Report on Form 10-K.
Some of the provisionsThe constitutionality of the PPACA have yet to be fully implemented, and there have been legal and political challenges to certain aspects of the PPACA. Since January 2017, President Trump has signed two executive orders and other directives designed to delay, circumvent, or loosen certain requirements mandatedis currently under review by the PPACA. Concurrently, Congress has considered legislation that would repeal or repealU.S. Supreme Court, and replace all or part of the PPACA. While Congress has not passed repeal legislation, two bills affecting the implementation of certain taxes under the PPACA have been signed into law. The Tax Cuts and Jobs Act of 2017 includes a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the PPACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate”. Additionally, on January 23, 2018, President Trump signed a continuing resolution on appropriations for fiscal year 2018 that delayed the implementation of certain PPACA-mandated fees, including the so-called “Cadillac” tax on certain high cost employer-sponsored insurance plans, the annual fee imposed on certain health insurance providers based on market share, and the medical device excise tax on non-exempt medical devices. Further, the Bipartisan Budget Act of 2018, or the BBA, among other things, amends the PPACA, effective January 1, 2019, to increase the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part D and to close the coverage gap in most Medicare drug plans. Moreover, in July 2018, CMS published a final rule permitting further collections and payments to and from certain PPACA qualified health plans and health insurance issuers under the PPACA risk adjustment program in response to the outcome of federal district court litigation regarding the method CMS uses to determine this risk adjustment. On December 14, 2018, a Texas U.S. District Court Judge ruled that the PPACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress as part of the Tax Act Cuts and Jobs Act of 2017. While the Texas U.S. District Court Judge, as well as the Trump Administration and CMS, have stated that the ruling will have no immediate effect pending appeal of the decision, it is unclear how thiswhen a decision subsequent appeals, and other efforts to repeal and replace the PPACA will impact the PPACA.
Other legislative changes have been proposed and adopted since the PPACA was enacted. These changes include aggregate reductions to Medicare payments to providers of up to 2% per fiscal year pursuant to the Budget Control Act of 2011, which began in 2013 and will remain in effect through 2025 unless additional Congressional action is taken. The American Taxpayer Relief Act of 2012, among other things, further reduced Medicare payments to several providers, including hospitals and cancer treatment centers, increased the statute of limitations period for the government to recover overpayments to providers from three to five years. Additional changes that may affect our business include the expansion of new programs such as Medicare payment for performance initiatives for physicians under the Medicare
Access and CHIP Reauthorization Act of 2015, or MACRA, which will be fully implemented in 2019. At this time it is unclear how the introduction of the Medicare quality payment program will impact overall physician reimbursement.
In addition, there have also been proposals to impose federal rebates on Medicare Part D drugs, requiring federally-mandated rebates on all drugs dispensed to Medicare Part D enrollees or on only those drugs dispensed to certain groups of lower income beneficiaries. If any of these proposals are adopted, they could result in our owing additional rebates, which could have a negative impact on revenues from sales of our products.
Also, there has been heightened governmental scrutiny over pharmaceutical pricing practices in light of the rising cost of prescription drugs and biologics. Such scrutiny has resulted in several recent Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. At the federal level, the Trump Administration’s budget proposal for fiscal year 2019 contains further drug price control measures that could be enacted during the 2019 budget process or in other future legislation, including, for example, measures to permit Medicare Part D plans to negotiate the price of certain drugs under Medicare Part B, to allow some states to negotiate drug prices under Medicaid, and to eliminate cost sharing for generic drugs for low-income patients. Additionally, the Trump Administration released a “Blueprint” to lower drug prices and reduce out of pocket costs of drugs that contains additional proposals to increase manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products and reduce the out of pocket costs of drug products paid by consumers. HHS has already started the process of soliciting feedback on some of these measures and, at the same, is immediately implementing others under its existing authority. Further, Congress and the Trump Administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs. At the state level, legislatures have become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, have been designed to encourage importation from other countries and bulk purchasing.
reached. We expect that the PPACA, as currently enacted or as it may be amended in the future, and other healthcare reform measures that may be adopted in the future, could have a material adverse effect on our industry generally and on our ability to maintain or increase sales of our existing products.
The continuing efforts of the government, insurance companies, managed care organizations, other payers of healthcare services, and patient and political groups to contain or reduce costs of healthcare may, among other things, adversely affect:
•our ability to set a price we believe is fair for our products;
•the reputation of our company;
•our ability to generate revenue and achieve or maintain profitability; and
•the availability of capital.
Our ability to commercialize our products successfully, and to attract commercialization partners for our products, will depend in significant part on the availability of adequate financial coverage and reimbursement from third-party payers, including, in the United States, governmental payers such as the Medicare and Medicaid programs, managed care organizations and private health insurers. Details of these considerations are discussed in the business heading “Other healthcare regulations” in Part I, Item 1, of this Annual Report on Form 10-K.
With the approval of GOCOVRI, we will continue to beWe are subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and subject us to penalties if we fail to comply with applicable regulatory requirements.
With the approval of GOCOVRI, theThe manufacturing, marketing, and further development of the approved productGOCOVRI are subject to continual review by the FDA and/or analogous non-U.S. regulatory authorities. Any regulatory approval that we or our collaboration partners receive for our product candidates will be subject to limitations on the
indicated uses for which the product may be marketed, and may be subject to requirements for potentially costly post-marketing follow-up studies to monitor the safety and efficacy of the product. In addition, if the FDA and/or analogous non-U.S. regulatory authorities approve any of our product candidates, we are and will be subject to extensive and ongoing regulatory requirements with regard to the labeling, packaging, adverse event reporting, storage, distribution, advertising, promotion, tracking, recordkeeping, and periodic reporting for our products. Further, we and our contract manufacturers of our drug products are required to comply with cGMP regulations, which include requirements related to quality control and quality assurance and maintenance of records and documentation. Regulatory authorities must approve manufacturing facilities before they can be used to manufacture our drug products, and these facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP regulations. Certain changes to the manufacturing processes for our product candidates, if approved, would also be subject to pre-approval by regulatory authorities. In addition, if we or a third party discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory authority may impose restrictions on that product, its manufacturer, or us, including but not limited to requiring withdrawal of the product from the market or suspension of manufacturing. If we, our product candidatesproducts or the manufacturing facilities for our product candidatesproducts fail to comply with regulatory requirements of the FDA and/or applicable non-U.S. regulatory authorities, we could be subject to administrative or other sanctions, including:
•warning letters or untitled letters;
•civil or criminal penalties and fines;
•injunctions;
•suspension, variation, or withdrawal of regulatory approval;
•suspension of ongoing clinical studies;
•voluntary or mandatory product recalls;
•requirements for dissemination of corrective information or modifications to promotional materials;
•refusal to approve pending applications for marketing approval of new drugs or supplements to approved applications filed by us;
•refusal to permit import or export of our products;
•restrictions on operations, including costly new manufacturing requirements; or
•seizure or detention of our products.
Regulatory requirements and policies may change, and we may need to comply with additional laws and regulations that are enacted. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or in other countries. If we are not able to maintain regulatory compliance, we may not be permitted to market, or continue to market, our future products and our business may suffer.
If we fail to comply with healthcare regulations, we could face substantial penalties and our business, operations, and financial condition could be adversely affected.
Healthcare providers, physicians, distributors, and third-party payers play a primary role in the distribution, recommendation, and prescription of any pharmaceutical product for which we obtain marketing approval. Our arrangements with third-party payers and customers expose us to broadly applicable federal and state fraud and abuse and other laws and regulations that may constrain the business or financial arrangements through which we market, sell and distribute GOCOVRI and other products for which we may obtain marketing approval. The laws and regulations that may affect our ability to operate include:
the federal healthcare program Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully offering, paying, soliciting, or receiving any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order, lease, arrangement or recommendation of, any good, facility, item, or service for which payment may be made, in whole or in part, under federal healthcare programs, such as the Medicare and Medicaid programs. Liability under the Anti-Kickback Statute may be established without a person or entity having actual knowledge of the statute or specific intent to violate it. In addition, the government may assert that a claim including items or services resulting from a violation of the Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act;
the federal civil and criminal false claims laws, and civil monetary penalties laws, including the federal civil False Claims Act which prohibits individuals or entities from, among other things, knowingly presenting, or causing to be presented, false or fraudulent claims for payment of government funds, or knowingly using false records or statements, to obtain payment from the federal government. In recent years, several pharmaceutical and other health care companies have faced enforcement actions under the False Claims Act for, among other things, allegedly submitting false or misleading pricing information to government healthcare programs, providing free product to customers with the expectation that the customers would bill federal programs, product and patient assistance programs, including reimbursement services, and marketing products for off-label or unapproved uses;
civil monetary penalties laws, the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which prohibits, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payer (e.g., public or private) and knowingly and willfully falsifying, concealing, or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items, or services relating to healthcare matters;
HIPAA,including as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and their implementing regulations, which impose obligations on HIPAA covered entities and their business associates, including mandatory contractual terms and required implementation of administrative, physical and technical safeguards to maintain the privacy and security of individually identifiable health information;
the federal Physician Payments Sunshine Act, being implemented as the Open Payments Program, which requires manufacturers of drugs, devices, biologicals, and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program (with certain exceptions) to report annually to the federal government information related to payments and other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors) and teaching hospitals, as well as certain ownership and investment interests held by physicians and their immediate family members; and
analogous state laws and regulations, such as anti-kickback, and false claims laws, which may be broader in scope and apply to items or services reimbursed by any third-party payer, including commercial insurers. Several states also require pharmaceutical companies to report expenses relating to the marketing and promotion of pharmaceutical products in those states and to report gifts and payments to individual health care providers in those states. Some of these states also prohibit certain marketing-relating activities, including the provision of gifts, meals, or other items to certain health care providers. Some states require reporting with respect to certain drug products. Certain state and localities also require the registration of pharmaceutical sales representatives. In addition, several states require pharmaceutical companies to implement compliance programs or marketing codes.
If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including significant civil, criminal and/or administrative penalties, damages, fines, disgorgement, possible exclusion from participation in Medicare, Medicaid, and other federal
healthcare programs, individual imprisonment, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results. Any action against us for violation of these or other laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. Moreover, achieving and sustaining compliance with applicable federal and state privacy, security, and fraud laws may prove costly.
In addition, in some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. Moreover, the requirements governing drug pricing and reimbursement vary widely from country to country. For example, in the European Union the sole legal instrument at the European Union level governing the pricing and reimbursement of medicinal products is Council Directive 89/105/EEC (the Price Transparency Directive). The aim of the Price Transparency Directive is to ensure that pricing and reimbursement mechanisms established in European Union member states are transparent and objective, do not hinder the free movement and trade of medicinal products in the European Union, and do not hinder, prevent or distort competition on the market. The Price Transparency Directive does not, however, provide any guidance concerning the specific criteria on the basis of which pricing and reimbursement decisions are to be made in individual European Union member states. The national authorities of the individual European Union member states are free to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices and/or reimbursement of medicinal products for human use. Some individual European Union member states adopt policies according to which a specific price or level of reimbursement is approved for the medicinal product. Other European Union member states adopt a system of reference pricing, basing the price or reimbursement level in their territory either, on the pricing and reimbursement levels in other countries, or on the pricing and reimbursement levels of medicinal products intended for the same therapeutic indication. Furthermore, some European Union member states impose direct or indirect controls on the profitability of the company placing the medicinal product on the market.
Health Technology Assessment, or HTA, of medicinal products is becoming an increasingly common part of the pricing and reimbursement procedures, in someand most European Union member states. These countries include the United Kingdom, France, Germany, and Sweden.states now have an HTA system. The HTA process in the European Union member states is governed by the national laws of these countries. HTA is the procedure according to which the assessment of the public health impact, therapeutic impact and the economic and societal impact of the use of a given medicinal product in the national healthcare systems of the individual country is conducted. HTA generally focuses on the clinical efficacy and effectiveness, safety, cost, and cost-effectiveness of individual medicinal products as well as their potential implications for the national healthcare system. Those elements of medicinal products are compared with other treatment options available on the market.
The outcome of HTA may influence the pricing and reimbursement status for specific medicinal products within individual European Union member states. The extent to which pricing and reimbursement decisions are influenced by the HTA of a specific medicinal product vary between the European Union member states.
In 2011, Directive 2011/24/EU was adopted at European Union level. This Directive concerns the application of patients’ rights in cross-border healthcare. The Directive is intended to establish rules for facilitating access to safe and high-quality cross-border healthcare in the European Union. Pursuant to Directive 2011/24/EU, a voluntary network of national authorities or bodies responsible for HTA in the individual EU member states was established. The purpose of the network is to facilitate and support the cooperation between national authorities or bodies and the exchange of scientific information concerning HTAs. This could lead to greater harmonization between European Union member states of the criteria taken into account in the conduct of HTA in pricing and reimbursement decisions and negatively impact price in at least some European Union member states.decisions.
If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate programProgram or other governmental pricing programs that we may join if we successfully commercialize any of our product candidates,in the United States, we could be subject to additional reimbursement requirements, penalties,fines, sanctions and fines,exposure under other laws which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.financial condition.
We participate in and have certain price reporting obligations to the Medicaid Drug Rebate program, as administered by the Centers for Medicare and Medicaid Services (CMS), and other governmental pricing programs.
programs in the United States, and we may participate in additional government pricing programs in the future.
Under the Medicaid Drug Rebate program, a manufacturer is required to pay a rebate to each state Medicaid program for its covered outpatient drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having federal funds being made available to the states for our drugs under Medicaid and Medicare Part B. Those rebates are based on pricing data reported by the manufacturer on a monthly and quarterly basis to CMS, the federal agency that administers the Medicaid Drug Rebate program.CMS. These data include the average manufacturer price and, in the case of innovator products, the best price for each drug which, in general, represents the lowest price available from the manufacturer to any entity in the United States in any pricing structure, calculated to include all sales and associated rebates, discounts and other price concessions.
The PPACA made significant changes to the Medicaid Drug Rebate program, as discussed under the heading “Other healthcare regulations” in Part I, Item 1, of this Annual Report on Form 10-K. On February 1, 2016, CMS issued final regulations to implement the changes to the Medicaid Drug Rebate program under the PPACA. These regulations became effective on April 1, 2016. The issuance of regulationsPricing requirements and coverage expansion by various governmental agencies relating to the Medicaid Drug Rebate program may increase our costs and the complexity of compliance and could have a material adverse effect on our results of operations if we participate in the Medicaid Drug Rebate Program if and when we successfully commercialize any of our product candidates.
Federal law requires that any company that participates in the Medicaid Drug Rebate program also participate in the Public Health Service’s 340B drug pricing program in order for federal funds to be available for the manufacturer’s drugs under Medicaid and Medicare Part B. The 340B program requires participating manufacturers to agree to charge no more than the 340B “ceiling price” for the manufacturer’s covered outpatient drugs to a variety of community health clinics and other entities that receive health services grants from the Public Health Service, as well as hospitals that serve a disproportionate share of low-income patients. The PPACA expanded the list of covered entities to include certain free-standing cancer hospitals, critical access hospitals, rural referral centers and sole community hospitals, but exempts “orphan drugs” from the ceiling price requirements for these covered entities. The 340B ceiling price is calculated using a statutory formula based on the average manufacturer price and rebate amount for the covered outpatient drug as calculated under the Medicaid Drug Rebate program. Changes to the definition of average manufacturer price and the Medicaid rebate amount under the Healthcare Reform Act and CMS’s final regulations implementing those changes also could affect the 340B ceiling pricerebate/discount calculations for any of our product candidates that we successfully commercialize and could negatively impact our results of operations.
The PPACA obligates the Secretary of the HHS to update the agreement that manufacturers must sign to participate in the 340B program to obligate a manufacturer to offer the 340B price to covered entities if the manufacturer makes the drug available to any other purchaser at any price and to report to the government the ceiling prices for its drugs. The Health Resources and Services Administration, or HRSA, recently initiated the process of updating the agreement with participating manufacturers. The PPACA also obligates the Secretary of the HHS to create regulations and processes to improve the integrity of the 340B program. In 2015, HRSA issued proposed omnibus guidance that addresses many aspects of the 340B program, and in August 2016, HRSA issued a proposed regulation regarding an administrative dispute resolution process for the 340B program. It is unclear when or whether the guidance or regulation will be released in final form under the Trump Administration. On January 5, 2017, HRSA issued a final regulation regarding the calculation of 340B ceiling price and the imposition of civil monetary penalties on manufacturers that knowingly and intentionally overcharge covered entities. The March 6, 2017 effective date of this regulation is subject to a temporary delay directed by the Trump Administration, and the regulation could be subject to further delay or other modification by the Trump Administration. Implementation of this final rule and the issuance of any other final regulations and guidance could affect our obligations under the 340B program in ways we cannot anticipate, if and when we successfully commercialize any of our product candidates and if we participate in the 340B program. In addition, legislation may be introduced that, if passed, would further expand the 340B program to additional covered entities or would require participating manufacturers to agree to provide 340B discounted pricing on drugs used in an inpatient setting.
Pricing and rebate calculationsare complex, vary acrossamong products and programs, are complex, and are often subject to interpretation by the reporting manufacturer, governmental or regulatory agencies and the courts. In the case of Medicaid pricing data, if we join the Medicaid Drug Rebate Program and become aware that our reporting for a prior quarter was incorrect, or has changed as a result of recalculation of the pricing data, we will be obligated to resubmit the corrected data for up to three years after those data originally were due. Such restatements and recalculations would increase our
costs for complying with the laws and regulations governing the Medicaid Drug Rebate program and could result in an overage or underage in our rebate liability for past quarters. Price recalculations also may affect the ceiling price at which we would be required to offer any of our product candidates that we successfully commercialize under the 340B drug discount program.
We will be liable for errors associated with any submission of pricing data. In addition to retroactive rebatesdata and the potential for 340B program refunds, if we are found to have knowingly submitted any false price information to the government, we may be liable for significant civil monetary penalties per item of false information. Our failure to submit the required price data on a timely basis could result in significant civil monetary penalties for each day the information is late beyond the due date. Such failure also could be grounds for CMS to terminate our Medicaid drug rebate agreement, pursuant to which we will participate in the Medicaid program if we join the program if and when we successfully commercialize any of our product candidates. In the event that CMS terminates our rebate agreement, federal payments may not be available under Medicaid or Medicare Part B for any overcharging of our product candidates that we successfully commercialize.
government payers. CMS and the OIG have pursued manufacturers that were alleged to have failed to report these data to the government in a timely manner. Governmental agencies may also make changes in program interpretations, requirements or conditions of participation, some of which may have implications for amounts previously estimated or paid. We cannot assure you that our submissions if we participate in the federal programs if and when we successfully commercialize any of our product candidates, will not be found by CMS to be incomplete or incorrect. There also can be no assurance that we will be able to identify all factors that may cause our discount and rebate payment obligations to vary from period to period, and our actual results may differ significantly from our estimated allowances for discounts and rebates. Changes in estimates and assumptions may have a material adverse effect on our business, results of operations and financial condition.
In order to be eligible to have any of our product candidates that we successfully commercialize paid for with federal funds under the Medicaid and Medicare Part B programs and purchased by the Department of Veterans Affairs, or VA, Department of Defense, Public Health Service, and Coast Guard, referred to collectively as the Big Four agencies, and certain federal grantees, we are required to participate in the VA Federal Supply Schedule, or FSS, pricing program, established under Section 603 of the Veterans Health Care Act of 1992. Under this program, we are obligated to make any of our product candidates that we successfully commercialize that meet the statutory definition of “covered drug” (biologics and single and innovator multiple source drugs) available for procurement on an FSS contract and charge a price to the Big Four agencies that is no higher than the Federal Ceiling Price, or FCP, which is a price calculated pursuant to a statutory formula. The FCP is derived from a calculated price point called the “non-federal average manufacturer price,” or Non-FAMP, which we will be required to calculate and report to the VA on a quarterly and annual basis. Pursuant to applicable law, knowing provision of false information in connection with a Non-FAMP filing can subject a manufacturer to significant penalties of $178,156 for each item of false information. The FSS contract also contains extensive disclosure and certification requirements.
Under Section 703 of the National Defense Authorization Act for FY 2008, we will be required to pay quarterly rebates on utilization of innovator products that are dispensed through the Tricare network pharmacies to Tricare beneficiaries. The rebates are calculated as the difference between the annual Non-FAMP and FCP. If we overcharge the government in connection with the FSS contract or Tricare Retail Pharmacy Rebate Program, whether due to a misstated FCP or otherwise, we are required to refund the difference to the government.
Failure to make necessary disclosures and/or to identify contract overcharges can result in allegations against us under the False Claims Act and other laws and regulations. Unexpected refunds to the government, and any response to government investigation or enforcement action, would be expensive and time-consuming, and could have a material adverse effect on our business, financial condition, results of operations and growth prospects if we successfully commercialize any offinancial condition. In addition, in the event that CMS were to terminate our product candidates.rebate agreement, no federal payments would be available under Medicaid or Medicare for our covered outpatient drugs.
If we fail to comply with data protection laws and regulations, we could be subject to government enforcement actions (which could include civil or criminal penalties), private litigation, increased compliance costs and/or adverse publicity, which could negatively affect our operating results and business.
We are subject to data protection laws and regulations (i.e., laws and regulations that address privacy and data security). In the United States, numerous federal and state laws and regulations, including state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), govern the collection, use, disclosure, and protection of health-related and other personal information. Failure to comply with data protection laws and regulations could result in government enforcement actions and create liability for us, including civil and/or criminal penalties, private litigation and/or adverse publicity that could negatively affect our operating results and business. In addition, we may obtain health information from third parties
(e.g. (e.g., healthcare providers who prescribe our products) that are subject to privacy and security requirements under HIPAA, as amended by HITECH. Although we are not directly subject to HIPAA—other than potentially with respect to providing certain employee benefits—we could be subject to criminal penalties if we knowingly obtain or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA. HIPAA generally requires that healthcare providers and other covered entities obtain written authorizations from patients prior to disclosing protected health information of the patient (unless an exception to the authorization requirement applies). If authorization is required and the patient fails to execute an authorization or the authorization fails to contain all required provisions, then we may not be allowed access to and use of the patient’s information and our research efforts could be delayed. Furthermore, use of protected health information that is provided to us pursuant to a valid patient authorization is subject to the limits set forth in the authorization (e.g., for use in research and in submissions to regulatory authorities for product approvals). In addition, HIPAA does not replace federal, state, international or other laws that may grant individuals even greater privacy protections.
On June 28, 2018, California enacted the California Consumer Privacy Act (CCPA), which takestook effect on January 1, 2020. The CCPA gives California residents expanded rights to access and delete their personal information, opt out of certain personal information sharing, and receive detailed information about how their personal information is used. The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation. The CCPA may increase our compliance costs and potential liability. Some observers have noted that the CCPA could mark the beginning of a trend toward more stringent state privacy legislation in the U.S., which could increase our potential liability and adversely affect our business.
In the EU, the General Data Protection Regulation (GDPR) took effect on May 25, 2018, introducing sweeping new data protection requirements that carry potential fines of up to the greater of 20 million Euros or 4% of annual global revenue. The GDPR introduces strict requirements for processing personal data, including potentially burdensome documentation requirements, more stringent requirements for obtaining valid consent, obligations to honor expanded rights of individuals to control the use and retention of their personal data, and requirements to notify regulators and affected individuals of certain personal data breaches. The GDPR also imposes heightened restrictions on processing of sensitive personal data, such as health and genetic data. In addition, the GDPR prohibits the transfer of personal data to countries outside of the European Economic Area (EEA), such as the United States, which are not considered by the European Commission to provide an adequate level of data protection. Switzerland has adopted similar restrictions. Although there are legal mechanisms to allow for the transfer of personal data from the EEA and Switzerland to the United States, they are subject to pending legal challenges that, if successful, could invalidate these mechanisms, restrict our ability to process personal data of Europeans outside of Europe and adversely impact our business. The GDPR will increase our responsibility and potential liability in relation to personal data that we process, expose us to substantial potential fines in the event of violations, increase our compliance costs and could restrict our operations in Europe. Furthermore, there is a growth towards the public disclosure of clinical trial data in the European Union which adds to the complexity of processing health data from clinical trials.
The regulatory approval process is expensive, time consuming, and uncertain and may prevent us or our collaboration partners from obtaining approvals for the commercialization of some or all of our product candidates.
The research, development, manufacturing, quality control, labeling, approval, safety, effectiveness, storage, record keeping, reporting, selling, import, export, advertising, promotion, marketing, and distribution of drug products are subject to extensive regulation by the FDA and other regulatory authorities in the United States, and by regulatory authorities in other countries, with different regulations from country to country. Neither we nor our collaboration partnersWe are not permitted to market our product candidatesproducts in the United States or other countries until we receive regulatory approvals. In August 2017, GOCOVRI was FDA-approved for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. The FDA will need to approve supplemental NDAs for GOCOVRI before we can market the drug for other indications, such as multiple sclerosis walking impairment.
To receive approval to commercialize any of our product candidates in the United States, we and our collaboration partners must demonstrate with substantial evidence from adequate and well-controlled clinical studies, and to the satisfaction of the FDA, that such
product candidates are safe and effective for their intended uses. Results from preclinical studies and clinical studies can be interpreted in different ways. Even if we and our collaboration
partners believe the preclinical or clinical data for our product candidates are promising, such data may not be sufficient to support approval by the FDA. Administering any of our product candidates to humans may produce undesirable side effects, which could interrupt, delay, or cause suspension of clinical studies of our product candidates and result in the denial of approval of our product candidates for any or all targeted indications.
FDA approval of an NDA is not guaranteed, and the approval process is expensive and may take several years. The FDA also has substantial discretion in the approval process. Despite the time and expense we invest, failure can occur at any stage, and we could encounter problems that require us to repeat clinical studies, perform additional preclinical studies and clinical studies, or abandon development and commercialization of a product candidate altogether. The number of preclinical studies and clinical studies that will be required for FDA approval varies depending on, among other factors, the product candidate, the disease or condition that the product candidate is designed to address, and the regulations applicable to any particular product candidate. The FDA can delay, limit, or deny approval of a product candidate for many reasons, including, but not limited to:
•disagreement with the design or implementation of our clinical trials;
•failure of clinical trials to show the level of statistical significance or clinical meaningfulness needed for approval;
•failure to demonstrate that a product candidate is safe or effective;
•insufficient data from preclinical and clinical studies to support an application;
•a finding by an institutional review board, or IRB, Data Safety Monitoring Board, or DSMB, Data Monitoring Committee, or DMC, or the FDA that the clinical trial exposes subjects or patients to an unacceptable health risk;
•disapproval of our or our third-party manufacturer’s processes or facilities; or
•changes to FDA’s approval policies or regulations.
If any of our product candidates fails to demonstrate safety and efficacy in clinical studies or does not gain regulatory approval, our business and results of operations will be materially and adversely harmed.
If the FDA concludes that our product candidates do not satisfy the requirements for approval under the Section 505(b)(2) regulatory approval pathway, or if the requirements for approval under Section 505(b)(2) are not as we expect, the approval pathway for our products will likely take significantly longer, cost significantly more, and entail significantly greater complications and risks than anticipated, and in any case may not be successful. Similar obstacles may arise in other countries.
Similar to the approval pathway for GOCOVRI, we are developing our current and future product candidates, with the expectation that they will be eligible for approval through the Section 505(b)(2) regulatory pathway. Section 505(b)(2) of the FDCA allows an NDA to rely in part on the FDA’s prior conclusions regarding the safety and effectiveness of an approved drug product, or reference listed drug, or RLD. Use of the Section 505(b)(2) regulatory pathway could reduce the time required for the development programs of our product candidates by, for example, potentially decreasing the amount of preclinical and/or clinical data specific to a product candidate that we would need to generate in order to obtain FDA approval. If the FDA does not allow us to pursue the Section 505(b)(2) regulatory pathway as anticipated, we may need to conduct additional clinical trials, provide additional data and information, and meet additional standards for product approval. If this were to occur, the time and financial resources required to obtain FDA approval for our product candidates, and the complications and risks associated with regulatory approval would likely substantially increase. Moreover, our inability to pursue the Section 505(b)(2) regulatory pathway may result in competitive products reaching the market more quickly than our product candidates, which would adversely impact our competitive position and prospects. Even if we are able to utilize the Section 505(b)(2) regulatory pathway, there is no guarantee that utilizing this pathway will ultimately lead to faster product development or earlier approval for any product candidate that we may attempt to develop and commercialize.
An NDA submitted through the Section 505(b)(2) regulatory pathway for a drug product with an active moiety that has been previously approved in another product (e.g., amantadine) may be entitled to three years of regulatory exclusivity if the NDA contains data from clinical investigations (other than bioavailability or bioequivalence studies) conducted by or for the sponsor and deemed essential to FDA’s approval of the NDA. This regulatory exclusivity precludes, among other things, approval of another 505(b)(2) NDA for a product with the same conditions of approval. Although obtaining such exclusivity for our product candidates could provide a competitive benefit for us, the availability of such exclusivity to competitors, if their products were to be approved before our product candidates, presents a risk. If a competing product were approved in our target indication and granted three years of exclusivity, and if the FDA were to find that our product candidate does not differ with respect to the relevant conditions of approval of the approved competing product, then approval of the 505(b)(2) NDA for our product candidate in the target indication may be delayed for as long as the competitor has exclusivity.
With a Section 505(b)(2) NDA, we also must certify to the FDA concerning any patents listed for the RLD in the Orange Book. A certification that our product candidate does not infringe the RLD’s Orange Book-listed patents, or that such patents are invalid (known as a paragraph iv certification) would require providing notice of that certification to the patent holder and the sponsor of the RLD NDA, and we could then be challenged in court by the patent owner or the holder of the approved NDA for the RLD. If such a lawsuit were to be filed within a specified timeframe, it would lead to a 30-month period during which FDA would be precluded from approving our NDA.
Risks related to intellectual property
Our ability to successfully commercialize GOCOVRI and ourany product candidates may be materially adversely affected if we are unable to obtain and maintain effective intellectual property rights for our products and product candidates.
Our success depends in large part on our ability to obtain and maintain patentexclusivity, patent(s), and other intellectual property protection in the United States and in other countries with respect to GOCOVRI, and our product candidates.candidates, and any in- and out-licensed programs. We have sought to protect GOCOVRI and our product candidatescandidate(s) by filing patent applications in the United States and abroad related to our novel discoveries, technologies, and products that are important to our business. This process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. In addition, we may not pursue or obtain patent protection in all relevant markets. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. Our pending and future patent applications may not result in patents being issued which protect our technology or products, in whole or in part. In addition, our existing patents and any future patents we obtain may not be sufficiently broad to prevent others from using our discoveries or technologies or from developing competing products and technologies.
The patent position of pharmaceutical and biotechnology companies generally is highly uncertain and involves complex legal and factual questions for which many legal principles remain unresolved. In recent years, patent rights have been the subject of significant litigation. As a result, the issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain. Our pending and future patent applications may not result in patents being issued in the United States or in other jurisdictions which protect our technology or products or which effectively prevent others from commercializing competitive technologies and products. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of
our patent protection. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot be certain that we were the first to make the inventions claimed in our patents or pending patent applications, or that we were the first to file for patent protection of such inventions. In addition, the United States Patent and Trademark Office, or USPTO, might require that the term of a patent issuing from a pending patent application be disclaimed and limited to the term of another patent that is commonly owned or names a common inventor. As a result, the issuance, scope, validity, enforceability, and commercial value of our patent rights is highly uncertain.
Current or futureThe United States has enacted and implemented wide-ranging patent reform legislation could increaselegislation. The United States Supreme Court has ruled on several patent cases in recent years, either narrowing the uncertainties and costs surroundingscope of patent protection available in certain circumstances or weakening the prosecutionrights of patent owners in certain situations. In addition to increasing uncertainty with regard to our patent applications andability to obtain patents in the enforcement or defensefuture, this combination of our issued patents. In March 2013, underevents has created uncertainty with respect to the Leahy-Smith America Invents Act, or America Invents Act,value of patents, once obtained. Depending on actions by the United States moved from a “firstCongress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to invent”obtain new patents or to a “first-to-file” system. Under a “first-to-file” system, assumingenforce patents that we have licensed or that we might obtain in the other requirements for patentability are met, the first inventor to file a patent application generally will be entitled to a patent on the invention regardless of whether another inventor had made the invention earlier. The America Invents Act includes a number of other significantfuture. Similarly, changes to U.S.in patent law including provisionsand regulations in other countries or jurisdictions or changes in the governmental bodies that affectenforce them or changes in how the wayrelevant governmental authority enforces patent applications are prosecuted, redefine prior art and establish alaws or regulations may weaken our ability to obtain new post-grant review system. The effects of these changes are currently unclear and/patents or uncertain, asto enforce patents that we have licensed or that we may obtain in the USPTO only recently developed new regulations and procedures in connection with the America Invents Act and many of the substantive changes to patent law, including the “first-to-file” provisions, became effective in March 2013. In addition, the courts have only recently started to address these provisions such that the law is still developing, and the applicability of the act and new regulations on specific patents discussed herein have not been determined and would need to be reviewed. However, the America Invents Act and its continued implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business and financial condition.future.
From time to time, we may become involved in opposition, interference, derivation, inter partes review, post-grant review, or other proceedings challenging our patent rights or the patent rights of others, and the outcome of any proceedings are highly uncertain. An adverse determination in any such proceeding could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us or Allergan, without payment to us.
Even if our patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us, or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our owned or licensed patents by developing similar or alternative technologies or products in a non-infringing manner. The issuance of a patent is not conclusive as to its scope, validity, or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in the patent claims of our owned or licensed patents being narrowed, invalidated, or held unenforceable, which could limit our ability to stop or prevent us from stopping others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and products. Given the amount of time required for the development, testing, and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours or otherwise provide us with a competitive advantage.
For our partnered assets, like Namzaric,NAMZARIC, we may not have the right to control the prosecution of patent application,applications, or to maintain or enforce the patent, covering our products or product candidates that we license to third parties or that we may license from third parties. Therefore, we cannot be certain that these patents and applications will be prosecuted and enforced in a manner consistent with the best interests of our business. In addition, if third parties who license patents to us or from us fail to maintain such patents, or lose rights to those patents, the rights we have licensed may be reduced or eliminated.
We may not be able to protect our intellectual property rights throughout the world.
Filing, prosecuting, and defending patents on all of our products and product candidates throughout the world would be prohibitively expensive. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection but where enforcement is not as strong as in the United States. These products may compete with our products and product candidates in jurisdictions where we do not have any issued patents, and our patent claims or other intellectual property rights may not be effective or sufficient to prevent them from so competing. Many companies have encountered significant problems in protecting and defending intellectual property rights in
foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biopharmaceuticals, which could make it difficult for us to stop the infringement of our patents or marketing of competing products against third parties in violation of our
proprietary rights generally. The initiation of proceedings by third parties to enforce our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business.
Obtaining and maintaining our patent protection depends upon compliance with various procedural, document submission, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment, and other provisions during the patent prosecution process and following the issuance of a patent. Our failure to comply with such requirements could result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been the case if our patent were in force.
We may become involved in lawsuits or other proceedings to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming, and if unsuccessful could materially harm our business.
Competitors may infringe or otherwise violate our patents, trademarks, copyrights or other intellectual property for GOCOVRI, our partnered products, any product candidates, and our product candidates.any in- and out-licensed programs. To counter infringement or unauthorized use, we or our licensees may be required to file infringement claims, which can be expensive and time-consuming. For example, on February 16, 2018, Osmotica Pharmaceuticals LLCtwo companies filed Abbreviated New Drug Applications and Vertical Pharmaceuticals LLC (“Osmotica”)we filed an actionsuit against us in U.S. District Court for the stateeach of Delaware, requesting a declaratory judgment that Osmotica’s newly-approved product Osmolex ER™ (amantadine) extended release tablets does not infringe certain ofthem to enforce our patents. For further information, see Litigationpatents and Other Legal Proceedings in “Note 8 - Commitments and Contingencies” in the accompanying “Notes to Consolidated Financial Statements” in this Annual Report.have subsequently settled these lawsuits.
We anticipate that the prosecution of theany lawsuits related to our partnered products and any lawsuits related to GOCOVRI willmay require a significant amount of time and attention offrom our chief executive officersenior executives and other senior executives.management. In addition, in a patent infringement proceeding, a court may decide that a patent of ours (or a patent we license) is invalid or unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the product in question. An adverse result in any litigations or proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly. Such a result could limit our ability to prevent others from using or commercializing similar or identical products, limit our ability to prevent others from launching generic versions of our products and could limit the duration of patent protection for our products, all of which could have a material adverse effect on our business. Also, a successful challenge to our patents could reduce or eliminate our right to receive royalties from Allergan under our license agreement with Allergan. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.
Third parties may initiate legal proceedings alleging that we or our partners are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
Our commercial success depends upon our ability and the ability of our partners to develop, manufacture, market, and sell our products and product candidates and to use our proprietary discoveries and technologies without infringing, misappropriating, or otherwise violating the proprietary rights or intellectual property of third parties. We or our partners may become party to, or be threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our products and technology, including interference, derivation, re-examination, inter partes review, post-grant review, opposition, or similar proceedings before the USPTO and its foreign counterparts. The costs of these proceedings could be substantial, and the proceedings may result in a loss of such intellectual property rights. Some of our competitors may be able to sustain the costs of complex patent disputes and litigation more effectively than we can, because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any disputes or litigation could adversely affect our ability to raise the funds necessary to continue our operations. Third parties may assert infringement claims against us or our partners based on existing patents or patents that may be granted in the future. Under our license agreement with Allergan we are obliged to indemnify Allergan under certain circumstances and our royalty entitlements may also be reduced. Our indemnification obligation to Allergan, while subject to customary limitations, has no monetary cap, and our right to
receive royalties from Allergan may be eliminated
in any calendar quarter in which certain third partythird-party generic competition exists. If we or our partners are found to infringe a third-party’s intellectual property rights, we could be required to obtain a license from such third-partythird party to continue developing and marketing our products and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced, including by court order, to cease commercializing the infringing technology or product. In addition, we could be found liable for monetary damages. A finding of infringement could prevent us from commercializing our products and product candidates or force us to cease some of our business operations, which could materially harm our business. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business.
We may be unable to protect the confidentiality of our trade secrets, thus harming our business and competitive position.
In addition to our patented technology and products, we rely upon trade secrets, including unpatented know-how, technology, and other proprietary information, to develop and maintain our competitive position, which we seek to protect, in part, by confidentiality agreements with our employees, our partners, and consultants. We also have agreements with our employees and selected consultants that obligate them to assign their inventions to us. However, while it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual property to execute such agreements, we may be unsuccessful in executing such an agreement with each party who in fact conceives or develops intellectual property that we regard as our own. In addition, it is possible that technology relevant to our business will be independently developed by a person that is not a party to such an agreement.
While to our knowledge the confidentiality of our trade secrets has not been compromised, if the employees, consultants or partners that are parties to these agreements breach or violate the terms of these agreements, we may not have adequate remedies for any such breach or violation, and we could lose our trade secrets through such breaches or violations. Further, our trade secrets could be disclosed, misappropriated, or otherwise become known or be independently discovered by our competitors. In addition, intellectual property laws in foreign countries may not protect our intellectual property to the same extent as the laws of the United States. If our trade secrets are disclosed or misappropriated, it would harm our ability to protect our rights and adversely affect our business.
Risks related to NamzaricNAMZARIC®
Under our license agreement with Allergan, if Allergan fails to successfully commercialize NamzaricNAMZARIC for any reason or if the license agreement with Allergan is terminated, the potential royalties we are eligible to receive under our license agreement with Allergan may not occur or may be minimal, and would have a negative impact on our revenue potential and harm our business.
In November 2012, we entered into a license agreement with Allergan pursuant to which we granted Allergan a right to develop and commercialize NamzaricNAMZARIC in the United States. Under that agreement, we expectbegan to receive future royalties from Allergan on the net sales of Namzaric,NAMZARIC, starting in May 2020. If for any reason Allergan fails to successfully commercialize Namzaric,NAMZARIC, including due to the impact of the COVID-19 pandemic, on which we are eligible to receive royalties in the low double digits percentage royalties,to mid-teens, we may not receive such future royalties or receive minimal amounts, and our business willmay be harmed. Even if we do receive royalties, based on recent trends of NAMZARIC net sales, we expect the tiered royalty to be in the low double digits through the term of the agreement.
UnderWe are the license agreement, we are reliant on Allergan to commercialize Namzaricsubject of litigation claiming violation of Federal and state false claims acts in that capacity Allergan hasconnection with the discretion to:
determine the efforts and resources that they apply towards commercialization;
market, manufacture, and distribute the licensed products or to otherwise not perform satisfactorily in carrying out these activities; and
to terminate the agreement without penalty and, such termination, may result in a need for additional capital to pursue further development or commercialization of the applicable current or future products.
Under the license agreement we are also eligible to receive royalties on net sales of NamendaNAMENDA XR but we do not expect to receive such royalties, due to the entry of generic versions of Namenda XR.
Under the license agreement,Allergansubstantially controls the intellectual property rights subject to the agreementandany ANDA litigation andpotentialsettlement thereof, and has economic interests different from ours. Accordingly,NAMZARIC by Allergan, may manage the litigation and settlements on terms which may have a material and negative impact on our business.
WeOn April 1, 2019, we were served with a complaint against us and several Allergan have been involvedentities alleging violations of Federal and state false claims acts (“FCA”) in various ANDA litigations to enforce our intellectual property rights against generic manufacturers, who are seeking to bring generic versionsconnection with the commercialization of Namzaric to the market. See NAMENDA XR and NAMZARIC by Allergan, as further described in Litigation and Other Legal Proceedings in “Note 89 - Commitments and Contingencies” in the accompanying “Notes to Consolidated Financial Statements” in this Annual Report. UnderThe complaint alleges that patents held by Allergan and us covering NAMENDA XR and NAMZARIC were procured through fraud on the termsUnited States Patent and Trademark Office and that these patents were asserted against potential generic
manufacturers of that license agreement, Allergan has the rightNAMENDA XR and NAMZARIC to enforce such intellectual property rights and control such litigation. Specifically, Allergan has the discretion to:
maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability; and
not adequately pursue litigation against ANDA filers or settle such litigation on unfavorable terms, and as Allergan substantially controls any ANDA litigation and terms of settlement and has different economic interests than ours, Allergan may grant licenses to generic manufacturers that permit them to make and sell generic versions of Namzaric, which would negatively impact the royalties we receive under our license with Allergan.
We have a right to participate in, but not control, such litigations. If Allergan decides not to enforce the intellectual property rights licensed under the agreement or the litigation is resolved in favor ofprevent the generic manufacturers or iffrom entering the FDA approvesmarket, thereby wrongfully excluding generic competition resulting in artificially high price being charged to government payors. The complaint includes a claim for damages of “potentially more than $2.5 billion dollars,” treble damages and statutory penalties. We are in the ANDA filed by the generic manufacturers, such manufacturersearly stages of this litigation. Defending this litigation may be ablecostly, divert time and attention of our management from the conduct of our business, and if we are unable to marketprevail in this litigation it may result in substantial damages, each of which could have a material and sell the generic form of the branded drug in competition with Namzaric. This could harmnegative impact on our business. Based upon settlement agreements with all the ANDA filers for Namzaric, the earliest date on which any of these agreements grants a license to market generic version of Namzaric is January 1, 2025 or earlier in certain limited circumstances.
Risks related to our financial condition and need for additional capital
Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations.
Our quarterly and annual operating results have fluctuated significantly, and we expect may fluctuate significantly in the future, particularly in light of the COVID-19 pandemic and the effect that it is having on patient demand and the economy as a whole, which makes it difficult for us to predict our future operating results. Any future revenue will depend on our ability to market and sell GOCOVRI, and ourOSMOLEX ER, any product candidates,candidate, the payment of royalties to us from Allergan under terms of our licensing agreement regarding Namzaric,NAMZARIC, or the establishment of potential future collaboration and license agreements, if any, and the achievement of any upfront or milestone payments provided thereunder. Furthermore, our operating results may fluctuate due to a variety of other factors, many of which are outside of our control and may be difficult to predict, including:
•uncertainties related to, and the duration of, the COVID-19 pandemic;
•the level of demand for our products, which may vary significantly as they are launched and compete for position in the marketplace;
•pricing and reimbursement policies with respect to GOCOVRI, OSMOLEX ER, and any product candidates,candidate, if approved, and the competitive response from existing and potential future therapeutic approaches that compete with our products and product candidates;candidate;
•the cost of manufacturing our products and any product candidates,candidate, which may vary due to a number of factors, including the terms of our agreements with contract manufacturing organizations, or CMOs;
•the timing, cost, level of investment, and success or failure of research and development activities relating to our preclinicalproducts and clinical-stageany product candidates,candidate, which may change from time to time;
•expenditures that we may incur to acquire and develop additional product candidates and technologies;
•the timing and success or failure of clinical studies for competing product candidates, or any other change in the competitive landscape of our industry, including consolidation among our competitors or partners;
•the timing and magnitude of upfront and milestone payments under any potential future collaboration and licensing agreements;
•future accounting pronouncements or changes in our accounting policies; and
•changing or volatile U.S., European, and global economic environments.environments, especially as a result of the COVID-19 pandemic.
The cumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results. As a result, comparing our operating results on a period-to-period basis may not be meaningful. Investors should not rely on our past results as an indication of our future performance. This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for any period. If our operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, or if the forecasts we provide to the market are below the expectations of analysts or investors, the price of our common stock could decline substantially. Such a stock price decline could occur even when we have met any previously publicly stated operating results and/or earnings guidance that we may provide.
If we donot have adequate funds to cover all of our development and commercial activities, we may have toraise additional capital orcurtail or cease operations.
We began to commercialize GOCOVRI for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, in January 2018, and it will require substantial funds to continue to commercialize GOCOVRI. In addition, funds are required for the continued operation of our business, as we seek to advance additional product candidates through the research and clinical development to regulatory approval and commercialization. In May 2017, webusiness. We have entered into a Sales Agreement with Cowen and Company, LLC under which we may offer and sell our common stock having aggregate sales proceeds of up to $50 million from time to time through Cowen and Company, LLC as our sales agent. As of December 31, 2018,2020, we have not made any saleshad issued 217,403 shares of common stock and raised net proceeds of $1.0 million under this facility. Subsequent to December 31, 2020, and through February 16, 2021, we issued an additional 1,335,896 shares of common stock under the sales agreement and raised net proceeds of approximately $7.2 million. As of December 31, 2018,2020, we had approximately $210.9$83.4 million in cash, cash equivalents, and investments. We believe that our available cash, cash equivalents, and investments will be sufficient to fund our anticipated level of operations for at least the next 12 months, but there can be no assurance that this will be the case.case, especially in light of the uncertainties related to, and the duration of, the COVID-19 pandemic.
We have financed our operations primarily through proceeds from our license agreement with Allergan, public and private equity offerings, our royalty-backed loan agreement (“Royalty-Backed LoanLoan”) with HealthCare Royalty Partners III, L.P. (“HCR”), or HCRP, since 2017 with sales of GOCOVRI, and, to a lesser extent, government grants, venture debt, and benefits from tax credits made available under a federal stimulus program supporting drug development. We have devoted substantially all of our efforts to research and development, including clinical studies, of our product candidates, including GOCOVRI for the treatment of dyskinesia in patients with Parkinson’s disease. We anticipate that our cash requirements will increase substantiallybe substantial as we:
enhance operational, financial, and information management systems and hire more personnel, including personnel to support development of our product candidates and, our commercial operations;
•commercialize GOCOVRI, including establishing distribution, marketing, and sales capabilities;
•manufacture GOCOVRI for commercial use;
•investigate ADS-5102 (GOCOVRI) in preclinical and clinical trials for the treatment of walking impairment in patients with MS, and potentially other indications;
conduct preclinical and clinical trials of ADS-4101 for the treatment of epilepsy (partial onset seizures);
•seek regulatory approvals for our products and any product candidates that successfully complete clinical studies;
•continue the research, development, and manufacture of our current products and product candidates;candidate; and
•seek to discover or in-license additional product candidates.
If we do not have adequate funds to support these activities, our business opportunities could be hindered.
If we need additional funds to operate our business andif we cannot raise additional capital when needed, or if additional capital is not available to us on favorable terms, our stockholders may be adversely affected or our business may be harmed.
If we need additional funds to support our business and additional funding is not available on favorable terms or at all, we may need to delay or reduce the scope of our research and clinical development programs or commercialization efforts. We do not have any committed external source of funds or other support for our development efforts. We expect to finance future cash needs through a combination of public or private equity offerings, debt financings, royalty financings, collaborations, strategic alliances, licensing arrangements, asset sales, and other marketing and distribution arrangements. The trading prices for our common stock, as well as the broader equity and debt markets, have been highly volatile since the advent of the COVID-19 pandemic. Additional financing may not be available to us when we need it or it may not be available on favorable terms. If we raise additional capital through debt financings, royalty financings, collaborations, strategic alliances, or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our products and product candidates,candidate, technologies, future revenue streams, or research programs or grant licenses on terms that may not be favorable to us. If we raise additional capital through equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, in addition to the repayment of principal and interest on negotiated terms, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of, or suspend one or more of our clinical studies or research and development programs or our commercialization efforts.
We have outstanding debt backed by twothree of our principal assets, GOCOVRI, OSMOLEX ER, and royalties we may receive on Namzaric,NAMZARIC, and failure by us or our royalty subsidiary to fulfill our obligations under the applicable loan agreements may cause the repayment obligations to accelerate.
In May 2017, we, through a newly formed wholly-owned subsidiary, entered into a royalty-backed note arrangementRoyalty-Backed Loan with HCRP,HCR, pursuant to which we initially borrowed $35 million and then borrowed an additional $65 million upon FDA approval and FDA’s recognition in the Orange Book of the seven-year orphan drug exclusivity that GOCOVRI earned upon approval in August 2017, for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. Certain key terms of the Royalty-Backed Loan were amended, with an effectiveness date of January 4, 2021.
InterestEffective with the January 4, 2021 amendment, interest and principal on the loan will beare payable from the proceeds of royalty on U.S. net sales of GOCOVRI, OSMOLEX ER, and up to $15 million of our annual royalties from Allergan on U.S. net sales of Namzaric starting in May 2020.NAMZARIC. The HCRPHCR notes mature in December 2026,March 2027, if not earlier repaid.
WeThe loan is secured the loan with rights to GOCOVRI (ADS-5102), OSMOLEX ER, and rights to certain payment amounts on NamzaricNAMZARIC and the loan documents further provide for assignment into our subsidiary holding these rights to any future intellectual property, licenses, assets and agreements with respect to the manufacture, development, supply, distribution, sale and commercialization of GOCOVRI.GOCOVRI and OSMOLEX ER. The loan documents contain customary events of default permitting HCRPHCR to accelerate and require mandatory prepayment of outstanding principal and interest, including: failure to timely pay principal and interest when due and payable; failure to perform specified covenants with respect to maintenance of the collateral and prohibitions on liens with respect to the collateral; limitations on payments of dividends, additional loans, acquisition or merger transactions not in accordance with the arrangement. Upon the occurrence, an event of default under the loan documents, we could be required to prepay the entire loan and, if we are not able to do so, we may lose control over certain rights and payments to GOCOVRI, OSMOLEX ER, and royalty payments with respect to Namzaric,NAMZARIC, either of which would seriously harm our business.
We are and in the future may be subject to securities litigation, which may be expensive and could divert management attention.
Risks relatedOur share price is volatile and in the past companies that have experienced volatility in the market price of their stock have been subject to ownershipsecurities class action litigation. We have become the target of this type of litigation and in May 2019 a putative class action lawsuit alleging violations of the federal securities laws was filed against us and certain of our current and former directors and officers alleging violations of the securities laws by us and certain of our current and former directors and officers in connection with our January 2018 secondary public offering of common stockstock. In addition, in December 2019, another putative class action lawsuit was filed against us and certain former officers alleging violations of the Securities Act of 1934. For more information, please see Litigation and Other Legal Proceedings in “Note 9 - Commitments and Contingencies” in the accompanying “Notes to Consolidated Financial Statements” in this Annual Report. Lawsuits such as this one can be expensive to defend and could divert our management’s attention from the conduct of our business, which could have an adverse effect on our business.
Our stock price may be volatile, and purchasers of our common stock could incur substantial losses.
Our stock price has fluctuated in the past and may be volatile in the future. The stock market in general and the market for securities of pharmaceutical and biotechnology companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. As a result of this volatility, investors may experience losses on their investments in our stock.
In addition, the clinical development stage of our operations may make it difficult for investors to evaluate the success of our business to date and to assess our future viability. The market price for our common stock may be influenced by many factors, including:
•uncertainties related to, and the duration of, the COVID-19 pandemic;
•our success in commercializing GOCOVRI for the treatment of OFF and dyskinesia in patients with Parkinson’s disease;
•the availability of reimbursement by third-party payers at acceptable levels, or at all, for GOCOVRI;
•the success of competitive products or technologies;
•results of clinical studies of our product candidates we may choose to develop or those of our competitors;
•introductions and announcements of new products and product candidates by us, our commercialization partners, or our competitors, and the timing of these introductions or announcements;
•actions taken by regulatory agencies with respect to our or our competitors’ products, product candidates, clinical studies, manufacturing process, or sales and marketing terms;
•variations in our financial results or those of companies that are perceived to be comparable to us;
•our revenue performance, both in absolute terms and relative to analyst and shareholder expectations;
•the success of our efforts to acquire or in-license additional products or product candidates;
•developments concerning our collaborations, including but not limited to those with our sources of manufacturing and our commercialization partners;
•announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, or capital commitments;
•developments or disputes concerning patents or other proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our current or future products;
•our ability or inability to raise additional capital and the terms on which we raise it;
•the recruitment or departure of key personnel;
•changes in the structure of healthcare reimbursement systems;
•regulatory or legal developments in the United States and other countries, especially changes in laws or regulations applicable to our current or future products;
•market conditions in the pharmaceutical and biotechnology sectors;
•actual or anticipated changes in revenue forecasts, earnings estimates or changes in stock market analyst recommendations regarding our common stock, other comparable companies or our industry generally;
•trading volume of our common stock;
•sales of our common stock by us or our stockholders;
•general economic, industry, and market conditions; and
•the other risks described in this “Risk Factors” section.
These broad market and industry factors may seriously harm the market price of our common stock, regardless of our operating performance. Additionally, following periods of volatility in the market, securities class-action litigation has often been instituted against companies. Such litigation, if instituted against us, could result in substantial costs and diversion of management’s attention and resources, which could materially and adversely affect our business, financial condition, results of operations, and growth prospects.
SalesOur ability to use net operating losses to offset future taxable income may be subject to limitations.
As of December 31, 2020, we had federal and, subject to the recent California franchise tax law change affecting California state net operating losses mentioned below, state net operating loss carryforwards of $375.1 million and $345.2 million, respectively. Portions of the federal net operating loss carryforwards will begin to expire, if not utilized, beginning in 2024, and the state net operating loss carryforward begins expiring in 2028. Portions of these net operating loss carryforwards could expire unused and be unavailable to offset future income tax liabilities. Under the current federal income tax law, federal net operating losses incurred in taxable years beginning after December 31, 2017,
and in future years may be carried forward indefinitely, but the deductibility of such federal net operating losses in taxable years beginning after December 31, 2020, is limited. It is still uncertain if and to what extent various states will conform to the changes in federal tax law. In addition, under Section 382 of the Internal Revenue Code of 1986, as amended, and corresponding provisions of state law, if a substantial number of shares of our common stockcorporation undergoes an “ownership change,” which is generally defined as a greater than 50% change, by value, in its equity ownership over a three-year period, the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to offset its post-change income or taxes may be limited. It is possible that we have experienced an ownership change. We may experience ownership changes in the public market by our existing stockholders could cause our stock price to fall.
Sales of a substantial number of shares of our common stock in the public market, or the perception that these sales might occur, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. We are unable to predict the effect that sales may have on the prevailing market price of our common stock.
Concentration of ownership of our common stock among our existing executive officers, directors, and principal stockholders may prevent new investors from influencing significant corporate decisions.
Our executive officers, directors and current beneficial owners of 5% or more of our common stock, in the aggregate, beneficially own a significant percentage of our outstanding common stock. These persons, acting together, will be able to significantly influence all matters requiring stockholder approval, including the election and removal of directors and any merger or other significant corporate transactions. The interests of this group of stockholders may not coincide with the interests of other stockholders.
We will continue to incur increased costs and demands upon managementfuture as a result of complyingsubsequent shifts in our stock ownership, some of which may be outside of our control. If an ownership change occurs and our ability to use our net operating loss carryforwards is materially limited, it would harm our future operating results by effectively increasing our future tax obligations. In addition, at the state level, there may be periods during which the use of net operating losses is suspended or otherwise limited, including a recent California franchise tax law change limiting the usability of California state net operating losses to offset taxable income in tax years beginning after 2019 and before 2023.
Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
Our operations have been affected by the COVID-19 pandemic and could be subject to earthquakes, power shortages, telecommunications failures, floods, hurricanes, fires, extreme weather conditions, other medical epidemics, and other natural or manmade disasters or business interruptions. The duration of the COVID-19 pandemic and the occurrence of any of these other business disruptions could seriously harm our operations and financial condition and increase our costs and expenses. Our corporate headquarters is located in California and certain clinical sites for our product candidates, operations of our existing and future partners, and suppliers are or will be located near major earthquake faults and fire zones. The ultimate impact on us, our significant partners, suppliers, and our general infrastructure of being located near major earthquake faults and fire zones and being consolidated in certain geographical areas is unknown, but our operations and financial condition could suffer in the event of a major earthquake, fire, or other natural or manmade disaster.
Any future operations or business arrangements with entities outside the United States present risks that could materially adversely affect our business.
If we obtain approval to commercialize any approved products or utilize CMOs outside of the United States, a variety of risks associated with international operations could materially adversely affect our business. If any product or product candidates that we may develop are approved for commercialization outside the United States, we will be subject to additional risks related to entering into international business relationships, including:
•impacts of the COVID-19 pandemic;
•different regulatory requirements for drug approvals in foreign countries;
•reduced protection for intellectual property rights;
•unexpected changes in tariffs, trade barriers, and regulatory requirements;
•different payer reimbursement regimes, governmental payers or patient self-pay systems and price controls;
•economic weakness, including inflation or political instability in particular foreign economies and markets;
•difficulties in assuring compliance with foreign corrupt practices laws;
•compliance with tax, employment, immigration, and labor laws and regulations affecting public companies, and we could fail to successfully improve our systems, procedures, and controls,for employees living or traveling abroad;
•foreign taxes, including withholding of payroll taxes;
•foreign currency fluctuations, which could affect ourresult in increased operating results.
As a public company, we will continue to incur legal, accountingexpenses and reduced revenue, and other expenses associatedobligations incident to doing business in another country;
•workforce uncertainty in countries where labor unrest is more common than in the United States;
•compliance with reporting requirementsprivacy laws;
•production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and corporate governance requirements,
•business interruptions resulting from geopolitical actions, including requirements under the Sarbanes-Oxley Actwar and terrorism, or natural disasters, including earthquakes, hurricanes or typhoons, floods, and fires.
Our internal computer systems, or those of 2002, the Dodd-Frank Wall Street Reform and Consumer Protection Actour CROs, CMOs, or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of 2010, as well as new rules implemented by the SEC and the Nasdaq Stock Market LLC. We expect that we will need to continue to improve existing, and implement new operational, financial, and information management systems, procedures, and controls to manage our business effectively. Any delay inbusiness.
Despite the implementation of security measures, our internal computer systems and those of our CROs, CMOs, specialty pharmacy, distributors, and other contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war, and telecommunication and electrical failures. While we are not aware of any material system failure, accident, or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our drug development programs or commercialization efforts. For example, the loss of clinical study data from completed or ongoing clinical studies for any of our products or product candidates could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. While we back-up our internal computer systems periodically and store such data off-site or in the transition to, new or enhanced systems, procedures, or controls may cause our operations to suffer and we may be unable to conclude that our internal control over financial reporting is effective.
An active trading market for our common stock may not be maintained.
Our stock is currently traded on Nasdaq, butcloud, we can provideoffer no assurance that wesuch off-site storage of data will be ableallow us to maintain an active trading market on Nasdaq or any other exchangecontinue our business without interruptions to our operations, which could result in the future or that the daily trading volume will be adequate to allow orderly purchases or salesa material disruption of our common stock without significantly impactingdrug development programs or commercialization efforts. To the price per share. If an active market forextent that any disruption or security breach were to result in a loss of or damage to our common stock is not maintained, it may be difficult for our stockholders to sell shares without depressingdata or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the market price for the shares or at all.
If securities or industry analysts do not publish research, or publish inaccurate or unfavorable research, about us or our business, our stock price and trading volume could decline.
The trading market for our common stock depends, in part, on the research and reports that securities or industry analysts publish about us or our business. Securities and industry analysts may cease to publish research on our company at any time in their discretion. If one or more of these analysts cease coveragefurther development of our company or fail to publish reports on us regularly, demand for our stockproducts and product candidates could decrease, which might cause our stock price and trading volume to decline. In addition, if one or more of the analysts who cover us downgrade our stock or publish inaccurate or unfavorable research about our business, our stock price would likely decline. If our operating results fail to meet the forecast of analysts, our stock price will likely decline.
be delayed.
Provisions in our corporate charter documents and under Delaware law could make an acquisition of us more difficult and may prevent attempts by our stockholders to replace or remove our current management.
Provisions in our corporate charter and our bylaws may discourage, delay, or prevent a merger, acquisition, or other change in control of us that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of our common stock, thereby depressing the market price of our common stock. In addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors. Because our board of directors is responsible for appointing the members of our management team, these provisions could in turn affect any attempt by our stockholders to replace current members of our management team. Among others, these provisions include that:
•our board of directors is divided into three classes with staggered three-year terms, which may delay or prevent a change of our management or a change in control;
•our board of directors has the right to change the size of our board of directors and to elect directors to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on our board of directors;
•our stockholders may not act by written consent or call special stockholders’ meetings; as a result, a holder, or holders, controlling a majority of our capital stock would not be able to take certain actions other than at annual stockholders’ meetings or special stockholders’ meetings called by the board of directors or the chairman of the board and chief executive officer;
•our certificate of incorporation prohibits cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates;
•stockholders must provide advance notice and additional disclosures in order to nominate individuals for election to the board of directors or to propose matters that can be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of our company; and
•our board of directors may issue, without stockholder approval, shares of undesignated preferred stock, and the ability to issue undesignated preferred stock makes it possible for our board of directors to issue
preferred stock with voting or other rights or preferences that could impede the success of any attempt to acquire us.
Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner.
Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be our stockholders’ sole source of gain.
We have never declared or paid cash dividends on our common stock. We currently intend to retain all of our future earnings, if any, to finance the growth and development of our business. In addition, the terms of existing or any future debt agreements may preclude us from paying dividends. As a result, capital appreciation, if any, of our common stock will be our stockholders’ sole source of gain for the foreseeable future.
Risks related to the operation of our business
Our future success depends on our ability to retain our chief executive officer and other key executives and to attract, retain, and motivate qualified personnel.
We are highly dependent on our chief executive officer and the other members of our executive, scientific, and commercial teams. Our executives may terminate their employment with us at any time. The loss of the services of any of these people could impede the achievement of our research, development, and commercialization objectives.
Recruiting and retaining qualified scientific, clinical, manufacturing, and commercial personnel will also be critical to our success. We may not be able to attract and retain these personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategies. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us.
We expect to expand our development and sales and marketing capabilities, and, as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
As of December 31, 2018, we had 159 full-time equivalent employees. Over the next several years, we expect to experience growth in the number of our employees and the scope of our operations. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational, informational, and financial systems, expand our facilities, and continue to recruit and train additional qualified personnel. Due to our limited financial resources and the limited experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The physical expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.
Our ability to use net operating losses to offset future taxable income may be subject to limitations.
As of December 31, 2018, we had federal and state net operating loss carryforwards of $271.6 million and $236.2 million, respectively. The federal net operating loss carryforwards will begin to expire, if not utilized, beginning in 2025, and the state net operating loss carryforward begins expiring in 2028. These net operating loss carryforwards could expire unused and be unavailable to offset future income tax liabilities. Under the newly enacted federal income tax law, federal net operating losses incurred in 2018 and in future years may be carried forward indefinitely, but the deductibility of such federal net operating losses is limited. It is still uncertain if and to what extent various states will conform to the newly enacted federal tax law. In addition, under Section 382 of the Internal Revenue Code of 1986, as amended, and corresponding provisions of state law, if a corporation undergoes an “ownership change,” which is generally defined as a greater than 50% change, by value, in its equity ownership over a three-year period, the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to offset its post-change income or taxes may be limited. It is possible that we have experienced an ownership change limitation. We may experience ownership changes in the future as a result of subsequent shifts in our stock ownership, some of which may be outside of our control. If an ownership change occurs and our ability to use our net operating loss carryforwards is materially limited, it would harm our future operating results by effectively increasing our future tax obligations.
We are an “emerging growth company,” and we cannot be certain whether the reduced reporting requirements applicable to emerging growth companies will make our common stock less attractive to investors.
We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, or the JOBS Act, which was enacted in April 2012. Until December 31, 2019, the date we will cease to be an emerging growth company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, reduced disclosure
obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may suffer or be more volatile.
Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
Our operations could be subject to earthquakes, power shortages, telecommunications failures, floods, hurricanes, fires, extreme weather conditions, medical epidemics, and other natural or manmade disasters or business interruptions. The occurrence of any of these business disruptions could seriously harm our operations and financial condition and increase our costs and expenses. Our corporate headquarters is located in California and certain clinical sites for our product candidates, operations of our existing and future partners, and suppliers are or will be located near major earthquake faults and fire zones. The ultimate impact on us, our significant partners, suppliers, and our general infrastructure of being located near major earthquake faults and fire zones and being consolidated in certain geographical areas is unknown, but our operations and financial condition could suffer in the event of a major earthquake, fire, or other natural or manmade disaster.
Any future operations or business arrangements with entities outside the United States present risks that could materially adversely affect our business.
If we obtain approval to commercialize any approved products or utilize CMOs outside of the United States, a variety of risks associated with international operations could materially adversely affect our business. If any product candidates that we may develop are approved for commercialization outside the United States, we will be subject to additional risks related to entering into international business relationships, including:
different regulatory requirements for drug approvals in foreign countries;
reduced protection for intellectual property rights;
unexpected changes in tariffs, trade barriers, and regulatory requirements;
different payer reimbursement regimes, governmental payers or patient self-pay systems and price controls;
economic weakness, including inflation or political instability in particular foreign economies and markets;
difficulties in assuring compliance with foreign corrupt practices laws;
compliance with tax, employment, immigration, and labor laws for employees living or traveling abroad;
foreign taxes, including withholding of payroll taxes;
foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;
workforce uncertainty in countries where labor unrest is more common than in the United States;
compliance with privacy laws;
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters, including earthquakes, hurricanes or typhoons, floods, and fires.
Our internal computer systems, or those of our CROs, CMOs, or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our business.
Despite the implementation of security measures, our internal computer systems and those of our CROs, CMOs, specialty pharmacy, distributors, and other contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war, and telecommunication and electrical failures. While we are not aware of any material system failure, accident, or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our drug development programs or commercialization efforts. For example, the loss of clinical study data from completed or ongoing clinical studies for any of our product candidates could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. While we back-up our internal computer systems periodically and store such data off-site or in the cloud, we can offer no assurance that such off-site storage of data will allow us to continue our business without interruptions to our operations, which could result in a material disruption of our drug development programs or commercialization efforts. To the extent that any disruption or security breach were to result in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development of our product candidates could be delayed.
Risks generally associated with a company-wide implementation of information systems may adversely affect our business and results of operations or the effectiveness of our internal controls over financial reporting.
In support of our anticipated growth and commercial-stage operations, we have selected and implemented a number of company-wide information systems, and may select and implement additional systems in the future, including adding new functionality to our enterprise resource planning, or ERP, and other similar systems. Many of these systems are complex and their successful and timely implementation is not assured, requires significant capital expenditures, and can be disruptive to our business operations. Any deficiencies in the design and implementation of these systems could result in potentially much higher costs than we had anticipated and could adversely affect our ability to develop and launch solutions, provide services, fulfill contractual obligations, file reports with the SEC in a timely manner, operate our business, or otherwise affect our controls environment. Any of these consequences could have an adverse effect on our results of operations and financial condition.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
ITEM 2. PROPERTIES
We lease approximately 37,626 square feet of office space in Emeryville, California, under an operating lease that expires April 30, 2025. We believe that our existing facility will be sufficient for our needs for the foreseeable future.
ITEM 3. LEGAL PROCEEDINGS
For information regarding legal proceedings, refer to Litigation and Other Legal Proceedings in “Note 89 - Commitments and Contingencies” in the accompanying “Notes to Consolidated Financial Statements” in this Annual Report, which information is incorporated by reference here.
ITEM 4. MINE SAFETY DISCLOSURES
The disclosure required by this item is not applicable.
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
Market Information
Our common stock is listed on the Nasdaq Global Market under the symbol “ADMS”.
Holders
As of February 28, 2019,16, 2021, there were 27,448,990 shares of our common stock issued and outstanding with 2317 holders of record of our common stock. The actual number of stockholders is greater than this number of record holders, and includes stockholders who are beneficial owners, but whose shares are held in street name by brokers and other nominees. This number of holders of record also does not include stockholders whose shares may be held in trust by other entities.
Dividends
We have never declared or paid, and do not anticipate declaring, or paying in the foreseeable future, any cash dividends on our capital stock. Future determination as to the declaration and payment of dividends, if any, will be at the discretion of our board of directors and will depend on then existing conditions, including our operating results, financial conditions, contractual restrictions, capital requirements, business prospects and other factors our board of directors may deem relevant.
ITEM 6. SELECTED FINANCIAL DATA
You should readWe are a smaller reporting company as defined by Rule 12b-2 of the following selected financial data together with the sectionSecurities Exchange Act of this report entitled “Management’s discussion1934 and analysis of financial condition and results of operations” and our financial statements and the related notes included in this report. The statement of operations data for the years ended December 31, 2018, 2017, and 2016, and the balance sheet data as of December 31, 2018 and 2017, are derived from our audited financial statements included elsewhere in this report. Statement of operations data for the year ended December 31, 2015 and 2014, and balance sheet data as of December 31, 2016, 2015, and 2014, are derived from our audited financial statements not included herein. Our historical results are not necessarily indicative ofrequired to provide the results to be expected in the future.information under this item.
|
| | | | | | | | | | | | | | | | | | | |
| | Years Ended December 31, |
| | 2018 | | 2017 | | 2016 | | 2015 | | 2014 |
| | (in thousands, except per share data) |
| Consolidated Statement of Operations data: | | | | | | | | | |
| Revenues: | | | | | | | | | |
| Product sales | $ | 34,046 |
| | $ | 568 |
| | $ | — |
| | $ | — |
| | $ | — |
|
| License and grant revenue(1) | — |
| | 3 |
| | 572 |
| | 1,916 |
| | 55,846 |
|
| Total revenues | 34,046 |
| | 571 |
| | 572 |
| | 1,916 |
| | 55,846 |
|
| Costs and operating expenses: | | | | | | | | | |
| Cost of product sales | 633 |
| | 17 |
| | — |
| | — |
| | — |
|
| Research and development | 39,300 |
| | 27,168 |
| | 31,230 |
| | 35,895 |
| | 21,860 |
|
| Selling, general and administrative, net | 109,135 |
| | 61,312 |
| | 30,326 |
| | 23,458 |
| | 15,472 |
|
| Total costs and operating expenses | 149,068 |
| | 88,497 |
| | 61,556 |
| | 59,353 |
| | 37,332 |
|
| Income (loss) from operations | (115,022 | ) | | (87,926 | ) | | (60,984 | ) | | (57,437 | ) | | 18,514 |
|
| Interest and other income (expense), net | 3,115 |
| | 1,351 |
| | 811 |
| | 363 |
| | (917 | ) |
| Interest expense | (19,092 | ) | | (4,645 | ) | | — |
| | — |
| | — |
|
| Income (loss) before income taxes | (130,999 | ) | | (91,220 | ) | | (60,173 | ) | | (57,074 | ) | | 17,597 |
|
| Provision (benefit) for income taxes | — |
| | (1,730 | ) | | (115 | ) | | (5,272 | ) | | 7,374 |
|
| Net income (loss) | $ | (130,999 | ) | | $ | (89,490 | ) | | $ | (60,058 | ) | | $ | (51,802 | ) | | $ | 10,223 |
|
| Net income (loss) attributable to common stockholders: | | | | | | | | | |
| Basic | $ | (130,999 | ) | | $ | (89,490 | ) | | $ | (60,058 | ) | | $ | (51,802 | ) | | $ | 8,968 |
|
| Diluted | $ | (130,999 | ) | | $ | (89,490 | ) | | $ | (60,058 | ) | | $ | (51,802 | ) | | $ | 9,069 |
|
| Net income (loss) per share attributable to common stockholders: | | | | | | | | | |
| Basic | $ | (4.87 | ) | | $ | (3.97 | ) | | $ | (2.77 | ) | | $ | (2.86 | ) | | $ | 0.60 |
|
| Diluted | $ | (4.87 | ) | | $ | (3.97 | ) | | $ | (2.77 | ) | | $ | (2.86 | ) | | $ | 0.53 |
|
| Weighted average number of shares used in computing net income (loss) attributable to common stockholders: | | | | | | | | | |
| Basic | 26,886 |
| | 22,558 |
| | 21,711 |
| | 18,111 |
| | 14,837 |
|
| Diluted | 26,886 |
| | 22,558 |
| | 21,711 |
| | 18,111 |
| | 17,107 |
|
| |
(1) | License and grant revenue in the year ended December 31, 2014, includes recognition of revenue relating to upfront and milestone payments called for within our license agreement with Forest Laboratories Holdings Limited (“Forest”), an indirect wholly-owned subsidiary of Allergan plc (collectively, “Allergan”), effective November 13, 2012, of $55.0 million. For further information, see “Note 7 - License Agreements” in the accompanying “Notes to Consolidated Financial Statements” in this Annual Report. |
|
| | | | | | | | | | | | | | | | | | | |
| | As of December 31, |
| | 2018 | | 2017 | | 2016 | | 2015 | | 2014 |
| | (in thousands) |
| Balance Sheet Data: | | | | | | | | | |
| Cash, cash equivalents, and available-for-sale securities | $ | 210,870 |
| | $ | 176,433 |
| | $ | 135,944 |
| | $ | 119,960 |
| | $ | 158,722 |
|
| Working capital | 204,097 |
| | 162,568 |
| | 107,244 |
| | 101,380 |
| | 110,982 |
|
| Total assets | 234,814 |
| | 186,176 |
| | 142,473 |
| | 128,743 |
| | 161,189 |
|
| Long-term debt | 117,457 |
| | 102,647 |
| | — |
| | — |
| | — |
|
| Total liabilities | 144,929 |
| | 120,050 |
| | 10,290 |
| | 12,556 |
| | 14,115 |
|
| Total stockholders’ equity | 89,885 |
| | 66,126 |
| | 132,183 |
| | 116,187 |
| | 147,074 |
|
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations together with the section of this report entitled “Selected financial data” and our consolidated financial statements and related notes included elsewhere in this report. This discussion and other parts of this report contain forward-looking statements that involve risk and uncertainties, such as statements of our plans, objectives, expectations and intentions.intentions, and the expected impact that the COVID-19 pandemic will continue to have on our business. Our actual results could differ materially from those discussed in these forward-looking statements. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Annual Report on Form 10-K, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section of this report entitledtitled “Risk factors.”
This discussion and analysis generally covers our financial condition and results of operations for the year ended December 31, 2020, as compared to the year ended December 31, 2019. For a discussion of the year ended December 31, 2019, as compared to the year ended December 31, 2018, refer to Item 7 of Part II, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2019, which was filed with the United States Securities and Exchange Commission on February 25, 2020. Overview
At Adamas Pharmaceuticals, Inc., our mission is to make everyday life significantly better for people affected by neurological diseases. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. With commercial and partnered medicines, we are pioneering time-dependentfocused on supporting our patient community and growing a portfolio of differentiated neurological therapies. We combine our proven expertise in discovery, development and commercialization with our passion for improving lives to deliver innovative medicines to meaningfully enhance the daily living experience of those affected by CNS disorders. Our vision is to create a world in which time-dependent medicines are the standard of care for CNS disorders. With one partnered product, a commercial medicine and robust pipeline of investigational programs focused on differentiated treatment options for patients, we believe we are well on our way. Our therapeutic targets include a broad range of neurologic diseases, including Parkinson’s disease, Alzheimer’s disease, multiple sclerosis, and epilepsy.
Our treatment innovations stem from a deep scientific understanding of time-dependent biology–the deliberate mapping of disease patterns and drug activity–along with a goal to meaningfully increase the efficacy of known molecules without compromising tolerability. This approach is designed to ensure that our medicines fit within, rather than define, people’s daily lives. Our goal is to lessenreduce the burden of chronic CNS disordersneurological diseases on patients, caregivers, and society. Currently, we are primarily focused on the commercialization of GOCOVRI in the United States. Additionally, we are integrating OSMOLEX ER, which we acquired on January 4, 2021, and are commercializing the product in the United States.
Our understanding of time-dependent biological processes informs our every innovation targeting advancements inGOCOVRI® (amantadine) extended release capsules is the first and only FDA-approved medicine indicated for the treatment of CNS disorders. Our expanding portfolio includes:
Approved Product:
| |
• | GOCOVRITM (amantadine) extended release capsules, formerly referred to as ADS-5102, is the first and only FDA-approved medication indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF in that population. GOCOVRI was approved for marketing by the U.S. Food and Drug Administration, or FDA, on August 24, 2017, with seven years of orphan exclusivity and additional patent protections out to 2034, and we fully launched GOCOVRI with a deployed sales force in January 2018.
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Potential Additional Indicationsdyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, and as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes. GOCOVRI was approved for marketing by the U.S. Food and Drug Administration, or FDA, on August 24, 2017 for its initial indication to treat dyskinesia. On February 1, 2021, we announced we had received marketing authorization from the FDA for a supplemental New Drug Application (sNDA) for GOCOVRI, (amantadine) Extended Release Capsulesgaining a second indication for the product as an adjunctive treatment for OFF episodes. The recent update to the label indication makes GOCOVRI the only medicine clinically proven and approved to reduce both OFF and dyskinesia in Parkinson’s patients taking a levodopa-based medication, resulting in a clinically meaningful increase in good ON time. On June 17, 2020, we announced that we had discontinued further development of (ADS-5102):
ADS-5102 in development a potential additional indication for GOCOVRI for the treatment of walking impairment in patients with multiple sclerosis. We have initiatedsclerosis (“MSW”).
OSMOLEX ER® (amantadine) extended release tablets, was approved by the firstFDA on February 16, 2018, for the treatment of two pivotal Phase 3 studiesParkinson’s disease and drug-induced extrapyramidal reactions in this supplemental indication withadult patients. On January 4, 2021, we acquired the enrollmentglobal rights to OSMOLEX ER from Osmotica Pharmaceuticals US LLC, a subsidiary of Osmotica Pharmaceuticals plc.
NAMZARIC® (memantine hydrochloride extended release and donepezil hydrochloride) capsules for the first patient in March 2018 and enrollment expectedtreatment of moderate to be completed in the first halfsevere dementia of 2019.
ADS-5102 in research and potential development for additional indications. We expect to complete and announce the results of our assessment of potential additional indications for ADS-5102 if and when specific clinical trials are initiated.
Product Candidates:
| |
• | ADS-4101 (lacosamide) modified release capsules in development for the treatment of partial onset seizures in patients with epilepsy. In 2019, we intend to continue to advance the development of ADS-4101 based on the feedback previously received from the FDA with the objective of having an approved medication upon the loss of exclusivity of VIMPAT®.
|
Namzaric®:
| |
• | Namzaric® (memantine hydrochloride extended release and donepezil hydrochloride) capsules for the treatment of moderate to severe dementia of an Alzheimer’s type, is marketed in the United States by Allergan plc under an exclusive license agreement between us and Forest Laboratories Holdings Limited (“Forest”), an indirect wholly-owned subsidiary of Allergan plc (collectively, “Allergan”).
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Products in our wholly-owned, non-partnered portfolio, potential additional indications for these products, and our product candidates, are protected by an array of intellectual property, including robust and diversified patent claims, and regulatory exclusivities. For example, GOCOVRI is protected by orphan exclusivity until August 2024 and additional patent protections through 2034.
Financial operations overview
Summary
As of December 31, 2018, we had cash, cash equivalents, and available-for-sale securities of $210.9 million. We are commercializing GOCOVRI through our deployed sales force targeting neurologists and movement disorder specialists in the United States by Allergan plc under an exclusive license agreement between us and may possibly commercialize GOCOVRI through partnership agreements with pharmaceutical companies outside the United States. AsForest Laboratories Holdings Limited (“Forest”), an indirect, wholly-owned subsidiary of December 31, 2018, we had an accumulated deficit of $342.7 million.
Prior to 2016, we raised an aggregate of approximately $140.5 million inAllergan plc (collectively, “Allergan”). We began recognizing royalty revenue on net sales of equity securities. In January 2016,
NAMZARIC in May 2020.
Going forward, we raised $61.8 million from the sale of 2,875,000 shares of common stock in a follow-on public offering. In May 2017,intend to expand our product pipeline by acquiring, through license or otherwise, additional candidates for research and development and potential commercialization.
On December 1, 2020, we entered into a salespurchase agreement (the “Asset Purchase Agreement”) with Cowen and Company, LLC,Osmotica pursuant to which we may, from timeacquired the global rights to time, issueOSMOLEX ER and sell sharesexisting inventory for $7.5 million and the assumption of common stock having an aggregate offering value of up the $50.0 million. As of February 15, 2019, we have not sold any shares under the sales agreement. Also in May 2017,certain liabilities. The Asset Purchase Agreement closed on January 4, 2021.
On December 1, 2020, we entered into aan agreement with HealthCare Royalty Partners III, L.P. (“HCR”) to amend certain key terms of our royalty-backed loan agreement (“Royalty-Backed Loan”) with HealthCare Royalty PartnersHCR, to be effective upon the closing of the Asset Purchase Agreement with Osmotica which subsequently closed on January 4, 2021. For further discussion of the amended terms of the Royalty-Backed Loan, see “Note 16 - Subsequent Events” in the accompanying “Notes to Consolidated Financial Statements” in this Annual Report.
On January 2, 2020, we announced we had granted Sandoz Inc. a license for its generic version of GOCOVRI as of March 4, 2030, which is over 12 years post GOCOVRI launch, or earlier in certain circumstances typical for such agreements. The agreement contains provisions that may accelerate the license date, including if unit sales of GOCOVRI for the 12-month period ending July 31, 2025 or any subsequent 12-month period decline by a specified percentage below GOCOVRI unit sales for the year ended December 31, 2019. On February 1, 2021, we announced we had granted Zydus a license for its generic version of GOCOVRI as of March 4, 2030. The agreement has similar terms as the Sandoz agreement, including the potential license acceleration provision. With these licenses granted to Sandoz and Zydus, the first filer ANDA challenges for GOCOVRI’s two available strengths have now been settled.
Impact of the COVID-19 pandemic on our company
The outbreak of the novel Coronavirus (“HCRP”COVID-19”), wherebywhich is understood to have begun in December 2019, continues to grow both within the U.S. and globally. The World Health Organization has declared the outbreak of COVID-19 to be a pandemic, and the U.S. federal government has declared it a national emergency.
How we borrowedare operating in the current COVID-19 shutdown
We are committed to the health and safety of our employees and their families and doing our part to slow the community spread of COVID-19. In mid-March, we implemented a totalnumber of $100.0actions, including a work-from-home policy for all our employees, allowing for flexible work schedules, and restrictions on in-person meetings. We are very proud of our entire team as we transitioned swiftly to working remotely. We are following the guidelines of the Centers for Disease Control and other federal, state and local authorities and will continue to assess when it is appropriate for our team to return to normal work practices.
Impact on our ability to sell GOCOVRI
We continue to see stable GOCOVRI prescription refill rates due to our continued strong patient persistence, adequate supply of GOCOVRI, and patient access to GOCOVRI through distribution from our specialty pharmacy directly to a patient’s home. However, we have seen that new prescription rates have been impacted due to several factors, including: a fluid environment in which office practices are changing frequently including many healthcare providers have temporarily closed their offices or are restricting patient visits; patients are postponing visits to healthcare provider facilities; and our sales force has moved to a mix of virtual and live interactions with healthcare providers, adapting to the local environment. While we believe this initial decline and continued impact on new prescriptions to be temporary, the duration and severity is dependent on future developments, which are highly uncertain and cannot be predicted with confidence.
Impact on our supply chain
Our GOCOVRI supply chain remains robust and thus far we have observed no disruptions to our inventory on hand or our planned manufacturing schedule. In October 2020, the FDA approved our sNDA for AMSA S.p.A. as a secondary supplier of active pharmaceutical ingredient for GOCOVRI. We have an adequate supply of GOCOVRI to address patients’ needs into mid-2022. Based on current information, we believe that our partners in our supply chain have been and will continue to operate during the current COVID-19 outbreak.
Impact on our financial condition and capital resources
The extent of the impact of COVID-19 on our business, financial results, liquidity and cash flows will depend largely on future developments, including new information that may emerge concerning the severity and duration of actions taken to contain or prevent further spread. With already imposed shelter-at-home orders in place, we have observed widespread closure of clinics, and cancellation or rescheduling of patient appointments have been combined with restriction of access to sales representatives in some institutions and a marked increase in telemedicine consultations that may result in further sales reductions. In light of restrictions on travel and in-person meetings, we have also experienced cost reductions related to the transition to virtual formats and other travel related costs, in addition to other certain cost management activities. As of December 31, 2020, we had cash, cash equivalents, and investments of $83.4 million. In January 2018, we raised $134.3 million in net proceeds from the sale of 3,450,000 shares of common stock in a follow-on public offering.
Financial operations overview
Revenue
The following table summarizes the sources of our revenue for the years ended December 31, 2018, 2017,2020 and 20162019 (in thousands):
|
| | | | | | | | | | | |
| | December 31, |
| | 2018 | | 2017 | | 2016 |
| Product sales | $ | 34,046 |
| | $ | 568 |
| | $ | — |
|
| Allergan reimbursement of development costs | — |
| | 3 |
| | 317 |
|
| NIH grants and government contracts | — |
| | — |
| | 255 |
|
| Total revenue | $ | 34,046 |
| | $ | 571 |
| | $ | 572 |
|
| | | | | | | | | | | | | |
| | Years Ended December 31, |
| | 2020 | | 2019 | | |
| Product sales | $ | 71,166 | | | $ | 54,637 | | | |
| Royalty revenue | 3,295 | | | — | | | |
| | | | | |
| | | | | |
| | | | | |
| Total revenues | $ | 74,461 | | | $ | 54,637 | | | |
Product sales consist of sales of GOCOVRI, which was approved by the FDA on August 24, 2017. We began commercial sales of GOCOVRI in the fourth quarter of 2017, and initiated the full commercial launch via the deployment of our sales team in January 2018.
Royalty revenue consists of royalties from Allergan for sales of NAMZARIC in the United States, which we began to recognize in May 2020.
Prior to the generation of product sales from GOCOVRI, our revenue had been generated primarily from payments under our license agreement with Allergan and to a lesser degree reimbursement for researchnon-refundable upfront license payments, milestone payments and development expenses from NIH grants and government contracts.
Pursuant to our license agreement with Allergan, we recognized revenue of zero, $3,000, and $0.3 million in reimbursements for research and development expenses for full-time equivalent employees assigned to the license agreement for the years ended December 31, 2018, 2017, and 2016, respectively.agreement. There are no further milestone payments to be earned under our license agreement with Allergan, and we expect reimbursements for full-time equivalents assigned to the license agreement to be inconsequential in future periods. Beginning in May 2020, we are entitledbegan to receiverecognize tiered royalties from Allergan in the low double digits to mid-teens, as a percent of net sales of NamzaricNAMZARIC in the United States.
Based on recent trends of NAMZARIC net sales, we expect the tiered royalty to be in the low double digits through the term of the agreement, but is eliminated in any quarter where there is significant competition from generics. Based on Allergan’s and our current settlement agreements with the NAMZARIC ANDA filers to date, the earliest date on which any of these agreements grant a license to market a NAMZARIC ANDA filer’s generic version of NAMZARIC is January 1, 2025 (or earlier in certain circumstances). Alternatively, the NAMZARIC ANDA filers with the earliest license date have the option to launch an authorized generic version of NAMZARIC beginning on January 1, 2026 instead of launching their own generic version of NAMZARIC on January 1, 2025. For further discussion of NAMZARIC ANDA filers, see Litigation and Other Legal Proceedings in “Note 9 - Commitments and Contingencies” in the accompanying “Notes to Consolidated Financial Statements” in this Annual Report.
Cost of product sales
Cost of product sales consistconsists primarily of direct and indirect costs related to the manufacturing of GOCOVRI products sold, including third-party manufacturing costs, packaging services, freight, allocation of overhead costs, and inventory adjustment charges. We began capitalizing inventory manufactured at the FDA approved locations upon FDA approval of GOCOVRI and upon FDA approval of a supplemental NDA for a second manufacturing site with our current third-party manufacturer. We recorded inventory acquired prior to the regulatory approvals as research and development expense.
Research and development expenses
Research and development expenses represent costs incurred to conduct research, such as the discovery and development of our wholly-owned product candidates. We recognize all research and development costs as they are incurred.
Research and development expenses consist of:
•fees paid to clinical investigators, clinical trial sites, consultants, and vendors, including contract research organizations, or CROs, in conjunction with implementing, conducting, and monitoring our clinical trials and acquiring and evaluating clinical trial data, including all related fees, such as for investigator grants, patient screening fees, laboratory work, and statistical compilation and analysis;
•expenses related to production of clinical supplies, including fees paid to contract manufacturing organizations, or CMOs;
•expenses related to establishment and validation of manufacturing capabilities for commercial supply;
•expenses related to the buildup of commercial supply to support commercial launch, prior to FDA approval;
•expenses related to compliance with regulatory requirements;
•other consulting fees paid to third parties; and
•employee-related expenses, which include salaries, benefits, and stock-based compensation.
The following table summarizes our research and development expenses incurred during the years ended December 31, 2018, 2017,2020 and 20162019 (in thousands):
| | | | | | | | | | | | | |
| | Years Ended December 31, |
| | 2020 | | 2019 | | |
| GOCOVRI(1) | $ | 8,024 | | | $ | 23,448 | | | |
| | | | | |
| ADS-4101(2) | — | | | 2,516 | | | |
| Other research and development expenses | 1,722 | | | 4,070 | | | |
| Total research and development expenses | $ | 9,746 | | | $ | 30,034 | | | |
|
| | | | | | | | | | | |
| | December 31, |
| | 2018 | | 2017 | | 2016 |
| GOCOVRI(1) | $ | 27,441 |
| | $ | 20,174 |
| | $ | 25,223 |
|
| ADS-4101 | 5,451 |
| | 5,202 |
| | 1,659 |
|
| Other research and development expenses | 6,408 |
| | 1,792 |
| | 4,348 |
|
| Total research and development expenses | $ | 39,300 |
| | $ | 27,168 |
| | $ | 31,230 |
|
| |
(1) | Includes program costs we incurred for GOCOVRI (formerly referred to as ADS-5102) for the treatment of dyskinesia in patients with Parkinson’s disease, and ADS-5102 (GOCOVRI) for additional potential CNS indications, including for the treatment of walking impairment in patients with multiple sclerosis. |
(2)We placed the ADS-4101 development program on hold during the quarter ended June 30, 2019.
The program-specific expenses summarized in the table above include costs directly attributable to our product candidates. Other research and development expenses include costs for early stage programs and costs not allocated to a specific program. We allocate benefits, stock-based compensation, and indirect costs to our product candidates on a program-specific basis, and we include these costs in the program-specific expenses. We begin to track and report program-specific expenses for early stage programs once they have been nominated and selected for further development and clinical-stage work has commenced.
Our investment in research and development activities, including the clinical development of our product candidates, has historically represented a significant portion of our total operating expenses. We anticipate incurring significanthave concluded the two-year Phase 3 open-label study of GOCOVRI, suspended investment in the development of ADS-4101, and completed additional analyses of the data from the INROADS trial for ADS-5102 for MSW and will not initiate further Phase 3 development. Our research and development expenses as we continue to support: clinical trialsefforts are focused on completing activities for ADS-5102 (GOCOVRI) in
indications beyond dyskinesia in patients with Parkinson’s disease, including but not limited to: walking impairment in patients with multiple sclerosis, or MS Walking,for MSW, primarily continuing the open-label extension study through the end of 2020 and other indications; ADS-4101publishing the data from the INROADS trial. As a result, we expect research and development costs to decrease from 2019 levels for the treatment of partial onset seizures in patients with epilepsy; and potentially additional clinical-stage programs in more indications or forforeseeable future, product candidates. based on this focused strategy.
The process of conducting the necessary clinical research to obtain FDA approval is costly and time consuming. We consider the active management and development of our clinical pipeline to be crucial to our long-term success.
The actual probability of success for each product candidate and clinical program may be affected by a variety of factors, including but not limited to, the quality of the product candidate, early clinical data, investment in the program, competition, manufacturing capability, and commercial viability. Furthermore, in the past we have entered into licensing arrangements with other pharmaceutical companies to develop and commercialize our product candidates, and we may enter into additional licensing arrangements or collaborations in the future. In situations in which third parties have control over the clinical development of a product candidate, the estimated completion dates are largely under the control of such third parties and not under our control. We cannot forecast with any degree of certainty which of our product candidates, if any, will be subject to future licensing or collaboration arrangements or how such arrangements would affect our development plans or capital requirements. As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates.
Selling, general and administrative expenses, net
Selling, general and administrative expenses, net, consist primarily of personnel and related benefit costs, including stock-based compensation, facilities, professional services, insurance, public company related expenses, charitable contribution expenses, as well as the costs associated with supporting the commercialization of GOCOVRI, reduced to a small degree by reimbursement from Allergan for external costs related to supporting prosecution andas well as litigation of intellectual property rights under our license agreement.settlement charges. We anticipate our selling, general and administrative expenses will remain significant and continue tomay increase as we continue to support the commercialization of GOCOVRI.
Interest and other income, net
Interest and other income, net, consists of changes in fair value of the embedded derivative liability related to our Royalty-Backed Loan with HCRP,HCR, in addition to interest received on our investments.
Interest expense
Interest expense consists of accrued interest pursuant to our Royalty-Backed Loan and amortization of debt issuance costs. Interest expense accrues using the effective interest rate method over the estimated period the debt is expected to be repaid. Interest expense over the life of the Royalty-Backed Loan includes an annual interest rate of 11% on the outstanding principal, a royalty rate of 6.25% on net sales of GOCOVRI after the principal amount is paid, and amortization of the debt discount, until a maximum aggregate repayment amount has been reached.
Critical accounting policies and significant judgments and estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with United States generally accepted accounting principles, or U.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenue generated and expenses incurred during the reporting periods. We base our estimates on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. We have discussed the development, selection, and disclosure of these estimates with the Audit Committee of our Board of Directors. Actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are described in more detail in Note 2 of our financial statements included in this Annual Report on Form 10-K, we believe the following accounting policies to be critical to the judgments and estimates used in the preparation of our financial statements.
Revenue Recognition
We recognize revenue in accordance with Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers (“ASC606”), which we adopted on January 1, 2018, using the full retrospective transition method. Adoption of this guidance did not have a material impact on amounts previously reported in our consolidated financial statements. We recognize revenue upon transfer of control of promised products or services to customers in an amount that reflects the consideration we expect to receive in exchange for those products or services. We expense incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that we would have recognized is one year or less.
Product sales
Our product sales in 2020 and 2019 consist solely of U.S. sales of GOCOVRI. GOCOVRI was approved by the FDA on August 24, 2017, and we commenced shipments of GOCOVRI to a specialty pharmacy during October 2017. We sell our products principally to a specialty pharmacy and certain specialty distributors (each a “Customer” or collectively our “Customers”). The Customer subsequently dispenses product directly to a patient. In addition, except for limited circumstances, the Customer has no right of product return to us. We recognize revenue from product sales when the Customer obtains control of our product, which occurs at a point in time, typically upon delivery to the Customer. We record revenue from product sales after considering the impact of the followingvarious forms of variable consideration, amountswhich include Medicare Part D coverage gap, rebates, chargebacks, co-payment assistance, distribution fees, and product returns. Each of these items of variable consideration we record at the time of revenue recognition:recognition and requires significant estimates, judgment and information obtained from external sources. If management’s estimates differ from actual results, we will record adjustments that would affect product sales in the period of adjustment. For a full description of our various forms of variable consideration, see Revenue Recognition in “Note 2 - Basis of Presentation and Summary of Significant Accounting Policies” in the accompanying “Notes to Consolidated Financial Statements” in this Annual Report. Medicare Part D coverage gap, rebates and chargebacks require the most complex and significant judgment and are described further below.
Distribution feesMedicare Part D coverage gap: Distribution fees include feesMedicare Part D coverage gap is a federal program to subsidize the costs of prescription drugs for Medicare beneficiaries in the United States, which mandates manufacturers to fund a portion of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. Funding of the coverage gap is generally invoiced and paid to our Customers for data and prompt payment discounts.in arrears. We record distribution feesestimate the Medicare Part D coverage gap using the expected-value method based on contractual terms.an amount expected to be incurred for the current quarter’s activity based on expected utilization, plus an accrual balance for known prior quarters and is adjusted quarterly based on actual experience. We estimate for expected utilization of the Medicare Part D coverage gap based on data received from the specialty pharmacy and historical utilization.
Rebates: Rebates include mandated discounts under the Medicaid Drug Rebate Program, Medicare Part D Prescription Drug Benefit Program, and TRICARE Retail Pharmacy Refunds Program (TRICARE)., and Managed Care contracts. Rebates are amounts owed after the final dispensing of the product to a benefit plan participant and are based upon contractual agreements or statutory requirements with benefit providers. We estimate rebates based on statutory discount rates and expected utilization. We estimate for expected utilization of rebates based on data received from the specialty pharmacy and specialty distributor. We use the expected-value method for estimating rebates and we adjust the estimates are adjusted quarterly to reflect actual experience.
Product ReturnsChargebacks: Consistent with industry practice, we offer limited product return rightsChargebacks are discounts that occur when Healthcare Providers purchase directly from our Customer. Healthcare Providers, which currently consist of Public Health Service institutions, non-profit clinics, government entities, group purchasing organizations, and health maintenance organizations, generally allow for the return of product that is damaged or defective, and within a few months prior to and up to a few months afterpurchase the product expiration date.at a discounted price. Our Customer, in turn, charges back to us the difference between the price initially paid by our Customer and the discounted price paid by the Healthcare Providers to our Customer. We do not allow product returnsbase the allowance for product that has been dispensed to a patient. We consider several factors in the estimation of potential product returns, including, expiration dates of the product shipped, the limited product return rights, third-party data in monitoring channel inventory levels, shelf life of the product, prescription trends, and other relevant factors. Product returns have been insignificant to date and are expected to be immaterial in the future.
Medicare Part D coverage gap: Medicare Part D coverage gap is a federal program to subsidize the costs of prescription drugs for Medicare beneficiaries in the United States, which mandates manufacturers to fund a portion of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. Funding of the coverage gap is generally invoiced and paid in arrears. The impact of the Medicare Part D coverage gap is estimated using the expected-value method basedchargebacks on an amount expectedestimate of sales through to be incurred for the current quarter’s activity, plus an accrual balance for known prior quarters and is adjusted quarterly based on actual experience.
Co-payment assistance: We provide co-payment assistance to patients who have commercial insurance and meet certain eligibility requirements. We estimate co-payment assistance using the expected-value method based on historical program participation and estimates of program redemption using data provided by third-party administrators.
Each of the above items are variable consideration, which we record at the time of revenue recognition, and require significant estimates, judgment and information obtainedHealthcare Providers from external sources. If management’s estimates differ from actuals, we will record adjustments that would affect product sales in the period of adjustment.
our Customer.
The following table summarizes activity with respect to our sales allowances and accruals for the years ended December 31, 20182020 and 20172019 (in thousands):
| | | | | | | | | | | | | | | | | |
| | Government and other rebates, and chargebacks | | Co-payment assistance, data fees, cash discounts and returns | | Total |
| | | | | |
| | | | | |
| | | | | |
| Balances at December 31, 2018 | $ | 924 | | | $ | 242 | | | $ | 1,166 | |
| Provision related to current period sales | 5,546 | | | 2,579 | | | 8,125 | |
| Credit or payments made during the period | (4,832) | | | (2,444) | | | (7,276) | |
| Balances at December 31, 2019 | 1,638 | | | 377 | | | 2,015 | |
| Provision related to current period sales | 9,073 | | | 3,294 | | | 12,367 | |
| Credit or payments made during the period | (8,223) | | | (3,242) | | | (11,465) | |
| Adjustment related to prior period sales | (829) | | | (115) | | | (944) | |
| Balances at December 31, 2020 | $ | 1,659 | | | $ | 314 | | | $ | 1,973 | |
|
| | | | | | | | | | | |
| | Government rebates and
co-payment assistance | | Data fees, cash discounts and returns | | Total |
| Balances at December 31, 2016 | $ | — |
| | $ | — |
| | $ | — |
|
| Provision related to current period sales | 86 |
| | 42 |
| | 128 |
|
| Credit or payments made during the period | (8 | ) | | (22 | ) | | (30 | ) |
| Balances at December 31, 2017 | 78 |
| | 20 |
| | 98 |
|
| Provision related to current period sales | 3,655 |
| | 919 |
| | 4,574 |
|
| Credit or payments made during the period | (2,707 | ) | | (799 | ) | | (3,506 | ) |
| Balances at December 31, 2018 | $ | 1,026 |
| | $ | 140 |
| | $ | 1,166 |
|
Stock-Based Compensation
We account for stock-based compensation of stock options granted to employees and directors and for employee stock purchase plan shares by estimating the fair value of stock-based awards using the Black-Scholes option-pricing model. We account for stock-based compensation of restricted stock units granted to employees based on the closing price of our common stock on the date of grant. We account for stock-based compensation of stock options and for employee stock purchase plan shares by estimating the fair value using the Black-Scholes option-pricing model. We recognize and amortize the fair value of stock-based awards, net of estimated forfeitures, over the applicable vesting period.
To estimate the value of share-based awards, we use theThe Black-Scholes option pricing model which requires the use of certain subjective assumptions. The most significant subjective assumptions are management’s estimates of the expected volatility and the expected term of the award. In addition, judgmentJudgment is also required in estimating the amount of share-based awards that we expect to be forfeited.
Clinical Trial Accruals
We base our clinical trial accruals on estimates of patient enrollment and related costs at clinical investigator sites, as well as estimates for the services received and efforts expended pursuant to contracts with multiple research institutions and CROs that conduct and manage clinical trials on our behalf. We estimate clinical trial expenses based on the services performed pursuant to these contracts. In accruing service fees, we obtain the reported level of patient enrollment at each site and estimate the time-period over which services will be performed and activity expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, we will adjust the accrual accordingly.
Long-Term Debt
Long-term debt consists of our Royalty-Backed Loan with HCRP,HCR, accounted for as a debt financing arrangement. We accrue interest expense using the effective interest rate method over the estimated period we expect the debt to be repaid. We must make certain assumptions and estimates, including future royalties and net product sales, in determining the expected repayment term, amortization period of the debt discount, and accretion of interest expense, as well as the classification between current and long-term portions. We will base payment amounts to HCRPHCR on actual royalties and net product sales. We periodically assess our assumptions and estimates and adjust the liabilities accordingly.
Embedded Derivatives Related to Debt Instruments
We evaluate and value embedded derivatives that are required to be bifurcated from their host contract separately from the debt instrument. Under our loan agreement with HCRP,HCR, upon the occurrence of a default or a change in control, we may be required to make mandatory prepayments of the borrowings. The prepayment premium is considered an embedded derivative, as the holder of the loans may exercise the option to require prepayment by us. Further, in the event of a regulatory change that results in a material adverse effect on HCRP’sHCR’s rate of return, we shall pay directly to HCRPHCR an amount that compensates HCRPHCR for such reduction. We remeasure the embedded derivatives
each reporting period and report changes in the estimated fair value as gains or losses in interest and other income, net, in our consolidated statementstatements of operations.
The model used in valuing the embedded derivative as a result of a change in control requires the use of significant estimates and assumptions including but not limited to: 1) expected cash flows we expect to receive on U.S. net sales of GOCOVRI and on royalties from Allergan on U.S. net sales of Namzaric;NAMZARIC; 2) our risk adjusted discount rates; and 3) the probability of a change in control occurring during the term of the note based on the percentage of similar companies that were acquired over the previous five year period. We evaluated the embedded derivative value as a result of an event of default and the value as a result of increased costs due to a regulatory change and considered both to have no material value based on current assessment of probability, but could become material in future periods if a specified event of default or regulatory change became more probable than is currently estimated.
Results of operations
Fluctuations in Operating Results
Our resultsresults of operations have fluctuated significantly from quarterperiod to quarterperiod in the past and, year to year andespecially in light of the COVID-19 pandemic, are likely to continue to do so in the future. For example,We anticipate that our quarterly and annual results of operations will be impacted for the approximateforeseeable future by several factors, including the impact on our operations as a result of the COVID-19 pandemic, fluctuations in product sales due to variances in the number of totalpaid prescriptions in the third and fourth quarter of 2018, were 4,740 and 5,730, respectively, a sequential quarterly increase of 1,310 and 990, respectively. The rate of total prescription growth slowed in the latter part of 2018, and we have continuedfrom period to see this slowing in the first part of 2019. During this same period, persistence has remained strong at six months, indicative of the durable impact GOCOVRI can have on patients with dyskinesia. To realize the full potential for GOCOVRI, we have implemented improvements toconversions from our commercial execution to increase total prescriptions across all regions, prescriber types and patient types. There are a number of seasonal factors that impact all pharmaceutical companies that may affect our results in the first quarter and potentially into the second quarter, including new year coverage and plan changes with deductible resets, and the Medicare Part D “donut hole”. In addition, our new free drug trial program while intended to benefit the amount of total prescriptions for the year, could have a near term negative impact on paid prescriptions, and quarterly revenue.fluctuations in our Medicare Part D Coverage Gap liability and the volume of purchases eligible for government mandated discounts and rebates, as well as changes in discount percentages that may be impacted by potential future price increases and other factors. Further, we expect the timing of expenditures related to our commercial activities associated with GOCOVRI to vary from period to period, including those associated with the label revision for GOCOVRI to include OFF episodes, and potential development of additional product candidates. Due to these fluctuations, we believe that the period to period comparisons of our operating results are not necessarily a good indication of our future performance.
Comparison of the years endedDecember 31, 20182020and20172019
The following table summarizes our results of operations for the years ended December 31, 20182020 and 20172019 (in thousands, except percentages):
| | | | December 31, | | Increase/ | | % Increase/ | | Years Ended December 31, | | Increase/ | | % Increase/ |
| | 2018 | | 2017 | | (Decrease) | | (Decrease) | | 2020 | | 2019 | | (Decrease) | | (Decrease) |
| Product sales | $ | 34,046 |
| | $ | 568 |
| | $ | 33,478 |
| | NM |
| Product sales | $ | 71,166 | | | $ | 54,637 | | | $ | 16,529 | | | 30 | % |
| Royalty revenue | | Royalty revenue | 3,295 | | | — | | | 3,295 | | | NM |
| | Cost of product sales | 633 |
| | 17 |
| | 616 |
| | NM |
| Cost of product sales | 2,038 | | | 2,469 | | | (431) | | | (17) | % |
| Research and development expenses | 39,300 |
| | 27,168 |
| | 12,132 |
| | 45 | % | Research and development expenses | 9,746 | | | 30,034 | | | (20,288) | | | (68) | % |
| Selling, general and administrative expenses, net | 109,135 |
| | 61,312 |
| | 47,823 |
| | 78 | % | Selling, general and administrative expenses, net | 106,841 | | | 114,369 | | | (7,528) | | | (7) | % |
| Interest and other income, net | 3,115 |
| | 1,351 |
| | 1,764 |
| | 131 | % | Interest and other income, net | 748 | | | 2,093 | | | (1,345) | | | (64) | % |
| Interest expense | 19,092 |
| | 4,645 |
| | 14,447 |
| | 311 | % | Interest expense | 13,987 | | | 15,044 | | | (1,057) | | | (7) | % |
NM - Not meaningful.
The following table summarizes the approximate number of total GOCOVRI paid prescriptions for the years ended December 31, 2020 and 2019:
| | | | | | | | | | | | | | | | | | | | | | | |
| Years Ended December 31, | | Increase | | % Increase |
| 2020 | | 2019 | | |
| Total GOCOVRI Paid Prescriptions | 31,070 | | | 25,780 | | | 5,290 | | | 21 | % |
Strong patient persistence of 45%-50% at 12 months continued in the fourth quarter of 2020. In addition to total paid prescriptions, we monitor new paid prescriptions as a key performance indicator for our business and starting with the first quarter of 2020 are reporting this metric. The following table summarizes the approximate number of total GOCOVRI paid prescriptions and approximate number of new GOCOVRI paid prescriptions for each of the quarterly periods presented:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three months ended |
| | December 31 | | September 30 | | June 30 | | March 31 |
| Total GOCOVRI paid prescriptions: | | | | | | | | |
| 2020(1) | | 8,165 | | | 7,785 | | | 7,915 | | | 7,205 | |
| 2019 | | 7,160 | | | 6,640 | | | 6,160 | | | 5,820 | |
| New GOCOVRI paid prescriptions: | | | | | | | | |
| 2020 | | 510 | | | 430 | | | 370 | | | 500 | |
(1)Total GOCOVRI paid prescriptions in 2020 for the three months ended September 30, June 30, and March 31 have been adjusted from previously reported amounts of 7,930, 8,150, and 7,210, respectively, to reflect reconciled 340b dispenses through the specialty distribution channel.
Product sales
Product sales consist of sales of GOCOVRI, which the FDA approved on August 24, 2017. We commenced shipments of GOCOVRI during October 2017 and fully launched with a deployed sales force in January 2018. Product sales increased by $33.5$16.5 million, or 30%, to $34.0$71.2 million for the year ended December 31, 20182020, from $0.6$54.6 million for the year ended December 31, 2017,2019, due to growth in sales of GOCOVRI since its launch, in addition to a 3% price increase that went into effect in January 2020. The approximate number of total paid prescriptions increased by 5,290, or 21%, to 31,070 for the year ended December 31, 2020, from 25,780 for the year ended December 31, 2019.
Royalty revenue
Royalty revenue was $3.3 million for the year ended December 31, 2020. We began recognizing royalty revenue on net sales of NAMZARIC in May 2020 and recognizing a full fiscalaccordingly had no royalty revenue for the year of sales.ended December 31, 2019.
Cost of product sales
Cost of product sales increaseddecreased by $0.6$0.4 million to $0.6$2.0 million, or 2%3% of product sales, for the year ended
December 31, 2020, from $2.5 million, or 5% of product sales, for the year ended December 31, 2018, from $17,000, or 3%2019. Included in cost of product sales for the year ended December 31, 2017. We received
regulatory approval for GOCOVRI from the FDA in August 2017 and cost of product sales were not incurred for the entire fiscal year 2017. Cost of product sales consists of certain fill finish costs incurred after FDA approval2019 is a one-time charge related to the cost of GOCOVRI products sold, in addition to certain distribution and overhead costs.amending our agreement with our CMO. Prior to receiving FDA approval we recorded all inventory costs incurred in the manufacture of GOCOVRI to be sold upon commercialization as research and development expense. We expect to use inventory previously expensed to research and development within the next fifteen months, and accordingly we expect our cost of product sales of GOCOVRI to increase as a percentage of product sales in future periods once this inventory has been sold and we produce and then sell inventory that reflects the full cost of manufacturing the product.
Research and development expenses
Research and development expenses increased by $12.1 million, or 45%, to $39.3 million for the year ended December 31, 2018, from $27.2 million for the year ended December 31, 2017. The increase in research and development expenses was mainly attributable to our Phase 3 study in support of ADS-5102 for the treatment of walking impairment in patients with multiple sclerosis. In addition, we incurred increased costs related to early stage programs. The increase was offset in part by decreased costs associated with GOCOVRI for the treatment of dyskinesia in patients with Parkinson’s disease related to lower manufacturing costs, due to our policy of expensing such costs prior to regulatory approval and capitalizing such costs thereafter, in addition to lower clinical costs due to the conclusion of the two-year Phase 3 open-label study of GOCOVRI. Included in research and development expenses was stock-based compensation expense, which was $2.8 million compared to $3.6 million for the years ended December 31, 2018 and 2017, respectively.
Selling, general and administrative expenses, net
Selling, general and administrative expenses, net, increased by $47.8 million, or 78%, to $109.1 million for the year ended December 31, 2018, from $61.3 million for the year ended December 31, 2017, primarily due to increased costs associated with the commercialization of GOCOVRI, which we made available for physician and patient use in the fourth quarter of 2017 and commenced the full commercial launch in January 2018. The overall increase consists of a $17.7 million increase for personnel related costs, including $3.2 million for stock-based compensation expense, mainly due to additional headcount, and a $30.1 million increase for expenses including GOCOVRI promotional costs, market research, legal fees to defend our intellectual property, and other professional services.
Interest and other income, net
Interest and other income, net, increased by $1.8 million, or 131%, to $3.1 million for the year ended December 31, 2018, from $1.4 million for the year ended December 31, 2017. The increase in interest and other income, net, in the year ended 2018 was primarily due to interest income earned on investments as a result of investing the cash from our follow-on public offering that occurred in January 2018, offset in part by a change in fair value of the embedded derivative liability related to our Royalty-Backed Loan with HCRP.
Interest expense
Interest expense increased by $14.4 million, or 311% to $19.1 million for the year ended December 31, 2018, compared to $4.6 million in the year ended December 31, 2017, due to the interest expense incurred on the $100 million Royalty-Backed Loan entered into in May 2017 and borrowed in two tranches: $35 million in May 2017 and $65 million in December 2017. The increase in interest is primarily due to the two tranches of the Royalty-Backed Loan being outstanding for the full year 2018 as compared to only portions of 2017.
Comparison of the years endedDecember 31, 2017and 2016
The following table summarizes our results of operations for the years ended December 31, 2017 and 2016 (in thousands, except percentages):
|
| | | | | | | | | | | | | | |
| | December 31, | | Increase/ | | % Increase/ |
| | 2017 | | 2016 | | (Decrease) | | (Decrease) |
| Product sales, net | $ | 568 |
| | $ | — |
| | $ | 568 |
| | NM |
|
| License and grant revenue | 3 |
| | 572 |
| | (569 | ) | | (99 | )% |
| Cost of product sales | 17 |
| | — |
| | 17 |
| | NM |
|
| Research and development expenses | 27,168 |
| | 31,230 |
| | (4,062 | ) | | (13 | )% |
| Selling, general and administrative expenses, net | 61,312 |
| | 30,326 |
| | 30,986 |
| | 102 | % |
| Interest and other income, net | 1,351 |
| | 811 |
| | 540 |
| | 67 | % |
| Interest expense | 4,645 |
| | — |
| | 4,645 |
| | NM |
|
NM - Not meaningful.
Product sales
Product sales of $0.6 million for the year ended December 31, 2017, consists of sales of GOCOVRI, which was approved by the FDA on August 24, 2017. We commenced shipments of GOCOVRI during October 2017; however, we did not fully launch GOCOVRI with a deployed sales force until January 2018.
License and grant revenue
License and grant revenue decreased by $0.6 million, or 99%, to $3,000 for the year ended December 31, 2017, from $0.6 million for the year ended December 31, 2016. Revenue for both periods presented was primarily related to reimbursement of certain expenses as provided for in our license agreement with Allergan, as well as from government contracts in 2016.
Cost of product sales
Cost of product sales of $17,000 for the year ended December 31, 2017, is related to certain fill finish costs incurred after FDA approval related to the cost of GOCOVRI products sold. Prior to receiving regulatory approval for GOCOVRI from the FDA in August 2017, we recorded all inventory costs incurred in the manufacture of GOCOVRI to be sold upon commercialization as research and development expense. As of December 31, 2020, substantially all the inventory that was previously expensed to research and development had been sold to customers. We do not expect our cost of product sales of GOCOVRI as a percentage of product sales to exceed 6% for the foreseeable future, excluding potential unknown one-time charges.
Research and development expenses
Research and development expenses decreased by $4.1$20.3 million, or 13%68%, to $27.2$9.7 million for the year ended December 31, 2017,2020, from $31.2$30.0 million for the year ended December 31, 2016.2019. The decrease in research and development expenses was mainly attributable to: decreased costs related to costs associated with the clinical development of GOCOVRI (formerly ADS-5102), which decreased by $5.0 million, or 20%, to $20.2 million from $25.2 millionactivity for the years ended December 31, 2017 and 2016, respectively, due to the conclusion of twoour Phase 3 clinical trials assessing GOCOVRIstudy in support of ADS-5102 for the treatment of dyskinesiawalking impairment in patients with Parkinson’s disease, in additionmultiple sclerosis mainly due to costs associated withcompletion of the open-label safety study. The decrease was offset in part by increased activityPhase 3 INROADS trial at the end of 2019; decreased costs related to clinical work associated withthe decision during the second quarter of 2019 to defer additional investment in the development of our product candidate ADS-4101 for the treatment of partial onset seizures in patients with epilepsy.epilepsy; and decreased costs related to early stage programs. Included in research and development expenses was stock-based compensation expense, which was $3.6$0.4 million compared to $2.9$1.7 million for the years ended December 31, 20172020 and 2016,2019, respectively.
Selling, general and administrative expenses, net
Selling, general and administrative expenses, net, increaseddecreased by $31.0$7.5 million, or 102%7%, to $61.3$106.8 million for the year ended December 31, 20172020, from $30.3$114.4 million for the year ended December 31, 2016.2019, primarily due to: decreased costs of approximately $6.6 million in personnel related costs, including stock-based compensation and other certain one-time charges in conjunction with a consulting agreement entered into during the prior year with our former Chief Executive Officer; and decreased costs of approximately $7.8 million related to legal fees, cost management activities, and other general corporate expense. The increasedecrease for the year ended December 31, 2020 was offset in part by a one-time charge of approximately $5.0 million related to a probable loss associated with the OSMOLEX ER settlement of patent litigation, in addition to approximately $1.9 million for GOCOVRI related promotional costs, market research, and other external professional services, as compared to the same period in the prior year. Included in selling, general and administrative expenses net, was primarily due to increased costs associated with the commercialization of GOCOVRI, which we made available for physician and patient use in the fourth quarter of 2017, although we commenced the full commercial launch in January 2018. The overall increase consists of a $10.2 million increase for personnel related costs, including $2.1 million for stock-based compensation expense, duewhich was $6.0 million compared to additional headcount,$11.1 million for the years ended December 31, 2020 and a
$20.8 million increase for expenses including GOCOVRI launch preparation costs, market research, and other professional services.2019, respectively.
Interest and other income, net
Interest and other income, net, increaseddecreased by $0.5$1.3 million, or 67%64%, to $1.4$0.7 million for the year ended December 31, 2017,2020, from $0.8$2.1 million for the year ended December 31, 2016.2019. The increasedecrease in interest and other income, net, in the year ended 2017 was primarily due todriven by lower interest income earned on lower cash and investment balances, offset in part by a change in fair value of the embedded derivative liability related to our Royalty-Backed Loan with HCRP. Also included in interestHCR, which was $0.2 million compared to $0.8 million for the years ended December 31, 2020 and other income, net, is interest income earned on investments.2019, respectively.
Interest expense
The increase in interestInterest expense of $4.6decreased by $1.1 million, or 7%, to $14.0 million for the year ended December 31, 2017,2020, compared to zero$15.0 million in the year ended December 31, 2016, was due to the2019. The decrease in interest expense incurredwas mainly related to a lower estimated effective interest rate on the $100 millionour Royalty-Backed Loan entered intowith HCR, offset in May 2017 and borrowed in two tranches: $35 million in May 2017 and $65 million in December 2017.part by a higher principal balance.
Liquidity and Capital Resources
Our principal sources of liquidity are our cash, cash equivalents, and investments, which totaled $83.4 million and $132.6 million at December 31, 2020 and 2019, respectively. As of December 31, 2020, we had an accumulated deficit of $505.3 million.
Prior to 2018, we raised an aggregate of approximately $202.3 million in sales of equity securities and entered into a Royalty-Backed Loan with HCR, whereby we borrowed a total of $100.0 million. As of December 31, 2020, the total remaining payment obligation of the Royalty-Backed Loan was $179.2 million. During the last three fiscal years,
we have funded our operations primarily through sales of our common stock, our Royalty-Backed Loan with HCRP, and since 2017 withGOCOVRI, through sales of GOCOVRI. In January 2016, we completed a follow-on public offering of our common stock, from which proceeds raised were approximately $61.8 million,and to a lesser extent through royalties received on net sales of underwriting discountsNAMZARIC. We made GOCOVRI available for physician and offering-related transaction costs. In May 2017, we entered into a Royalty-Backed Loan with HCRP, whereby we initially borrowed $35.0 million, followed by an additional $65.0 million receivedpatient use in the fourth quarter 2017.of 2017, with a full commercial launch in January 2018. Prior to the generation of revenue from GOCOVRI, we had not generated any commercial revenue from the sale of our products. In January 2018, we completed a follow-on public offering of our common stock from which proceeds raised were approximately $134.3 million, net of underwriting discounts, commissions, and offering-related transaction costs.
costs from the sale of 3,450,000 shares of common stock. In May 2017,November 2019, we entered into a sales agreement with Cowen and Company, LLC, pursuant to which we may, from time to time, issue and sell shares of common stock having an aggregate offering value of up to $50.0 million. As of December 31, 2018, no2020, we had issued 217,403 shares had been soldof common stock and raised net proceeds of $1.0 million under the sales agreement.
We made GOCOVRI available for physician Subsequent to December 31, 2020, and patient usethrough February 16, 2021, we issued an additional 1,335,896 shares of common stock under the sales agreement and raised net proceeds of approximately $7.2 million. Beginning in May 2020, we began to recognize tiered royalties from Allergan in the fourth quarterlow double digits to mid-teens, as a percent of 2017, with a full commercial launch vianet sales of NAMZARIC in the deploymentUnited States. As of our sales team in January 2018. Prior to the generation of revenue from GOCOVRI,December 31, 2020, we had not generated any commercial revenue from the salenon-cancelable purchase commitments of our products. Our principal sources of liquidity were our cash, cash equivalents, and investments, which totaled $210.9$2.4 million and $176.4 million at December 31, 2018 and 2017, respectively.due within one year.
We believe our existing cash, cash equivalents, and investments at December 31, 2020 will be sufficient to fund our projected operating requirements, including operations related to the continued development of our product candidates and commercialization of GOCOVRI for the treatment of OFF and dyskinesia in patients with Parkinson’s disease and operations related to completing activities for ADS-5102 in MSW, for at least 12 months from the issuance of this annual report on Form 10-K. However, it is possible that we will not achieve the progress that we expect, because revenues from GOCOVRI may be less than anticipated, especially in light of the current COVID-19 pandemic, and the actual costs and timing of drug development, particularly clinical studies, and regulatory approvals are difficult to predict, subject to substantial risks and delays, and often vary depending on the particular indication and development strategy. The duration and severity of the COVID-19 pandemic is unknown and makes projecting the outcome of future developments highly uncertain and cannot be predicted with confidence. Moreover, the costs associated with commercializing drugs are high and market acceptance is uncertain.
We expect to incur substantial expenses and operating losses for the foreseeable future. We expect to continue significant spending in connection with the continued commercialization of GOCOVRI for the treatment of OFF and dyskinesia in patients with Parkinson’s disease, as well as the development of ADS-5102 for other indications, the development of ADS-4101 for indications in epilepsy,OSMOLEX activities, and potential development of additional product candidates.To continue these activities, we may decide to raise additional funds through a combination of public or private equity offerings, debt financings, royalty financings, collaborations, strategic alliances, licensing arrangements, asset sales, and other marketing and distribution arrangements. Sufficient additional funding may not be available on acceptable terms, or at all.all, especially as a result of the economic downturn occurring and expected to continue as a result of the actions taken to contain the spread of COVID-19. If adequate funds are not available in the future, we may need to delay, reduce the scope of, or put on hold our clinical studies, research and development programs, or commercialization efforts.
The following table summarizes our cash flows for the periods indicated (in thousands):
| | | | | | | | | | | | | |
| | Years Ended December 31, |
| | 2020 | | 2019 | | |
| Net cash (used in) provided by: | | | | | |
| Operating activities | $ | (50,708) | | | $ | (80,779) | | | |
| Investing activities | 54,940 | | | 88,863 | | | |
| Financing activities | 1,654 | | | 1,085 | | | |
| Net increase (decrease) in cash and cash equivalents | $ | 5,886 | | | $ | 9,169 | | | |
|
| | | | | | | | | | | |
| | Year Ended December 31, |
| | 2018 | | 2017 | | 2016 |
| Net cash (used in) provided by: | | | | | |
| Operating activities | $ | (104,223 | ) | | $ | (66,827 | ) | | $ | (48,068 | ) |
| Investing activities | (69,338 | ) | | 25,565 |
| | (26,709 | ) |
| Financing activities | 138,850 |
| | 108,843 |
| | 65,408 |
|
| Net increase (decrease) in cash and cash equivalents | $ | (34,711 | ) | | $ | 67,581 |
| | $ | (9,369 | ) |
Net Cash Used In Operating Activities
Net cash used in operating activities was $104.2$50.7 million for the year ended December 31, 2018. Net2020 and consisted primarily of our net loss of $131.0$57.4 million for the year ended December 31, 2018, included netless non-cash adjustments of $36.5$21.9 million, which consisted primarilymainly for accretion of interest expense of $14.0 million and stock-based compensation of $15.8$6.4 million, in addition to payments related to our Royalty-Backed Loan with HCR of $11.7 million, and interest expensechanges to our assets and liabilities of $19.1 million. The use$3.5 million due to timing of cash forpayments in the year ended December 31, 2018, was primarily related to commercialization activities for GOCOVRI. Additionally, we used cash to fund research and development programs, including the developmentordinary course of ADS-5102 for the treatment of walking impairment in patients with multiple sclerosis and ADS-4101 for indications in epilepsy.business.
Net cash used in operating activities was $66.8$80.8 million for the year ended December 31, 2017. Net2019 and consisted primarily of our net loss of $89.5$105.2 million for the year ended December 31, 2017, included netless non-cash adjustments of $19.4$29.6 million, which consisted primarily ofmainly for stock-based compensation of $13.4$12.9 million and non-cash interest expense of $4.6 million. The primary use of cash for the year ended December 31, 2017, was$15.0 million, in addition to fund activities in support of the NDA and pre-commercial activities in preparation for the commercialization of GOCOVRI. Additionally, we used cash to fund development of ADS-4101 for indications in epilepsy.
Net cash used in operating activities was $48.1 million for the year ended December 31, 2016. Net loss of $60.1 million for the year ended December 31, 2016, included net non-cash adjustments of $11.1 million, primarilypayments related to $10.6 millionour Royalty-Backed Loan with HCR of stock-based compensation. The primary use of cash for the year ended December 31, 2016 was to fund the ongoing clinical studies and product development activities related to GOCOVRI.$6.5 million.
Net Cash Provided By (Used In) Investing Activities
Net cash used in investing activities was $69.3 million for the year ended December 31, 2018 as a result of net purchases of available-for-sale securities of $68.3 million and purchases of property and equipment of $1.1 million.
Net cash provided by investing activities was $25.6$54.9 million for the year ended December 31, 2017. In the year ended December 31, 2017, we received $26.8 million2020, as a result of net maturities and sales of available-for-sale securities, offset in part by $1.3 million in purchasesnet of property and equipment.purchases.
Net cash used inprovided by investing activities was $26.7$88.9 million for the year ended December 31, 2016. Net cash used in investing activities for the year ended 2016 was a result of $25.1 million in net purchases of available-for-sale securities2019, primarily as a result of investing the cash from our follow-on public offering that occurred in January 2016, and $1.6 million in purchasesmaturities of property and equipment.available-for-sale securities, net of purchases.
Net Cash Provided By Financing Activities
Net cash provided by financing activities was $138.9$1.7 million for the year ended December 31, 2018. In the year ended December 31, 2018, we received net2020, as a result of cash proceeds of $134.3$1.0 million related to the sale of common stock under a follow-on public offering; in addition, we received cash proceeds of $4.6controlled equity offering coupled with $0.6 million related to the exercise of stock options and purchases of common stock under the Employee Stock Purchase Plan (ESPP).
Net cash provided by financing activities was $108.8$1.1 million for the year ended December 31, 2017. In the year ended December 31, 2017, we received2019, as a result of cash proceeds of $99.6 million from the issuance of long-term debt and $9.9 million related to the exercise of stock options and purchases of common stock under the ESPP.
Net cash provided by financing activities was $65.4 million for the year ended December 31, 2016. In the year ended December 31, 2016, we received net cash proceeds of $61.8 million related to the sale of common stock under a follow-on public offering, coupled with $3.6 million related to the exercise of stock options and purchases of common stock under the ESPP.
Off-balance sheet arrangements
Since our inception, we have not engaged in any off-balance sheet arrangements, including the use of structured finance, special purpose entities, or variable interest entities.
Contractual obligations
Our future non-cancelable contractual obligations at December 31, 2018, were as follows (in thousands):
|
| | | | | | | | | | | | | | | | | | | |
| | | | Payments Due by Period |
| | Total | | Less than 1 year | | 2 - 3 years | | 4 - 5 years | | More than 5 years |
| Operating lease obligations | $ | 13,300 |
| | $ | 1,938 |
| | $ | 4,052 |
| | $ | 4,299 |
| | $ | 3,011 |
|
| Purchase commitments | 8,563 |
| | 4,126 |
| | 3,087 |
| | 1,350 |
| | — |
|
| Long-term debt | 197,382 |
| | 1,664 |
| | — |
| | — |
| | 195,718 |
|
| Total contractual obligations | $ | 219,245 |
| | $ | 7,728 |
| | $ | 7,139 |
| | $ | 5,649 |
| | $ | 198,729 |
|
Operating Lease Obligations
Operating lease obligations in the table above relates to our office facilities. We lease approximately 37,626 square feet of office space in Emeryville, California underAs a lease that expires April 30, 2025.
Purchase Commitments
We enter into certain other long-term commitments for the supply of API, the manufacture of commercial supply of GOCOVRI, and other agreements for the provision of services, including services related to data access and packaging. To the extent these long-term commitments are non-cancelable, they are reflected in the above table. We also enter into contracts in the normal course of business that generally provide for termination upon notice, and thereforesmaller reporting company, we are not reflected inrequired to provide the table above.disclosure required by Item 303(a)(5) of Regulation S-K.
Long-Term Debt
Long-term debt consists of our Royalty-Backed Loan with HCRP. Under the terms of the Royalty-Backed Loan, our principal payments are entirely variable, with no fixed minimums, payable based on U.S. net sales of GOCOVRI and based on royalties from Allergan on U.S. net sales of Namzaric. See “Note 9 - Long-Term Debt” in the accompanying “Notes to Consolidated Financial Statements” in this Annual Report for additional information on our Royalty-Backed Loan. Total payment obligations, including both principal and interest, are included in the above table. The long-term portion is included based on the contractual loan maturity date of December 2026.
Recent Accounting Pronouncements
For a discussion of new accounting pronouncements, see “Note 2 - Basis of Presentation and Summary of Significant Accounting Policies” in the accompanying “Notes to Consolidated Financial Statements” in this annual report.Annual Report.
JOBS Act Accounting Election
We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards, and,
therefore, are subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to provide the information under this item.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
ADAMAS PHARMACEUTICALS, INC.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
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Consolidated Financial StatementsStatements: | |
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Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders
of Adamas Pharmaceuticals, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Adamas Pharmaceuticals, Inc. and its subsidiaries (the “Company”) as of December 31, 20182020 and December 31, 2017,2019, and the related consolidated statements of operations, of comprehensive loss, of stockholders’ equity (deficit) and of cash flows for each of the three years in the periodthen ended, December 31, 2018, including the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 20182020 and December 31, 2017,2019, and the results of its operations and its cash flows for each of the three years in the periodthen ended December 31, 2018 in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Accrued Sales Deductions for the Medicare Part D Coverage Gap
As described in Notes 2 and 5 to the consolidated financial statements, revenue from product sales is recorded after considering the impact of the variable consideration, including mandated payments to fund a portion of the Medicare Part D coverage gap, which can decrease the transaction price, at the time of revenue recognition. As of December 31, 2020, the liability for accrued sales deductions was $1.6 million, of which a portion related to accrued sales deductions for the Medicare Part D coverage gap. Management estimates the liability related to accrued sales deductions for the Medicare Part D coverage gap using the expected-value method based on an amount expected to be incurred for the current quarter’s activity based on expected utilization. The liability is adjusted quarterly based on actual experience.
Management's estimate for expected utilization of the Medicare Part D coverage gap is based on data received from the specialty pharmacy and historical utilization.
The principal considerations for our determination that performing procedures relating to accrued sales deductions for the Medicare Part D coverage gap is a critical audit matter are the high degree of auditor judgment, subjectivity, and effort in performing procedures relating to accrued sales deductions due to the significant judgment by management when developing the estimate.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included, among others (i) obtaining an understanding of management’s process and methodology used to develop the estimate of the accrued sales deductions for the Medicare Part D coverage gap, (ii) performing retrospective comparison of actual third party invoices received subsequent to the prior and current year-end to evaluate the reasonableness of the prior and current period estimate, (iii) developing an independent estimate by utilizing third party data, (iv) comparing the independent estimate to management’s estimate, and (v) testing claims paid by the Company.
/s/ PricewaterhouseCoopers LLP
San Jose, California
March 4, 2019February 23, 2021
We have served as the Company’s auditor since 2007.
ADAMAS PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
|
| | | | | | | |
| | December 31, |
| | 2018 | | 2017 |
| Assets | | | |
| Current assets | | | |
| Cash and cash equivalents | $ | 56,605 |
| | $ | 91,316 |
|
| Available-for-sale securities | 154,265 |
| | 82,126 |
|
| Accounts receivable, net | 5,511 |
| | 367 |
|
| Inventory | 5,121 |
| | 1,704 |
|
| Prepaid expenses and other current assets | 6,871 |
| | 3,662 |
|
| Total current assets | 228,373 |
| | 179,175 |
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| Property and equipment, net | 3,652 |
| | 3,132 |
|
| Available-for-sale securities, non-current | — |
| | 2,991 |
|
| Prepaid expenses and other non-current assets | 2,789 |
| | 878 |
|
| Total assets | $ | 234,814 |
| | $ | 186,176 |
|
| Liabilities and stockholders’ equity | | | |
| Current liabilities | | | |
| Accounts payable | $ | 6,570 |
| | $ | 3,878 |
|
| Accrued liabilities | 17,194 |
| | 12,385 |
|
| Other current liabilities | 512 |
| | 344 |
|
| Total current liabilities | 24,276 |
| | 16,607 |
|
| Long-term debt | 117,457 |
| | 102,647 |
|
| Other non-current liabilities | 3,196 |
| | 796 |
|
| Total liabilities | 144,929 |
| | 120,050 |
|
| Commitments and Contingencies (Note 8) |
| |
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| Stockholders’ equity | | | |
| Preferred stock, $0.001 par value — 5,000,000 shares authorized, and zero shares issued and outstanding at December 31, 2018 and December 31, 2017 | — |
| | — |
|
| Common stock, $0.001 par value — 100,000,000 shares authorized, 27,434,358 and 23,320,551 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively | 32 |
| | 28 |
|
| Additional paid-in capital | 432,815 |
| | 277,964 |
|
| Accumulated other comprehensive loss | (264 | ) | | (167 | ) |
| Accumulated deficit | (342,698 | ) | | (211,699 | ) |
| Total stockholders’ equity | 89,885 |
| | 66,126 |
|
| Total liabilities and stockholders’ equity | $ | 234,814 |
| | $ | 186,176 |
|
| | | | | | | | | | | |
| | December 31, |
| 2020 | | 2019 |
| Assets | | | |
| Current assets | | | |
| Cash and cash equivalents | $ | 71,660 | | | $ | 65,774 | |
| Available-for-sale securities | 11,705 | | | 66,833 | |
| Accounts receivable, net | 8,042 | | | 5,770 | |
| Inventory | 7,294 | | | 5,267 | |
| Prepaid expenses and other current assets | 13,035 | | | 6,676 | |
| Total current assets | 111,736 | | | 150,320 | |
| Property and equipment, net | 1,598 | | | 2,449 | |
| Operating lease right-of-use assets | 6,657 | | | 8,048 | |
| | | |
| Prepaid expenses and other non-current assets | 38 | | | 1,341 | |
| Total assets | $ | 120,029 | | | $ | 162,158 | |
| Liabilities and stockholders’ deficit | | | |
| Current liabilities | | | |
| Accounts payable | $ | 2,144 | | | $ | 6,932 | |
| Accrued liabilities | 27,164 | | | 16,117 | |
| Current portion of long-term debt | 3,657 | | | 2,041 | |
| Other current liabilities | 1,902 | | | 1,858 | |
| Total current liabilities | 34,867 | | | 26,948 | |
| Long-term debt | 126,307 | | | 125,674 | |
| Long-term portion of operating lease liabilities | 6,453 | | | 8,272 | |
| Other non-current liabilities | 2,378 | | | 2,157 | |
| Total liabilities | 170,005 | | | 163,051 | |
| Commitments and Contingencies (Note 9) | 0 | | 0 |
| Stockholders’ deficit | | | |
| Preferred stock, $0.001 par value — 5,000,000 shares authorized, and 0 shares issued and outstanding at December 31, 2020 and December 31, 2019 | 0 | | | 0 | |
| Common stock, $0.001 par value — 100,000,000 shares authorized, 28,866,956 and 27,964,778 shares issued and outstanding at December 31, 2020 and December 31, 2019, respectively | 34 | | | 33 | |
| Additional paid-in capital | 455,277 | | | 446,942 | |
| Accumulated other comprehensive income | 0 | | | 16 | |
| Accumulated deficit | (505,287) | | | (447,884) | |
| Total stockholders’ deficit | (49,976) | | | (893) | |
| Total liabilities and stockholders’ deficit | $ | 120,029 | | | $ | 162,158 | |
The accompanying notes are an integral part of these consolidated financial statements.
ADAMAS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
|
| | | | | | | | | | | |
| | Years Ended December 31, |
| | 2018 | | 2017 | | 2016 |
| Revenues: | | | | | |
| Product sales | $ | 34,046 |
| | $ | 568 |
| | $ | — |
|
| License and grant revenue | — |
| | 3 |
| | 572 |
|
| Total revenues | 34,046 |
| | 571 |
| | 572 |
|
| Costs and operating expenses: | | | | | |
| Cost of product sales | 633 |
| | 17 |
| | — |
|
| Research and development | 39,300 |
| | 27,168 |
| | 31,230 |
|
| Selling, general and administrative, net | 109,135 |
| | 61,312 |
| | 30,326 |
|
| Total costs and operating expenses | 149,068 |
| | 88,497 |
| | 61,556 |
|
| Loss from operations | (115,022 | ) | | (87,926 | ) | | (60,984 | ) |
| Interest and other income, net | 3,115 |
| | 1,351 |
| | 811 |
|
| Interest expense | (19,092 | ) | | (4,645 | ) | | — |
|
| Loss before income taxes | (130,999 | ) | | (91,220 | ) | | (60,173 | ) |
| Benefit for income taxes | — |
| | (1,730 | ) | | (115 | ) |
| Net loss | $ | (130,999 | ) | | $ | (89,490 | ) | | $ | (60,058 | ) |
| Net loss per share, basic and diluted | $ | (4.87 | ) | | $ | (3.97 | ) | | $ | (2.77 | ) |
| Weighted average shares used in computing net loss per share, basic and diluted | 26,886 |
| | 22,558 |
| | 21,711 |
|
| | | | | | | | | | | | | |
| | Years Ended December 31, |
| | 2020 | | 2019 | | |
| Revenues: | | | | | |
| Product sales | $ | 71,166 | | | $ | 54,637 | | | |
| Royalty revenue | 3,295 | | | 0 | | | |
| | | | | |
| Total revenues | 74,461 | | | 54,637 | | | |
| Costs and operating expenses: | | | | | |
| Cost of product sales | 2,038 | | | 2,469 | | | |
| Research and development | 9,746 | | | 30,034 | | | |
| Selling, general and administrative, net | 106,841 | | | 114,369 | | | |
| Total costs and operating expenses | 118,625 | | | 146,872 | | | |
| Loss from operations | (44,164) | | | (92,235) | | | |
| Interest and other income, net | 748 | | | 2,093 | | | |
| Interest expense | (13,987) | | | (15,044) | | | |
| | | | | |
| | | | | |
| Net loss | $ | (57,403) | | | $ | (105,186) | | | |
| | | | | |
| | | | | |
| | | | | |
| Net loss per share, basic and diluted | $ | (2.03) | | | $ | (3.80) | | | |
| | | | | |
| | | | | |
| Weighted average shares used in computing net loss per share, basic and diluted | 28,305 | | | 27,677 | | | |
| | | | | |
| | | | | |
The accompanying notes are an integral part of these consolidated financial statements.
ADAMAS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OFCOMPREHENSIVE LOSS
(in thousands)
|
| | | | | | | | | | | |
| | Years Ended December 31, |
| | 2018 | | 2017 | | 2016 |
| Net loss | $ | (130,999 | ) | | $ | (89,490 | ) | | $ | (60,058 | ) |
| Unrealized gain (loss) on available-for-sale securities | (97 | ) | | 26 |
| | (35 | ) |
| Comprehensive loss | $ | (131,096 | ) | | $ | (89,464 | ) | | $ | (60,093 | ) |
| | | | | | | | | | | | | |
| | Years Ended December 31, |
| | 2020 | | 2019 | | |
| Net loss | $ | (57,403) | | | $ | (105,186) | | | |
| Other comprehensive income (loss) | | | | | |
| Reclassification of realized gain on available-for-sale securities recognized in interest and other income, net | (34) | | | 0 | | | |
| Unrealized gain on available-for-sale securities | 18 | | | 280 | | | |
| Total other comprehensive income (loss) | (16) | | | 280 | | | |
| Comprehensive loss | $ | (57,419) | | | $ | (104,906) | | | |
The accompanying notes are an integral part of these consolidated financial statements.
ADAMAS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
(in thousands, except share data)
|
| | | | | | | | | | | | | | | | | | | | | | |
| | Common Stock | | Additional Paid-In Capital | | Accumulated Other Comprehensive Loss | | Accumulated Deficit | | Total Stockholders’ Equity |
| | Shares | | Amount | | | | |
| Balances at December 31, 2015 | 18,505,462 |
| | $ | 23 |
| | $ | 178,473 |
| | $ | (158 | ) | | $ | (62,151 | ) | | $ | 116,187 |
|
| Exercise of stock options | 586,956 |
| | 1 |
| | 3,041 |
| | — |
| | — |
| | 3,042 |
|
| Vesting of common stock | — |
| | — |
| | 34 |
| | — |
| | — |
| | 34 |
|
| Issuance of common stock in conjunction with Secondary Offering, net of commissions and issuance costs | 2,875,000 |
| | 3 |
| | 61,819 |
| | — |
| | — |
| | 61,822 |
|
| Net unrealized loss on available-for-sale securities | — |
| | — |
| | — |
| | (35 | ) | | — |
| | (35 | ) |
| Stock issued under employee stock purchase plan | 46,226 |
| | — |
| | 620 |
| | — |
| | — |
| | 620 |
|
| Stock-based compensation | — |
| | — |
| | 10,571 |
| | — |
| | — |
| | 10,571 |
|
| Net loss | — |
| | — |
| | — |
| | — |
| | (60,058 | ) | | (60,058 | ) |
| Balances at December 31, 2016 | 22,013,644 |
| | $ | 27 |
| | $ | 254,558 |
| | $ | (193 | ) | | $ | (122,209 | ) | | $ | 132,183 |
|
| Exercise of stock options | 1,183,353 |
| | 1 |
| | 9,033 |
| | — |
| | — |
| | 9,034 |
|
| Restricted stock units vested | 64,471 |
| | — |
| | 201 |
| | — |
| | — |
| | 201 |
|
| Stock issued under employee stock purchase plan | 59,083 |
| | — |
| | 766 |
| | — |
| | — |
| | 766 |
|
| Net unrealized gain on available-for-sale securities | — |
| | — |
| | — |
| | 26 |
| | — |
| | 26 |
|
| Stock-based compensation | — |
| | — |
| | 13,406 |
| | — |
| | — |
| | 13,406 |
|
| Net loss | — |
| | — |
| | — |
| | — |
| | (89,490 | ) | | (89,490 | ) |
| Balances at December 31, 2017 | 23,320,551 |
| | $ | 28 |
| | $ | 277,964 |
| | $ | (167 | ) | | $ | (211,699 | ) | | $ | 66,126 |
|
| Issuance of common stock in conjunction with Secondary Offering, net of commissions and issuance costs | 3,450,000 |
| | 4 |
| | 134,264 |
| | — |
| | — |
| | 134,268 |
|
| Exercise of stock options | 478,454 |
| | — |
| | 3,362 |
| | — |
| | — |
| | 3,362 |
|
| Restricted stock units vested | 105,396 |
| | — |
| | — |
| | — |
| | — |
| | — |
|
| Stock issued under employee stock purchase plan | 79,957 |
| | — |
| | 1,237 |
| | — |
| | — |
| | 1,237 |
|
| Net unrealized loss on available-for-sale securities | — |
| | — |
| | — |
| | (97 | ) | | — |
| | (97 | ) |
| Stock-based compensation | — |
| | — |
| | 15,988 |
| | — |
| | — |
| | 15,988 |
|
| Net loss | — |
| | — |
| | — |
| | — |
| | (130,999 | ) | | (130,999 | ) |
| Balances at December 31, 2018 | 27,434,358 |
| | $ | 32 |
| | $ | 432,815 |
| | $ | (264 | ) | | $ | (342,698 | ) | | $ | 89,885 |
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Common Stock | | Additional Paid-In Capital | | Accumulated Other Comprehensive Income (Loss) | | Accumulated Deficit | | Total Stockholders’ Equity (Deficit) | | | | |
| | Shares | | Amount | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| Balances at December 31, 2018 | 27,434,358 | | | $ | 32 | | | $ | 432,815 | | | $ | (264) | | | $ | (342,698) | | | $ | 89,885 | | | | | |
| | | | | | | | | | | | | | | |
| Exercise of stock options | 184,626 | | | — | | | 293 | | | — | | | — | | | 293 | | | | | |
| Restricted stock units vested | 151,288 | | | — | | | — | | | — | | | — | | | — | | | | | |
| Stock issued under employee stock purchase plan | 194,506 | | | 1 | | | 774 | | | — | | | — | | | 775 | | | | | |
| Other comprehensive income | — | | | — | | | — | | | 280 | | | — | | | 280 | | | | | |
| Stock-based compensation | — | | | — | | | 13,060 | | | — | | | — | | | 13,060 | | | | | |
| Net loss | — | | | — | | | — | | | — | | | (105,186) | | | (105,186) | | | | | |
| Balances at December 31, 2019 | 27,964,778 | | | $ | 33 | | | $ | 446,942 | | | $ | 16 | | | $ | (447,884) | | | $ | (893) | | | | | |
| Exercise of stock options | 237,425 | | | — | | | 176 | | | — | | | — | | | 176 | | | | | |
| Restricted stock units vested | 258,819 | | | — | | | — | | | — | | | — | | | — | | | | | |
| Stock issued under employee stock purchase plan | 188,531 | | | — | | | 437 | | | — | | | — | | | 437 | | | | | |
| Issuance of common stock in conjunction with equity offering, net of commissions and issuance costs | 217,403 | | | 1 | | | 1,040 | | | — | | | — | | | 1,041 | | | | | |
| Other comprehensive loss | — | | | — | | | — | | | (16) | | | — | | | (16) | | | | | |
| Stock-based compensation | — | | | — | | | 6,682 | | | — | | | — | | | 6,682 | | | | | |
| Net loss | — | | | — | | | — | | | — | | | (57,403) | | | (57,403) | | | | | |
| Balances at December 31, 2020 | 28,866,956 | | | $ | 34 | | | $ | 455,277 | | | $ | 0 | | | $ | (505,287) | | | $ | (49,976) | | | | | |
The accompanying notes are an integral part of these consolidated financial statements.
ADAMAS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
|
| | | | | | | | | | | |
| | Years Ended December 31, |
| | 2018 | | 2017 | | 2016 |
| Cash flows from operating activities | | | | | |
| Net loss | $ | (130,999 | ) | | $ | (89,490 | ) | | $ | (60,058 | ) |
| Adjustments to reconcile net loss to net cash used in operating activities | | | | | |
| Depreciation | 1,460 |
| | 1,194 |
| | 808 |
|
| Stock-based compensation | 15,786 |
| | 13,367 |
| | 10,571 |
|
| Accretion of interest expense | 19,092 |
| | 4,645 |
| | — |
|
| Change in fair value of embedded derivative liability | 882 |
| | (294 | ) | | — |
|
| Net accretion of discounts and amortization of premiums of available-for-sale securities | (1,045 | ) | | 456 |
| | (301 | ) |
| Loss on disposal of fixed assets | 123 |
| | — |
| | — |
|
| Provision for write-down of inventory | 232 |
| | — |
| | — |
|
| Changes in assets and liabilities | | | | | |
| Accrued interest of available-for-sale securities | 74 |
| | (161 | ) | | (2 | ) |
| Inventory | (3,273 | ) | | (1,646 | ) | | — |
|
| Prepaid expenses and other assets | (5,036 | ) | | (2,036 | ) | | 2,643 |
|
| Accounts receivable, net | (5,144 | ) | | 427 |
| | 490 |
|
| Accounts payable | 2,759 |
| | 333 |
| | 502 |
|
| Accrued liabilities and other liabilities | 866 |
| | 6,378 |
| | (2,721 | ) |
| Net cash used in operating activities | (104,223 | ) | | (66,827 | ) | | (48,068 | ) |
| Cash flows from investing activities | | | | | |
| Purchases of property and equipment | (1,064 | ) | | (1,258 | ) | | (1,624 | ) |
| Purchases of available-for-sale securities | (200,354 | ) | | (62,510 | ) | | (103,528 | ) |
| Maturities of available-for-sale securities | 132,080 |
| | 89,333 |
| | 78,443 |
|
| Net cash provided by (used in) investing activities | (69,338 | ) | | 25,565 |
| | (26,709 | ) |
| Cash flows from financing activities | | | | | |
| Proceeds from public offerings, net of offering costs | 134,268 |
| | — |
| | 61,822 |
|
| Proceeds from issuance of long-term debt | — |
| | 99,600 |
| | — |
|
| Payment of debt issuance costs | — |
| | (633 | ) | | — |
|
| Proceeds from issuance of common stock upon exercise of stock options | 3,345 |
| | 9,110 |
| | 2,966 |
|
| Proceeds from employee stock purchase plan | 1,237 |
| | 766 |
| | 620 |
|
| Net cash provided by financing activities | 138,850 |
| | 108,843 |
| | 65,408 |
|
| Net increase (decrease) in cash and cash equivalents | (34,711 | ) | | 67,581 |
| | (9,369 | ) |
| Cash and cash equivalents at beginning of period | 91,316 |
| | 23,735 |
| | 33,104 |
|
| Cash and cash equivalents at end of period | $ | 56,605 |
| | $ | 91,316 |
| | $ | 23,735 |
|
| Supplemental disclosure | | | | | |
| Cash paid for interest | $ | 2,618 |
| | $ | — |
| | $ | — |
|
| Supplemental disclosure of noncash activities | | | | | |
| Property and equipment in accounts payable and accrued expense | $ | 7 |
| | $ | 61 |
| | $ | 148 |
|
| Stock-based compensation capitalized in inventory | $ | 202 |
| | $ | 39 |
| | $ | — |
|
| Stock option exercise settled after period end | $ | 17 |
| | $ | — |
| | $ | 76 |
|
| Property and equipment acquired through tenant improvement allowance | $ | 1,129 |
| | $ | — |
| | $ | — |
|
| | | | | | | | | | | | | |
| | Years Ended December 31, |
| | 2020 | | 2019 | | |
| Cash flows from operating activities | | | | | |
| Net loss | $ | (57,403) | | | $ | (105,186) | | | |
| Adjustments to reconcile net loss to net cash used in operating activities | | | | | |
| Depreciation | 851 | | | 1,214 | | | |
| Stock-based compensation | 6,431 | | | 12,852 | | | |
| Accretion of interest expense | 13,987 | | | 15,044 | | | |
| Change in fair value of embedded derivative liability | 221 | | | 805 | | | |
| | | | | |
| Net accretion of discounts and amortization of premiums of available-for-sale securities | (135) | | | (1,219) | | | |
| | | | | |
| Realized gain on available-for-sale securities | (55) | | | 0 | | | |
| Provision for write-down of inventory | 595 | | | 884 | | | |
| Changes in assets and liabilities | | | | | |
| Accrued interest of available-for-sale securities | 362 | | | 50 | | | |
| Accounts receivable, net | (2,272) | | | (259) | | | |
| Inventory | (2,205) | | | (970) | | | |
| Prepaid expenses and other assets | (5,056) | | | 1,560 | | | |
| Operating lease right-of-use assets | 1,437 | | | 1,008 | | | |
| Accounts payable | (4,979) | | | 398 | | | |
| Current portion of long-term debt | (11,738) | | | (6,450) | | | |
| Long-term portion of operating lease liabilities | (1,696) | | | (1,188) | | | |
| Accrued liabilities and other liabilities | 10,947 | | | 678 | | | |
| Net cash used in operating activities | (50,708) | | | (80,779) | | | |
| Cash flows from investing activities | | | | | |
| Purchases of property and equipment | 0 | | | (18) | | | |
| Purchases of available-for-sale securities | (68,936) | | | (93,869) | | | |
| Maturities of available-for-sale securities | 106,810 | | | 182,750 | | | |
| Sales of available-for-sale securities | 17,066 | | | 0 | | | |
| Net cash provided by investing activities | 54,940 | | | 88,863 | | | |
| Cash flows from financing activities | | | | | |
| Proceeds from public offerings, net of offering costs | 1,041 | | | 0 | | | |
| | | | | |
| | | | | |
| Proceeds from Paycheck Protection Program Loan | 2,650 | | | 0 | | | |
| Repayment of Paycheck Protection Program Loan | (2,650) | | | 0 | | | |
| Proceeds from issuance of common stock upon exercise of stock options | 176 | | | 310 | | | |
| Proceeds from employee stock purchase plan | 437 | | | 775 | | | |
| | | | | |
| | | | | |
| Net cash provided by financing activities | 1,654 | | | 1,085 | | | |
| Net increase in cash and cash equivalents | 5,886 | | | 9,169 | | | |
| Cash and cash equivalents at beginning of period | 65,774 | | | 56,605 | | | |
| Cash and cash equivalents at end of period | $ | 71,660 | | | $ | 65,774 | | | |
| Supplemental disclosure | | | | | |
| | | | | |
| Cash paid for interest | $ | 11,738 | | | $ | 6,450 | | | |
| Supplemental disclosure of noncash activities | | | | | |
| | | | | |
| | | | | |
| Right-of-use assets obtained in exchange for operating lease liabilities | $ | 46 | | | $ | 9,056 | | | |
| | | | | |
| Stock-based compensation capitalized in inventory | $ | 251 | | | $ | 208 | | | |
| | | | | |
| | | | | |
The accompanying notes are an integral part of these consolidated financial statements.
ADAMAS PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
ADAMAS PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. DESCRIPTION OF BUSINESS
Adamas Pharmaceuticals, Inc. (the “Company”) focusesis a commercial-stage pharmaceutical company focused on pioneering time-dependent medicinesgrowing a portfolio of therapies to meaningfully enhance the daily living experienceaddress a range of those affected by CNS disorders.neurological diseases. In August 2017, the U.S. Food and Drug Administration (FDA) approved GOCOVRI™GOCOVRI® (amantadine) extended release capsules, (previously ADS-5102), the first and only FDA-approved medication indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. TheIn February 2021, the FDA approved a second indication for GOCOVRI for use as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes. On January 4, 2021, the Company is also advancing its pipelineacquired the global rights to OSMOLEX ER® (amantadine) extended release tablets from Osmotica Pharmaceuticals US LLC, a subsidiary of differentiated investigational programs, which includes: ADS-5102Osmotica Pharmaceuticals plc. In November 2012, the Company granted Forest Laboratories Holdings Limited “Forest”, an indirect wholly-owned subsidiary of Allergan plc (collectively “Allergan”) an exclusive license, with right to sublicense, certain of the Company’s intellectual property rights relating to human therapeutics containing memantine in developmentthe United States. In connection with these rights, Allergan markets and sells NAMZARIC® (memantine hydrochloride extended release and donepezil hydrochloride) capsules for the treatment of walking impairmentmoderate to severe dementia related to Alzheimer’s disease. In May 2020, the Company became entitled to receive royalties at rates in patients with multiple sclerosis; and ADS-4101 (lacosamide) modified release capsulesthe low double digits to mid-teens from Allergan for sales of NAMZARIC in development for the treatment of partial onset seizures in patients with epilepsy. The Company’s goal is to lessen the burden of chronic CNS disorders on patients, caregivers and society.United States.
The Company was incorporated in the State of Delaware on November 15, 2000, and operates as one1 segment. The Company’s headquarters and operations are located in Emeryville, California.
2. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”).
Use of Estimates
The preparation of the accompanying consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses in the consolidated financial statements and the accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition and variable consideration, lease assets and liabilities, clinical trial accruals, fair value of assets and liabilities including short-term and long-term classification, embedded derivatives, income taxes, inventory, and stock-based compensation. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results may differ from those estimates.
Risks and Uncertainties
The outbreak of the novel Coronavirus (“COVID-19”), which is understood to have begun in December 2019, continues to grow both within the U.S. and globally. The World Health Organization has declared the outbreak of COVID-19 to be a pandemic, and the U.S. federal government has declared it a national emergency. The Company is subject to risks and uncertainties as a result of the outbreak of COVID-19. Despite disruptions to the Company’s business operations, the COVID-19 pandemic did not significantly impact GOCOVRI prescription refill rates for the year ended December 31, 2020, and thus far management has observed no disruptions to its inventory on hand or planned manufacturing schedule. However, new prescription rates have been impacted due to several factors, including: a fluid environment in which office practices are changing frequently including many healthcare providers have temporarily closed their offices or are restricting patient visits; patients are postponing visits to healthcare provider facilities; and the sales force has moved to a mix of virtual and live interactions with healthcare providers, adapting to the local environment. While management believes this initial decline and continued impact on new prescriptions to be temporary, the duration and severity is dependent on future developments, including new information that may emerge concerning the actions taken to contain or prevent further spread, all of which are highly uncertain and cannot be predicted with confidence.
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As of the date of issuance of these consolidated financial statements, due to the numerous uncertainties surrounding the COVID-19 pandemic, the Company is unable to predict the extent to which the COVID-19 pandemic may materially adversely affect the Company’s future business, financial results, liquidity and cash flows.
Liquidity
During the last three fiscal years, the Company has funded its operations primarily through sales of GOCOVRI, through sales of its common stock, and to a lesser extent through royalties received on net sales of NAMZARIC. The Company made GOCOVRI available for physician and patient use in the fourth quarter of 2017, with a full commercial launch in January 2018. Prior to the generation of revenue from GOCOVRI, the Company had not generated any commercial revenue from the sale of its products. In January 2018, the Company completed a follow-on public offering of its common stock from which proceeds raised were approximately $134.3 million, net of underwriting discounts, commissions, and offering-related transaction costs. In November 2019, the Company entered into a sales agreement with Cowen and Company, LLC, pursuant to which it may, from time to time, issue and sell shares of common stock having an aggregate offering value of up to $50.0 million. As of December 31, 2020, the Company had issued 217,403 shares of common stock and raised net proceeds of $1.0 million under the sales agreement.
As of December 31, 2020, the Company had $83.4 million of cash, cash equivalents, and investments, which management believes will be sufficient to fund its projected operating requirements for at least 12 months from the issuance of these consolidated financial statements. However, it is possible that the Company will not achieve the progress it expects, because revenues from GOCOVRI may be less than anticipated, especially in light of the current COVID-19 pandemic.
Inventory
Inventory is stated at the lower of cost or estimated net realizable value with cost determined under the first-in first-out method. Inventory consists of raw materials, work-in-process, and GOCOVRI finished goods. Raw materials and work-in-process that may be utilized for both commercial and clinical programs are identical and, as a result, the inventory has an “alternative future use” as defined in authoritative guidance and are included in inventory. Amounts in inventory associated with clinical development programs are charged to research and development expense when the product enters the research and development process and can no longer be used for commercial purposes and, therefore, does not have “alternative future use”. Costs include active pharmaceutical ingredient (API), third-party contract manufacturing, third-party packaging services, freight, labor costs for personnel involved in the manufacturing process, and indirect overhead costs. If the Company identifies excess, obsolete or unsalable product, the Company will write down its inventory to its net realizable value in the period it is identified. During 2018, the Company recorded a $0.2 million write-down of GOCOVRI inventory. No such charges were recorded in 2017.
The Company begins capitalizing costs as inventory when the product candidate receives regulatory approval. Prior to regulatory approval, inventory costs related to product candidates are recorded as research and development expense. The Company received FDA approval for GOCOVRI on August 24, 2017, and began capitalizing inventory manufactured at the FDA approved location, after FDA approval.
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Cash and Cash Equivalents
Cash and cash equivalents consist of highly liquid investments with original maturities, when purchased, of less than three months.
Investments
The Company classifies its investments as “available-for-sale.” In general, these investments are free of trading restrictions. The Company carries these investments at fair value, based on quoted market prices or other readily available market information. Quoted market prices for U.S. government and corporate bonds include both principal and accrued interest components. Unrealized gains and losses are included in accumulated other comprehensive income, which is reflected as a separate component of stockholders’ equity in its Consolidated Balance Sheets.consolidated balance sheets. Gains and losses are recognized when realized as gains or losses in its Consolidated Statementsinterest and other income, net, in the consolidated statements of Income.operations. When the Company determines that an other-than-temporary decline in fair value has occurred, the amount of the decline that is related to a credit loss is recognized in income. Gains and losses are determined using the specific identification method. The Company considers all marketable debt securities with a maturity of less than one year to be short-term investments, with all others considered to be long-term investments.
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All of the Company’s available-for-sale securities are subject to a periodic impairment review. The Company recognizes an impairment charge when a decline in the fair value of its investments below the cost basis is judged to be other-than-temporary. Factors considered in determining whether a loss is temporary include the length of time and extent to which the investments’ fair value has been less than the cost basis, the financial condition and near-term prospects of the investee, extent of the loss related to credit of the issuer, the expected cash flows from the security, its intent to sell or hold the security, and whether or not the Company will be required to sell the security before the recovery of its amortized cost.
Consolidation
The consolidated financial statements include the accounts of the Company and its wholly ownedwholly-owned subsidiaries. Intercompany balances and transactions have been eliminated in consolidation.
Segments
In accordance with ASC 280-10-50, Segment Reporting, operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company operates in one1 reportable segment: the development and commercialization of therapeutics targeting chronic disorders of the central nervous system. All revenues for the years ended December 31, 2018, 2017,2020 and 20162019 were generated in the United States.
Revenue Recognition
Effective January 1, 2018, the Company adopted Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers, using the full retrospective transition method. The Company recognizes revenue upon transfer of control of promised products or services to customers in an amount that reflects the consideration the Company expects to receive in exchange for those products or services. The Company expenses incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that the Company would have recognized is one year or less.
To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct.
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Product sales
The Company’s product sales consist of U.S. sales of GOCOVRI. GOCOVRI was approved by the FDA on August 24, 2017, and the Company commenced shipments of GOCOVRI to a specialty pharmacy during October 2017. The Company sells its products principally to a specialty pharmacy and certain specialty distributors (each a “Customer” or collectively its “Customers”). These agreements with its Customers provide for transfer of title to the product at the time the product has been delivered to and accepted by the Customer. The Customer subsequently dispenses product directly to a patient. In addition, except for limited circumstances, the Customer has no right of product return to the Company.
The Company recognizes revenue on product sales when the Customer obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the Customer. The Company has determined that the delivery of its product to Customers constitutes a single performance obligation as there are no other promises to deliver goods or services. Shipping and handling activities are considered to be fulfillment activities and are not considered to be a separate performance obligation. The Company has assessed the existence of a significant financing component in the agreements with its Customers. The trade payment terms with its Customers do not exceed one year and therefore the Company has elected to apply the practical expedient and no amount of consideration has been allocated as a financing component.
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The Company considers the effects of items which can decrease the transaction price such as variable consideration and consideration payable to a Customer or payer. Amounts related to such items are estimated at contract inception and updated at the end of each reporting period as additional information becomes available. The amount of variable consideration may be constrained and is included in the transaction price only to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved. Revenue from product sales is recorded after considering the impact of the following variable consideration amounts at the time of revenue recognition:
Distribution Fees: Distribution fees include fees paid to the Company’s Customers for data and prompt payment discounts. Distribution fees are recorded based on contractual terms.
Rebates: Rebates include mandated discounts under the Medicaid Drug Rebate Program, Medicare Part D Prescription Drug Benefit Program, and TRICARE Retail Pharmacy Refunds Program (TRICARE)., and Managed Care contracts. Rebates are amounts owed after the final dispensing of the product to a benefit plan participant and are based upon contractual agreements or statutory requirements with benefit providers. Rebates are estimated based on statutory discount rates and expected utilization. The expected utilization of rebates is estimated based on data received from the specialty pharmacy and specialty distributor. The Company uses the expected-value method for estimating rebates and estimates are adjusted quarterly to reflect actual experience.
Chargebacks: Chargebacks are discounts that occur when Healthcare Providers purchase directly from a Customer. Healthcare Providers, which currently consist of Public Health Service institutions, non-profit clinics, government entities, group purchasing organizations, and health maintenance organizations, generally purchase the product at a discounted price. The Customer, in turn, charges back to the Company the difference between the price initially paid by the Customer and the discounted price paid by the Healthcare Providers to the Customer. The allowance for chargebacks is based on an estimate of sales through to Healthcare Providers from the Customer.
Product Returns: Consistent with industry practice, the Company offers limited product return rights and generally allows for the return of product that is damaged or defective, and within a few months prior to and up to a few months after the product expiration date. The Company does not allow product returns for product that has been dispensed to a patient. The Company considers several factors in the estimation of potential product returns, including expiration dates of the product shipped, the limited product return rights, third-party data in monitoring channel inventory levels, shelf life of the product, prescription trends, and other relevant factors. Product returns have been insignificant to date and are expected to be immaterial in the future.
Medicare Part D Coverage Gap: Medicare Part D coverage gap is a federal program to subsidize the costs of prescription drugs for Medicare beneficiaries in the United States, which mandates manufacturers to fund a portion of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. Funding of the coverage gap is generally invoiced and paid in arrears. The impact of the Medicare Part D coverage gap is estimated using the expected-value method based on an amount expected to be incurred for the current quarter’s activity based on expected utilization, plus an accrual balance for known prior quarters and is adjusted quarterly based on actual experience. The expected utilization of the Medicare Part D coverage gap is estimated based on data received from the specialty pharmacy and historical utilization.
Co-payment Assistance: The Company provides co-payment assistance to patients who have commercial insurance and meet certain eligibility requirements. Co-payment assistance is estimated using the expected-value method based on historical program participation and estimates of program redemption using data provided by third-party administrators.
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Each of the above items are variable consideration, are recorded at the time of revenue recognition, and require significant estimates, judgment and information obtained from external sources. The Company determined a significant reversal of revenue would not occur in a future period for the estimates of variable consideration detailed above and, therefore, the transaction price was not reduced during the periods presented. If management’s estimates differ from actual results, the Company will record adjustments that would affect product sales in the period of adjustment.
License agreement revenue
The Company generates revenue from collaboration and license agreements for the development and commercialization of products. Collaboration and license agreements may include non-refundable upfront license fees,
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partial or complete reimbursement of research and development costs, contingent consideration milestone payments based on the achievement of defined objectives, and royalties on sales of commercialized products. Such agreements may contain various promises to customers which are generally capable of being distinct and accounted for as separate performance obligations. The Company’s duties and responsibilities under the collaboration and license agreements typically include the license or transfer of intellectual property rights, obligations to provide research and development services and related materials, and obligations to participate on certain development and/or commercialization committees with the partners. These promises may be regarded as separate performance obligations, or bundled as a single performance obligation, depending upon the nature of the arrangement.
For agreements with multiple performance obligations, the Company allocates estimated revenue to each performance obligation at contract inception based on the estimated relative standalone selling price (SSP) of each performance obligation in the arrangement. Revenue allocated to each performance obligation is then recognized when the entity satisfies the performance obligation by transferring control of the promised good or service to the customer.
Licenses for Intellectual Property (IP): If the Company determines that the license for IP is distinct from the other performance obligations identified in the arrangement, revenue from non-refundable, up-front fees allocated to the license is recognized when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, judgment is applied to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
Milestone Payments: For contracts with customers that contain payments that are contingent upon achievement of a substantive milestone, at the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative SSP basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration and other revenues and earnings in the period of adjustment.
Reimbursement of Research and Development Costs: Amounts related to research and development funding and full-time equivalent employees assigned to the license agreement are recognized over time as the related services or activities are performed, in accordance with the contract terms.
Royalties: For arrangements that include sales-based royalties, and the licensed IP is deemed to be the predominant item to which the royalties relate, the Company recognizes the related royalty revenue at the later of (i) when the related sales occur, or (ii) the satisfaction or partial satisfaction of the performance obligation to which the royalty relates.
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Sales-based royalties are recorded based on estimated quarterly net sales of NAMZARIC. Differences between actual results and estimated amounts are adjusted in the period in which they become known, which typically follows the quarterly period in which the estimate is made. To date, actual royalties received have not differed materially from estimates. Receivables related to NAMZARIC royalties are recorded in prepaid expenses and other current assets on the consolidated balance sheets.
Cost of Product Sales
Cost of product sales consists primarily of direct and indirect costs related to the manufacturing of GOCOVRI products sold, including third-party manufacturing costs, packaging services, freight, and allocation of overhead costs. Cost of product sales may also include period costs related to certain inventory manufacturing services, inventory adjustment charges, as well as manufacturing variances. In connection with the FDA approval of GOCOVRI on August 24, 2017, the Company began capitalizing inventory manufactured at the FDA approved location starting in August
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2017. Prior to receiving regulatory approval for GOCOVRI from the FDA, the Company expensed all costs incurred in the manufacture of GOCOVRI as research and development.
Concentration of Risk
Credit Risk
Financial instruments that potentially subject the Company to credit risk consist principally of cash and cash equivalents and short and long-term investments. Cash, cash equivalents, and investments are deposited with financial institutions or invested in security issuers that management believes are credit worthy. Deposits may, at times, exceed the amount of insurance provided on such deposits. Risks associated with cash, cash equivalents, and investments are mitigated by the Company’s investment policy which defines allowable investments and establishes guidelines relating to credit quality, diversification, and maturities of its investments to preserve principal and maintain liquidity.
Major Customers
The Company has entered into distribution agreements with a specialty pharmacy and certain limited specialty distributors. For the yearyears ended December 31, 2018,2020 and 2019, the Company’s largest customer represented approximately 99%95% and 98% of the Company’s product revenue, respectively, and approximately 99%94% and 96% of the Company’s accounts receivable balance at December 31, 2018.2020 and 2019, respectively.
Major Suppliers
The Company does not currently have any of its own manufacturing facilities, and therefore it depends on an outsourced manufacturing strategy for the production of GOCOVRI for commercial use and for the production of its product candidates for clinical trials. The Company has contracts in place with one third-party manufacturer that is approved for the commercial production of GOCOVRI and onetwo third-party suppliersuppliers that isare approved for GOCOVRI’s active pharmaceutical ingredient. Although there are potential sources of supply other than the Company’s existing manufacturers and suppliers, any new supplier would be required to qualify under applicable regulatory requirements.
Accounts Receivable, net
The Company’s accounts receivable balance consists of amounts due from sales of GOCOVRI and amounts due from Allergan, in accordance with the contract terms of the license agreement.GOCOVRI. Receivables from sales of GOCOVRI are recorded net of allowances which generally include chargebacks, doubtful accounts, and discounts. Allergan receivables are for research and development funding and full-time equivalent employees assigned to the Allergan license agreement, as well as for reimbursement of external costs, recorded as contra-expense, associated with supporting prosecution and litigation of intellectual property rights.
The Company’s estimate of the allowance for doubtful accounts is based on an evaluation of the aging of its receivables. Accounts receivable balances are written off against the allowance when it is probable that the receivable will not be collected. Given the nature and historical collectability of the Company’s accounts receivable, the Company determined that an allowance for doubtful accounts was not required at December 31, 2018.2020.
Property and Equipment
Property and equipment are stated at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the assets. Leasehold improvements are amortized on a straight-line basis over the lesser of their useful life or the term of the lease. Maintenance and repairs are charged to expense as incurred, and improvements and betterments are capitalized. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are
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removed from the consolidated balance sheetsheets and any resulting gain or loss is reflected in operations in the period realized.
Estimated useful lives by major asset category are as follows:
|
| | | | |
| Useful Lives |
| Computer equipment and software | 3 years |
| Equipment | 5 years |
| Furniture and fixtures | 10 years |
Leases
At the inception ofThe Company determines if an arrangement is, or contains, a lease at inception. An arrangement is, or contains, a lease if it conveys the right to control the use of identified property, plant or equipment (i.e., an identified asset) for a
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period of time in exchange for consideration. The Company’s arrangements determined to be or contain a lease include explicitly or implicitly identified assets where the Company evaluateshas the lease agreementright to determine whethersubstantially all of the lease is an operating, capital or build-to-suit lease usingeconomic benefits of the criteria in ASC 840, “Leases.” Certain lease agreements also requireassets and has the Companyability to make additional paymentsdirect how and for taxes, insurance, and other operating expenses incurredwhat purpose the assets are used during the lease period, whichterm. Operating leases are expensed as incurred. Forincluded in operating leases,lease right-of-use (“ROU”) assets, other current liabilities, and operating lease liabilities on its consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term and any amounts probable of being owed under a residual value guarantee (if applicable). In determining the incremental borrowing rate used to calculate the present value of lease payments, the Company recognizes rentuses the interest rate specified in the lease. If the rate is not readily determinable, which is generally the case for the Company, the Company uses its incremental borrowing rate based on the information available at the commencement date. The operating lease ROU assets also include any lease payments made (including any prepaid rents and initial direct costs) and excludes lease incentives. The lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise any such options. Lease expense for lease payments is recognized on a straight-line basis over the expected lease termterm. The Company has lease agreements with lease components and recordsnon-lease components. For its facility and office equipment lease, the difference between cashCompany accounts for the lease and non-lease components separately. For its vehicle leases, the Company elected the practical expedient to not separate lease components, such as base rent payments, and the recognition of rent expense as a deferred liability. Where lease agreements contain rent escalation clauses, rent abatements and/or concessions,non-lease components, such as rent holidaysinterest, and tenant improvement allowances,also applies a portfolio approach to effectively account for the Company applies themoperating lease ROU assets and liabilities, given the volume of individual leases involved in the determination of straight-line expense over the lease term.overall arrangement.
Accounting for Long-Lived Assets
The Company reviews its long-lived assets, including property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by the comparison of the carrying amount to the future net cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the projected discounted future net cash flows arising from the asset. There have been no such impairments of long-lived assets as of December 31, 2018.2020.
Clinical Trial Accruals
The Company’s clinical trial accruals are based on estimates of patient enrollment and related activities at clinical investigator sites, as well as estimates for the services received and efforts expended pursuant to contracts with multiple research institutions and contract research organizations (“CROs”) that conduct and manage clinical trials on the Company’s behalf. The Company estimates clinical trial expenses based on the estimated services performed pursuant to these contracts, as provided by the CRO. These estimates are reviewed for reasonableness by the Company’s internal clinical personnel. The Company monitors patient enrollment levels and related activities using available information; however, if the Company underestimates activity levels associated with various studies at a given point in time, the Company could be required to record significant additional R&D expenses in future periods when the actual activity level becomes known. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. Payments made to third parties under these arrangements in advance of the receipt of the related services are recorded as prepaid expenses until the services are rendered.
Research and Development
Research and development (“R&D”) expenses include salaries and related compensation, contractor and consultant fees, external clinical trial expenses performed by CROs, licensing fees, acquired intellectual property with no alternative future use, and facility and administrative expense allocations. In addition, the Company funds R&D at research institutions under agreements that are generally cancelable at its option. Research costs typically consist of applied research and preclinical and toxicology work. Pharmaceutical manufacturing development costs consist of pre-approval inventory purchases, product formulation, chemical analysis, and the transfer and scale-up of manufacturing at facilities operated by the Company’s contract manufacturers. Clinical development costs include the costs of Phase 1, Phase 2, and Phase 3 clinical trials. These costs are a significant component of the Company’s research and development expenses.
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Long-Term Debt
Long-term debt consists of the Company’s royalty-backed loan agreement (“Royalty-Backed Loan”) with HealthCare Royalty Partners (“HCRP”HCR”). The Company accounted for the loan agreement as a debt financing arrangement. Interest expense is accrued using the effective interest rate method over the estimated period the debt will be repaid. Debt issuance costs have been recorded as a debt discount in the Company’s consolidated balance sheets and are being amortized and recorded as interest expense throughout the life of the loan using the effective interest rate method. The Company must make certain assumptions and estimates, including future royalties and net product sales, in determining the expected repayment term, amortization period of the debt discount, accretion of interest expense, as well as the classification between current and long-term portions. The Company periodically assesses these assumptions and estimates, and adjusts the liabilities accordingly. Under the terms of the loan, HCR has recourse to Adamas Pharma, LLC, not the Company. See Note 910 - Long-Term Debt, for further details of the Company’s long-term debt.
Embedded Derivatives Related to Debt Instruments
Embedded derivatives that are required to be bifurcated from their host contract are evaluated and valued separately from the debt instrument. Under the Company’s loan agreement with HCRP,HCR, upon the occurrence of a default or a change in control, the Company may be required to make mandatory prepayments of the borrowings. The prepayment premium is considered an embedded derivative, as the holder of the loans may exercise the option to require prepayment by the Company. Further, in the event of a regulatory change that results in a material adverse effect on HCRP’sHCR’s rate of return, the Company shall pay directly to HCRPHCR an amount that compensates HCRPHCR for such reduction. The embedded derivative is presented as a component of other non-current liabilities. The Company will remeasure the embedded derivatives each reporting period and report changes in the estimated fair value as gains or losses in interest and other income, net, in the consolidated statementstatements of operations.operations and in operating activities in the consolidated statements of cash flows.
Fair Value of Financial Instruments
The carrying value of the Company’s cash and cash equivalents, short-term investments, accounts receivable, long-term investments and other current assets, other assets, accounts payable, accrued liabilities approximate fair value due to the short-term nature or determinable value of these items. See also Note 3 - Fair Value Measurements for further details of the Company’s fair value instruments.
Income Taxes
The Company accounts for income taxes under the asset and liability approach. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized.
The Company follows the provisions of ASC 740, Income Taxes, under which it assesses all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by relevant taxing authorities. Assessing an uncertain tax position begins with the initial determination of the position’s sustainability and is measured at the largest amount of benefit that is greater than fifty percent likely of being realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed, and the Company will determine whether (i) the factors underlying the sustainability assertion have changed and (ii) the amount of the recognized tax benefit is still appropriate. The recognition and measurement of tax benefits requires significant judgment. Judgments concerning the recognition and measurement of a tax benefit might change as new information becomes available.
Basic and Diluted Net Loss Per Share
Basic net loss per share is based upon the weighted average number of common shares outstanding during the period. Diluted net loss per share is based upon the weighted average number of common shares outstanding and dilutive common stock equivalents outstanding during the period. Common stock equivalents are equity awards granted under the Company’s stock awards plans and are calculated under the treasury stock method. Common equivalent shares from unexercised stock options and unvested restricted stock units are excluded from the computation when there is a loss as
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their effect is anti-dilutive, or if the exercise price of such options is greater than the average market price of the stock for the period.
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Stock-Based Compensation
The Company accounts for stock-based compensation of stock options granted to employees and directors and for employee stock purchase plan shares by estimating the fair value of stock-based awards using the Black-Scholes option-pricing model. The Company accounts for stock-based compensation of restricted stock units granted to employees based on the closing price of the Company’s common stock on the date of grant. The fair value of stock-based awards, net of estimated forfeitures, is recognized and amortized over the applicable vesting period. All stock options awarded
Contingencies
In the normal course of business, the Company is involved from time to non-employeestime in various legal proceedings and other matters which are accountedcomplex in nature and have outcomes that are difficult to predict. The company records accruals for atloss contingencies when it is both probable that a liability has been incurred and the fair valueamount of the consideration received or the fair value of the equity instrument issued,loss can be reasonably estimated. The Company considers all relevant factors when making assessments regarding these contingencies. Litigation expenses are expensed as calculated using the Black-Scholes model. Stock options granted to non-employees are subject to periodic revaluation at each reporting date as the underlying equity instruments vest.incurred.
Recent Accounting Pronouncements
Accounting Pronouncements Adopted in 20182020
In May 2014,August 2018, the FASB issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers with amendments in 2015, 2016, and 2017. The amendment in this ASU provides guidance on the revenue recognition to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The core principle of this update provides guidance to identify the performance obligations under the contract(s) with a customer and how to allocate the transaction price2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the performance obligations inDisclosure Requirements for Fair Value Measurement, which modifies the contract. It further provides guidance to recognize revenue when (or as) the entity satisfies a performance obligation. In addition, the standard requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. This standard replaces most existing revenue recognition guidance.requirements on fair value measurements. The Company adopted the new standardguidance effective January 1, 2018, using the full retrospective transition method,2020, and determined the adoption of this guidance todid not have noa material impact on amounts previously reported in its consolidated financial statements. Disclosures are updated in Note 3 “Fair Value Measurements”.
ASU 2014-09 also codified the guidance on other assets and deferred costs relating to contracts with customers with the addition of ASC 340-40. This guidance relates to the accounting for costs of an entity to obtain and fulfill a contract to provide goods or services to the customer. Under the new guidance, an entity shall recognize as an asset the incremental costs of obtaining a contract with a customer if the entity expects to recover those costs. In the Company’s review of the various costs to obtain contracts with customers, it has determined that currently no significant costs are incurred that meet the capitalization criteria. The Company’s costs to fulfill contracts are outside the scope of ASC 340-40 and are typically expensed as incurred.
In May 2017,November 2018, the FASB issued ASU No. 2017-09, Compensation-Stock Compensation2018-18, Collaborative Arrangements (Topic 718) – Scope of Modification Accounting. The new guidance clarifies when808): Clarifying the Interaction between Topic 808 and Topic 606, which amends ASC 808 to account for a changeclarify ASC 606 should apply in entirety to the terms or conditions of a share-based payment award as a modification.certain transactions between collaborative arrangement participants. The Company adopted the new standardguidance effective January 1, 2018, on a prospective basis. The2020, and determined the adoption of this guidance did not have ana material impact on the Company’sits consolidated financial statements or disclosures.statements.
New Accounting Pronouncements Not Yet Adopted
In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). The authoritative guidance significantly amends the current accounting for leases. Under the new provisions, all lessees will report a right-of-use asset and a liability for the obligation to make payments for all leases with the exception of those leases with a term of 12 months or less. All other leases will fall into one of two categories: (i) a financing lease or (ii) an operating lease. Lessor accounting remains substantially unchanged with the exception that no leases entered into after the effective date will be classified as leveraged leases. For sale leaseback transactions, a sale will only be recognized if the criteria in the new revenue recognition standard are met. For public business entities, this guidance is effective for fiscal periods beginning after December 15, 2018 and interim periods thereafter. Early adoption is permitted. In July 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842 (Leases), which amends narrow aspects of the guidance issued in the amendments in ASU 2016-02,and ASU No. 2018-11, Leases (Topic 842): Targeted Improvements, which allows entities to recognize a cumulative-effect adjustment from the application of ASU 2016-02 to the opening balance of retained earnings in the period of adoption. The Company will adopt the standard in the first quarter of 2019 using this optional method. Pursuant to the guidance, the Company also plans to elect the optional package of practical expedients, which will allow the Company to not reassess: (i) whether any expired or existing contracts are considered or contain
ADAMAS PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
leases; (ii) lease classification for any expired or existing leases; and (iii) initial direct costs for any existing leases. The new standard also allows entities to make certain policy elections, including a policy to separate lease and non-lease components, which the Company also plans to elect. The Company is still evaluating the effect the new guidance will have on its consolidated financial statements and disclosures; however, it anticipates that the new standard will result in the Company recording additional right-of-use assets and corresponding lease liabilities on its consolidated balance sheet.
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments, andInstruments; in November 2018 the FASB issued a subsequent amendment ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments—Credit Losses.Losses; in April 2019 the FASB issued ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments—Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments; in May 2019 the FASB issued ASU No. 2019-05, Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief; and in November 2019 the FASB issued ASU No. 2019-11, Codification Improvements to Topic 326, Financial Instruments—Credit Losses. The new guidance changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. ThisIn November 2019 the FASB issued ASU No. 2019-10, Financial Instruments—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842)—Effective Dates, which defers the effective date of ASU 2016-13 for all entities except SEC reporting companies that are not smaller reporting companies. As a smaller reporting company, this guidance is effective for fiscal years beginning after December 15, 2019.2022. Early adoption is permitted. The Company is currently evaluating the timing and effect the new guidance will have on its consolidated financial statements.
In June 2018,December 2019, the FASB issued ASU 2018-07, Compensation – Stock Compensation2019-12, Income Taxes (Topic 718),Improvements to Nonemployee Share-Based Payment740)—Simplifying the Accounting for Income Taxes, which expands the scope of Topic 718is intended to include share-based payment transactions for acquiring goods and services from nonemployees. Previously,simplify accounting for share-based payments to employees was covered by ASC Topic 718 while accounting for such payments to non-employees was covered by ASC Subtopic 505-50. Under this new guidance, both sets of awards, for employees and non-employees, will essentially follow the same model, with small variations related to determining the term assumption when valuing a non-employee award as well as a different expense attribution model for non-employee awards as opposed to employee awards. This guidance is effective for fiscal years beginning after December 15, 2018. Early adoption is permitted. The Company is currently evaluating the effect the new guidance will have on its consolidated financial statements.
In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changesincome taxes. It removes certain exceptions to the Disclosure Requirements for Fair Value Measurement, which modifies the disclosure requirements on fair value measurements.general principles in Topic 740 and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019.2020. Early adoption is permitted. The Company is currently evaluating the effectdoes not expect the new guidance willto have a material impact on its consolidated financial statements.
In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606, which amends ASC 808 to clarify ASC 606 should apply in entirety to certain transactions between collaborative arrangement participants. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Early adoption is permitted. The Company is currently evaluating the effect the new guidance will have on its consolidated financial statements.
ADAMAS PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
3. FAIR VALUE MEASUREMENTS
In accordance with ASC 820-10, Fair Value Measurements and Disclosures, the Company determines the fair value of financial and non-financial assets and liabilities using the fair value hierarchy, which establishes three levels of inputs that may be used to measure fair value, as follows:
•Level 1 inputs, which include quoted prices in active markets for identical assets or liabilities;
•Level 2 inputs, which include observable inputs other than Level 1 inputs, such as quoted prices for similar assets or liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the asset or liability. For available-for-sale securities, the Company reviews trading activity and pricing as of the measurement date. When sufficient quoted pricing for identical securities is not available, the Company uses market pricing and other observable market inputs for similar securities obtained from various third-party data providers. These inputs either represent quoted prices for similar assets in active markets or have been derived from observable market data; and
ADAMAS PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
•Level 3 inputs, which include unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the underlying asset or liability. Level 3 assets and liabilities include those whose fair value measurements are determined using pricing models, discounted cash flow methodologies, or similar valuation techniques, as well as significant management judgment or estimation.
The following table represents the fair value hierarchy for the Company’s financial assets and liabilities which require fair value measurement on a recurring basis (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| | December 31, 2020 |
| | Total | | Level 1 | | Level 2 | | Level 3 |
| Assets: | | | | | | | |
| Money market | $ | 48,152 | | | $ | 48,152 | | | $ | 0 | | | $ | 0 | |
| Corporate debt | 6,706 | | | 0 | | | 6,706 | | | 0 | |
| U.S. Treasury securities | 4,999 | | | 0 | | | 4,999 | | | 0 | |
| | | | | | | |
| Total assets measured at fair value | $ | 59,857 | | | $ | 48,152 | | | $ | 11,705 | | | $ | 0 | |
| Liabilities: | | | | | | | |
| Embedded derivative liability | $ | 2,378 | | | $ | 0 | | | $ | 0 | | | $ | 2,378 | |
| Total liabilities measured at fair value | $ | 2,378 | | | $ | 0 | | | $ | 0 | | | $ | 2,378 | |
|
| | | | | | | | | | | | | | | |
| | December 31, 2018 |
| | Total | | Level 1 | | Level 2 | | Level 3 |
| Assets: | | | | | | | |
| Money market | $ | 17,789 |
| | $ | 17,789 |
| | $ | — |
| | $ | — |
|
| Corporate debt | 19,792 |
| | — |
| | 19,792 |
| | — |
|
| U.S. Treasury notes | 131,512 |
| | — |
| | 131,512 |
| | — |
|
| Commercial paper | $ | 2,961 |
| | $ | — |
| | $ | 2,961 |
| | $ | — |
|
| Total assets measured at fair value | $ | 172,054 |
| | $ | 17,789 |
| | $ | 154,265 |
| | $ | — |
|
| Liabilities: | | | | | | | |
| Embedded derivative liability | $ | 1,352 |
| | $ | — |
| | $ | — |
| | $ | 1,352 |
|
| Total liabilities measured at fair value | $ | 1,352 |
| | $ | — |
| | $ | — |
| | $ | 1,352 |
|
| | | | December 31, 2017 | | December 31, 2019 |
| | Total | | Level 1 | | Level 2 | | Level 3 | | Total | | Level 1 | | Level 2 | | Level 3 |
| Assets: | | | | | | | | Assets: | | | | | | | |
| Money market | $ | 68,501 |
| | $ | 68,501 |
| | $ | — |
| | $ | — |
| Money market | $ | 27,720 | | | $ | 27,720 | | | $ | 0 | | | $ | 0 | |
| Corporate debt | 23,471 |
| | — |
| | 23,471 |
| | — |
| Corporate debt | 22,576 | | | 0 | | | 22,576 | | | 0 | |
| U.S. Treasury notes | 61,646 |
| | — |
| | 61,646 |
| | — |
| |
| U.S. Treasury securities | | U.S. Treasury securities | 37,811 | | | 0 | | | 37,811 | | | 0 | |
| Commercial paper | | Commercial paper | 10,928 | | | 0 | | | 10,928 | | | 0 | |
| Total assets measured at fair value | $ | 153,618 |
| | $ | 68,501 |
| | $ | 85,117 |
| | $ | — |
| Total assets measured at fair value | $ | 99,035 | | | $ | 27,720 | | | $ | 71,315 | | | $ | 0 | |
| Liabilities: | | | | | | | | Liabilities: | | | | | | | |
| Embedded derivative liability | $ | 470 |
| | $ | — |
| | $ | — |
| | $ | 470 |
| Embedded derivative liability | $ | 2,157 | | | $ | 0 | | | $ | 0 | | | $ | 2,157 | |
| Total liabilities measured at fair value | $ | 470 |
| | $ | — |
| | $ | — |
| | $ | 470 |
| Total liabilities measured at fair value | $ | 2,157 | | | $ | 0 | | | $ | 0 | | | $ | 2,157 | |
Money market funds are highly liquid investments and are actively traded. The pricing information on these investment instruments are readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 of the fair value hierarchy.
ADAMAS PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
Corporate debt, U.S. Treasury notes,securities, and commercial paper are measured at fair value using Level 2 inputs. The Company reviews trading activity and pricing for these investments as of each measurement date. When sufficient quoted pricing for identical securities is not available, the Company uses market pricing and other observable market inputs for similar securities obtained from various third-party data providers. These inputs represent quoted prices for similar assets in active markets or these inputs have been derived from observable market data. This approach results in the classification of these securities as Level 2 of the fair value hierarchy. In certain cases where there is limited activity or less transparency around inputs to valuation, the related assets or liabilities are classified as Level 3. The Company classified an embedded derivative related to theits Royalty-Backed Loan with HCR as a Level 3 liability.
The fair value of the embedded derivative as a result of a change in control was calculated using a probability-weighted discounted cash flow model. The model used in valuing this embedded derivative requires the use of significant estimates and assumptions including but not limited to: 1) expected cash flows the Company expects to receive on U.S. net sales of GOCOVRI and on royalties from Allergan on U.S. net sales of Namzaric;NAMZARIC; 2) the Company’s risk adjusted discount rates; and 3) the probability of a change in control occurring during the term of the note based on the percentage of similar companies that were acquired over the previous five year period. Changes in the estimated fair value of the bifurcated embedded derivative are reported as gains or losses in interest and other income, net, in the consolidated statementstatements of operations. In the periods presented, the Company evaluated the embedded derivative value as
ADAMAS PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
a result of an event of default and the value as a result of increased costs due to a regulatory change and considered both to have no material value based on current assessment of probability, but could become material in future periods if a specified event of default or regulatory change became more probable than is currently estimated. See Note 910 “Long-Term Debt” for further description.
At December 31, 2020, the embedded derivative related to the Royalty-Backed Loan was the only recurring fair value measurement with Level 3 unobservable inputs. A risk-adjusted discount rate of 16.7% and a probability of a change in control of 3.0% were applied to calculate the value of the embedded derivative. Significant increases (or decreases) in the discount rate, and significant increases (or decreases) in the probability of a change in control would result in a significantly higher (or lower) fair value measurement.
The following table sets forth a summary of the changes in the estimated fair value of the Company’s embedded derivative, which isLevel 3 liabilities measured at fair value as a Level 3 liability on a recurring basis for the years ended December 31, 2020 and 2019 (in thousands):
|
| | | | |
| Balance as of December 31, 2016 | | $ | — |
|
| Issuance of long-term debt with embedded derivative | | 764 |
|
| Change in fair value included in interest and other income, net | | (294 | ) |
| Balance as of December 31, 2017 | | 470 |
|
| Change in fair value included in interest and other income, net | | 882 |
|
| Balance as of December 31, 2018 | | $ | 1,352 |
|
| | | | | | | | |
| | |
| | |
| | |
| Balance as of December 31, 2018 | | $ | 1,352 | |
| Change in fair value included in interest and other income, net | | 805 | |
| Balance as of December 31, 2019 | | 2,157 | |
| Change in fair value included in interest and other income, net | | 221 | |
| Balance as of December 31, 2020 | | $ | 2,378 | |
There were no transfers between anyinto or out of the levels of the fair value hierarchyLevel 3 during the years ended December 31, 20182020 and 2017.2019.
4. INVESTMENTS
The Company’s investments consist of corporate debt, U.S. Treasury notes,securities, and commercial paper classified as available-for-sale securities.
The Company limits the amount of investment exposure as to institution, maturity, and investment type. To mitigate credit risk, the Company invests in investment grade corporate debt, United StatesU.S. Treasury notes,securities, and commercial paper. Such securities are reported at fair value, with unrealized gains and losses excluded from earnings and shown separately as a component of accumulated other comprehensive lossincome (loss) within stockholders’ equity. Realized gains and losses are reclassified from other comprehensive lossincome (loss) to other income on the consolidated statements of operations when incurred. The Company may pay a premium or receive a discount upon the purchase of available-for-sale securities. Interest earned and gains realized on available-for-sale securities and amortization of discounts received and accretion of premiums paid on the purchase of available-for-sale securities are included in investment income.
ADAMAS PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
The following table is a summary of amortized cost, unrealized gain and loss, and the fair value of available-for-sale securities as of December 31, 2018,2020, and 20172019 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| December 31, 2020 |
| Amortized Cost | | Gross Unrealized Gains | | Gross Unrealized Losses | | Fair Value |
| | | |
| Investments: | | | | | | | |
| Corporate debt | $ | 6,706 | | | $ | 0 | | | $ | 0 | | | $ | 6,706 | |
| U.S. Treasury securities | 4,999 | | | 0 | | | 0 | | | 4,999 | |
| | | | | | | |
| Total | $ | 11,705 | | | $ | 0 | | | $ | 0 | | | $ | 11,705 | |
| Reported as: | | | | | | | |
| Short-term investments | $ | 11,705 | | | $ | 0 | | | $ | 0 | | | $ | 11,705 | |
| | | | | | | |
| Total | $ | 11,705 | | | $ | 0 | | | $ | 0 | | | $ | 11,705 | |
|
| | | | | | | | | | | | | | | |
| | December 31, 2018 |
| | | | Gross Unrealized | | Gross Unrealized | | |
| | Amortized Cost | | Gains | | Losses | | Fair Value |
| Investments: | | | | | | | |
| Corporate debt | $ | 19,833 |
| | $ | — |
| | $ | (41 | ) | | $ | 19,792 |
|
| U.S. Treasury notes | 131,735 |
| | 10 |
| | (233 | ) | | 131,512 |
|
| Commercial paper | 2,961 |
| | — |
| | — |
| | 2,961 |
|
| Total | $ | 154,529 |
| | $ | 10 |
| | $ | (274 | ) | | $ | 154,265 |
|
| Reported as: | | | |
| | |
| | |
|
| Short-term investments | $ | 154,529 |
| | $ | 10 |
| | $ | (274 | ) | | $ | 154,265 |
|
| Long-term investments | — |
| | — |
| | — |
| | — |
|
| Total | $ | 154,529 |
| | $ | 10 |
| | $ | (274 | ) | | $ | 154,265 |
|
ADAMAS PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
| | | | December 31, 2017 | | December 31, 2019 |
| | | | Gross Unrealized | | Gross Unrealized | | | | Amortized Cost | | Gross Unrealized Gains | | Gross Unrealized Losses | | Fair Value |
| | Amortized Cost | | Gains | | Losses | | Fair Value | | |
| Investments: | | | | | | | | Investments: | | | | | | | |
| Corporate debt | $ | 23,507 |
| | $ | — |
| | $ | (36 | ) | | $ | 23,471 |
| Corporate debt | $ | 22,582 | | | $ | 3 | | | $ | (9) | | | $ | 22,576 | |
| U.S. Treasury notes | 61,777 |
| | — |
| | (131 | ) | | 61,646 |
| |
| U.S. Treasury securities | | U.S. Treasury securities | 37,789 | | | 22 | | | 0 | | | 37,811 | |
| Commercial paper | | Commercial paper | 6,446 | | | 0 | | | 0 | | | 6,446 | |
| Total | $ | 85,284 |
| | $ | — |
| | $ | (167 | ) | | $ | 85,117 |
| Total | $ | 66,817 | | | $ | 25 | | | $ | (9) | | | $ | 66,833 | |
| Reported as: | | | |
| | |
| | |
| Reported as: | | | | | | | |
| Short-term investments | $ | 82,280 |
| | $ | — |
| | $ | (154 | ) | | $ | 82,126 |
| Short-term investments | $ | 66,817 | | | $ | 25 | | | $ | (9) | | | $ | 66,833 | |
| Long-term investments | 3,004 |
| | — |
| | (13 | ) | | 2,991 |
| |
| | Total | $ | 85,284 |
| | $ | — |
| | $ | (167 | ) | | $ | 85,117 |
| Total | $ | 66,817 | | | $ | 25 | | | $ | (9) | | | $ | 66,833 | |
Short-term investments include accrued interest of $0.5$0.1 million and $0.4 million as of December 31, 2018. Short-term2020 and long-term investments includes accrued interest of $0.6 million and $14,000, respectively, as of2019, respectively. For the year ended December 31, 2017. The Company has not incurred any2020, there were gross realized gains on investments of $55,000 and 0 gross realized losses. There were 0 gross realized gains or losses on investments for the yearsyear ended December 31, 20182019. Realized gains are reflected in interest and 2017.other income, net, in the consolidated statements of operations, using the specific-identification method. Investments are classified as short-term or long-term depending on the underlying investment’s maturity date. The Company had no investments with a maturity date of greater than 12 months as of December 31, 2018.2020 and 2019. All investments with unrealized losses at December 31, 2018,2020, have been in a loss position for less than twelve months or the loss is not material and were temporary in nature. The Company does not intend to sell the investments that are in an unrealized loss position before recovery of their amortized cost basis.
5. BALANCE SHEET COMPONENTS
| | | | | | | | | | | |
| Prepaid expenses and other current assets (in thousands) | | | |
| December 31, |
| 2020 | | 2019 |
| Insurance litigation recovery | $ | 7,500 | | | $ | 0 | |
| Prepaid expenses | 3,126 | | | 2,624 | |
| Royalty receivables | 1,252 | | | 0 | |
| Prepaid clinical trial | 928 | | | 2,710 | |
| Income tax receivable | 0 | | | 1,259 | |
| Other current assets | 229 | | | 83 | |
| Prepaid expenses and other current assets | $ | 13,035 | | | $ | 6,676 | |
ADAMAS PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
|
| | | | | | | |
| Prepaid expenses and other current assets (in thousands) | | | |
| | December 31, |
| | 2018 | | 2017 |
| Prepaid expenses | $ | 2,969 |
| | $ | 2,638 |
|
| Prepaid clinical trial | 2,299 |
| | — |
|
| Income tax receivable | 840 |
| | 1,007 |
|
| Other current assets | 763 |
| | 17 |
|
| Prepaid expenses and other current assets | $ | 6,871 |
| | $ | 3,662 |
|
| | Property and equipment, net (in thousands) | | | | Property and equipment, net (in thousands) | |
| | December 31, | | December 31, |
| | 2018 | | 2017 | | 2020 | | 2019 |
| Computer equipment and software | $ | 3,286 |
| | $ | 3,289 |
| Computer equipment and software | $ | 3,297 | | | $ | 3,297 | |
| Equipment | 384 |
| | 252 |
| Equipment | 384 | | | 384 | |
| Furniture and fixtures | 336 |
| | 466 |
| Furniture and fixtures | 336 | | | 336 | |
| Leasehold improvements | 1,891 |
| | 1,645 |
| Leasehold improvements | 1,891 | | | 1,891 | |
| | 5,897 |
| | 5,652 |
| | 5,908 | | | 5,908 | |
| Less: Accumulated depreciation and amortization | (2,245 | ) | | (2,520 | ) | Less: Accumulated depreciation and amortization | (4,310) | | | (3,459) | |
| Property and equipment, net | $ | 3,652 |
| | $ | 3,132 |
| Property and equipment, net | $ | 1,598 | | | $ | 2,449 | |
Depreciation expense was $1.5 million, $1.2$0.9 million and $0.8$1.2 million for the years ended December 31, 2018, 2017,2020 and 2016,2019, respectively.
| | | | | | | | | | | |
| Accrued liabilities (in thousands) | | | |
| | December 31, |
| | 2020 | | 2019 |
| Litigation settlement liability (see Note 9) | $ | 7,500 | | | $ | 0 | |
| Accrued employee related costs | 9,403 | | | 7,682 | |
| Patent litigation settlement liability (see Note 9) | 5,000 | | | 0 | |
| Clinical trial accruals | 616 | | | 1,680 | |
| Accrued consulting and other professional fees | 2,657 | | | 4,867 | |
| | | |
| | | |
| Accrued sales deductions | 1,571 | | | 1,822 | |
| Other | 417 | | | 66 | |
| Accrued liabilities | $ | 27,164 | | | $ | 16,117 | |
ADAMAS PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
|
| | | | | | | |
| Accrued liabilities (in thousands) | | | |
| | December 31, |
| | 2018 | | 2017 |
| Accrued employee related costs | $ | 7,472 |
| | $ | 5,499 |
|
| Clinical trial accruals | 2,434 |
| | 1,720 |
|
| Accrued consulting and other professional fees | 4,230 |
| | 4,897 |
|
| Current portion of long-term debt | 1,664 |
| | — |
|
| Accrued sales deductions | 1,053 |
| | 91 |
|
| Other | 341 |
| | 178 |
|
| Accrued liabilities | $ | 17,194 |
| | $ | 12,385 |
|
6. INVENTORY
TheIf the Company began capitalizingidentifies excess, obsolete, or unsalable product, the Company will write down its inventory to net realizable value in August 2017 once the FDA approved GOCOVRI.period it is identified. During the years ended December 31, 2020 and 2019, the Company recorded a provision for the write-down of inventory to cost of sales of $0.6 million and $0.9 million, respectively. Inventory consists of the following (in thousands):
| | | | | | | | | | | |
| December 31, |
| 2020 | | 2019 |
| Raw materials | $ | 795 | | | $ | 1,057 | |
| Work-in-process | 4,403 | | | 1,925 | |
| Finished goods | 2,096 | | | 2,285 | |
| Total inventory | $ | 7,294 | | | $ | 5,267 | |
|
| | | | | | | |
| | December 31, 2018 | | December 31, 2017 |
| Raw materials | $ | 1,330 |
| | $ | 859 |
|
| Work-in-process | 2,174 |
| | 817 |
|
| Finished goods | 1,617 |
| | 28 |
|
| Total inventory | $ | 5,121 |
| | $ | 1,704 |
|
7. LICENSE AGREEMENTS
In November 2012, the Company granted Forest Laboratories Holdings Limited “Forest”, an indirect, wholly-owned subsidiary of Allergan plc (collectively “Allergan”) an exclusive license, with right to sublicense, certain of the Company’s intellectual property rights relating to human therapeutics containing memantine in the United States. In connection with these rights, Allergan markets and sells Namzaric®NAMZARIC and NamendaNAMENDA XR® for the treatment of moderate to severe dementia related to Alzheimer’s disease.
Pursuant to the agreement, Allergan made an upfront payment of $65.0 million which the Company recognized as revenue on a straight-line basis over the period from November 2012 to February 2013.
million. The Company earned and received additional cash payments totaling $95.0 million upon achievement by Allergan of certain development and
ADAMAS PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
regulatory milestones. In November and December 2013, the Company received a total of $40.0 million in milestone payments for the successful completion of studies that supported the New Drug Application (“NDA”) filing with the FDA for Namzaric by Allergan. In May 2014, the Company received an additional $25.0 million milestone payment as a result of the FDA’s acceptance of the NDA for Namzaric. In December 2014, the Company received a final $30.0 million milestone payment in connection with the FDA approval of Namzaric. These amounts were recorded as revenue when received during 2013 and 2014, respectively.
Under the agreement, external costs incurred related to the prosecution and litigation of intellectual property rights are reimbursable. Reimbursable external costs are recorded as a reduction to selling, general and administrative, net. For the twelve months ended December 31, 20182020 and 2017,2019, there were $1,000 and $33,000 of0 reimbursable external costs respectively.for prosecution or litigation of intellectual property rights were not material.
In addition, the Company may earn tiered royalty payments based on future net sales of NamzaricNAMZARIC and Namenda XR; however, Allergan’s obligation to pay royalties for any product covered by the license is eliminated in any quarter where there is significant competition from generics.NAMENDA XR. Beginning in May 2020, the Company will bebecame entitled to receive royalties at rates in the low double digits to mid-teens from Allergan for sales of NamzaricNAMZARIC in the United States. The Company recognized $3.3 million in NAMZARIC royalty revenue for the twelve months ended December 31, 2020, and recognized 0 royalty revenue for the twelve months ended December 31, 2019. Allergan’s obligation to pay royalties with respect to fixed-dose memantine-donepezil products, including Namzaric,NAMZARIC, continues until the later of (i) 15
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
years after the commercial launch of the first fixed-dose memantine-donepezil product by Allergan in the United States or (ii) the expiration of the Orange Book listed patents for which Allergan obtained rights from the Company covering such product.product, but is eliminated in any quarter where there is significant competition from generics. Based on Allergan’s and the Company’s current settlement agreements with the NAMZARIC ANDA filers to date, the earliest date on which any of these agreements grant a license to market a NAMZARIC ANDA filer’s generic version of NAMZARIC is January 1, 2025 (or earlier in certain circumstances). Alternatively, the NAMZARIC ANDA filers with the earliest license date have the option to launch an authorized generic version of NAMZARIC beginning on January 1, 2026 instead of launching their own generic version of NAMZARIC on January 1, 2025. For further discussion of NAMZARIC ANDA filers, see Litigation and Other Legal Proceedings in “Note 9 - Commitments and Contingencies.” Beginning in June 2018, the Company was entitled to receive royalties at rates in the low to mid-single digits for sales of NamendaNAMENDA XR in the United States. The Company does not expect to receive royalties on net sales of NamendaNAMENDA XR, due to the entry of generic versions of NamendaNAMENDA XR.
The Company evaluated the Allergan agreement under Topic 606. Based on that evaluation, the Company has determined that at the date of adoption it has satisfied all performance obligations associated with the upfront and milestone payments for each comparative period presented. Royalties under the license agreement will be recognized when the related sales occur, in accordance with the sales-based royalty exception.
8. COMMITMENTS AND CONTINGENCIESLEASES
Lease Commitments
The Company performed an evaluation of its contracts in accordance with Topic 842 and determined that, except for its facility, vehicle, and office equipment leases, described below, none of its other contracts contain a lease. The Company evaluated all its leases and determined they were operating leases.
In January 2018, the Company amended its Emeryville, California, operatingoffice facility lease agreement to extend the term of its lease from April 30, 2020, to April 30, 2025, and relocate and expand its office space from 18,500 square feet to 37,626 rentable square feet within the same building. The lease contains an option to extend the term for 1 additional five-year period. The extension option has not been considered in the determination of the right-of-use asset or the lease liability as the Company completed its relocation during the third quarter of 2018.did not consider it reasonably certain that it would exercise such option. The lease provides for a tenant improvement allowance of approximately $1.1 million, which the Company fully utilized during the third quarter of 2018. The tenant improvement allowance is accounted
In 2018, the Company entered into a three-year lease for as a lease incentive obligationoffice equipment that commenced in June 2018 and amortized as a reduction of rent expense on a straight-line basis overwill be required to make cash payments totaling $0.2 million during the term of the lease. The
In March 2019, the Company entered into a three-year vehicle lease provides for periods of escalating rent. The total cash payments over the lifeagreement, pursuant to which it currently leases 67 vehicles. Delivery of the lease are divided byvehicles commenced during the total numbersecond quarter of 2019. The term for each leased vehicle commences upon the delivery of the vehicle and is for a period of 12 months, inwith renewal terms at the Company’s discretion that can extend the lease period andterm up to 50 months.
As of December 31, 2020, the average rent is chargedCompany did not have additional operating leases that have not yet commenced.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
Supplemental balance sheet information related to expense each month during the lease period. operating leases were as follows (in thousands):
| | | | | | | | | | | |
| December 31, |
| | 2020 | | 2019 |
| Assets | | | |
| Operating lease right-of-use assets | $ | 6,657 | | | $ | 8,048 | |
| Total right-of-use assets | $ | 6,657 | | | $ | 8,048 | |
| Liabilities | | | |
| Current portion included in other current liabilities | $ | 1,855 | | | $ | 1,669 | |
| Long-term portion of operating lease liabilities | 6,453 | | | 8,272 | |
| Total operating lease liabilities | $ | 8,308 | | | $ | 9,941 | |
The Company’s total rent expenselease cost was approximately $1.2 million, $0.7$2.8 million and $0.6$2.4 million for the years ended December 31, 2018, 2017,2020 and 2016,2019, respectively. The components of lease costs, which were included in selling, general and administrative, net in its consolidated statements of operations, were as follows (in thousands):
| | | | | | | | | | | | | |
| Years Ended December 31, |
| 2020 | | 2019 | | |
| Operating lease cost | $ | 2,373 | | | $ | 2,037 | | | |
| Variable lease cost | 464 | | | 320 | | | |
| Total lease cost | $ | 2,837 | | | $ | 2,357 | | | |
As of December 31, 2020, the maturities of operating lease liabilities were as follows (in thousands):
| | | | | |
| | Operating leases |
| 2021 | $ | 2,622 | |
| 2022 | 2,446 | |
| 2023 | 2,191 | |
| 2024 | 2,247 | |
| 2025 | 764 | |
| Thereafter | 0 | |
| Total lease payments | 10,270 | |
| Less: Imputed interest | (1,962) | |
| Operating lease liabilities | $ | 8,308 | |
As of December 31, 2020, the weighted average remaining lease term is 4.1 years and the weighted average operating discount rate used to determine the operating lease liability was 10.5%.
9. COMMITMENTS AND CONTINGENCIES
Purchase Commitments
The Company has entered into agreements for the supply of APIactive pharmaceutical ingredients with Moehs Ibérica, S.L. and AMSA S.p.A., and the manufacture of commercial supply of GOCOVRI with Moehs Ibérica, S.L. and Catalent Pharma Solutions, LLC, respectively.LLC. Under the terms of the agreements, the Company will supply the vendors with non-cancelable firm commitment purchase orders and must meet certain annual minimum requirements for the manufacture of commercial supply of GOCOVRI.orders. The Company has also entered into other agreements with certain vendors for the provision of services, including services related to data access and packaging, under which the Company is contractually obligated to make certain payments to the vendors.
The Company enters into contracts in the normal course of business that include, among others, arrangements with CROs for clinical trials, vendors for preclinical research, and vendors for manufacturing. These contracts generally provide for termination upon notice, and therefore the Company believes that its obligations under these agreements are not material.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
As of December 31, 2018, future minimum lease payments under2020, the non-cancelable facility operating lease,Company had non-cancelable purchase commitments and annual minimum requirements were as follows (in thousands):
|
| | | |
| | December 31, 2018 |
| 2019 | $ | 6,064 |
|
| 2020 | 3,733 |
|
| 2021 | 3,406 |
|
| 2022 | 3,468 |
|
| 2023 | 2,181 |
|
| Thereafter | 3,011 |
|
| Total | $ | 21,863 |
|
Contingencies
In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. The Company’s exposure under these
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
agreements is unknown, because it involves claims that may be made against the Company in the future, but have not yet been made. The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated.
Indemnification
In accordance with the Company’s amended and restated certificate of incorporation and amended and restated bylaws, the Company has indemnification obligations to its officers and directors for certain events or occurrences, subject to certain limits, while they are serving in such capacity. There have been no claims to date, and theThe Company has a directors and officers liability insurance policy that may enable it to recover a portion of any amounts paid for future claims. In addition, in the normal course of business, the Company enters into contracts and agreements that may contain a variety of representations and warranties and provide for general indemnifications.
Litigation and Other Legal Proceedings
In November 2012, the Company granted Forest an exclusive license to certain of the Company’s intellectual property rights relating to human therapeutics containing memantine in the United States. Under the terms of that license agreement, Forest has the right to enforce such intellectual property rights which are related to its right to market and sell NamzaricNAMZARIC and NamendaNAMENDA XR for the treatment of moderate to severe dementia related to Alzheimer’s disease. The Company has a right to participate in, but not control, such enforcement actions by Forest.
In 2018 and as of the issuance date of this filing,these consolidated financial statements, multiple generic companies have launched generic versions of NamendaNAMENDA XR.
As of the issuance date of this filing,these consolidated financial statements, a number of companies have submitted ANDAs including one or more certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(iv) to the FDA requesting approval to manufacture and market generic versions of Namzaric,NAMZARIC, on which the Company is entitled to receive royalties from Forest beginning in May 2020.
As of the issuance date of this filing,these consolidated financial statements, the Company and Forest have settled with all such NamzaricNAMZARIC ANDA filers, including all first filers on all the available dosage forms of Namzaric.NAMZARIC. Subject to those agreements, the earliest date on which any of these agreements grantsgrant a license to market a NAMZARIC ANDA filer’s generic version of NamzaricNAMZARIC is January 1, 2025 or(or earlier in certain circumstances). Alternatively, the alternative, anNAMZARIC ANDA filers with the earliest date have the option to launch an authorized generic version of NamzaricNAMZARIC beginning on January 1, 2026 or earlier in certain circumstances.instead of launching their own generic version of NAMZARIC on January 1, 2025. The Company and Forest intend to continue to enforce the patents associated with Namzaric.NAMZARIC.
On February 16, 2018, Osmotica PharmaceuticalsPharmaceutical US LLC and Vertical Pharmaceuticals LLC (“Osmotica”) filed an action against the Company in U.S. District Court for the state of Delaware, requesting a declaratory judgment that Osmotica’s newly-approved product Osmolex ER™OSMOLEX ER® (amantadine) extended release tablets doesdo not infringe certain of the Company’s patents. On September 20, 2018, the Company filed its first amended answer including infringement counterclaims against Osmotica asserting Osmotica has infringed nine9 Company patents under 35 U.S.C. §§ 271(a), (b), and/or (c) and 35 U.S.C. § 271(e)(2)(A) and seeking various forms of relief, including damages, treble damages, injunctive relief, and an order pursuant to 35 U.S.C. § 271(e)(4)(A) that the effective date of any approval of Osmotica’s NDA for Osmolex ER™OSMOLEX ER be a date that is not earlier than the latest expiration date of the Company patents involved in the lawsuit. This actionOn December 1, 2020, the Company entered into a purchase agreement (the “Asset Purchase Agreement”) with Osmotica pursuant to which: both parties gave each other mutual releases and agreed to dismiss their respective claims relating to the patent litigation; the Company will acquire the global rights to OSMOLEX ER and existing inventory for $7.5 million and the assumption of certain liabilities; and Osmotica will not engage in the U.S. in the
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
development, manufacture, or sale of any product that is ongoing.
On March 13, 2018, the FDA’s New Paragraph IV Certifications list was updated to reflect that an ANDA seeking authorization from the FDA to manufacture, use, or sell a generic version of GOCOVRI™ (amantadine) extended release capsules, containing one or moreany dosage strength of OSMOLEX ER for a period of
five years from the closing of the Asset Purchase Agreement. The Company also entered into a supply agreement pursuant to which Osmotica will be the sole manufacturer of OSMOLEX ER. The Asset Purchase Agreement subsequently closed on January 4, 2021. Management determined, in accordance with ASC 450, that as of December 31, 2020, a probable loss had occurred as a result of the litigation settlement. As a result, the Company recorded a patent litigation settlement liability of $5.0 million, based on management’s best estimate, which is included in other current liabilities on the consolidated balance sheets and reported as selling, general and administrative, net, in the consolidated statements of operations for the twelve months ended December 31, 2020.
On July 1, 2020, the Company received a letter dated June 29, 2020, notifying the Company that Zydus Worldwide DMCC (“Zydus Worldwide”) submitted to the FDA an ANDA for Amantadine Extended-Release Capsules, 68.5 mg and 137 mg that contains certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“paragraph IV certification”), was submittedwith respect to the FDA on January 16, 2018, and has been accepted for filing. Subsequent to this date, the Company received a letter from attorneys representing Sandoz, Inc. (“Sandoz”) dated March 29, 2018, notifying it that Sandoz filed an ANDA for Amantadine Extended-Release Capsules, 137 mg that contains paragraph IV certifications seeking to obtain approval to engage in the commercial manufacture, use or sale of Amantadine Extended-Release Capsules, 137 mg before the expiration ofCompany’s U.S. Patent Nos. 8,389,578; 8,741,343; 8,796,337; 8,889,740; 8,895,614; 8,895,615; 8,895,616; 8,895,617; 8,895,618; 9,867,791; 9,867,792; 9,867,793; 9,877,933; and 9,877,933.10,154,971, that these patents are invalid or will not be infringed by the manufacture, use or sale of Zydus Worldwide’s Amantadine Extended-Release Capsules, 68.5 mg and 137 mg. On May 10, 2018,August 13, 2020, the Company filed a lawsuit against SandozZydus Worldwide and Zydus Pharmaceuticals (USA), Inc. (collectively “Zydus”) alleging infringement of thethose patents against Sandozand U.S. Patent No. 10,646,456 by Zydus in the United States District Court for the District of New Jersey. On July 30, 2018, SandozU.S. Patent No. 10,646,456 was not listed in the Orange Book at the time Zydus Worldwide filed its answer, defenses, and counterclaims assertingANDA, but on or about September 3, 2020, the Company received a letter dated September 2, 2020, notifying the Company that the asserted Company patents are invalid and not infringed in responseZydus Worldwide submitted a certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) with respect to the Company’s U.S. Patent No. 10,646,456 with respect to its ANDA for Amantadine Extended-Release Capsules, 68.5 mg and 137 mg. On January 30, 2021, Adamas Pharma, LLC entered into a definitive agreement (the “Settlement Agreement”) with Zydus pursuant to which the parties agreed to end the lawsuit and dismiss it without prejudice, and the Court dismissed the lawsuit on February 3, 2021. Pursuant to the Settlement Agreement, Adamas Pharma, LLC grants Zydus a license to make, use, sell, offer to sell and import a generic version of GOCOVRI (amantadine) extended release capsules (including for any new indications approved under the GOCOVRI NDA), effective as of March 4, 2030, or earlier in certain circumstances typical for such agreements. The Settlement Agreement contains provisions that may accelerate the license date, including if unit sales of GOCOVRI for the 12-month period ending July 31, 2025 or any subsequent 12-month period decline by a specified percentage below GOCOVRI unit sales for the year ended December 31, 2019. The Company and Adamas Pharma LLC intend to continue to enforce the patents associated with GOCOVRI.
On April 1, 2019, the Company was served with a complaint filed in the United States District Court for the Northern District of California (Case No. 3:18-cv-03018-JCS) against the Company and several Allergan entities alleging violations of Federal and state false claims acts (“FCA”) in connection with the commercialization of NAMENDA XR and NAMZARIC by Allergan. The lawsuit is a qui tam complaint brought by a named individual, Zachary Silbersher, asserting rights of the Federal government and various state governments. The lawsuit was originally filed in May 10, 2018 complaint.under seal, and the Company became aware of the lawsuit when it was served. The complaint alleges that patents held by Allergan and the Company covering NAMENDA XR and NAMZARIC were procured through fraud on the United States Patent and Trademark Office and that these patents were asserted against potential generic manufacturers of NAMENDA XR and NAMZARIC to prevent the generic manufacturers from entering the market, thereby wrongfully excluding generic competition resulting in an artificially high price being charged to government payors. The Company’s patents in question were licensed exclusively to Forest. The complaint includes a claim for damages of “potentially more than $2.5 billion dollars,” treble damages “under the federal FCA and most of the State FCAs,” and “statutory penalties that can be assessed for each false claim.” This action is ongoing.
The federal and state governments have declined to intervene in this action. To the Company’s knowledge, the individual plaintiff is pursuing the lawsuit in his individual capacity. This case is currently stayed pending the Company and Allergan’s Petition for Permission to Appeal Under 28 U.S.C. § 1292(b) in the United States Court of Appeals for the Ninth Circuit (Case No. 21-80005), which was filed on February 8, 2021, and seeks permission for an interlocutory appeal of the District Court’s December 11, 2020 order denying the Company’s and Allergan’s motion to dismiss the complaint. The Company believes it has strong factual and legal defenses and intends to defend itself vigorously.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
On May 13, 2019, a putative class action lawsuit alleging violations of the federal securities laws was filed by Plymouth County Contributory Retirement System against the Company and certain of the Company’s current and former directors and officers in California Superior Court for the County of Alameda (Case No. RG19018715). The lawsuit alleges violations of the Securities Act of 1933 by the Company and certain of the Company’s current and former directors and officers for allegedly making false statements and omissions in the registration statement and prospectus filed by the Company in connection with its January 24, 2018, secondary public offering of common stock. On October 29, 2020, Adamas signed a Memorandum of Understanding to settle this lawsuit for a payment of $7.5 million to eligible settlement class members in resolution of claims asserted against the Company, its officers, directors, and the other defendants. The settlement will be paid by the Company’s Director & Officer liability insurance. As a result of signing the Memorandum of Understanding and the potential liability becoming probable and estimable, the Company has recorded a litigation settlement liability of $7.5 million, which is included in accrued liabilities on the consolidated balance sheets. Additionally, the Company has recorded an insurance litigation recovery of $7.5 million within prepaid expenses and other current assets on the consolidated balance sheets, which represents the estimated insurance proceeds agreed with the Company’s insurance carrier in excess of the Company’s retention. The Company and the other defendants continue to deny each of the plaintiff’s claims and all liability. The Company has agreed to the settlement to resolve the disputes, avoid the costs and risks of further litigation, and avoid further distractions to management. This settlement remains subject to final documentation and approval by the court. A final non-appealable closure of this court action is expected in mid-2021.
On December 10, 2019, another putative class action lawsuit alleging violations of the federal securities laws was filed by Ali Zaidi against the Company and certain of the Company’s current and former directors and officers in federal court in the Northern District of California (Case No. 4:19-cv-08051). This lawsuit alleges violations of the Securities Exchange Act of 1934 by the Company and certain of the Company’s current and former officers. On March 16, 2020, a shareholder derivative lawsuit was filed by Patrick Van Camp in federal court in the Northern District of California (Case No. 4:20-cv-01815) naming the Company and certain of the Company’s current and former directors and officers as defendants. This lawsuit alleges breaches of fiduciary duty and violations of the Securities Exchange Act of 1934 by certain of the Company’s current and former directors and officers. The Company is named as a nominal defendant only. On April 6, 2020, another, virtually identical, shareholder derivative lawsuit was filed by James Druzbik in federal court in the Northern District of California (Case No. 4:20-cv-02320) naming the Company and certain of the Company’s current and former directors and officers as defendants. This lawsuit contains the same allegations, claims, and defendants as the first derivative action. The Company is named as a nominal defendant only. Other similar cases may be filed in the future. In all of these actions, Plaintiffs seek unspecified monetary damages and other relief. These actions are ongoing. The Company believes it has strong factual and legal defenses to all actions and intends to defend itself vigorously.
From time to time, the Company may be party to legal proceedings, investigations, and claims in the ordinary course of its business. Other than the matters described above, the Company is not0t currently party to any material legal proceedings.
9.10. LONG-TERM DEBT
Royalty-Backed Loan Agreement
In May 2017, the Company, through a new wholly-owned subsidiary, Adamas Pharma, LLC, entered into a Royalty-Backed Loan with HCRP,HCR, whereby the Company initially borrowed $35.0$35 million, followed by an additional $65.0$65 million received in the fourth quarter 2017 upon FDA’s recognition in the Orange Book of seven-year orphan drug exclusivity, which GOCOVRI earned upon approval on August 24, 2017. Principal and interest will be payable quarterly from the proceeds of a 12.5% royalty on U.S. net sales of GOCOVRI and up to $15.0$15 million of the Company’s annual royalties from Allergan on U.S. net sales of NamzaricNAMZARIC starting in May 2020, pursuant to the Company’s license agreement with Allergan. The royalty rate on net sales of GOCOVRI will drop to 6.25% after the principal amount of the loan has been repaid in full, until the Company has made total payments of 200% of the funded amounts. The Company may elect to voluntarily prepay the loan at any time, or may be required to prepay subject to specified prepayment trigger events as described below, in which case the amount due will be 200% of the funded amounts, less total payments made to date. Royalty rates are subject to increase to 17.5% and 22.5% if total principal and interest payments have not reached minimum specified levels at measurement dates on December 2021 and December 2022, respectively. Under the
ADAMAS PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
terms of the loan, HCRPHCR has recourse to Adamas Pharma, LLC, not the Company. The loan agreement matures in December 2026 but as the repayment of the loan amount is contingent upon the sales volumes of GOCOVRI and royalties from Allergan, the repayment term may be shortened depending on the actual sales of GOCOVRI and actual royalties received from Allergan.
The loans bear interest at an annual rate of 11% on the outstanding principal amount and includes an interest-only period until the interest payment date following the ninth full calendar quarter after the $65.0$65 million additional loan received in the fourth quarter 2017. To the extent that royalties arewere insufficient to pay interest in full during the first nine quarters of the loan, any unpaid portion of the quarterly interest payment will bewas added to the principal amount of the loans. This payment-in-kind period ended in the first quarter of 2020.
In connection with the Royalty-Backed Loan, in 2017 the Company paid HCRPHCR a lender expense amount of $0.4 million and incurred additional debt issuance costs totaling $0.8 million. The lender expense and additional debt issuance costs have been recorded as a debt discount and are being amortized and recorded as interest expense over the estimated term of the loan using the effective interest method. The Company recorded interest expense, including amortization of the debt discount, related to the Royalty-Backed Loan, of $19.1$14.0 million and $4.6$15.0 million for the twelve months ended December 31, 20182020 and 2017,2019, respectively. Interest expense over the life of the Royalty-Backed Loan includes an annual interest rate of 11% on the outstanding principal, a royalty rate of 6.25% on net sales of GOCOVRI after the principal amount is paid, and amortization of the debt discount. The effective interest rate as of December 31, 20182020 on the amounts borrowed under the Royalty-Backed Loan, including the amortization of the debt discount, was 14.5%12.8%.
The assumptions used in determining the expected repayment term of the loan and amortization period of the debt discount require that the Company make estimates that could impact the short and long-term classification of these costs, as well as the period over which these costs will be amortized and the effective interest rate.
The Company may be required to make mandatory prepayments of the borrowings under the Royalty-Backed Loan upon the occurrence of specified prepayment trigger events, including: (1) the occurrence of any event of default or (2) the occurrence of a change in control. Upon the prepayment of all or any of the outstanding principal balance, the Company shall pay, in addition to such prepayment, a prepayment premium. As HCRP,HCR, as the holder of the loans, may exercise the option to require prepayment by the Company, the prepayment premium is considered to be an embedded derivative which is required to be bifurcated from its host contract and accounted for as a separate financial instrument. The valuation of the embedded derivative is described further in Note 3.
ADAMAS PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
3 - Fair Value Measurements.
Payment obligations under the Royalty-Backed Loan are as follows (in thousands):
| | | | | | | | December 31, |
| | December 31, 2018 | | December 31, 2017 | | 2020 | | 2019 |
| Total repayment obligation | $ | 200,000 |
| | $ | 200,000 |
| Total repayment obligation | $ | 200,000 | | | $ | 200,000 | |
| Less: Interest to be accreted in future periods | (78,261 | ) | | (97,353 | ) | Less: Interest to be accreted in future periods | (49,230) | | | (63,217) | |
| Less: Payments made | (2,618 | ) | | — |
| Less: Payments made | (20,806) | | | (9,068) | |
| Carrying value of loans payable | $ | 119,121 |
| | $ | 102,647 |
| Carrying value of loans payable | $ | 129,964 | | | $ | 127,715 | |
| Less: Current portion of long-term debt | (1,664 | ) | | — |
| Less: Current portion of long-term debt | (3,657) | | | (2,041) | |
| Non-current portion of long-term debt | $ | 117,457 |
| | $ | 102,647 |
| Non-current portion of long-term debt | $ | 126,307 | | | $ | 125,674 | |
The estimated fair value of the long-term debt, as measured using Level 3 inputs, approximates $95.7$109.4 million as of December 31, 2018.2020. The estimated fair value was calculated in the same methodology as the valuation of the embedded derivative as described further in Note 3.3 - Fair Value Measurements.
There are no contractual minimum principal payments due until the loan matures in December 2026 as the repayment of the loan amount is contingent upon the sales volumes of GOCOVRI and royalties from Allergan.Allergan on U.S. net sales of NAMZARIC.
On December 1, 2020, Adamas Pharma, LLC entered into an agreement with HCR to amend certain key terms of the Royalty-Backed Loan to be effective upon the closing of the Company’s Asset Purchase Agreement with Osmotica. The Asset Purchase Agreement subsequently closed on January 4, 2021, and is described further in Note 9 -
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
Commitments and Contingencies. For further discussion of the key terms amended under the Royalty-Backed Loan, see Note 17 - Subsequent Events.
Paycheck Protection Program
On April 15, 2020, the Company received proceeds from a loan in the amount of $2.7 million (the “PPP Loan”) from JPMorgan Chase Bank, N.A. (the “Lender”), pursuant to the Small Business Association (“SBA”) Paycheck Protection Program (or “PPP”) of the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). At the time the Company applied for the PPP loan, the Company believed it qualified to receive the funds pursuant to the then published qualification requirements. On April 23, 2020, the SBA, in consultation with the Department of Treasury, issued new guidance regarding qualification requirements for public companies. Based on the Company’s assessment of the new guidance, on April 29, 2020, the Company repaid the principal and interest on the PPP loan.
11. CONVERTIBLE PREFERRED STOCK
The Company’s amended and restated certificate of incorporation filed on April 15, 2014, authorizes 5,000,000 shares of preferred stock, of which there were no0 shares outstanding as of December 31, 20182020 and 2017.2019.
11.12. STOCKHOLDERS’ EQUITY
Common Stock
The amended and restated certificate of incorporation authorizes the Company to issue 100,000,000 shares of common stock. Common stockholders are entitled to dividends as and when declared by the board of directors, subject to the rights of holders of all classes of stock outstanding having priority rights as to dividends. There have been no0 dividends declared to date. Each share of common stock is entitled to one1 vote.
Public Offering
In January 2016, the Company completed a follow-on public offering of 2,875,000 shares of common stock, which includes the exercise in full by the underwriters of their option to purchase 375,000 shares of common stock, at an offering price of $23.00 per share. Proceeds from the follow-on public offering were approximately $61.8 million, net of underwriting discounts and offering-related transaction costs.
In January 2018, the Company completed a follow-on public offering of 3,450,000 shares of common stock, which includes the exercise in full by the underwriters of their option to purchase 450,000 shares of common stock, at an offering price of $41.50 per share. Proceeds from the follow-on public offering were approximately $134.3 million, net of underwriting discounts and offering-related transaction costs.
Sales Agreement
In May 2017,November 2019, the Company entered into a sales agreement (“2017 Sales Agreement”) with Cowen and Company, LLC (“Cowen”), as sales agent, pursuant to which the Company may, from time to time, issue and sell at its option, shares of the Company’s common stock for an aggregate offering price of up to $50.0 million under an at-the-market offering (“ATM Offering”). Sales of the common stock, if any, will be made pursuant to a shelf registration statement that was declared effective by the Securities and Exchange Commission (“SEC”) on November 21, 2016.December 2, 2019. Cowen is acting as sole sales agent for any sales made under the Sales Agreement and the Company will pay Cowen a commission of up to 3% of the gross proceeds. The Company’s common stock will be sold at prevailing market prices at the time of the sale, and, as a result, prices may vary. The Company is not obligated to make any sales of shares of common stock under the Sales Agreement. Unless otherwise terminated earlier, the Sales Agreement continues until all
ADAMAS PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
shares available under the Sales Agreement have been sold. As of December 31, 2018, noNaN shares have beenwere sold under the Sales Agreement.Agreement during the fiscal year ended December 31, 2019. During the fiscal year ended December 31, 2020, 217,403 shares were sold at an average price of $4.94, for net proceeds of $1.0 million.
Shares Reserved for Future Issuance
Shares of the Company’s common stock reserved for future issuance are as follows:
| | | | | | | | | | | |
| December 31, |
| 2020 | | 2019 |
| Common stock awards issued and outstanding | 7,172,029 | | | 6,874,633 | |
| Authorized for future issuance under 2014 Equity Incentive Plan | 3,518,414 | | | 2,376,613 | |
| Authorized for future issuance under 2016 Inducement Plan | 469,419 | | | 236,269 | |
| Employee stock purchase plan | 1,018,060 | | | 926,943 | |
| Total | 12,177,922 | | | 10,414,458 | |
|
| | | | | |
| | December 31, 2018 | | December 31, 2017 |
| Common stock awards issued and outstanding | 5,949,436 |
| | 5,564,635 |
|
| Authorized for future issuance under 2014 Equity Incentive Plan | 1,814,179 |
| | 1,723,733 |
|
| Authorized for future issuance under 2016 Inducement Plan | 512,440 |
| | 188,715 |
|
| Employee stock purchase plan | 847,105 |
| | 693,856 |
|
| Total | 9,123,160 |
| | 8,170,939 |
|
ADAMAS PHARMACEUTICALS, INC. 12.NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
13. STOCK-BASED COMPENSATION
Stock Compensation Plans
In October 2002, the Company established its 2002 Employee, Director, and Consultant Stock Plan and in December 2007, the Company established its 2007 Stock Plan. NoNaN further grants were then made under the 2002 Plan.
In February 2014, the Company’s board of directors adopted, and in March 2014 the Company’s stockholders approved, the 2014 Equity Incentive Plan (the “2014 Plan”), which became effective on the completion of the IPO. NoNaN further grants were then made under the 2007 Plan. Under the 2014 Plan, 1,993,394 shares of the Company’s common stock were made available for issuance which included all shares that, as of the effective time, were reserved for issuance pursuant to the 2007 Plan, and is subject to further increase for shares that were subject to outstanding options under the 2007 Plan and the 2002 Plan as of the effective time that thereafter expire, terminate, or otherwise are forfeited or reacquired. The number of shares of the Company’s common stock reserved for issuance pursuant to the 2014 Plan will automatically increase on the first day of each fiscal year for a period of up to 10ten years, commencing on the first day of the fiscal year following 2014, in an amount equal to 4% of the total number of shares of the Company’s capital stock outstanding on the last day of the preceding fiscal year, or a lesser number of shares as determined by the Company’s board of directors. For 2018, 2017, 2016, and 2015,On January 1, 2020, the common stock available for issuance under the 2014 Plan increased by 932,822, 880,362, 739,708, and 701,763 shares of common stock, respectively.1,118,591 shares. As of December 31, 2018,2020, the number of shares available for issuance under the 2014 Plan was 1,814,179.3,518,414.
Options granted under the 2014 Stock Plan may have terms of up to ten years. All options issued to date have had a ten year life. The exercise price of an ISO shall not be less than 100% of the estimated fair value of the shares on the date of grant, as determined by the board of directors. The exercise price of an ISO and NSO granted to a 10% stockholder shall not be less than 110% of the estimated fair value of the shares on the date of grant, respectively, as determined by the board of directors. The exercise price of a NSO shall not be less than the par value per share of common stock. The optionsOptions and restricted stock units granted generally vest over four years and vest at a rateyears. Certain grants have other vesting periods approved by the Company’s Board of 25% upon the first anniversary of the issuance date and 1/48th per month thereafter. Restricted stock units granted generally vest at a rate of 25% per year over four years.Directors or an authorized committee.
In March 2016, the Company’s board of directors approved the 2016 Inducement Plan (the “Inducement Plan”) under which 450,000 shares of the Company’s common stock were made available for issuance. In each of January 2017 and November 2017, anAn amendment to the Inducement Plan was approved to increase the number of shares available for issuance by an additional 450,000 shares in each of January 2017, November 2017, March 2019, and February 2020, and an additional 600,000 shares in October 2020, for a total of 900,0002,400,000 shares, resulting in a total of 1,350,0002,850,000 shares of common stock issuable under the Inducement Plan. As of December 31, 2018,2020, the number of shares available for issuance under the Inducement Plan was 512,440.469,419. Options granted under the Inducement Plan may have terms of up to ten years. All options issued to date have had a ten year life. Consistent with the 2014 Plan, options granted generally vest over four years and vest at a rate of 25% upon the first anniversary of the issuance date and 1/48th per month thereafter. Restricted
ADAMAS PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
restricted stock units granted generally vest at a rate of 25% per year over four years. The Inducement Plan was adopted by the board of directors without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.
ADAMAS PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS(Continued)
Stock Option Activity
Stock option activity under all of the Company’s stock compensation plans is summarized as follows:
| | | | | Outstanding Options | | Weighted Average Remaining Contractual Term (years) | | Aggregate Intrinsic Value (thousands) | | Outstanding Options | | Weighted Average Remaining Contractual Term (years) | | Aggregate Intrinsic Value (thousands) |
| | | Number of Shares | | Weighted Average Exercise Price | | | Number of Shares | | Weighted Average Exercise Price | |
| Stock Options | | Weighted Average Remaining Contractual Term (years) | Stock Options | | Weighted Average Remaining Contractual Term (years) |
| Balances, December 31, 2017 | | 5,137,584 |
| | $ | 12.12 |
| | | |
| |
| Balances, December 31, 2019 | | Balances, December 31, 2019 | | 5,516,684 | | | $ | 12.06 | | | |
| Options granted | | 1,289,396 |
| | 25.27 |
| | | | | Options granted | | 1,562,148 | | | 3.71 | | | | | |
| Options exercised | | (478,454 | ) | | 7.03 |
| | | | |
| Options exercised | | (237,425) | | | 0.74 | | | | | |
| Options forfeited | | (586,197 | ) | | 19.11 |
| | | | | Options forfeited | | (558,612) | | | 12.48 | | | | | |
| Options expired | | (61,263 | ) | | 14.97 |
| | | | | Options expired | | (693,580) | | | 17.98 | | | | | |
| Balances, December 31, 2018 | | 5,301,066 |
| | $ | 14.98 |
| | 6.33 | | $ | 6,525 |
| |
| Vested and expected to vest, December 31, 2018 | | 5,179,804 |
| | $ | 14.81 |
| | 6.28 | | $ | 6,525 |
| |
| Exercisable, December 31, 2018 | | 3,599,021 |
| | $ | 11.49 |
| | 5.18 | | $ | 6,525 |
| |
| Balances, December 31, 2020 | | Balances, December 31, 2020 | | 5,589,215 | | | $ | 9.43 | | | 5.56 | | $ | 2,806 | |
| Vested and expected to vest, December 31, 2020 | | Vested and expected to vest, December 31, 2020 | | 5,369,025 | | | $ | 9.57 | | | 5.43 | | $ | 2,700 | |
| Exercisable, December 31, 2020 | | Exercisable, December 31, 2020 | | 3,387,312 | | | $ | 11.69 | | | 3.53 | | $ | 1,740 | |
The aggregate intrinsic value of options outstanding, vested and expected to vest, and exercisable were calculated as the difference between the exercise price of the options and the fair value of the Company’s common stock as of December 31, 20182020 of $8.54.$4.33. The intrinsic value of options exercised, calculated as the difference between the exercise price and the fair value of the Company’s common stock on the date of exercise, was approximately $9.2 million, $18.1$0.9 million and $6.6$0.9 million for the years ended December 31, 2018, 2017,2020 and 2016,2019, respectively.
Restricted stock unit activity under all of the Company’s stock compensation plans is summarized as follows:
In February 2014, the Company’s board of directors adopted and, in March 2014, the Company’s stockholders approved, the 2014 Employee Stock Purchase Plan (the “ESPP”), which became effective on the completion of the Company’s IPO. The ESPP authorized the issuance of 262,762 shares. Under the ESPP, employees, subject to certain restrictions, may purchase shares of common stock at 85% of the fair market value at either the beginning of the offering
period or the date of purchase, whichever is less. Purchases are limited to the lesser of 15% of each employee’s eligible annual compensation or $25,000. Through the end of 2018,2020, the Company has issued a total of 229,320612,357 shares under the ESPP. The number of shares available for future issuance under the plan were 847,1051,018,060 at December 31, 2018.2020. Beginning January 1, 2015 and continuing through and including January 1, 2024, the amount of common stock reserved for issuance under the ESPP will increase annually on that date by the lesser of (i) one percent (1%) of the total number of shares of common stock outstanding on such December 31, (ii) 520,000 shares of common stock, or (iii) a number of shares as determined by the board of directors prior to the beginning of each year, which shall be the lesser of (i) or (ii) above. For 2018, 2017, 2016, and 2015,On January 1, 2020, the common stock available for issuance under the ESPP increased by 233,206, 220,090, 184,927, and 175,440 shares of common stock, respectively.279,648 shares.
The following table reflects stock-based compensation expense recognized for the years ended December 31, 2018, 2017,2020 and 20162019 (in thousands):
