As used in this Form 10-K, “we,” “us,” “our,” and “the Company” refer to Insys Therapeutics Inc. and our subsidiaries. We are a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve patients’ quality of life. We have two marketed products: SUBSYS®, a proprietary sublingual fentanyl spray indicated for the management of BTCP patients 18 years of age and older who are already receiving and are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain; and SYNDROS®, a proprietary, orally administered liquid formulation of dronabinol for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments and anorexia associated with weight loss in patients with AIDS. As discussed below, on November 5, 2018, we announced a process to review strategic alternatives for our opioid-related assets including SUBSYS®. The Company has also engaged Lazard Freres & Co. LLC to advise the Company on capital planning and the evaluation of strategic alternatives. Additional potential transactions that we may consider include a variety of different business arrangements including spin-offs, strategic licensing and partnerships, joint ventures, restructurings, divestitures, business combinations and investments.
Heightened attention on the use of opioids, including government litigation changes in policies, legislation and leadership at the federal and state level, could hinder or prevent the commercial success of SUBSYS® and any potential future opioid product candidates.
If SUBSYS®, SYNDROS®, or any of our product candidates for which we receive regulatory approval, do not maintain broad market acceptance or coverage by third-party payers, the revenues that we generate from these products will be limited.
The manner by which we utilize our commercial sales force has evolved over time and may continue to evolve in the future. We or our collaborators may not be successful in executing sales and marketing strategies for SUBSYS®, SYNDROS®, or any additional product candidates for which we obtain regulatory approval. If such sales and marketing strategies are not successful, we may not be able to maintain or increase our revenues.
Our business is subject to volatility and fluctuations in the number of employees we have across our enterprise. We may need to adjust the size and complexity of our organization in the future, depending upon the strategies we attempt to implement.
We may encounter manufacturing failures that could impede or delay commercial production of SYNDROS® or the preclinical and clinical development or regulatory approval of our product candidates.
We have expanded our SYNDROS® production capacity by constructing a second facility. We may encounter a number of challenges relating to the management and operation of such a facility, and we may never realize a return on our investment.
We are dependent on numerous third parties in our supply chain for the commercial supply of SUBSYS® and SYNDROS®, and if we fail to maintain our supply and manufacturing relationships with these third parties or fail to develop new relationships with other third parties, we may be unable to continue to commercialize SUBSYS® and SYNDROS®, or to develop other product candidates.
We may encounter delays in the manufacturing of SUBSYS® or fail to generate revenue if our supply of the components of our sublingual spray delivery system is interrupted.
We face intense competition, including from generic products. If our competitors market or develop alternative treatments that are approved more quickly or marketed more effectively than our product candidates or are demonstrated to be safer or more effective than our products, our commercial opportunities will be reduced or eliminated.
We depend on wholesale distributors and specialty retail pharmacies for retail distribution of SUBSYS® and SYNDROS®; if we lose any of our significant wholesale distributors or specialty retail pharmacies, our business could be harmed.
In addition to the level of commercial success of our approved products, our future growth is also dependent on our ability to successfully develop a pipeline of product candidates, and we cannot give any assurance that any of our product candidates will receive regulatory approval or acceptable DEA classification, if applicable, or that any approved products will be successfully commercialized.
Clinical trials for our product candidates are expensive, time consuming, uncertain and susceptible to change, delay or termination.
We have in the past relied and expect to continue to rely on third parties to conduct and oversee our clinical trials. If these third parties do not meet our deadlines or otherwise conduct the trials as required, we may not be able to obtain regulatory approval for or commercialize our product candidates when expected or at all.
Since the starting materials we utilize to manufacture dronabinol are sourced out of India, we are exposed to a number of risks and uncertainties associated with that geographic region.
Our failure to successfully develop, acquire and market additional product candidates or approved products would impair our ability to grow our business.
If we fail to attract and keep management and other key personnel, as well as our board members, we may be unable to continue to successfully commercialize SUBSYS® or SYNDROS®, develop our product candidates or otherwise implement our business plan.
Our current and former employees may engage, or have engaged, in misconduct or other improper activities, including noncompliance with regulatory standards.
We face potential exposure on various fronts, including securities class actions and derivative cases, as well as product and other liability exposure, and our existing and future insurance coverage may be inadequate to cover any successful claims brought against us, or settlements which we choose to resolve, which could result in substantial liability that could materially and adversely affect our financial condition and results of operations.
Our business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental, health and safety laws and regulations, which can be expensive and restrict how we do business.
We may be adversely affected by natural disasters or other events that disrupt our business operations and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
The auditor's opinion on our audited financial statements for the fiscal year ended December 31, 2018, included in this annual report on Form 10-K, contains an explanatory paragraph relating to our ability to continue as a going concern.
We have had significant and increasing operating expenses, including litigation expenses and liabilities, and will require additional funding.
Unanticipated changes in our tax provisions, the adoption of new tax legislation or exposure to additional tax liabilities could affect our financial performance.
Our ability to utilize our net operating loss carryforwards, or NOLs, and research and development income tax credit carryforwards may be limited.
Ongoing legal proceedings, whether or not the Company is a party, may result in challenges by the IRS to tax positions taken by the Company in prior tax years.
We recently announced that we commenced a process to review strategic alternatives for our portfolio of opioid-related assets, including SUBSYS®, as well as formulations of buprenorphine and the combination of buprenorphine/naloxone. This and other strategic transactions we may pursue could impact our liquidity, increase our expenses and present significant distractions to our management, and which ultimately may not be successful.
Annual DEA quotas on the amount of dronabinol and CBD allowed to be produced in the United States and our specific allocation of dronabinol and CBD by the DEA could significantly limit the production of SYNDROS® and our CBD product candidates for which we seek to obtain regulatory approval as well as significantly delay the clinical development of our CBD product candidates.
If we fail to comply with federal and state healthcare laws, including fraud and abuse and health information privacy and security laws, we could face substantial penalties and our business, results of operations, financial condition and prospects could be adversely affected.
Healthcare reform measures and changes in policies, funding, staffing and leadership at the FDA and other agencies could hinder or prevent the commercial success of our products and any of our product candidates that may be approved by the FDA.
Our products and the intellectual property related to such products face competition from lower cost generic or follow-on products.
We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights, and we may be unable to protect our rights to our products and technology.
We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed to us alleged trade secrets of their other clients or former employers.
Obtaining and maintaining our patent protection depends on 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.
Our common stock price has been volatile, which could result in substantial losses for stockholders.
Future sales of our common stock or securities convertible into our common stock may depress our stock price.
Anti-takeover provisions in our stockholder rights plan, charter documents and Delaware law might deter acquisition bids for us that you and other stockholders might consider favorable.
We have never paid dividends on our capital stock, and we do not anticipate paying any cash dividends in the foreseeable future.
Net Revenue. Net revenue decreased $16.3 million, or 68.2%, to $7.6 million for the three months ended March 31, 2019, compared to $23.9 million for the three months ended March 31, 2018. The decrease in net revenue was primarily attributable to a 67.3% decrease in SUBSYS® shipments to our customers for the three months ended March 31, 2019 primarily due to reduced demand for SUBSYS®, as compared to the three months ended March 31, 2018, and a 1.6% decrease in net sales price due to changes in mix of prescribed dosages and changes in provisions for wholesaler discounts, patient discounts, rebates, and returns, partially offset by a price increase in January 2019. Provisions for patient discounts, wholesaler discounts, rebates, and returns were $0.9 million, $1.1 million, $3.3 million, and $0.8 million, respectively, for the three months ended March 31, 2019, compared to $1.7 million, $2.9 million, $6.6 million, and $3.4 million, respectively, for the three months ended March 31, 2018. The decrease in product sales allowances was primarily attributable to lower sales of SUBSYS® and a decrease in product returns during the three months ended March 31, 2019 as compared to the three months ended March 31, 2018. As we have previously disclosed, the continuing sensitivity by some health care professionals to prescribe, and pharmacies to dispense, opioids, scrutiny by third-party payers and governmental agencies, ongoing state and federal investigations, and media reports related thereto, will likely result in our inability to grow full-year SUBSYS® revenue for the remainder of 2019 when compared to 2018. In addition, for the same reasons, we anticipate that we will experience future declines in SUBSYS® revenue for the remainder of 2019 when compared to prior quarters in 2018. On May 9, 2019, the Company was notified by its logistics provider that such provider has ceased shipments to a specialty pharmaceutical retailer, which accounted for approximately 19% of our total product shipments for the three months ended March 31, 2019. As a result, the Company is effectively precluded from shipping products to this specialty pharmaceutical retailer at this time. Management is monitoring the situation and evaluating the impact of this cessation on its operations and future results.