Content analysis
?Positive | ||
Negative | ||
Uncertain | ||
Constraining | ||
Legalese | ||
Litigous | ||
Readability |
H.S. senior Avg
|
New words:
abnormal, began, brain, buying, category, channel, CI, confidence, customary, DFCI, diarrhea, distributor, divided, doubtful, essential, explicitly, FIFO, fifteenth, forecasted, forthcoming, forward, freight, ground, handling, hazard, hearing, inclusion, indirect, ingredient, interval, inventory, Keytruda, lesser, liberal, merit, mitigation, mix, neutropenia, outplacement, overhead, pembrolizumab, PFS, pool, posted, preferred, prepaid, ratably, ratio, reconsideration, recoverability, recycling, redemption, refractory, regularly, relapsing, rulemaking, salary, shipping, sixteenth, statistically, unabsorbed, vigorously, visibility, write
Removed:
appeal, ATRA, attachment, automatic, automatically, Barack, BBA, Bellina, bipartisan, Breakthrough, Cadillac, checkpoint, Circuit, circumvent, close, commonly, concentration, conjugated, debilitating, deeming, deficit, dosage, durvalumab, excise, extend, Fighting, formula, Frank, humanized, ideally, imaging, Imfinzi, influencing, investigate, Johnson, Joint, Jordan, judicial, leading, letter, Matthew, McLinn, Michael, Mongiello, naked, Northern, Obama, Opioid, optimize, Pehl, permitting, pharmacy, poverty, Prevention, priority, Promoted, qualifying, question, reach, recommending, recover, reduced, relate, Relief, remain, renewed, repealed, repealing, resolution, resolving, revising, sequestration, shared, specificity, struck, tasked, Taxpayer, TCJA, Trickett, trillion, unconstitutional, universe, unlabeled, violated, Wendler, window
Financial report summary
?Competition
Celldex Therapeutics • X.T.L. Biopharmaceuticals • Mabvax Therapeutics • Molecular Templates • Ocuphire Pharma • Sutro Biopharma • Genmab • Mersana Therapeutics • ONCOSEC MEDICAL • Calithera BiosciencesRisks
- The outbreak of the SARS-CoV-2 virus and the COVID-19 disease that it causes , or similar public health crises, could have a material adverse impact on our business, financial condition and results of operations, including clinical development of our products and product candidates, manufacturing, commercial operations and sales.
- We have a long history of operating losses and it is likely that our operating expenses will continue to exceed our revenues for the foreseeable future.
- We have significant future capital needs and may be unable to raise capital when needed, which could force us to delay or reduce our clinical development efforts.
- Although we received accelerated approval of our BLA for Trodelvy for patients with metastatic triple-negative breast cancer, our other most advanced therapeutic product candidates are still only in the clinical development stage, and may require us to raise capital in the future in order to fund further expensive and time-consuming studies before they can even be submitted for final regulatory approval. A failure of a clinical trial could severely harm our business and results of operations.
- Our clinical trials may not adequately show that our drugs are safe or effective, and a failure to achieve the planned endpoints could result in termination of product development or a withdrawal of our accelerated approval for Trodelvy.
- Information obtained from our Expanded Access Program launched in January 2020 may not reliably predict the efficacy of our product or product candidates in company-sponsored clinical trials and may lead to adverse events that could limit approval.
- Should the clinical development process be successfully completed, our ability to derive revenues from the sale of therapeutics will depend upon our first obtaining FDA as well as foreign regulatory approvals, all of which are subject to a number of unique risks and uncertainties.
- In order to fund future operations, we will need to raise significant amounts of additional capital. Because it can be difficult for a mid-cap company like ours to raise equity capital on acceptable terms, we cannot assure you that we will be able to obtain the necessary capital when we need it, or on acceptable terms, if at all.
- If we, or any of our collaboration partners, or our or their contract manufacturers, cannot successfully and efficiently manufacture the compounds that make up our products and product candidates, our ability, and the ability of our collaboration partners, to sell products and conduct clinical trials will be impaired.
- Although historically we have been a research and development company, we are commercializing our lead product internally rather than licensing such asset. There can be no assurance that we will be successful in developing and expanding commercial operations or balancing our research and development activities with our commercialization activities.
- We may not successfully establish and maintain collaborative and licensing arrangements, which could adversely affect our ability to develop and commercialize certain of our product and product candidates. Any of our collaboration partners may not adequately perform their responsibilities under our agreements, which could adversely affect our development and commercialization program.
- Our future success will depend upon our ability to first obtain and then adequately protect our patent and other intellectual property rights, as well as avoiding the infringement of the rights of others.
- We may be liable for contamination or other harm caused by hazardous materials that we use in the operations of our business.
- The nature of our business exposes us to significant liability claims, and our insurance coverage may not be adequate to cover any future claims.
- Certain potential for conflicts of interest, both real and perceived, exist which could result in expensive and time-consuming litigation.
- The commercial success of our product and product candidates depends on the availability and sufficiency of third-party payor coverage and reimbursement. Given that recent cancer therapeutics for solid cancers such as the ones we are developing can cost approximately in the range of $13,000 to $30,000 a month, even if our products and product candidates become available for sale it is likely that federal and state governments, insurance companies and other payors of health care costs will try to first limit the use of these drugs to certain patients, and may be reluctant to provide a level of reimbursement that permits us to earn a significant profit on our investment, if any.
- A portion of our funding has come from federal government grants and research contracts. Due to reductions in funding, we may not be able to rely on these grants or contracts as a continuing source of funds.
- We face a number of risks relating to the maintenance of our information systems and our use of information relating to clinical trials.
- Legislative or regulatory reform of the healthcare system may affect our ability to sell our products profitably.
- Our industry and we are subject to intense regulation from the United States Government and other governments and quasi-official authorities regulating where our products are and product candidates may be sold.
- Our failure to comply with foreign data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.
- Our employees and our independent contractors, principal investigators, consultants or commercial collaborators, as well as their respective sub-contractors, if any, may engage in misconduct or fail to comply with certain regulatory standards and requirements, which could expose us to liability and adversely affect our reputation.
- Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
- We may add lease lines to finance capital expenditures and may obtain additional long‑term debt and lines of credit. If we issue other debt securities in the future, our debt service obligations will increase further.
- Shares eligible for future sale may adversely affect our ability to sell equity securities.
- Our outstanding options may adversely affect our ability to consummate future equity-based financings due to the dilution potential to future investors.
- The market price of our common stock has fluctuated widely in the past, and is likely to continue to fluctuate widely based on a number of factors, many of which are beyond our control.
- Our principal stockholder can significantly influence all matters requiring the approval by our stockholders.
- There are limitations on the liability of our directors, and we may have to indemnify our officers and directors in certain instances.
- We are exposed to potential risks from legislation requiring companies to evaluate controls under Section 404 of the Sarbanes-Oxley Act.
- We do not intend to pay dividends on our common stock. Until such time as we pay cash dividends, our stockholders, must rely on increases in our stock price for appreciation.
Management Discussion
- Our results for any interim period, such as those described in the following analysis, are not necessarily indicative of the results for the entire year or any other future period.
- We began to record product revenue, net in the second quarter of 2020 following the approval of Trodelvy by the FDA in April 2020 and its subsequent commercial launch in the United States. We did not generate any revenue from product sales prior to the three months ended June 30, 2020. Total product revenue, net for the three months ended June 30, 2020 was $20.1 million.
- Total costs and expenses for the three months ended June 30, 2020 increased $5.9 million compared to the three months ended June 30, 2019, primarily due to an increase in general and administrative expenses of $8.1 million, an increase in sales and marketing expenses of $6.5 million, and an increase in costs of goods sold of $1.7 million, partially offset by a decrease in research and development expenses of $10.4 million.