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H.S. senior Avg
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New words:
acquisition, alleging, announced, announcement, Antitrust, asserted, assumption, attention, body, called, cease, Committee, COMP, consummate, consummated, consummation, court, curtail, CVR, decree, diversion, duly, enacted, exacerbated, firm, Gurnet, illegal, impression, incomplete, incurrence, independently, injunction, led, lung, medicinal, merit, misleading, motivate, Nordisk, Novo, Oaktree, officially, pendency, preliminary, proxy, purport, purported, purportedly, purpose, recommended, served, short, split, statute, stockholder, timeframe, unanimously, undertaken, vote, waiting, wealth, workforce
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achieve, attractive, committed, declared, declaring, difficult, limiting, liquidation, ownership, prefer, profitability, relinquish, sustain, terminable, valuable, volatility
Financial report summary
?Competition
Abbott Laboratories • Melinta Therapeutics • Abbvie • Nabriva Therapeutics • Iterum Therapeutics • Motif Bio • Spero TherapeuticsRisks
- We have incurred significant losses since inception and anticipate that we will incur losses for the foreseeable future. To date we have not generated sufficient revenue from product sales to cover corresponding expenses and we may never achieve or sustain profitability.
- Raising additional capital or entering into certain debt financings or other arrangements may cause dilution to our stockholders, restrict our operations or require us to relinquish rights.
- If clinical trials for omadacycline are prolonged, delayed or stopped, we may be unable to obtain regulatory approval and commercialize omadacycline for the treatment of additional indications on a timely basis.
- The results of previous clinical trials may not be predictive of future results, and the results of any ongoing or future clinical trials may not satisfy the requirements of the FDA or non-U.S. regulatory authorities.
- The regulatory approval process is expensive, time consuming and uncertain and may prevent us or our partners from obtaining approvals for the commercialization of our product candidates.
- Even though NUZYRA and SEYSARA have been approved by the FDA in the U.S., they face post-approval development and regulatory requirements, which may limit how they are manufactured and marketed, and could materially impair our ability to generate revenue.
- Our products may have undesirable side effects that may require them to be taken off the market or otherwise limit their sales.
- Coverage and reimbursement decisions by third-party payors may have an adverse effect on pricing and market acceptance. If there is not sufficient coverage and reimbursement for our products, it is less likely that our products will be widely used.
- Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.
- In the U.S. there is increasing scrutiny of drug prices and federal or state reforms could impact our ability to establish what we believe is a fair price for our products, and ultimately diminish our revenue prospects.
- If we or our partners market products in a manner that violates fraud and abuse and other healthcare laws, or if we or our partners violate government price reporting laws, we or our partners may be subject to administrative civil and/or criminal penalties.
- If BARDA were to eliminate, reduce, or delay funding for our contract, we would experience a negative impact on our programs associated with such funding and perhaps on our ability to maintain the infrastructure necessary to maximize our NUZYRA commercial opportunity.
- The BARDA contract includes special requirements, which subject us to the risk of a reduction or loss of funding.
- Termination and audit provisions in our BARDA contract could create additional risks for our business.
- Sales of NUZYRA and SEYSARA may be slow or limited for a variety of reasons including competing therapies or safety issues. If NUZYRA and SEYSARA are not successful in gaining broad commercial acceptance, our business would be harmed.
- A pandemic, epidemic or outbreak of an infectious disease, such as COVID-19, has and may in the future adversely affect our business, results of operations and financial condition.
- We face significant competition and if our competitors develop and market products that are more effective, safer or less expensive than our products, our commercial opportunities will be negatively impacted.
- If the FDA or other applicable regulatory authorities approve generic products that compete with NUZYRA, SEYSARA or any of our or our partners’ product candidates, or if existing generic antibiotics are viewed as being equally effective
- to NUZYRA, SEYSARA or any of our or our partners’ product candidates, the sales of NUZYRA, SEYSARA or, if approved, such product candidates would be adversely affected.
- We rely and will continue to rely on outsourcing arrangements for manufacturing of NUZYRA and any future product candidates, which could impair the commercialization of NUZYRA or delay approval of any future product candidates.
- We have continued to build our sales and distribution infrastructure. If we are unable to develop our sales, marketing and distribution capability on our own or through collaborations with marketing partners, we will not be successful in commercializing NUZYRA or any future product candidates to their full potential.
- If we are unable to establish and maintain our agreements with third parties to distribute NUZYRA to patients, our results of operations and business could be adversely affected.
- Independent clinical investigators and CROs that we engage to conduct our clinical trials may not devote sufficient time or attention to our and our partners’ clinical trials or be able to repeat their past success.
- If NUZYRA or SEYSARA do not achieve broad market acceptance among physicians, patients, the medical community and third-party payors, our revenue generated from their sales will be limited.
- Even though NUZYRA and SEYSARA have been approved for marketing in the U.S., we or our partners may never obtain approval of or commercialize NUZYRA or SEYSARA outside of the U.S., which would limit our ability to realize their full market potential.
- Bacteria might develop resistance to NUZYRA, which would decrease the efficacy and commercial viability of NUZYRA.
- If any product liability lawsuits are successfully brought against us or any of our collaborative partners, we may incur substantial liabilities and may be required to limit commercialization of our products, including NUZYRA and SEYSARA.
- If we fail to attract and retain key management and scientific personnel, we may be unable to successfully commercialize NUZYRA or any future product candidates.
- We depend on various consultants and advisors for the success and continuation of our development efforts.
- We have grown our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.
- Our employees, contractors, partners, principal investigators, CROs, consultants and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- The Notes are subordinated to our senior indebtedness, effectively subordinated to our secured indebtedness and structurally junior to any liabilities of our subsidiaries.
- We may not have the ability to raise the funds necessary to repurchase the Notes upon a fundamental change, and our existing or future debt may contain limitations on our ability to repurchase the Notes.
- We may fail to pay any cash amount upon repurchase of the Notes.
- If we are unable to obtain and enforce patent protection for products, our product candidates and related technology, our business could be materially harmed.
- Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties.
- If we or our partners fail to comply with our obligations under our intellectual property licenses with third parties, we could lose license rights that are important to our business.
- If we or our partners are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, 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.
- If we do not obtain protection under the Hatch-Waxman Amendments and similar foreign legislation by extending the term of patents covering each of our product candidates, our business may be materially harmed.
- The trading price of our common stock is volatile.
- We do not anticipate that we will pay any cash dividends in the foreseeable future.
- Anti-takeover provisions in our 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 management.
- Future sales of shares by existing stockholders could cause the trading price of our common stock to decline.
- Future sales of our common stock or equity-linked securities in the public market could lower the market price for our common stock.
- Because our merger resulted in an ownership change under Section 382 of the Internal Revenue Code for Transcept, Transcept’s pre-merger net operating loss carryforwards and certain other tax attributes are subject to limitations. The
- net operating loss carryforwards and other tax attributes of the former Paratek entity and us may also be subject to limitations as a result of ownership changes.
- If securities or industry analysts do not publish research or reports or publish inaccurate or unfavorable research about us, the trading price and trading volume of our common stock could decline.
- Maintaining and improving our financial controls and the requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain qualified board members.
- Our and our partners’ business may become subject to economic, political, regulatory, and other risks associated with international operations.
- If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.
- We enter into various contracts in the normal course of our business in which we indemnify the other party to the contract. In the event we have to perform under these indemnification provisions, it could have a material adverse effect on our business, financial condition, and results of operations.
- We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of former employers.
Management Discussion
- Net product revenue recognized on sales of NUZYRA in the U.S. was $33.8 million and $25.1 million for the three months ended June 30, 2023 and June 30, 2022, respectively. The increase in net product revenue is primarily the result of an increase in sales volume due to higher customer demand during the three months ended June 30, 2023.
- Government contract service revenue earned under our BARDA contract was $3.6 million and $1.9 million for the three months ended June 30, 2023 and June 30, 2022, respectively. The increase in government contract service revenue was primarily due to additional work performed under the anthrax development program.
- Government contract grant revenue earned under our BARDA contract was $1.9 million and $2.1 million for the three months ended June 30, 2023 and June 30, 2022, respectively. Government contract grant revenue recognized in both periods represents the reimbursement under the BARDA contract of costs incurred for our on-going post-marketing required clinical studies.