Plan to continue driving TYRVAYA® Launch with approximately 150-200 commercial resources in the field
The plan is expected to generate approximately $6-8 million in expense savings in the second half of 2022 and $40-48 million in 2023
The company will refocus its research and development efforts on OC-01 nasal spray (varenicline solution) for neurotrophic keratopathy and its ETFMC Gene therapy program
Study Results for OLYMPIA Phase 2 Clinical Trial for Stage 1 Neurotrophic Keratopathy Expected in Q4 2022
PRINCETON, NJ, June 28, 2022 (GLOBE NEWSWIRE) — Oyster Point Pharma, Inc. (OYST), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases illnesses, announced today that it will implement an operating expense rationalization plan that will include reduced employee and non-employee expenses across the organization. The Company plans to continue to pilot the launch of TYRVAYA® with around 150-200 commercial resources in the field.
“Today’s announcement is part of a strategic plan to maximize the market potential of TYRVAYA Nasal Spray (Varenicline Solution) and create value for Oyster Point stakeholders,” said Jeffrey Nau, Ph.D., MMS, President and CEO of Oyster Point Pharma. “The plan is designed to prioritize launch expenses for TYRVAYA and its field sales resources, streamline business operating expenses to increase efficiency and strengthen our balance sheet, including seeking sources of non-dilutive capital. We believe this plan will continue to drive the launch of TYRVAYA while reducing the total operating expenses needed to achieve future profitability. I remain in awe of what the Oyster Point team has achieved, including approximately 7,000 unique TYRVAYA prescribers since launch to date June 22.n/a, and I look forward to the next steps to come. I would also like to recognize the employees involved for their contributions to furthering our mission to improve the care of patients with ophthalmic diseases. »
To reflect these strategic priorities, the Company is also announcing that Daniel Lochner, its current Chief Financial Officer, will take on additional responsibilities now assuming a dual role as Chief Financial Officer and Chief Commercial Officer of the Company.
Michael Campbell, the company’s current vice president of sales and business operations, will be promoted to senior vice president, chief commercial officer, and John Snisarenko, chief commercial officer, will retire from the company effective July 1, 2022.” I look forward to continuing to work closely with Dan and Mike and thank John for his partnership over the past 2 years,” said Jeffrey Nau, Ph.D., MMS, President and CEO of Oyster Point Pharma.
The plan is expected to reduce operating expenses by approximately $6-8 million in the second half of 2022, net of severance benefits, and reduce operating expenses by approximately $40-48 million in 2023. reduction in operating expenses is expected to be primarily driven by lower general and administrative and non-employee research and development expenses and, to a lesser extent, by the reduction of up to 50 positions across the organization. Total operating expenses in 2023 are expected to be lower than total operating expenses in 2022.
The plan also includes refocusing the Company’s research and development efforts on OC-01 nasal spray (varenicline solution) to target stage 1 neurotrophic keratopathy and enriched tear film (ETF™) gene therapy to target the stage 2 and 3 neurotrophic keratopathy. The company is expecting study results for the OLYMPIA phase 2 clinical trial for stage 1 neurotrophic keratopathy in the fourth quarter of 2022. The company has submitted a request for a pre- IND to the Food and Drug Administration (FDA) regarding the ETF™ gene therapy program and plans to hold the pre-IND meeting in the second half of 2022.
About Oyster Point Pharma
Oyster Point Pharma is a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases. In October 2021, Oyster Point Pharma received FDA approval for TYRVAYA® Nasal Spray (Varenicline Solution) for the treatment of signs and symptoms of dry eye disease. Oyster Point has a growing pipeline of clinical and preclinical programs and continues to expand its research and development pipeline through internal innovation and external collaborations. Oyster Point continually strives to advance cutting-edge science and deliver therapies aimed at addressing the unmet needs of patients with ophthalmic diseases and the eye care professionals who care for them. For more information, visitwww.oysterpointrx.com and follow @OysterPointRx on Twitter and LinkedIn.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the future of the Company’s business. , the Company’s future plans and strategies, business opportunities, interactions with regulators, regulatory approvals, preclinical and clinical results, future financial condition, timing of preclinical and clinical trials, including data from such trials and other expected milestones, the timing of coverage determinations for TYRVAYA Nasal Spray and the therapeutic potential and clinical benefits of the Company’s product candidates and other future conditions. The words “if approved”, “may”, “shall”, “should”, “would”, “expect”, “plan”, “plan”, “anticipate”, “could”, “has intention”, “target”, “plan”, “contemplate”, “believe”, “estimate”, “predict”, “potential” or “continue” or the negative form of these terms or other similar expressions are intended to identify forward-looking statements, although all forward-looking statements contain these identifying words. The reader is cautioned not to rely on these forward-looking statements. All forward-looking statements contained in this press release are based on the Company’s current expectations and assumptions and are subject to a number of risks, uncertainties and assumptions, including, among others: the Company’s plans and its potential for success in commercializing TYRVAYA; the beneficial characteristics, safety, efficacy and therapeutic effects of TYRVAYA and the Company’s preclinical and clinical product candidates; the Company’s plans for the development and manufacturing of TYRVAYA and its preclinical and clinical candidates, including potential additional indications or disease areas to be evaluated and pursued; the timing of the launch of the Company’s future preclinical studies or clinical trials; the uncertainties inherent in pharmaceutical research and development, including the likelihood of positive preclinical study results and the likelihood of clinical trials demonstrating the safety and efficacy of the Company’s products or product candidates; the timing or likelihood of regulatory filings and approvals of TYRVAYA and our clinical and preclinical candidates, including in potential additional indications for TYRVAYA and potential filings in other jurisdictions; the prevalence of dry eye disease and neurotrophic keratopathy (NK) and the size of market opportunities for the Company’s product candidates; the potential benefits expected from strategic collaborations with third parties and the Company’s ability to attract employees with development, regulatory and commercialization expertise; existing regulations and regulatory developments in the United States and other jurisdictions; the Company’s plans and ability to obtain or protect intellectual property rights worldwide, including term extensions of existing patents, if any; the Company’s continued reliance on third parties to conduct additional preclinical studies and clinical trials on its product candidates, and for the manufacture of its products and product candidates; economic factors, such as interest rate and currency exchange rate fluctuations; manufacturing difficulties or delays, either internally or within the supply chain; product efficacy or safety issues resulting in product recalls or regulatory action; financial instability of international economies and legal systems and sovereign risk; risks related to the impact of the global COVID-19 pandemic, such as the extent and duration of the outbreak, government actions and restrictive measures implemented in response, significant delays and cancellations of proceedings medical, supply chain disruptions and other impacts on the business, or on the Company’s ability to execute business continuity plans, as a result of the COVID-19 pandemic; the Company’s ability to recruit and retain key personnel necessary to develop and commercialize its products and product candidates, and to grow the Company; the accuracy of the Company’s estimates of expenses, future revenues, capital needs and additional financing needs; the financial performance of the Company; market conditions; the adequacy of the Company’s existing capital resources to fund its future operating expenses and capital expenditure requirements; and the Company’s expectations regarding the period during which it will be considered an emerging growth company under the JOBS law. A list and additional descriptions of these risks, uncertainties and other factors can be found in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, including in the sections titled “Special Note Regarding forward-looking statements”. and “Item 1A. Risk Factors,” and in the company’s subsequent quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission from time to time. Copies of these filings are available online at www.oysterpointrx.com. Any forward-looking statements made in this press release speak only as of the date of this release. The Company does not undertake to update forward-looking statements as a result of new information or future events or developments, except as required by law. No representation or warranty (express or implied) is made as to the accuracy of these forward-looking statements.