Optinose Announces CEO Transition and Company Update


Optinose, Inc.

Optinose, Inc.

Ramy Mahmoud, MD, MPH Named CEO and Board Member

YARDLEY, Pa., Jan. 31, 2023 (GLOBE NEWSWIRE) — Optinose (NASDAQ: OPTN), a pharmaceutical company specializing in patients treated by ear, nose and throat (ENT) specialists and allergists, announced today that Peter Miller named CEO and member of the board of directors, and that Ramy Mahmoud, MD, MPH was named chief executive officer and member of the board of directors.

Announcing his departure, Peter Miller said: “It has been a privilege to work with Optinose’s incredible group of colleagues. I am proud of all we have accomplished and the impact we continue to have in our mission to improve the lives of patients. “

During Mr. Miller’s nearly 13 years as CEO, the company has experienced significant growth. His leadership led to the successful development and licensing of the company’s first product, ONZETRA Xsail®becoming a Nasdaq-listed public company, and transitioning from a clinical-stage company to a commercial-stage company through the successful development, FDA approval and commercialization of XHANCE®.

Dr. Mahmoud, the company’s president and chief operating officer since 2010, will succeed Mr. Miller as Optinose’s new CEO and as a member of the board of directors, effective immediately. Dr. Mahmoud led both the commercial and R&D functions during his tenure at Optinose and was instrumental in the successful development and FDA approval of all of the company’s products, including XHANCE, during this time. , and for the clinical research program supporting the potential first- approval of a drug product for chronic sinusitis.

“Ramy’s leadership and accomplishments, his deep industry experience and his medical background make him an ideal candidate to succeed Peter as CEO of Optinose,” said Joseph C. Scodari, Chairman of the Board of Optinose. Optinose administration.

Prior to joining Optinose, Dr. Mahmoud spent 14 years at Johnson & Johnson where he was Chief Medical Officer and member of the Global Board of Directors for the Ethicon group of companies. He has also held leadership positions in the pharmaceutical industry, serving on the board of several operating companies and leading various functions in R&D and commercial organizations. Dr. Mahmoud has participated in the development, launch and/or commercialization of dozens of pharmaceutical products and medical devices covering several therapeutic categories.

Dr. Mahmoud also served 10 years on active duty in the U.S. Army and an additional 10 years in the Army Reserves, achieving the rank of Lieutenant Colonel and heading the Department of Epidemiology at the Walter Reed Army Institute of Research. . He has published over 80 peer-reviewed articles and textbook chapters, and served as scientific reviewer for a number of journals and textbooks. Dr. Mahmoud holds a master’s degree in health care management and policy from the Harvard School of Public Health and an MD from the University of Miami.

Dr Mahmoud shared: “It has been a privilege to have the opportunity to work in partnership with Peter; he has led the company with vision, energy and passion through many important milestones. I am personally grateful for the time we have spent working together, and I know that I speak for all of my Optinose colleagues when I say that we deeply appreciate his many important contributions to the organization.

“Ramy is a great friend and an exceptional leader. We have done things side by side since our partnership in 2010 to start OptiNose, Inc. and I have great confidence that he will lead the company to new heights,” said Mr Miller.

Business advice

Financial orientation

The Company reiterated its previous financial guidance:

  • XHANCE’s full-year 2022 net revenue is expected to be between $74 million and $78 million.

  • XHANCE’s average net income per prescription for the full year of 2022 is expected to be approximately $220.

  • total GAAP operating expenses (selling, general and administrative, and research and development) for full-year 2022 are expected to be between $127 million and $131 million, of which the company expects stock-based compensation of approximately $9 million.

This financial information is preliminary, subject to change and has not been reviewed by the Company’s independent registered public accounting firm.

XHANCE sNDA for Chronic Sinusitis

The company plans to submit a supplemental new drug application to the FDA for a potential label extension of XHANCE for the treatment of chronic sinusitis in February, consistent with previous guidance from early 2023. According to claims data, there are more than 10 times more doctor visits with a diagnosis of chronic sinusitis than with a diagnosis of nasal polyps, the current indication for XHANCE, and there are no FDA-approved drugs for patients with chronic sinusitis.

About Optinose
Optinose is a global specialty pharmaceutical company focused on patient needs supported by ear, nose and throat (ENT) specialists and allergists. To learn more, visit www.optinose.com or follow us on Twitter and LinkedIn.

Caution Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among other things, statements relating to the company’s expectation to submit a supplemental new drug application to the FDA in February 2023 for a potential label extension of XHANCE for the treatment of chronic sinusitis; the potential for XHANCE to be the first FDA-approved drug product for chronic sinusitis and the potential benefits of such label expansion; future growth potential; the company expects XHANCE net revenues for the full year of 2022 to be between $74 million and $78 million, XHANCE average net revenues per prescription for the full year of 2022 to be approximately $220 and that total GAAP operating expenses (sales, general and administrative expenses, and research and development expenses) for 2022 will be between $127 million and $131 million, of which the Company expects revenue-based compensation. ‘shares will be about 9 million; and other statements regarding future operations, prospects, objectives and other future events of the Company. Forward-looking statements are based on management’s current expectations and assumptions and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated. by such forward-looking statements, including, without limitation: physician and patient acceptance of XHANCE for its current indication and any potential future indications; possibility of variable interpretation of the results of clinical trials of XHANCE for the treatment of chronic sinusitis; risks and uncertainties related to FDA approval of XHANCE for the treatment of chronic sinusitis; the prevalence of chronic sinusitis and market opportunities for XHANCE may be lower than the Company forecasts; the potential for changes in XHANCE’s net income, XHANCE’s average net income per prescription and operating expenses for the full year 2022 as part of the Company’s finalization of financial results for the full the year 2022 and the review of these financial results by the Company’s independent committee, a registered public accounting firm; and the risks, uncertainties and other factors discussed under “Item 1A. Risk Factors” and elsewhere in our most recent Forms 10-K and 10-Q filed with the Securities and Exchange Commission – which are available at www.sec. govt. Accordingly, you are cautioned not to place undue reliance on forward-looking statements. All forward-looking statements made in this press release speak only as of the date of this press release, and we assume no obligation to update any such forward-looking statements, whether as a result of new information, future developments or otherwise.

Optinose investor contact
Jonathan Neley
[email protected]



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