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YARDLEY, Pa., Jan. 31, 2023 (GLOBE NEWSWIRE) — OptiNose AS (NASDAQ: OPTN ), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, announced that it has Peter Miller. He stepped down as CEO and board member, and Rami Mahmoud, MD, MPH, was appointed as CEO and board member.
Announcing his departure, Peter Miller said, “It has been a privilege to work with the amazing colleagues at Optinose. I am proud of everything we have accomplished and the impact we are making in our mission to improve patients’ lives.”
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, the ONZETRA Xsail.®Becoming a public company listed on Nasdaq and transitioning from a clinical-stage company to a commercial-stage company through successful development, FDA approval and commercialization of XHANCE®.
Dr. Mahmoud, who has been the company’s president and chief operating officer since 2010, will replace Mr. Miller as Optinos’ new CEO and board member. During his time at Optinos, Dr. Mahmoud led both commercial and R&D functions and during this time was instrumental in supporting the FDA approval and early phase of the clinical research program for all of the company’s products, including XHANCE. Always approve pharmaceutical products for chronic sinusitis.
“Rami’s leadership and accomplishments, deep industry experience and medical background make him the perfect successor to Peter as CEO of Optinos,” said Joseph C. Scodari, chairman of Optinos’ board of directors.
Prior to joining Optinoz, Dr. Mahmoud served as Chief Medical Officer at Johnson & Johnson for 14 years and as a member of the Global Board of Directors of the Ethicon Group of Companies. He has also held senior roles in the pharmaceutical sector, serving on the board of directors of several operating companies and leading various functions in both R&D and commercial organizations. Dr. Mahmoud has been involved in the development, launch and/or commercialization of dozens of drugs and medical devices spanning multiple medical categories.
Dr. Mahmoud served for 10 years in the US Army and an additional 10 years in the Army Reserve, attaining the rank of lieutenant colonel and directing the Department of Epidemiology at the Walter Reed Army Research Institute. He has published more than 80 peer-reviewed papers and textbooks, and has served as a scientific reviewer for numerous journals and textbooks. Dr. Mahmoud holds a Masters in Health Care Management and Policy from the Harvard School of Public Health and an MD from the University of Miami.
Dr. Mahmoud said, “It has been a privilege to partner with Peter. He led the company with vision, energy and many milestones. I am personally grateful for the time we spent working together. And I know I speak for my colleagues at Optinos when I say that we deeply appreciate his many valuable contributions to the organization.
“Rami is a great friend and an exceptional leader. We have worked side by side to launch OptiNose, Inc. since our partnership in 2010. I am confident that he will lead the company to new heights,” said Mr. Miller.
Corporate guidance
Financial guidance
The company reiterated its previous financial guidance:
- XHANCE’s full-year 2022 net revenues are expected to be between $74 million and $78 million.
- XHANCE’s average net revenue per prescription for the full year 2022 is expected to be approximately $220.
- Total GAAP operating expenses (selling, general and administrative expenses and research and development expenses) for the full year 2022 are estimated to be between $127 million and $131 million, of which the company expects stock-based compensation to be 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 expects to submit a new drug application to the FDA in February for additional labeling of XHANCE for the treatment of chronic sinusitis, up from last year. According to the 2023 start guide. Many doctors visit the diagnosis of chronic sinusitis instead of diagnosing nasal polyps, a current symptom of XHANCE, and there is no FDA-approved medication for patients with chronic sinusitis.
About Optinose
Optinose is a global specialty pharmaceutical company focused on serving the needs of patients cared for by ear, nose and throat (ENT) and allergy specialists. To learn more, please visit www.optinose.com or follow us on Twitter and LinkedIn.
A cautionary note on forward-looking statements
This press release Contains forward-looking statements within the meaning of the US Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are designated as forward-looking statements for this purpose and include statements related to, among others, the Company’s anticipation of an additional new drug application to the FDA in February 2023 for a potential label extension for XHANCE for the treatment of chronic sinusitis. the potential for XHANCE to be the first FDA-approved chronic sinusitis drug product and the benefits of this label expansion; Potential for future growth; The Company expects XHANCE’s full-year 2022 net revenue to be $74 million to $78 million, with average XHANCE net revenue from prescription drug sales of $220 million for the full year, and total GAAP operating expenses (selling, general and administrative expenses, and research and development expenses) for 2022. It will be between $127-$131 million, of which the company expects stock-based compensation to be about $9 million. and other statements regarding the company’s future operations, expectations, objectives and other future events. Forward-looking statements are based on management’s current expectations and assumptions and are subject to numerous risks, uncertainties and other factors that could cause actual results and events to differ materially or adversely from those expressed in the forward-looking statements and others. Physician and patient acceptance of XHANCE for any current or future indication; The ability to create different interpretations of the results of the XHANCE clinical trial for the treatment of chronic sinusitis; risks and uncertainties regarding the 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 expects. The potential for changes in XHANCE’s net revenues, average XHANCE net revenues per prescription, and operating expenses for the full year 2022 in connection with the completion of the Company’s financial results for the full year 2022 and the evaluation of the financial results by the Company’s independent party. A registered public accounting firm; and risks, uncertainties and other factors described in “Item 1a. Risk Factors” and other recent Form 10-K and Form 10-Q filings with the Securities and Exchange Commission – available at www.sec. gov. As a result, you are cautioned not to place undue reliance on forward-looking statements. Any forward-looking statements made in this press release speak only as of the date of this press release, and we undertake no obligation to update any such forward-looking statements as a result of new information, future developments or otherwise.
Optinose Investor Contact
Jonathan Neely
jonathan.neely@optinose.com
267.521.0531
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