Yardley, Pennsylvania, Jan. Dec. 31, 2023 (GLOBE NEWSWIRE) — OptiNose AS (Nasdaq: OPTN ), a pharmaceutical company focused on patients treated by ear, nose, throat (ENT) and allergist specialists, today announced that Peter Miller Has resigned as CEO and board member Ramy Mahmoud, MD, MPH, was named CEO and board member.
In announcing his departure, Peter Miller shared: “It has been a privilege to work with the amazing colleagues at Optinose. I am grateful for what we have accomplished and what we continue to generate in our mission to improve the lives of patients.” Impact is proud.”
During Mr. Miller’s nearly 13 years as CEO, the company experienced significant growth.Under his leadership, the company’s first product, ONZETRA Xsail, was successfully developed and licensed®became a Nasdaq-listed company and transitioned 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 board member, effective immediately. During his tenure at Optinose, Dr. Mahmoud led the commercial and R&D functions and during this time was instrumental in the successful development and FDA approval of all of the company’s products, including XHANCE, as well as supporting clinical study programs for potential first approval or use in chronic sinus inflammatory drug products.
“Ramy’s leadership and accomplishments, deep industry experience and medical background make him an excellent fit to succeed Peter as CEO of Optinose,” said Joseph C. Scodari, Chairman of the Optinose Board of Directors.
Prior to joining Optinose, Dr. Mahmoud worked for Johnson & Johnson for 14 years as Chief Medical Officer and member of the Global Management Board of the Ethicon group of companies. He also held senior positions in the pharmaceutical industry, serving on the management boards of several operating companies and leading a range of functions in the R&D and commercial organisations. Dr. Mahmoud has been involved in the development, launch and/or commercialization of dozens of pharmaceutical and medical device products across multiple therapeutic categories.
Dr. Mahmoud also served 10 years in the US Army and 10 years in the Army Reserve, earning the rank of Lieutenant Colonel and heading the Department of Epidemiology at the Walter Reed Army Research Institute. He has published more than 80 peer-reviewed papers and textbook chapters, and serves as a scientific reviewer for several journals and textbooks. Dr. Mahmoud received his MS in Healthcare Administration and Policy from the Harvard School of Public Health and his MD from the University of Miami.
Dr. Mahmoud shared: “It has been a privilege to have the opportunity to work with Peter; he has led the company through many important milestones with vision, energy and enthusiasm. I am personally very grateful for the time we spent working together and I say we are very grateful With his many important contributions to the organization, I know I speak for all of my colleagues at Optinose.”
“Ramy has been a great friend and an outstanding leader. We have worked side by side since co-founding OptiNose, Inc. in 2010, and I have every confidence that he will lead the company to new heights,” said Mr. Miller.
Corporate Guidelines
financial guidance
The company reiterated its previous financial guidance:
- XHANCE’s full-year 2022 net revenue is expected to be between $74 and $78 million.
- The average net revenue per prescription for XHANCE is expected to be approximately $220 for the full year 2022.
- Total GAAP operating expenses (selling, general and administrative expenses, and research and development expenses) for the full year 2022 are expected to be in the range of $12.7 to $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 supplemental New Drug Application to the FDA in February to expand the potential label of XHANCE for the treatment of chronic sinusitis, consistent with previous guidance in early 2023. According to claims data, more than 10 times as many physician visits are diagnosed with chronic sinusitis rather than nasal polyps, which is the current indication for XHANCE, and there is no FDA-approved drug for patients with chronic sinusitis.
About Opnos
Optinose is a global specialty pharmaceutical company focused on meeting the needs of patients cared for by ear nose throat (ENT) and allergists. To learn more, visit www.optinose.com or follow us on Twitter and LinkedIn.
Cautionary note on 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, including but not limited to statements related to the company’s anticipated submission of a supplemental New Drug Application to the FDA in February 2023 to expand the potential labeling of XHANCE for the treatment of chronic sinusitis; Potential for the first FDA-approved chronic sinusitis drug product and the potential benefits of this label expansion; Potential for future growth; Company expects XHANCE’s full-year 2022 net revenue to be in the range of $74-$78 million for full-year 2022 Average XHANCE net revenue per prescription is approximately $220, GAAP total operating expenses (selling, general and administrative expenses and R&D expenses in 2022 will be between $12.7 and $131 million, of which the company expects stock-based compensation to be approximately $900 and other statements regarding the Company’s future operations, prospects, objectives and other future events. 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, Certainty and other factors could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements, including: physicians’ and patients’ acceptance of XHANCE for current and any potential future indications; use of XHANCE to treat chronic Potential for different interpretations of clinical trial results in sinusitis; risks and uncertainties associated with FDA approval of XHANCE for the treatment of chronic sinusitis; prevalence of chronic sinusitis and market opportunity for XHANCE may be smaller than company expectations; full year 2022 XHANCE net income, average XHANCE net income per prescription, and operating expenses are subject to change as the Company’s full-year 2022 financial results are finalized and such financial results are reviewed by the Company’s independent registered public accounting firm; and our Risks, uncertainties and other factors discussed in most recent Form 10-K and Form 10-Q filed with the SEC under the heading “Item 1A. Risk Factors” and elsewhere – available at www.sec.government Therefore, you are cautioned not to place undue reliance on any 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 such forward-looking statements, whether as a result of new information , future development or other reasons.
Optinose Investor Contact
Jonathan Neely
jonathan.neely@optinose.com
267.521.0531
