Optinose Announces Q1 2024 Financial Results and Recent Highlights

Optinose, a pharmaceutical company dedicated to serving patients treated by ear, nose, and throat (ENT) and allergy specialists, has released its financial results for the first quarter of 2024, ending March 31. The company reported significant growth in net revenue from its product XHANCE, totaling $14.9 million, a 26% increase compared to the same period in 2023. Optinose anticipates that XHANCE's net revenues for the full year 2024 will range between $85.0 to $95.0 million. They also project that peak year net revenues could reach at least $300 million from their current specialist-focused prescriber audience.

In March 2024, the U.S. Food and Drug Administration (FDA) approved XHANCE as the first prescription medication for treating chronic rhinosinusitis without nasal polyps in adult patients. This approval was based on evidence from multiple randomized placebo-controlled trials, making it a significant milestone for the company. CEO Ramy Mahmoud, MD, MPH, emphasized the potential impact of this approval, noting that it could expand the total addressable market by up to ten times. The company has launched this new opportunity using its existing commercial infrastructure aimed at specialty prescribers, with expectations to achieve positive income from operations by 2025.

The first quarter of 2024 also saw the publication of the ReOpen clinical program results in the Journal of Allergy and Clinical Immunology: In Practice. This program evaluated the efficacy and safety of XHANCE in adult patients with chronic rhinosinusitis. The trials demonstrated statistically significant improvements in symptoms, inflammation inside the sinuses, and a reduction in acute disease exacerbations in patients treated with XHANCE compared to those receiving a placebo.

In addition, the FDA approved a second manufacturing site for XHANCE units in March 2024. Hikma Pharmaceuticals USA Inc.’s affiliate, West-Ward Columbus Inc., received approval for commercial production and sampling, enhancing the company's manufacturing capabilities.

Optinose also completed a $55 million registered direct offering of its common stock and pre-funded common stock warrants to existing and new institutional investors on May 10, 2024. The company expects that its post-offering cash and cash equivalents, totaling approximately $100 million, will be sufficient to fund its operations and meet debt service obligations through 2025.

For the first quarter of 2024, Optinose's research and development expenses were $1.2 million, while selling, general, and administrative expenses were $20.5 million. The net loss for the period was $14.1 million, or $0.12 per share. The company's balance sheet showed cash and cash equivalents of $51.6 million as of March 31, 2024, not including the $55 million from the registered direct offering.

Looking ahead, Optinose expects XHANCE's average net revenue per prescription to exceed $230 for the full year 2024. The company also projects total GAAP operating expenses for 2024 to range between $95.0 to $101.0 million, with stock-based compensation estimated at approximately $6.0 million. The positive income from operations is anticipated by the full year 2025.

To discuss these financial results and corporate updates, Optinose's leadership team hosted a conference call and webcast on May 14, 2024, at 10:00 a.m. Eastern Time. The conference call was accessible via a live webcast on the company's website, with a replay available for 60 days following the event.

Optinose continues its mission as a global specialty pharmaceutical company focused on addressing the needs of patients under the care of ENT and allergy specialists. Their flagship product, XHANCE, combines a drug and device using the Exhalation Delivery System to deliver a topical steroid to the nasal cavity, approved for treating chronic rhinosinusitis with and without nasal polyps in patients aged 18 and older.