Optinose (OPTN) shares underperformed yesterday following the positive Phase 3 results for Sanofi (SNY) and Regeneron's (REGN) Dupixent in treating patients with chronic rhinosinusitis with nasal polyps, Jefferies analyst David Steinberg tells investors in a research note titled "Biologics Competitor as Expected; Real World Pricing Issues Likely to Limit Us." The analyst says that while Dupixent demonstrated strong efficacy, clinicians he's spoken with believe that the "massive" pricing disparity versus nasal steroids will likely result in payer "step edits" that could limit widespread adoption of the "expensive" biologics currently under development. Further, Dupixent's head-to-head comparison with Optinose's Xhance's "strong" efficacy profile is difficult, the analyst adds. Steinberg still sees a "major" long-term opportunity for Xhance and keeps a Buy rating on Optinose with a $31 price target.

Oppenheimer analyst Hartaj Singh raised the firm's price target on Regeneron to $1,175 from $1,125 and keeps an Outperform rating on the shares ahead of the Q1 earnings report on May 2. Oppenheimer believes the areas of focus will be the status and dynamics of the Eylea High Dose launch, questions around the impending Dupixent COPD PDUFA, the status of the two oncology approvals expected in 2024, updates on various pipeline projects in immunology and oncology, and comments on capital allocation and financial planning by the new CFO at the company.

Optinose announced corporate updates detailing its commercial plans and expectations for XHANCE following the recent FDA approval of a new indication for the treatment of chronic rhinosinusitis without nasal polyps in patients 18 year of age and older. The Company will host an investor call at 10:00 a.m. Eastern Time today to discuss its commercial strategy and financial outlook. "The recent FDA approval of XHANCE as the first and only approved drug treatment for chronic sinusitis is a landmark achievement," said Ramy Mahmoud, MD, MPH, CEO of Optinose. "Because we plan to leverage our current commercial infrastructure, including 75 sales territories, we expect to need limited incremental spend to effectively reach the estimated 3 million patients with chronic sinusitis who are cared for by ENT and Allergy specialists. To prepare for an effective launch, we have recently optimized our sales alignment towards a chronic sinusitis call target universe and partnered with a specialty pharmacy hub to improve patient and physician office experience and increase prescription fill and reimbursement rates. Based on our market analysis, we believe that our base planned efforts focused on a specialty prescriber audience can grow XHANCE peak year net revenues to more than $300 million and allow Optinose to produce positive income from operations for full year 2025. With incremental investments in the future, we believe the market opportunity could be expanded to over 30 million patients through outreach to the 7 million patients being treated by primary care physicians and by direct-to-consumer activation of the 20 million patients who report suffering from chronic sinusitis symptoms," he concluded. Financial Outlook: XHANCE Net Revenue: The Company expects peak XHANCE net revenues to exceed $300 million based on its current promotional focus on a specialty audience of mostly ENT and Allergy specialists. Income from Operations: The Company expects to produce positive income from operations for full year 2025.

The Company announced preliminary XHANCE net product revenue of $14.9 million for the three months ended March 31, 2024, representing growth of approximately 26% over the first quarter of 2023.

Reports business EPS of EUR 1.78, down 17.6% reported and 7.4% at CER. Reports Q1 IRFS net sales EUR 10.464B, up 2.4%. Paul Hudson, Chief Executive Officer, commented: "We are off to an excellent start in 2024, delivering on our strategic priorities and a transformation of our portfolio of medicines and vaccines to become a development-driven, tech-powered biopharma company committed to serving patients and accelerating growth. Continued strong performance by Dupixent and our new launches drove sales growth of seven percent. In parallel, we are delivering on our promise of increased investments in our late-stage pipeline to fully realize its value for patients and Sanofi. We are awaiting regulatory decisions for Dupixent in COPD, a progressive disease with limited effective treatment options. If approved, Dupixent will be the first biologic treatment in COPD. With the robust progress in our portfolio transformation, we reaffirm our financial guidance for 2024."