The application is based on phase 3 results from the ReOpen clinical trial program showing XHANCE significantly reduced symptoms and sinus opacification in participants with chronic rhinosinusitis
If approved, XHANCE is expected to be the first and only drug indicated for the treatment of chronic rhinosinusitis, a diagnosis which is assigned at approximately 10 million patient visits annually
Outlook and Target
Fiscal Year 2024 Outlook
We are maintaining our revenue outlook for fiscal year 2024 at $353 million to $356 million, implying year-over-year growth of 26% to 27%.
We are raising our Adjusted EBITDA outlook for fiscal year 2024 to approximately negative $39 million from a previous range of negative $54 million to negative $49 million.
Fiscal Year 2025 Outlook and Target
We are introducing our revenue outlook for fiscal 2025. We expect revenue to be in the range of $424 million to $434 million. The revenue range provided for fiscal 2025 assumes no additional revenue from potential future acquisitions completed between now and January 31, 2025.
In conjunction with our initial revenue outlook for fiscal 2025, we are revising our timeline for reaching annualized revenue of $500 million. Over the past two months, in order to accelerate our path to profitability1, we have made decisions to hold back on certain planned investments in our go to market and in the payer space because we do not believe the revenue from those investments will be realized soon enough to justify the returns in the current cost of capital environment. As a result of these decisions, we now expect to achieve $500 million of annualized revenue in a quarter in fiscal 20262 as compared to our previous target of a quarter in fiscal 2025.
In conjunction with our increased prioritization of achieving profitability1, we are introducing our Adjusted EBITDA Outlook for fiscal 2025. We expect Adjusted EBITDA for fiscal 2025 to be in the range of $10 million to $20 million. Our new outlook represents an acceleration to profitability1 compared to our previous target of achieving profitability1 at some point during fiscal year 2025. We believe our decisions will enhance long-term shareholder value.
We believe our $103.4 million in cash and cash equivalents as of October 31, 2023, along with cash generated in our normal operations gives us sufficient flexibility to reach our fiscal 2025 revenue and Adjusted EBITDA outlook. Additionally, our available borrowing capacity under our credit facility with Capital One provides us with an additional source of capital to pursue future growth opportunities not incorporated into our fiscal 2025 revenue and Adjusted EBITDA outlook.
Sera Prognostics Inc., The Pregnancy Company® (Nasdaq: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced that the Data Safety Monitoring Board (DSMB) overseeing its pivotal Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal OutcoMEs (PRIME) study recommended stopping enrollment due to efficacy, reporting that either of the co-primary endpoints met the stopping criteria for statistical significance at the pre-planned interim analysis. The Company has adopted the DSMB's recommendation and will stop PRIME study enrollment to focus on analyzing and reporting the available data.
"We are excited by this report of efficacy from the DSMB," said Zhenya Lindgardt, President and CEO of Sera Prognostics. "It is unexpected for trials to stop early for efficacy since most statistical power is typically reserved for the final analysis, which makes this event that much more encouraging. We look forward to sharing top-line results once we have had a chance to analyze the interim look data. We believe this will add to the PREVENT and AVERT studies in the growing, consistent body of evidence for our PreTRM® test that advances our mission to save lives and improve health for mothers and babies across the globe."
Obesity has been linked to development of a range of diseases and unfortunately, cancer. More specifically, the National Cancer Institute estimated that colorectal cancer is 1.3 times more likely in obese individuals. Therefore, this is a highly lucrative segment for pharmaceutical companies. Yet, the big pharma giant, Pfizer Inc (NYSE: PFE) abandoned its obesity drug that failed during the phase 2 trial due to exhibited side-effects. But a clinical-stage company, Altimmune Inc (NASDAQ: ALT), announced positive top-line results from the 48-week phase II MOMENTUM study of its obesity drug candidate. Roche Holding AG (OTC: RHHBY) also entered this lucrative market as it announced its acquisition of obesity drug maker for $2.7 billion. A molecular genetics diagnostic company specializing in the early detection of cancer, Mainz Biomed N.V. (NASDAQ: MYNZ) reported groundbreaking results from U.S. eAArly detect study that evaluated the use of novel mRNA biomarkers in the next version of its test for colorectal cancer, which is a major breakthrough in CRC diagnostics.
Pfizer faced a setback, but it is still in the race for finding a cure for obesity.
On Friday, Pfizer dropped its twice-daily obesity oral pill as most patients dropped out of its midstage trial due to side effects that include nausea and vomiting. But Pfizer is still developing its once-daily version of the weight-loss pill, but early data on this formulation won’t be available until the first half of 2024. Although the setback is not the outcome Pfizer hoped for, the pharma giant is not giving up on its $10-billion-a-year product, as stated by Pfizer CEO Albert Bourla.
Altimmune advances with its obesity drug candidate.
While Pfizer faced a setback, a small company with a market value of less than $200 million reported on Thursday that its experimental obesity drug helped reduce weight by as much as 15.6% over a midstage trial that lasted 48 weeks and included 391 patients. Upon its good news, Altimmune shares rose more than 45% at $4.61.
Results of Phase 3 HER2CLIMB-02 trial featured in an oral presentation and official press program at the 2023 San Antonio Breast Cancer Symposium --
