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Veru Inc (DE:FMW)
:FMW
Earnings Data
Report Date
Aug 07, 2025TBA Not Confirmed
Period Ending
2025 (Q3)Consensus EPS Forecast
-0.05Last Year’s EPS
-0.06Same Quarter Last Year
Moderate Buy
Based on 0 Analysts Ratings
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Earnings Call Summary
Earnings Call Date:May 08, 2025
|% Change Since: 4.44%
|Next Earnings Date:Aug 07, 2025
Earnings Call Sentiment|Neutral
The earnings call presented several positive developments, such as successful Phase 2b study results for enobosarm and financial improvements in net loss from continuing operations. However, the company faces challenges with increased R&D costs, a significant decrease in cash reserves, and a net loss on the sale of the FC2 business. While there are promising regulatory and clinical catalysts ahead, the need for additional funding is a concern.Company Guidance
During Veru Inc.'s Q2 fiscal year 2025 investor call, the company provided detailed guidance on its ongoing clinical programs, particularly focusing on their obesity program. The discussion highlighted the progress of Enobosarm, an oral selective androgen receptor modulator, in combination with semaglutide for weight management in older patients. A Phase 2b study showed that Enobosarm, when combined with semaglutide, led to a 71% preservation of total lean body mass, with a significant p-value of 0.002, and a 99% mean relative reduction in loss of lean mass for the 3 mg dose group (p<0.001). The study also reported a 46% greater relative loss of fat mass in the Enobosarm 6 mg group compared to placebo (p=0.014), with a notable shift in body composition favoring fat loss. The company plans to advance into a Phase 3 clinical program, with the primary endpoint focused on physical function improvements, and expects regulatory clarity following an upcoming end-of-Phase 2 FDA meeting. Additionally, Veru announced the development of a novel modified-release oral Enobosarm formulation, anticipated to be available for Phase 3 studies and commercialization, with patent protection expected until 2045. Financially, Veru reported a net loss of $7.9 million for continuing operations, with cash and equivalents totaling $20 million as of March 31, 2025, and emphasized the need for additional capital to support ongoing drug development efforts.Positive Phase 2b Study Results for Enobosarm
The Phase 2b quality clinical study demonstrated that enobosarm combined with GLP-1 receptor agonists resulted in a 71% preservation of total lean body mass in patients, with a p-value of 0.002. The enobosarm 3 mg dose showed a 99% mean relative reduction in loss of lean mass, with a p-value of less than 0.001.
Improved Body Composition and Physical Function
Enobosarm treatment resulted in a 46% greater relative loss of fat mass compared to placebo plus semaglutide over 15 weeks, with a p-value of 0.014. There was also a significant reduction in the proportion of patients experiencing a decline in physical function, with a 62.4% relative reduction in the enobosarm 3 mg group, compared to placebo.
Financial Improvement
Net loss from continuing operations decreased from $8.7 million to $7.9 million compared to the prior year's quarter. Additionally, the sale of the FC2 female condom business generated net proceeds of approximately $16.3 million.
Regulatory and Clinical Catalysts
Upcoming catalysts include results of unblinded safety data for Phase 2b, efficacy and safety results for the Phase 2b extension study, and expected regulatory clarity from an end-of-Phase 2 FDA meeting in Q3 2025.
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DE:FMW Earnings History
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat
Missed
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DE:FMW Earnings-Related Price Changes
Report Date | Price 1 Day Before | Price 1 Day After | Percentage Change |
|---|---|---|---|
May 08, 2025 | €0.45 | €0.45 | +0.22% |
Feb 13, 2025 | €0.50 | €0.53 | +6.01% |
Aug 08, 2024 | €0.74 | €0.73 | -1.35% |
May 08, 2024 | €1.44 | €1.36 | -5.64% |
Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.
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FAQ
When does Veru Inc (DE:FMW) report earnings?
Veru Inc (DE:FMW) is schdueled to report earning on Aug 07, 2025, TBA Not Confirmed.
What is Veru Inc (DE:FMW) earnings time?
Veru Inc (DE:FMW) earnings time is at Aug 07, 2025, TBA Not Confirmed.
Where can I see when companies are reporting earnings?
You can see which companies are reporting today on our designated earnings calendar.
What companies are reporting earnings today?
You can see a list of the companies which are reporting today on TipRanks earnings calendar.
What is the P/E ratio of Veru Inc stock?
The P/E ratio of Veru is N/A.
What is DE:FMW EPS forecast?
DE:FMW EPS forecast for the fiscal quarter 2025 (Q3) is -0.05.
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