Supernus Pharmaceuticals, Inc. Q4 2025 Earnings Call Summary - Moby Strategic Performance and Operational Context Achieved record 2025 revenues of $719 million, successfully transitioning the business model following the loss of exclusivity for legacy products Trokendi XR and Oxtellar XR. Growth was primarily driven by a 40% revenue increase across four key products: Qelbree, GOCOVRI, ZURZUVAE, and ONAPGO, which now represent 76% of total revenues. Successfully integrated the Sage Therapeutics acqui ...

Supernus Pharmaceuticals (NasdaqGM:SUPN) Q4 2025 Earnings call February 24, 2026 04:30 PM ET Company ParticipantsJack A. Khattar - President and CEOPeter Vozzo - Managing DirectorTim Dec - CFONone - Company RepresentativeConference Call ParticipantsDavid Amsellem - Managing Director and Senior Research AnalystJon Cox - AnalystKristen Kluska - AnalystPavan Patel - Biopharma Equity Research AnalystStacy Ku - AnalystOperatorGood afternoon. Welcome to Supernus Pharmaceuticals for the quarter and full year 2025 ...

Supernus Pharmaceuticals (NasdaqGM:SUPN) Q4 2025 Earnings call February 24, 2026 04:30 PM ET Company ParticipantsJack A. Khattar - President and CEOPeter Vozzo - Managing DirectorTim Dec - CFONone - Company RepresentativeConference Call ParticipantsDavid Amsellem - Managing Director and Senior Research AnalystJon Cox - AnalystKristen Kluska - AnalystPavan Patel - Biopharma Equity Research AnalystStacy Ku - AnalystOperatorGood afternoon. Welcome to Supernus Pharmaceuticals for the quarter and full year 2025 ...

Core Insights - Entera Bio Ltd. has appointed Geno J. Germano as Chairman of the Board, effective February 4, 2026, succeeding Gerald Lieberman [1] - The company is advancing two oral PTH peptide programs into clinical testing in 2026, including a Phase 3 study for EB613 in osteoporosis and a first-in-human study for Long-Acting Oral PTH in hypoparathyroidism [2] Company Developments - Entera's lead clinical asset, EB613, is positioned to transform osteoporosis treatment by providing an oral anabolic therapy, which could broaden its use among patients [3] - The company has established a foundation for its oral peptide pipeline and is transitioning to late-stage clinical testing, with Germano's leadership expected to enhance its development and commercialization efforts [3][4] Leadership Background - Geno J. Germano brings over 30 years of experience in the pharmaceutical and life sciences sectors, having held senior roles at Pfizer, including leading a $14 billion innovative medicines portfolio [4] - Germano's previous board experience includes roles at various biotechnology companies, indicating a strong background in guiding clinical-stage firms [4] Product Pipeline - Entera is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab® technology platform [5] - The company's most advanced product, EB613, is being developed as the first oral treatment for post-menopausal women with low bone mineral density and high-risk osteoporosis [5] - Additional programs include an oral PTH(1-34) tablet for hypoparathyroidism and an oral oxyntomodulin for obesity and metabolic syndromes [5]

Summary of Supernus Pharmaceuticals Conference Call Company Overview - **Company**: Supernus Pharmaceuticals (NasdaqGM:SUPN) - **Focus**: CNS-focused biopharma with a diversified portfolio of products - **Revenue Guidance**: $685 million - $705 million for the current year [3][4] Key Products and Growth Drivers 1. **Qelbree**: - A non-stimulant ADHD treatment launched four and a half years ago - Current annualized prescriptions: approximately 1 million, representing about 1% market share - Expected peak sales: $320 million with a growth rate of over 20% [6][7] 2. **GOCOVRI**: - Unique product for Parkinson's, approved for dyskinesia and off episodes [3] 3. **ONAPGO**: - Apomorphine infusion device for Parkinson's launched this year - Initial peak sales estimate: $200 million - $300 million, but demand has exceeded expectations [9][10] 4. **ZURZUVAE**: - Oral treatment for postpartum depression acquired from Sage Therapeutics - Sales guidance not yet provided, but milestones based on sales levels are expected to be achievable [10][11] Business Development and Financial Strategy - **Cash Position**: Approximately $300 million post-acquisition of Sage Therapeutics - **Future Acquisitions**: Business development remains a priority, with potential transaction sizes estimated between $1 billion - $1.5 billion [12][13] - **Leverage Strategy**: Comfortable with a leverage ratio of 2 to 2.5 times EBITDA [13] Supply Chain and Production Challenges - **ONAPGO Supply Issues**: - Current production challenges due to competing priorities on the production line - Decision made to pause new patient initiation to prioritize existing patients [19][20] - Efforts are ongoing to increase production capacity and explore alternative suppliers [24][30] Market Position and Competitive Landscape - **Differentiation of ONAPGO**: - Apomorphine acts like dopamine without the need for metabolic conversion, unlike levodopa - Strong clinical need for alternatives to levodopa in Parkinson's treatment [32][34] - **ZURZUVAE Market Potential**: - Consistent growth of 19%-20% quarter over quarter - Focus on educating OB-GYNs for better diagnosis and treatment of postpartum depression [37][38] Pipeline and Future Developments - **Upcoming Data**: - Phase 2B data for epilepsy compound SPN-817 expected in 2027 - New stimulant for ADHD (SPN-443) to enter SAD-MAD study in 2026 [43][45] - **Potential New Assets**: - Evaluation of Sage's pipeline for future development opportunities [42] Conclusion - Supernus Pharmaceuticals is positioned for growth with a strong focus on CNS products, ongoing development efforts, and a commitment to addressing supply chain challenges. The company is optimistic about its product pipeline and market opportunities in the coming years.

Core Insights - Biogen's Zurzuvae (zuranolone) has received approval from the European Commission for the treatment of postpartum depression (PPD) in adults, making it the first and only approved treatment for this indication in the European Union [1][7] - The approval is based on the successful phase III SKYLARK study, which demonstrated rapid and sustained relief from depressive symptoms [2][7] - Biogen's stock has underperformed this year, with a 5% decline compared to a 3% growth in the industry [3] Product Performance - Zurzuvae was launched in the United States in December 2023, and sales reached $46.4 million in Q2 2025, reflecting a 68% increase sequentially due to rising demand [6][7] - The drug's launch exceeded Biogen's internal expectations, indicating strong market acceptance [6][7] Strategic Partnerships - Zurzuvae was developed in collaboration with Sage Therapeutics, which has been acquired by Supernus Pharmaceuticals. Biogen and Supernus share profits and losses from the commercialization of Zurzuvae in the U.S. [5] Future Growth Potential - Zurzuvae is one of four new product launches by Biogen, alongside Leqembi for Alzheimer's disease, Skyclarys for Friedreich's Ataxia, and Qalsody for ALS, which are expected to drive long-term growth [8]

Core Viewpoint - Biogen Inc. has received marketing authorization from the European Commission for ZURZUVAE® (zuranolone), the first and only treatment indicated for postpartum depression (PPD) in the European Union, representing a significant advancement in maternal health care [1][2][7]. Group 1: Product Information - ZURZUVAE is a once-daily, oral treatment for PPD, administered over a 14-day period, and can show symptom improvement as early as day 3 [2][6]. - The approval is based on the SKYLARK study, which demonstrated a significant mean reduction in depression severity as measured by the Hamilton Rating Scale for Depression (HAMD-17) at day 15 compared to placebo, with all key secondary endpoints also met [4][7]. - The most common side effects reported in patients treated with ZURZUVAE 50 mg include somnolence, dizziness, and sedation, occurring in 5% or more of patients [4]. Group 2: Market Context - Up to 20% of women in Europe experience symptoms of PPD, which is often underdiagnosed and undertreated due to varying clinical guidelines across countries [3][7]. - PPD is a leading cause of maternal mortality in Europe, highlighting the critical need for effective treatment options [3][7]. Group 3: Regulatory and Development Background - ZURZUVAE was previously approved by the U.S. Food and Drug Administration in August 2023 and received regulatory approval in the U.K. in August 2025 [5][8]. - Biogen entered into a collaboration with Sage Therapeutics in 2020 to develop and commercialize ZURZUVAE, with Supernus Pharmaceuticals completing the acquisition of Sage Therapeutics in July 2025 [7][8].

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $165 million, a decrease from $168 million in the same quarter last year [17] - Net product sales were $158 million, with royalty, licensing, and other revenues at $7 million; excluding Trokendi XR and Oxtellar XR, total revenues increased by 17% compared to the same quarter last year [17] - GAAP net earnings were $22 million or $0.40 per diluted share, compared to $20 million or $0.36 per diluted share in the same quarter last year [18] - As of June 30, 2025, the company had approximately $523 million in cash, cash equivalents, and marketable securities, up from $454 million as of December 31, 2024 [21] Business Line Data and Key Metrics Changes - KELBY experienced 31% growth in net sales and 23% growth in prescriptions, with approximately 36,000 prescribers, a 23% increase year-over-year [8][9] - GOCOVRI saw a 16% increase in net sales and a 14% increase in prescriptions, reaching approximately 1,900 prescribers [10] - ONAPCO launched successfully with over 750 patient enrollment forms submitted by more than 300 prescribers [11] - ZERZUVE reported Q2 2025 net revenues of $23.2 million, a 68% increase from $13.8 million in Q2 2024 [12] Market Data and Key Metrics Changes - KELBY's adult prescriptions grew by 29%, while pediatric prescriptions grew by 20% [30] - GOCOVRI's Medicare copay decreased significantly, with 97% of prescriptions having a copay of less than $25, down from 77% in 2024 [10] Company Strategy and Development Direction - The company is transitioning from legacy products to a new growth phase, focusing on KELBY, GOCOVRI, ONAPCO, and ZERZUVE as core growth drivers [7][70] - The acquisition of Sage Therapeutics is expected to accelerate mid to long-term revenue growth and cash flow [12] - Corporate development will prioritize revenue-generating products and opportunities in women's health, particularly in the OBGYN space [49] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, highlighting strong performance in the first half of 2025 and the positive impact of the Sage acquisition [22] - The company expects total revenues for 2025 to range from $670 million to $700 million, up from a previous range of $600 million to $630 million [22] - Operating loss for the full year 2025 is expected to be between $70 million and $80 million, primarily due to acquisition-related costs [23] Other Important Information - The company is on track to initiate a phase 2b trial for SPN-820 in adults with major depressive disorder [13] - The company completed a pharmacokinetic study for SPN-443, a new product candidate for ADHD and other CNS disorders [14] Q&A Session Summary Question: Pricing dynamics for KELBY and adult segment update - Management indicated that net pricing for KELBY remains above $300 per prescription, with adult prescriptions growing significantly [26][28] Question: Enrollment forms and sales for ONAPCO - Management reported over 750 enrollment forms submitted and approximately 200 patients currently receiving the product, with reimbursement processes going smoothly [27][32] Question: Sales growth for ZERZUVE - Management noted a 36% growth in prescriptions for ZERZUVE, attributing it to strong sales force expansion and investment [37][39] Question: KELBY launch initiatives and prescriber interest - Management highlighted the importance of new label changes and educational efforts for physicians, contributing to strong performance [45][46] Question: Future M&A focus and cash position post-Sage acquisition - Management confirmed a strong cash position of approximately $240 million to $260 million post-acquisition, with a focus on revenue-generating products in CNS and women's health [48][51]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $165 million, a slight decrease from $168 million in the same quarter last year [15] - Excluding net product sales of Trokendi XR and Oxtellar XR, total revenues for Q2 2025 increased by 17% compared to the same quarter last year [15] - GAAP net earnings for Q2 2025 were $22 million or $0.40 per diluted share, compared to $20 million or $0.36 per diluted share in the same quarter last year [16] - As of June 30, 2025, the company had approximately $523 million in cash, cash equivalents, and marketable securities, up from $454 million as of December 31, 2024 [20] Business Line Data and Key Metrics Changes - KELBY had a robust performance with a 23% growth in prescriptions and a 31% growth in net sales [7] - GOCOVRI saw a 14% increase in prescriptions and a 16% increase in net sales compared to the same quarter last year [9] - ONAPCO launched successfully with over 750 patient enrollment forms submitted by more than 300 prescribers [10] - ZERZUVEY reported net revenues of $23.2 million in Q2 2025, up from $13.8 million in Q2 2024, representing a 68% increase [11] Market Data and Key Metrics Changes - KELBY's adult business prescriptions increased by 29% in Q2 2025 compared to the same period last year, reaching 35% of total KELBY prescriptions [8] - GOCOVRI's Medicare prescriptions had a copay of less than $25 for 97% of cases, up from 77% in 2024 [9] Company Strategy and Development Direction - The company is transitioning from legacy products to a new growth phase with the addition of ZERZUVEY and the launch of ONAPCO [6][11] - Corporate development will focus on revenue-generating products and potential M&A opportunities, particularly in the women's health sector [12][50] Management's Comments on Operating Environment and Future Outlook - Management expects 2025 to be a turning point for accelerated growth, with total revenue guidance updated to $670 million to $700 million [21] - The company anticipates an operating loss of $70 million to $80 million for the full year 2025, primarily due to acquisition-related costs [22] Other Important Information - The acquisition of Sage Therapeutics was completed on July 31, 2025, which is expected to enhance mid to long-term revenue growth [11] - The company maintains a strong balance sheet with no debt, providing financial flexibility for future growth opportunities [20] Q&A Session Summary Question: Can you discuss the net pricing dynamics for KELBY and the adult segment's launch progress? - Management indicated that net pricing remains above $300 per prescription, with adult prescriptions growing by 29% [28][30] Question: What is the status of ONAPCO's enrollment and reimbursement? - Management reported over 750 enrollment forms submitted and smooth reimbursement processes, with over 200 patients currently receiving the product [31][35] Question: Were there any one-time events driving ZERZUVEY's sales growth? - Management noted a 36% growth in prescriptions for ZERZUVEY, attributing it to strong brand momentum and sales force expansion [39] Question: How does the company plan to balance investments in OBGYN and psychiatry? - Management stated that 70% to 80% of prescriptions are generated by OBGYNs, and they will explore opportunities in both areas with Biogen [56] Question: What is the commercial infrastructure for ZERZUVEY in postpartum depression? - Management refrained from providing specific details about the sales force and infrastructure until discussions with Biogen are completed [66]

Financial Performance - Sage Therapeutics reported a quarterly loss of $0.79 per share, better than the Zacks Consensus Estimate of a loss of $0.96, and an improvement from a loss of $1.7 per share a year ago, representing an earnings surprise of +17.71% [1] - The company posted revenues of $31.66 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 80.91%, compared to revenues of $8.65 million in the same quarter last year [2] - Over the last four quarters, Sage Therapeutics has surpassed consensus revenue estimates two times [2] Stock Performance - Sage Therapeutics shares have increased approximately 60.2% since the beginning of the year, significantly outperforming the S&P 500's gain of 8.3% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.79 on revenues of $26.88 million, and for the current fiscal year, it is -$3.65 on revenues of $82.09 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Sage Therapeutics belongs, is currently ranked in the top 37% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, suggesting that the industry outlook can significantly impact stock performance [5][8]