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Supernus Pharmaceuticals (NasdaqGM:SUPN) 2025 Conference Transcript
2025-11-17 15:32
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.
Supernus Announces Third Quarter 2025 Financial Results
Globenewswire· 2025-11-04 21:01
Core Insights - Supernus Pharmaceuticals reported strong operating results for Q3 2025, driven by growth from its key products Qelbree, GOCOVRI, and collaboration revenue from ZURZUVAE, alongside a promising launch of ONAPGO [2][5]. Financial Performance - Combined revenues from the four growth products increased by 52% to $149.2 million in Q3 2025 compared to Q3 2024, contributing to total revenues of $192.1 million, a 9% increase year-over-year [5][9]. - The company completed the acquisition of Sage Therapeutics on July 31, 2025, which is expected to enhance its product portfolio [5]. - Cash, cash equivalents, and current marketable securities stood at approximately $281.2 million as of September 30, 2025 [5][15]. Product Highlights - ONAPGO generated net product sales of $6.8 million in its first full quarter post-launch, with over 1,300 enrollment forms submitted by prescribers [6]. - Collaboration revenue from ZURZUVAE was $20.2 million in Q3 2025, reflecting a 150% increase in U.S. sales compared to Q3 2024 [6][5]. - Qelbree's net sales rose by 31% to $81.4 million, while GOCOVRI's net sales increased by 15% to $40.8 million in Q3 2025 [6][5]. Product Pipeline - SPN-817, a novel AChE inhibitor for epilepsy, is currently in a Phase 2b study with an enrollment target of approximately 258 adult patients [4]. - SPN-820, aimed at treating major depressive disorder, is expected to initiate a Phase 2b trial by the end of 2025 [7]. - SPN-443, a novel stimulant for ADHD, is set to begin a Phase 1 study in 2026 [7]. Financial Guidance - The company updated its full-year 2025 revenue guidance to $685 - $705 million, reflecting strong performance in the first nine months [12]. - Adjusted operating earnings guidance for 2025 has been raised to $125 - $145 million [12].
Biogen(BIIB) - 2025 Q3 - Earnings Call Presentation
2025-10-30 12:30
Financial Performance - Total revenue increased by 3% year-over-year to $2.53 billion in Q3 2025[59, 61, 64] - Launch products revenue grew 67% year-over-year, reaching $257 million in Q3 2025[19, 59] - GAAP diluted EPS increased by 19% year-over-year to $3.17, while Non-GAAP diluted EPS increased by 18% year-over-year to $4.81[59, 64] - The company generated $1.23 billion of free cash flow in Q3 2025[59] Product Performance - LEQEMBI achieved $121 million in in-market sales, demonstrating sustained sequential global demand growth[19, 48] - SKYCLARYS revenue grew 30% year-over-year and is now available in 34 markets globally[19, 52] - ZURZUVAE revenue increased by over 150% year-over-year, with 80% of prescriptions for first-line therapy[19, 55] Pipeline Advancement - Litifilimab Phase 3 studies for SLE are fully enrolled, with data expected in H2 2026[19, 34, 41] - A Phase 1 study was initiated for BIIB142, an IRAK4 degrader for autoimmune diseases[19, 21, 34, 35] - The company expects 3-4 potential new INDs[34, 35] Financial Guidance - Full year 2025 Non-GAAP diluted EPS is expected to be between $14.50 and $15.00[59] - Full year 2025 total revenue is expected to be approximately flat to increasing 1% at constant currency[59, 74] - The company expects to deliver $1 billion gross savings / $800 million net savings as part of the "Fit for Growth" initiative by the end of 2025[24, 79]
J.L. Bainbridge Exits Most of Biogen Stake as Biotech Stock Eyes Turnaround
The Motley Fool· 2025-10-20 00:58
Core Insights - J. L. Bainbridge & Co. sold 119,376 shares of Biogen for approximately $16.1 million during the third quarter, significantly reducing its holdings to just 2,969 shares valued at $415,898 as of September 30 [2][7] Company Overview - Biogen specializes in therapies for complex neurological and neurodegenerative conditions, with a diversified product suite and a robust pipeline [6][10] - As of the latest market close, Biogen's stock price was $143, with a market capitalization of $21 billion, revenue of $10 billion, and net income of $1.5 billion for the trailing twelve months [4] Financial Performance - Biogen's shares have declined by 23% over the past year, despite a strong second-quarter report showing a 7% year-over-year revenue growth to $2.6 billion and raised full-year guidance [3][8] - The company highlighted growth in its Alzheimer's therapy LEQEMBI, rare-disease drug SKYCLARYS, and postpartum-depression treatment ZURZUVAE, indicating strong execution in reshaping its portfolio for sustainable growth [11] Investment Strategy - J. L. Bainbridge's decision to significantly reduce its Biogen holdings aligns with its strategy to concentrate on proven large-cap growth names like Microsoft, Apple, and Alphabet [12] - The upcoming earnings report on October 30 will be crucial for assessing whether Biogen's new drug launches can offset the decline in its older franchises [12]
Supernus Pharmaceuticals (SUPN) 2025 Conference Transcript
2025-09-03 13:02
Summary of Supernus Pharmaceuticals (SUPN) Conference Call Company Overview - Supernus Pharmaceuticals is a CNS-focused biopharmaceutical company with a portfolio of about eight to nine products on the market [2][3] - The company is profitable and has a clean balance sheet, recently completing the acquisition of Sage Therapeutics [2][3] - Supernus has transitioned from the loss of exclusivity on two legacy products and is now in a re-accelerated growth phase driven by key products like Qelbree, Gocovri, Onapgo, and ZURZUVAE [3] Key Products and Market Insights Qelbree (ADHD Treatment) - Qelbree is a novel non-stimulant ADHD medication that works as early as week one, addressing a significant market need for effective non-stimulant options [7][8] - The ADHD market consists of approximately 100 million prescriptions annually, with Supernus currently holding less than 2% market share, indicating substantial growth potential [8][19] - The adult segment represents 67% of the ADHD market, and Supernus has seen growth in this segment, with 35% of their business coming from adults [18][19] - Qelbree has shown a growth rate of 20% plus, with recent data indicating a 25-26% growth during the back-to-school season [18][19] Onapgo (Parkinson's Treatment) - Onapgo is a new continuous infusion device for apomorphine, launched in April, aimed at treating off episodes in Parkinson's patients [23][24] - The device has received positive initial responses, and its market potential is still being evaluated, with estimates ranging from $200 to $300 million [29][30] - The product is designed for advanced patients but may also be used for earlier-stage patients, which could expand its market opportunity [29][30] ZURZUVAE (Postpartum Depression) - ZURZUVAE is the first oral medication approved for postpartum depression (PPD), a condition affecting 1 in 7 women [31] - There is a significant lack of awareness and education regarding PPD, with only about 40% of women diagnosed over the years [31][32] - Supernus is actively working on educating healthcare providers and patients about PPD, emphasizing the importance of screening and diagnosis [32][38] Industry Dynamics and Challenges - The ADHD treatment landscape has historically relied on stimulants, which do not work for 15-30% of patients, creating a demand for effective non-stimulant alternatives [9][10] - In the Parkinson's space, approximately 90-95% of patients experience off episodes after five years of diagnosis, highlighting the need for effective treatments [22][25] - The company is addressing the stigma around ADHD and PPD through influencer partnerships and educational initiatives [21][38] Conclusion - Supernus Pharmaceuticals is positioned for significant growth with its innovative product offerings in ADHD, Parkinson's, and postpartum depression - The company is focused on expanding its market share and improving patient outcomes through education and effective treatment options, indicating a strong potential for future success in the biopharmaceutical industry [3][19][31]
Biogen(BIIB) - 2025 Q2 - Earnings Call Presentation
2025-07-31 12:30
Financial Performance - Total revenue increased by 7% year-over-year to $265 billion[53] - Launch products generated $252 million in revenue, a 26% increase quarter-over-quarter and a 91% increase year-over-year[53] - Non-GAAP diluted EPS increased by 4% year-over-year to $547[53] - The company generated $134 million of free cash flow, which includes a $745 million impact from Q2 2025 tax payments[53] - The company expects full-year 2025 Non-GAAP diluted EPS between $1550 and $1600, up from the previous guidance of $1450 to $1550[53] - The company expects full-year 2025 total revenue to be approximately flat at constant currency versus FY 2024, an increase from a mid-single-digit decline previously[53] Product Performance - SKYCLARYS worldwide sales reached $130 million in Q2, up 30% year-over-year and 5% quarter-over-quarter[47] - SKYCLARYS U S sales were $78 million, up 3% year-over-year and 13% quarter-over-quarter[47] - ZURZUVAE U S sales were $46 million in Q2, up 213% year-over-year and 68% quarter-over-quarter[48] - LEQEMBI worldwide sales were $160 million in Q2, excluding $35 million in stocking in China; U S sales increased 20% quarter-over-quarter to $63 million[49] Pipeline and Development - Phase 3 studies were initiated for felzartamab in IgAN and PMN, and for SKYCLARYS in pediatric FA[18] - Positive Phase 1b results for salanersen support moving to registrational status for SMA, with a Phase 3 study expected to start by early 2026[18,32] - New analyses of dapirolizumab pegol Phase 3 data in SLE show improvement in fatigue and reduction in disease activity[18]
Supernus Pharmaceuticals Announces Expiration of Hart-Scott-Rodino Waiting Period for Sage Therapeutics, Inc. Tender Offer
Globenewswire· 2025-07-28 12:25
Core Viewpoint - Supernus Pharmaceuticals has announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act for its proposed acquisition of Sage Therapeutics, indicating progress towards completing the merger [1][3]. Acquisition Details - Supernus and Sage entered into a Merger Agreement on June 13, 2025, with the necessary premerger notifications filed with regulatory authorities shortly thereafter [2]. - The Offer to Purchase for Sage's outstanding shares is set at $8.50 per share in cash, plus a contingent value right (CVR) that could yield up to an additional $3.50 per share based on specific milestones [4]. Contingent Value Rights (CVR) - The CVR includes milestone payments contingent on the commercial success of the product ZURZUVAE, with payments structured as follows: - $0.50 per CVR upon the first commercial sale in Japan after regulatory approval by June 30, 2026 [5]. - $1.00 per CVR if net sales of ZURZUVAE reach $250 million in the U.S. by December 31, 2027 [6]. - $1.00 per CVR if net sales reach $300 million in the U.S. by December 31, 2028 [7]. - $1.00 per CVR if net sales reach $375 million in the U.S. by December 31, 2030 [8]. - The total maximum payout for each CVR is capped at $3.50, with no guarantee that any payments will be made [9][10]. Merger Completion - Upon completion of the Offer, Supernus plans to merge its wholly owned subsidiary with Sage, resulting in Sage becoming a wholly owned subsidiary of Supernus [11]. - Shares not purchased in the Offer will be converted into the right to receive the Offer Price, and Sage's shares will be delisted from NASDAQ [11]. Advisory Information - Moelis & Company LLC is the exclusive financial advisor for Supernus, while Goldman Sachs & Co. LLC serves as the exclusive financial advisor for Sage [12].
Supernus Pharmaceuticals (SUPN) Earnings Call Presentation
2025-06-18 07:03
Acquisition Overview - Supernus Pharmaceuticals is acquiring Sage Therapeutics, Inc for an offer price of $8.50 per share in cash at closing[9] - A contingent value right (CVR) of up to $3.50 per share is payable based on ZURZUVAE U S net sales milestones and commercialization in Japan[9] - $1.00 per share if ZURZUVAE U S net sales reach $250 million or more by YE 2027[9] - $1.00 per share if ZURZUVAE U S net sales reach $300 million or more by YE 2028[9] - $1.00 per share if ZURZUVAE U S net sales reach $375 million or more by YE 2030[9] - $0.50 per share at commercialization in Japan by June 30, 2026[9] - The equity value at closing is $561 million, with a total potential value of up to approximately $795 million[9] - The acquisition is expected to close in Q3 2025[9] Financial Impact and Synergies - The acquisition is expected to be significantly accretive to adjusted operating income (non-GAAP), operating income, and EPS in 2026[9, 11] - Strong fit with existing Supernus infrastructure yields up to $200 million in potential synergies on an annual basis[9, 11] - The transaction will be financed through cash on the balance sheet[9] ZURZUVAE and Market Opportunity - ZURZUVAE is the first and only oral treatment specifically indicated for the treatment of women with PPD (Postpartum Depression)[12] - Approximately 500,000 new women experience symptoms of PPD each year, with approximately 175,000 diagnosed and approximately 100,000 treated[19] - ZURZUVAE demonstrated statistically significant improvement in depressive symptoms vs placebo at day 15 following a 14-day treatment course in clinical trials[12] Revenue and Growth - ZURZUVAE U S collaboration revenue has shown growth since launch, with Q1 2025 reaching $13.8 million[22] - This represents 123% year-over-year growth and 21% quarter-over-quarter growth[22]
Sage Therapeutics(SAGE) - 2025 Q1 - Earnings Call Presentation
2025-04-30 00:14
Commercial Performance of ZURZUVAE - In Q1 2025, over 3,000 shipments of ZURZUVAE were made to women with PPD[13] - Approximately 80% of ZURZUVAE prescriptions in Q1 2025 were written by OBGYNs[15] - More than 70% of women prescribed ZURZUVAE received it as their first new treatment for PPD[17] - The company is strategically investing in the commercialization of ZURZUVAE in the PPD market[12] Financial Results (Q1 2025) - Total revenue was $14.1 million, compared to $7.9 million in Q1 2024[23] - Collaboration revenue was $13.8 million, compared to $6.2 million in Q1 2024[23] - Net loss was ($62.2 million), compared to ($108.5 million) in Q1 2024[23] - Research and Development (R&D) expenses were $22.8 million, compared to $71.7 million in Q1 2024[23] - Cash and marketable securities totaled $0.4 billion, compared to $0.7 billion in Q1 2024[23] Pipeline and Strategic Focus - The company is focused on developing novel programs in diseases with high unmet needs in Neurodevelopmental Disorders & Neuropsychiatry[12] - The company is evaluating potential indications for SAGE-324, including seizures in developmental and epileptic encephalopathies (DEEs), with an update expected in mid-2025[24]