Core Viewpoint - Sandoz has launched Pyzchiva® (ustekinumab) autoinjector in Europe, marking it as the first biosimilar of ustekinumab available in an autoinjector format, aimed at improving patient adherence in managing chronic inflammatory diseases [2][3][5]. Product Launch - Pyzchiva® is approved for treating adults with plaque psoriasis, psoriatic arthritis, Crohn's disease, and pediatric plaque psoriasis for patients aged six years and older weighing over 60 kg [2][5]. - The autoinjector features include comfortable self-administration, accurate automatic dosing, reduced injection pain, compact design, and flexible storage options, which may enhance treatment adherence [2][3][6]. Market Context - Europe has the highest prevalence of psoriasis globally, affecting approximately 6.4 million people, and inflammatory bowel diseases like Crohn's disease affect about 2.5 to 3 million people [3][4]. - Non-adherence to biologic therapies can lead to disease progression, increased flares, and higher healthcare costs due to increased hospitalizations and additional treatments [3][4]. Strategic Importance - Pyzchiva® is a significant value driver in Sandoz's growth strategy, with its launch in 23 European markets, starting with Spain [3][4]. - The company entered a development and commercialization agreement with Samsung Bioepis in September 2023, allowing Sandoz to commercialize Pyzchiva® in multiple regions including Brazil, the US, and the European Economic Area [4][5]. Company Overview - Sandoz is a global leader in generic and biosimilar medicines, with a mission to pioneer access for patients, employing over 20,000 people and providing 900 million patient treatments annually, generating substantial healthcare savings [15].

Core Viewpoint - Alvotech, a global biotech company focused on biosimilar medicines, successfully completed an oversubscribed offering of Swedish Depository Receipts (SDRs) in connection with its listing on Nasdaq Stockholm, which is expected to enhance its market presence and access to capital [2][5][8]. Offering Details - The offering attracted strong interest, resulting in over 3,000 new shareholders and was multiple times oversubscribed [2][8]. - The final price per SDR was set at SEK 87.51, reflecting a 10% discount from the volume-weighted average price of the ordinary shares during the application period [8]. - The gross proceeds from the offering amounted to approximately SEK 39 million [8]. Strategic Expansion - Alvotech aims to expand its R&D capabilities, having recently acquired Xbrane Biopharma AB's R&D operations in Sweden, which will enhance its scientific and innovation capabilities [4]. - The integration of Xbrane's workforce is expected to strengthen Alvotech's presence in the Swedish life-science sector and support its growth trajectory [4]. Market Positioning - The listing on Nasdaq Stockholm is anticipated to improve Alvotech's recognition in Nordic and European markets, attracting a broader base of institutional and retail investors [5]. - There is strong investor demand for opportunities in European biotech, biopharma, and biosimilar stocks among Nordic and international institutional investors [5]. Trading Information - Trading of the SDRs on Nasdaq Stockholm is set to commence on May 19, 2025, under the ticker symbol "ALVO SDB" [8]. - A free conversion period for existing shareholders to convert their shares into SDRs will be offered for one year from the first trading day [7].

– Continue to conduct analytical studies to prepare for a potential Biosimilar Biological Product Development (“BPD”) Type 2a meeting with the FDA in the second half of 2025 – – Pursuing a 351(k) regulatory pathway for ABP-450, which offers potential access to the U.S. market under a single approval for all of BOTOX’s currently approved and future therapeutic indications – – Appointed Rob Bancroft as the Company’s President and Chief Executive Officer; Mr. Bancroft also joined AEON’s Board of Directors – IR ...

Summary of Regeneron Conference Call Company Overview - **Company**: Regeneron Pharmaceuticals - **Key Speakers**: - Marianne McCourt, Executive Vice President of Commercial - Ryan Crow, Senior Vice President, Investor Relations and Strategic Analysis Industry Context - **Industry**: Biopharmaceuticals - **Key Products**: EYLEA, DUPIXENT, Libtayo Core Points and Arguments Financial Performance - **EYLEA**: Experienced challenges in the retina space, with Q1 sales impacted by seasonality and inventory issues. Sales dropped from $6 billion last year to an expected $4 billion this year due to biosimilar competition [3][29]. - **DUPIXENT**: Grew 19% globally, leading in prescription share across approved indications, except for Chronic Spontaneous Urticaria (CSU) which was recently approved [3][50]. - **Libtayo**: Grew 21% in the US, now second in new to brand share in advanced lung cancer [4]. Pipeline Developments - Upcoming pivotal readouts include: - Itapakimab for COPD in former smokers [4]. - Combination of LAG-three antibody fianlimab with Libtayo for advanced melanoma [5]. - Pivotal readout for semdisiran in generalized myasthenia gravis [5]. - PDUFA dates for limboceltimab and rotranextamab in July [5]. Capital Allocation - Regeneron is investing approximately $7 billion in R&D and manufacturing capabilities in the US. A dividend program was initiated to return capital to shareholders alongside a buyback program [6]. Regulatory Environment - The company is assessing the impact of the Most Favored Nation (MFN) executive order and potential tariffs on its operations. Regeneron aims to engage with the administration to navigate these changes [8][9]. - The company emphasizes the importance of innovation and patient access to medicines amidst regulatory changes [13][14]. Mergers and Acquisitions (M&A) - Regeneron does not plan to change its conservative approach to M&A, focusing on organic growth and partnerships rather than transformative acquisitions [11][12]. EYLEA Challenges - EYLEA faces competition from biosimilars and affordability issues, leading to increased prescribing of Avastin. Despite a disappointing Q1, EYLEA HD showed a 5% increase in demand [31][32]. - The upcoming approval of a prefilled syringe and new indications are expected to enhance EYLEA's market position [33]. DUPIXENT Launch and Market Dynamics - DUPIXENT is performing well with strong uptake in COPD, achieving 85-90% payer access. The product is expected to reach $20 billion in sales by 2030 [50][52]. - The company is optimistic about the upcoming itapacumab product, which targets a different COPD patient population [53][55]. Competitive Landscape - Regeneron acknowledges competition in the atopic dermatitis market, particularly from Lilly's new product, but maintains confidence in DUPIXENT's established position [61][62]. Additional Important Insights - The company is adapting its copay assistance strategy, moving towards a matching donation model to support patient access [45][46]. - Regeneron is focused on maintaining its commitment to innovation while navigating the complexities of the US healthcare system [14][22]. This summary encapsulates the key points discussed during the Regeneron conference call, highlighting the company's current performance, pipeline developments, regulatory challenges, and strategic direction.

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in the BofA Securities Healthcare Conference 2025, which will be held in Las Vegas, Nevada, May 13-15, 2025. Members of the management team will host one-on-one meetings at the conference. Alvotech will also be participating in a fireside chat on Wednesday, May 14, 2025, at 11:40 am -12:10 pm EDT (15:40-16:10 GMT / 17:40-18:10 CET ...

Financial Data and Key Metrics Changes - Alvotech raised its full-year revenue guidance for 2025 to $600 million to $700 million and adjusted EBITDA guidance to $200 million to $280 million [7][39] - The company achieved $110 million in product revenues during Q1 2025, an increase of $97 million or 784% compared to the same period in the prior year [30][31] - Adjusted EBITDA for Q1 2025 was $21 million, compared to negative adjusted EBITDA of $38 million for the same period in the prior year [39] Business Line Data and Key Metrics Changes - The Stellara biosimilar was launched in the U.S. market in late February 2025, following successful launches in Europe, Japan, and Canada [8][9] - Alvotech's biosimilar to Humira saw strong uptake in the U.S. market, with a penetration rate of at least 21% by year-end 2024 [20][21] - The company expects to move from two marketed biosimilars to six by early 2026, with three biosimilar filings under review in major markets [11][27] Market Data and Key Metrics Changes - In the U.S. market, Alvotech's Humira biosimilar represented about 12% of total demand for Humira and Humira biosimilars in 2024 [19][21] - The European Stellara market expanded by 9% year-over-year due to the entry of biosimilars, with Alvotech aiming for a double-digit market share by the end of 2025 [23] - Alvotech is the only developer to launch a Stellara biosimilar in Japan, indicating a strong competitive position in that market [24] Company Strategy and Development Direction - Alvotech plans to significantly increase the pace of development, moving four to six new biosimilar candidates into in-house process development each year [12] - The company is focused on a B2B model, which allows it to address a global patient population through 20 strategic commercial partnerships across 90 markets [12] - Alvotech aims to maintain a focus on quality and reliability rather than sacrificing value for market share in a competitive environment [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of the Stellara biosimilar in the U.S. market, especially after receiving the interchangeable designation [45] - The company anticipates that if tariffs on pharmaceuticals are applied, they will not disrupt operations or competitiveness in the U.S. market [13] - Management expects to be free cash flow positive in 2025, marking a significant milestone for the company [40] Other Important Information - Alvotech's net debt stood at $1.058 billion as of March 31, 2025, with expectations of mid-single-digit leverage by year-end [41] - The company closed the period with 301.9 million shares outstanding, including unvested earn-out shares [42] Q&A Session Summary Question: Can you clarify the interchangeable exclusivity and its implications? - Management confirmed the receipt of the interchangeable designation and noted that while some competitors may also obtain it, this designation is expected to drive faster uptake of their product [45][46] Question: What is the impact of stocking on the Stellara biosimilar sales? - Management clarified that the sales figures are driven by timing of orders rather than stocking, as they operate on a B2B model [50][51]

Core Viewpoint - Alvotech intends to list Swedish Depository Receipts (SDRs) on Nasdaq Stockholm to broaden its investor base and enhance visibility among Nordic and European institutional investors following the acquisition of Xbrane Biopharma AB's R&D operations [2][3][8] Offering Details - The Offering will be directed solely into Sweden during an application period from May 9–16, 2025, with a maximum price of SEK 90 per SDR [6][12] - The gross proceeds are estimated to be approximately SEK 30 million, with 441,600 SDRs offered, each representing one Share [6][12] - The first day of trading on Nasdaq Stockholm is expected to be May 19, 2025 [6][12] Strategic Importance - The acquisition of Xbrane's R&D operations is a strategic priority to enhance Alvotech's R&D capabilities and establish a strong presence in the Swedish life-science sector [5][8] - The integration of Xbrane's workforce will expand Alvotech's scientific and innovation capabilities, allowing access to a broader talent pool [5][8] Market Positioning - The listing on Nasdaq Stockholm is expected to strengthen Alvotech's recognition in Nordic and European markets, improving access to regional capital and attracting a broader base of institutional and retail investors [3][8] - Alvotech aims to be a global leader in the biosimilar space, with a current pipeline that includes nine disclosed biosimilar candidates targeting various diseases [13][14] Investor Engagement - A free conversion period will be offered to existing shareholders to convert their Shares into SDRs, with conversion fees covered by Alvotech for one year from the first trading day [9][10] - A prospectus detailing the Offering has been published and is available on Alvotech's website and other financial platforms [10][11]

Amphastar Pharmaceuticals (AMPH) Q1 2025 Earnings Call May 07, 2025 05:00 PM ET Company Participants Dan Dischner - Senior Vice President of Human Resources & Corporate CommunicationBill Peters - EVP, CFO & DirectorTony Marrs - Executive VP of Regulatory Affairs & Clinical OperationsCerena Chen - VP - Biotech and Pharma Equity Research Conference Call Participants David Amsellem - Sr. Research AnalystJason Gerberry - MD & Equity Research Analyst - Biotech & PharmaEkaterina Knyazkova - AnalystNone - Analyst ...

Financial Data and Key Metrics Changes - Net revenues for Q1 2025 were $170,500,000, reflecting a 1% decline compared to $171,800,000 in the same period last year [6][15] - Gross margins decreased to 50% from 52.4% year-over-year, primarily due to the shift in distribution of Baqsimi and pricing declines for epinephrine [16][17] - Net income decreased to $25,300,000 or 51¢ per share from $43,200,000 or 81¢ per share in Q1 2024 [18] Business Line Data and Key Metrics Changes - Vaxemia achieved sales of $38,300,000, closely aligned with the previous year's combined sales of $38,700,000 [7] - Primatene Mist sales grew to $29,000,000, a 20% increase from $24,000,000 in the same period last year [8][15] - Glucagon injection sales declined 27% to $20,800,000 due to increased competition [16] Market Data and Key Metrics Changes - The competitive landscape for critical care products like dextrose and epinephrine has intensified, leading to softened demand [6] - Epinephrine sales decreased 29% to $18,600,000 due to increased competition for the multidose vial product [16] - Other finished pharmaceutical product sales decreased to $50,000,000 from $52,200,000, influenced by competition for enoxaparin, naloxone, and dextrose [16] Company Strategy and Development Direction - The company is focused on expanding its branded product portfolio, particularly through strategic partnerships and new product launches [7][9] - The transition from a generic-driven business model to a diversified portfolio, including proprietary and interchangeable biosimilar products, is a key strategic focus [13] - The company aims to enhance patient access to vital treatments through the acceptance of its Biologics License Application for insulin aspart [12] Management's Comments on Operating Environment and Future Outlook - Management anticipates that trends observed in Q1 will continue throughout the year, acknowledging the cyclical nature of drug shortages [6] - The company remains optimistic about its pipeline, particularly regarding the FDA's communication concerning AMP-two filing [10] - Management expressed confidence in achieving flat revenue guidance for the year, supported by potential sales from upcoming product approvals [26] Other Important Information - The company received the Drug Shortage Assistance Award from the U.S. FDA, recognizing its efforts in preventing drug shortages [5] - Cash flow from operations was approximately $35,100,000, with $11,000,000 used for share buybacks [19] - The estimated impact of tariffs on costs is about $500,000 per quarter, primarily affecting imported active ingredients and components [19] Q&A Session Summary Question: Expectations for new launches and their impact on competition - Management is optimistic about the potential for approvals of AMP-007, AMP-002, and AMP-015, which could contribute to revenue later in the year [24][26] Question: Clarification on Baqsimi's commercial support initiatives - The company has increased its sales force and established a co-promotion agreement with MannKind to enhance outreach, primarily focusing on endocrinologists [27][28] Question: Insights on the insulin aspart opportunity and competitive dynamics - The insulin aspart market presents a significant opportunity, with the goal of becoming the first interchangeable biosimilar [32][34] Question: Outlook for sales and margin pressures - Management indicated that while there are pressures on margins, growth in higher-margin products like Primatene Mist and Vaximi is expected to offset some of these challenges [45] Question: Regulatory landscape and potential impacts - Management has not observed significant impacts on application timelines due to changes at the FDA, categorizing any delays as minor [48] Question: Tariff implications and market share opportunities - The company is well-positioned as a U.S. manufacturer and is monitoring tariff impacts on imported components, with a focus on leveraging its U.S. footprint for market share [50][51]

Q1 2025 Earnings and Business Update May 8, 2025 Disclaimer This presentation ("Presentation") does not contain or constitute an offer to sell, a solicitation of an offer to buy, or a recommendation to purchase any security of Alvotech (the "Company") to any person in the United States or in any jurisdiction to whom or in which such offer or solicitation is unlawful. Any trademarks, servicemarks, trade names and copyrights of the Company and other companies contained in this Presentation are the property of ...