Amphastar Pharmaceuticals (AMPH) 2025 Conference June 05, 2025 02:00 PM ET Speaker0 Good afternoon and welcome to day two of the Jefferies Global Healthcare Conference. My name is Dennis Ding, biotech analyst here. I have the great pleasure of having Amphastar Pharmaceuticals here up with me for fireside chat. We have CFO Bill Peters as well as the EVP of Corporate Administration Jacob Liawatadui, here with us. Welcome. Speaker1 Thank you. Thank you. Speaker0 So maybe to kick things off, like, don't you giv ...

All statements in this presentation and in the conference call referenced above that are not historical are forward-looking statements, including, among other things, statements relating to our expectations regarding future financial performance and business trends, our future growth, sales and marketing of our products, market size and expansion, product portfolio, product development, the timing of FDA filings or approvals, including the DMFs of ANP, the timing of product launches, acquisitions and other ...

Summary of Amphastar Pharmaceuticals (AMPH) 2025 Conference Call Company Overview - Amphastar Pharmaceuticals is undergoing a transition year in 2025, facing competition in its legacy generic business while also having growth opportunities from its pipeline, which includes proprietary brands and generics, particularly Baqsimi [1][2] Core Industry Insights - The company anticipates declining sales for several products in 2025 due to increased competition, particularly in the epinephrine vial and glucagon products [2][3] - Despite initial declines, Amphastar expects sales to stabilize and potentially increase later in the year due to new product launches [3] Regulatory Environment - The FDA's operational changes, including headcount reductions, have not negatively impacted Amphastar's inspection timelines; in fact, the company has experienced efficient interactions with the FDA [5][6] - Amphastar is actively engaged in discussions regarding the administration's investigation into reliance on foreign manufacturing, positioning itself as a U.S.-based manufacturer [9] Product Pipeline and Launches - The company has four products expected to launch in 2025, with a focus on AMP-2 and AMP-7 as key near-term opportunities [10][11] - AMP-2 has faced delays but recent communication with the FDA has improved confidence in its approval timeline [12][13] - AMP-7 received a Complete Response Letter (CRL) but is expected to have a minor issue, with a potential action date in Q3 2025 [40][41] Competitive Landscape - The glucagon kit and epinephrine products are facing competitive pressures, with new entrants impacting sales and pricing [71][72] - Amphastar has maintained a strong supply position in the market, particularly for the epinephrine prefilled syringe, which has been awarded by the FDA [73] Market Dynamics - The company believes that the market for Primatene Mist is unlikely to attract generic competition due to its OTC status and existing patent protections [48][50] - Baqsimi is protected by multiple patents, making it difficult for competitors to enter the market [54][56] Strategic Partnerships - Amphastar has formed a co-promotion agreement with MannKind to enhance sales efforts for Baqsimi, leveraging MannKind's existing sales force [58][61] Financial Outlook - The company is focused on maintaining healthy pricing while acknowledging that market share for certain products may remain niche, estimating less than 25% market share for some products [36][38] - The company is exploring opportunities for business development, particularly in the endocrinology space, while also considering proprietary product expansions [76][77] Capital Allocation - Amphastar has made significant investments in insulin production and is focused on achieving interchangeable status for its insulin products to enhance market access [79][80] Conclusion - Amphastar Pharmaceuticals is navigating a challenging competitive landscape while positioning itself for future growth through strategic product launches, regulatory engagement, and partnerships. The company remains optimistic about its pipeline and market opportunities despite current sales pressures.

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Financial Performance - Total net revenues for the three months ended March 31, 2025, were $170,528,000, a decrease of 1% compared to $171,836,000 for the same period in 2024[146]. - Product revenues increased by 8% to $170,528,000, driven primarily by a 177% increase in BAQSIMI® sales, which reached $38,355,000[146][147]. - Gross profit for the three months ended March 31, 2025, was $85,251,000, representing a gross margin of 50%, down from 52% in the prior year[146][152]. - Net income for Q1 2025 was $25.3 million, compared to $43.2 million in Q1 2024, reflecting a decrease of 41.5%[167][169]. Expenses - Research and development expenses increased by 18% to $20,096,000, primarily due to higher salaries, clinical trial costs, and FDA fees[156][157]. - Selling, distribution, and marketing expenses rose by 27% to $11,866,000, reflecting expanded sales and marketing efforts for BAQSIMI® and Primatene MIST®[154]. - The company expects research and development expenses to continue increasing annually due to ongoing clinical trials for insulin and inhalation product candidates[158]. Cash Flow - Net cash provided by operating activities for Q1 2025 was $35.1 million, down 36.5% from $55.3 million in Q1 2024[167][169]. - Net cash outflow from changes in operating assets and liabilities was $16.7 million in Q1 2025, primarily due to increases in accounts receivables and inventories[168]. - Net cash provided by investing activities was $10.5 million in Q1 2025, down 30.5% from $15.2 million in Q1 2024[170][171]. - Net cash used in financing activities was $14.5 million in Q1 2025, compared to $13.6 million in Q1 2024, reflecting an increase of 6.6%[172][173]. Working Capital and Future Requirements - Working capital increased by $28.6 million to $388.9 million as of March 31, 2025, compared to $360.3 million at December 31, 2024[164]. - The company anticipates significant cash requirements for future milestones related to the BAQSIMI® acquisition, totaling up to $575 million[162]. Compliance and Risks - As of March 31, 2025, all manufacturing facilities and CMOs were in compliance with FDA and DEA regulations, following inspections with no observations[179]. - The company is exposed to market risks including investment risk, interest rate risk, and foreign currency exchange risk, with no material changes reported since the last annual report[181]. Other Financial Metrics - Non-cash items in Q1 2025 included $16.0 million in depreciation and amortization, with share-based compensation expense of $8.4 million[167]. - The increase in accounts receivables in Q1 2025 was primarily due to the timing of sales, while inventory increases were linked to purchases for BAQSIMI®[168]. - The effective tax rate increased to 18% for the three months ended March 31, 2025, compared to 9% in the same period of 2024[161]. - The company incurred $10.7 million in purchases of property, plant, and equipment in Q1 2025, with significant investments in the United States, France, and China[170].

Core Insights - Amphastar Pharmaceuticals reported revenue of $170.53 million for the quarter ended March 2025, reflecting a year-over-year decline of 0.8% [1] - The earnings per share (EPS) for the same period was $0.74, down from $1.04 a year ago, with a surprise of +12.12% compared to the consensus estimate of $0.66 [1] - The reported revenue was a surprise of -0.69% against the Zacks Consensus Estimate of $171.71 million [1] Revenue Breakdown - Primatene MIST generated net revenues of $29.05 million, exceeding the average estimate of $27.64 million, representing a year-over-year increase of +20.2% [4] - Glucagon reported net revenues of $20.84 million, slightly above the estimated $20.24 million, but showed a year-over-year decline of -27% [4] - Lidocaine achieved net revenues of $13.64 million, surpassing the average estimate of $13.15 million, with a year-over-year increase of +6.8% [4] - Epinephrine's net revenues were $18.59 million, above the estimated $18.21 million, but reflected a significant year-over-year decline of -28.8% [4] Stock Performance - Amphastar's shares returned +0.5% over the past month, while the Zacks S&P 500 composite increased by +10.6% [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating expected performance in line with the broader market in the near term [3]

Core Insights - Amphastar Pharmaceuticals reported quarterly earnings of $0.74 per share, exceeding the Zacks Consensus Estimate of $0.66 per share, but down from $1.04 per share a year ago, indicating a 29% year-over-year decline in earnings [1] - The company posted revenues of $170.53 million for the quarter, missing the Zacks Consensus Estimate by 0.69% and down from $171.84 million a year ago, marking a slight revenue decrease [2] - Amphastar's stock has underperformed, losing approximately 35.7% year-to-date compared to the S&P 500's decline of 4.7% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $0.71, with expected revenues of $173.78 million, while the estimate for the current fiscal year is $3.14 on revenues of $738.05 million [7] - The trend of earnings estimate revisions for Amphastar is mixed, leading to a Zacks Rank of 3 (Hold), suggesting the stock is expected to perform in line with the market [6] Industry Context - The Medical - Generic Drugs industry, to which Amphastar belongs, is currently ranked in the top 19% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Data and Key Metrics Changes - Amphastar reported net revenues of $170.5 million for Q1 2025, reflecting a modest 1% decline compared to $171.8 million in the same period last year [7][16] - Gross margins declined to 50% in Q1 2025 from 52.4% in the previous year, primarily due to the shift in distribution of Baqsimi and pricing declines for epinephrine [18][19] - Net income decreased to $25.3 million or $0.51 per share in Q1 2025 from $43.2 million or $0.81 per share in Q1 2024 [20] Business Line Data and Key Metrics Changes - Paxini revenues grew 177% to $38.4 million compared to $13.8 million in the prior year [16] - Primatene Mist sales reached $29.1 million, a 20% increase from $24.2 million in the same period last year [18] - Glucagon injection sales declined 27% to $20.8 million from $28.5 million due to increased competition [18] - Epinephrine sales decreased 29% to $18.6 million from $26.1 million, also due to increased competition [18] Market Data and Key Metrics Changes - Vaxemia achieved sales of $38.3 million in Q1 2025, closely aligned with the combined sales of $38.7 million recorded in the same period last year [8] - The competitive landscape for critical care products such as dextrose and epinephrine has intensified, impacting demand [7][11] Company Strategy and Development Direction - Amphastar is focused on expanding its portfolio with proprietary and interchangeable biosimilar products, including insulin aspart [13][14] - The company aims to enhance its commercial position and strengthen its product pipeline within high-value therapeutic areas [14] - A strategic partnership with MannKind has been established to enhance promotional reach for Vaxmi, with expectations for benefits to materialize in the second half of 2025 [9] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the cyclical nature of drug shortages and anticipates trends observed in Q1 to continue throughout the year [7] - The company remains optimistic about the potential for new product approvals and revenue contributions from upcoming launches [30][31] - Management is closely monitoring tariff discussions, believing that their domestic manufacturing position provides a competitive advantage [13][56] Other Important Information - The company received the Drug Shortage Assistance Award from the U.S. FDA, recognizing its efforts in preventing drug shortages [5][6] - Cash flow from operations was approximately $35.1 million, with $11 million used for share buybacks [21] Q&A Session Summary Question: Expectations for new launches and impact of competition - Management expressed optimism about potential new product launches and their ability to cushion the impact of competition [25][28] Question: Commercial support initiatives for Baqsimi - Management clarified that the increase in sales force and promotional efforts are aimed at endocrinologists, addressing previous disruptions during the transition from Lilly [31][32] Question: Insulin aspart opportunity and competitive dynamics - Management highlighted the large market opportunity for insulin aspart and the goal to become the first interchangeable biosimilar [36][39] Question: Outlook for flat sales in 2025 - Management confirmed that flat revenue guidance is based on expected contributions from new product approvals later in the year [30][42] Question: Margin pressure and future expectations - Management indicated that while margin pressures are expected, growth in higher-margin products like Primatene Mist and Vaximi will help offset some of the declines [50][51] Question: Regulatory landscape and tariff impacts - Management noted that recent changes at the FDA have not significantly impacted application timelines, and their U.S. manufacturing footprint positions them well against potential tariff impacts [52][56]

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]