Core Insights - Amphastar Pharmaceuticals reported revenue of $174.41 million for the quarter ended June 2025, a decrease of 4.4% year-over-year, with EPS at $0.85 compared to $0.94 in the same quarter last year [1] - The revenue exceeded the Zacks Consensus Estimate of $169.84 million, resulting in a surprise of +2.69%, while the EPS surprised by +19.72% against the consensus estimate of $0.71 [1] Revenue Breakdown - Primatene MIST generated net revenues of $22.88 million, slightly below the average estimate of $25.95 million, reflecting a year-over-year change of +0.1% [4] - Glucagon reported net revenues of $20.6 million, significantly lower than the average estimate of $28.32 million, marking a year-over-year decline of -24.7% [4] - Lidocaine achieved net revenues of $15 million, surpassing the average estimate of $13.14 million, with a year-over-year increase of +17.2% [4] - Epinephrine's net revenues were $16.18 million, falling short of the average estimate of $17.77 million, indicating a year-over-year decrease of -42.1% [4] Stock Performance - Amphastar's shares have returned -7.2% over the past month, contrasting with the Zacks S&P 500 composite's +1.2% change [3] - The stock currently holds a Zacks Rank 2 (Buy), suggesting potential outperformance against the broader market in the near term [3]

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]

Financial Data and Key Metrics Changes - The company reported revenues of $732 million for the fiscal year 2024, a 14% increase compared to the prior year [7] - For Q4 2024, revenues were $186 million, reflecting a solid 5% year-over-year growth [7] - Gross margins decreased to 46.5% in Q4 2024 from 54% in Q4 2023, primarily due to increased costs and changes in sales structure [23] - Net income for Q4 2024 was $34 million or $0.74 per share, compared to $36.2 million or $0.68 per share in the previous year [25] Business Line Data and Key Metrics Changes - BAQSIMI sales grew 12% at the factory level, contributing $41.8 million to net product sales [20] - Primatene MIST sales reached $28.9 million in Q4 2024, an 18% increase from $24.5 million in the prior year [22] - Glucagon sales declined to $25.6 million from $31.2 million due to increased competition [22] - Epinephrine sales also decreased to $18.7 million from $24.6 million in the previous year [22] Market Data and Key Metrics Changes - The company anticipates continued unit growth in the high single-digit range for BAQSIMI following a 3% price increase in the U.S. [27] - The competitive landscape for glucagon is expected to lead to pricing and unit volume drops [34] Company Strategy and Development Direction - The company is focusing on expanding its branded and proprietary product portfolio, with significant growth expected from Primatene MIST and BAQSIMI [18] - A strategic partnership with MannKind has been established to enhance the sales reach of BAQSIMI [8] - The company plans to ramp up spending on clinical trials and materials for its insulin portfolio and other proprietary products [30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential approval of four key products in 2025, despite some delays [14] - The company is well-positioned to mitigate impacts from U.S. trade policies due to its domestic manufacturing capabilities [17] - Future sales growth is expected to be offset by declines in certain products due to increased competition [28] Other Important Information - The company plans to finance its expansion project through cash flow from operations and intends to continue stock buybacks [31] Q&A Session Summary Question: Outlook on Primatene MIST and glucagon for next year - Management expects high single-digit sales growth for Primatene MIST and anticipates pricing and unit volume drops for glucagon due to increased competition [34] Question: Preparedness for upcoming GDUFA dates - The company is not expecting to launch new products until the third quarter following potential approvals in the second quarter [37] Question: Impact of MannKind collaboration on BAQSIMI - The collaboration is expected to significantly increase the sales force and enhance market penetration, although it is still early to assess the full impact [42] Question: Competitive overview of epinephrine - The company remains the only player in the prefilled syringe market, while competition in the multi-dose vial market has increased [58]

Financial Data and Key Metrics Changes - The company reported revenues of $732 million for the fiscal year 2024, a 14% increase compared to the prior year [7] - For Q4 2024, revenues were $186 million, reflecting a solid 5% year-over-year growth [7] - Gross margins decreased to 46.5% in Q4 2024 from 54% in Q4 2023, primarily due to increased costs and changes in sales structure [23] - Net income for Q4 2024 was $34 million or $0.74 per share, compared to $36.2 million or $0.68 per share in the previous year [25] Business Line Data and Key Metrics Changes - BAQSIMI sales grew 12% at the factory level, contributing $41.8 million to net product sales [20] - Primatene MIST sales reached $28.9 million in Q4 2024, an 18% increase from $24.5 million in the prior year [22] - Glucagon sales declined to $25.6 million from $31.2 million due to increased competition [22] - Epinephrine sales also decreased to $18.7 million from $24.6 million in the previous year [22] Market Data and Key Metrics Changes - The company anticipates continued unit growth in the high single-digit range for BAQSIMI following a 3% price increase in the U.S. [27] - Primatene MIST is expected to see high single-digit sales growth as the physician sampling program expands [27] - Increased competition is expected to lead to sales declines for glucagon, epinephrine, phytonadione, and enoxaparin [28] Company Strategy and Development Direction - The company is focusing on its branded and proprietary portfolio, with significant sales milestones achieved for Primatene MIST and BAQSIMI [18] - A strategic partnership with MannKind aims to enhance the sales reach of BAQSIMI [8] - The company plans to ramp up spending on clinical trials and expand its manufacturing capacity to support new product launches [30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential of Primatene MIST and BAQSIMI, expecting them to be key revenue contributors through 2025 [11] - The company is preparing for potential approval of four key products in 2025, despite some delays [14] - Management noted that the vertically integrated business model positions the company well to mitigate impacts from trade policies [17] Other Important Information - The company plans to finance its expansion project with cash flow from operations and intends to continue stock buybacks [31] - Research and development expenditures decreased by 11% in Q4 2024, primarily due to lower spending on clinical trials [24] Q&A Session Summary Question: Outlook on Primatene MIST and glucagon for 2025 - Management expects high single-digit sales growth for Primatene MIST and anticipates unit volume drops for glucagon due to increased competition [34] Question: Preparedness for upcoming GDUFA dates - Management indicated that they may not be ready to launch new products until the quarter following their approval [37] Question: Impact of MannKind collaboration on BAQSIMI - The collaboration is expected to significantly increase the sales force, enhancing market coverage and potentially accelerating sales growth [56] Question: Competitive overview of epinephrine - The company remains the only player in the prefilled syringe market, while competition in the multi-dose vial segment has increased [58]