Amphastar Pharmaceuticals(AMPH)
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Amphastar Pharmaceuticals(AMPH) - 2024 Q3 - Earnings Call Transcript
2024-11-07 02:12
Financial Data and Key Metrics Changes - In Q3 2024, Amphastar reported net revenues of $191.2 million, a 6% increase year-over-year from $180.6 million [5][15] - Net income decreased by 18% to $40.4 million or $0.78 per share compared to $49.2 million or $0.91 per share in Q3 2023 [22] - Adjusted net income decreased to $49.6 million or $0.96 per share from $61.9 million or $1.15 per share in the previous year [22] Business Line Data and Key Metrics Changes - BAQSIMI sales totaled $40.4 million in Q3, with a net economic benefit of $2.4 million from Eli Lilly's sales of $6.4 million [15][16] - Primatene Mist achieved record sales of $26 million, up from $24.8 million, representing a 5% growth [7][18] - Glucagon sales decreased by 9% to $26.8 million due to a shift towards ready-to-use products [8][17] - Epinephrine sales increased by 6% to $21.3 million, driven by the introduction of prefilled syringes in Canada [18] - Phytonadione sales surged by 57% to $11.7 million due to increased demand [19] Market Data and Key Metrics Changes - The company faced a temporary supply disruption in 14 European countries, limiting BAQSIMI sales by approximately $2 million to $3 million [16][26] - Overall sales were negatively impacted by Hurricane Helene, resulting in $2 million to $4 million in expected sales not recognized in Q3 [20] Company Strategy and Development Direction - Amphastar's strategic initiatives are focused on regulatory filings and expanding its commercial portfolio, particularly with BAQSIMI and Primatene Mist [6][13] - The company plans to enhance the visibility of BAQSIMI in the U.S. by strengthening its sales force [8][12] - The launch of the Albuterol MDI product marks a significant expansion in the respiratory portfolio [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of BAQSIMI, with peak sales expected to reach $250 million to $275 million [27] - The company is optimistic about its pipeline, including AMP-002 and AMP-007, with ongoing discussions with the FDA [39][40] - The focus remains on advancing proprietary filings and high-value areas like biosimilars for sustainable growth [13] Other Important Information - Selling, distribution, and marketing expenses increased by 40% to $9 million due to the expansion of the BAQSIMI sales force [21] - Research and development expenditures rose by 26% to $21.1 million, reflecting increased material costs related to insulin pipeline products [21] Q&A Session Summary Question: Insights on BAQSIMI uptake and competitive dynamics - Management noted a smooth transition for BAQSIMI despite a temporary supply disruption in Europe, with peak sales still targeted at $250 million to $275 million [26][27] Question: Role in the GLP-1 category - Management acknowledged a crowded market for GLP-1 products and indicated it is too early to discuss specific strategies [28] Question: Drivers of lower revenue in epinephrine - The decrease was attributed to competition from new entrants in the multi-dose vial market, partially offset by increased sales from prefilled syringes in Canada [31] Question: Year-over-year decline in BAQSIMI - The decline was not primarily due to competition but rather supply issues in Europe and increased wholesaler fees affecting pricing [32] Question: Sales footprint for Albuterol generic - Management expects a meaningful contribution from Albuterol in 2025, with a cautious approach to market share acquisition [38] Question: Updates on AMP-002 and AMP-007 - Ongoing high-level discussions with the FDA for AMP-002 are encouraging, while AMP-007's GDUFA goal date has been extended without alarming feedback from the agency [39][40]
Here's What Key Metrics Tell Us About Amphastar (AMPH) Q3 Earnings
ZACKS· 2024-11-07 00:00
Core Insights - Amphastar Pharmaceuticals reported revenue of $191.21 million for the quarter ended September 2024, reflecting a 5.9% increase year-over-year, but fell short of the Zacks Consensus Estimate by 2.51% [1] - The company's EPS was $0.96, down from $1.15 in the same quarter last year, with an EPS surprise of -4.95% compared to the consensus estimate of $1.01 [1] Revenue Performance by Product - Primatene MIST generated net revenues of $26.06 million, exceeding the average estimate of $23.98 million, marking a year-over-year increase of 4.9% [3] - Epinephrine revenues were reported at $21.34 million, below the average estimate of $27.30 million, with a year-over-year increase of 5.7% [3] - Lidocaine revenues reached $15.88 million, surpassing the average estimate of $13.62 million, reflecting a 2.3% year-over-year increase [3] - Phytonadione revenues were $11.72 million, significantly above the average estimate of $9.43 million, showing a remarkable year-over-year increase of 57.4% [3] - API (Active pharmaceutical ingredients) revenues were reported at $1.46 million, falling short of the average estimate of $2.89 million, with a substantial year-over-year decline of 65.1% [3] - Enoxaparin revenues were $5.62 million, slightly below the average estimate of $6.08 million, representing a year-over-year decrease of 27.1% [3] - Naloxone revenues were $4.04 million, exceeding the average estimate of $3.83 million, but showing a year-over-year decline of 14.4% [3] - Total finished pharmaceutical products net revenues were $187.36 million, below the average estimate of $192.57 million, with a year-over-year increase of 26.9% [3] - Glucagon revenues were reported at $26.79 million, slightly above the average estimate of $26.65 million, reflecting a year-over-year decrease of 9.2% [3] Stock Performance - Amphastar's shares have returned +11.4% over the past month, outperforming the Zacks S&P 500 composite, which saw a +0.7% change [4] - The stock currently holds a Zacks Rank 3 (Hold), indicating expected performance in line with the broader market in the near term [4]
Amphastar Pharmaceuticals (AMPH) Lags Q3 Earnings and Revenue Estimates
ZACKS· 2024-11-06 23:36
Core Viewpoint - Amphastar Pharmaceuticals reported quarterly earnings of $0.96 per share, missing the Zacks Consensus Estimate of $1.01 per share, and down from $1.15 per share a year ago, indicating a -4.95% earnings surprise [1] Financial Performance - The company posted revenues of $191.21 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 2.51%, but up from $180.56 million year-over-year [2] - Over the last four quarters, Amphastar has surpassed consensus EPS estimates three times and topped consensus revenue estimates three times as well [2] Stock Performance - Amphastar shares have declined approximately 16.6% since the beginning of the year, contrasting with the S&P 500's gain of 21.2% [3] - The current Zacks Rank for Amphastar is 3 (Hold), indicating expected performance in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $0.99 on revenues of $198.38 million, and for the current fiscal year, it is $4.03 on revenues of $748.75 million [7] - The estimate revisions trend for Amphastar is mixed, and future changes in estimates will be closely monitored following the recent earnings report [6][7] Industry Context - The Medical - Generic Drugs industry, to which Amphastar belongs, is currently in the top 20% of over 250 Zacks industries, suggesting a favorable outlook compared to the bottom 50% [8]
Amphastar Pharmaceuticals(AMPH) - 2024 Q3 - Quarterly Results
2024-11-06 21:31
Financial Performance - Net revenues for the third quarter of 2024 were $191.2 million, representing a 6% increase from $180.6 million in the same period of 2023[4]. - GAAP net income for the third quarter was $40.4 million, or $0.78 per share, compared to $49.2 million, or $0.91 per share, in the prior year[2]. - Adjusted non-GAAP net income was $49.6 million, or $0.96 per share, down from $61.9 million, or $1.15 per share, year-over-year[2]. - Total net revenues for the three months ended September 30, 2024, were $191,214, an increase of 6.1% compared to $180,556 for the same period in 2023[19]. - Product revenues for the same period reached $188,819, up 24.3% from $151,855 in the prior year[19]. - Net income for the three months ended September 30, 2024, was $40,429, down from $49,222 in the same period of 2023, representing a decrease of 17.5%[19]. - Basic net income per share for the three months ended September 30, 2024, was $0.83, compared to $1.01 for the same period in 2023[19]. - Adjusted non-GAAP net income for the nine months ended September 30, 2024, was $153,569 million, up from $128,823 million in the same period of 2023, representing an increase of about 19%[26]. - The company reported GAAP revenue of $258,237 million for the nine months ended September 30, 2024, compared to $211,309 million for the same period in 2023, indicating a growth of approximately 22%[28]. - Non-GAAP net income for the three months ended September 30, 2024, was $49,585 million, compared to $61,898 million in the same period of 2023, a decrease of around 20%[26]. Sales and Revenue Growth - BAQSIMI® sales reached $40.4 million, while Primatene MIST® sales increased by 5% to $26.1 million, trending towards a goal of $100 million in annual sales[5]. - Total finished pharmaceutical products net revenues increased by 27% to $187.4 million, driven by higher sales volumes[4]. - The company anticipates continued revenue growth from the integration of BAQSIMI® and plans to pivot towards high-value and high-growth market areas[17]. Expenses and Costs - Research and development expenses rose by 26% to $21.1 million, reflecting increased investment in insulin pipeline products[7]. - Operating expenses totaled $44,893 for the three months ended September 30, 2024, an increase of 25.7% from $35,725 in the same period of 2023[19]. - The gross profit margin decreased to 53.3% from 60.0% due to increased labor and component costs[6]. - The company incurred expenses related to the BAQSIMI® acquisition amounting to $2,182 million for the three months ended September 30, 2023[26]. - Share-based compensation for the nine months ended September 30, 2024, totaled $18,736 million, compared to $15,620 million for the same period in 2023, reflecting an increase of approximately 20%[26]. - Total costs of revenue for the nine months ended September 30, 2024, were $197,689 million, compared to $211,309 million for the same period in 2023[29]. Assets and Liabilities - Cash flow from operating activities for the nine months ended September 30, 2024, was $184.4 million[8]. - Cash and cash equivalents increased to $192,116 as of September 30, 2024, from $144,296 at the end of 2023[21]. - Total assets as of September 30, 2024, were $1,545,178, up from $1,512,912 at the end of 2023[22]. - The company reported a total of $159,010 in current liabilities as of September 30, 2024, compared to $225,407 at the end of 2023[20]. Shareholder Actions - A $50 million increase to the company's share buyback program was authorized to offset dilution from equity compensation programs[9].
Are Investors Undervaluing Amphastar Pharmaceuticals (AMPH) Right Now?
ZACKS· 2024-10-25 14:45
Core Insights - Amphastar Pharmaceuticals (AMPH) is currently rated as a Zacks Rank 2 (Buy) and has a Value grade of A, indicating strong potential for value investors [2] - The PEG ratio for AMPH is 0.79, which is lower than the industry average of 1.09, suggesting that the stock may be undervalued relative to its expected earnings growth [2] - AMPH's P/B ratio stands at 3.40, which is attractive compared to the industry average of 3.98, indicating a favorable valuation based on book value [2] - The P/CF ratio for AMPH is 11.24, significantly lower than the industry average of 28.71, further supporting the notion that AMPH is undervalued based on its cash flow outlook [3] Valuation Metrics - PEG Ratio: AMPH's PEG ratio is 0.79, with a 52-week range of 0.53 to 0.97 and a median of 0.74 [2] - P/B Ratio: AMPH's P/B ratio is 3.40, with a 52-week range of 2.54 to 5.10 and a median of 3.28 [2] - P/CF Ratio: AMPH's P/CF ratio is 11.24, with a 12-month range of 8.34 to 19.33 and a median of 10.95 [3]
Will Amphastar (AMPH) Beat Estimates Again in Its Next Earnings Report?
ZACKS· 2024-10-18 17:16
Core Viewpoint - Amphastar Pharmaceuticals (AMPH) has a strong history of beating earnings estimates and is well-positioned for continued success in upcoming quarterly reports [1][2]. Earnings Performance - Amphastar has surpassed earnings estimates by an average of 27.79% over the last two quarters [1]. - In the most recent quarter, the company reported earnings of $0.94 per share, exceeding the expected $0.78 per share by 20.51% [1]. - For the previous quarter, Amphastar's earnings of $1.04 per share surpassed the consensus estimate of $0.77 per share by 35.06% [1]. Earnings Estimates and Predictions - There has been a favorable change in earnings estimates for Amphastar, with a positive Zacks Earnings ESP (Expected Surprise Prediction) indicating potential for another earnings beat [2]. - Stocks with a positive Earnings ESP and a Zacks Rank of 3 (Hold) or better have a nearly 70% chance of producing a positive surprise [2]. Earnings ESP Metric - Amphastar currently has an Earnings ESP of +10.35%, suggesting that analysts have recently become more optimistic about the company's earnings prospects [3]. - The Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate, with the Most Accurate Estimate reflecting the latest analyst revisions [3]. Importance of Earnings ESP - The Earnings ESP is a crucial metric for predicting earnings performance, as it helps identify stocks likely to beat consensus estimates [4].
Amphastar Pharmaceuticals Offers Interesting Growth And Income Prospects
Seeking Alpha· 2024-09-13 11:20
Company Overview - Amphastar Pharmaceuticals engages in the production and sale of generic and proprietary drugs, utilizing various administration methods including injectable, inhalation, and intranasal dosings [3] - The company is recognized for its over-the-counter inhalant, Primatene MIST, and is experiencing growth from its acquisition of BAQSIMI, the first nasally administered glucagon treatment for severe hypoglycemia [3] Financial Performance - Amphastar's net revenue has shown consistent growth, increasing from $438 million in 2021 to an estimated $745.6 million in 2023, with a projected rise to $819.4 million in 2024 [7] - Gross profit has also improved significantly, from $200 million in 2021 to an estimated $351 million in 2023, indicating a gross margin increase from 45.6% to 59.2% during the same period [7] - The company reported a diluted EPS growth from $1.25 in 2021 to an estimated $3.93 in 2023, with expectations of $4.32 in 2024 [7] Balance Sheet Strength - Amphastar maintains a solid balance sheet with cash and equivalents totaling $190 million and total assets of $1.5 billion [4] - The current ratio stands at 3.52, indicating good liquidity and flexibility to respond to market changes [5] - The price/book ratio is 3.02, higher than the sector median of 2.42, suggesting a need for monitoring [5] Market Position and Growth Prospects - The company has a strong track record in developing and commercializing new products, which is crucial for its growth [6] - Amphastar's P/E ratio is currently at 11.29, significantly below the sector median of 20.01, indicating potential value for growth investors [7] - Expectations for continued revenue and earnings growth are supported by improving margins and successful product launches [8]
6 Beaten Down Stocks Rated Buy (SA Quant)
Seeking Alpha· 2024-08-19 09:00
Market Overview - The S&P 500 experienced an over 8% decline in a three-week selloff due to recession fears, with significant drops in the Tech (15%) and Consumer Discretionary (12%) sectors, while defensive sectors like real estate, staples, and utilities posted positive returns [1] - The market rebounded after CPI data showed inflation below the 3% consensus estimate, leading to expectations of Federal Reserve rate cuts starting in September [1] Investment Opportunities - Amid the selloff, a search for safer investments emerged, with the CBOE Volatility Index reaching pandemic-era levels, contrasting with the previous year's market greed [1] - Six stocks identified by Seeking Alpha Quant Ratings have shown strong investment fundamentals despite recent declines, with all having Buy or Strong Buy ratings and trading at attractive valuations [3][21] Company Highlights Carnival Corporation (CCL) - Market capitalization of $19.69 billion, with a Strong Buy rating and ranked 2nd in its industry [4] - CCL's stock fell over 15% in the past month despite strong fundamentals, including record Q2 results and significant growth in revenue (+34%) and operating cash flow (+516%) [4][5] - The company anticipates strong demand for 2025 sailings, indicating pricing power and a positive outlook for future growth [4] Trip.com Group Limited (TCOM) - Market capitalization of $27.35 billion, also rated Strong Buy [6] - Despite a 10% decline in the last 30 days, TCOM benefits from a booming travel season in China, with a 150% increase in foreign visitors and a 400% rise in inbound bookings [7][8] - TCOM's profitability is strong, with a gross profit margin of 80% and an EBIT margin of 26%, alongside a forward PEG of 0.29x, indicating an attractive valuation [8] Amphastar Pharmaceuticals, Inc. (AMPH) - Market capitalization of $2.21 billion, rated Buy [9] - AMPH's stock is up over 10% in the last 30 days but down 20% over the past year, with Q2 revenue growth of 25% YoY [9][11] - The company focuses on high-margin proprietary and biosimilar products, with a projected annual market size of over $13 billion [11] Corporacion America Airports S.A. (CAAP) - Market capitalization of $2.57 billion, rated Buy [12] - CAAP's stock is down approximately 10% in the past 30 days, affected by declining passenger traffic [12][15] - Despite recent challenges, CAAP has shown solid fundamentals with EPS growth of 108% in the trailing twelve months and projected FY24 EPS growth of 20% [15] Twilio Inc. (TWLO) - Market capitalization of $9.75 billion, rated Strong Buy [16] - TWLO's stock is up 4.5% in the last 30 days but down over the past year, with a strong earnings track record and 28 upward revisions in the last 90 days [16][17] - The company is positioned for growth through enhanced customer engagement solutions and is trading at a 68% discount to the sector based on a forward PEG of 0.59x [17] Sterling Infrastructure, Inc. (STRL) - Market capitalization of $3.52 billion, rated Strong Buy [18] - STRL's stock is down 13% in the last month but up 38% over the past year, with Q2 revenue beating expectations [18][20] - The company has a projected EPS growth of 26% in FY24, supported by a strong backlog and solid profitability metrics [20] Conclusion - The recent market selloff presents opportunities to acquire stocks with strong growth prospects and attractive valuations, as identified by Seeking Alpha [21]
Amphastar Pharmaceuticals(AMPH) - 2024 Q2 - Earnings Call Presentation
2024-08-09 23:48
Corporate Presentation August 2024 Highly Purified Peptide/Protein Injectables Inhalation Intranasal Biosimilar Interchangeable Proprietary Complex Generic Combination Products Forward Looking Statements This presentation and the accompanying oral presentation contain forward-looking statements, of Amphastar Pharmaceuticals, Inc. ("Amphastar", "we". "our" and that are based on our management's current expectations and assumptions and on information currently available to management. Forward-looking statemen ...
Amphastar Pharmaceuticals(AMPH) - 2024 Q2 - Earnings Call Transcript
2024-08-09 23:47
Financial Data and Key Metrics - Total revenues for Q2 2024 increased by 25% year-over-year to $182.4 million, driven by strong sales growth across key products [6] - Primatene MIST sales grew by 38% to $22.9 million, while Epinephrine sales surged by 67% to $27.9 million [6][12] - BAQSIMI achieved worldwide sales of $38.5 million, a 10% increase compared to the same period last year [5] - Gross margins improved to 52.2% from 49.9% in the previous year, supported by higher-margin products like BAQSIMI and Primatene MIST [16] - Net income increased by 45% to $37.9 million, or $0.73 per share, compared to $26.1 million, or $0.49 per share, in Q2 2023 [17] Business Line Performance - Primatene MIST is on track to meet the $100 million sales target by the end of 2024, with in-store sales growing by 14% year-over-year [6] - Epinephrine sales benefited from supplier shortages, with increased production capacity helping to meet demand [7][12] - Glucagon injection sales remained flat, with declines in the U.S. offset by growth in Canada [13] - Phytonadione sales decreased to $10.3 million due to increased competition, while Enoxaparin and Naloxone sales also declined [13] - Other finished pharmaceutical product sales decreased to $34.7 million, primarily due to a $4.6 million drop in medroxyprogesterone sales [13] Market Performance - BAQSIMI sales in the U.S. and Europe contributed $30.9 million in net revenues, with an additional $7.6 million from Lilly's distribution under a transition service agreement [14] - The company expects to transition more countries to its own distribution for BAQSIMI throughout 2024, which will increase product sales but reduce net economic benefits [15] - The Insulin API business saw sales increase to $3.5 million, up from $2.8 million last year [16] Strategic Direction and Industry Competition - The company is focused on transitioning from generics to higher-value products, including branded offerings, biosimilars, and complex products [10] - Amphastar is strategically enhancing manufacturing efficiencies to meet current and future market demand, particularly for Epinephrine and Primatene MIST [7] - The company is advancing its pipeline with three significant product approvals expected in the second half of 2024, including teriparatide (AMP-015), AMP-007, and AMP-002 [10] - The lawsuit filed by Teva regarding generic albuterol is being vigorously defended, with the company confident in its position [8] Management Commentary on Operating Environment and Future Outlook - Management highlighted the strong performance of BAQSIMI and Primatene MIST as key drivers of growth [5][6] - The company is optimistic about the second half of 2024, with potential product approvals expected to contribute significantly to revenue growth [10] - Management noted the importance of operational efficiencies and manufacturing enhancements in supporting long-term growth [11] Other Important Information - The company completed the first contract year of the five-year milestone payment agreement with Lilly for BAQSIMI, with cumulative sales of $163.2 million, below the threshold for milestone payments [15] - Research and development expenses increased by 5% to $17.7 million, driven by salary increases and the ANDA filing fee for AMP-018 [17] - The company repurchased $8.5 million worth of shares and paid down an $8 million mortgage during the quarter [19] Q&A Session Summary Question: Epinephrine franchise outlook and generic ProAir opportunity [22] - Epinephrine sales are expected to remain strong, with competitor shortages likely to persist until Q4 2024 [23] - Generic ProAir has been launched, with the company working to secure market share and increase packaging capacity over the next few quarters [25][26] Question: Pipeline updates on AMP-002, GLP-1 (AMP-018), and AMP-007 [28] - AMP-002 is nearing resolution with the FDA, with progress expected soon [29] - AMP-018 (GLP-1) is a Paragraph IV filing, with potential competition expected upon launch [29] - AMP-007 is also a Paragraph IV filing, with market competition details undisclosed for competitive reasons [29] Question: BAQSIMI's impact on gross margins and business development strategy [31][32] - BAQSIMI's transition to Amphastar's distribution will reduce gross margins due to higher cost of goods [33] - The company is actively pursuing business development opportunities, focusing on both in-development and market-ready assets [34] Question: REXTOVY performance and selling/marketing costs outlook [36] - REXTOVY is expected to have limited impact due to market competition, with a focus on government and first responder contracts [37] - Selling and marketing costs are expected to grow by 10% as the company expands its sales force and distribution efforts [39] Question: BAQSIMI sales growth drivers and country-by-country transition timeline [41][46] - BAQSIMI's sales growth was driven by unit volume, with pricing decreases in the U.S. offset by growth in other markets [42] - The transition to Amphastar's distribution is expected to be completed for most countries by the end of Q3 2024, with final transitions likely in Q4 or early 2025 [48] Question: Supply dynamics for lidocaine and phytonadione [49] - Competitor supply issues are expected to ease in Q4 2024, potentially impacting sales of certain products [50] - The company has increased production capacity to better respond to market shortages and demand fluctuations [50]