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]

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]

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]

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].

Here at Zacks, we focus on our proven ranking system, which places an emphasis on earnings estimates and estimate revisions, to find winning stocks. But we also understand that investors develop their own strategies, so we are constantly looking at the latest trends in value, growth, and momentum to find strong companies for our readers.Considering these trends, value investing is clearly one of the most preferred ways to find strong stocks in any type of market. Value investors use tried-and-true metrics a ...

If you are looking for a stock that has a solid history of beating earnings estimates and is in a good position to maintain the trend in its next quarterly report, you should consider Amphastar Pharmaceuticals (AMPH) . This company, which is in the Zacks Medical - Generic Drugs industry, shows potential for another earnings beat.When looking at the last two reports, this specialty pharmaceutical company has recorded a strong streak of surpassing earnings estimates. The company has topped estimates by 27.79% ...

ozgurcankaya My background isn't in medicine, so I tend to spend some extra time when a pharmaceutical company shows up on my screeners. It's not that I'm suspicious of the industry but that I feel the need to better understand the operation that the company is engaged in. Today, I'm going to be looking at Amphastar Pharmaceuticals (NASDAQ:AMPH), a company that engages in interesting types of administration of prescriptions and over-the-counter medication. We'll be looking at what the company offers, the pr ...

sefa ozel The S&P 500 fell over 8% in a three-week selloff amid fears of recession. The market bounced back last week despite big tech AI bubble fears triggered by weak jobs data and uncertainty over the impact and timing of Fed emergency rate cuts. The Tech (XLK) and Consumer Discretionary (XLY) sectors led the free fall, plunging by 15% and 12%, respectively, followed by the Industrial (XLI) and Energy (XLE) sectors, which both fell over 5%. Three defensive sectors - real estate, staples, and utilitie ...

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 ...

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]