The most recent trading session ended with Amphastar Pharmaceuticals (AMPH) standing at $54.03, reflecting a -1.44% shift from the previouse trading day's closing. This change lagged the S&P 500's daily loss of 0.07%.Prior to today's trading, shares of the specialty pharmaceutical company had lost 11.19% over the past month. This has lagged the Medical sector's gain of 7.37% and the S&P 500's gain of 3.98% in that time.Market participants will be closely following the financial results of Amphastar Pharmace ...

Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) Q3 2023 Earnings Conference Call November 8, 2023 5:00 PM ET Company Participants Dan Dischner - SVP of Corporate Communications Bill Peters - CFO Conference Call Participants Glen Santangelo - Jefferies Tim Chiang - Capital One Operator Greetings and welcome to the Amphastar Pharmaceuticals Third Quarter Earnings Conference Call. [Operator Instructions] Please note that certain statements made during this call regarding matters that are not historical facts, in ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ⌧ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (I.R.S. Employer Identification No.) 11570 6 th Street Rancho Cucamonga, CA 91730 (Address of principal executive offices) (zip code) (909) 980-9484 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2023 or ◻ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period fro ...

Financial Data and Key Metrics Changes - The company reported revenue of $145.7 million for Q2 2023, an 18% increase from $123.5 million in the same period last year [5][11] - Net income rose to $26.1 million or $0.49 per share, compared to $17.3 million or $0.33 per share in Q2 2022 [17] - Adjusted net income increased by 68% to $34.8 million or $0.65 per share, up from $20.7 million or $0.39 per share in the previous year [17] Business Line Data and Key Metrics Changes - Glucagon injection sales reached $27.3 million, more than doubling from $11.8 million in the prior year, driven by strong market demand [5][11] - Sales of Primatene Mist decreased to $16.5 million from $19 million due to inventory adjustments by retailers, although retail sales grew by 5% [6][12] - Epinephrine sales declined to $16.7 million as competitors returned to normal distribution levels [6][12] - Other finished pharmaceutical products saw a 47% increase in sales, benefiting from competitor shortages [6] Market Data and Key Metrics Changes - The company anticipates a significant role in addressing nationwide drug shortages, particularly in the hospital setting [7] - The FDA approved the brand name Ruxovi for the intranasal naloxone product, with a planned launch delayed to Q4 2023 [7] Company Strategy and Development Direction - The acquisition of BAQSIMI enhances the diabetes portfolio and aligns with the company's focus on proprietary products, biosimilars, and complex products [4] - The company plans to launch glucagon injection in Canada, expanding sales opportunities [14] - Research and development remain a priority, with a focus on advancing the product pipeline and improving margins and cash flow [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about growth opportunities from new products emerging from the pipeline [10] - The company is in positive dialogue with the FDA regarding AMP-002 and remains hopeful for a successful response [8][35] - Management noted that while there will be an increase in sales from shortage products, it will be incremental due to existing production capacity constraints [30] Other Important Information - Gross margins slightly decreased to 50% from 51% year-over-year, impacted by an impairment charge of $2.7 million related to UK product rights [15] - Selling, distribution, and marketing expenses increased due to higher advertising costs for Primatene Mist [16] Q&A Session Summary Question: Marketing strategy for BAQSIMI and expected sales trends - The transition for BAQSIMI will occur in phases, with the company taking over marketing in Q3, anticipating higher sales during the back-to-school period [20] Question: Sales recovery expectations for Primatene Mist - Sales trends are uncertain, but there is an expectation that the current inventory destocking will eventually stabilize sales [21] Question: Future benefits from ongoing supply shortages - The company expects to continue benefiting from supply shortages, particularly in the hospital market [22][29] Question: Glucagon sales mix and institutional penetration - Approximately 60% of glucagon sales are from retail, with significant growth opportunities in the institutional market [27] Question: Nature of CRL for AMP-008 - The CRL is considered minor, and the company plans to respond in Q3 [28] Question: Impact of Pfizer facility damage on product shortages - The company anticipates some benefits from the damage at the Pfizer facility, particularly in hospital products [30]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ⌧ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2023 or ◻ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-36509 | --- | --- | |----------------------------------------------------------------------------------------------------- ...

Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) Q1 2023 Results Conference Call May 9, 2023 5:00 PM ET Company Participants Dan Dischner - VP of HR & Corporate Communication William Peters - CFO, Executive VP of Finance, Treasurer & Director Conference Call Participants Tim Chiang - Capital One David Amsellem - Piper Sandler Operator Greetings, and welcome to the Amphastar Pharmaceuticals, Inc. First Quarter Earnings Call. [Operator Instructions] Please note that certain statements made during this call regar ...

[Part I. FINANCIAL INFORMATION](index=6&type=section&id=Part%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents Amphastar Pharmaceuticals, Inc.'s unaudited condensed consolidated financial statements for the three months ended March 31, 2023, encompassing balance sheets, statements of operations, comprehensive income, stockholders' equity, and cash flows with accompanying notes Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Total Assets** | **$773,656** | **$741,987** | | Total Current Assets | $407,670 | $378,319 | | **Total Liabilities** | **$225,079** | **$213,329** | | Total Current Liabilities | $105,635 | $94,862 | | **Total Stockholders' Equity** | **$548,577** | **$528,658** | Condensed Consolidated Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | **Net Revenues** | **$140,022** | **$120,368** | | Gross Profit | $73,840 | $55,826 | | Income from Operations | $33,433 | $21,614 | | **Net Income** | **$26,032** | **$24,253** | | **Diluted EPS** | **$0.50** | **$0.47** | Condensed Consolidated Statement of Cash Flows Highlights (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | **Net cash provided by operating activities** | **$40,382** | **$50,765** | | Net cash used in investing activities | ($6,333) | ($9,110) | | Net cash used in financing activities | ($13,548) | $4,648 | | **Net increase in cash** | **$20,517** | **$46,274** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed disclosures supporting the financial statements, covering accounting policies, revenue recognition, segment performance, debt, share-based compensation, legal matters, and the planned BAQSIMI® acquisition - The company focuses on developing, manufacturing, and marketing technically challenging generic and proprietary injectable, inhalation, and intranasal products, as well as insulin API products, with most products used in hospital or urgent care settings[31](index=31&type=chunk) Provision for Chargebacks and Rebates (in thousands) | | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Beginning balance | $26,606 | $20,167 | | Provision | $69,027 | $46,779 | | Credits and payments | ($67,289) | ($48,394) | | **Ending balance** | **$28,344** | **$18,552** | Segment Net Revenues and Gross Profit (in thousands) | Segment | Net Revenues Q1 2023 | Gross Profit Q1 2023 | Net Revenues Q1 2022 | Gross Profit Q1 2022 | | :--- | :--- | :--- | :--- | :--- | | Finished pharmaceutical products | $136,010 | $76,176 | $116,546 | $56,939 | | API | $4,012 | ($2,336) | $3,822 | ($1,113) | | **Total** | **$140,022** | **$73,840** | **$120,368** | **$55,826** | - On April 20, 2023, the Company agreed to acquire BAQSIMI® from Eli Lilly for **$500.0 million** in cash at closing, a **$125.0 million** guaranteed payment one year after closing, and up to **$450.0 million** in contingent milestone payments[135](index=135&type=chunk) - To finance the BAQSIMI® acquisition, the Company has entered into a debt commitment letter for a **$500.0 million** senior secured term loan facility and a **$150.0 million** senior secured revolving credit facility[138](index=138&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=43&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2023 financial performance, noting a **16% increase in net revenues to $140.0 million** driven by glucagon sales, alongside gross margin improvements, operating expense trends, liquidity, and the planned BAQSIMI® acquisition - The company's largest products by net revenue are Primatene MIST®, glucagon, epinephrine, lidocaine, enoxaparin, and phytonadione[143](index=143&type=chunk) - In March 2023, the FDA approved the company's naloxone hydrochloride nasal spray 4mg, with a planned launch in Q3 2023[144](index=144&type=chunk) - The company entered into an agreement to acquire BAQSIMI® from Eli Lilly, a significant strategic move to be financed with **$500M** in cash at closing and substantial new debt[152](index=152&type=chunk) [Results of Operations](index=47&type=section&id=Results%20of%20Operations) Q1 2023 net revenues increased **16% to $140.0 million**, primarily from **134% glucagon sales growth**, with gross margin improving to **53%** and R&D expenses rising **22% to $19.8 million** due to clinical trials Net Revenues by Key Product (in thousands) | Product | Q1 2023 | Q1 2022 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Glucagon | $25,696 | $10,984 | $14,712 | 134% | | Primatene MIST® | $23,483 | $24,697 | ($1,214) | (5)% | | Epinephrine | $20,091 | $15,156 | $4,935 | 33% | | Lidocaine | $13,646 | $10,590 | $3,056 | 29% | | Phytonadione | $7,713 | $10,475 | ($2,762) | (26)% | | Naloxone | $4,957 | $7,413 | ($2,456) | (33)% | - The increase in sales of glucagon was primarily due to an increase in unit volumes, while the increase in epinephrine sales was due to higher demand caused by competitor shortages[158](index=158&type=chunk) - Gross margins increased to **53%** in Q1 2023 from **46%** in Q1 2022, driven by higher sales of high-margin products like glucagon and epinephrine, and the launch of ganirelix and vasopressin[162](index=162&type=chunk) - Research and development expenses increased by **22% to $19.8 million**, primarily due to increased salary and personnel costs, and a significant rise in clinical trial expenses for the insulin and inhalation product pipeline[165](index=165&type=chunk) [Liquidity and Capital Resources](index=52&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2023, working capital reached **$302.0 million**, with **$40.4 million** in operating cash flow, deemed sufficient for future operations despite anticipated significant cash requirements for clinical trials and acquisitions - The company expects cash requirements to increase significantly to fund clinical trials, expand manufacturing facilities in the U.S. and China, and pursue strategic acquisitions[172](index=172&type=chunk) - Working capital increased by **$18.5 million** to **$302.0 million** at March 31, 2023, from **$283.5 million** at December 31, 2022[174](index=174&type=chunk) - Net cash from operating activities was **$40.4 million** in Q1 2023, compared to **$50.8 million** in Q1 2022, with the decrease primarily due to changes in working capital, including an increase in accounts receivable[177](index=177&type=chunk)[178](index=178&type=chunk) - Net cash used in financing activities was **$13.5 million**, mainly due to **$8.0 million** in treasury stock purchases and **$4.5 million** used to settle share-based compensation awards[180](index=180&type=chunk) [Item 3. Quantitative and Qualitative Disclosure about Market Risk](index=57&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20about%20Market%20Risk) The company faces market risks from investments, interest rates, and foreign currency exchange, with no material changes reported since the December 31, 2022, Annual Report on Form 10-K - The company is exposed to market risk from changes in the value of its investments, interest rate fluctuations, and foreign currency exchange rate changes[188](index=188&type=chunk) [Item 4. Controls and Procedures](index=57&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of March 31, 2023, with no material changes to internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[189](index=189&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended March 31, 2023, that have materially affected, or are reasonably likely to materially affect, internal controls[190](index=190&type=chunk) [Part II. OTHER INFORMATION](index=59&type=section&id=Part%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=59&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to Note 19 of the Condensed Consolidated Financial Statements for detailed information on the company's legal proceedings - For information regarding legal proceedings, the report refers to Note 19 in Part I, Item 1 of the financial statements[192](index=192&type=chunk) [Item 1A. Risk Factors](index=59&type=section&id=Item%201A.%20Risk%20Factors) This section outlines new risks from the proposed BAQSIMI® acquisition, including deal completion failure and increased indebtedness up to **$650 million**, alongside ongoing risks from COVID-19, geopolitical issues, and healthcare legislation - Failure to complete the BAQSIMI® acquisition could negatively impact the stock price and business, and may require payment of a **$5.0 million** termination fee under certain circumstances[193](index=193&type=chunk)[194](index=194&type=chunk) - To finance the acquisition, the company will incur up to **$650.0 million** in new debt, which will materially increase indebtedness and could adversely affect operating results, cash flows, and operational flexibility due to restrictive covenants[202](index=202&type=chunk)[203](index=203&type=chunk)[209](index=209&type=chunk) - The acquisition is subject to regulatory clearance, including under the HSR Act, which could delay or impose conditions on the completion of the transaction[214](index=214&type=chunk)[215](index=215&type=chunk) - Ongoing risks include disruptions from the COVID-19 pandemic affecting supply chains and clinical trials, geopolitical and trade risks associated with manufacturing in China, and the impact of sanctions related to the Russia-Ukraine conflict[221](index=221&type=chunk)[227](index=227&type=chunk)[232](index=232&type=chunk) - The company faces risks from healthcare legislation like the Affordable Care Act and the Inflation Reduction Act of 2022, which could increase costs, mandate price controls, and negatively impact profitability[234](index=234&type=chunk)[240](index=240&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=75&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) In Q1 2023, the company repurchased **263,131 shares** at an average of **$30.44 per share**, with **$35.6 million** remaining for repurchase under the authorized buyback program as of March 31, 2023 Issuer Purchases of Equity Securities (Q1 2023) | Period | Total Number of Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | January 2023 | 138,190 | $28.92 | | February 2023 | 98,504 | $31.35 | | March 2023 | 26,437 | $34.93 | - As of March 31, 2023, **$35.6 million** remained available for repurchase under the company's share buyback program, which was increased by **$50.0 million** in November 2022[245](index=245&type=chunk) [Item 3. Defaults Upon Senior Securities](index=75&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section is not applicable to the company's current reporting - Not applicable[245](index=245&type=chunk) [Item 4. Mine Safety Disclosures](index=75&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company's current reporting - Not applicable[245](index=245&type=chunk) [Item 5. Other Information](index=75&type=section&id=Item%205.%20Other%20Information) This section is not applicable to the company's current reporting - Not applicable[245](index=245&type=chunk) [Item 6. Exhibits](index=77&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including Amended and Restated Bylaws, a contract research agreement amendment, and required CEO/CFO certifications - The report includes several exhibits, such as an amendment to a research agreement with Nanjing Hanxin Pharmaceutical Technology Co., Ltd., and required CEO/CFO certifications (302 and 906)[250](index=250&type=chunk)

Injectables Proprietary Biosimilars Complex Generic Inhalation Corporate Presentation Needham Conference April 2023 Forward Looking Statements This presentation and the accompanying oral presentation contain forward-looking statements that are based on our management's current expectations and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including, but not limited t ...

Financial Data and Key Metrics Changes - The company reported net revenues for the fiscal year of $499 million, a 14% increase, with gross profit rising by 25% [5] - In Q4 2022, net revenues reached $135 million, a 12% increase from $120.9 million in the previous year [12] - Net income for Q4 2022 was $33.9 million or $0.66 per share, up 72% and 66% respectively compared to the previous year's Q4 [14] Business Line Data and Key Metrics Changes - Glucagon sales increased by 19% to $18.3 million in Q4 2022, driven by competitor product discontinuation [12] - Primatene MIST sales grew to $22.3 million from $21.5 million in the prior year [12] - Other finished pharmaceutical products saw a 52% increase in sales, totaling $33.1 million, attributed to sodium bicarbonate, dextrose, and isoproterenol [12][14] Market Data and Key Metrics Changes - The glucagon market is experiencing growth opportunities due to competitor exits, allowing the company to expand its market share [27] - The company anticipates continued strength in its product portfolio throughout 2023, despite potential fluctuations due to competitor capacity [8] Company Strategy and Development Direction - The company plans to increase marketing spend for Primatene MIST by an additional $2 million to $3 million [6] - A significant increase in R&D investment is planned to support the pipeline and capacity expansion [11][16] - The company is expanding its manufacturing capacity to double output for glucagon and quadruple capacity for inhalation products [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about sustaining growth in 2023, particularly from glucagon and Primatene MIST [15][30] - The company expects gross margins to remain flat year-over-year due to increased labor and input costs [16] - Management highlighted the importance of maintaining a strong cash position to support stock buybacks and operational expansions [17] Other Important Information - The company reported positive cash flow from operations of approximately $15.2 million in Q4 2022 [15] - The FDA has approved increased manufacturing capacity for glucagon, allowing the company to meet additional market demand [7] Q&A Session Summary Question: What is driving the growth in other finished product sales? - The growth is attributed to market shortages for products like sodium bicarbonate and dextrose, along with increased capacity at the factory [20] Question: How does the company feel about AMP-002 leading up to the potential approval date? - The company remains optimistic about AMP-002 and continues to engage with the agency [21] Question: Can you comment on the growth trajectory for glucagon? - The company sees opportunities for growth due to competitor exits and plans to expand market share [27] Question: What about the filing for AMP-007 and AMP-027? - AMP-007 is expected to be a P4 filing, and AMP-027 is planned for filing in Q2 [29]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to _____ Commission File Number 001-36509 AMPHASTAR PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) | --- | |-------| | | | | | | | | | | | ...