RANCHO CUCAMONGA - Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) ('Amphastar' or the 'Company') today reported results for the three months and full-year ended December 31, 2023.
Fourth Quarter Highlights
Net revenues of $178.1 million for the fourth quarter
GAAP net income of $36.2 million, or $0.68 per share, for the fourth quarter
Adjusted non-GAAP net income of $46.9 million, or $0.88 per share, for the fourth quarter
Full-Year Highlights
Net revenues of $644.4 million for the fiscal year
GAAP net income of $137.5 million, or $2.60 per share, for the fiscal year
Adjusted non-GAAP net income of $175.7 million, or $3.32 per share, for the fiscal year
Dr. Jack Zhang, Amphastar's President and Chief Executive Officer, commented: 'We enter 2024 with strong momentum. 2023 was an important year for the Company driven by the strong performance of glucagon and Primatene MIST alongside the acquisition of BAQSIMI, which strengthened our diabetes portfolio. The recent submission of our first BLA for Insulin Aspart, known as AMP-004, underscores our continued pipeline development in diabetes management, and marks another milestone for Amphastar.'
Changes in product revenues as compared to the fourth quarter of the prior year were primarily driven by: Glucagon sales increased primarily due to an increase in unit volumes, as a result of two competitors discontinuing their glucagon injection products at the end of 2022
Epinephrine sales increased primarily due to an increase in unit volumes, as a result of supplier shortages
Lidocaine sales increased primarily due to higher unit volumes as supply chain issues eased allowing us to fulfill backorders
Primatene MIST sales increased $1.3 million due to an increase in unit volumes, with the remainder of the increase due to an increase in average selling price
Enoxaparin and naloxone sales decreased primarily due to a decrease in unit volumes
Other finished pharmaceutical product sales increased primarily due to: Higher unit volumes of atropine, calcium chloride, and sodium bicarbonate, due to increased demand caused by supplier shortages during the fourth quarter
Launch of regadenoson in April 2023
Active Pharmaceutical Ingredient ('API') sales increased primarily due to the timing of customer purchases
Other revenues are comprised of net revenues from the sales of BAQSIMI of $22.5 million during the three months ended December 31, 2023, which was recognized on a net basis similar to a royalty arrangement and based on Eli Lilly & Company's ('Lilly') reported BAQSIMI net sales of $37.6 million. Currently, BAQSIMI is being sold by Lilly on our behalf under the Transition Services Agreement ('TSA') with Lilly, whereby Lilly provides certain services to support the transition of the BAQSIMI operations to us. Once Amphastar takes over the distribution of BAQSIMI, Amphastar will recognize the entire revenue amount. This revenue recognition change is expected to be phased in by country during 2024.
Company Information
Amphastar is a bio-pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells insulin API products. Most of the Company's finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers.
Amphastar's logo and other trademarks or service marks of Amphastar, including, but not limited to Amphastar, BAQSIMI, Primatene MIST, REXTOVYTM, Amphadase, and Cortrosyn, are the property of Amphastar.
Non-GAAP Financial Measures
To supplement its consolidated financial statements, which are prepared and presented in accordance with U.S. generally accepted accounting principles ('GAAP'), the Company is disclosing non-GAAP financial measures when providing financial results. The Company believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared only in accordance with GAAP. As a result, the Company is disclosing certain non-GAAP results, including (i) Adjusted non-GAAP net income (loss) and (ii) Adjusted non-GAAP diluted EPS, which exclude amortization expense, share-based compensation, impairment charges, expenses related to our acquisition of BAQSIMI, debt issuance costs, legal settlements, and other one-time events in order to supplement investors' and other readers' understanding and assessment of the Company's financial performance because the Company's management uses these measures internally for forecasting, budgeting, and measuring its operating performance. Whenever the Company uses such non-GAAP measures, it will provide a reconciliation of non-GAAP financial measures to their most directly comparable GAAP financial measures.
Forward-Looking Statements
All statements in this press release 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 matters related to our pipeline of product candidates, the timing and results of clinical trials, the prospective benefits of the acquisition of BAQSIMI, and other future events. These statements are not facts but rather are based on Amphastar's historical performance and our current expectations, estimates, and projections regarding our business, operations, and other similar or related factors. Words such as 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'anticipate,' 'predict,' 'potential,' 'continue,' 'expect,' 'intend,' 'plan,' 'project,' 'believe,' 'estimate,' and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar's control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar's filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 1, 2023, in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, filed with the SEC on May 9, 2023, in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, filed with the SEC on August 8, 2023, and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, filed with the SEC on November 8, 2023. In particular, there can be no guarantee that the acquisition of BAQSIMI will be beneficial to our business, that any event, change or other circumstance could cause the results of the acquisition and integration of BAQSIMI into our product portfolio to differ from Amphastar's expectation, that all or any of the contingent consideration will be payable on the terms described herein or at all, or that Amphastar can reliably predict the impact of BAQSIMI on its financial results or financial guidance. You can locate these reports through our website at http://ir.amphastar.com and on the SEC's website at www.sec.gov. The forward-looking statements in this release speak only as of the date of the release. Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this press release or the conference call referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause our expectations to change.
Contact:
Bill Peters
Tel: (909) 476-3416
AMPHASTAR PHARMACEUTICALS, INC. 
