Hyaluronidase(Amphastar)

Reports Net Revenues of $171.8 Million for the Three Months Ended March 31, 2024 RANCHO CUCAMONGA, CA / ACCESSWIRE / May 8, 2024 / Amphastar Pharmaceuticals, Inc., (NASDAQ:AMPH) ("Amphastar" or the "Company") today reported results for the three months ended March 31, 2024. First Quarter Highlights Net revenues of $171.8 million for the first quarter GAAP net income of $43.2 million, or $0.81 per share, for the first quarter Adjusted non-GAAP net income of $55.3 million, or $1.04 per share, for the first quarter Dr. Jack Zhang, Amphastar's President and Chief Executive Officer, commented: "Amphastar's strong first quarter results were led by BAQSIMI ® revenue growth of 22% over what Eli Lilly & Company ("Lilly") reported for the first quarter of 2023. This significant increase demonstrates a strong transition and the potential for continued growth of BAQSIMI ® ." Three Months Ended March 31, 2024 2023 (in thousands, except per share data) Net revenues $ 171,836 $ 140,022 GAAP net income $ 43,177 $ 26,032 Adjusted non-GAAP net income* $ 55,296 $ 32,143 GAAP diluted EPS $ 0.81 $ 0.50 Adjusted non-GAAP diluted EPS* $ 1.04 $ 0.62 ____________________________________ * Adjusted non-GAAP net income and adjusted non-GAAP diluted EPS are non-GAAP financial measures. Please see the discussion in the section entitled "Non-GAAP Financial Measures" and the reconciliation of GAAP to non-GAAP financial measures in Table III of this press release. First Quarter Results Three Months Ended March 31, Change 2024 2023 Dollars % (in thousands) Product revenues: Glucagon $ 28,535 $ 25,696 $ 2,839 11 % Epinephrine 26,110 20,091 6,019 30 % Primatene MIST ® 24,166 23,483 683 3 % BAQSIMI ® 13,843 - 13,843 N/A Lidocaine 12,773 13,646 (873 ) (6 )% Phytonadione 9,973 7,713 2,260 29 % Enoxaparin 7,096 9,867 (2,771 ) (28 )% Naloxone 4,287 4,957 (670 ) (14 )% Other finished pharmaceutical products 29,154 30,557 (1,403 ) (5 )% Total finished pharmaceutical products net revenues $ 155,937 $ 136,010 $ 19,927 15 % API 1,692 4,012 (2,320 ) (58 )% Other revenues 14,207 - 14,207 N/A Total net revenues $ 171,836 $ 140,022 $ 31,814 23 % Changes in net revenues as compared to the first quarter of the prior year were primarily driven by: BAQSIMI ® sales consisting of $13.8 million in sales made by the Company directly to its customers which are recorded as part of Product Revenues, net, and $24.6 million in sales made by Lilly on behalf of the Company under the Transition Services Agreement ("TSA"), which resulted in a net payment to the Company of $14.2 million after deducting cost of sales and other expenses and was recorded in Other Revenues Glucagon sales increased due to a growth in unit volumes, impacting sales by $1.8 million as well as a higher average selling price, impacting sales by $1.1 million as we launched glucagon in Canada Epinephrine and Phytonadione sales increased primarily due to an increase in unit volumes, as a result of other supplier shortages Primatene MIST ® sales increased primarily due to an increase in unit volumes and a higher average selling price Lidocaine sales decreased primarily due to a decrease in unit volumes, as a result of other suppliers returning to their historical distribution levels Enoxaparin and Naloxone sales decreased primarily due to a decrease in unit volumes Other finished pharmaceutical product sales changes were primarily due to: Lower unit volumes of MPA, as our Active Pharmaceutical Ingredient ("API") supplier discontinued making the active ingredient This decrease was partially offset by higher unit volumes of dextrose and sodium bicarbonate caused by other supplier shortages during the quarter Launch of regadenoson in April 2023 API sales decreased primarily due to the timing of customer purchases Three Months Ended March 31, Change 2024 2023 Dollars % (in thousands) Net revenues $ 171,836 $ 140,022 $ 31,814 $ 23 Cost of revenues 81,736 66,182 15,554 24 % Gross profit $ 90,100 $ 73,840 $ 16,260 $ 22 % as % of net revenues 52.4 % 52.7 % Changes in the cost of revenues and the resulting gross margins were primarily driven by: Increase in depreciation and amortization expense related to the acquired BAQSIMI ® assets Increases in labor costs and certain component costs Charges included in cost of revenues to adjust our inventory and related purchase commitments to their net realizable value These factors were partially offset by increased sales of higher-margin products: BAQSIMI ® which was acquired in June 2023 Glucagon, Primatene MIST ® , and epinephrine Regadenoson launched in April 2023 Three Months Ended March 31, Change 2024 2023 Dollars % (in thousands) Selling, distribution, and marketing $ 9,371 $ 7,109 $ 2,262 32 % General and administrative 15,676 13,483 2,193 16 % Research and development 17,043 19,815 (2,772 ) (14) % Non-operating (expenses) income, net (134 ) 136 (270 ) NM Selling, distribution, and marketing expenses increased primarily due to the expansion of our sales and marketing efforts related to BAQSIMI ® General and administrative expenses increased primarily due to an increase in expenses related to BAQSIMI ® Research and development expenses decreased due to the timing of clinical trial expenses, as well as a decrease in materials and supply expenses, primarily related to our insulin and inhalation pipeline products, as a result of a ramp-up in 2023 Cash flow provided by operating activities for the three months ended March 31, 2024, was $55.3 million. Pipeline Information The Company currently has four abbreviated new drug applications ("ANDAs") on the U.S. Food and Drug Administration (the "FDA") targeting products with a market size of over $3 billion, three biosimilar products in development targeting products with a market size of over $7 billion, and four generic products in development targeting products with a market size of over $3 billion. This market information is based on IQVIA data for the 12 months ended March 31, 2024. The Company is developing multiple proprietary products with injectable and intranasal dosage forms. Amphastar's Chinese subsidiary, Amphastar Nanjing Pharmaceuticals, Co., Ltd. ("ANP"), currently has multiple Drug Master Files ("DMFs"), on the FDA and is developing several additional DMFs. 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. More information and resources are available at . Amphastar's logo and other trademarks or service marks of Amphastar, including, but not limited to Amphastar ® , BAQSIMI ® , Primatene MIST ® , REXTOVY TM , 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 ® , certain 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. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most directly comparable GAAP measures set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP. Conference Call Information The Company will hold a conference call to discuss its financial results today, May 8, 2024, at 2:00 p.m. Pacific Time. To access the conference call, dial toll-free (877) 407-0989 or (201) 389-0921 for international callers, ten minutes before the conference. The call can also be accessed on the Investors page on the Company's website 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 ® , including its potential for continued revenue growth, the success of our integration 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, 2023, filed with the SEC on February 29, 2024. 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 and on the SEC's website at 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 Information: Amphastar Pharmaceuticals, Inc. Bill Peters Chief Financial Officer (909) 476-3416 Table I Amphastar Pharmaceuticals, Inc. Condensed Consolidated Statement of Operations (Unaudited; in thousands, except per share data) Three Months Ended March 31, 2024 2023 Net revenues: Product revenues, net $ 157,629 $ 140,022 Other revenues 14,207 - Total net revenues 171,836 140,022 Cost of revenues 81,736 66,182 Gross profit 90,100 73,840 Operating expenses: Selling, distribution, and marketing 9,371 7,109 General and administrative 15,676 13,483 Research and development 17,043 19,815 Total operating expenses 42,090 40,407 Income from operations 48,010 33,433 Non-operating (expenses) income, net (134 ) 136 Income before income taxes 47,876 33,569 Income tax provision 4,126 6,752 Net income before equity in losses of unconsolidated affiliate 43,750 26,817 Equity in losses of unconsolidated affiliate (573 ) (785 ) Net income $ 43,177 $ 26,032 Net income per share: Basic $ 0.90 $ 0.54 Diluted $ 0.81 $ 0.50 Weighted-average shares used to compute net income per share: Basic 48,212 48,000 Diluted 53,013 51,970 Table II Amphastar Pharmaceuticals, Inc. Condensed Consolidated Balance Sheet (Unaudited; in thousands, except per share data) March 31, December 31, 2024 2023 (unaudited) ASSETS Current assets: Cash and cash equivalents $ 201,148 $ 144,296 Restricted cash 235 235 Short-term investments 88,407 112,510 Restricted short-term investments 2,200 2,200 Accounts receivable, net 138,114 114,943 Inventories 115,494 105,833 Income tax refunds and deposits 784 526 Prepaid expenses and other assets 8,696 9,057 Total current assets 555,078 489,600 Property, plant, and equipment, net 288,523 282,746 Finance lease right-of-use assets 516 564 Operating lease right-of-use assets 31,352 32,333 Investment in unconsolidated affiliate - 527 Goodwill and intangible assets, net 607,064 613,295 Long-term investments 15,163 14,685 Other assets 23,369 25,910 Deferred tax assets 53,252 53,252 Total assets $ 1,574,317 $ 1,512,912 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and accrued liabilities $ 116,697 $ 93,366 Accrued payments for BAQSIMI ® 128,245 126,090 Income taxes payable 5,857 1,609 Current portion of long-term debt 428 436 Current portion of operating lease liabilities 3,942 3,906 Total current liabilities 255,169 225,407 Long-term reserve for income tax liabilities 6,066 6,066 Long-term debt, net of current portion and unamortized debt issuance costs 594,006 589,579 Long-term operating lease liabilities, net of current portion 28,739 29,721 Other long-term liabilities 17,981 22,718 Total liabilities 901,961 873,491 Commitments and contingencies Stockholders' equity: Preferred stock: par value $0.0001; 20,000,000 shares authorized; no shares issued and outstanding - - Common stock: par value $0.0001; 300,000,000 shares authorized; 60,160,459 and 48,841,343 shares issued and outstanding as of March 31, 2024 and 59,390,194 and 48,068,881 shares issued and outstanding as of December 31, 2023, respectively 6 6 Additional paid-in capital 476,072 486,056 Retained earnings 452,445 409,268 Accumulated other comprehensive loss (8,769 ) (8,478 ) Treasury stock (247,398 ) (247,431 ) Total equity 672,356 639,421 Total liabilities and stockholders' equity $ 1,574,317 $ 1,512,912 Table III Amphastar Pharmaceuticals, Inc. Reconciliation of Non-GAAP Measures (Unaudited; in thousands, except per share data) Three Months Ended March 31, 2024 2023 GAAP net income $ 43,177 $ 26,032 Adjusted for: Intangible asset amortization 6,167 241 Share-based compensation 7,360 6,111 Expenses related to BAQSIMI ® acquisition 1,826 1,217 Income tax provision on pre-tax adjustments (3,234 ) (1,458 ) Adjusted non-GAAP net income $ 55,296 $ 32,143 Adjusted non-GAAP net income per share: Basic $ 1.15 $ 0.67 Diluted $ 1.04 $ 0.62 Weighted-average shares used to compute adjusted non-GAAP net income per share: Basic 48,212 48,000 Diluted 53,013 51,970 Three Months Ended March 31, 2024 Cost of revenue Selling, distribution and marketing General and administrative Research and development Non-operating (expenses) income, net Income tax provision GAAP $ 81,736 $ 9,371 $ 15,676 $ 17,043 $ (134 ) $ 4,126 Intangible asset amortization (6,147 ) - (3 ) (17 ) - - Share-based compensation (2,125 ) (260 ) (3,876 ) (1,099 ) - - Expenses related to BAQSIMI ® acquisition - - - - 1,826 - Income tax provision on pre-tax adjustments - - - - - 3,234 Non-GAAP $ 73,464 $ 9,111 $ 11,797 $ 15,927 $ 1,692 $ 7,360 Three Months Ended March 31, 2023 Cost of revenue Selling, distribution and marketing General and administrative Research and development Non-operating (expenses) income, net Income tax provision GAAP $ 66,182 $ 7,109 $ 13,483 $ 19,815 $ 136 $ 6,752 Intangible asset amortization (211 ) - (30 ) - - - Share-based compensation (1,706 ) (209 ) (3,357 ) (839 ) - - Expenses related to BAQSIMI ® acquisition - - (1,217 ) - - - Income tax provision on pre-tax adjustments - - - - - 1,458 Non-GAAP $ 64,265 $ 6,900 $ 8,879 $ 18,976 $ 136 $ 8,210 SOURCE: Amphastar Pharmaceuticals, Inc. View the original press release on accesswire.com

RANCHO CUCAMONGA, CA / ACCESSWIRE / April 1, 2024 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced today that Bill Peters, CFO, Tony Marrs, EVP of Regulatory Affairs and Clinical Operations, and Dan Dischner SVP of Corp. Communication, will participate in an Analyst-Moderated fireside chat at the 23rd Annual Needham Virtual Healthcare Conference on April 9th, 2024 at 3:00 pm EST. For access, visit Amphastar's Pharmaceuticals website at . This webcast will be available for 30 days following the presentation. About Amphastar: Amphastar is a biopharmaceutical 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 active pharmaceutical ingredient 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. More information is available at the Company's website at . The Amphastar Pharmaceuticals' logo and other trademarks or service marks of Amphastar Pharmaceuticals, Inc., including, but not limited to Primatene MIST®, Amphadase®, Cortrosyn®, REXTOVY® and BAQSIMI® are the property of Amphastar Pharmaceuticals, Inc. Forward-Looking Statements All statements in this press release and in the webcast 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, including potential contingent consideration amounts and terms related to the acquisition of BAQSIMI®, the anticipated benefits of BAQSIMI® to our product portfolio, Amphastar's commitment to strategically maximizing the commercial potential 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, 2023, filed with the SEC on February 29, 2024, 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 and on the SEC's website at . 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 webcast 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 Chief Financial Officer (909) 476-3416 SOURCE: Amphastar Pharmaceuticals, Inc. View the original press release on accesswire.com