Amphastar Nanjing Pharmaceuticals, Inc.

Reports Net Revenues of $135.0 Million for the Three Months Ended December 31, 2022 RANCHO CUCAMONGA, CA / ACCESSWIRE / February 28, 2023 / Amphastar Pharmaceuticals, Inc., (NASDAQ:AMPH) ("Amphastar" or the "Company") today reported results for the three months and full-year ended December 31, 2022. Fourth Quarter Highlights Net revenues of $135.0 million for the fourth quarter GAAP net income of $33.9 million, or $0.66 per share, for the fourth quarter Adjusted non-GAAP net income of $37.6 million, or $0.73 per share, for the fourth quarter Full-Year Highlights Net revenues of $499.0 million for the fiscal year GAAP net income of $91.4 million, or $1.74 per share, for the fiscal year Adjusted non-GAAP net income of $103.2 million, or $1.97 per share, for the fiscal year Dr. Jack Zhang, Amphastar's President and Chief Executive Officer, commented: "We are pleased to report our strongest quarter yet, driven by sales of epinephrine, Primatene MIST®, glucagon, and other finished pharmaceutical products. Looking ahead to 2023, we anticipate launching multiple new products to continue driving our growth." Three Months Ended Year Ended December 31, December 31, 2022 2021 2022 2021 (in thousands, except per share data) Net revenues $ 135,023 $ 120,887 $ 498,987 $ 437,768 GAAP net income attributable to Amphastar $ 33,913 $ 19,760 $ 91,386 $ 62,116 Adjusted non-GAAP net income attributable to Amphastar* $ 37,638 $ 20,833 $ 103,186 $ 67,999 GAAP diluted EPS attributable to Amphastar stockholders $ 0.66 $ 0.39 $ 1.74 $ 1.25 Adjusted non-GAAP diluted EPS attributable to Amphastar stockholders* $ 0.73 $ 0.42 $ 1.97 $ 1.37 * Adjusted non-GAAP net income attributable to Amphastar and Adjusted non-GAAP diluted EPS attributable to Amphastar stockholders 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. Fourth Quarter Results Three Months Ended December 31, Change 2022 2021 Dollars % (in thousands) Net revenues: Primatene MIST® $ 22,279 $ 21,489 $ 790 4 % Epinephrine 21,427 18,868 2,559 14 % Glucagon 18,319 15,335 2,984 19 % Lidocaine 13,286 12,099 1,187 10 % Phytonadione 11,666 13,921 (2,255 ) (16 )% Enoxaparin 7,812 7,942 (130 ) (2 )% Naloxone 4,845 6,546 (1,701 ) (26 )% Other finished pharmaceutical products 33,082 21,776 11,306 52 % Total finished pharmaceutical products net revenues $ 132,716 $ 117,976 $ 14,740 12 % API 2,307 2,911 (604 ) (21 )% Total net revenues $ 135,023 $ 120,887 $ 14,136 12 % Changes in net revenues as compared to fourth quarter in prior year were primarily driven by: Primatene MIST® sales increased primarily due to an increase in unit volumes Epinephrine sales increased by $1.8 million due to an increase in average selling price, with the remainder of the increase due to increased unit volumes as a result of competitor shortages Glucagon sales increased primarily due to an increase in unit volumes Phytonadione sales decreased due to decreased unit volumes Naloxone sales decreased primarily due to a lower average selling price Other finished pharmaceutical product sales changes were primarily due to: An increase in unit volumes for dextrose and sodium bicarbonate, which were in high demand due to competitor shortages Higher unit volumes of isoproterenol Launches of ganirelix and vasopressin, in June 2022 and August 2022, respectively Active Pharmaceutical ingredient ("API") sales decreased primarily due to the timing of customer purchases Three Months Ended December 31, Change 2022 2021 Dollars % (in thousands) Net revenues $ 135,023 $ 120,887 $ 14,136 12 % Cost of revenues 63,855 64,653 (798 ) (1 )% Gross profit $ 71,168 $ 56,234 $ 14,934 27 % as % of net revenues 53% 47% Changes in the cost of revenues and the resulting increase in gross margins were primarily driven by: Increased sales of higher-margin products such as Primatene MIST®, epinephrine, and glucagon, as well as the launches of ganirelix and vasopressin in 2022 These factors were partially offset by overall increases in labor and input costs Three Months Ended December 31, Change 2022 2021 Dollars % (in thousands) Selling, distribution, and marketing $ 5,472 $ 4,075 $ 1,397 34 % General and administrative 10,628 10,621 7 0 % Research and development 17,236 17,286 (50 ) 0 % Non-operating income (expense), net 3,428 2,910 518 18 % Selling, distribution, and marketing expenses increased primarily due to increased advertising and freight expenses Research and development expenses remained flat during the quarter as a result of a decrease in expenditure for materials and components, which was partially offset by an increase in clinical trial expense for our insulin and inhalation product pipeline The change in non-operating income, net is primarily a result of foreign currency gains Year-End Results Year Ended December 31, Change 2022 2021 Dollars % (in thousands) Net revenues: Primatene MIST® $ 84,309 $ 73,113 $ 11,196 15 % Epinephrine 74,204 57,530 16,674 29 % Glucagon 55,322 47,639 7,683 16 % Lidocaine 52,539 44,413 8,126 18 % Phytonadione 49,500 45,498 4,002 9 % Enoxaparin 34,950 35,962 (1,012 ) (3 )% Naloxone 26,269 27,540 (1,271 ) (5 )% Other finished pharmaceutical products 109,412 87,875 21,537 25 % Total finished pharmaceutical products net revenues $ 486,505 $ 419,570 $ 66,935 16 % API 12,482 18,198 (5,716 ) (31 )% Total net revenues $ 498,987 $ 437,768 $ 61,219 14 % Changes in net revenues were primarily driven by: Primatene MIST® sales increased primarily due to increased unit volumes, which was primarily a result of the continued success of our advertising campaign throughout the year Epinephrine sales increased primarily due to an increase in unit volumes, arising from high demand due to competitor shortages, contributing $9.0 million in sales, as well as a higher average selling price, which contributed $7.7 million to the increase in sales Glucagon sales increased due to an increase in unit volumes as the prior year period did not include a full year of sales due to glucagon's launch in the first quarter of 2021 Lidocaine sales increased due to an increase in unit volumes, which contributed $4.4 million, as well as a higher average selling price, which contributed $3.8 million to the increase in sales Phytonadione sales increased due to a higher average selling price Other finished pharmaceutical product sales changes were primarily due to: Higher unit volumes of calcium chloride, dextrose, and sodium bicarbonate, which were in high demand due to competitor shortages Launches of ganirelix and vasopressin in June 2022 and August 2022, respectively API sales decreased primarily due to the timing of customer purchases Year Ended December 31, Change 2022 2021 Dollars % (in thousands) Net revenues $ 498,987 $ 437,768 $ 61,219 14 % Cost of revenues 250,127 238,029 12,098 5 % Gross profit $ 248,860 $ 199,739 $ 49,121 25 % as % of net revenues 50% 46% Changes in the cost of revenues and the resulting increase in gross margins were primarily driven by: Increased sales of higher-margin products such as Primatene MIST®, epinephrine, and glucagon, as well as the launches of ganirelix and vasopressin in 2022 These factors were partially offset by overall increases in labor and input costs Year Ended December 31, Change 2022 2021 Dollars % (in thousands) Selling, distribution, and marketing $ 21,531 $ 17,486 $ 4,045 23 % General and administrative 45,061 51,434 (6,373 ) (12 )% Research and development 74,771 60,932 13,839 23 % Non-operating income (expense), net 8,543 14,252 (5,709 ) (40 )% Selling, distribution, and marketing expenses increased due to increased freight expense and advertising expense for Primatene MIST® General and administrative expenses decreased primarily due to a decrease in legal expenses and a decrease in expenses in China due to the restructuring of Amphastar's Chinese subsidiary, Amphastar Nanjing Pharmaceutical, Co., Ltd. ("ANP"), in 2021 Research and development expenses increased due to: Increases in expenditures for materials and components, primarily for our AMP-018 and insulin products candidates An increase in clinical trial expense primarily due to external studies related to our insulin and inhalation product pipeline This was partially offset by a decrease in expenses in China due to the completion of the restructuring of ANP in 2021 The change in non-operating income, net is primarily due to: $5.4 million litigation settlement received in January 2022 in connection with the Regadenoson patent litigation $13.6 million gain on the deconsolidation of Hanxin Pharmaceutical Technology Co., Ltd related to the ANP restructuring in 2021 Cash flow provided by operating activities for the year ended December 31, 2022 was $89.2 million. Pipeline Information The Company currently has three ANDAs on 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 $11 billion, and six generic products in development targeting products with a market size of over $9 billion. This market information is based on IQVIA data for the 12 months ended December 31, 2022. The Company is developing multiple proprietary products with injectable and intranasal dosage forms. Amphastar's Chinese subsidiary, ANP, currently has 17 Drug Master Files, or 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®, Primatene MIST®, 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) attributed to Amphastar and (ii) Adjusted non-GAAP diluted EPS attributed to Amphastar's stockholders, which exclude amortization expense, share-based compensation, impairment charges, 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, February 28, 2023, 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, five minutes before the conference. The call can also be accessed on the Investors page on the Company's website at . 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, backlog, sales and marketing of our products, market size and expansion, 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, our share buyback program, and other future events, such as the impact of the COVID-19 pandemic including its variants, the Russia-Ukraine conflict and resulting macroeconomic conditions, such as inflation and rising interest rates, and related responses of business and governments to the pandemic and international conflict on our operations and personnel, and on commercial activity and demand across our business operations and results of operations. 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, 2021, filed with the SEC on March 11, 2022, in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, filed with the SEC on May 10, 2022, in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, filed with the SEC on August 9, 2022, and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, filed with the SEC on November 7, 2022. In particular, the extent of COVID-19 including its variants, the Russia-Ukraine conflict and resulting macroeconomic conditions, such as inflation and rising interest rates, impacts on our business will depend on several factors, including the actions taken by governments, businesses, and consumers in response, which continues to evolve and remain uncertain at this time. 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) 980-9484 Table I Amphastar Pharmaceuticals, Inc. Condensed Consolidated Statement of Operations (Unaudited; in thousands, except per share data) Three Months Ended Year Ended December 31, December 31, 2022 2021 2022 2021 Net revenues $ 135,023 $ 120,887 $ 498,987 $ 437,768 Cost of revenues 63,855 64,653 250,127 238,029 Gross profit 71,168 56,234 248,860 199,739 Operating expenses: Selling, distribution, and marketing 5,472 4,075 21,531 17,486 General and administrative 10,628 10,621 45,061 51,434 Research and development 17,236 17,286 74,771 60,932 Total operating expenses 33,336 31,982 141,363 129,852 Income from operations 37,832 24,252 107,497 69,887 Non-operating income (expense), net 3,428 2,910 8,543 14,252 Income before income taxes 41,260 27,162 116,040 84,139 Income tax provision 7,290 7,194 23,477 20,630 Net income before equity in losses of unconsolidated affiliate 33,970 19,968 92,563 63,509 Equity in losses of unconsolidated affiliate (57 ) (208 ) (1,177 ) (208 ) Net income $ 33,913 $ 19,760 $ 91,386 $ 63,301 Net income attributable to non-controlling interests $ - $ - $ - $ 1,185 Net income attributable to Amphastar $ 33,913 $ 19,760 $ 91,386 $ 62,116 Net income per share attributable to Amphastar stockholders: Basic $ 0.70 $ 0.41 $ 1.88 $ 1.30 Diluted $ 0.66 $ 0.39 $ 1.74 $ 1.25 Weighted-average shares used to compute net income per share attributable to Amphastar stockholders: Basic 48,298 47,836 48,551 47,777 Diluted 51,716 50,057 52,427 49,784 Table II Amphastar Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets (Unaudited; in thousands, except share data) December 31, December 31, 2022 2021 ASSETS Current assets: Cash and cash equivalents $ 156,098 $ 126,353 Restricted cash 235 235 Short-term investments 19,664 10,320 Restricted short-term investments 2,200 2,200 Accounts receivable, net 88,804 78,804 Inventories 103,584 92,807 Income tax refunds and deposits 171 126 Prepaid expenses and other assets 7,563 7,274 Total current assets 378,319 318,119 Property, plant, and equipment, net 238,266 244,244 Finance lease right-of-use assets 753 353 Operating lease right-of-use assets 25,554 26,894 Investment in unconsolidated affiliate 2,414 3,985 Goodwill and intangible assets, net 37,298 38,870 Other assets 20,856 16,665 Deferred tax assets 38,527 22,399 Total assets $ 741,987 $ 671,529 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and accrued liabilities $ 84,242 $ 89,545 Income taxes payable 4,571 9,081 Current portion of long-term debt 3,046 2,202 Current portion of operating lease liabilities 3,003 2,982 Total current liabilities 94,862 103,810 Long-term reserve for income tax liabilities 7,225 6,531 Long-term debt, net of current portion and unamortized debt issuance costs 72,839 74,776 Long-term operating lease liabilities, net of current portion 23,694 24,703 Deferred tax liabilities 144 534 Other long-term liabilities 14,565 15,653 Total liabilities 213,329 226,007 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; 58,110,231 and 48,112,069 shares issued and outstanding as of December 31, 2022 and 56,440,202 and 47,714,912 shares issued and outstanding as of December 31, 2021, respectively 6 6 Additional paid-in capital 455,077 422,423 Retained earnings 271,723 180,337 Accumulated other comprehensive loss (8,624 ) (6,765 ) Treasury stock (189,524 ) (150,479 ) Total equity 528,658 445,522 Total liabilities and stockholders' equity $ 741,987 $ 671,529 Table III Amphastar Pharmaceuticals, Inc. Reconciliation of Non-GAAP Measures (Unaudited; in thousands, except per share data) Three Months Ended Year Ended December 31, December 31, 2022 2021 2022 2021 GAAP net income $ 33,913 $ 19,760 $ 91,386 $ 63,301 Adjusted for: Intangible amortization 331 360 1,419 1,290 Share-based compensation 4,304 3,850 17,860 18,687 Impairment of long-lived assets - 9 - 348 Gain on ANP Restructuring - - - (13,587 ) Reserves for litigation and settlements - (2,717 ) (4,929 ) 274 Income tax provision on pre-tax adjustments (910 ) (429 ) (2,550 ) (2,043 ) Non-GAAP net income $ 37,638 $ 20,833 $ 103,186 $ 68,270 Non-GAAP net income attributable to non-controlling interests $ - $ - $ - $ 271 Non-GAAP net income attributable to Amphastar $ 37,638 $ 20,833 $ 103,186 $ 67,999 Non-GAAP net income per share attributable to Amphastar stockholders: Basic $ 0.78 $ 0.44 $ 2.13 $ 1.42 Diluted $ 0.73 $ 0.42 $ 1.97 $ 1.37 Weighted-average shares used to compute non-GAAP net income per share attributable to Amphastar stockholders: Basic 48,298 47,836 48,551 47,777 Diluted 51,716 50,057 52,427 49,784 Three Months Ended December 31, 2022 Selling, General Research Non-operating Non-controlling Cost of distribution and and income Income interest revenue and marketing administrative development (expense), net tax provision adjustment GAAP $ 63,855 $ 5,472 $ 10,628 $ 17,236 $ 3,428 $ 7,290 $ - Intangible amortization (205 ) - (126 ) - - - - Share-based compensation (941 ) (186 ) (2,791 ) (386 ) - - - Income tax provision on pre-tax adjustments - - - - - 910 - Non-GAAP $ 62,709 $ 5,286 $ 7,711 $ 16,850 $ 3,428 $ 8,200 $ - Three Months Ended December 31, 2021 Selling, General Research Non-operating Non-controlling Cost of distribution and and income Income interest revenue and marketing administrative development (expense), net tax provision adjustment GAAP $ 64,653 $ 4,075 $ 10,621 $ 17,286 $ 2,910 $ 7,194 $ - Intangible amortization (235 ) - (125 ) - - - - Share-based compensation (811 ) (158 ) (2,553 ) (328 ) - - - Impairment of long-lived assets (9 ) - - - - - - Reserves for litigation and settlements - - - - (2,717 ) - - Income tax provision on pre-tax adjustments - - - - - 429 - Non-GAAP $ 63,598 $ 3,917 $ 7,943 $ 16,958 $ 193 $ 7,623 $ - Year Ended December 31, 2022 Selling, General Research Non-operating Non-controlling Cost of distribution and and income Income interest revenue and marketing administrative development (expense), net tax provision adjustment GAAP $ 250,127 $ 21,531 $ 45,061 $ 74,771 $ 8,543 $ 23,477 $ - Intangible amortization (865 ) - (554 ) - - - - Share-based compensation (4,179 ) (726 ) (11,180 ) (1,775 ) - - - Reserves for litigation and settlements - - (800 ) - (5,729 ) - - Income tax provision on pre-tax adjustments - - - - - 2,550 - Non-GAAP $ 245,083 $ 20,805 $ 32,527 $ 72,996 $ 2,814 $ 26,027 $ - Year Ended December 31, 2021 Selling, General Research Non-operating Non-controlling Cost of distribution and and income Income interest revenue and marketing administrative development (expense), net tax provision adjustment GAAP $ 238,029 $ 17,486 $ 51,434 $ 60,932 $ 14,252 $ 20,630 $ 1,185 Intangible amortization (963 ) - (327 ) - - - 26 Share-based compensation (3,778 ) (596 ) (12,622 ) (1,691 ) - - 870 Impairment of long-lived assets (93 ) - (33 ) (222 ) - - 7 Gain on ANP Restructuring - - - - (13,587 ) - (2,062 ) Reserves for litigation and settlements - - (1,295 ) - (1,021 ) - - Income tax provision on pre-tax adjustments - - - - - 2,043 245 Non-GAAP $ 233,195 $ 16,890 $ 37,157 $ 59,019 $ (356 ) $ 22,673 $ 271 SOURCE: Amphastar Pharmaceuticals, Inc. View source version on accesswire.com:

Reports Net Revenues of $123.5 Million for the Three Months Ended June 30, 2022 RANCHO CUCAMONGA, CA / ACCESSWIRE / August 8, 2022 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) ("Amphastar" or the "Company") today reported results for the three months ended June 30, 2022. Second Quarter Highlights Net revenues of $123.5 million for the second quarter GAAP net income of $17.3 million, or $0.33 per share, for the second quarter Adjusted non-GAAP net income of $20.7 million, or $0.39 per share, for the second quarter Dr. Jack Zhang, Amphastar's President and Chief Executive Officer, commented: "We've maintained momentum through the first half of 2022. Sales remained strong through the second quarter, allowing us to increase our investment in research and development. We are optimistic that sales will continue their upward trajectory into the third quarter, particularly with ganirelix's full quarter of sales and the upcoming launch of vasopressin this month, each of which presents new opportunities for further diversification of our revenue streams." Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 (in thousands, except per share data) Net revenues $ 123,467 $ 101,663 $ 243,835 $ 204,683 GAAP net income attributable to Amphastar $ 17,346 $ 7,767 $ 41,599 $ 12,808 Adjusted non-GAAP net income attributable to Amphastar* $ 20,730 $ 10,615 $ 45,316 $ 24,168 GAAP diluted EPS attributable to Amphastar stockholders $ 0.33 $ 0.16 $ 0.79 $ 0.26 Adjusted non-GAAP diluted EPS attributable to Amphastar stockholders* $ 0.39 $ 0.21 $ 0.86 $ 0.49 * Adjusted non-GAAP net income attributable to Amphastar and Adjusted non-GAAP diluted EPS attributable to Amphastar stockholders 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. Second Quarter Results Three Months Ended June 30, Change 2022 2021 Dollars % (in thousands) Net revenues: Primatene Mist® $ 18,974 $ 16,680 $ 2,294 14 % Epinephrine 18,119 9,192 8,927 97 % Lidocaine 16,042 11,594 4,448 38 % Phytonadione 13,381 10,421 2,960 28 % Glucagon 11,795 12,131 (336 ) (3 )% Enoxaparin 9,031 9,328 (297 ) (3 )% Naloxone 7,193 6,625 568 9 % Other finished pharmaceutical products 25,588 18,751 6,837 36 % Total finished pharmaceutical products net revenues $ 120,123 $ 94,722 $ 25,401 27 % API 3,344 6,941 (3,597 ) (52 )% Total net revenues $ 123,467 $ 101,663 $ 21,804 21 % Changes in net revenues were primarily driven by: Primatene Mist® sales increased due to an increase in unit volumes as a result of the continued success of our advertising campaign Epinephrine sales increased due to an increase in unit volumes as a result of competitor shortages Lidocaine sales increased as a result of an increase in unit volumes Phytonadione sales increased due to an increase in unit volumes and higher average selling price Other finished pharmaceutical product sales increased due to higher demand for certain products such as dextrose and sodium bicarbonate, largely resulting from competitor shortages, as well as the launch of ganirelix prefilled syringe in late June 2022 API sales decreased due to the timing of orders from MannKind Corporation Three Months Ended June 30, Change 2022 2021 Dollars % (in thousands) Net revenues $ 123,467 101,663 $ 21,804 21 % Cost of revenues 60,111 54,287 5,824 11 % Gross profit $ 63,356 47,376 $ 15,980 34 % as % of net revenues 51 % 47 % Changes in the cost of revenues and the resulting increase in gross margin were primarily driven by: Increased sales of higher-margin products such as Primatene Mist® Decreased in heparin and enoxaparin component purchase commitments since these components are reserved to the lower of cost or net realizable value at the time of commitment These factors were partially offset by an overall increases in labor costs, as well as increased costs for heparin, the starting material for enoxaparin, and a lower average selling price for enoxaparin Three Months Ended June 30, Change 2022 2021 Dollars % (in thousands) Selling, distribution, and marketing $ 5,756 $ 4,129 $ 1,627 39 % General and administrative 9,979 14,565 (4,586 ) (31 )% Research and development 22,798 18,122 4,676 26 % Non-operating income (expense), net (1,672 ) 3,657 (5,329 ) (146 )% Selling, distribution, and marketing expenses increased primarily due to increased advertising and freight expenses General and administrative expenses decreased primarily due to a decrease in legal expenses and a decrease in expenses in China due to the restructuring of our subsidiary, Amphastar Nanjing Pharmaceuticals, Co., Ltd. ("ANP"), in 2021 Research and development expenses increased due to: An increase in expenditure for materials and components, primarily for our AMP-018 and insulin products This increase was partially offset by a decrease in clinical trial expense as a result of a shift in timing for some of our clinical trial studies, as well as a decrease in expenses in China due to the restructuring of ANP in 2021 The change in non-operating income (expense) net is primarily a result of: Foreign currency fluctuations in 2022 A final settlement with Aventis in June 2021 which resulted in the reduction of accrued expense by $2.7 million Cash flow provided by operating activities for the six months ended June 30, 2022 was $53.6 million. Pipeline Information The Company currently has three ANDAs on 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 $12 billion, and eight generic products in development targeting products with a market size of over $9 billion. This market information is based on IQVIA data for the 12 months ended June 30, 2022. The Company is developing multiple proprietary products with injectable and intranasal dosage forms. Amphastar's Chinese subsidiary, ANP, currently has 17 Drug Master Files, or 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®, Primatene Mist®, 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) attributed to Amphastar and (ii) Adjusted non-GAAP diluted EPS attributed to Amphastar's stockholders, which exclude amortization expense, share-based compensation, impairment charges, 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, August 8, 2022, 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, five minutes before the conference. The call can also be accessed on the Investors page on the Company's website at . 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, backlog, sales and marketing of our products, market size and growth, 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, our share buyback program, and other future events, such as the impact of the COVID-19 pandemic including its variants, the Russia-Ukraine conflict and resulting macroeconomic conditions, such as inflation and rising interest rates, and related responses of business and governments to the pandemic on our operations and personnel, and on commercial activity and demand across our business operations and results of operations. 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, 2021, filed with the SEC on March 11, 2022 and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, filed with the SEC on May 10, 2022. In particular, the extent of COVID-19's impact on our business will depend on several factors, including the severity, duration and extent of the pandemic including its variants, as well as actions taken by governments, businesses, and consumers in response to the pandemic, all of which continue to evolve and remain uncertain at this time. 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) 980-9484 Table I Amphastar Pharmaceuticals, Inc. Condensed Consolidated Statement of Operations (Unaudited; in thousands, except per share data) Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Net revenues $ 123,467 $ 101,663 $ 243,835 $ 204,683 Cost of revenues 60,111 54,287 124,653 112,361 Gross profit 63,356 47,376 119,182 92,322 Operating expenses: Selling, distribution, and marketing 5,756 4,129 11,275 8,666 General and administrative 9,979 14,565 22,449 29,903 Research and development 22,798 18,122 39,021 32,887 Total operating expenses 38,533 36,816 72,745 71,456 Income from operations 24,823 10,560 46,437 20,866 Non-operating income (expenses), net (1,672 ) 3,657 5,747 (1,535 ) Income before income taxes 23,151 14,217 52,184 19,331 Income tax provision 5,551 5,595 9,628 6,750 Net income before equity in losses of unconsolidated affiliate 17,600 8,622 42,556 12,581 Equity in losses of unconsolidated affiliate (254 ) - (957 ) - Net income $ 17,346 $ 8,622 $ 41,599 $ 12,581 Net income (loss) attributable to non-controlling interests $ - $ 855 $ - $ (227 ) Net income attributable to Amphastar $ 17,346 $ 7,767 $ 41,599 $ 12,808 Net income per share attributable to Amphastar stockholders: Basic $ 0.35 $ 0.16 $ 0.86 $ 0.27 Diluted $ 0.33 $ 0.16 $ 0.79 $ 0.26 Weighted-average shares used to compute net income per share attributable to Amphastar stockholders: Basic 48,864 47,731 48,501 47,626 Diluted 53,227 49,552 52,603 49,535 Table II Amphastar Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets (Unaudited; in thousands, except share data) June 30, December 31, 2022 2021 ASSETS Current assets: Cash and cash equivalents $ 166,157 $ 126,353 Restricted cash 235 235 Short-term investments 17,234 10,320 Restricted short-term investments 2,200 2,200 Accounts receivable, net 80,810 78,804 Inventories 98,733 92,807 Income tax refunds and deposits 5,878 126 Prepaid expenses and other assets 5,898 7,274 Total current assets 377,145 318,119 Property, plant, and equipment, net 237,564 244,244 Finance lease right-of-use assets 201 353 Operating lease right-of-use assets 26,962 26,894 Investment in unconsolidated affiliate 3,065 3,985 Goodwill and intangible assets, net 37,700 38,870 Other assets 18,683 16,665 Deferred tax assets 22,399 22,399 Total assets $ 723,719 $ 671,529 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and accrued liabilities $ 97,665 $ 89,545 Income taxes payable 597 9,081 Current portion of long-term debt 2,057 2,202 Current portion of operating lease liabilities 3,315 2,982 Total current liabilities 103,634 103,810 Long-term reserve for income tax liabilities 6,531 6,531 Long-term debt, net of current portion and unamortized debt issuance costs 73,871 74,776 Long-term operating lease liabilities, net of current portion 24,680 24,703 Deferred tax liabilities 364 534 Other long-term liabilities 15,332 15,653 Total liabilities 224,412 226,007 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; 57,896,337 and 48,992,289 shares issued and outstanding as of June 30, 2022 and 56,440,202 and 47,714,912 shares issued and outstanding as of December 31, 2021, respectively 6 6 Additional paid-in capital 443,042 422,423 Retained earnings 221,936 180,337 Accumulated other comprehensive loss (8,709 ) (6,765 ) Treasury stock (156,968 ) (150,479 ) Total equity 499,307 445,522 Total liabilities and stockholders' equity $ 723,719 $ 671,529 Table III Amphastar Pharmaceuticals, Inc. Reconciliation of Non-GAAP Measures (Unaudited; in thousands, except per share data) Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 GAAP net income $ 17,346 $ 8,622 $ 41,599 $ 12,581 Adjusted for: Intangible amortization 344 277 696 553 Share-based compensation 4,235 6,084 9,257 10,918 Impairment of long-lived assets - 308 - 314 Reserves for litigation and settlements (383 ) (2,704 ) (5,729 ) 2,991 Income tax provision on pre-tax adjustments (812 ) (306 ) (507 ) (2,535 ) Non-GAAP net income $ 20,730 $ 12,281 $ 45,316 $ 24,822 Non-GAAP net loss attributable to non-controlling interests $ - $ 1,666 $ - $ 654 Non-GAAP net income attributable to Amphastar $ 20,730 $ 10,615 $ 45,316 $ 24,168 Non-GAAP net income per share attributable to Amphastar stockholders: Basic $ 0.42 $ 0.22 $ 0.93 $ 0.51 Diluted $ 0.39 $ 0.21 $ 0.86 $ 0.49 Weighted-average shares used to compute non-GAAP net income per share attributable to Amphastar stockholders: Basic 48,864 47,731 48,501 47,626 Diluted 53,227 49,552 52,603 49,535 Three Months Ended June 30, 2022 Selling, General Research Non-operating Non-controlling Cost of distribution and and income Income interest revenue and marketing administrative development (expense), net tax provision adjustment GAAP $ 60,111 $ 5,756 $ 9,979 $ 22,798 $ (1,672 ) $ 5,551 $ - Intangible amortization (219 ) - (125 ) - - - - Share-based compensation (938 ) (194 ) (2,718 ) (385 ) - - - Reserves for litigation and settlements - - - - (383 ) - - Income tax provision on pre-tax adjustments - - - - - 812 - Non-GAAP $ 58,954 $ 5,562 $ 7,136 $ 22,413 $ (2,055 ) $ 6,363 $ - Three Months Ended June 30, 2021 Selling, General Research Non-operating Non-controlling Cost of distribution and and income Income interest revenue and marketing administrative development (expense), net tax provision adjustment GAAP $ 54,287 $ 4,129 $ 14,565 $ 18,122 $ 3,657 $ 5,595 $ 855 Intangible amortization (244 ) - (33 ) - - - 11 Share-based compensation (932 ) (147 ) (4,568 ) (437 ) - - 791 Impairment of long-lived assets (84 ) - (2 ) (222 ) - - 1 Reserves for litigation and settlements - - - - (2,704 ) - - Income tax provision on pre-tax adjustments - - - - - 306 8 Non-GAAP $ 53,027 $ 3,982 $ 9,962 $ 17,463 $ 953 $ 5,901 $ 1,666 Six Months Ended June 30, 2022 Selling, General Research Non-operating Non-controlling Cost of distribution and and income Income interest revenue and marketing administrative development (expense), net tax provision adjustment GAAP $ 124,653 $ 11,275 $ 22,449 $ 39,021 $ 5,747 $ 9,628 $ - Intangible amortization (454 ) - (242 ) - - - - Share-based compensation (2,323 ) (362 ) (5,579 ) (993 ) - - - Reserves for litigation and settlements - - - - (5,729 ) - - Income tax provision on pre-tax adjustments - - - - - 507 - Non-GAAP $ 121,876 $ 10,913 $ 16,628 $ 38,028 $ 18 $ 10,135 $ - Six Months Ended June 30, 2021 Selling, General Research Non-operating Non-controlling Cost of distribution and and income Income interest revenue and marketing administrative development (expense), net tax provision adjustment GAAP $ 112,361 $ 8,666 $ 29,903 $ 32,887 $ (1,535 ) $ 6,750 $ (227 ) Intangible amortization (486 ) - (67 ) - - - 22 Share-based compensation (2,078 ) (274 ) (7,536 ) (1,030 ) - - 862 Impairment of long-lived assets (84 ) - (8 ) (222 ) - - 3 Reserves for litigation and settlements - - (1,295 ) - 1,696 - - Income tax provision on pre-tax adjustments - - - - - 2,535 (6 ) Non-GAAP $ 109,713 $ 8,392 $ 20,997 $ 31,635 $ 161 $ 9,285 $ 654 SOURCE: Amphastar Pharmaceuticals, Inc. View source version on accesswire.com: