Calcium Chloride Hydrate

GLENDALE HEIGHTS, Ill.--( BUSINESS WIRE )--Medefil, Inc., a domestic manufacturer of injectable products, has announced availability of its FDA-approved ANDA products, Atropine Sulfate Injection, USP, 1 mg per 10 mL (0.1 mg/mL), and 10% Calcium Chloride Injection, USP, 1000 mg per 10 mL (100 mg/mL). Both are offered in a single-dose prefilled syringe. These products are currently listed on the FDA drug shortage list and are available immediately for purchase from Medefil through national wholesalers. Atropine Sulfate Injection, USP, is used for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest. 10% Calcium Chloride Injection, USP is used for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels. “ Medefil is proud to supply two prefilled syringe products that have been approved by the FDA in a ready-to-administer format, critical for emergency situations,” said Pradeep Aggarwal, CEO & President of Medefil, Inc. “ We look forward to growing our injectables portfolio while maintaining our reputation as a consistent and reliable supplier of US developed and manufactured products.” For complete prescribing information and risks, please see the following link for Atropine Sulfate Injection, USP, and the following link for 10% Calcium Chloride Injection, USP. About Medefil, Inc. Medefil is a fully integrated specialty pharmaceutical company that develops, manufactures, and markets flush syringes and injectable drug products. The Company manufactures all products at its fully automated state-of-the-art facility in Glendale Heights, Illinois. Developing and manufacturing products at the highest quality levels with a reliable supply while ensuring safety for patients and ease-of use for providers is our key mission. For more information about Medefil, Inc. and our products, please visit https://www.medefilinc.com

Reports Net Revenues of $145.7 Million for the Three Months Ended June 30, 2023 RANCHO CUCAMONGA, CA / ACCESSWIRE / August 8, 2023 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) ("Amphastar" or the "Company") today reported results for the three months ended June 30, 2023. Second Quarter Highlights Net revenues of $145.7 million for the second quarter GAAP net income of $26.1 million, or $0.49 per share, for the second quarter Adjusted non-GAAP net income of $34.8 million, or $0.65 per share, for the second quarter Dr. Jack Zhang, Amphastar's President and Chief Executive Officer, commented: "We are pleased with the second quarter's results, which are partially attributable to glucagon and phytonadione delivering strong sales growth along with sales from newer products such as regadenoson, ganirelix and vasopressin adding another layer of strength. Additionally, with the completion of our strategic acquisition of BAQSIMI® on June 30, we increased our proprietary products sales pro continue to execute our strategic vision of advancing the Company with a durable portfolio of branded, biosimilar, and complex products." Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands, except per share data) Net revenues $ 145,712 $ 123,467 $ 285,734 $ 243,835 GAAP net income $ 26,124 $ 17,346 $ 52,156 $ 41,599 Adjusted non-GAAP net income* $ 34,782 $ 20,730 $ 66,925 $ 45,316 GAAP diluted EPS $ 0.49 $ 0.33 $ 0.99 $ 0.79 Adjusted non-GAAP diluted EPS* $ 0.65 $ 0.39 $ 1.27 $ 0.86 * 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. Second Quarter Results Three Months Ended June 30, Change 2023 2022 Dollars % (in thousands) Net revenues: Glucagon $ 27,276 $ 11,795 $ 15,481 131 % Phytonadione 17,855 13,381 4,474 33 % Epinephrine 16,714 18,119 (1,405 ) (8 )% Primatene MIST® 16,520 18,974 (2,454 ) (13 )% Lidocaine 14,006 16,042 (2,036 ) (13 )% Enoxaparin 7,872 9,031 (1,159 ) (13 )% Naloxone 5,102 7,193 (2,091 ) (29 )% Other finished pharmaceutical products 37,521 25,588 11,933 47 % Total finished pharmaceutical products net revenues $ 142,866 $ 120,123 $ 22,743 19 % API 2,846 3,344 (498 ) (15 )% Total net revenues $ 145,712 $ 123,467 $ 22,245 18 % Changes in net revenues as compared to the second 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 suppliers discontinuing their glucagon injection products at the end of 2022 Phytonadione sales increased due to increased unit volumes, as a result of supplier shortages Primatene MIST® sales decreased due to a decrease in unit volumes, as a result of inventory drawdowns by retailers The decrease in sales of epinephrine and lidocaine was primarily due to a decrease in unit volumes, as a result of suppliers returning to their historical distribution levels The decrease in sales of enoxaparin and naloxone was primarily due to a decrease in unit volumes Other finished pharmaceutical product sales increased primarily due to: An increase in unit volumes for dextrose, atropine, calcium chloride, and sodium bicarbonate, due to increasing demand caused by supplier shortages A full quarter of sales for ganirelix and vasopressin, which were launched in June 2022 and August 2022, respectively Launch of regadenoson in April 2023 Active Pharmaceutical ingredient ("API") sales increased primarily due to the timing of customer purchases Three Months Ended June 30, Change 2023 2022 Dollars % (in thousands) Net revenues $ 145,712 $ 123,467 $ 22,245 18 % Cost of revenues 72,974 60,111 12,863 21 % Gross profit $ 72,738 $ 63,356 $ 9,382 15 % as % of net revenues 50 % 51 % Changes in the cost of revenues and gross margin were primarily driven by: Increased sales of higher-margin products such as glucagon and epinephrine, the sales of ganirelix and vasopressin that were launched in 2022, as well as the sales of regadenoson, which we launched in April 2023 These factors were partially offset by an impairment charge of $2.7 million related to the impairment of the IMS (UK) international product rights, as well as charges included in cost of revenue to adjust our inventory and related purchase commitments to their net realizable value Three Months Ended June 30, Change 2023 2022 Dollars % (in thousands) Selling, distribution, and marketing $ 6,718 $ 5,756 $ 962 17 % General and administrative 12,281 9,979 2,302 23 % Research and development 16,843 22,798 (5,955 ) (26 )% Non-operating income (expense), net (4,088 ) (1,672 ) (2,416 ) 144 % Selling, distribution, and marketing expenses increased primarily due to increased advertising expenses for Primatene MIST® General and administrative expenses increased primarily due to an increase in salary and personnel-related expenses, as well as costs related to the acquisition of BAQSIMI® Research and development expenses decreased due to: Decreases in materials and supply expense, as a result of a ramp-up of expenses in 2022 for AMP-018 and our insulin pipeline products This decrease was partially offset by an increase in salary and personnel-related expenses and an increase in clinical trial expenses related to our insulin and inhalation product pipeline The change in non-operating income (expense), net is primarily a result of: Foreign currency fluctuations Mark-to-market adjustments relating to our interest rate swap contracts Costs incurred in connection with the syndicated credit agreement we entered into with Wells Fargo Bank, as syndication agent, to finance the acquisition of BAQSIMI® Cash flow provided by operating activities for the six months ended June 30, 2023 was $95.3 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 June 30, 2023. 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®, BAQSIMI®, 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) and (ii) Adjusted non-GAAP diluted EPS, 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, 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, ten 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, 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 acquisition of BAQSIMI®, 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, 2022, filed with the SEC on March 1, 2023 and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, filed with the SEC on May 9, 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 of BAQSIMI® 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 the acquisition 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 Six Months Ended June 30, June 30, 2023 2022 2023 2022 Net revenues $ 145,712 $ 123,467 $ 285,734 $ 243,835 Cost of revenues 72,974 60,111 139,156 124,653 Gross profit 72,738 63,356 146,578 119,182 Operating expenses: Selling, distribution, and marketing 6,718 5,756 13,827 11,275 General and administrative 12,281 9,979 25,764 22,449 Research and development 16,843 22,798 36,658 39,021 Total operating expenses 35,842 38,533 76,249 72,745 Income from operations 36,896 24,823 70,329 46,437 Non-operating income (expenses), net (4,088 ) (1,672 ) (3,952 ) 5,747 Income before income taxes 32,808 23,151 66,377 52,184 Income tax provision 6,383 5,551 13,135 9,628 Net income before equity in losses of unconsolidated affiliate 26,425 17,600 53,242 42,556 Equity in losses of unconsolidated affiliate (301 ) (254 ) (1,086 ) (957 ) Net income $ 26,124 $ 17,346 $ 52,156 $ 41,599 Net income per share: Basic $ 0.54 $ 0.35 $ 1.08 $ 0.86 Diluted $ 0.49 $ 0.33 $ 0.99 $ 0.79 Weighted-average shares used to compute net income per share: Basic 48,404 48,864 48,202 48,501 Diluted 53,102 53,227 52,536 52,603 Table II Amphastar Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets (Unaudited; in thousands, except share data) June 30, December 31, 2023 2022 (unaudited) ASSETS Current assets: Cash and cash equivalents $ 148,595 $ 156,098 Restricted cash 2,685 235 Short-term investments 14,541 19,664 Restricted short-term investments 2,200 2,200 Accounts receivable, net 104,715 88,804 Inventories 104,617 103,584 Income tax refunds and deposits 1,329 171 Prepaid expenses and other assets 5,872 7,563 Total current assets 384,554 378,319 Property, plant, and equipment, net 278,526 238,266 Finance lease right-of-use assets 657 753 Operating lease right-of-use assets 26,327 25,554 Investment in unconsolidated affiliate 1,462 2,414 Goodwill and intangible assets, net 625,603 37,298 Other assets 20,269 20,856 Deferred tax assets 40,868 38,527 Total assets $ 1,378,266 $ 741,987 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and accrued liabilities $ 217,536 $ 84,242 Income taxes payable 17,696 4,571 Current portion of long-term debt 12,920 3,046 Current portion of operating lease liabilities 3,133 3,003 Total current liabilities 251,285 94,862 Long-term reserve for income tax liabilities 7,225 7,225 Long-term debt, net of current portion and unamortized debt issuance costs 488,280 72,839 Long-term operating lease liabilities, net of current portion 24,407 23,694 Deferred tax liabilities 201 144 Other long-term liabilities 17,633 14,565 Total liabilities 789,031 213,329 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; 59,068,477 and 48,818,806 shares issued and outstanding as of June 30, 2023 and 58,110,231 and 48,112,069 shares issued and outstanding as of December 31, 2022, respectively 6 6 Additional paid-in capital 471,110 455,077 Retained earnings 323,880 271,723 Accumulated other comprehensive loss (8,324 ) (8,624 ) Treasury stock (197,437 ) (189,524 ) Total equity 589,235 528,658 Total liabilities and stockholders' equity $ 1,378,266 $ 741,987 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, 2023 2022 2023 2022 GAAP net income $ 26,124 $ 17,346 $ 52,156 $ 41,599 Adjusted for: Intangible amortization 242 344 483 696 Share-based compensation 4,865 4,235 10,976 9,257 Impairment of long-lived assets 2,700 - 2,700 - Expenses related to BAQSIMI® acquisition 3,307 - 4,524 - Litigation settlements - (383 ) - (5,729 ) Income tax provision on pre-tax adjustments (2,456 ) (812 ) (3,914 ) (507 ) Non-GAAP net income $ 34,782 $ 20,730 $ 66,925 $ 45,316 Non-GAAP net income per share: Basic $ 0.72 $ 0.42 $ 1.39 $ 0.93 Diluted $ 0.65 $ 0.39 $ 1.27 $ 0.86 Weighted-average shares used to compute non-GAAP net income per share: Basic 48,404 48,864 48,202 48,501 Diluted 53,102 53,227 52,536 52,603 Three Months Ended June 30, 2023 Selling, General Research Non-operating Income Cost of distribution and and income tax revenue and marketing administrative development (expense), net provision GAAP $ 72,974 $ 6,718 $ 12,281 $ 16,843 $ (4,088 ) $ 6,383 Intangible amortization (222 ) - (20 ) - - - Share-based compensation (1,158 ) (227 ) (2,991 ) (489 ) - - Impairment of long-lived assets (2,700 ) - - - - - Expenses related to BAQSIMI® acquisition - - (283 ) - (3,024 ) - Income tax provision on pre-tax adjustments - - - - - 2,456 Non-GAAP $ 68,894 $ 6,491 $ 8,987 $ 16,354 $ (7,112 ) $ 8,839 Three Months Ended June 30, 2022 Selling, General Research Non-operating Income Cost of distribution and and income tax revenue and marketing administrative development (expense), net provision 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 ) - - Litigation settlements - - - - (383 ) - Income tax provision on pre-tax adjustments - - - - - 812 Non-GAAP $ 58,954 $ 5,562 $ 7,136 $ 22,413 $ (2,055 ) $ 6,363 Six Months Ended June 30, 2023 Selling, General Research Non-operating Income Cost of distribution and and income tax revenue and marketing administrative development (expense), net provision GAAP $ 139,156 $ 13,827 $ 25,764 $ 36,658 $ (3,952 ) $ 13,135 Intangible amortization (433 ) - (50 ) - - - Share-based compensation (2,864 ) (436 ) (6,348 ) (1,328 ) - - Impairment of long-lived assets (2,700 ) - - - - - Expenses related to BAQSIMI® acquisition - - (1,500 ) - (3,024 ) - Income tax provision on pre-tax adjustments - - - - - 3,914 Non-GAAP $ 133,159 $ 13,391 $ 17,866 $ 35,330 $ (6,976 ) $ 17,049 Six Months Ended June 30, 2022 Selling, General Research Non-operating Income Cost of distribution and and income tax revenue and marketing administrative development (expense), net provision 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 ) - - Litigation settlements - - - (5,729 ) - Income tax provision on pre-tax adjustments - - - - - 507 Non-GAAP $ 121,876 $ 10,913 $ 16,628 $ 38,028 $ 18 $ 10,135 SOURCE: Amphastar Pharmaceuticals, Inc. 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