Nebivolol hydrochloride

Third Quarter 2023 Financial Results -- Record quarterly net revenues of $131.8 million, representing year-over-year growth of 57.3%; net income available to common shareholders of $9.5 million and diluted GAAP income per share of $0.45 -- -- Record quarterly adjusted non-GAAP EBITDA of $36.5 million representing year-over-year growth of 98.3%; adjusted non-GAAP diluted earnings per share of $1.27 -- -- Lead Rare Disease asset, Purified Cortrophin® Gel (Repository Corticotrophin Injection USP) 80 U/ml (Cortrophin Gel) reported net sales of $29.7 million, a year-over-year increase of 135.9% -- -- Generics, Established Brands and Other reported net sales of $102.1 million, representing year-over-year growth of 43.4% -- Full Year 2023 Guidance -- Company raises guidance: net revenue to $468 million to $478 million from $425 million to $445 million; adjusted non-GAAP EBITDA to $128 million to $133 million from $115 million to $125 million; adjusted non-GAAP earnings per share to $4.29 to $4.57 from $3.62 to $4.11-- -- Company is raising Cortrophin Gel specific revenue guidance to $100 million to $107 million from $90 million to $100 million, representing 139.9% to 156.7% growth as compared to $41.7 million recognized in 2022 -- -- Mid-point of revised total Company guidance represents year-over-year growth in net revenues of 49.5%, adjusted non-GAAP EBITDA of 133.6%, and adjusted non-GAAP earnings per diluted share of 225.7% -- Company Highlights -- Continued strong momentum for Cortrophin Gel; record number of new patient starts and new cases initiated in the third quarter of 2023; ACTH market posted six consecutive quarters of year-over-year growth according to IQVIA -- -- Continued increase in new unique prescribers, including growth with prescribers who are naive to ACTH therapy; ongoing strength in targeted specialties of neurology, nephrology, rheumatology and continued gains in pulmonology -- -- Announced FDA approval and commercial availability of new 1-mL vial size of Cortrophin Gel, the only approved purified corticotrophin indicated for the treatment of acute gouty arthritis flares; received specific J-Code to support physician administration of 1 ml vial -- -- Company’s Generics and Established Brands businesses continued to respond to pharmaceutical shortages arising from supply-chain disruptions by leveraging the Company’s operational excellence and U.S.-based manufacturing footprint; softening seen with specific market opportunities that persisted in prior quarters -- -- Company’s strong R&D organization delivered five new product launches and filed three new ANDAs and two new 505(b)(2) applications in the quarter; retained number two ranking in Competitive Generic Therapy (CGT) approvals -- -- Generated $74.2 million in cash from operating activities (year-to-date), ending Q3 with $193.1 million in cash -- BAUDETTE, Minn., Nov. 08, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced business highlights and financial results for the three months ended September 30, 2023. Nikhil Lalwani, President and CEO of ANI stated, “Strong execution has resulted in another record quarter for revenue and adjusted non-GAAP EBITDA, positioning us to raise full year 2023 guidance for the third consecutive quarter. Launch momentum of our lead Rare Disease asset, Purified Cortrophin Gel, continues to accelerate, with record quarterly new cases initiated and new patient starts, and increasing momentum with new unique prescribers, including many prescribers who were naive to ACTH therapy. In addition, the Company has received positive initial physician response in our new areas of pulmonology and acute gouty arthritis. We remain committed to increasing the scope and scale of our Rare Disease portfolio and believe that the strength of our financial results and cash flow position us well for targeted M&A and in-licensing.” “Our Generics and Established Brands businesses also performed well, delivering record quarterly revenues, and we continued to leverage our operational excellence and U.S.-based manufacturing footprint to serve patients facing pharmaceutical shortages due to supply chain disruptions. While we see softening of specific market opportunities that persisted in prior quarters, we believe we are poised to capitalize on current and future opportunities as a partner of choice for our customers. Our strong R&D capabilities were further demonstrated through the launch of five new products as well as the filing of three ANDAs and two 505(b)2 applications during the quarter. As we approach the end of 2023, I believe that our efforts during the year have created a strong foundation for continued success and fulfilling our purpose of Serving Patients, Improving Lives,” concluded Lalwani. Third Quarter 2023 Financial Highlights: Net revenues were $131.8 million compared to $83.8 million in Q3 2022.GAAP net income available to common shareholders was $9.5 million, and diluted GAAP income per share was $0.45.Adjusted non-GAAP EBITDA was $36.5 million compared to $18.4 million in Q3 2022.Adjusted non-GAAP diluted earnings per share was $1.27, compared to diluted earnings per share of $0.58 in Q3 2022.Cash and cash equivalents were $193.1 million with year-to-date (nine month) cash flow from operations of $74.2 million. Third Quarter and Recent Business Highlights: Rare Disease Business Update Revenues for our lead asset, Cortrophin Gel, totaled $29.7 million for the third quarter of 2023, an increase of 135.9% over the same period in 2022, driven by increased volume in this second year of launch. During the quarter, the Company achieved a record number of new cases initiated and new patient starts, and a continued increase in the number of new unique and repeat prescribers. Many of the new unique prescribers were naive to ACTH therapy. We believe the Company’s efforts to increase effectiveness of the field sales force and improve awareness of ACTH therapy for appropriate patients have yielded results. Since the launch of Cortrophin Gel, the overall ACTH category has experienced six consecutive quarters of year-over-year growth from second quarter 2022 to third quarter 2023. Growth continued across both the initially targeted specialties of neurology, rheumatology, and nephrology, and two new areas. The Company saw positive physician response and momentum in pulmonology, a focus area that was initiated in the second quarter of 2023. The Company also announced the FDA approval and commercial availability of a 1-mL vial size of Purified Cortrophin® Gel for adjunctive treatment of certain patients with acute gouty arthritis flares. Recently, the Company received a specific J-Code for Cortrophin to support physician administration of the 1 ml vial. The commercial launch of the 1 ml vial is supported by ANI’s existing field sales force. The Company is raising its 2023 revenue guidance for Cortrophin Gel to $100 million to $107 million, representing 139.9% - 156.7% year-over-year growth. We continue to believe that Rare Disease remains ANI’s largest future growth driver, and the Company is actively exploring opportunities to acquire assets and/or establish partnerships to increase the scope and scale of its Rare Disease platform. Generics Business, Established Brands and Other Update Sales of generic pharmaceuticals products, established brands and other grew 43.4% year-over-year in the third quarter of 2023. We believe that the Company’s generics business is well positioned for delivering sustainable growth, driven by a strong R&D organization launching new products, cost competitiveness and supply reliability. During the quarter, ANI launched five products, including Colestipol Hydrochloride Tablets, Estradiol Gel, 0.1% and Thyroid Tablets, USP, filed five new ANDAs and two 505(b)2 applications, while maintaining its number two ranking in Competitive Generic Therapy approvals. ANI continued to leverage its operational excellence and U.S.-based manufacturing during the quarter to take advantage of certain opportunities arising from supply disruptions in both generics and established brands. Recently, certain of these market conditions changed, and as a result, we expect fourth quarter 2023 demand and resultant revenues for certain generic and established brand products to be significantly lower as compared to the rate achieved during the first nine months of 2023. We remain well positioned to take advantage of current and future opportunities when they arise. In fact, to support the ongoing growth of the Generics, Established Brands and Other business segment, the Company has invested in expanding the manufacturing footprint and capacities at its New Jersey facility and expects these to be operational by early 2024. Third Quarter 2023 Financial Results Three Months Ended September 30, (in thousands) 2023 2022 Change % ChangeGenerics, Established Brands, and Other Segment Generic pharmaceutical products $70,593 $53,136 $17,457 32.9%Established brand pharmaceutical products, royalties, and other pharmaceutical services 31,502 18,083 13,419 74.2%Generics, established brands, and other segment total net revenues $102,095 $71,219 $30,876 43.4%Rare Disease Segment Rare disease pharmaceutical products 29,734 12,602 17,132 135.9%Total net revenues $131,829 $83,821 $48,008 57.3% Net revenues for generic pharmaceutical products were $70.6 million during the three months ended September 30, 2023, an increase of 32.9% compared to $53.1 million for the same period in 2022, driven by increased volumes on the base business and the inclusion of 2022 launches and new product launches in 2023. From a product perspective, the increase was principally driven by revenues from year over year increases in products such as Colestipol, Famotidine, Mixed Amphetamine Salts Extended Release, Nitrofurantoin, Thyroid and various other products tempered by a decrease in revenues of Fenofibrate, Nebivolol, and Prazosin, among others. Net revenues for established brand pharmaceutical products, royalties, and other pharmaceutical services were $31.5 million during the three months ended September 30, 2023, an increase of 74.2% compared to $18.1 million for the same period in 2022, driven by a net increase in volume. Net revenues of Rare Disease pharmaceutical products, which consist entirely of sales of Cortrophin Gel, were $29.7 million during the three months ended September 30, 2023, an increase of $17.1 million from $12.6 million for the same period in 2022. This increase was driven by increased volume in this second year of launch (product was launched in late January 2022). Operating expenses increased by 28.2% to $113.9 million for the three months ended September 30, 2023, from $88.8 million in the prior year period as a result of the following factors: For the three months ended September 30, 2023, cost of sales increased to $48.1 million from $32.9 million for the same period in 2022, an increase of $15.2 million, or 46.2%, primarily due to a significant growth in sales volumes of generic and Rare Disease pharmaceutical products. Research and development expenses increased from $7.7 million to $11.1 million for the three months ended September 30, 2023, an increase of $3.5 million or 45.2%, primarily due to expenses related to a 505(b)(2) filing for one product of approximately $1.6 million, and a higher level of activity associated with ongoing and new projects in the three months ended September 30, 2023. Selling, general, and administrative expenses increased from $30.1 million to $42.0 million for the three months ended September 30, 2023, an increase of $11.9 million, or 39.6%, primarily due to increased employment related costs, legal expenses, as well as an overall increase in activities required to support the growth in our business. Depreciation and amortization expense was $15.2 million for the three months ended September 30, 2023, compared to $14.2 million for the same period in 2022, an increase of $1.0 million, primarily due to the amortization of intangible assets acquired in the Slayback and Akorn asset acquisitions, and amortization of acquired in-process research, and development ("IPR&D") which commenced during the quarter. We recognized a gain of $(2.6) million and loss of $2.5 million in the three months ended September 30, 2023 and 2022, respectively, for the contingent consideration fair value adjustment. The change in the fair value adjustment is primarily related to a change in the anticipated cash flows, specifically extending the timeframe over which cash flows will be generated by the products, and the passage of time (i.e., moving closer to the anticipated payment date of the consideration), and an increase to the probability of payment for the product development-based milestone payments. The Company recognized restructuring activities of $1.5 million of expense in the three months ended September 30, 2022, in relation to the closure of its Oakville, Ontario, Canada facility. Costs included $0.3 million in termination benefits, $1.2 million in fixed asset impairments and accelerated depreciation. There were no restructuring expenses in the three months ended September 30, 2023. Manufacturing operations ceased at the Oakville, Ontario, site in January 2023, with the successful relocation of the Oakville products to U.S. facilities. On November 6, 2023, the Company entered into an agreement for the purchase and sale of the Oakville, Ontario site, at a total purchase price of $17.85 million Canadian dollars, or approximately $13.0 million US dollars based on the current exchange rate, subject to certain market adjustments. Closing of the sale is expected to occur in the first quarter of 2024. Net income available to common shareholders for the third quarter of 2023 was $9.5 million as compared to net loss of $(9.0) million in the prior year period. Diluted earnings per share for the three months ended September 30, 2023, was $0.45 compared to diluted GAAP loss per share of $(0.55) in the prior year period. Adjusted non-GAAP diluted earnings per share was $1.27 in the third quarter of 2023 compared to diluted earnings per share of $0.58 in the third quarter of 2022. For reconciliations of adjusted non-GAAP EBITDA and adjusted non-GAAP diluted earnings per share to the most directly comparable GAAP financial measure, please see Table 3 and Table 4, respectively. Liquidity As of September 30, 2023, the Company had $193.1 million in unrestricted cash and cash equivalents, $178.8 million in net accounts receivable and $294.8 million (face value) in outstanding debt. The Company generated year-to-date cash flow from operations of $74.2 million. 2023 Financial Guidance Upward Revisions Revised Full Year 2023 Guidance Prior Full Year 2023 Guidance Prior YearActual GrowthNet Revenue (total Company)$468 million - $478 million $425 million - $445 million $316.4 million 47.9% - 51.1%Cortrophin Gel Net Revenue$100 million - $107 million $90 million - $100 million $41.7 million 139.9% - 156.7%Adj. Non-GAAP Gross Margin63.0% to 63.8% 63% to 64.8% 58.3% 4.7 pts to 5.5 ptsAdjusted Non-GAAP EBITDA$128 million - $133 million $115 million - $125 million $55.9 million 129.1% - 138.1%Adjusted Non-GAAP Diluted EPS$4.29 - $4.57 $3.62 - $4.11 $1.36 215.4% - 236.0% In addition, ANI currently anticipates between 19.2 million and 19.3 million shares outstanding for purpose of calculating EPS and a U.S. GAAP effective tax rate of between approximately 9.0% to 13.0%. The Company will continue to tax affect adjustments for computation of adjusted non-GAAP diluted earnings per share at a tax rate of 24.0%. Conference Call As previously announced, ANI management will host its third quarter 2023 conference call as follows: Date Wednesday, November 8, 2023 Time 8:30 a.m. ETToll free (U.S.) 800-445-7795 Webcast (live and replay) www.anipharmaceuticals.com, under the “Investors” section A replay of the conference call will be available within two hours of the call’s completion and will remain accessible for two weeks by dialing 800-839-6737 and entering access code 4379958. Non-GAAP Financial Measures Adjusted non-GAAP EBITDA ANI’s management considers adjusted non-GAAP EBITDA to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by non-cash stock-based compensation and differences in capital structures, tax structures, capital investment cycles, ages of related assets, and compensation structures among otherwise comparable companies. Management uses adjusted non-GAAP EBITDA when analyzing Company performance. Beginning in the fourth quarter of 2022, ANI no longer excludes expense for In-Process Research & Development or Cortrophin Gel pre-launch charges and sales and marketing expenses from its non-GAAP results. Historically, the Company excluded these charges. These changes have been made to align with views expressed by the U.S. Securities and Exchange Commission. Prior periods have been recast to reflect these changes. Adjusted non-GAAP EBITDA is defined as net income (loss), excluding tax expense or benefit, interest expense, (net), other expense, (net), depreciation, amortization, the excess of fair value over cost of acquired inventory, non-cash stock-based compensation expense, Novitium transaction expenses, contingent consideration fair value adjustment, and certain other items that vary in frequency and impact on ANI’s results of operations. Adjusted non-GAAP EBITDA should be considered in addition to, but not in lieu of, net income or loss reported under GAAP. A reconciliation of adjusted non-GAAP EBITDA to the most directly comparable GAAP financial measure is provided below. ANI is not providing a reconciliation for the forward-looking full year 2023 adjusted EBITDA guidance because it does not currently have sufficient information to accurately estimate all of the variables and individual adjustments for such reconciliation, including “with” and “without” tax provision information. As such, ANI’s management cannot estimate on a forward-looking basis without unreasonable effort the impact these variables and individual adjustments will have on its reported results. Adjusted non-GAAP Net Income (Loss) ANI’s management considers adjusted non-GAAP net income (loss) to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by the excess of fair value over cost of acquired inventory sold, non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, Novitium transaction expenses, contingent consideration fair value adjustment, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses adjusted non-GAAP net income (loss) when analyzing Company performance. Beginning in the fourth quarter of 2022, ANI no longer excludes expense for In-Process Research & Development or Cortrophin Gel pre-launch charges and sales and marketing expenses from its non-GAAP results. Historically, the Company excluded these charges. These changes have been made to align with views expressed by the U.S. Securities and Exchange Commission. Prior periods have been recast to reflect these changes. Adjusted non-GAAP net income (loss) is defined as net income (loss), plus the excess of fair value over cost of acquired inventory sold, non-cash stock-based compensation expense, Novitium transaction expenses, non-cash interest expense, depreciation and amortization expense, contingent consideration fair value adjustment, and certain other items that vary in frequency and impact on ANI’s results of operations, less the tax impact of these adjustments calculated using an estimated statutory tax rate. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI’s results. Adjusted non-GAAP net income (loss) should be considered in addition to, but not in lieu of, net income (loss) reported under GAAP. A reconciliation of adjusted non-GAAP net income (loss) to the most directly comparable GAAP financial measure is provided below. Adjusted non-GAAP Diluted (Loss)/Earnings per Share ANI’s management considers adjusted non-GAAP diluted (loss)/earnings per share to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by the excess of fair value over cost of acquired inventory sold, non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, Novitium transaction expenses, contingent consideration fair value adjustment, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses adjusted non-GAAP diluted (loss)/earnings per share when analyzing Company performance. Adjusted non-GAAP diluted (loss)/earnings per share is defined as adjusted non-GAAP net income (loss), as defined above, divided by the diluted weighted average shares outstanding during the period. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI’s results. Adjusted non-GAAP diluted (loss)/earnings per share should be considered in addition to, but not in lieu of, diluted earnings or loss per share reported under GAAP. A reconciliation of adjusted non-GAAP diluted (loss)/earnings per share to the most directly comparable GAAP financial measure is provided below. ANI is not providing a reconciliation for the forward-looking full year 2023 adjusted diluted earnings per share guidance because it does not currently have sufficient information to accurately estimate all of the variables and individual adjustments for such reconciliation, including “with” and “without” tax provision information. As such, ANI’s management cannot estimate on a forward-looking basis without unreasonable effort the impact these variables and individual adjustments will have on its reported results. About ANI ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. Our team is focused on delivering sustainable growth by scaling up our Rare Disease business through the successful launch of our lead asset, Purified Cortrophin® Gel, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities. For more information, please visit our website www.anipharmaceuticals.com. Forward-Looking Statements To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, those relating to the commercialization and potential sales of the product and any additional product launches from the Company’s generic pipeline, other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” other words of similar meaning, derivations of such words and the use of future dates. Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to: risks that we may face with respect to importing raw materials and delays in delivery of raw materials and other ingredients and supplies necessary for the manufacture of our products from both domestic and overseas sources due to supply chain disruptions or for any other reason; delays or failure in obtaining and maintaining approvals by the FDA of the products we sell; changes in policy or actions that may be taken by the FDA and other regulatory agencies, including drug recalls; the ability of our manufacturing partners to meet our product demands and timelines; our dependence on single source suppliers of ingredients due to the time and cost to validate a second source of supply; acceptance of our products at levels that will allow us to achieve profitability; our ability to develop, license or acquire, and commercialize new products; the level of competition we face and the legal, regulatory and/or legislative strategies employed by our competitors to prevent or delay competition from generic alternatives to branded products; our ability to protect our intellectual property rights; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the impact of any litigation to which we are, or may become, a party; our ability, and that of our suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; our ability to maintain the services of our key executives and other personnel; whether we experience difficulties finding a buyer for the plant and property resulting from the closure of our Oakville, Ontario manufacturing plant; and general business and economic conditions, such as inflationary pressures, geopolitical conditions including but not limited to the conflict between Russia and the Ukraine, the conflict between Israel and Gaza, and the effects and duration of outbreaks of public health emergencies, such as COVID-19, and other risks and uncertainties that are described in ANI’s Annual Report on Form 10-K, quarterly reports on Form 10-Q, and other periodic reports filed with the Securities and Exchange Commission. More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission (SEC), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. Investor Contact Lisa M. Wilson, In-Site Communications, Inc. 212-452-2793 lwilson@insitecony.com SOURCE: ANI Pharmaceuticals, Inc. FINANCIAL TABLES FOLLOW ANI Pharmaceuticals, Inc. and SubsidiariesTable 1: US GAAP Statement of Operations(unaudited, in thousands, except per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Net Revenues$131,829 $83,821 $355,162 $222,153 Operating Expenses Cost of sales (excluding depreciation and amortization) 48,101 32,894 128,093 102,459 Research and development 11,121 7,657 24,419 17,096 Selling, general, and administrative 42,007 30,081 117,235 90,856 Depreciation and amortization 15,207 14,167 44,597 42,488 Contingent consideration fair value adjustment (2,555) 2,476 (559) 2,134 Restructuring activities — 1,541 1,132 4,111 Intangible asset impairment charge — — — 112 Total Operating Expenses 113,881 88,816 314,917 259,256 Operating Income (Loss) 17,948 (4,995) 40,245 (37,103) Other Expense, net Interest expense, net (6,398) (7,264) (21,194) (20,546)Other (expense) income, net (39) 37 (126) 712 Income (Loss) Before Income Tax (Expense) Benefit 11,511 (12,222) 18,925 (56,937) Income tax (expense) benefit (1,571) 3,622 (1,301) 13,284 Net Income (Loss)$9,940 $(8,600) $17,624 $(43,653) Dividends on Series A Convertible Preferred Stock (406) (406) (1,219) (1,218) Net Income (Loss) Available to Common Shareholders$9,534 $(9,006) $16,405 $(44,871) Basic and Diluted Income (Loss) Per Share: Basic Income (Loss) Per Share$0.46 $(0.55) $0.84 $(2.76)Diluted Income (Loss) Per Share$0.45 $(0.55) $0.83 $(2.76) Basic Weighted-Average Shares Outstanding 18,883 16,303 17,663 16,238 Diluted Weighted-Average Shares Outstanding 19,125 16,303 17,823 16,238 ANI Pharmaceuticals, Inc. and SubsidiariesTable 2: US GAAP Balance Sheets(unaudited, in thousands) September 30,2023 December 31,2022Current Assets Cash and cash equivalents$193,078 $48,228 Current restricted cash — 5,006 Accounts receivable, net 178,842 165,438 Inventories 106,590 105,355 Prepaid income taxes — 3,827 Assets held for sale 8,020 8,020 Prepaid expenses and other current assets 10,690 8,387 Total Current Assets 497,220 344,261 Non-current Assets Property and equipment, net 44,189 43,246 Deferred tax assets, net of deferred tax liabilities and valuation allowance 84,389 81,363 Intangible assets, net 219,828 251,635 Goodwill 28,221 28,221 Derivatives and other non-current assets 16,067 11,361 Total Assets$889,914 $760,087 Current Liabilities Income taxes payable$594 $— Current debt, net of deferred financing costs 850 850 Accounts payable 34,077 29,305 Accrued royalties 11,975 9,307 Accrued compensation and related expenses 15,328 10,312 Accrued government rebates 10,923 10,872 Returned goods reserve 31,438 33,399 Current contingent consideration 23,939 — Accrued expenses and other 5,228 5,394 Total Current Liabilities 134,352 99,439 Non-current Liabilities Non-current debt, net of deferred financing costs and current component 285,032 285,669 Non-current contingent consideration 10,560 35,058 Other non-current liabilities 5,259 1,381 Total Liabilities$435,203 $421,547 Mezzanine Equity Convertible Preferred Stock, Series A 24,850 24,850 Stockholders’ Equity Common Stock 2 1 Treasury stock (9,850) (5,094)Additional paid-in capital 506,513 403,901 Accumulated deficit (80,880) (97,286)Accumulated other comprehensive income, net of tax 14,076 12,168 Total Stockholders’ Equity 429,861 313,690 Total Liabilities, Mezzanine Equity, and Stockholders’ Equity$889,914 $760,087 ANI Pharmaceuticals, Inc. and SubsidiariesTable 3: Adjusted non-GAAP EBITDA Calculation and US GAAP to Non-GAAP Reconciliation (unaudited, in thousands) Reconciliation of certain adjusted non-GAAP accounts: Net Revenues Cost of sales (excluding depreciation and amortization) Selling, general, and administrative Research and development Three Months Ended September 30, Three Months Ended September 30, Three Months Ended September 30, Three Months Ended September 30, Three Months Ended September 30, 2023 2022 2023 2022 2023 2022 2023 2022 2023 2022Net Income (Loss) $9,940 $(8,600) As reported: $131,829 $83,821 $48,101 $32,894 $42,007 $30,081 $11,121 $7,657 Add/(Subtract): Interest expense, net 6,398 7,264 Other expense (income), net 39 (37) Income tax expense (benefit) 1,571 (3,622) Depreciation and amortization 15,207 14,167 Contingent consideration fair value adjustment (2,555) 2,476 Restructuring activities — 1,541 Impact of Canada operations (1) 275 840 Impact of Canada operations (1) — (969) (128) (681) (147) (1,052) — (76)Stock-based compensation 5,444 3,869 Stock-based compensation — — (182) (149) (5,023) (3,524) (239) (196)Excess of fair value over cost of acquired inventory — 443 Excess of fair value over cost of acquired inventory — — — (443) — — — — Novitium transaction expenses 165 59 Novitium transaction expenses — — — — (165) (59) — — Adjusted non-GAAP EBITDA $36,484 $18,400 As adjusted: $131,829 $82,852 $47,791 $31,621 $36,672 $25,446 $10,882 $7,385 (1) Impact of Canada operations includes CDMO revenues, cost of sales relating to CDMO revenues, all selling, general, and administrative expenses, and all research and development expenses recorded in Canada in the period presented, exclusive of restructuring activities, stock-based compensation, and depreciation and amortization, which are included within their respective line items above. The adjustment of Canada operations represents revenues, cost of sales and expense that will not recur after the completion of the closure of our Canada operations, which was completed as of March 31, 2023. The adjustment of Canada operations does not adjust for revenues, cost of sales, and expense that will recur at our other manufacturing facilities after the transfer of certain manufacturing activities is complete. Reconciliation of certain adjusted non-GAAP accounts: Net Revenues Cost of sales (excluding depreciation and amortization) Selling, general, and administrative Research and development Nine Months Ended September 30, Nine Months Ended September 30, Nine Months Ended September 30, Nine Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 2023 2022 2023 2022 2023 2022 Net Income (Loss) $17,624 $(43,653) As reported: $355,162 $222,153 $128,093 $102,459 $117,235 $90,856 $24,419 $17,096 Add/(Subtract): Interest expense, net 21,194 20,546 Other expense (income), net (1) 126 38 Income tax expense (benefit) 1,301 (13,284) Depreciation and amortization 44,597 42,488 Contingent consideration fair value adjustment (559) 2,134 Intangible asset impairment charge — 112 Restructuring activities 1,132 4,111 Impact of Canada operations(2) 2,414 2,661 Impact of Canada operations(2) (565) (2,014) (1,833) (1,930) (1,073) (2,598) (73) (147)Stock-based compensation 15,031 10,862 Stock-based compensation — — (521) (442) (13,839) (9,858) (671) (562)Excess of fair value over cost of acquired inventory — 5,246 Excess of fair value over cost of acquired inventory — — — (5,246) — — — — Novitium transaction expenses 757 1,276 Novitium transaction expenses — — — — (757) (1,276) — — Adjusted non-GAAP EBITDA $103,617 $32,537 As adjusted: $354,597 $220,139 $125,739 $94,841 $101,566 $77,124 $23,675 $16,387 (1) Adjustment to Other expense (income), net excludes $750 thousand of income related to the sale of an ANDA during the nine months ended September 30, 2022.(2) Impact of Canada operations includes CDMO revenues, cost of sales relating to CDMO revenues, all selling, general, and administrative expenses, and all research and development expenses recorded in Canada in the period presented, exclusive of restructuring activities, stock-based compensation, and depreciation and amortization, which are included within their respective line items above. The adjustment of Canada operations represents revenues, cost of sales and expense that will not recur after the completion of the closure of our Canada operations, which was completed as of March 31, 2023. The adjustment of Canada operations does not adjust for revenues, cost of sales, and expense that will recur at our other manufacturing facilities after the transfer of certain manufacturing activities is complete. ANI Pharmaceuticals, Inc. and SubsidiariesTable 4: Adjusted non-GAAP Net Income and Adjusted non-GAAP Diluted Earnings per Share Reconciliation (unaudited, in thousands, except per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Net Income (Loss) Available to Common Shareholders$9,534 $(9,006) $16,405 $(44,871) Add/(Subtract): Non-cash interest expense 856 963 2,530 2,883 Depreciation and amortization 15,207 14,167 44,597 42,488 Contingent consideration fair value adjustment (2,555) 2,476 (559) 2,134 Restructuring activities — 1,541 1,132 4,111 Intangible asset impairment charge — — — 112 Impact of Canada operations(1) 275 840 2,414 2,661 Stock-based compensation 5,444 3,869 15,031 10,862 Excess of fair value over cost of acquired inventory — 443 — 5,246 Novitium transaction expenses 165 59 757 1,276 Less: Estimated tax impact of adjustments (calc. at 24%) (4,654) (5,846) (15,816) (17,226) Adjusted non-GAAP Net Income Available to Common Shareholders (2)$24,272 $9,506 $66,491 $9,676 Diluted Weighted-Average Shares Outstanding 19,125 16,303 17,823 16,238 Adjusted Diluted Weighted-Average Shares Outstanding 19,125 16,317 17,823 16,252 Adjusted non-GAAP Diluted Earnings per Share$1.27 $0.58 $3.73 $0.60 (1) Impact of Canada operations includes CDMO revenues, cost of sales relating to CDMO revenues, all selling, general, and administrative expenses, and all research and development expenses recorded in Canada in the period presented, exclusive of restructuring activities, stock-based compensation, and depreciation and amortization, which are included within their respective line items above. The adjustment of Canada operations represents revenues, cost of sales and expense that will not recur after the completion of the closure of our Canada operations (complete as of March 31, 2023) and the sale of the facility (on-going as of September 30, 2023). The adjustment of Canada operations does not adjust for revenues, cost of sales, and expense that will recur at our other manufacturing facilities after the transfer of certain manufacturing activities is complete.(2)Adjusted non-GAAP Net Income (Loss) Available to Common Shareholders excludes undistributed earnings to participating securities.

很多药物活性物质的名称中的后缀，透露了药物的类型和治疗领域，例如很多含有vir后缀的药物就是抗病毒类活性物质。 本文笔者总结了常见的药物名称（通用名）中后缀包含的信息，分享给大家： 01-pril 药物（普利） 以-pril（普利）作为后缀的药物一般是ACE抑制剂（Angiotensin-converting enzyme inhibitor, 血管紧张素转换酶抑制剂），例如： Benazepril (Lotensin) 贝那普利（洛汀新）Captopril 卡托普利Enalapril (Vasotec) 依那普利Fosinopril 福辛普利Lisinopril (Prinivil, Zestril) 赖诺普利Moexipril莫昔普利Perindopril培哚普利Quinapril (Accupril) 喹那普利Ramipril (Altace) 雷米普利Trandolapril群多普利 血管紧张素转换酶 (ACE) 抑制剂是有助于放松静脉和动脉以降低血压的药物。ACE 抑制剂阻止体内酶产生血管紧张素 II（angiotensin II），血管紧张素 II 是一种使血管变窄的物质。这种狭窄会导致高血压，并迫使心脏更加努力地工作。血管紧张素 II 还会释放升高血压的激素。 ACE 抑制剂用于预防、治疗或改善以下病症的症状： 高血压冠状动脉疾病心脏衰竭糖尿病某些慢性肾病心脏病一种涉及皮肤和结缔组织硬化的疾病（硬皮病） 偏头痛 有时，另一种降压药，如利尿剂或钙通道阻滞剂，会与 ACE 抑制剂一起开处方。 ACE 抑制剂不应与血管紧张素受体阻滞剂（angiotensin receptor blocker）或与直接肾素抑制剂（renin inhibitor）一起服用。 02-lol降压药物（洛尔） 以-lol为后缀的药物通常是β受体阻滞剂（Beta blockers），也称为β-肾上腺素能阻断剂（beta-adrenergic blocking agents），是降低血压的药物。 β受体阻滞剂通过阻断肾上腺素（adrenaline，或称epinephrine）起作用。β 受体阻滞剂可使心脏跳动更慢且力度更小，从而降低血压。β 受体阻滞剂还有助于扩张静脉和动脉以改善血液流动。常见的口服-lol药物包括： Acebutolol醋丁洛尔Atenolol (Tenormin) 阿替洛尔Bisoprolol (Zebeta) 比索洛尔Metoprolol (Lopressor, Toprol XL) 美托洛尔Nadolol (Corgard) 纳多洛尔Nebivolol (Bystolic) 奈必洛尔Propranolol (Inderal, InnoPran XL) 普萘洛尔 03-dipine降压药物（地平） 以-dipine（地平）为后缀的药物通常是钙通道阻滞剂（Calcium channel blockers），它们是用于降低血压的药物。 地平药物的作用是防止钙进入心脏和动脉细胞，钙会使心脏和动脉更强烈地收缩。钙通道阻滞剂允许血管松弛和开放，一些钙通道阻滞剂还可以减慢心率，从而进一步降低血压。这些药物也可能用于缓解胸痛（心绞痛）和控制心律不齐。钙通道阻滞剂也称为钙拮抗剂（calcium antagonists）。常见的钙通道阻滞剂类地平药物包括： Amlodipine (Norvasc) 氨氯地平Felodipine非洛地平Isradipine伊拉地平Nicardipine尼卡地平Nifedipine (Procardia) 硝苯地平Nisoldipine (Sular) 尼索地平 04-sartan降压药物（沙坦） 以-sartan结尾的药物通常是血管紧张素 II 受体阻滞剂 (ARB，Angiotensin II receptor blockers) ，常用于治疗高血压、心力衰竭和慢性肾病。医生有时可能会建议使用 ARB 代替血管紧张素转换酶 (ACE) 抑制剂进行治疗。 血管紧张素 II （Angiotensin II）是身体产生的一种激素，它可以收缩血管，还有助于体内的盐分和水分滞留。体内盐分增加和血管收紧可能会导致血压升高。ARB 和 ACE 抑制剂均作用于血管紧张素 II。ACE 抑制剂限制血管紧张素 II 的形成，ARB 会阻断血管紧张素 II 的某些受体。当 ARB 阻断血管紧张素 II 时，会减少血管紧缩，降低血压。常见的-sartan类药物包括： azilsartan (Edarbi) 阿齐沙坦candesartan (Atacand) 坎地沙坦eprosartan mesylate (Teveten) 甲磺酸依普沙坦olmesartan (Benicar) 奥美沙坦irbesarten (Avapro) 厄贝沙坦losartan potassium (Cozaar) 氯沙坦钾telmisartan (Micardis) 替米沙坦valsartan (Diovan) 缬沙坦  05-actone利尿剂药物（内酯） 利尿剂 (diuretics)，有时称为水丸（water pills），有助于排出体内的盐分（钠）和水。这些药物中的大多数可以帮助肾脏向尿液中释放更多的钠。钠有助于去除血液中的水分，减少流经静脉和动脉的液体量。这样可以降低血压。利尿剂分为三种类型： 噻嗪类Thiazide环形Loop保钾Potassium sparing 每种利尿剂都会影响肾脏的不同部位。有些药品结合了一种以上的利尿剂，或者将一种利尿剂与另一种降压药结合使用。 以α-内酯（-actone）结尾的药物是保钾利尿剂（Potassium sparing diuretics）。这些利尿剂会增加肾脏排出的液体，同时将钾保留在体内（被认为是弱利尿剂）。保钾利尿剂的例子包括： Amiloride（Midamor）阿米洛利Eplerenone (Inspra)依普利农Spironolactone（Aldactone，Carospir）螺内酯Triamterene（Dyrenium）氨苯蝶啶 06-thiozide利尿剂药物（噻嗪） 噻嗪类利尿剂以-thiozide结尾，主要用于治疗高血压和水肿，口服噻嗪类利尿剂的例子包括： Chlorothiazide氯噻嗪Hydrochlorothiazide氢氯噻嗪 07-afil勃起功能障碍药物（那非） 磷酸二酯酶抑制剂（phosphodiesterase inhibitor）是一种药物，可阻断磷酸二酯酶 (PDE，phosphodiesterase) 的五种亚型中的一种或多种，从而防止细胞内第二信使环磷酸腺苷 (cAMP) 和环磷酸鸟苷 (cGMP) 被相应的 PDE失活。 西地那非Sildenafil（伟哥）、他达拉非tadalafil、伐地那非vardenafil以及较新的乌地那非udenafil和阿伐那非avanafil选择性地抑制 PDE5，PDE5 是 cGMP 特异性的，负责海绵体中 cGMP(环磷酸鸟苷) 的降解。这些磷酸二酯酶抑制剂主要用作治疗勃起功能障碍的药物，以及一些其他医学应用，例如治疗肺动脉高压。  08-statin降胆固醇药物（他汀） 健康的生活方式是抵御高胆固醇的第一道防线。但有时饮食和运动是不够的，可能还需要服用降胆固醇药物来帮助： 降低低密度脂蛋白 (LDL) 胆固醇（low-density lipoprotein cholesterol），有也是被称为“坏胆固醇”，会增加患心脏病的风险；降低甘油三酯（triglycerides）是血液中的一种脂肪，也会增加患心脏病的风险；增加高密度脂蛋白 (HDL) 胆固醇（high-density lipoprotein cholesterol），有时也被称为“好胆固醇”，是一种可以预防心脏病的胆固醇。 以-statin结尾的药物通常是降低低密度脂蛋白和甘油三酯的药物，同时略微增加高密度脂蛋白。常见的他汀类药物包括： Atorvastatin (Lipitor) 阿托伐他汀Fluvastatin (Lescol XL) 氟伐他汀Lovastatin (Altoprev) 洛伐他汀Pitavastatin (Livalo) 匹伐他汀Pravastatin (Pravachol) 普伐他汀Rosuvastatin (Crestor) 瑞舒伐他汀Simvastatin (Zocor) 辛伐他汀  从化学结构来看，他汀药物的结构共同点在于含有3，5-二羟基戊酸，或相应的六元环内酯结构。 09-arin和-xaban抗凝血剂药物 以-arin或-xaban结尾的药物有可能是抗凝血剂。抗凝血剂（anticoagulants）是有助于防止血栓 (blood clots) 形成的药物。它们被提供给有高血栓风险的人，以减少他们患上中风和心脏病等严重疾病的机会。 血凝块是由血液形成的密封层，用于阻止伤口流血。虽然它们可用于止血，但在错误的位置形成，会阻塞血管并阻止血液流向大脑、心脏或肺等器官。抗凝血剂通过中断血块形成过程起作用，有时被称为“血液稀释”药物，尽管它们实际上并没有使血液稀释。 虽然它们的用途相似，但抗凝剂与抗血小板药物不同（例如低剂量阿司匹林和氯吡格雷）。常见-arin和-xaban抗凝血剂包括： heparin肝素warfarin华法林rivaroxaban (Xarelto) 利伐沙班apixaban (Eliquis) 阿哌沙班edoxaban (Lixiana) 依度沙班  10-cycline, -mycin和-floxacin抗生素 四环素（tetracyclines）类抗生素通常带有-cycline后缀，四环素用于治疗皮肤、肠道、呼吸道、泌尿道、生殖器、淋巴结和其他身体系统的许多不同细菌感染。通常用于治疗严重的痤疮或性传播疾病，如梅毒、淋病或衣原体感染。在某些情况下，当青霉素或其他抗生素不能用于治疗炭疽、李斯特菌、梭菌、放线菌等严重感染时，会使用四环素。常见四环素类抗生素： Tetracycline四环素Chlortetracycline金霉素Oxytetracycline土霉素Demeclocycline去甲金霉素Lymecycline赖甲环素Meclocycline甲氧环素Methacycline美他环素Minocycline米诺环素Rolitetracycline罗利四环素Doxycycline强力霉素Tigecycline替加环素Glycecyclines甘油环素类Eravacycline埃拉瓦环素Sarecycline沙霉素Omadacycline奥马达环素  氨基糖苷类 (Aminoglycosides) 是另一种以-mycin结尾的抗生素，如新霉素 (neomycin) 和妥布霉素 (tobramycin)。  氟喹诺酮类是一种以-floxacin结尾的广谱抗生素，如环丙沙星 (ciprofloxacin) 和左氧氟沙星 (levofloxacin)。  11-vir抗病毒药物 (韦) 抗生素治疗细菌感染，而抗病毒药物治疗病毒感染。如果结尾是-vir，很可能是抗病毒药，比如Covid-19药物中的两款活性物质尼马曲韦nirmatrelvir和利托那韦ritonavir。  12-azine药物 以-azine 结尾的药物，如异丙嗪promethazine，是一种用于治疗恶心和呕吐的止吐药。  13-prazole, -tidine 抗溃疡药物（拉唑、替丁） 质子泵抑制剂（Proton pump inhibitors）抗溃疡药物（Anti-ulcer Drug）以 -prazole 结尾，例如兰索拉唑 (lansoprazole) 和奥美拉唑 (omeprazole)，是一些减少胃酸产生的抗溃疡药物。  另一种抗溃疡药物是 H2 受体拮抗剂（H2 receptor antagonists）或 H2 阻滞剂（H2 blockers），它可以阻断组胺在胃中的作用，减少胃酸的产生。这些药物通常以 -tidine 结尾，例如西咪替丁 (cimetidine)、法莫替丁 (famotidine) 和雷尼替丁 (ranitidine)。  14-terol，-phylline支气管扩张剂药物（胺醇、碱） 支气管扩张剂（Bronchodilators）扩张支气管和细支气管，降低气道阻力并增加肺部气流。这些药物用于治疗哮喘和慢性阻塞性肺病，包括以 -terol 和 -phylline 结尾的药物，例如沙丁胺醇albuterol、左沙丁胺醇levalbuterol、茶碱theophylline和氨茶碱aminophylline。  15-ine 抗组胺药物 抗组胺药（Antihistamines）用于治疗过敏症状，如打喷嚏、流鼻涕、瘙痒或荨麻疹，包括以 -ine 结尾的药物，如苯海拉明diphenhydramine、氯雷他定loratadine和溴苯那敏brompheniramine。  16-pam, -lam, -triptyline 抑郁症和抗焦虑药 以 -pam 或 -lam 结尾的药物很可能是苯二氮卓类（benzodiazepine）药物，用于治疗焦虑症，长期使用可能会导致身体依赖。苯二氮卓类药物包括阿普唑仑 (alprazolam)、地西泮 (diazepam) 和劳拉西泮 (lorazepam)。  几种三环类抗抑郁药以 -triptyline 结尾，例如阿米替林amitriptyline和去甲替林nortriptyline。这些药物用于治疗抑郁症、躁郁症、焦虑症和其他情绪障碍。  17-pram, -ine类SSRIs（选择性血清素摄取抑制剂） SSRIs阻断或延迟血清素的重吸收，用于治疗重度抑郁症和焦虑症。它们很多都以 -pram 或 -ine 结尾，例如氟西汀 (fluoxetine)、舍曲林 (sertraline)、西酞普兰 (citalopram) 和依他普仑 (escitalopram)。  18-sone, -lone皮质类固醇抗炎药物 皮质类固醇（Corticosteroid）是用于控制许多不同症状的抗炎药，但不能治愈潜在的疾病过程。大多数皮质类固醇以 -sone 或 -lone 结尾，包括地塞米松dexamethasone、泼尼松prednisone、甲泼尼龙methylprednisolone和去炎松triamcinolone。  Ref.· Mayo Clinic· Drug Suffixes. Mometrix 声明：本内容为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | Smmer转载开白 | 马老师 18323856316（同微信） 阅读原文，是昨天最受欢迎的文章哦