Famotidine

DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®. "We're proud to provide affordable choices to healthcare providers and their appropriate patients while strengthening our reputation as a reliable, quality supplier," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. The combination medication is used to relieve the signs and symptoms of rheumatoid arthritis and osteoarthritis while decreasing the risk of developing ulcers of the stomach and upper intestines people may experience from ibuprofen alone. According to IQVIA™, ibuprofen-famotidine tablet sales were approximately $49 million for the 12 months ended December 31, 2023. DUEXIS® is a registered trademark of Horizon Therapeutics USA, Inc. CONTRAINDICATIONS: Ibuprofen and famotidine tablets are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to ibuprofen or famotidine or any components of the drug product. History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients. In the setting of coronary artery bypass graft (CABG) surgery. Ibuprofen and famotidine tablets should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists. Cross sensitivity with other H2-receptor antagonists has been observed. WARNINGS AND PRECAUTIONS Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI), and stroke, which can be fatal. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur. Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke. NSAIDs are contraindicated in the setting of CABG. Post-MI Patients Avoid the use of ibuprofen and famotidine in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If ibuprofen and famotidine is used in patients with a recent MI, monitor patients for signs of cardiac ischemia. Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs, including ibuprofen, cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDS. Strategies to Minimize the GI Risks in NSAID-treated patients: Use the lowest effective dosage for the shortest possible duration. Avoid administration of more than one NSAID at a time. Avoid use in patients at higher risk unless benefits are expected to outweigh the increased risk of bleeding. For such patients, as well as those with active GI bleeding, consider alternate therapies other than NSAIDs. Remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy. If a serious GI adverse event is suspected, promptly initiate evaluation and treatment, and discontinue ibuprofen and famotidine until a serious GI adverse event is ruled out. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, monitor patients more closely for evidence of GI bleeding. Active Bleeding When active and clinically significant bleeding from any source occurs in patients receiving ibuprofen and famotidine, the treatment should be withdrawn. Patients with initial hemoglobin values of 10 g or less who are to receive long-term therapy should have hemoglobin values determined periodically. Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), discontinue ibuprofen and famotidine immediately, and perform a clinical evaluation of the patient. Hypertension NSAIDs, including ibuprofen and famotidine, can lead to new onset of hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking angiotensin converting enzyme (ACE) inhibitors, thiazide diuretics, or loop diuretics may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure (BP) during the initiation of NSAID treatment and throughout the course of therapy. Heart Failure and Edema Fluid retention and edema have been observed in some patients treated with NSAIDs. Use of ibuprofen may blunt the CV effects of several therapeutic agents used to treat these medical conditions (e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers [ARBs]). Avoid the use of ibuprofen and famotidine in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If ibuprofen and famotidine is used in patients with severe heart failure, monitor patients for signs and symptoms of worsening heart failure. Renal Toxicity and Hyperkalemia Renal Toxicity Avoid the use of ibuprofen and famotidine in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal failure. If ibuprofen and famotidine is used in patients with advanced renal disease, monitor patients for signs of worsening renal function. Hyperkalemia Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment. In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state. Anaphylactic Reactions Ibuprofen has been associated with anaphylactic reactions in patients with and without known hypersensitivity to ibuprofen and in patients with aspirin-sensitive asthma. Seek emergency help if an anaphylactic reaction occurs. Seizures Central nervous system (CNS) adverse effects including seizures, delirium, and coma have been reported with famotidine in patients with moderate (creatinine clearance <50 mL/min) and severe renal insufficiency (creatinine clearance <10 mL/min), and the dosage of the famotidine component in ibuprofen and famotidine is fixed. Therefore, ibuprofen and famotidine is not recommended in patients with creatinine clearance < 50 mL/min. Exacerbation of Asthma Related to Aspirin Sensitivity Because cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, ibuprofen and famotidine is contraindicated in patients with this form of aspirin sensitivity. When ibuprofen and famotidine is used in patients with preexisting asthma (without known aspirin sensitivity), monitor patients for changes in the signs and symptoms of asthma. Serious Skin Reactions NSAIDs, including ibuprofen, which is a component of ibuprofen and famotidine tablets, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin reactions and to discontinue the use of ibuprofen and famotidine at the first appearance of skin rash or any other sign of hypersensitivity. Ibuprofen and famotidine is contraindicated in patients with previous serious skin reactions to NSAIDs. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as ibuprofen and famotidine. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis. If such signs or symptoms are present, discontinue ibuprofen and famotidine and evaluate the patient immediately. Fetal Toxicity Limit use of NSAIDs, including ibuprofen and famotidine, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus. Masking of Inflammation and Fever The pharmacological activity of ibuprofen and famotidine in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections. Laboratory Monitoring Because serious GI bleeding, hepatotoxicity, and renal injury can occur without warning symptoms or signs, consider monitoring patients on long-term NSAID treatment with a CBC and chemistry profile periodically. Concomitant NSAID Use Ibuprofen and famotidine tablets contain ibuprofen as one of its active ingredients. It should not be used with other ibuprofen-containing products. The concomitant use of NSAIDs, including aspirin, with ibuprofen and famotidine may increase the risk of adverse reactions. Aseptic Meningitis If signs or symptoms of meningitis develop in a patient on ibuprofen and famotidine, the possibility of its being related to ibuprofen should be considered. Ophthalmological Effects Blurred and/or diminished vision, scotomata, and/or changes in color vision have been reported. If a patient develops such complaints while receiving ibuprofen and famotidine, the drug should be discontinued, and the patient should have an ophthalmologic examination which includes central visual fields and color vision testing. ADVERSE EVENTS Most common adverse reactions (>1% and greater than ibuprofen alone) are nausea, diarrhea, constipation, upper abdominal pain, and headache. INDICATION AND USAGE Ibuprofen and famotidine tablets, a combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months. Click for Full Prescribing Information, including BOXED WARNING and Medication Guide. About Endo Endo (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation including, but not limited to, the statements by Mr. Sims, any statements relating to product launch, quality, affordability, efficacy, reliability or sales, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "intend," "guidance," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect the Company's current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the outcome of the Company's contingency planning and restructuring activities; the timing, impact or results of any pending or future litigation, investigations, proceedings or claims, including opioid, tax and antitrust related matters; any actual or contingent liabilities; settlement discussions or negotiations; the Company's liquidity, financial performance, cash position and operations; the risks and uncertainties associated with chapter 11 proceedings; the time, terms and ability to complete a chapter 11 plan of reorganization or to pursuen an alternative emergence transaction; the risk that the Company's chapter 11 cases may be converted to cases under chapter 7 of the Bankruptcy Code; the adequacy of the capital resources of the Company's businesses and the difficulty in forecasting the liquidity requirements of the operations of the Company's businesses; the unpredictability of the Company's financial results; the Company's ability to discharge claims in chapter 11 proceedings; negotiations with the holders of the Company's indebtedness and its trade creditors and other significant creditors; the risks and uncertainties with performing under the terms of the restructuring support agreement and any other arrangement with lenders or creditors while in chapter 11 proceedings; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; and the Company's ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by the Company, as well as the Company's public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S. Securities and Exchange Commission. SOURCE Endo International plc

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.