Latest news with #CortrophinGel
Yahoo
22-05-2025
- Health
- Yahoo
ANI Pharmaceuticals Announces Initiation of Phase 4 Clinical Trial of Purified Cortrophin® Gel for the Treatment of Acute Gout Flares
Purified Cortrophin Gel is the only ACTH therapy approved by the FDA for the treatment of acute gout flares Trial to be conducted by Dr. Hyon Choi at Massachusetts General Hospital and will compare the safety and efficacy of two dose levels of Purified Cortrophin Gel for the treatment of acute gout flares PRINCETON, N.J., May 22, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the initiation of a Phase 4 clinical trial at Massachusetts General Hospital to compare the safety and efficacy of two dose levels (40 USP units and 80 USP units) of Purified Cortrophin Gel (repository corticotropin injection USP) (Cortrophin Gel) for the treatment of acute gout flares. Cortrophin Gel is indicated for short-term administration as an adjunctive therapy during an acute episode or exacerbation in acute gouty arthritis. Cortrophin Gel is contraindicated for intravenous administration. For additional important safety information, please see below. 'Gout is a chronic disease that affects millions of patients, including acute flares that can cause extreme pain and temporary disability,' said Hyon Choi, MD, DrPH, principal investigator of the study and clinical investigator and physician in the Rheumatology Unit at Mass General Research Institute/Massachusetts General Hospital (MGH). 'For some patients, conventional anti-inflammatory treatments do not provide adequate relief from these flares. We look forward to initiating this dose-ranging study, which we believe will provide valuable scientific information about Cortrophin Gel in the treatment of acute gout flares.' Dr. Choi has been a leading physician investigator with a primary focus on gout and other inflammatory arthritic conditions throughout his academic career. He has authored more than 150 gout-related peer-reviewed papers in leading journals, and his findings have been referenced by many articles as well as guidelines from the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). Dr. Choi directs the MGH Gout & Crystal Arthropathy Center and co-directs the Gout, Hyperuricemia and Crystal-Associated Disease Network (G-CAN), a non-profit organization dedicated to creating research and education initiatives to fill the knowledge gap in gout. 'This Phase 4 study in gout is the first clinical trial launched by ANI as part of our commitment to building the scientific evidence and clinical data supporting the use of Cortrophin Gel,' said Mary Pao, MD, PhD, Chief Medical Officer of Rare Disease at ANI. 'Our goal with the study is to generate meaningful clinical information for the dosing of Cortrophin Gel in patients with acute gout flares by comparing the safety and efficacy of two dose levels of the product. We believe this study will provide physicians with more data to inform their approach to patient care.' 'We have seen steady growth in the use of Cortrophin Gel as an adjunctive therapy for gout flares since we launched our 1-mL vial, which we developed to help increase access for in-office treatment, in October 2023,' said Nikhil Lalwani, President and Chief Executive Officer at ANI. 'We believe our new Phase 4 study will provide valuable insights for patients and healthcare providers and further strengthen the profile of Cortrophin Gel in this indication.' About the Cortrophin Gel Phase 4 Gout TrialThe Phase 4 trial is a randomized, single-center, double-blind, single administration study to evaluate the efficacy and safety of Cortrophin Gel at two dose levels (40 USP units/0.5 mL and 80 USP units/mL) administered as a single injection in patients with acute gout flares for whom non-steroidal anti-inflammatory drugs (NSAIDs) or colchicine did not previously provide an adequate response, among other criteria. The trial will randomize up to 160 patients in a 1:1 ratio between the two doses with the objective of enrolling 70 evaluable patients per dose group for the primary endpoint assessment. Cortrophin Gel will be administered as a single dose, followed by a 7-day follow-up period with patient reported assessments conducted at days 1, 2, 3 and 7 post-administration. The primary endpoint of the study is the change in gout pain intensity from baseline in the target joint following Cortrophin Gel administration measured by Visual Analog Scale (VAS) at day 3 post-administration. Secondary endpoints include change in gout pain intensity at days 1, 2 and 7 post-administration, time to onset of effect, time to response, use of rescue medication, patient and physician assessments of response, and safety parameters. Exploratory endpoints include evaluating the effect of Cortrophin Gel on inflammatory biomarkers, health-related quality-of-life measures and health-care resource utilization. Indication Cortrophin Gel is a prescription medicine that is injected subcutaneously or intramuscularly. It is indicated for: Short-term administration as an adjunctive therapy during an acute episode or exacerbation in acute gouty arthritis Important Safety Information Contraindications Cortrophin Gel is contraindicated for intravenous administration. Cortrophin Gel is contraindicated in patients who have any of the following conditions: scleroderma; osteoporosis; systemic fungal infections; ocular herpes simplex; recent surgery; history of or the presence of a peptic ulcer; congestive heart failure; hypertension; primary adrenocortical insufficiency; adrenocortical hyperfunction; or sensitivity to proteins derived from porcine sources. Warnings and Precautions Infections: Corticotropin therapy may increase susceptibility to infections and may mask the symptoms of infections. Adrenal insufficiency: Prolonged corticotropin therapy can increase the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by gradually reducing the corticotropin dosage. Hormone therapy should be reinstituted if stressful situations arise during discontinuation. Elevated blood pressure, salt and water retention, and hypokalemia: Corticotropin can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium or calcium. Masking symptoms of other diseases: Corticotropin may only suppress signs and symptoms of chronic disease without altering the natural course of disease. Psychiatric reactions: Psychic derangements may appear when corticotropin is used, ranging from euphoria, insomnia, mood swings, personality changes, and depression to psychosis. Existing conditions may be aggravated. Ophthalmic reactions: Prolonged use of corticotropin may produce posterior subcapsular cataracts and glaucoma with possible damage to the optic nerves. Immunogenicity potential: Prolonged administration of Cortrophin Gel may increase the risk of hypersensitivity reactions. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH and Cortrophin Gel activity. Vaccination: Patients should not be vaccinated against smallpox while on corticotropin therapy. Other immunizations should be undertaken with caution due to possible neurologic complications and lack of antibody response. Use in patients with hypothyroidism and cirrhosis: There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis. Use in patients with latent tuberculosis or tuberculin reactivity: Closely observe for reactivation of the disease. Comorbid diseases: Corticotropin should be used with caution in patients with diabetes, abscess, pyogenic infections, diverticulitis, renal insufficiency, and myasthenia gravis. Growth and development: Carefully observe growth and development of infants and children on prolonged corticotropin therapy. Acute gouty arthritis: Treatment of acute gouty arthritis should be limited to a few days. Conventional concomitant therapy should be administered during corticotropin treatment and for several days after it is stopped. Drug interactions: Aspirin should be used cautiously with corticotropin in hypoprothrombinemia. Pregnancy: Since fetal abnormalities have been observed in animals, Cortrophin Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Adverse Reactions Adverse reactions for Cortrophin Gel include fluid or sodium retention; muscle weakness; osteoporosis; peptic ulcer with possible perforation and hemorrhage; injection site reactions; impaired wound healing; hypertension; convulsions; headache; development of Cushingoid state; suppression of growth in children; and weight gain. These are not all the adverse reactions reported with Cortrophin Gel. Please see full Prescribing Information. About ANI Pharmaceuticals, Inc. ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company committed to its mission of 'Serving Patients, Improving Lives" by developing, manufacturing, and commercializing innovative and high-quality therapeutics. The Company is focused on delivering sustainable growth through its Rare Disease business, which markets novel products in the areas of ophthalmology, rheumatology, nephrology, neurology, and pulmonology; its Generics business, which leverages R&D expertise, operational excellence, and U.S.-based manufacturing; and its Brands business. For more information, visit Forward-Looking Statements This press release contains not only historical information, but also forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements represent the Company's expectations or beliefs concerning future events. These forward-looking statements generally are identified by the words 'believe,' 'project,' 'expect,' 'anticipate,' 'estimate,' 'intend,' 'continue,' 'strategy,' 'future,' 'opportunity,' 'plan,' 'may,' 'should,' 'will,' 'shall,' 'would' other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the ability of our approved products, including Cortrophin Gel, ILUVIEN and YUTIQ, to achieve commercialization at levels of market acceptance that will continue to allow us to achieve profitability; our ability to complete or achieve any, or all of the intended benefits of acquisitions and investments, including the acquisition of Alimera, in a timely manner or at all; the limitation of our cash flow as a result of the indebtedness and liabilities incurred from the acquisition of Alimera; the risks that our acquisitions and investments, including the acquisition of Alimera, could disrupt our business and harm our financial position and operating results; delays and disruptions in production of our approved products, increased costs and potential loss of revenues if we need to change suppliers due to the limited number of suppliers for our raw materials, active pharmaceutical ingredients, expedients, and other materials; delays and disruptions in production of our approved products as a result of our reliance on single source third party contract manufacturing supply for certain of our key products, including Cortrophin Gel, ILUVIEN and YUTIQ; 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, United States Drug Enforcement Administration and other regulatory agencies, and the focus of the current U.S. presidential administration, including among other things, drug recalls, regulatory approvals, facility inspections and potential enforcement actions; 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, including increased costs due to tariffs; the ability of our manufacturing partners to meet our product demands and timelines; the impact of changes or fluctuations in exchange rates; our ability to develop, license or acquire, and commercialize new products; our obligations in agreements under which we license, develop or commercialize rights to products or technology from third parties and our ability to maintain such licenses; 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; 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 in the Middle East, conflicts related to the attacks on cargo ships in the Red Sea, and the effects and duration of outbreaks of public health emergencies. 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 Relations:Lisa M. Wilson, In-Site Communications, Inc.T: 212-452-2793E: lwilson@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
09-05-2025
- Business
- Yahoo
ANI Pharmaceuticals (NASDAQ:ANIP) Reports Strong Q1, Full-Year Outlook Slightly Exceeds Expectations
Specialty pharmaceutical company ANI Pharmaceuticals (NASDAQ:ANIP) reported Q1 CY2025 results exceeding the market's revenue expectations , with sales up 43.4% year on year to $197.1 million. The company's full-year revenue guidance of $780.5 million at the midpoint came in 1.4% above analysts' estimates. Its non-GAAP profit of $1.70 per share was 23% above analysts' consensus estimates. Is now the time to buy ANI Pharmaceuticals? Find out in our full research report. Revenue: $197.1 million vs analyst estimates of $179.6 million (43.4% year-on-year growth, 9.8% beat) Adjusted EPS: $1.70 vs analyst estimates of $1.38 (23% beat) Adjusted EBITDA: $50.75 million vs analyst estimates of $42.4 million (25.7% margin, 19.7% beat) The company lifted its revenue guidance for the full year to $780.5 million at the midpoint from $766 million, a 1.9% increase Management raised its full-year Adjusted EPS guidance to $6.45 at the midpoint, a 2.2% increase EBITDA guidance for the full year is $200 million at the midpoint, above analyst estimates of $195.8 million Operating Margin: 13.3%, down from 14.8% in the same quarter last year Market Capitalization: $1.45 billion 'We are pleased to report another strong quarter, with record revenue, adjusted EBITDA and adjusted EPS driven by continued strong demand for Cortrophin Gel, exceptional performance for our Generics business, and increased demand for our Brands portfolio,' said Nikhil Lalwani, President and CEO of ANI. With a diverse portfolio of 116 pharmaceutical products and a growing rare disease platform, ANI Pharmaceuticals (NASDAQ:ANIP) develops, manufactures, and markets branded and generic prescription pharmaceuticals, with a focus on rare disease treatments. Reviewing a company's long-term sales performance reveals insights into its quality. Any business can have short-term success, but a top-tier one grows for years. Over the last five years, ANI Pharmaceuticals grew its sales at an exceptional 27.1% compounded annual growth rate. Its growth beat the average healthcare company and shows its offerings resonate with customers. We at StockStory place the most emphasis on long-term growth, but within healthcare, a half-decade historical view may miss recent innovations or disruptive industry trends. ANI Pharmaceuticals's annualized revenue growth of 37.1% over the last two years is above its five-year trend, suggesting its demand was strong and recently accelerated. This quarter, ANI Pharmaceuticals reported magnificent year-on-year revenue growth of 43.4%, and its $197.1 million of revenue beat Wall Street's estimates by 9.8%. Looking ahead, sell-side analysts expect revenue to grow 16.2% over the next 12 months, a deceleration versus the last two years. Despite the slowdown, this projection is commendable and implies the market sees success for its products and services. Unless you've been living under a rock, it should be obvious by now that generative AI is going to have a huge impact on how large corporations do business. While Nvidia and AMD are trading close to all-time highs, we prefer a lesser-known (but still profitable) stock benefiting from the rise of AI. Click here to access our free report one of our favorites growth stories. Operating margin is one of the best measures of profitability because it tells us how much money a company takes home after subtracting all core expenses, like marketing and R&D. ANI Pharmaceuticals was roughly breakeven when averaging the last five years of quarterly operating profits, lousy for a healthcare business. On the plus side, ANI Pharmaceuticals's operating margin rose by 3.4 percentage points over the last five years, as its sales growth gave it operating leverage. The company's two-year trajectory shows its performance was mostly driven by its recent improvements. In Q1, ANI Pharmaceuticals generated an operating profit margin of 13.3%, down 1.5 percentage points year on year. This reduction is quite minuscule and indicates the company's overall cost structure has been relatively stable. We track the long-term change in earnings per share (EPS) for the same reason as long-term revenue growth. Compared to revenue, however, EPS highlights whether a company's growth is profitable. ANI Pharmaceuticals's EPS grew at an unimpressive 3.5% compounded annual growth rate over the last five years, lower than its 27.1% annualized revenue growth. However, its operating margin actually expanded during this time, telling us that non-fundamental factors such as interest expenses and taxes affected its ultimate earnings. We can take a deeper look into ANI Pharmaceuticals's earnings to better understand the drivers of its performance. A five-year view shows ANI Pharmaceuticals has diluted its shareholders, growing its share count by 68.4%. This dilution overshadowed its increased operating efficiency and has led to lower per share earnings. Taxes and interest expenses can also affect EPS but don't tell us as much about a company's fundamentals. In Q1, ANI Pharmaceuticals reported EPS at $1.70, up from $1.21 in the same quarter last year. This print easily cleared analysts' estimates, and shareholders should be content with the results. Over the next 12 months, Wall Street expects ANI Pharmaceuticals's full-year EPS of $5.69 to grow 13.1%. We were impressed by how significantly ANI Pharmaceuticals blew past analysts' revenue, EPS, and EBITDA expectations this quarter. We were also glad it raised it full-year guidance across all three metrics. Zooming out, we think this was a solid "beat-and-raise" quarter. The stock traded up 4.2% to $74.69 immediately following the results. ANI Pharmaceuticals may have had a good quarter, but does that mean you should invest right now? If you're making that decision, you should consider the bigger picture of valuation, business qualities, as well as the latest earnings. We cover that in our actionable full research report which you can read here, it's free.
Yahoo
09-05-2025
- Business
- Yahoo
Cortrophin Demand Is Soaring For ANI Pharma, CEO Says Well-Positioned To Mitigate Potential Tariff Impact
ANI Pharmaceuticals Inc (NASDAQ:ANIP) reported first-quarter adjusted earnings of $1.70 per share on Friday, up from $1.21 a year ago, beating the consensus of $1.38 per share. The company reported sales of $197.12 million, up 43.4% year over year, beating the consensus of $180.68 million. On an organic basis, excluding the acquisition of Alimera, total net revenues grew 31.7% year-over-year. Net revenues for rare diseases, which include Cortrophin gel, Iluvien, and Yutiq, increased by 86.7% to $69.0 million. Cortrophin Gel net revenues increased 43.1% to $52.9 million, driven by increased the quarter, the company saw increasing demand with the highest number of new patient starts and new cases initiated since launch. Cortrophin Gel experienced growth across existing and new prescribers, and ANI continued to expand the overall base of Cortrophin Gel prescribers. Iluvien and Yutiq generated net revenues of $16.1 million. Performance for retina assets outside the U.S. was in line with expectations. Performance in the U.S. was impacted by reduced access for Medicare patients due to a lack of funding for third-party co-pay assistance programs, turnover in our sales force, and seasonality. Brands' net revenues decreased 2.2% to $25.1 million, driven by a modest net decrease in volume. Net revenues for Generic pharmaceutical products increased 40.5% to $98.7 million, driven by increased volumes in the base business and contributions from new product launches. Reported gross margin decreased from 64.2% to 62.9%. Adjusted gross margin decreased from 64.4% to 63.1%, primarily due to mix, including significant growth of royalty-bearing products, including Cortrophin Gel. Nikhil Lalwani, President and CEO, commented, 'Based on our first quarter performance and favorable demand trends for Cortrophin Gel and our Generics and Brands portfolio, we are raising our 2025 guidance for total revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP EPS. While we await more visibility on potential pharmaceutical industry-specific tariffs, we believe we are well-positioned based on our strong U.S. footprint with over 90% of our revenues coming from finished goods manufactured in the U.S. and less than 5% of our revenues with direct reliance on China.' Guidance: ANI Pharmaceuticals raised its 2025 revenue guidance from $756 million to $776 million to $768 million to $793 million, versus the consensus of $769.64 million. The company expects adjusted EBITDA of $195 million to $205 million compared to prior guidance of $190 million to $200 million. ANI Pharmaceuticals expects 2025 adjusted EPS of $6.27 to $6.62 versus prior guidance of $6.12 to $6.49 and a consensus of $6.34. Price Action: ANIP stock is down 4.95% to $67.99 at the last check on A Recession, These Waste Management Stocks Have Outperformed S&P 500 Historically Image by JHVEPhoto via Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? ANI PHARMACEUTICALS (ANIP): Free Stock Analysis Report This article Cortrophin Demand Is Soaring For ANI Pharma, CEO Says Well-Positioned To Mitigate Potential Tariff Impact originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
Yahoo
23-04-2025
- Business
- Yahoo
Zacks.com featured highlights include ANI Pharmaceuticals, Heritage Insurance, Avista and Exelon
Chicago, IL – April 23, 2025 – Stocks in this week's article are ANI Pharmaceuticals ANIP, Heritage Insurance HRTG, Avista AVA and Exelon EXC Stocks hitting their 52-week high and delivering consistent performance offer attractive opportunities to investors while building a portfolio. This is because stocks near that level are perceived to be winners. However, stocks touching a new 52-week high are often predisposed to profit-taking, resulting in pullbacks and trend reversals. Moreover, given the high price, investors often wonder if the stock is overpriced. While the speculations are not absolutely baseless, all stocks hitting a 52-week high are not necessarily overpriced. In fact, investors might lose out on top gainers in an attempt to avoid the steep prices. Stocks such as ANI Pharmaceuticals, Heritage Insurance, Avista and Exelon are expected to maintain their momentum and keep scaling new highs. Extensive information on a stock is necessary to understand whether or not there is scope for further upside. Here, we discuss a strategy to find the right stocks. The strategy borrows from the basics of momentum investing. This technique bets on "buy high, sell higher." Many times, stocks that hit a 52-week high fail to scale higher despite having potential. This is because investors fear that the stocks are overvalued and expect the price to crash. In fact, overvaluation is natural for most of these stocks as investors' focus (or willingness to pay a premium) has helped them reach the level. But that does not always indicate an impending decline. Factors such as robust sales, surging profit levels, earnings growth prospects and strategic acquisitions that encourage investors to bet on these stocks could keep them motivated if there is no tangible negative. In other words, the momentum might continue. Also, when a string of positive developments dominates the market, investors find their under-reaction unwarranted, even if there are no company-specific driving forces. Here are four stocks that made it through the screen: ANI Pharmaceuticals represents a compelling investment opportunity in 2025 as it strategically strengthens its Rare Disease portfolio and enhances financial flexibility. The company recently boosted 2025 revenue guidance to $756-776 million with Rare Disease products representing nearly half of total revenues. Its lead asset, Cortrophin Gel, delivered record quarterly revenues of $59.4 million with impressive 42.3% year-over-year growth. The ILUVIEN/YUTIQ ophthalmology franchise shows significant expansion potential following the FDA approval for chronic NIU-PS and the elimination of a perpetual royalty obligation. With strong adjusted EBITDA growth of 66% to $50 million, robust commercial execution, and strategic investments in supply security, ANI is positioned for accelerated growth in high-value therapeutic areas while maintaining strong cash flow generation. The Zacks Consensus Estimate for ANIP's 2025 earnings has remained steady at $6.34 per share in the past 30 days. The company surpassed the Zacks Consensus Estimate in the trailing four quarters, the average surprise being 17.32%. Heritage Insurance's growing commercial residential business, expanding E&S business and improving pricing are expected to deliver better margins and boost earnings. Rate adequacy, selective profit-oriented underwriting criteria and restricting new business in over-concentrated markets or products should drive profitability for Heritage Insurance. HRTG focuses on selective underwriting. There has been a decline in policy count, though average premiums per policy increased. However, HRTG expects the headwind from declining policies to begin to moderate over the next few quarters. The excess and supply (E&S) business is another growth lever for Heritage. HRTG stated that it will consider and evaluate growth opportunities in a greater number of states. Its reinsurance program shields Heritage Insurance from exposure to hurricanes and other severe weather events in the coastal area. The insurer expects a substantial reduction in the ceded premium ratio, given a combination of improvements in the reinsurance program from a cost and structure standpoint and growing gross premiums earned. The Zacks Consensus Estimate for HRTG's 2025 earnings has moved north by 8% to $2.43 per share in the past 30 days. The company surpassed the Zacks Consensus Estimate in three of the trailing four quarters while missing the same once, the average surprise being 328.63%. Avista's strategic capital expenditures help it improve its transmission and distribution and generation capacity. This should enhance its overall performance. Regulatory approvals for new electric rates help the company boost its top line. Given its growth opportunities, Avista makes for a solid investment option in the utility sector. The company has been consistently increasing the value of its shareholders through dividends. It expects a dividend CAGR of 3.8% through 2025 (from 2021 baseline). Currently, Avista's quarterly dividend is 49 cents per share. This represents an annualized dividend of $1.96 per share, up 3.2% from the previous level. The company expects a targeted annual dividend payout ratio of 65-75%. Its current dividend yield is 4.94%, better than the Zacks S&P 500 composite's average of 1.3%. The company expects to invest nearly $2.98 billion during 2025-2029 in infrastructure upgrades. Nearly 48% of the total investments during 2025-2027 are for transmission and distribution. Avista expects an annual rate base growth of 5-6% during 2025-2029, driven by its capital expenditures. The Zacks Consensus Estimate for AVA's 2025 earnings has moved north by 2% to $2.61 per share in the past 30 days. The company surpassed the Zacks Consensus Estimate twice in the trailing four quarters while missing the same twice, the average surprise being 31.26%. Exelon's investment will strengthen its transmission and distribution infrastructure and assist in providing reliable services to customers. Exelon's initiatives in grid modernization are going to improve the resilience of its operations and revenue decoupling mitigates the impact of load fluctuation. Stable cash flow allows the company to pay regular dividends. The development of data centers is going to increase demand. Our model projects revenues to increase year over year in the 2025-2027 period. Exelon invests substantially in infrastructure projects and plans to invest nearly $38 billion during 2025-2028 in regulated utility operations. The new capital expenditure indicates a 10% increase from the prior plan and will be utilized to support customer needs and grid reliability. The company is set to invest $21.7 billion in electric distribution, $12.6 billion in electric transmission and $3.8 billion in gas delivery in the 2025-2028 period. The Zacks Consensus Estimate for EXC's 2025 earnings has moved north by a penny to $2.66 per share in the past 30 days. The company surpassed the Zacks Consensus Estimate in three of the trailing four quarters while missing the same once, the average surprise being 7.63%. The Research Wizard is a great place to begin. It's easy to use. Everything is in plain language. And it's very intuitive. Start your trial to the Research Wizard today. And the next time you read an economic report, open up the Research Wizard, plug your finds in, and see what gems come out. Click here to sign up for a free trial to the Research Wizard today. For the rest of this Screen of the Week article please visit at: Disclosure: Officers, directors and/or employees of Zacks Investment Research may own or have sold short securities and/or hold long and/or short positions in options that are mentioned in this material. An affiliated investment advisory firm may own or have sold short securities and/or hold long and/or short positions in options that are mentioned in this material. About Screen of the Week created the first and best screening system on the web earning the distinction as the "#1 site for screening stocks" by Money Magazine. But powerful screening tools is just the start. That is why Zacks created the Screen of the Week to highlight profitable stock picking strategies that investors can actively use. Strong Stocks that Should Be in the News Many are little publicized and fly under the Wall Street radar. They're virtually unknown to the general public. Yet today's 220 Zacks Rank #1 "Strong Buys" were generated by the stock-picking system that has more than doubled the market from 1988 through 2016. Its average gain has been a stellar +25% per year. See these high-potential stocks free >>. Follow us on Twitter: Join us on Facebook: Zacks Investment Research is under common control with affiliated entities (including a broker-dealer and an investment adviser), which may engage in transactions involving the foregoing securities for the clients of such affiliates. Contact: Jim Giaquinto Company: Phone: 312-265-9268 Email: pr@ Visit: provides investment resources and informs you of these resources, which you may choose to use in making your own investment decisions. Zacks is providing information on this resource to you subject to the Zacks "Terms and Conditions of Service" disclaimer. Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit information about the performance numbers displayed in this press release. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Exelon Corporation (EXC) : Free Stock Analysis Report Avista Corporation (AVA) : Free Stock Analysis Report ANI Pharmaceuticals, Inc. (ANIP) : Free Stock Analysis Report Heritage Insurance Holdings, Inc. (HRTG) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio
Yahoo
28-02-2025
- Business
- Yahoo
ANI Pharmaceuticals (NASDAQ:ANIP) Delivers Impressive Q4, Stock Soars
Specialty pharmaceutical company ANI Pharmaceuticals (NASDAQ:ANIP) announced better-than-expected revenue in Q4 CY2024, with sales up 44.8% year on year to $190.6 million. The company's full-year revenue guidance of $766 million at the midpoint came in 5.7% above analysts' estimates. Its non-GAAP profit of $1.63 per share was 13.6% above analysts' consensus estimates. Is now the time to buy ANI Pharmaceuticals? Find out in our full research report. Revenue: $190.6 million vs analyst estimates of $175.6 million (44.8% year-on-year growth, 8.5% beat) Adjusted EPS: $1.63 vs analyst estimates of $1.44 (13.6% beat) Adjusted EBITDA: $50.04 million vs analyst estimates of $44.42 million (26.3% margin, 12.7% beat) Management's revenue guidance for the upcoming financial year 2025 is $766 million at the midpoint, beating analyst estimates by 5.7% and implying 24.7% growth (vs 26.1% in FY2024) Adjusted EPS guidance for the upcoming financial year 2025 is $6.31 at the midpoint, beating analyst estimates by 13.4% EBITDA guidance for the upcoming financial year 2025 is $195 million at the midpoint, above analyst estimates of $186 million Operating Margin: -2.3%, down from 5.1% in the same quarter last year Market Capitalization: $1.07 billion Nikhil Lalwani, President and CEO of ANI stated, 'We're thrilled to report another year of strong execution for ANI, capped by our record fourth quarter results, with total net revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted EPS all finishing above our previously announced guidance for the full year. Cortrophin Gel generated nearly $200 million in sales during 2024, in just the third year since launch, and our Generics business delivered its third straight year of double-digit growth. In addition, we expanded our Rare Disease business with the addition of the durable ophthalmology franchise of ILUVIEN and YUTIQ, through the acquisition of Alimera Sciences in September.' Founded in 2001, ANI Pharmaceuticals (NASDAQ:ANIP) develops, manufactures, and markets branded and generic pharmaceutical products, with a focus on complex formulations and niche markets. The generic pharmaceutical industry operates on a volume-driven, low-cost business model, producing bioequivalent versions of branded drugs once their patents expire. These companies benefit from consistent demand for affordable medications, as they are critical to reducing healthcare costs. Generics typically face lower R&D expenses and shorter regulatory approval timelines compared to branded drug makers, enabling cost efficiencies. However, the industry is highly competitive, with intense pricing pressures, thin margins, and frequent legal challenges from branded pharmaceutical companies over patent disputes. Looking ahead, the industry is supported by tailwinds such as the role of AI in streamlining drug development (reverse engineering complex formulations) and manufacturing efficiency (optimize processes and remove inefficiencies). Governments and insurers' focus on reducing drug costs can also boost generics' adoption. However, headwinds include escalating pricing pressure from large buyers like pharmacy chains and healthcare distributors as well as evolving regulatory hurdles. A company's long-term sales performance can indicate its overall quality. Any business can put up a good quarter or two, but many enduring ones grow for years. Luckily, ANI Pharmaceuticals's sales grew at an excellent 24.4% compounded annual growth rate over the last five years. Its growth beat the average healthcare company and shows its offerings resonate with customers. Long-term growth is the most important, but within healthcare, a half-decade historical view may miss new innovations or demand cycles. ANI Pharmaceuticals's annualized revenue growth of 39.4% over the last two years is above its five-year trend, suggesting its demand was strong and recently accelerated. This quarter, ANI Pharmaceuticals reported magnificent year-on-year revenue growth of 44.8%, and its $190.6 million of revenue beat Wall Street's estimates by 8.5%. Looking ahead, sell-side analysts expect revenue to grow 17.4% over the next 12 months, a deceleration versus the last two years. Despite the slowdown, this projection is noteworthy and suggests the market is baking in success for its products and services. Here at StockStory, we certainly understand the potential of thematic investing. Diverse winners from Microsoft (MSFT) to Alphabet (GOOG), Coca-Cola (KO) to Monster Beverage (MNST) could all have been identified as promising growth stories with a megatrend driving the growth. So, in that spirit, we've identified a relatively under-the-radar profitable growth stock benefiting from the rise of AI, available to you FREE via this link. ANI Pharmaceuticals's high expenses have contributed to an average operating margin of negative 2.4% over the last five years. Unprofitable healthcare companies require extra attention because they could get caught swimming naked when the tide goes out. It's hard to trust that the business can endure a full cycle. On the plus side, ANI Pharmaceuticals's operating margin rose by 7.8 percentage points over the last five years, as its sales growth gave it operating leverage. This performance was mostly driven by its recent improvements as the company's margin has increased by 11.2 percentage points on a two-year basis. In Q4, ANI Pharmaceuticals generated a negative 2.3% operating margin. The company's consistent lack of profits raise a flag. We track the long-term change in earnings per share (EPS) for the same reason as long-term revenue growth. Compared to revenue, however, EPS highlights whether a company's growth is profitable. ANI Pharmaceuticals's flat EPS over the last five years was below its 24.4% annualized revenue growth. However, its operating margin actually expanded during this time, telling us that non-fundamental factors such as interest and taxes affected its ultimate earnings. Diving into the nuances of ANI Pharmaceuticals's earnings can give us a better understanding of its performance. A five-year view shows ANI Pharmaceuticals has diluted its shareholders, growing its share count by 63.6%. This dilution overshadowed its increased operating efficiency and has led to lower per share earnings. Taxes and interest expenses can also affect EPS but don't tell us as much about a company's fundamentals. In Q4, ANI Pharmaceuticals reported EPS at $1.63, up from $0.98 in the same quarter last year. This print easily cleared analysts' estimates, and shareholders should be content with the results. Over the next 12 months, Wall Street expects ANI Pharmaceuticals's full-year EPS of $5.13 to grow 4.5%. We were impressed by how significantly ANI Pharmaceuticals blew past analysts' revenue expectations this quarter. We were also excited its full-year EPS guidance outperformed Wall Street's estimates by a wide margin. Zooming out, we think this was a good quarter with some key areas of upside. The stock traded up 8.3% to $59.10 immediately following the results. Sure, ANI Pharmaceuticals had a solid quarter, but if we look at the bigger picture, is this stock a buy? When making that decision, it's important to consider its valuation, business qualities, as well as what has happened in the latest quarter. We cover that in our actionable full research report which you can read here, it's free. Sign in to access your portfolio
