Latest news with #Liraglutide
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Business Standard
4 days ago
- Business
- Business Standard
Biocon Q1 results: Net profit down 95%, revenue rises 15% to ₹4,022 cr
Bengaluru-based biopharma company Biocon on Thursday reported a 95.2 per cent year-on-year (Y-o-Y) decline in consolidated net profit at Rs 31 crore in the first quarter of FY26, compared to Rs 660 crore in the same period last year. The Q1 FY25 profit included a one-time divestment gain, impacting this year's base. The company posted profit before tax (PBT) of Rs 97 crore, down 91.3 per cent Y-o-Y in Q1 FY26. Consolidated revenue rose 15 per cent to Rs 4,022 crore on a like-for-like basis after adjusting for the one-time gain in the base quarter. Operating revenue increased 15 per cent to Rs 3,942 crore in Q1 FY26, up from Rs 3,433 crore in Q1 FY25. EBITDA stood at Rs 829 crore, up 19 per cent, with a maintained margin of 21 per cent. 'Biocon opened FY26 with a strong performance, driven by continued gains in biosimilars and CRDMO, and a steady showing in generics. The recent QIP has strengthened our balance sheet and enables us to increase our ownership in Biocon Biologics by facilitating the exit of structured equity investors, aligning capital structure with long-term strategic priorities,' said Kiran Mazumdar-Shaw, chairperson, Biocon Group. During the quarter, key developments included the launch of Yesafili in Canada and US Food and Drug Administration (FDA) approval for Insulin Aspart—marking Biocon's second interchangeable biosimilar insulin. The generics business reported revenue of Rs 697 crore, a 6 per cent Y-o-Y increase, supported by new launches such as Liraglutide in the EU and Dasatinib and Lenalidomide in the US, along with higher volumes in the API segment. 'The sequential financial performance reflects the one-time positive impact of Lenalidomide launch quantities in Q4 FY25. Capitalisation of new manufacturing facilities in the previous fiscal impacted margins. We remain focused on launching new products, including the commercialisation of Liraglutide across key strategic markets,' said Siddharth Mittal, chief executive officer and managing director, Biocon Limited. Biocon Biologics, the group's biosimilars business, reported revenue of Rs 2,458 crore, up 18 per cent Y-o-Y. EBITDA rose 36 per cent on a like-for-like basis to Rs 645 crore, with a 300-basis-point sequential margin improvement, driven by improved operating leverage. With regulatory approvals for its Denosumab products—Vevzuo and Efraxy—in Europe and the UK, Biocon Biologics now has a global portfolio of 12 approved biosimilar molecules. 'The US FDA approval of Kirsty™ (bAspart) builds on the strong foundation established with Semglee (bInsulin Glargine), enabling us to offer patients the full range of affordable short- and long-acting insulin therapies. The launch of Yesafili (bAflibercept) in Canada marked our entry into ophthalmology and the successful commercialisation of our 10th biosimilar globally. As we enter the 'Accelerate' phase, we are confident in our ability to scale, deepen market presence, and deliver sustained growth,' said Shreehas Tambe, chief executive officer and managing director, Biocon Biologics Limited. The CRDMO business, Syngene, reported revenue of Rs 875 crore, up 11 per cent Y-o-Y, driven by continued momentum in research services as pilot programmes transitioned into long-term contracts. 'In biologics manufacturing, operations have commenced at our Unit III facility in Bengaluru, and preparations are advancing for the Bayview facility in the US, scheduled to launch later this year. With a positive first quarter start and strategic investments in scientific capabilities, we remain confident in our ability to deliver on our guidance for the year,' said Peter Bains, CEO and managing director, Syngene International. In the US, Biocon launched Micafungin, an injectable echinocandin anti-fungal for treating and preventing a range of fungal and yeast infections, along with Everolimus (Zortress) tablets, indicated for the prevention of kidney and liver transplant rejection. Final approval was also received for Rivaroxaban tablets, used in treating deep vein thrombosis in adults. Domestically, Biocon received approval for Liraglutide (gVictoza) under the Government of India's newly introduced 'Reliance on Recognised Regulatory Authorities' framework, which acknowledges approvals granted by established global regulators. This marks Biocon's first Indian approval for its vertically integrated GLP-1 drug product. Preparations for launch are underway with commercialisation partners. In Bengaluru, the oral solid dosage facility underwent an EU-GMP inspection by the Malta Medicines Authority, which issued one major observation. A response has been submitted, according to the company. Biocon highlighted that its emerging markets business remained robust, driven by a sharper focus on eight high-impact, self-led markets, which delivered a notable increase in revenue contribution in Q1 FY26. The company executed 12 product launches from its existing portfolio across the region and secured several strategic regulatory approvals. It also continued to file new product applications, laying the foundation for future growth.
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Business Standard
5 days ago
- Business
- Business Standard
Gland Pharma shares jump 6% post Q1 show; should you buy, sell or hold?
Gland Pharma share price today: Shares of pharmaceutical company, Gland Pharma, jumped over 6 per cent on Wednesday, August 6, 2025, hitting an intraday high of ₹2,089.40. At 9:35 AM, Gland Pharma shares were trading at ₹2,004.1, up over 2 per cent on the National Stock Exchange. In comparison, Nifty50 was trading largely flat, albeit with a negative bias, quoting 24,631.90 level, down by 17 points or 0.07 per cent. The shares of the company were trading just 6 per cent lower when compared to 52-week high of ₹2,220. The total market capitalisation of the company stood at ₹32,974.35 crore. The buying interest on the counter came after the company released its earnings for the first quarter of the financial year 2025-2026 (Q1FY26). Gland Pharma Q1FY26 earnings The pharma company's profit after tax (PAT) for the quarter ended June 30, 2025, stood at ₹215 crore, up 50 per cent from ₹143 crore reported in the corresponding quarter of the previous fiscal year. Consolidated revenue from operations figures stood at ₹1,505 crore in Q1FY26, as against ₹1,401 crore reported in the year-ago period, marking a rise of 7 per cent. Earnings before interest, taxes, depreciation and amortisation (Ebitda) figure advanced 39 per cent to ₹367 crore during the quarter under review as compared to ₹265 crore reported in the first quarter of the last fiscal year. PAT margins stood at 14 per cent in Q1FY26. The figure stood at 10 per cent in the year-ago period. That apart, the company launched 12 new molecules in regulated markets, including Colistimethate, Epinephrine, Vancomycin (three new strengths), Liraglutide and Acetaminophen Bags. 'This quarter's performance, with improved margins and Cenexi achieving Ebitda break even, reinforces the progress we are making in delivering our long-term vision. By enhancing our base business, investing in differentiated products, and driving operational efficiencies, we are positioning ourselves for sustained growth," said Shyamakant Giri, chief executive officer of Gland Pharma. What should investors do? The pharma company reported a strong double-digit rise in earnings after four quarters of consecutive decline. While the company's core market sales remained moderate, analysts at Motilal Oswal Financial Services believe that new launches will improve the outlook for the coming quarters. The brokerage firm has maintained a 'Buy' rating on the stock with a target price (TP) of ₹2,340. "After three years of earnings decline, we expect a compound annual growth rate (CAGR) of 14 per cent/20 per cent/27 per cent in revenue/Ebitda/Pat over FY25-27. Gland is fortifying its positioning in the complex injectable space through in-house product development as well as partnerships. It is in the process of adding capacity to cater to upcoming GLP-1 opportunities as well. Considering 1Q earnings growth and valuation, we maintain 'BUY' on the stock," the brokerage firm said. However, Ravi Singh, SVP-retail research at Religare Broking, has called for a cautious stance, saying that existing investors should wait for an extended price action. "On the weekly chart, the stock has strong resistance around ₹2,220 level, which can act as selling pressure and buyers may get trapped, so traders should cautiously watch the price action near this level. Overall, for now sentiments remain on the sideways to positive side with levels to be focused, existing investors can trail their positions to cost or book some profit near the immediate resistance of ₹2,120 and fresh positions can be recommended once it sustains above ₹2,120-₹2,150 level," said Ravi Singh.
Business Standard
6 days ago
- Business
- Business Standard
Gland Pharma Q1 profit jumps 50% on core growth, Cenexi turnaround
Hyderabad-based Gland Pharma reported a 50 per cent increase in its consolidated net profit year-on-year (Y-o-Y), reaching ₹215 crore for the first quarter of the financial year (Q1FY26). Revenue from operations rose 7 per cent Y-o-Y to ₹1,505 crore. The growth was driven by robust performance in its core business and a successful turnaround at Cenexi, a French pharmaceutical contract development and manufacturing organisation (CDMO) specialising in sterile injectable and lyophilised drug products, which Gland Pharma acquired in 2023. Sequentially, the company's net profit rose by 15 per cent, and revenue increased by 6 per cent. 'We're off to a positive start this year with growth in revenue and a jump in profitability. Our strategic priorities are progressing and we are strengthening our capabilities, adding new capacity, and boosting R&D with complex products and key partnerships,' said Srinivas Sadu, executive chairman, Gland Pharma. 'By enhancing our base business, investing in differentiated products and driving operational efficiencies, we are positioning ourselves for sustained growth. Our focus on adherence to global quality standards and investment in capability building position us to scale further, tap new markets and deliver long-term value,' said Shyamakant Giri, chief executive officer, Gland Pharma. During the quarter, research and development (R&D) expenses stood at ₹46 crore, accounting for 4.4 per cent of revenue. The company launched 12 new molecules in regulated markets, including Colistimethate, Epinephrine, Vancomycin (three new strengths), Liraglutide and Acetaminophen bags. One abbreviated new drug application (ANDA) was filed and nine were approved during the quarter, bringing cumulative US ANDA filings to 372 (325 approved and 47 pending). Its in-house complex pipeline saw six product launches, with three more awaiting approval. Complex injectables remain a key driver of long-term growth, with more products being added to the pipeline. Fifteen products are in co-development (seven under the 505(b)(2) pathway and eight ANDAs), with commercialisation expected to begin in FY28. One ready-to-use (RTU) infusion bag was filed this quarter, bringing the total RTU product filings in the US to 20 (14 approved). Another 10 are in development, targeting a $767 million market. The company expanded its GLP-1 portfolio, launching Liraglutide in the UK and Australia, and is increasing GLP-1/pen/cartridge capacity from 40 million to 140 million units. It also received a good manufacturing practice (GMP) compliance certificate from the Danish Medicines Agency for aseptically prepared powder for injection, infusion and inhalation. The results were announced after market hours. Gland Pharma's stock fell by 0.95 per cent, ending the day's trade at ₹1,962.30 per share on the BSE.
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Business Standard
6 days ago
- Business
- Business Standard
Eris Lifesciences to target insulin, semaglutide mkt opportunities in FY26
Ahmedabad-based Eris Lifesciences is looking to target opportunities in the nearly ₹5,000-crore Indian insulin market after Danish drugmaker Novo Nordisk announced a withdrawal of its insulin products in April this year. For Q1FY26, Eris Lifesciences recorded a 40 per cent year-on-year (Y-o-Y) rise in consolidated profit after tax (PAT) to ₹125 crore. Revenue rose to ₹773 crore during the June quarter against ₹720 crore in the year-ago period. 'We expect that Novo's cartridge inventory in the market will run out by October. So this market opportunity is something that one can start monetising from the November-December time frame,' the company's executive director and chief executive officer (CEO) Krishnakumar Vaidyanathan told Business Standard. He added that the timing fits Eris' plans as its Bhopal unit's cartridge filling capability will start getting operational from January. Vial manufacturing has already been commissioned at the Bhopal unit, with the company creating a strategic stock of insulins. This comes at a time when Eris already is the largest domestic player in insulin. The company had last year acquired the India formulations business of Biocon Biologics last year, including established insulin brands Basalog and Insugen. 'Before the Biocon deal, we had a couple of homegrown insulin brands in the market, which did a combined ₹60 crore in revenue last year. Basalog and Insugen had combined revenues of ₹200 crore at the time of acquisition,' he said. He added that with this, the company's insulin franchise has become really large with a 10 per cent market share. Eris is also among the prominent drugmakers looking to roll out generic versions of blockbuster molecule semaglutide once its patent expires around March next year. Semaglutide is a GLP-1 (glucagon-like peptide 1) receptor agonist that is used as an active pharmaceutical ingredient in medications for obesity management and Type-II diabetes. According to Eris' investor presentation for the June quarter of the financial year 2025-26 (Q1FY26), the company is on track to be among the first launches in India in March 2026. The company has initiated validation of synthetic semaglutide cartridges at its European Union (EU)-approved AMD injectables site. 'We are also planning the validation of the recombinant semaglutide in our Bhopal plant later this year,' he added. As far as the go-to market is concerned, the company said it is already in a strong position because of its dominant position in insulins and prior presence in the GLP market with the launch of Liraglutide in September last year.
The Hindu
24-07-2025
- Business
- The Hindu
Lupin gets U.S. FDA nod for two generic diabetes drugs
Generic drugmaker Lupin has received U.S. Food and Drug Administration approval for its abbreviated new drug applications for Liraglutide Injection single-patient-use prefilled pens and Glucagon for injection vials. Both the products will be manufactured at the company's injectable facility in Nagpur, Lupin said. Liraglutide injection 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pen is bioequivalent to Novo Nordisk's Victoza injection and had an estimated annual sale of $458 million in the U.S, the company said citing IQVIA MAT May numbers. The drug is indicated to improve glycaemic control in adults and children, aged above 10 years, with type 2 diabetes mellitus. Glucagon for Injection USP, 1 mg/vial, is bioequivalent to Eli Lilly and Company's Glucagon for Injection, 1 mg/vial. It is indicated for treatment of severe hypoglycaemia in paediatric and adult patients with diabetes mellitus and as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. It had an estimated annual sale of $124 million in the U.S. Chief Scientific Officer Shahin Fesharaki said the two products are a meaningful enhancement to the company's portfolio.
