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Biocon share rises as arm secures UK MHRA nod for plaque psoriasis drug
Biocon share rises as arm secures UK MHRA nod for plaque psoriasis drug

Business Standard

time26-05-2025

  • Business
  • Business Standard

Biocon share rises as arm secures UK MHRA nod for plaque psoriasis drug

Biocon share price: Bengaluru-based pharmaceutical company Biocon shares rose as much as 1.14 per cent to hit an intraday high of ₹334.45 per share on Monday, May 26, 2025. At 9:36 AM, Biocon share price was trading 0.73 per cent higher at ₹333.05 per share. In comparison, BSE Sensex was trading 0.79 per cent higher at 82,363.10 level. Why did Biocon share price rise on Monday? Biocon share price rose after the company announced that Biocon Biologics, a fully integrated global biosimilars company and subsidiary of Biocon Ltd, has been granted market authorisation in the UK for Yesintek, a biosimilar of Ustekinumab, from the Medicines and Healthcare products Regulatory Agency (MHRA), UK. Yesintek is approved for the treatment of adults and children aged 6 years and older with moderate to severe plaque psoriasis, as well as adults with active psoriatic arthritis or moderately to severely active Crohn's disease. Clinical trials have shown that our Ustekinumab biosimilar delivers comparable safety and efficacy to the reference product. In Europe, the European Commission (EC) has recently granted marketing authorisation for Yesintek, enabling its commercialisation across all European Union (EU) member states and countries in the European Economic Area (EEA). Biocon Q4 results Biocon reported a 153 per cent year-on-year (Y-o-Y) jump in consolidated net profit to ₹344 crore for the fourth quarter of FY25, up from ₹136 crore in the same period last year. The company's profit before tax (PBT) rose 53 per cent Y-o-Y to ₹487 crore. Total consolidated revenue for the quarter stood at ₹4,454 crore, compared to ₹3,966 crore in Q4 FY24. Ebitda increased 16 per cent to ₹1,115 crore, with the Ebitda margin maintained at 25 per cent. The strong quarterly performance was driven by robust growth across its generics, biologics, and research services segments. Biocon's Board has also approved a proposal to raise up to ₹4,500 crore through various instruments, including qualified institutional placement (QIP), rights issue, or other permissible routes. READ MORE About Biocon Biocon is among the leading global biopharmaceutical companies committed to delivering affordable, high-quality medicines and innovative therapies for chronic and complex diseases such as diabetes, cancer, and autoimmune disorders. Operating in over 120 countries, Biocon has established a robust international presence. The company is a major player in the biosimilars segment, producing cost-effective alternatives to complex biologics like human insulin and insulin glargine.

Biocon sees mid-teens revenue growth on biosimilars, generics push
Biocon sees mid-teens revenue growth on biosimilars, generics push

Mint

time13-05-2025

  • Business
  • Mint

Biocon sees mid-teens revenue growth on biosimilars, generics push

Biocon Ltd expects its overall revenue to grow in mid-teens this financial year, and the company is betting on a robust launch pipeline in its generics as well as biosimilars businesses to drive sales in the coming years, its chief executive and managing director Siddharth Mittal said on Tuesday. The Bengaluru-based company expects mid-to-high teens growth for its generics as well as biosimilars businesses in FY26. The company's listed contract development and manufacturing organization (CDMO) arm Syngene is likely to report revenue growth in the mid-single digits this fiscal year, the company's management has guided. 'At a company level, you are looking at a blended mid-teens growth,' Mittal told Mint. 'We are on course to meeting our objectives…And I think there is huge opportunity in the years to come, so we are well placed,' Mittal said. 'There is a lot of focus on cost improvement, capacity expansions, various quality matrices, supply chains, etc," he added. Biocon Biologics, the company's biosimilars business, delivered a robust 9% year-on-year revenue growth to ₹ 2,463 crore in Q4FY25 on a like-for-like basis, driven by significant market share gains in the US. For the full fiscal year ended 31 March 2025, Biocon Biologics' revenues increased 15%, on a like-for-like basis, to ₹ 9,017 crore. The biosimilars business accounted for 58% of the company's overall revenue in FY25. Biocon Biologics had previously said that it would likely list itself on the stock exchanges by March 2026. However, the company said after its January-March earnings that its board is setting up a committee to evaluate strategic restructuring options, including a merger of its biosimilars arm Biocon Biologics Ltd with its listed parent Biocon Ltd. '…given the market volatility that we are seeing on the IPO front, the board was of the opinion that we should look at other strategic options which also includes evaluating a merger," Kiran Mazumdar-Shaw, chairperson, Biocon Group, told investors in an earnings call on Friday. 'This is an evaluation phase only, and all options will be carefully considered with the best interest of all stakeholders in mind,' Mittal told Mint. Overall, Biocon reported consolidated revenue of ₹ 4,454 crore in Q4FY25 (on a like-for-like basis), up 15% YoY, beating estimates. It reported an Ebitda (earnings before interest, taxes, depreciation, and amortization) of ₹ 1,115 crore for Q4FY25, up 16% YoY and a net profit of ₹ 344 crore, which jumped 153% over the previous year. The company's consolidated revenue for FY25 was ₹ 16,470 crore, up 5% from the previous year, while it reported an Ebitda of ₹ 4,374 crore and a net profit of ₹ 1,013 crore. Biocon's high net debt, however, remains a concern. 'As you are aware, the company has financial obligations of over $1.75 billion, we are evaluating various options to pare down this obligation," Mittal said. Biocon's board has approved raising up to ₹ 4,500 crore by way of issue of securities via qualified institutional placements (QIPs), rights issue, or other permissible routes, in one or more tranches, the company said. 'These funds will be used to meet financial commitments related to Biocon and its subsidiaries,' Mittal said. The company has sought shareholder approval for the fundraise via a postal ballot dated 2 May 2025. The company plans to complete the first tranche of equity sale by mid-June 2025. Four of Biocon Biologics' biosimilars in the US reported sales of $200 million each in FY25. The company also launched its fifth biosimilar product, and five new launches are expected over the next 12-18 months. The company will focus on a combination of launching new products as well as gaining more market share for the products which are already commercialised, Mittal said. Some of the company's biosimilars have gained significant market share in the US. 'Pegfilgrastim is at 30% market share, Trastuzumab is at 25-26% and Glargine is about 18%,' Mittal said. However, sluggish value accretion remains a concern, analysts at Kotak Institutional Equities said in a note. 'With five key launches planned over the next 12-18 months, including the recently launched Stelara, meaningful traction across these products remains critical for the company,' the analysts said. Biocon's generics business saw a boost, with revenues crossing ₹ 1,000 crore for the first time, driven by the sale of launch quantities of cancer drug Lenalidomide (Revlimid) in the US, as well as other products such as cancer drugs Dasatinib, and anti-diabetes medicine Liraglutide in the UK. Biocon supplied a large part of the initial allocated market share of Lenalidomide (according to the settlement with the innovator) in Q4FY25, and sales for the drug will remain lumpy until the market opens for unlimited volume generic launches in January 2026. 'You will see our revenue go down again in Q1FY26,' Mittal said. However, the company has several new launches planned for the year, and growth is expected to be driven by the launch of Liraglutide in Europe and other key markets, as well as other products like generic Copaxone, which the company soon hopes to get US FDA approval for. The company is betting big on the GLP-1 market, with Liraglutide first, and Semaglutide, which goes off-patent in some markets early next year. GLP-1, or glucagon-like peptide-1, is a hormone that regulates blood sugar levels and appetite. 'We have completed our development for Semaglutide and it has been charged on stability and we will be filing in early second quarter in various markets,' Mittal said. 'We are hoping that in the calendar year 2026, at least in some of the countries, regulators will review this in an expeditious manner and give us approval…but we really see a big impact coming in CY2027 onwards,' Mittal said. Semaglutide, a key weight loss drug by Novo Nordisk, marketed under brand names Ozempic and Wegovy, goes off-patent in countries like India, Canada, China and other emerging markets in early 2026. While many Indian drugmakers are racing to launch Semaglutide in India early next year, Biocon is anticipating a launch sometime mid-next-year. It will first launch Liraglutide, another GLP-1, in India this year.

Biocon Biologics secures multiple market access agreements in US for Yesintek
Biocon Biologics secures multiple market access agreements in US for Yesintek

Time of India

time05-05-2025

  • Business
  • Time of India

Biocon Biologics secures multiple market access agreements in US for Yesintek

New Delhi: Biocon Ltd on Monday said its arm Biocon Biologics Ltd has secured multiple market access agreements in the US for its biosimlar, Yesintek, that has been approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. Yesintek (ustekinumab-kfce), is biosimilar to Stelara (ustekinumab). #Pahalgam Terrorist Attack Inside Operation Tupac: Pakistan's secret project to burn Kashmir Who is Asim Munir, the Zia-style general shaping Pakistan's faith-driven military revival 'Looking for partners, not preachers': India's strong message for EU amid LoC tensions "The market access agreements from numerous plans represent over 100 million lives in the United States," Biocon said in a regulatory filing. "Yesintek represents an important milestone for Biocon Biologics, as this is the first product we have launched in the United States as a fully integrated biosimilars company," Biocon Biologics CEO & Managing Director Shreehas Tambe said. Play Video Pause Skip Backward Skip Forward Unmute Current Time 0:00 / Duration 0:00 Loaded : 0% 0:00 Stream Type LIVE Seek to live, currently behind live LIVE Remaining Time - 0:00 1x Playback Rate Chapters Chapters Descriptions descriptions off , selected Captions captions settings , opens captions settings dialog captions off , selected Audio Track Picture-in-Picture Fullscreen This is a modal window. Beginning of dialog window. Escape will cancel and close the window. Text Color White Black Red Green Blue Yellow Magenta Cyan Opacity Opaque Semi-Transparent Text Background Color Black White Red Green Blue Yellow Magenta Cyan Opacity Opaque Semi-Transparent Transparent Caption Area Background Color Black White Red Green Blue Yellow Magenta Cyan Opacity Transparent Semi-Transparent Opaque Font Size 50% 75% 100% 125% 150% 175% 200% 300% 400% Text Edge Style None Raised Depressed Uniform Drop shadow Font Family Proportional Sans-Serif Monospace Sans-Serif Proportional Serif Monospace Serif Casual Script Small Caps Reset restore all settings to the default values Done Close Modal Dialog End of dialog window. He further said,"the strong adoption of Yesintek... in the US reflects their confidence in our science, supply reliability, and commercial capability. The listing of Yesintek on multiple formularies is another validation that payors in the US are committed to broaden access to affordable treatment options." Biocon Biologics said Express Scripts has added Yesintek to the National Preferred Formulary (NPF) effective March 21, 2025, while Cigna has added the biosimilar to its commercial formulary beginning on March 21, 2025. Live Events Similarly, UnitedHealthcare has added Yesintek to several formularies, including commercial beginning May 1, 2025; managed Medicaid beginning March 1, 2025; and Medicare beginning June 1, 2025. CVS Health and Optum Rx have added Yesintek to their premium and select formularies beginning July 1, 2025. The company further said Yesintek has also been selected on several other formularies, including Navitus, Costco Health Solutions, MedImpact, Priority Health, University of Pittsburgh Medical Center (UPMC), and several other regional health plans. Additionally, it has been selected as the exclusive Ustekinumab by Blue Cross Blue Shield of Michigan (BCBSM), Florida Healthcare Plan, and several closed-door health systems, it added. "The company is also finalising formulary agreements with other commercial carriers," it added. Yesintek is approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, increasing patient access to more cost-effective treatment options for use in the treatment of common chronic autoimmune diseases, Biocon Biologics said. It is available in all the same formulations currently provided by STELERA in presentations of 45 mg/0.5 mL PFS, 90 mg/mL PFS (prefilled syringe), 45 mg/0.5 mL vial, and 130 mg/26 mL vial, it added.

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