Latest news with #BioconLtd
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Business Standard
5 days ago
- Business
- Business Standard
Biocon Biologics to launch Eylea biosimilar Yesafili in Canada next month
Biocon Biologics, a subsidiary of Biocon Ltd, has received approval from Health Canada for Yesafili (aflibercept), a biosimilar to Eylea, marking the first such approval for an Eylea biosimilar in the country. The authorisation, granted via a Notice of Compliance (NOC), covers both vial and prefilled syringe formats (2 mg/0.05 mL). Yesafili is set to launch in Canada on July 4. Shreehas Tambe, chief executive officer and managing director, Biocon Biologics, said: 'The approval of Yesafili by Health Canada—the first biosimilar to Eylea in Canada—is a proud moment for Biocon Biologics. We are excited that in July, Canada will be the first country where we will launch Yesafili, making it our 10th biosimilar to be commercialised worldwide. This milestone reflects our science-driven innovation, global commercialisation strength and continued commitment to expanding access to high-quality, affordable biologics for patients across the globe.' Yesafili is a vascular endothelial growth factor (VEGF) inhibitor indicated for treating several retinal conditions that cause visual impairment. These include neovascular (wet) age-related macular degeneration (AMD), macular oedema resulting from central or branch retinal vein occlusion (CRVO and BRVO), diabetic macular oedema (DME), and myopic choroidal neovascularisation (myopic CNV). Furthermore, the company said the approval is based on a comprehensive package of analytical, nonclinical and clinical data, confirming that Yesafili is highly similar with no clinically meaningful differences to Eylea regarding quality, safety and efficacy. In April this year, Yesafili received approval for launch in the United States. In May 2024, the US Food and Drug Administration approved Yesafili.
New Indian Express
6 days ago
- Health
- New Indian Express
Biocon Biologics gets Health Canada approval for its AMD biosimilar Yesafili
CHENNAI: Biocon Biologics, the biosimilars subsidiary of Biocon Ltd, said on Friday that Health Canada has granted a Notice of Compliance (NOC) for its age-related macular degeneration (AMD) drug, Yesafili. The drug is a biosimilar to aflibercept, marketed under the brand name Eylea by US biotech major Regeneron Pharmaceuticals. This approval clears the way for the Canadian launch of Yesafili injection on July 4, 2025, making it the first biosimilar to Eylea approved by Health Canada. A biosimilar is the biological equivalent of a generic drug in the field of biologics—highly similar to an already authorized reference product, with no clinically meaningful differences in terms of safety, purity, or potency. Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following central retinal vein occlusion (CRVO), macular edema following branch retinal vein occlusion (BRVO), and diabetic macular edema (DME), and myopic choroidal neovascularization (myopic CNV). The approval of Yesafili was based on a comprehensive submission of analytical, nonclinical, and clinical data. Health Canada concluded that the biosimilar is highly similar to Eylea, with no clinically meaningful differences in terms of quality, safety, or efficacy.
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Business Standard
24-06-2025
- Business
- Business Standard
Biocon's ₹4,500 crore equity raise to reduce debt by FY26, says S&P
Biocon Ltd's equity fund raise worth Rs 4,500 crore will help the pharmaceutical firm reduce its adjusted debt to Rs 20,000 crore by March 2026, against an earlier expectation of over Rs 25,000 crore, according to S&P Global Ratings. The adjusted debt includes $1 billion in compulsorily convertible preference shares issued to Viatris Inc. On 20 June 2025, the Biocon group completed its qualified institutional placement (QIP) of equity shares in Biocon Ltd, raising Rs 4,500 crore. In a statement, the rating agency said: 'We believe the group will use proceeds from the equity issuance to repay debt over fiscal 2026.' This would include optionally convertible debentures and commercial paper borrowings amounting to about Rs 2,300 crore, along with Rs 2,100 crore to repay additional debt by mid-2026. An equity issuance by Biocon Ltd will support the group's liquidity. The group will have more flexibility to plan future fundraising following the issuance. 'We believe debt repayments for structured instruments will strengthen Biocon's capital structure,' it added. The agency considers Biocon Biologics Ltd (BBL) a core and inseparable part of the Biocon group. Therefore, the issuer credit rating on BBL (BB/Stable/--) reflects the view of the group credit profile. Deleveraging at the Biocon group is likely to progress at a steady pace. New product launches in the group's generics and biosimilars segments, along with steady growth in its contract research, development and manufacturing business, will underpin the group's operating cash flow. The group is estimated to generate Rs 2,000–2,500 crore in annual operating cash flow in fiscals 2026 and 2027. This will be sufficient to meet capital investment requirements, with limited need for further fundraising, it added.
Indian Express
24-06-2025
- Business
- Indian Express
After a $3.3 bn acquisition, is it finally time to look at Biocon?
For years, Biocon has been the stock market equivalent of watching paint dry. While the Nifty 500 surged in 2022, Biocon's shares have been trading in a range since 2018. But things could be changing. This isn't the same Biocon of a few years ago. It's bigger, more complex, and carries more debt. But it also has more firepower. So, let's peel back the layers and see if the numbers are finally starting to catch up with the story. Biocon's financial trajectory: Growth, margin stability, and profit rebound Over FY16-25, Biocon's revenues grew more than 4.5x (18.36% CAGR), from Rs 3,347 crore to Rs 15,262 crore, driven by scale-up in biosimilars, acquisitions, and consistent expansion in its contract research arm, Syngene International Ltd. However, despite this topline surge, operating margins remained range-bound at 21-25%, reflecting rising R&D costs, pricing pressure in generics, and integration expenses. During the same period, earnings per share (EPS) barely grew from Rs 4.5 per share to Rs 8.5 per share (7.3% CAGR). This is owing to a 2% EBITDA margin contraction, equity dilution, and an increasing interest cost on account of the Viatris acquisition (Rs 68 crore to Rs 897 crore in the last three years). An evaluation of a more recent period offers a better outlook on the business. A closer look: The last 4 years FY22 was an inflection point. It marked the acquisition of Viatris Biologics by Biocon Ltd. That's the reason why, after consolidating its 90% shareholding (70.4% fully diluted basis), Biocon's consolidated revenue jumped from Rs 8,185 crore to Rs 15,262 crore. Incidentally, the market did not look at the $3.3 billion acquisition of Viatris Biologics favourably, punishing the stock in its wake. Since FY22, Biocon Ltd's EBITDA jumped by 1.8x, PAT by 2x, yet, EPS grew by just 1.56x owing to equity dilution. Over the last 10 years, Biocon Ltd earned Rs 15,314 crore in cash flow from operations; meanwhile, the estimated spend on capex, growth, acquisition, etc, totalled around Rs 44,044 crore. From the management's perspective, it's an attempt to position the company as a unique biopharma company across the entire value chain, from R&D and drug discovery to manufacturing to commercialising, marketing, and sales of the final product. Whether this strategy of having control over the entire value chain will yield benefits in the form of higher margins and/or profitability remains to be seen. Whatever the underlying rationale, this extra spending of about Rs 29,000 crore was undertaken by loading up more debt, selling off non-core assets (and shareholding in core assets), and equity dilution. This could partially explain why the stock price has remained stagnant in the last 7-8 years. Biocon Ltd has decided to further dilute its shareholding by raising Rs 4,500 crore through a Qualified Institutional Placement (QIP) to bring down its gross debt of Rs 17,756 crore ($2.1 billion). But what are these underlying businesses that Biocon felt compelled to spend aggressively on? Three engines, one Biotech story: Inside Biocon's business model Biocon's business today runs on three distinct engines: Biosimilars, contract research, and generics. As of FY2025, these contributed 58%, 23%, and 19%, respectively, to total revenues. Each plays a different role in the group's evolution, from steady cash flow to long-term growth bets. Let's break them down. 1. Generics: Quiet but Gritty (19.8% of FY25 revenue) Biocon's generics business has had a relatively quiet FY2025. Price pressures and subdued demand, particularly in active pharmaceutical ingredients (APIs), kept this segment soft. But the fourth quarter offered some bounce, with new product launches like Lenalidomide, Dasatinib, and Liraglutide in the UK markets, triggering a rebound. GLP-1 drugs such as Liraglutide offer immense growth opportunities for the company. GLP-1 drugs are a class of medications used to manage diabetes to lower blood sugar levels. With the approval of Liraglutide in the UK, Biocon is one of the first generic companies to obtain approval for a generic GLP-1 medicine in a major regulated market. A bigger trigger lies ahead. The much-awaited Liraglutide launch in the EU and US is expected in FY26, subject to regulatory approvals, and could materially shift the trajectory of this segment. 2. Biosimilars: The flagship growth engine (59% of FY25 revenue) If generics are Biocon's foundation, biosimilars (through its subsidiary Biocon Biologics Ltd) are its marquee. Biocon Ltd owns 90.2% (71.4% on a fully diluted basis) in Biocon Biologics Ltd (BBL). According to the QIP letter of offer document dated 16 June 2025, Biocon Ltd has four new products planned to be launched in their biosimilars business over the next 12 to 18 months. After acquiring Viatris' global biosimilar business, BBL can now commercialise products independently, capturing full economic upside rather than splitting margins. 3. Research services: Syngene keeps the base warm Completing the trio is Syngene, Biocon's listed contract research and manufacturing arm. Biocon owns 52% in Syngene International Ltd (a market cap of Rs 26,000 crore). It offers integrated discovery-to-development services for global pharma clients, and its contribution of ~24% to overall revenue adds useful diversification. Syngene enjoys a strong brand recall in global R&D circles, and its revenue growth and EBITDA margins have been steady, underpinned by capex-backed capacity additions and long-term contracts. As commercialisation of its new facilities gathers pace, this segment should continue delivering operating leverage. This brings us to the ultimate question : Is Biocon Ltd undervalued? The most appropriate way to assign a value to Biocon's 3 major business segments would be to follow a sum of the parts (SOTP) valuation approach. Please note that our estimates are back-of-the-envelope in nature. 1. What's BBL worth? Private Transaction Benchmarks can offer some clues. Several equity raises in the past have provided clear market signals: January 2021: Abu Dhabi's ADQ invested $75 million for a 1.8% stake, implying a post-money valuation of ~$4.1 billion for BBL. November 2020: Goldman Sachs subscribed to $150 million of convertible debentures, placing BBL's valuation at approximately $3.94 billion July 2020: Tata Capital invested $30 million for a 0.85% stake, suggesting a valuation of around $3.5 billion. Essentially, BBL was being valued at $3.5-4 billion in 2020-2021. This was before Viatris' biosimilar business had been acquired for $3.3 billion. On a fully diluted basis, Biocon Ltd owns 71.4 % in BBL (Biocon Biologics Ltd), which is equivalent to 71.4% of Rs 60,500 crore. 2. What's Syngene International worth? Given Syngene international is a listed company, this value should be much easier to estimate. At a current market capitalisation of Rs 25,900 crore, Biocon Ltd's share is Rs 13,660 crore. 3. What's Biocon's generics business worth? With revenues of Rs 3,017 crore in FY25 and EBITDA margins of 15% (Rs 450 crore), a 7-8x multiple (lower end of peer valuations) implies a valuation of around Rs 3,150 crore to 3,600 crore. Finally, we must add the net debt of Rs 13,000 crore ($1.518 billion x 86.32) to arrive at the Enterprise valuation or the valuation a private buyer would pay for the entire company (Equity + Debt). SOTP valuation estimate Compared to the current enterprise value of Rs 54,100 crore and an estimated SOTP-derived Enterprise value of Rs 73,175 crore, Biocon Ltd offers a 26% discount. However, if we consider Biocon Ltd a holding company, a Holdco discount also applies, It's possible that the difference in EV implied by current market cap and SOTP calculation is on account of this discount. If that's the case, there might not be an undervaluation at all. As the overall balance sheet deleverages, the process for which is already underway with the QIP raise of Rs 4500 crore, Biocon Ltd equity value should logically inch by an equivalent amount. Another 'trigger' for value unlocking/enhancing could be the IPO of BBL or the merger of BBL into Biocon Ltd. A committee has already been formed which is evaluating the best course of action. As per the management, the company is at an 'inflection point'. An investor should keenly watch as Biocon's balance sheet deleverages, and the benefits of the acquisitions begin showing up in the numbers. Note: We have relied on data from and throughout this article. Only in cases where the data was not available, have we used an alternate, but widely used and accepted source of information. Rahul Rao has helped conduct financial literacy programmes for over 1,50,000 investors. He also worked at an AIF, focusing on small and mid-cap opportunities. Disclosure: The writer and his dependents do not hold the stocks discussed in this article. The website managers, its employee(s), and contributors/writers/authors of articles have or may have an outstanding buy or sell position or holding in the securities, options on securities or other related investments of issuers and/or companies discussed therein. The content of the articles and the interpretation of data are solely the personal views of the contributors/ writers/authors. Investors must make their own investment decisions based on their specific objectives, resources and only after consulting such independent advisors as may be necessary.
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Business Standard
20-06-2025
- Business
- Business Standard
Biocon closes ₹4,500 crore QIP to boost innovation, expand global access
Biocon Ltd announced on Friday that it has successfully raised ₹4,500 crore through a qualified institutions placement (QIP), marking its first equity fundraising since its initial public offering in 2004. In a regulatory filing, the company stated it had issued over 136.3 million equity shares, each with a face value of ₹5, to eligible institutional investors. The shares were priced at ₹330 per unit, which includes a premium of ₹325. The QIP was open from June 16 to 19, 2025, and received strong interest from both Indian and global investors. Biocon said this response reflects growing confidence in the company's long-term strategic vision. Capital to support innovation and access to affordable healthcare 'The strong response to our QIP reflects deep investor conviction in Biocon's differentiated strategy and consistent execution,' said Siddharth Mittal, CEO and Managing Director of Biocon Ltd. 'This capital raise further strengthens our balance sheet, enabling us to invest in innovation, expand global access to lifesaving biopharmaceuticals, and advance our purpose of delivering affordable healthcare solutions that address pressing health inequities worldwide,' Mittal added. Proceeds allocated for strategic and financial needs Biocon stated that part of the capital raised will be used to purchase outstanding optionally convertible debentures of its subsidiary, Biocon Biologics Limited, from Goldman Sachs India AIF Scheme - 1 and Goldman Sachs India Alternative Investment Trust AIF Scheme - 2. Additionally, the funds will be used to repay, pre-pay, or redeem certain borrowings and financial instruments, and meet other financial requirements, including general corporate expenses.
