Tag: Biocon

Biocon arm gets complete response letter from USFDA for Bevacizumab biosimilar licence application

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Global biopharmaceuticals company Biocon on Friday, February 9, said the United States Food and Drug Administration (USFDA) has issued a complete response letter (CRL) for its licence application for the cancer drug Bevacizumab.

The US drug regulator has called for completion of a pre-approval inspection of its manufacturing facility, the company said in a stock exchange filing.

A complete response letter (CRL) indicates that any licence application for a drug cannot be approved in the present form.

The company said that the CRL did not identify any outstanding scientific issues on the dossier.

The letter has highlighted the need for the completion of a pre-approval inspection of the Bevacizumab manufacturing facility, the company said.

Biocon mentioned that it continues to be engaged with the USFDA and is hopeful of bringing affordable biosimilar Bevacizumab to the US market.

The drug maker reported a net profit at ₹660 crore for the December quarter against a loss of ₹42 crore in the year-ago quarter on the back of other income. The company reported a consolidated revenue of ₹4,519 crore for the December quarter of FY24, driven by 65% growth in biosimilars and 9% growth in Research Services.

Consolidated operating profit or EBITDA jumped 106% year-on-year to ₹1,492 crore.

On Biocon Biologics Ltd, which is an integrated biosimilars company and a subsidiary of Biocon, the company said the business delivered 65% year-on-year growth during the quarter.

The company continued to see robust demand for its products with market shares increasing across geographies. BBL onboarded new customers and won several key tenders, Biocon mentioned in its statement.

Biocon shares were trading 3.69% lower at ₹274.2 apiece at 10.30am. The stock is in the F&O ban, which means no new positions can be created.

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Biocon bounces back to black, reports ₹660 crore net profit, revenue up 34%

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Biotechnology major Biocon Ltd on Thursday (February 8) reported a net profit of ₹660 crore for the third quarter that ended December 31, 2023. In the corresponding quarter last year, Biocon posted a net loss of ₹41.8 crore, the company said in a regulatory filing.

The company’s revenue from operations increased 34.4% to ₹3,953.7 crore as against ₹2,941.1 crore in the corresponding period of the preceding fiscal. At the operating level, EBITDA jumped 43.8% to ₹926 crore in the third quarter of this fiscal over ₹644.3 crore in the corresponding period in the previous fiscal.

EBITDA margin stood at 23.4% in the reporting quarter as compared to 21.9% in the corresponding period in the previous fiscal. EBITDA is earnings before interest, tax, depreciation, and amortisation.

Consolidated revenue for Q3 of FY24 grew 50% year-on-year to ₹4,519 crore. This growth was supported by income from the divesture of two non-core business assets of Biocon Biologics’ Branded Formulations India business amounting to ₹350 crore and a gain of ₹456 crore from Biocon’s stake dilution in Bicara Therapeutics.

Net R&D investments for the quarter were ₹329 crore, representing 11% of revenue exSyngene. Profit Before Tax and exceptional items stood at ₹787 crore. Nicholas Robert Haggar has been appointed as an Independent Director on the Board of Biocon Biologics for a period of three years with effect from February 6, 2024. Also, Nitin Prabhakar Shenoy has been appointed as Head of IT & Digital Transformation at Biocon.

Biosimilars: Biocon Biologics

Biocon Biologics reported a YoY growth of 65% for Q3 of FY24 with revenue at ₹2,483 crore. EBITDA for the quarter reported a growth of 98% at ₹714 crore, representing an EBITDA margin of 29%. During the quarter, net R&D investments stood at ₹265 crore, representing 11% of Biocon Biologics’ revenue for the quarter, reflecting the advancement of our biosimilars pipeline.

Core EBITDA at ₹587 crore, with core EBITDA margins at 28%, was impacted on account of a series of transition-related expenses and one-off costs. Biocon Biologics prepaid $200 million towards reducing the acquisition-related debt during the quarter.

Research Services: Syngene

In Q3 of FY24, the research services business delivered positive performances in the development and manufacturing services divisions as well as in the dedicated centers. Syngene’s performance in Discovery Services was impacted by the slowdown of funding in the global biotech ecosystem.

In manufacturing services, the company continued to make good progress on the long-term biologics manufacturing partnership with Zoetis. Overall, the company maintained healthy EBITDA margins of 30%.

“Biocon delivered consolidated Revenue of ₹4,519 crore for Q3 of FY24, driven by 65% growth in biosimilars and 9% growth in Research Services. Consolidated EBITDA at ₹1,492 crore grew by 106%. Net profit, boosted by other income, stood at ₹660 crore,” Kiran Mazumdar Shaw, Executive Chairperson, Biocon and Biocon Biologics said.

Biocon’s third-quarter results came after market hours. Shares of Biocon Ltd ended at ₹284.45, down by ₹5.95, or 2.05%, on the BSE.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Syngene Q3 results: Biocon unit cuts FY24 revenue growth guidance

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Syngene International posted a net profit of ₹111.5 crore in the quarter ended December 31, 2023. The net profit rose marginally by 1.6% from ₹109.7 crore the listed contract research and manufacturing services arm of Biocon had posted in Q3FY23. Sequentially, the net profit dropped from ₹116.5 crore it had posted in the September quarter results.

Syngene’s revenue in the third quarter of the current financial year jumped 8.6% on a year-on-year basis to ₹853.5 crore, compared to ₹785.9 crore in Q3FY23. On a sequential basis, the revenue dropped from ₹910.1 crore the pharma R&D firm had posted in the September quarter results.

#3QWithCNBCTV18 | Syngene reports Q3 earnings 👇

>>Net Profit up 1.6% at ₹111.5 cr Vs 109.7 cr (YoY)

>>Revenue up 8.6% at ₹853.5 cr Vs ₹785.9 cr (YoY) pic.twitter.com/DDEBmPudV0

— CNBC-TV18 (@CNBCTV18Live) January 25, 2024

Syngene’s EBITDA came in flat at ₹231.5 crore in Q3FY24 against ₹231 crore it had posted a year ago in the same quarter. The Biocon subsidiary’s margin dropped to 27% in the December quarter on a YoY basis. Its margin was at 29% in Q3FY23.

Syngene has further cut its FY24 revenue growth guidance to be around double digits from earlier mid-teens it had projected in the September quarter, which was also reduced from its high-teens projections before the Q2 results. The company said that a temporary slowdown in biotech funding in the United States will impact growth in the near term.

Syngene International’s stock price, however, traded flat in the red, quoting at ₹694.

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Biocon Biologics, Sandoz ink deal to market immune disorder injection adalimumab in Japan

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Biotechnology major Biocon Ltd on Friday (December 22) said its subsidiary Biocon Biologics Ltd has signed a distribution agreement with Sandoz, granting the company the exclusive rights to promote, sell, and distribute “adalimumab BS for subcutaneous injection (FKB)” in Japan.

Based on this agreement, Viatris has completed the marketing and promotion of the product as of December 15, 2023, but will continue to provide transition support till Sandoz gradually assumes responsibilities for the product starting February 15, 2024.

Biocon Biologics has acquired the global biosimilars portfolio of Viatris, including adalimumab. Fujifilm Kyowa Kirin Biologics Co Ltd, the developer of the drug, has concluded an exclusive global marketing licence agreement with Biocon Biologics Ltd affiliate.

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Adalimumab BS for subcutaneous injection (FKB) is a biosimilar of Humira  — generic name: adalimumab (genetical recombination) — and is indicated for immune system-related diseases such as rheumatoid arthritis, psoriasis vulgaris, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis.

Sandoz is committed to further strengthening its product pipeline to drive sustainable business growth. The transfer of the distribution rights of this product is part of this strategy, and its addition to the product portfolio will strengthen Sandoz’s immunology and biosimilar portfolio.

Biocon Biologics recently announced the successful completion of its integration of the acquired Viatris’ biosimilars business in 120 countries ahead of schedule, marking a significant milestone in the company’s journey as a fully integrated, global biosimilars enterprise.

At a global level, Biocon Biologics has a robust pipeline of 20 assets for diabetology, oncology, immunology, and ophthalmology. Serving over 5.7 million patients annually, the company is committed to providing access to high-quality therapies and solutions to patients, healthcare systems, and governments across the globe.

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Shares of Biocon Ltd ended at ₹246.20, up by ₹0.55, or 0.22%, on the BSE.

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Biocon chief sees generics business firing up next year

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Bengaluru-headquartered Biocon expects generics business sales growth to improve to high-teens in the financial year 2025.

Siddharth Mittal, the company’s Managing Director and CEO said the generics business has huge potential. The company plans to introduce some new differentiated molecules as well as peptides by the end of calendar year 2024 or early 2025, which will drive growth.

Biocon’s generics business includes the active pharmaceutical ingredient (API) and the formulations businesses. While the formulations business continues to deliver high double-digit growth, the API business has been weak.

“The API business has been under pressure due to pricing pressure faced by our customers and some stocking that few customers had done anticipating tenders which they were not able to secure. So they are trying to liquidate that inventory now,” Mittal told CNBC-TV18.

The company commissioned a peptides API manufacturing unit in Bengaluru and a greenfield fermentation-based immunosuppressant API facility in Visakhapatnam in FY23.

The generics business is roughly 20% of Biocon’s total sales. The segment’s  revenue grew around 4% year-on-year (YoY) in the second quarter of financial year 2024 to around ₹676 crore.

Over FY18-23, the generics business has seen 12% compounded annual growth rate (CAGR), per a note released by brokerage firm Motilal Oswal on November 3.

The challenges in the generics API business and the phasing of the phasing of supplies due to planned shutdown has weighed down Biocon‘s shares with net losses year-to-date at around 3%. This is after factoring in over 8% gains in the last month.

Motilal Oswal has a ‘neutral’ rating on the stock as the brokerage sees limited upside in price from the current levels.

The company’s market capitalisation is around ₹30,500 crore.

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Biocon Biologics takes charge of Viatris’ biosimilars across 120 countries

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Biotechnology major Biocon Ltd on Monday (December 18) said its subsidiary Biocon Biologics Ltd has assumed direct control of Viatris’ biosimilar brands across approximately 120 countries.

This expansion includes a direct presence in the United States, Canada, Europe, and nine key emerging market countries, namely India, UAE, Saudi Arabia, Morocco, South Africa, Brazil, Malaysia, Thailand, and the Philippines.

“Over 10 emerging markets along with Japan, Australia, and New Zealand have transitioned in this final phase of the integration of the biosimilars business acquired from Viatris.

With the completion of this milestone, Biocon Biologics is now a unique, fully integrated ‘lab to market’ biosimilars company committed to serving millions of patients across the globe,” Biocon said in a regulatory filing.

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The move sees Biocon Biologics taking charge of all Viatris’ biosimilar brands, such as Ogivri, Hertraz (bTrastuzumab), Abevmy (bBevacizumab), Fulphila (bPegfilgrastim), Hulio (bAdalimumab), Nepexto (bEtanercept), Semglee (bGlargine), and Kirsty (bAspart).

These biosimilars cover a diverse portfolio in key therapeutic areas, including diabetology, oncology, and immunology. Notably, most of these products have been developed by Biocon Biologics and are manufactured at the company’s state-of-the-art facilities in India and Malaysia.

The direct presence in these global markets positions Biocon Biologics to establish closer connections with patients while strengthening relationships with prescribers and payers. This strategic shift is not only expected to enhance patient reach but also generate significant cost savings for healthcare systems.

With the transition of marketing responsibilities, Biocon Biologics aims to ensure seamless business continuity for patients, prescribers, partners, and healthcare systems. The company’s commitment to delivering high-quality biosimilars is reinforced by the consolidation of these brands under its direct management.

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Shreehas Tambe, CEO and Managing Director of Biocon Biologics Ltd, said, “I am very proud and excited that we have successfully completed the integration of the acquired business across 120 countries. The conclusion of this final wave of transition is a significant milestone and marks the beginning of Biocon Biologics’ transformation to a fully integrated global company.”

Shares of Biocon Ltd ended at ₹254, up by ₹2.40, or 0.95%, on the BSE.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Targeted cancer therapy player Bicara Therapeutics raises $165 mn in Series C financing

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Biotechnology major Biocon Ltd on Wednesday (December 13) said its associate company Bicara Therapeutics Inc has successfully concluded its Series C financing, raising $165 million on December 12, 2023.

The infusion of funds is earmarked to drive the ongoing development of Bicara’s lead product candidate, BCA101, a pioneering bifunctional EGFR/TGF-β inhibitor currently undergoing clinical trials for multiple cancer types. The funds will play a crucial role in furthering the clinical development of this first-in-class inhibitor.

Following the completion of the Series C funding and the subsequent allotment of shares by Bicara, Biocon’s shareholding in Bicara, on a fully diluted basis, will dip below the 20% threshold. Consequently, Bicara will cease to be an associate company of Biocon.

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The financing was co-led by Braidwell LP and TPG, which is investing in the company through TPG Life Sciences Innovations (TPG LSI) and The Rise Fund, with additional new investors including Deerfield Management, Fairmount, Aisling Capital and a leading biotechnology investor associated with one of the largest alternative asset managers.

Bicara Therapeutics is a clinical-stage biotechnology company developing first-in-class biologics engineered to combine the precision of well-validated, tumour-targeting antibodies with the power of tumour microenvironment modulators.

Shares of Biocon Ltd ended at ₹249.25, up by ₹10.65, or 4.46%, on the BSE.

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IBLA 2023 19th Edition: Kiran Mazumdar-Shaw awarded Outstanding Business Leader of the Year

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Biocon’s Kiran Mazumdar-Shaw was honoured as the Outstanding Business Leader of the Year at the 19th edition of CNBC-TV18’s India Business Leader Awards (IBLA), held in Mumbai on December 2.

In business, as in everything else, leadership extends beyond profit margins. It’s about transforming lives. Kiran Mazumdar-Shaw lives and breathes that mission every day.

An exceptional biotech entrepreneur, healthcare visionary and global influencer, she has nurtured and led Biocon from a small startup into a globally renowned and respected business with a footprint that covers over 100 countries.

Biocon is today India’s largest global Biosimilars Company, with revenues in excess of $1.4 billion and total assets worth over $6.5 billion. It has positively impacted 5.7 million lives by making life-saving therapies more accessible and affordable and innovating to increase treatment options.

Kiran Mazumdar-Shaw has spearheaded Biocon through crucial breakthroughs – it created the world’s first biosimilar Trastuzumab to treat breast cancer and is the first company in the world to commercialise a synthetic version of human insulin to battle diabetes.

Her four-decade long entrepreneurial journey has led her to not one, but two of India’s highest civilian honours: the Padma Shri, and the Padma Bhushan.

But Kiran Mazumdar-Shaw’s legacy goes beyond the lab and the boardroom — She is the first woman business leader from India to sign the Giving Pledge, and set aside a major portion of her wealth to assist transformative causes.

CNBC-TV18 celebrates Kiran Mazumdar-Shaw —a true pioneer, visionary leader, and inspiration.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow