Tag: Biocon

Biocon partners Biomm to commercialise diabetes drug in Brazil

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

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Biotechnology firm Biocon on Wednesday said it has tied up with Brazil-based Biomm SA for the commercialisation of its diabetes drug in the Latin American nation.

Under the terms of the agreement, Biocon will undertake the development, manufacturing and supply of Semaglutide (gOzempic), and Biomm will be responsible for obtaining regulatory approval and commercialization in the Brazilian market.

Biomm focuses on developing, manufacturing and commercialising complex biotech and biosimilar drug products at its production facility in Nova Lima. “Our partnership with Biomm marks another important step forward in our strategy to expand our global footprint beyond the US and Europe for Peptides,” Biocon CEO and MD Siddharth Mittal said in a statement.

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This is also in line with the growth strategy of bringing to market a portfolio of complex, GLP-1 drug-device combination products, he added. “We are confident that our collaboration with Biomm will provide patients in Brazil, who are living with diabetes, much-needed access to advanced, high-quality treatment options to help them manage the disease better,” Mittal said.

Biomm CEO Heraldo Marchezini said Brazil is the fifth country in the world with the highest incidence of diabetes, having 16.8 million adults in the age group of 20 to 79 years with the disease, and an estimated 21.5 million cases by 2030, according to the Diabetes Atlas of the International Diabetes Federation (IDF).

“We have, therefore, prioritised strategic partnerships to expand the population’s access to advanced treatments for this disease and enhance the quality of life for people,” he added. As per the IQVIA MAT data, the total addressable market opportunity of Semaglutide in Brazil is around $580 million.

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Biocon becomes the first generics company to get a diabetes drug approval in the UK

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

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Biocon Ltd. has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) UK for its complex formulation Liraglutide filed through its European partner, Zentiva. Liraglutide is a 6 mg / ml solution for injection in a pre-filled pen.

Liraglutide is a drug-device combination formulation used in the treatment of type 2 Diabetes Mellitus, a disorder in which the body does not produce enough or respond normally to insulin, causing blood sugar levels to be abnormally high.

Siddharth Mittal, Biocon’s MD & CEO called this an important milestone and said that the focus will now be on commercialising this asset expeditiously in the UK, in partnership with Zentiva.

As per the IQVIA data for Q4 2023, the total addressable market opportunity for GLP-1 in diabetes and weight loss in the UK was $425 million.

Earlier this month, Biocon’s subsidiary Biocon Biologics signed a long-term commercial collaboration with Eris Lifesciences to expand patient access to its portfolio of metabolic, oncology and critical care products in India.

The total transaction value was ₹1,242 crore, which represents an accretive multiple of 3.4 times of revenue and 18 times of EBITDA, the company said in an exchange filing.

Biocon Biologics’ CEO also called this deal with Eris as ‘enabling’ and not ‘restricting.’

“It does not prevent us from working with others but certainly these particular brands – Basalog and Insugen – that we have commercialised, would be exclusive to Eris Lifesciences,” CEO Shreehas Tambe said.

Shares of Biocon ended little changed on Wednesday at ₹256.95. The stock has risen 27% over the last 12 months.

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Biocon Biologics CEO terms Eris Lifesciences deal as enabling, not restricting

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

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Biocon Biologics’ collaboration with Eris Lifesciences is not a restrictive arrangement but an enabling one, said Shreehas Tambe, MD and CEO of Biocon Biologics in an interview with CNBC-TV18.

“It does not prevent us from working with others but certainly these particular brands – Basalog and Insugen – that we have commercialised, would be exclusive to Eris Lifesciences,” he said.

Basalog and Insugen are insulin products used in the treatment of diabetes.

Biocon Biologics, the biosimilars company and a subsidiary of Biocon., sold its Indian formulation business to Eris Lifesciences for ₹1,242 crore.

Biocon Biologics also entered into a long-term commercial collaboration with Eris Lifesciences to expand patient access to its portfolio of metabolics, oncology and critical care products in India.

Tambe sees this as a complementary collaboration between two existing partners building on a relationship that allows to deliver on that ambition of reaching one in five insulin-dependent diabetics in the country.

Biocon Biologics will continue to manufacture and supply its high-quality biologics to patients in India. “We are not looking to exit anything, we are very committed to India and patients here and we will be looking to strengthen our presence along with Eris Lifesciences – a chronic therapy-focused drug firm – who will represent far stronger commercial reach than we had,” he mentioned.

The transaction value of ₹1,242 crore translates to an accretive multiple of 3.4 times of revenue and 18 times of earnings before interest, taxes, depreciation, and amortisation (EBITDA).

Also Read | Biocon Biologics gets Canada market entry date for ophthalmic drug Yesafili

The US Food and Drug Administration (USFDA) has classified Biocon Biologics’ Malaysian plant as Official Action Indicated (OAI).

Tambe said the company is working with the USFDA to see how it can resolve it.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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Biocon Biologics signs 10-year supply pact with Eris Life for ₹1,242 crore

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

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Biocon Biologics, the biosimilars company and a subsidiary of Biocon Ltd., announced a long-term commercial collaboration with Eris Lifesciences to expand patient access to its portfolio of metabolics, oncology and critical care products in India.

The total transaction value is ₹1,242 crore, which represents an accretive multiple of 3.4 times of revenue and 18 times of EBITDA, the company said in an exchange filing.

The collaboration is in-line with Biocon Biologics’ strategy to unlock value from its legacy business of branded formulations and extend its existing partnership with Eris for Biocon’s Nephrology and Dermatology business announced in December 2023.

As part of the deal 430 employees associated with the business are expected to transition to Eris, the company said.

The transaction is likely to come into effect before April 15, 2024, subject to customary closing conditions.

In November last year, Biocon Biologics had signed definitive agreements with Eris Life for divesting its dermatology and nephrology branded formulations business units in India.

The total transaction value of the divestment was ₹366 crore.

“This strategic collaboration with Eris Lifesciences for our portfolio of Metabolics, Oncology, and Critical Care products in India aligns with our commercial strategy to maximize patient reach and market potential,” Shreehas Tambe, CEO & MD of Biocon Biologics was quoted as saying.

Shares of Biocon ended 4.3% higher at ₹263.75.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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Biocon Biologics gets Canada market entry date for ophthalmic drug Yesafili

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

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Biocon Biologics shall launch its ophthalmic drug Yesafili in Canada no later than July 1, 2025, the subsidiary of biotechnology major Biocon said on March 4.

“Biocon Biologics Ltd, a globally integrated biosimilars company and a subsidiary of Biocon Ltd, has announced the signing of a settlement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. This agreement paves the way for the introduction of Yesafili, a proposed biosimilar to EYLEA® (aflibercept) Injection, into the Canadian market,” the company said in an exchange filing.

According to the statement, under the terms of the agreement, Biocon Biologics has secured a launch date for Yesafili 2 mg NDS for vials and prefilled syringes (yet to be filed), set no later than July 1, 2025. It added that Health Canada had granted tentative approval for Yesafili 2 mg vials, subject to resolution of any patent issues, in March 2023.

The settlement resolves multiple parallel patent infringement proceedings in the Federal Court of Canada involving six patents, and associated judicial review proceedings, under Canada’s Patented Medicines (Notice of Compliance) Regulations addressing pre-entry pharmaceutical patent litigation, they told the stock exchanges.

The drug Yesafili is designed to address a spectrum of ophthalmic conditions, including neovascular age-related macular degeneration (wet AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), diabetic macular edema (DME), and myopic choroidal neovascularisation (myopic CNV).

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The biosimilar’s potency lies in its striking similarity to the reference product Eylea (aflibercept), a well-established treatment in the field. Rigorous data analysis underscores that Yesafili demonstrates comparable quality, safety, and efficacy to Eylea.

In November 2023, Biocon Biologics received marketing authorisation approval from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency for Yesafili.

The firm had then said that with aflibercept brand sales in the UK reaching $790 million, the approval of Yesafili opens up new avenues for Biocon Biologics. Yesafili is a registered trademark of Biocon Biologics.

Following the announcement, Biocon Biologics shares opened almost half a percent higher at Rs 278.10 on BSE.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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Biocon gets over ₹3 crore penalty over GST related issues

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

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Biocon Ltd on Friday said it has been imposed a penalty of over ₹3 crore over GST-related issues. The company has received an order of adjudication imposing a penalty of ₹3,03,78,465 dated February 22, 2024, from the office of Deputy Commissioner of Commercial Taxes, Divisional GST Office, Bangalore, Biocon Ltd said in a regulatory filing.

The demand is related to input tax credit reporting error in GST monthly returns, denial of input tax credit on sales and promotional expenditures, valuation issue GST under corporate guarantee, and denial of exemption on export of services, it added. Biocon further said it is “in the process of taking appropriate actions, including but not limited to, filing of the necessary appeal with the appellate authority in this regard”.

There is no material impact on the financials, operations or other activities of the company, the filing said.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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

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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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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

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.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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