Biocon has announced its consolidated financial results for the first quarter ended 30th June, 2021.

Commenting on the results, Kiran Mazumdar-Shaw, Executive Chairperson, Biocon, said, “Biocon has seen a strong 41 per cent YoY growth in research services and a steady growth in its biosimilars business, reporting revenue of Rs 758 crores, up 10 per cent over the same period last year, and 14 per cent over the preceding quarter. Consolidated revenues, at Rs 1,808 crores, saw a muted growth on account of COVID-related operational challenges at Biocon’s API facilities, both in Bengaluru and Hyderabad. Q1FY22 P&L was also impacted by a share of loss in its Boston-based associate start-up entity, Bicara Therapeutics. Excluding this share of loss, profit before tax was Rs 224 crores. Novel Biologics are investment-intensive, and we will explore external venture funding to support clinical development for long-term value creation. Business sentiments are favourable for biosimilars, generics and research services. Globally, we see a strong demand for biosimilars and generic drugs, given the growing emphasis on affordable drug pricing. Net profit, excluding the share of loss from Bicara, was at Rs 142 crores and reported net profit was at Rs 84 crores.”

She added, “The outlook for the rest of the year is promising with several drug approvals on the anvil, contingent to timely US FDA onsite inspections in India and Malaysia, whilst research services continue to see a rising demand.”

“John Shaw has decided to step down from the Board effective the end of the Annual General Meeting this year, due to health reasons. My colleagues on the Board, join me to place on record our heartfelt appreciation for the critical and invaluable role he has played in building Biocon,” she added.

The company has expanded its global footprint with entry into seven new markets; received marketing authorisation approval for bBevacizumab (Abevmy) from TGA, Australia and MHRA, UK. In addition, the US FDA scheduled pre-approval inspection of the company’s Malaysia facility in Q3 of CY2021 in support of the BLA for bAspart. It has also commissioned rooftop solar power generation at some of its manufacturing facilities, potentially reducing carbon emissions by 400 tons annually.

Commenting on the performance, Dr Arun Chandavarkar, Managing Director, Biocon Biologics, said, “The highlight of this quarter was our ability to pull out all stops to make available our COVID-care portfolio, anchored by Alzumab-L, our novel antibody Itolizumab, to many thousand patients in critical need. Whilst we certainly hope that the surge in infections does not manifest as severely in future, we are now fully geared to address the future patient demand.”

He also said, “We reported revenues of Rs 758 crores, representing a YoY growth of 10 per cent. This was driven by strong growth in India, led by our COVID-care portfolio, and continued growth in other markets for biosimilars. Core EBITDA margins were a healthy 36 per cent and after accounting for R&D, our EBITDA was at Rs 215 crores, representing a 28 per cent margin. This translated to a profit before tax of Rs 101 crores.”

Q1FY22 revenue grew 10 per cent YoY to Rs 758 crores, driven by a strong performance from branded formulations India and steady sales of our insulins and monoclonal antibodies (mAbs) across developed and emerging markets. Through our comprehensive COVID-19 portfolio, we addressed the needs of thousands of patients in India, which has also contributed to the topline performance for the quarter.

The company has also expanded its footprint in emerging markets with the launch of key products, bTrastuzumab, bGlargine and rh-Insulin in additional markets. bTrastuzumab recorded a strong uptake in key emerging markets like Brazil, where it retained its leadership position with a 39 per cent market share in the retail segment.

Through its partner Viatris, Biocon saw a steady increase in market share for bTrastuzumab (Ogivri), bPegfilgrastim (Fulphila) and bGlargine (Semglee) in the US despite increased competition. Sales in Europe improved on the back of new market entries and steady market share in key countries. Sales in emerging markets also picked up this quarter.

The company had also stepped up production of Itolizumab, an anti-CD6 monoclonal antibody repurposed for COVID-19, to address the rise in demand in the second wave of the pandemic.

In addition to Biocon’s brand ALZUMAb-L, Sun Pharma also markets its Itolizumab under the brand name Itolizac.

Doctors have used Itolizumab extensively across the country during the second wave of the pandemic. Dosing the right patient at the right time is critical for favourable outcomes with Itolizumab. The results from the 300-patient, multi-centric, phase-4 study of Itolizumab in COVID-19, are expected to be available for publishing in the near future.

Further, the regulatory process for the grant of ‘interchangeability’ designation to bGlargine (Semglee) is progressing under the 351(k) pathway in the US with the goal date of July end this year.