By: IPP Bureau
Last updated : December 07, 2021 12:59 pm
Key takeaways of recent quarter & conference call highlights
Revenues grew 5.5% YoY to Rs 1840.4 crore (I-direct estimate: Rs 1921.1 rore). Biosimilars grew 9.8% YoY to Rs 742.5 crore, lower than I-direct estimates of Rs 840.6 crore. Research services segment grew 17.4% YoY at Rs 610.2 crore, above I-direct estimate of Rs 571.6 crore. Generic sales de-grew 11.5% YoY to Rs 530 crore (I-direct estimate: Rs 509 crore) due to continued pricing pressure in US and slower ramp up of demand for some APIs
EBITDA margins improved 179 bps YoY to 24.2% (I-direct estimate: 22%) mainly due to steady gross margin at 69.3% and lower other expenditure.
EBITDA improved 13.9% YoY to Rs 445.8 crore against I-direct estimate of Rs 423 crore
Net profit de-grew 18.3% YoY to Rs 138.3 crore (I-direct estimate: Rs 107 crore). Delta vis-a vis EBITDA was on account of higher interest cost, depreciation and tax expenses
Q2FY22 Earnings Conference Call highlights
Generics: Pricing pressure in US for formulations portfolio, and a slower than expected ramp up of demand for some key APIs. Expanding formulations portfolio with the launch of Everolimus tablets in US in October 2021. In September, USFDA conducted a Remote Interactive Evaluation for oral solid dosage manufacturing facility in Bengaluru, as part of a pre-approval review for previously filed ANDAs. The final close out report from the agency is awaited. Greenfield immunosuppressant’s API manufacturing facility in Visakhapatnam, remains on track to be commissioned in the latter part of FY22, with qualification and validation in FY23.
Novel Biologics: Equillium to initiate a Phase-3 Pivotal Study for use of Itolizumab in First-Line treatment of Acute Graft Versus Host Disease (aGVHD) and is on track to initiate the study in Q4 of CY21. During Q2FY22, Bicara Therapeutics continued to make progress in the dose finding part of the Phase 1 trial for BCA101, as single agent and in combination with a PD1 inhibitor. Anticipated recommended dose for expansion by the end of CY21.
Biosimilars: Interchangeable bGlargine (brand name Semglee) to be listed as a preferred insulin brand on National Preferred Formulary of Express Scripts, a leading US pharmacy benefit management organisation. Commercialised bBevacizumab in several EU markets, and Malaysia. Received approval for bAspart from Health Canada. Entered into a strategic alliance with Serum Institute Life Sciences (SILS) for a foray into vaccines; will get committed access to 100 million doses of SILS’ vaccines annually for 15 years in exchange for 15% stake at a post-money valuation of ~US$4.9 billion. Partnered with Adagio Therapeutics to manufacture and commercialise a broadly neutralising antibody, ADG20, for the prevention and treatment of Covid-19, for select markets across GCC & Asia, including India.
Market shares of bPegfilgrastim and bTrastuzumab continue to grow in Europe, with bTrastuzumab being the leading biosimilar in some EU markets. In US, bTrastuzumab (Ogivri) and bPegfilgrastim (Fulphila) maintained a high single-digit market share while bGlargine (Semglee) continues to report a steady increase in market share. bTrastuzumab continues to be a leading biosimilar in Canada and Australia. Biocon Biologics has submitted a Corrective and Preventive Action Plan (CAPA) to USFDA, in response to the pre-approval inspection of the manufacturing facility in Malaysia, for bAspart, held in September 2021.
Emerging Markets: In the AFMET region, launched bGlargine, bPegfilgrastim and bTrastuzumab in some new markets like Tunisia, Belarus, Israel, etc. In LatAm, bTrastuzumab (Zedora) continued to retain its leadership position in Brazil with a strong double-digit market share while in Argentina further inroads made with bTrastuzumab.
Research Services: Strong performances in all divisions. In Discovery Services, there was a positive demand for new services like Protein Degradation Technology (PROTACS) and Peptide Synthesis. Expanded the client base in biologics powered by expansion of microbial manufacturing and capacity building in mammalian manufacturing.