Biocon - Notes from AR 2020-21 -
- Total sales - 7360 cr, up 14 pc.
Break up -
Generics - 2335 cr - grew by 6 pc
Biosimilars - 2800 cr - grew by 21 pc
Research services - 2184 cr - grew by 9 pc
Domestic sales of total - 19 pc
Intl Sales of total - 81 pc
R&D spending at 627 cr, up 19 pc ( at 13 pc of revenues Ex - Syngene ie Research services ). This is expected to remain in the 12-15 pc band in near future
EBITDA at 1907 cr, up 8 pc
EBITDA margins at 26 pc
PAT - 740 cr, down 3 pc
Adjusted for exceptional items ( a gain of Rs 159 cr on account of ceding control in Bicara ), NP would have been at 594 cr
- Biosimilars - One of the select few companies globally to have co-developed 05 biosimilars. These are -
bTrastuzumab ( used to treat breast cancer ) - named Ogivri
bPegfilgrastim ( to reduce infections in patients receiving chemotherapy ) - named Fulphila
bBevacizumab ( used to treat a number of Cancers ) - named Abevmy
bGlargine ( long acting manmade version of human insulin ) - named Semglee
bAspart ( short acting manmade version of human insulin )
Company has also commercialised rh-Insulin ( recombinant human insulin ) in many developing markets
Company commercialised third Biosimilar in US - Insulin Glargine. Only company from India to have 3 commercial biosimilars in US markets
Obtained regulatory approvals for Biosimilars - Bevacizumab and Insulin Aspart in EU Biocon is among a select few companies to have 5 biosimialrs approved in EU
Commercialised Pegfilgrastim ( Fulphila ) in Australia and Canada.
Company saw fund infusion totalling $ 330 million by funds such as - Tata Capital, Glodman Sachs and Abu Dabhi based ADQ - valuing Biocon Biologics at $ 4.2 billion. Funds being used for Capex, R&D and Opex and to redeem Biocon ltd’s preference shares in Biocon Biologics which will further be used for Capex in generics business. For now, company is adequately funded for near term capex requirements
Mkt opportunity in biosimilars remains strong as biosimialrs worth $ 90 billion are set to lose exclusivity over the next decade
Total capex for the FY in the Biologics business - $ 125 million primarily for expansion of production capacity for monoclonal anti bodies. Additional capex lined up for FY 22 at $ 100 million. Company’s new facility for monoclonal antibodies, largest in India is awaiting commercialisation
Company continuously investing in R&D in biologics space. Will continue to do the same to commercialise second wave to Biosimilars in second half of the decade
- Generics - Company supplies Statins ( family of drugs used to lower cholesterol ), immunosuppressants, narrow spectrum antibiotics and other APIs to over 100 countries. **Company is one of the largest manufacturer of Statins and Immunosuppressants globally.**Company is a late entrant in formulations business and aims to replicate the success of its API growth story into formulations by successfully forward integrating in nice , difficult to make APIs. APIs continue to remain biggest contributors in the company’s generics business. Key highlights in generics business include - launch of Tacrolimus capsules ( used as an immunosuppressant during organ transplants ) in US , approval for Everolimus ( generic to Afinitor - immunosuppressant used to treat cancer ) , DMF approval for Sitagliptin API in China and company’s new tie ups in Brazil, Singapore and Thailand. Company aims to enter Japan and Russian markets in FY 22
Statin formulations continue to hold mid teens mkt share in US
Continue to witness intense pricing pressures in APIs and formulations particularly in competitive markets like US. Stockpiling of medicines in the first half led to demand slowdown in the second half.
Filed for 33 APIs globally and got approvals for 14 APIs during the year
Also filed for 09 formulations - globally
API capex projects are in various stages of execution. Experiencing some delays in Greenfield capex at Vizag ( immunosuppressants APIs facility ) due COVID. This facility is expected to go commercial in FY 22. Various cost saving programs are also under implementation. Company working towards reducing single vendor / single geography dependence for key materials for API manufacturing - Novel Biologics business - Company’s portfolio of novel biological assets comprise therapeutics for diabetes, autoimmune disease and cancer. Itolizumab - initially launched in India for treatment of plaque psoriasis in 2013. In Sep 20, Itolizumab approved by DGCI for treatment of Cytokine release syndrome in moderate to severe ARDS ( acute respiratory distress syndrome )
Also out licensed Itolizumab to their US biotech partner - Equillium Inc in 2017. Equillium is developing Itolizumab for multiple severe immune-inflammatory disease including acute graft vs host disease, lupus and lupus nephritis and uncontrolled asthma. Company is expecting clinical data from these studies in 2021
Insulin - Tregopil ( a first in class oral insulin molecule ) - Phase 2 studies have been submitted to DCGI and USFDA. Data from type - 2 diabetes studies has been encouraging, marketing authorisation applications were delayed in wake of the pandemic. In FY 20, company had also commenced studies for Type 1 Diabetes in Germany. Expected to be completed by FY 22
Bicara - Its lead program - BCA 101 entered phase -1/2 studies at leading US and Canadian cancer centres in Jul 20. Biocon ceded control over the board of Bicara. Biocon now classifies Bicara as an associate company now from being a subsidiary - **Total Capex guidance - For FY 22, expected to be in the range of $ 300-320 million. $ 100 million each for Biosimilars, Generics and $ 120 million for contract research.**Funds already raised via PE placement in FY 21 and the rest would be made up via internal accruals
I ve deliberately not covered the CRO business here. One can get notes on the same from the thread on Syngene International as the same is separately listed
Disc : Invested, Biased