- Amongst the leading APIs and Formulations manufacturers with strong capabilities in the therapeutic area of oncology and non-oncology.
- Supplies 30+ oncology APIs to the USA, Europe, Japan, etc (10yrs+ experience in regulated markets) | Aim to commercialise 3-4 molecules per year.
- In the process of debottlenecking oncology production blocks by enhancing capacity by 40-70%.
- sale of non-oncology APIs: Ambroxol (Mucolytic agent) in Europe and Tranexamic Acid and Ursodeoxycholic acid in India.
- Formulations: 16 injectable dosage forms, 19 oral solid dosage forms under SML & 13 Formulations under SML’s wholly-owned subsidiary Shilpa Therapeutics Private Limited.
- Supplies 30+ oncology APIs to the USA, Europe, Japan, etc (10yrs+ experience in regulated markets) | Aim to commercialise 3-4 molecules per year.
How big is Cancer?
Cancer is the second leading cause of death. According to a WHO, report cancer caused an estimated 9.6 million deaths in 2018.
Globally, about 1 in 6 deaths is due to cancer. Approximately 70% of deaths from cancer occur in low- and middle-income countries.
Of the 15,267 assets across all phases of development, about 34% are oncolytics, up from 30% in 2013.
- Company has forayed into Biologics, Oral Dissolving Films and Transdermal Patches.
- While stepping into FY2021, acquired FTF Pharma, an integrated drug development company.
- Biosimilars: 4 of the top 15 products in the pipeline.
- A combo line at the upcoming facility in Bangalore for Oral Disintegrating Films and Transdermal patches will be commissioned soon.
- 265+ scientists | 357 patents filed with 47 granted |
- Formulation product pipeline consists of 61 with 38 approvals.
- Highlights of the year gone by one ANDA & 6 FTF in pipeline | Good CashFlow Conversion | Gross block up 13% YoY to 875crs; CWIP: 482crs; Intangible Assets under development: 182crs.
- Form 483 with 15 observations at the Jadcherla, Telangana formulation plant.
- Our oncology APIs segment has delivered as per plan and will continue to progress based on our attractive pipeline and diversified base of intermediates.
- 1st company in India to launch ODF and among the first few in Nano.
- Capacity: 120m tablets & capsules | 15m Liquid & Lyophilised Injections | 2m Prefilled Syringes | 350 tonnes API
- Biologics Capabilities: Need to monitor.
- Interesting development
- Launched green tea films- revolutionary technology
- Formed new subsidiary to manufacture “Recombinant Human Albumin (RHS), recombinant peptides, analogues and polymers”
API Manufacturing: What is the opportunity size for India?
India is a source of about 20% of the world’s generic drugs supply. Drug and pharma exports from India rose 11.7% on year to touch $19.15 billion in the 11 months to February 2020.
The global API market is expected to reach US$ 245 billion (6.1% CAGR) by 2024.
- Regulatory Filings Summary: Progressing towards more complex generics | Product Development & License fees: 135crs | R&D expense: 16% of rev.
- On the Biologics front: The Company is in an advanced stage for setting up of a world-class biologics manufacturing facility for Monoclonal antibodies and biologics in Belur, Dharwad.
- The facility consists of two production lines for Drug Substance. The first, second lines are currently in qualification and expected to be completed by 2020.
- Company is forging ahead with clinical trials on 1 no MAb, 1 nos fusion protein and 1 nos NBE during the course of the coming financial year, while 1 other is expected to complete preclinical studies. (combined market size ~$20 billion.)
- 2 more are expected to be added in the next financial year to the clinical trial pipeline, with a market size of about $12 billion.
- Complex Capital Structure: A common theme in pharmaceutical companies.
- 1754 permanent employees | median increase of 9.53% YoY
- Constant promoter Shareholding: 53.80%
We covered the Q1FY21 results here:
More Annual report takeaways here.
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