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Contract Development and Manufacturing Organization
1. Company Overview:
-Suven Pharma is a Contract Development and Manufacturing Organization (CDMO).
-They provide innovative process research and development, supplies to clinical trials and commercial manufacturing services to innovative companies in the Pharmaceutical and
-Suven Pharma is a Contract Development and Manufacturing Organization (CDMO).
-They provide innovative process research and development, supplies to clinical trials and commercial manufacturing services to innovative companies in the Pharmaceutical and
Specialty Chemical industries.
-Their services include custom synthesis, process R&D, scale-up and contract manufacturing of intermediates, APIs and formulations
-Their services include custom synthesis, process R&D, scale-up and contract manufacturing of intermediates, APIs and formulations
-In 2018, Suven Life Sciences was demerged into 2 listed entities - Suven Life Sciences and Suven Pharma. The Drug Discovery business stayed in Suven Life Sciences and the CDMO and Formulations business went to Suven Pharma.
-The effects of the demerger were immediately visible
-The effects of the demerger were immediately visible
as Suven Pharmaโs margins increased by 15-20%.
-This was mainly due to a significant drop in the R&D expense. The R&D expense of the combined entity was very high with about 90% of the R&D being spent on New Drug Discovery.
-Post the demerger, the R&D expense in the CDMO was
-This was mainly due to a significant drop in the R&D expense. The R&D expense of the combined entity was very high with about 90% of the R&D being spent on New Drug Discovery.
-Post the demerger, the R&D expense in the CDMO was
4. Pharma CDMO
-This is the companyโs main vertical and contributes about 60% of the companyโs revenues. This vertical includes the development of intermediates, small batch manufacturing for clinical trials and commercial supply of patented molecules.
-This is the companyโs main vertical and contributes about 60% of the companyโs revenues. This vertical includes the development of intermediates, small batch manufacturing for clinical trials and commercial supply of patented molecules.
-The success of this business depends on a molecule moving from one phase of the clinical trials to the next and eventual commercialization. This is a high margin business as the molecules that the company manufactures are under patent.
The revenues from this segment are very lumpy and cannot be looked at on a quarter on quarter basis. This is because orders for 1 product are received only once a year or once every 18 months.
-This is a high value and high margin business and Suven has the highest margins in
-This is a high value and high margin business and Suven has the highest margins in
the industry. Their Pharma CRAMS business has EBITDA margins of 40-50%.
5. Specialty Chemicals CDMO
-In the specialty chemicals CDMO business, Suven manufactures intermediates for innovative agrochemicals.
-They got into this business because the capabilities required in this
5. Specialty Chemicals CDMO
-In the specialty chemicals CDMO business, Suven manufactures intermediates for innovative agrochemicals.
-They got into this business because the capabilities required in this
business were very similar to the ones that they had in the Pharma business.
-The time to commercialization in this business is lower than the Pharma business as the molecule doesnโt go through clinical trials.
-Another major difference between these 2 businesses is in Pharma
-The time to commercialization in this business is lower than the Pharma business as the molecule doesnโt go through clinical trials.
-Another major difference between these 2 businesses is in Pharma
they do not know the quantities to be supplied until the product is commercialized. Even when it is commercialized, they do not know if it will be an annual, 18 month or 24 month cycle. In Specialty Chemicals, the customer usually gives them an indication of what kind of
manufacturing of niche formulations
-Suven had filed an ANDA for Malathion lotion which is a very niche product for head lice. They have licensed this ANDA to Taro Pharmaceuticals who pays them royalties based on the sales of the product.
-In the Generic ANDAs, the company
-Suven had filed an ANDA for Malathion lotion which is a very niche product for head lice. They have licensed this ANDA to Taro Pharmaceuticals who pays them royalties based on the sales of the product.
-In the Generic ANDAs, the company
manufactures formulations which are then sold by other pharmaceutical companies who are their marketing partners.
-The strategy that the company follows for formulations is that they enter molecules which have a very small market and therefore very limited competition.
-The strategy that the company follows for formulations is that they enter molecules which have a very small market and therefore very limited competition.
-They hope to make 2-4 million dollars in net profit per product. This small opportunity size is the reason that other generic companies are not interested in these products which helps them maintain margins.
-Suven does the development work on the ANDAs and either files them in
-Suven does the development work on the ANDAs and either files them in
their own name or their partner does the ANDA filing. Suven does the manufacturing of the product and the partner handles the marketing.
-Suven follows a profit sharing model which enables them to have better margins than directly selling in the US
-Suven follows a profit sharing model which enables them to have better margins than directly selling in the US
7. Casper Pharma
-Suven acquired a 25% stake in Rising Pharmaceuticals in 2019 for 35 million dollars. Rising Pharmaceuticals is a generic formulation marketing company and they had a partnership agreement with Suven Pharma for 3 ANDAs.
-Rising filed for bankruptcy in 2019 and
-Suven acquired a 25% stake in Rising Pharmaceuticals in 2019 for 35 million dollars. Rising Pharmaceuticals is a generic formulation marketing company and they had a partnership agreement with Suven Pharma for 3 ANDAs.
-Rising filed for bankruptcy in 2019 and
Suven purchased a 25% share in the business for 35 million. Their rationale at the time was that they would use Rising Pharmaceuticals as a marketing partner for their formulation business.
-Then in December 2021, HIG Capital - a private equity firm acquired the company. Suven
-Then in December 2021, HIG Capital - a private equity firm acquired the company. Suven
-When HIG Capital acquired Rising, they acquired Casper Pharma as well and merged both the companies. This facility in India was not part of the deal.
-This is a brand new facility which has a capacity of 1.2 billion tablets or capsules. They have already filed 2 ANDAs from
-This is a brand new facility which has a capacity of 1.2 billion tablets or capsules. They have already filed 2 ANDAs from
there and have just completed the USFDA inspection for this facility.
-They already have a marketing partnership with Rising Pharma in place and plan to file another 15 ANDAs under this partnership in FY23.
-They already have a marketing partnership with Rising Pharma in place and plan to file another 15 ANDAs under this partnership in FY23.
-They have a formulation facility and API facility in Pashamylaram and another facility in Visakhapatnam where they manufacture APIs and advanced intermediates
9. Capex
-Suven completed 320 crores of capex at the end of FY21. They spent 120 crores for setting up a multi purpose
9. Capex
-Suven completed 320 crores of capex at the end of FY21. They spent 120 crores for setting up a multi purpose
plant in Vizag which will be used to manufacture intermediates and APIs.
-They also spent 110 crores for setting up the OEL4 facility for high potency compounds and 90 crores for a formulation facility in Pashamylaram.
-Management has indicated that due to Covid, clients were
-They also spent 110 crores for setting up the OEL4 facility for high potency compounds and 90 crores for a formulation facility in Pashamylaram.
-Management has indicated that due to Covid, clients were
unable to audit these facilities which is causing a delay in getting new projects.
-Before they finished the 320 crores capex, they had already announced another round of capex for 600 crores which was started in FY22.
-Most of this money will not be spent on capacity addition
-Before they finished the 320 crores capex, they had already announced another round of capex for 600 crores which was started in FY22.
-Most of this money will not be spent on capacity addition
but investing in modernizing their facilities.
-Their Suryapet plant is 32 years old with outdated technology. They will be spending 200 crores to replace the facility block by block. This will add a lot of new capabilities which will not increase the capacity by much, but will
-Their Suryapet plant is 32 years old with outdated technology. They will be spending 200 crores to replace the facility block by block. This will add a lot of new capabilities which will not increase the capacity by much, but will
allow them to manufacture much more advanced products
-They have been in talks with innovators about what kind of technologies they would need in the future and will be incorporating them into the new facility. They have finalized continuous flow chemistry to be incorporated in
-They have been in talks with innovators about what kind of technologies they would need in the future and will be incorporating them into the new facility. They have finalized continuous flow chemistry to be incorporated in
the new blocks.
-They will be spending about 150 crores to move their R&D center in Jeedimetla. There is a government order that any facility located in the outer ring road may have to move out. They donโt know when they might have to move so they are proactively shifting their
-They will be spending about 150 crores to move their R&D center in Jeedimetla. There is a government order that any facility located in the outer ring road may have to move out. They donโt know when they might have to move so they are proactively shifting their
-They are getting into the manufacturing of high potency APIs and intermediates. These are high value products which are complex to manufacture and have higher margins.
-They have set up an OEL4 facility which is used to manufacture highly toxic compounds. OEL stands for
-They have set up an OEL4 facility which is used to manufacture highly toxic compounds. OEL stands for
occupational exposure level.
-The facility has to have a high level of automation and care has to be taken to ensure that the workers are not exposed to the drug compound. All handling of the drug must be done in a dedicated enclosure through glove ports.
-The facility has to have a high level of automation and care has to be taken to ensure that the workers are not exposed to the drug compound. All handling of the drug must be done in a dedicated enclosure through glove ports.
-The company is also entering into drug life cycle management. In this business, Suven would offer to manufacture the drugs for innovators after their drug has gone off patent. The drug doesnโt necessarily have to be one that Suven was involved in when it was patented.
-When a drug goes off patent, the innovator reduces the price of the drug and sells it as an authorized generic. Suven will manufacture these drugs for the innovator to be sold under their brand name
-This would be a cost effective solution for the innovators as it would be
-This would be a cost effective solution for the innovators as it would be
cheaper than manufacturing it themselves and innovators become price sensitive when a drug becomes generic
-Apart from this, Suven is also looking to forward integrate in their CDMO business where they are trying to get the business of manufacturing the APIs for the intermediates
-Apart from this, Suven is also looking to forward integrate in their CDMO business where they are trying to get the business of manufacturing the APIs for the intermediates
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