- They handle manufacturing and last mile distribution for their products which allows them to eliminate intermediaries. They have managed to replace importers in the smaller geographies and will be replacing distributors in larger geographies like USA, Mexico, Brazil, Europe, South Africa and CIS countries.
- They have identified a niche in the Mexico market where they can replace the distributor and will give them enough volumes in the years to come.
- Brazil is the largest market in South America. They have already received approval for the facility and are in the process of filing their dossiers. The entry barriers are high in Brazil, the model to register in Brazil requires you to have an importing laboratory to register your product. They have identified a company with an importing laboratory who will handle the registrations.
- They will be entering Western Europe later and will be focusing on Eastern Europe. They will enter Western Europe when they have set up the API and formulation backward integration which will enable them to be competitive against the bigger players when participating in tenders.
- Russia is a country where there is no price erosion unlike other geographies which is a very good opportunity for them.
- They are expanding into oncology tablets and injectables. Most companies in injectables do contract manufacturing. They will be filing their own ANDAs and setting up their own front end.
- In Caplin Steriles, last 9 month sales overtook the 12-month sales of last year. They have 12 ANDAs approved on its own and a further 6 approved through partners. Out of these, 15 have been launched and the other 3 would be launched by the next two quarters.
- The first ophthalmic product has been approved from Caplin Steriles facility that has happened without an inspection of the ophthalmic section because of their track record in the injectables space. They also filed their first product in China through a partner.
- They are signing 2 new distribution agreements which have all the things important to them such as non-exclusivity, nominal license fee and majority profit share.
- They have ordered 2 new state-of-the-art vial filling lines from Bosch in Germany and some other equipment. All this will arrive by Q3 of this year and they will be able to sell commercial batches by Q2 of the following year. This will triple their current capacity.
- They are working on a new drug delivery system with a party in the UK and are hoping to make it available by 2025.
- They have 10 to 11 products in the premix bag line. They have a pipeline of 45 to 50 products of which about 12 are premix bags. Typically, the competition in premix bags is less than vials – only 3 companies in India have premix bags. The margins in premix bags are better than vials usually, but right now due to high freight costs they may see some depletion in margins.
- The revenue target for 2026 is $100 million. They are installing capacity in a way that they will not need to do capex till 2026. Right now they have 2 vial lines, 1 ophthalmic line and a bag line coming up over the next couple of months. They are going to be adding 2 more lines that run at twice the speed of the existing lines. They also have other capacities coming in. So all put together it will triple their capacities.
- They are completely debt-free and all further capex will be funded from internal accruals.
- They had set a target of filing 8 to 10 ANDAs for the full year. Due to COVID related elays and plant shutdowns, they were only able to do 3. They have been able to launch 4 products in the last 2 quarters.
- The primary strategy that they have been following for injectables is to out license their products for a profit share. Usually their share is 50% but recently they have signed distribution deals where they have gotten 65-70% share. So they lose a significant portion of margin to distributors which is why they are trying to get into distribution.
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