Laurus Labs, which heavily relies on antiretroviral (ARV) active pharmaceutical ingredients (APIs) and formulations, has said that going forward it will focus on non-ARV products targeting diabetes and cardiovascular to drive growth.
"Over the next 3-4 years, we will diversify our entire business from ARV focussed API and formulations to broadly diversified revenue. No therapy will contribute significantly from 2025. For that we need time and investment, we need to develop APIs, we need to do product validations, we need to build both API and formulation capacity, and then get to market, that's what we are doing now," said Satyanarayana Chava, Founder and CEO of Laurus Labs in an interview to Moneycontrol.
ARVs are drug used in treatment of HIV (human immunodeficiency virus) and AIDS (acquired immunodeficiency syndrome). Laurus Labs is one of the leading supplies of both the APIs and formulations of ARVs. Currently about 60 percent of Laurus Labs revenues comes from ARV APIs and formulations. Chava said the company is in the process of developing a non-ARV portfolio.
"We have lined up portfolios of non-ARV APIs, some of those ANDAs are filed. Some are approved, some are awaiting approval," Chava said.
Building for future
Chava said since there aren't many ARV APIs and ARVs ANDAs to be developed, those resources are now being diverted to non-ARV APIs and formulations.
"We can develop 10 (non-ARV) products per year," Chava said.
On capex, Chava said the company is investing Rs 1,500- Rs 1,700 on capex, in next two years.
"When it comes to formulation - we are building another massive block in Vizag at our Unit 2, from October to March we will operationalise an additional 4 billion tablets capacity. That will take care of formulation capacity. We are adding 25 percent additional capacity to our existing API capacities in the next 12 months," Chava said.
On whether Laurus is entering crowded segments like diabetes and cardiovascular, Chava said "if we are worried about competition we never have entered ARVs. Competition makes us do concerted effort, offer unique products - build capacity, maintain good regulatory track record, give right quality at right price, that's how we want to be part of the market."
Chava said he would follow the template of ARVs, where the company became a leading supplier of APIs and then entered formulations. "
"Our choice of products would be based on the ability to backward and forward integrate the value chain," Chava said.
"We put efforts from the very basic stage of intermediates and APIs, and also do formulation, then only we will garner good market share," he added.
Chava said despite the focus on non-ARV products for future, it will continue to secure its ARVs market share.
"Formulation approvals, especially for various ARVs, came on time. We always had a good supply track record with Global Fund and the US President's Emergency Plan for AIDS Relief (PEPFAR) so we were getting a good share of the formulations and we were able to meet the timelines," Chava said.
On USFDA inspections, Chava said except for an R&D unit inspection, there are no pending inspections with the agency that can delay any potential approvals.