Biocon Biologics India, a subsidiary of Biocon, is engaged in developing affordable biosimilars. The company along with Mylan recently announced the launch of Semglee™ (insulin glargine injection) in the US to expand access for patients living with diabetes. In an interaction with BusinessLine , Christiane Hamacher, CEO & Managing Director, Biocon Biologics, said the demand for biosimilars in most of the world markets is rising and hence the company has a promising future. Excerpts:

How much will the US market contribute to Biocon Biologics in revenues?

We believe the US market represents a great opportunity for Biocon Biologics and we expect Semglee to contribute significantly to our goal of impacting 5 million patients’ lives and achieving $1 billion revenue by end of FY22. This is the third product through our partnership with Mylan, to be commercialised in the US.

What are the company’s plans to unlock value through equity investments? How do you plan to utilise $30 million raised via PE investment from Tata Capital? Will you be raising more funds?

We have raised $105 million so far this calendar year through two primary equity infusions. Through the latest round of primary equity investment by Tata Capital Growth Fund, we are raising $30 million (₹225 crore) for a 0.85 per cent minority stake in the biosimilar business.

Earlier this year in January, we had raised $75 million as primary equity infusion by True North Fund for a 2.44 per cent stake in the business. The latest round of equity infusion is at a pre-money equity valuation of $3.5 billion, representing a 22 per cent increase in valuation compared to the last round and 44 per cent increase on an annualised basis. We expect to complete the balance fundraising over the next six months. As indicated last year, our total fundraising plans are in the range of $200-300 million.

What is the capex for this year and how do you plan to raise funds?

Biocon Biologics has plans to invest $200 million per year in capex for FY21 and FY22. This unlocking of value through PE funding will enable us to fund capex investments for further strengthening our business. Additionally, as the biosimilars business scales up and generates good margins that will also generate operating cash to fund our investment objectives.

We understand Biocon Biologics is planning to go for initial public offering (IPO) what would be the timeline and the potential size of the IPO?

We intend to list Biocon Biologics on the Indian capital markets in the next two to three years. However, it would be early to comment on specific IPO timelines as it is dependent on business performance and market conditions. As and when we are ready to approach the capital markets for an IPO, we will keep our shareholders informed on the timing and the potential size of the IPO offering.

Given that Eli Lily has a strong franchise, how do you expect Semglee to take on the competition in the US market?

Our partner Mylan is providing Semglee at a competitive price on the market. Semglee will be available in vial and pen presentations at a 65 per cent discounted list price. We believe that the US market represents a great opportunity given that there is only one insulin glargine other than Lantus currently available. In addition, there is an important need to address the diabetes pandemic in an affordable way. Through our Semglee, we are confident of enabling expanding access to the millions of patients in the US who are currently under-served due to the cost of insulin, and hence, are rationing. Semglee will increase access to treatment options for more than 30 million Americans living with diabetes in the US.

What is the update on your other insulin products aimed at the US market?

The Semglee launch furthers our continued efforts to serve patients through the availability of a full portfolio of short- and long-acting insulins, which also includes our insulin as part, co-developed with Mylan, which we expect to launch next year.

What has been the performance of your insulin glargine in most of the world markets? When will Semglee be available to patients?

Biocon Biologics Insulin Glargine has received good traction in South Korea, Malaysia and Algeria amongst other most of the world markets and continue to grow overall in emerging markets. We expect our partner Mylan to begin shipping the product this week and it would be available soon after that. The product is likely to be available at pharmacies later this week.

Is your insulin glargine different than a biosimilar?

Biocon Biologics and Mylan’s Semglee is a biologic licensed under the 351(a) pathway, consistent with all currently marketed insulin products. Semglee, which received final approval from the US Food and Drug Administration (FDA), has an identical amino acid sequence to Sanofi’s Lantus® and is approved for the same indications.

Will you be pursuing interchangeability (drugs which have the same clinically significant formulation characteristics)? Has Semglee been approved pediatric use and for which age group?

Yes. along with our partner Mylan, we continue to be engaged in active discussions with the FDA and have submitted to the agency all necessary documentation. We hope to achieve interchangeable status as quickly as possible. Semglee was approved by the FDA to control high blood sugar in pediatric patients (ages 6-15) with type 1 diabetes.

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