The successful integration of the acquired Biosimilars business dominated the Biocon Biologics growth story last year. In fiscal year 2024-25 (FY25), we have turned our focus to consolidating the acquired business and paving the way for future growth. Our performance in the first quarter of FY25 gives us confidence that we are on the right track.

FY25 is off to a solid start for Biocon Biologics. We remained the largest revenue contributor to the Biocon Group at 59% in Q1FY25, with a revenue of Rs 2,083 Crore. Our core EBITDA stood at Rs 614 crore this quarter, with a healthy margin of 30%, and EBITDA was Rs 474 crore, with a margin of 23%.

While the reported year-on-year revenue growth of 3% might not seem substantial, we need to make some adjustments to that number to get a view of our underlying performance.

A deeper look at our revenue growth

The first adjustment we need to make is for our long-term commercial collaboration with Eris Lifesciences to expand patient access to our portfolio of Metabolics, Oncology, and Critical Care products in India, and we are already seeing positive results. Taking into account this strategic alliance, we see a revenue growth of 11% on a like-for-like basis.

For our EBITDA performance, we have always targeted the mid-20s range, and we have maintained it this quarter. The EBITDA margin of 23% in Q1 FY25 does not, however, account for any income from one-off transactions, such as the Eris Lifesciences deal. This indicates not just growth in revenue, but also a very strong profitable growth.

To get a clearer picture of our performance this quarter, we also need to consider that we did not report any licensing income in Q1 FY25, unlike in Q1 FY24.

Our revenue growth this quarter came on the back of increasing market shares for our products across geographies and strong product sales. If we adjust for that, our growth is actually 19%. This number is more reflective of our performance this quarter, and of what we want to do, going forward.

Growing Market Shares and Product Sales

With a strong demand for key drugs in the U.S. market, combined with a formidable market share in the European market and boost in sales of key products in the Emerging Markets, Biocon Biologics’ biosimilars are rapidly gathering steam across geographies.

In North America, all our products have shown significant growth in market share, reflecting a strong acceptance of our high-quality biosimilars from patients and prescribers. In the U.S., bPegfilgrastim, which is branded as Fulphila®, has gone up to 20% this quarter, from less than 16% market share last year. Similarly, for bTrastuzumab (Ogivri®), the market share has increased to 19% from 11% a year ago. For Insulin Glargine (Semglee®), the third product we have commercialized, we ended the quarter with 11% market share. If we add 3-4% share from a large closed-door pharmacy network that we supply to, we will have ~15% market share for Insulin Glargine. This is a sizeable market and a sizeable opportunity because it has put us well on track to reach a fifth of the diabetes population, which is a significant achievement.

In Europe, Belgium, Germany, and France have been our three key geographies. Our markets shares have been over 20% in Belgium, 18% in Germany and around 12% in France.

Looking Ahead At a Sustainable Growth Trajectory

The fact that the Q1 growth is driven by product sales and market shares bodes well for the quarters ahead of us, because this growth is continuous and sustainable, unlike a one-off licensing income.

New products will drive future growth, and we have six products lined up for launch in the U.S. in the next two years, subject to approval — bBevacizumab, bAspart, bUstekinumab, bDenosumab, bAflibercept and bPertuzumab. In Europe and the rest of the world, we have four products (bBevacizumab, bUstekinumab, bDenosumab and bAflibercept) that we are looking to launch in the next two years. These are multi-billion-dollar assets that will lose exclusivity, and that is a huge opportunity for us. It is also unique, since there aren’t many companies that can boast of an opportunity of this magnitude.

We have already received approval from the U.S., EU, UK, and Canada for Yesafili™ (bAflibercept), which has sales of over USD 10 billion globally. It became the first interchangeable biosimilar to be approved by the U.S. FDA. We will launch the product in Canada in July 2025.

Our bUstekinumab filing has been accepted for review by the U.S. FDA. We have also signed a patent settlement agreement with the innovator, Janssen Biotech Inc., and Johnson & Johnson, allowing us to commercialize the product in the U.S. by February 2025, pending regulatory approval. This will position Biocon Biologics among the first wave of companies to launch this product in the U.S.

Biosimilars are increasingly becoming the treatment of choice for both patients and customers, given that the assurance of high-quality therapy at an affordable price is what the world needs, to reduce the growing burden of healthcare costs. The entire industry is looking at a promising future with newer opportunities for growth. Our performance this quarter was just the momentum we needed to seize on that opportunity and seal our position as a global biosimilars leader.