"We currently have adequate capacity to cater to increased market share or to anticipated regulatory approvals of our biosimilars in various jurisdictions," said Christiane Hamacher, CEO and Managing Director of Biocon Biologics in an email interview to Moneycontrol
Biocon Biologics is well on track to achieve its FY22 revenue target with new approvals and key regulatory approvals of its facilities in place, Christiane Hamacher, CEO & Managing Director of Biocon Biologics told Moneycontrol in an email interview.
Biocon Biologics, a subsidiary of Biocon, is banking on its biosimilar portfolio and a strong pipeline of future launches to reach its $1 billion revenue target by end of FY22
The company Tuesday said it has received the certificate of GMP compliance from EMA for multiple Biologics Drug Substance (DS) and Drug Product (DP) manufacturing facilities at Biocon Park, Bengaluru. These facilities manufacture Bevacizumab, Trastuzumab, Pegfilgrastim and secondary packaging of Insulin Glargine for EU markets.
Hamacher also spoke about scaling up biosimilar business, new launches, recent operational challenges faced by the company on account of COVID-19 lockdown and fundraising plans.
What is your state of preparation in terms of manufacturing capacity to achieve your FY22 revenue milestone of $1 billion?A. We currently have adequate capacity to cater to increased market share or to anticipated regulatory approvals of our biosimilars in various jurisdictions. We are pleased with the latest EU GMP certification for multiple biologics Drug Substance and Drug Product manufacturing facilities in Bengaluru. This approval will support the penetration of Trastuzumab and Pegfilgrastim in Europe and further enable the approval of biosimilar Bevacizumab in the EU.
Also, we received USFDA's approval for enhanced manufacturing capacity for two of our key biosimilar products, Trastuzumab and Pegfilgrastim, in FY20.These approvals will enable us to scale up capacity multi-fold and address the growing market opportunities in the US.
Additionally, the first phase of our state-of-the-art, new 250,000 square feet Drug Substance facility for monoclonal antibodies at Bengaluru has been commissioned in late FY20 and is undergoing qualification. This facility once fully ready for commercialization will expand our capacities significantly and will enable us to address the growing patient needs across markets.
You had spoken about operational challenges related to COVID-19 impacting your biosimilars business in Q4FY20. What kind of challenged did you face? Are these issues behind you?A. In terms of operational challenges, we largely faced logistics issues in India, as well as, in shipping our products out of India across the world because of disruptions in distribution channels and logistics movement due to COVID.
We faced these logistics issues at the beginning of the lockdown in India, in March. The situation has now begun to improve after the relaxation provided by the government in early May, which allows for unhindered movement of goods vehicles across the country. We have also seen imports for raw materials gradually normalise. Outbound logistics have also now improved. Having adequate inventory of key raw materials to sustain operations during the period of the lockdown has helped us tide over this challenging period. Our strong performance in first three quarters enabled us to post a robust 29 percent growth in FY 20.
Do you have any immediate plans for fundraising in Biocon Biologics? Can you share any visibility on the timelines for your IPO?
A. We started the value unlocking process for Biocon Biologics in FY20 when Activ Pine LLP, an affiliate of True North Fund, made the private equity investment of $75 million in Biocon Biologics. This was a primary equity infusion for a 2.44 percent stake at an equity valuation of $3 billion and an enterprise valuation of $3.5 billion on a pre-money basis. The fundraise met our immediate requirement.
As indicated earlier, we may consider additional investments to fund the group’s funding requirements over the medium term. While there is intent to list the Biocon Biologics, however it would be early to comment on specific IPO timelines.
Do you see the setback to your revenue growth in Q4FY20 impacting your FY22 revenue goal?
A. We don’t see any impact on our revenue goal for FY22. Biocon Biologics has reported strong revenue growth of 29 percent at Rs 1,951 crore for the full year FY20 on the back of excellent performance in three consecutive quarters. Going forward, we expect to maintain the upward trajectory by capitalizing on the new global opportunities.
Five molecules from our portfolio of 28 have been commercialised globally (Trastuzumab, Pegfilgrastim, Glargine, rH-Insulin, Bevacizumab).
In the US, Pegfilgrastim and Trastuzumab have been commercialised. Market share of our two biosimilars in the US has sustained. We expect Pegfilgrastim and Trastuzumab sales to pick up with new contracting in the US. We remain on track for commercialisation of Semglee (Glargine) in the US in mid-2020.
We have received US FDA approval for our Malaysia manufacturing facility after pre-approval inspection for Insulin Glargine. We also received a favourable US District Court decision with respect to our ongoing patent litigation for Insulin Glargine. Glargine is a $2.2 billion market in the US and we believe this product will be an important contributor to our growth in FY21 and beyond.Recent launches of Pegfilgrastim in Canada and Australia have added to our oncology portfolio with Trastuzumab in both countries. In Australia and Canada, the potential market Fulphila can address is estimated to be $74 million.
Better penetration of Trastuzumab and Pegfilgrastim and launch of Glargine in near term, along with Bevacizumab and Aspart in the long term, will make US, the biggest driver of our growth going forward.
Our BLA for Bevacizumab is currently under review with the US FDA and EMA. We are also on track with the development of Insulin Aspart for the global markets.
We expect Pegfilgrastim and Trastuzumab sales to gain traction in many markets across Europe. With respect to Glargine, we are starting to see some nice market penetration in certain parts of Europe, and our partner will build on this experience to expand in other countries.In most of the world (MoW) markets, our biosimilars business continues to do well. In Latin America, we hold registrations for our biosimilar Trastuzumab in over 10 countries and during FY20 we commercialized it in many of these markets.
Are you on track on your Insulin Glargine launch plans in the US? How do you see the competitive landscape for the product in the US?
A. We are on track to launch Semglee (Insulin Glargine) in the US in mid-CY20. We look forward to the launch of Semglee in the US market, which represents a great opportunity given that there is only one biosimilar glargine currently available. We are uniquely positioned as we are an early mover in the Glargine space, which has limited competition in the United States. It is not a crowded market with 5- 6 players.
In general, we should expect more disciplined approach to pricing and limited competition. Insulin Glargine is a $2.2 billion market and we believe this product will be an important contributor to our growth in FY 21 and beyond.