<p>As Biocon Biologics works with its partner to come out with a Covid jab, Kiran Mazumdar-Shaw, Executive Chairperson, Biocon Limited, India’s largest biopharmaceutical company, tells Veena Mani and Mahesh Kulkarni that Covid-19 has become an endemic from a pandemic. Excerpts:</p>.<p><strong>How has Covid-19 impacted your business? Some of that is reflected in your quarterly numbers. But what about product approvals during the pandemic? </strong></p>.<p>Travel restrictions made it difficult for us to get approvals. For example, the USFDA could not travel to our India site for a pre-approval inspection due to the pandemic. Hence, the agency’s approval of biosimilar Bevacizumab is delayed. These delays in approvals have impacted our new product launches. Largely, Covid has hurt our growth trajectory. We are back to 80% of our operations.</p>.<p>We need to get back to 100% operations, which will happen only when the pending regulatory approvals come through. These pending regulatory approvals have taken us back by two years. We were supposed to get a biosimilar approval in December 2019, but that got delayed due to Covid-related travel restrictions. We are yet to have the necessary pre-approval inspection needed to move forward. Since we cannot predict how the Covid-19 situation will pan out, it is difficult to say anything on 100% operations.</p>.<p><strong>You mentioned that Covid impacted the company. Given this, has the role of your medical representatives changed? Is their role limited now? Are you laying them off? </strong></p>.<p>Our India formulations business is not as big as Cipla, Sun Pharma or any other Indian pharma player. We are a speciality company with a much smaller sales force. Doctors still want to have information about companies and their products. Digital tools eliminate the need for our sales representatives to be physically present. We hold webinars to engage with doctors and attend to their requests and queries through various digital, video, mobile, platforms including zoom calls.</p>.<p>We cannot put a number on what revenue we get from each salesforce using digital. Our focus is to address doctors and patients needs. We are trying to refresh our marketing strategy with extensive use of digital tools and will like to go back to a hybrid model of digital and physical once the Covid-19 pandemic is over.</p>.<p><strong>How is the recent USFDA approval for the interchangeable insulin going to help the company?</strong></p>.<p>It is the first interchangeable biosimilar in the world. This approval has a lot of potential for our product. But for the potential to be realised, the Covid situation has to get better first. We have made investments in building a global scale for manufacturing insulins in India and Malaysia. We can produce both recombinant insulin and insulin analogues.</p>.<p>With this interchangeable label, we can compete with the big insulin companies. We can even expand the capacity further in India and Malaysia. We are undoubtedly the most affordable insulin maker globally.</p>.<p><strong>How long would the Bicara losses show up in the P&L?</strong></p>.<p>Bicara is an exciting start-up we have created in Boston. It is working in the area of bispecific antibodies. T-cell engaging antibodies are extremely exciting. It has teams in Boston and Bangaluru. Bicara started operating as a standalone company under an independent management team in FY21 and since then has been reclassified from subsidiary to associate. Biocon has supported Bicara with funds so that they can advance their exciting programmes until they raise external finance. Bicara is in the process of raising capital. The share of losses due to Bicara will continue on Biocon’s P&L till the end of this fiscal.</p>.<p><strong>Biocon Biologics has set a target of achieving $1 billion in revenue. By when do we expect that to happen?</strong></p>.<p>At a consolidated level, Biocon’s annual revenues have crossed a billion dollars. We had set an aspirational target of achieving $1 billion in revenues by FY22 in our biologics business. But a challenging business environment aggravated by the Covid-19 pandemic has led us to recalibrate our outlook. We continue to aspire for the $1 billion revenue target, but it would be difficult to provide specific guidance around the timeline to hit the mark.</p>.<p><strong>When are you planning to list Biocon Biologics?</strong></p>.<p>Biocon Biologics IPO will happen. We are building a robust business on the back of our strong business fundamentals, scientific know-how, efficient operations, early-mover learnings, and a broad product portfolio. However, a lot of this depends on how the Covid-19 pandemic plays out. We would like to raise capital for advancing Biocon Biologics’ R&D pipeline and expanding manufacturing infrastructure and commercialisation footprint. We would like to front-end our commercialisation in the US ourselves, at some time. Right now, our partner Viatris is doing this. Biocon Biologics is working on developing recombinant human insulin for the benefit of diabetes patients in the US.</p>.<p>The $330 million raised from marquee funds such as True North, Tata Capital Growth, Goldman Sachs, and the Abu Dhabi-based ADQ so far will take care of our near-term capital needs, allowing us to be flexible with our IPO timelines.</p>
<p>As Biocon Biologics works with its partner to come out with a Covid jab, Kiran Mazumdar-Shaw, Executive Chairperson, Biocon Limited, India’s largest biopharmaceutical company, tells Veena Mani and Mahesh Kulkarni that Covid-19 has become an endemic from a pandemic. Excerpts:</p>.<p><strong>How has Covid-19 impacted your business? Some of that is reflected in your quarterly numbers. But what about product approvals during the pandemic? </strong></p>.<p>Travel restrictions made it difficult for us to get approvals. For example, the USFDA could not travel to our India site for a pre-approval inspection due to the pandemic. Hence, the agency’s approval of biosimilar Bevacizumab is delayed. These delays in approvals have impacted our new product launches. Largely, Covid has hurt our growth trajectory. We are back to 80% of our operations.</p>.<p>We need to get back to 100% operations, which will happen only when the pending regulatory approvals come through. These pending regulatory approvals have taken us back by two years. We were supposed to get a biosimilar approval in December 2019, but that got delayed due to Covid-related travel restrictions. We are yet to have the necessary pre-approval inspection needed to move forward. Since we cannot predict how the Covid-19 situation will pan out, it is difficult to say anything on 100% operations.</p>.<p><strong>You mentioned that Covid impacted the company. Given this, has the role of your medical representatives changed? Is their role limited now? Are you laying them off? </strong></p>.<p>Our India formulations business is not as big as Cipla, Sun Pharma or any other Indian pharma player. We are a speciality company with a much smaller sales force. Doctors still want to have information about companies and their products. Digital tools eliminate the need for our sales representatives to be physically present. We hold webinars to engage with doctors and attend to their requests and queries through various digital, video, mobile, platforms including zoom calls.</p>.<p>We cannot put a number on what revenue we get from each salesforce using digital. Our focus is to address doctors and patients needs. We are trying to refresh our marketing strategy with extensive use of digital tools and will like to go back to a hybrid model of digital and physical once the Covid-19 pandemic is over.</p>.<p><strong>How is the recent USFDA approval for the interchangeable insulin going to help the company?</strong></p>.<p>It is the first interchangeable biosimilar in the world. This approval has a lot of potential for our product. But for the potential to be realised, the Covid situation has to get better first. We have made investments in building a global scale for manufacturing insulins in India and Malaysia. We can produce both recombinant insulin and insulin analogues.</p>.<p>With this interchangeable label, we can compete with the big insulin companies. We can even expand the capacity further in India and Malaysia. We are undoubtedly the most affordable insulin maker globally.</p>.<p><strong>How long would the Bicara losses show up in the P&L?</strong></p>.<p>Bicara is an exciting start-up we have created in Boston. It is working in the area of bispecific antibodies. T-cell engaging antibodies are extremely exciting. It has teams in Boston and Bangaluru. Bicara started operating as a standalone company under an independent management team in FY21 and since then has been reclassified from subsidiary to associate. Biocon has supported Bicara with funds so that they can advance their exciting programmes until they raise external finance. Bicara is in the process of raising capital. The share of losses due to Bicara will continue on Biocon’s P&L till the end of this fiscal.</p>.<p><strong>Biocon Biologics has set a target of achieving $1 billion in revenue. By when do we expect that to happen?</strong></p>.<p>At a consolidated level, Biocon’s annual revenues have crossed a billion dollars. We had set an aspirational target of achieving $1 billion in revenues by FY22 in our biologics business. But a challenging business environment aggravated by the Covid-19 pandemic has led us to recalibrate our outlook. We continue to aspire for the $1 billion revenue target, but it would be difficult to provide specific guidance around the timeline to hit the mark.</p>.<p><strong>When are you planning to list Biocon Biologics?</strong></p>.<p>Biocon Biologics IPO will happen. We are building a robust business on the back of our strong business fundamentals, scientific know-how, efficient operations, early-mover learnings, and a broad product portfolio. However, a lot of this depends on how the Covid-19 pandemic plays out. We would like to raise capital for advancing Biocon Biologics’ R&D pipeline and expanding manufacturing infrastructure and commercialisation footprint. We would like to front-end our commercialisation in the US ourselves, at some time. Right now, our partner Viatris is doing this. Biocon Biologics is working on developing recombinant human insulin for the benefit of diabetes patients in the US.</p>.<p>The $330 million raised from marquee funds such as True North, Tata Capital Growth, Goldman Sachs, and the Abu Dhabi-based ADQ so far will take care of our near-term capital needs, allowing us to be flexible with our IPO timelines.</p>