Biocon chairperson speaks about the company's Q2 results and the challenges that India will encounter in vaccine distribution
The buzz around the imminent covid-19 vaccine has raised hope for billions of people affected by the pandemic as a way back to normalcy. Kiran Mazumdar-Shaw, chairperson and managing director of Bengaluru-headquartered Biocon Ltd, said she is hopeful that the vaccine will be in India by next June. However, delivering the vaccine to India’s over 1.2 billion population has its own challenges, she said. Biocon, which announced its September quarter earnings on Friday, saw its net profit fall 23% to ₹169 crore as compared to ₹216 crore in the year-ago period. In an interview, Shaw shared her views on the vaccine and its challenges, and the way forward for Biocon. Edited excerpts:
My expectation is that the first mRNA vaccines will be approved by the end of the year. But they are not going to be available in India because they require a -80 degree cold chain and that is not something which we can handle here. I expect that by January, some of the other vaccines could be approved like AstraZeneca’s or one of our own Indian vaccines like the one by Bharat Biotech. If we finish the clinical trials in the next 2-3 months, even those may be approved by January-February. So I would expect that in Q1FY22 we should have vaccines available in India and other parts of the world. But these will be emergency use authorization (EUA) only because you need to see durability of responses before you get the full approval.
What are the challenges you foresee in vaccine distribution here?
This scale of adult vaccination has never been done before. Polio vaccine was done over many years. Polio vaccine can be given by ASHA workers and others but covid vaccine will be an intra-muscular injection and you will need nurses, doctors, MBBS students to deliver the vaccine. Apart from human resources, we need to get infrastructure for cold chains to be set up properly. Also, it is a vaccine that has to been given twice (one month apart). This brings in a lot of complexity. You need a digital backbone to do all this very efficiently. You need to track durability of the two doses to have data on chain traceability and trackability.
I think Aadhaar is the best way to do it as it allows you to do something at a massive scale in such an efficient way unlike any other country can do.
What is the update on Biocon developing a product portfolio to treat covid-19 patients?
This is an important segment in the current times because covid-19 needs to be treated in different ways and Biocon is just doing its role. The numbers will depend on how this pandemic continues and the need for these drugs. But it certainly can contribute to our business for over the next 12 months and beyond. It is a long-term plan since covid is not going away ever like any of the other viral diseases. There is a place for every drug and we are trying to make sure that across the disease continuum, we have drugs.
What is the progress on Itolizumab, the monoclonal antibody to treat covid?
We have commenced phase IV studies and Itolizumab is also going to start a global phase III study. In India, over 2,000 patients have received Itolizumab and most of them have done extremely well. There is a lot of misreporting and misinterpretation of this drug. Itolizumab is an approved drug, which went through all three phases of trials in India before it was approved for psoriasis. The safety data is already there for the last seven years. Remdesvir was given emergency use authorization (EUA) without going through a major trial.
We are now building real world evidence through the phase four trial. For the first time, the US is going to do a phase three trial by bypassing phase two trials based on the India data. It has so far been approved only in India and Cuba only on EUA. These are considered repurposed drugs. We believe that our drug is doing very well and has been included in the state protocols of Maharashtra, Karnataka, Gujarat and Chhattisgarh.
How would you evaluate the covid situation in India? Have we let our guard down?
Of course, we have. This is a virus, which is going to infect people, and if you don't wear masks, avoid crowds, gatherings, then obviously it's going to infect. US president Donald Trump was not very encouraging of masks and a lot of people have been infected there. Any country that has let its guard down has seen a huge surge in cases. The festivities are here and our traditional and cultural mindset is getting together with a large number of people. Now, when that happens, you're going to see infection levels rise.
You need to be more vigilant, stricter and make sure there is more public advocacy done. Governments on their own can't do it. The people owe it to themselves to be responsible.
I would use lockdowns as a kind of a penalty for allowing large outbreaks. Opening up the economy is important but you have to do it safely.
Why did Biocon’s net profit decline in the September quarter?
We have been impacted by much higher research and development (R&D) spend that has gone up by almost ₹44 crore and a net loss of ₹18 crore in forex compared to a net gain last year. We've had other expenses and higher staff costs. So I think that's also resulted in muted profitability.
How long will it take Biocon to recover and what’s the way forward?
We have been impacted by muted growth in Biologics and that is going to be corrected in the coming quarters. It’s not for a want of demand as there is very strong demand but the supply needs to be sorted out. Because of covid, we’ve had some operational challenges, like limited travel resulting in sales not happening at the end of the quarter. You will see stronger Q3 and Q4. We have taken some measures to make sure that some of these operational issues don't occur again. Travel restrictions are causing delays and we have fixed it with remote releases, IT based solutions and remote methodologies.
Biocon's insulin (Semglee) has recently been commercialised in the US. What's the strategy in that market?
USA actually has a huge need for affordable insulin and that’s where we will disrupt the market. We have just entered the US this quarter so it’s too early to comment on sales but you can see it coming between Q3 and Q4. There has been an increase in market share in other drugs like Pegfilgrastim, Trastuzumab. So you will see that we have a very large portfolio within the next 12 months.
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