BIOCONNSEQ4 FY22May 6, 2022

Biocon Limited

12,431words
120turns
0analyst exchanges
14executives
Management on call
Kiran Mazumdar
Shaw – Executive Chairperson, Biocon Limited
Siddharth Mittal
CEO & Managing Director, Biocon Limited
Arun Chandavarkar
Managing Director, Biocon Biologics Limited
Shreehas Tambe
Deputy Chief Executive Officer, Biocon Biologics Limited
Indranil Sen
Chief Financial Officer, Biocon Limited
M.B. Chinappa
Chief Financial Officer, Biocon Biologics Limited
Abhijit Zutshi
Commercial Head - Global Generics, Biocon Limited
Nehal Vora
Commercial Head - Global API, Biocon Limited
Matthew Erick
Chief Commercial Officer – Advanced Markets, Biocon Biologics Limited
Paul Thomas
Chief Commercial Officer - US, Biocon Biologics Limited
Susheel Umesh
Chief Commercial Officer – Emerging Markets, Biocon Biologics Limited
Aishwarya Sitharam
Head - Investor Relations, Biocon Limited
Nikunj Mall
Head - Investor Relations, Biocon Biologics Limited
Dinesh Mahajan
Individual Investor
Key numbers — 40 extracted
rs,
6, 2022 To, The Secretary BSE Limited Department of Corporate Services Phiroze Jeejeebhoy Towers, Dalal Street, Mumbai – 400 001 Scrip Code - 532523 Dear Sir/Madam, Subject: Transcript of Earni
₹8,397 crore
the back of a strong performance in the year that has just concluded. Biocon reported revenues of ₹8,397 crores or US$1.1 billion this fiscal. This year, Biocon has entered into a transformative acquisition w
1.1 billion
performance in the year that has just concluded. Biocon reported revenues of ₹8,397 crores or US$1.1 billion this fiscal. This year, Biocon has entered into a transformative acquisition with its long-term p
3.335 billion
isition with its long-term partner, Viatris, to acquire its biosimilars business portfolio for US$3.335 billion. This is in order to create a vertically integrated structure that will ensure an efficient value
₹700 crore
search and development to drive long term business growth. Towards this objective, we invested over ₹700 crores in R&D this fiscal, to advance our development programs in the Biosimilars and Generics. During th
21%
he Quarter and followed by the Full year. At a consolidated group level, revenues for Q4FY22 grew 21% year-on-year basis and 11% sequentially to ₹2,476 crores. Revenues from our Biosimilars Business
11%
the Full year. At a consolidated group level, revenues for Q4FY22 grew 21% year-on-year basis and 11% sequentially to ₹2,476 crores. Revenues from our Biosimilars Business delivered a strong year-on-
₹2,476 crore
a consolidated group level, revenues for Q4FY22 grew 21% year-on-year basis and 11% sequentially to ₹2,476 crores. Revenues from our Biosimilars Business delivered a strong year-on-year growth of 48%, while that
48%
o ₹2,476 crores. Revenues from our Biosimilars Business delivered a strong year-on-year growth of 48%, while that of our Generics Business grew at a healthy rate of 26% and Research Services revenue
26%
strong year-on-year growth of 48%, while that of our Generics Business grew at a healthy rate of 26% and Research Services revenue grew by 15%. Our Gross R&D spend was at ₹232 crores, an increase of
15%
that of our Generics Business grew at a healthy rate of 26% and Research Services revenue grew by 15%. Our Gross R&D spend was at ₹232 crores, an increase of 70% over last fiscal, corresponding to 14
₹232 crore
ew at a healthy rate of 26% and Research Services revenue grew by 15%. Our Gross R&D spend was at ₹232 crores, an increase of 70% over last fiscal, corresponding to 14% of revenue, ex- Syngene. Of this, ₹191
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Guidance — 20 items
Dr. Kiran Mazumdar-Shaw
opening
We are on track to qualify and validate our Greenfield, fermentation-based, immunosuppressant API manufacturing facility in Vishakhapatnam.
Dr. Kiran Mazumdar-Shaw
opening
We also plan to augment our existing API manufacturing infrastructure in Hyderabad and Bengaluru, as well as, set up a new injectable facility in Bengaluru.
Dr. Kiran Mazumdar-Shaw
opening
This rate of growth is much faster than the 21% witnessed in FY21 and this, I might add, is in-line with our guidance.
Dr. Kiran Mazumdar-Shaw
opening
We expect our B2B business to be bolstered by the integration of the Viatris transaction, allowing us to target a larger segment of emerging markets.
Dr. Kiran Mazumdar-Shaw
opening
We expect that the continued focus on salesforce excellence, brand building and KOL engagement will generate sustainable growth for the business.
Dr. Kiran Mazumdar-Shaw
opening
Our portfolio of next wave of biosimilars will address a market opportunity of approximately US$20 billion to drive growth in the medium term.
Dr. Kiran Mazumdar-Shaw
opening
We expect deal closure in the second half of the CY2022.
Shreehas Tambe
opening
What will happen going forward is you will see that market share strengthen further and the profit share starting to move in the coming quarters, towards the latter half of the year.
Shreehas Tambe
opening
But, as you rightly pointed out, the CAGR in terms of the volume growth in the US alone has been at around that 4-5% range and in Europe, even higher around that 14-16% range.
Shreehas Tambe
opening
If you looked at how the R&D spend have been for the course of FY22 for our programs, we have said that we will be moving into the clinic towards the end of the year and that’s exactly what we have announced today.
Risks & concerns — 10 flagged
Pricing pressure headwinds in several markets further added to this impact.
Dr. Kiran Mazumdar-Shaw
Once we continue to be resilient, we are cognizant of potential headwinds, such as pricing pressure and rising input costs, and we will continue to focus on building cost and operational efficiencies to sustain growth.
Dr. Kiran Mazumdar-Shaw
I think Damayanti you have two questions, one is to see as to why these numbers have been more or less flattish and a concern if this has anything to do with pricing pressure in the US.
Shreehas Tambe
I think let me lay to rest the first part of it, the part related to pricing, we do not see the pricing pressure at all on this aspect.
Shreehas Tambe
We do see pricing tending towards the decline, which is also a factor of the competition that we see increasing with the number of players there, which is expected when you have this kind of market condition.
Shreehas Tambe
In fact the sequential flatness, what we are witnessing in the Biologics sales, despite the ramp up what you have mentioned in the prescriptions for interchangeable insulin, which obviously you have not witnessed any pricing pressure as such.
Surya Patra
Now you have to choose whether you continue to be part of that pricing pressure, continue to lower prices or you opt out of some of these tenders and of course, we have to do both depending on the circumstances, but I also request Abhijit, who heads our Generic Formulations business to add his perspective.
Siddharth Mittal
I think you summed it correctly that the pricing pressure is there and the key is to add new products and we are planning for new launches through a dual strategy of in-licensing products as well as internal pipeline kicking in, so you would see more launches as we grow in this business.
Abhijit Zutshi
Is that the concern or are there some opportunity that you find from the Biosimilar User Fee Act?
Surya Patra
Second question for me, the ₹3,400 crores of CWIP on the Balance Sheet, what would be a major portion of that and what would trigger the capitalization of it and further annual cost impact of that on P&L?
Tarang Agarwal
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Speaking time
M.B Chinappa
15
Nikunj Mall
14
Shreehas Tambe
13
Kiran Mazumdar-Shaw
12
Prakash Agarwal
12
Surya Patra
11
Siddharth Mittal
10
Tarang Agarwal
6
Sameer Baisiwala
5
Damayanti Kerai
4
Opening remarks
Aishwarya Sitharam
Good morning, everyone. I am Aishwarya Sitharam from the Biocon Investor Relations team and I would like to welcome you to Biocon’s Earnings Call for Q4 and full year FY22. I would like to indicate that all participants will be in the listen-only mode, and there will be an opportunity for you to ask questions after the opening remarks conclude. Should you need to raise questions, please select the ‘Raise Hand’ option under the ‘Reactions’ tab of your Zoom application. We will call out your name and unmute your line to enable you to ask the question. While asking, please begin with your name and your organization. Please note that we will not be monitoring any questions on the chat box, but you can raise any technical concerns that you may be facing for our support team to help. I would also like to bring to your attention that this conference is being recorded and the recording will be available on our website within a day and the transcript for this call will be available within next
Dr. Kiran Mazumdar-Shaw
Thank you, Aishwarya. Good morning, everyone. I welcome you to Biocon's earnings call for the fourth quarter and full year fiscal FY22. I would like to start this earnings call on a note of optimism, on the back of a strong performance in the year that has just concluded. Biocon reported revenues of ₹8,397 crores or US$1.1 billion this fiscal. This year, Biocon has entered into a transformative acquisition with its long-term partner, Viatris, to acquire its biosimilars business portfolio for US$3.335 billion. This is in order to create a vertically integrated structure that will ensure an efficient value chain, with embedded agility and competitiveness. We believe that this deal will enhance Biocon’s position as a true biosimilar powerhouse. At Biocon, our key priorities of ‘Patient Centricity’ and ‘Access to All’ drive our decisions and the way we operate. Environment, Social and Governance (ESG) has now further assumed a greater prominence in our business objectives. Recognizing our
Nikunj Mall
Thank you, Ma'am. Should you need to ask a question, please select the ‘Raise Hand’ option under the ‘Reactions’ tab of your Zoom application. We will call out your name and unmute your line to ask the question. The first question is from Damayanti Kerai from HSBC.
Damayanti Kerai
Good morning. Ma’am, my first question is on biosimilars. We have seen a good pickup in prescription volume in most of the launched products but when we look at the reported sale for fourth quarter, sequentially it's looking flat despite having full quarter benefit of Semglee. So, can we have some clarity there, whether it's due to more squeeze on the pricing? How is the pricing environment for most of the launched products, especially insulin Glargine? Kiran Mazumdar-Shaw: So, let me start by saying that the insulin Glargine business is showing a strong pickup, like you mentioned, and as it has already been reported, from a 3% market share in the earlier part of the year, we have now registering a double-digit market share by the end of this fourth quarter. Yes, I think there has been almost like a flat performance of biosimilars in Q3 and Q4, but you must understand that this is more reflection of the kind of market improvement of the business. Q1 tends to be slightly sort of lower q
Shreehas Tambe
Thanks, Kiran. I think Damayanti you have two questions, one is to see as to why these numbers have been more or less flattish and a concern if this has anything to do with pricing pressure in the US. I think let me lay to rest the first part of it, the part related to pricing, we do not see the pricing pressure at all on this aspect. We've got a formulary Transcript - Biocon Limited Q4 and full year FY22 Earnings Call listing through Viatris and that's something that we see staying consistent to the course of the year. So that's really, the second piece there. I think the aspect related to the flattish numbers that you talked about, let me draw your attention to the earlier part of the fiscal, where we had a run rate of about ₹750 to ₹800 crores in the early part of the year as our revenues for the quarter, which we broke through in Q3 in that ₹950 to ₹980 crores range, which is largely on the back of the launch supplies for our 351(k) interchangeable insulin. What you saw in Q4 effec
Damayanti Kerai
And my second question is again, on pricing environment for some of the products which we are anticipating to launch, say Bevacizumab, once we get finally FDA approval. So, what numbers we saw reported by some of the competitors in the similar space, I guess the volume were steady to growing but even they mentioned declined in ASP. So, can you comment on pricing for some other biosimilars where we are looking to enter?
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