How should we think about consolidated margin for the full year — pressure from Syngene capacity build + Generics headwinds vs Biosimilars ramp?
the first quarter and first half will be under pressure. We have multiple launches coming up. We are launching liraglutide in the Europe this quarter, along with our partners, Zentiva, we are expecting a few other launches. And the margins are going to ramp up, by H2 is when you will see the impact of all these launches coming in. And on a full year basis, again, I do expect generics to get back to the profitable and growth trajectory on the margins front. And I think Kiran already alluded in her concluding remarks that with all these upcoming launches, generics will have a strong double-digit growth on a revenue front.
On recombinant human insulin opportunity with Novo exiting — how are you positioned from capacity standpoint? Where is Malaysia Phase II expansion?
the Malaysia facility, as you know, we have doubled the expansion of the drug product line, and that is going to be operational very imminently. However, it obviously will only cater to certain markets till all the regulatory inspections are through. Having said that, I think from a positioning point of view, the insulin opportunity is very, very large, and we are addressing this as much as we can. We do have a growing capacity in Malaysia in terms of I think drug substance, we have adequate supplies, but it's really the drug product that we need to ramp up. But I think from the Malaysia facility, we are really focusing on Advanced Markets supplies largely with some of it going to certain Emerging Markets.
What's happening to Adalimumab in US — pricing trends, private label dynamics, and 12-month outlook?
The Adalimumabfor Biocon continues to be work in progress. We are going through a payor cycle in which we're bidding aggressively. But the attributes in the U.S. are still high concentration. Don't forget, we have a huge franchise in Europe in which Adalimumab has been very successful. As we see the trends, as you asked, with Adalimumab, we see the pricing starting to soften, meaning that we believe the market price is settling on Adalimumab. And we won't see these huge swings that we saw in the beginning. So more to come after the January 1, but we're in the mix. The attributes that are currently being driven in the U.S. preferred by most of the payors are still the high concentration.
Biosimilars 18% revenue growth but gross margin declined ~150 bps — is growth coming from discounted tender channels?
I think if you noted Kiran's commentary, the biosimilars, Biologics business has performed very strongly in the quarter, not only has the revenue grown 18% year-on-year. There's also been an improvement in the EBITDA margin. There's a 36% increase in EBITDA on a quarter-on-quarter basis. There's a 300-basis point improvement that we are demonstrating, which is actually coming on the back of operating leverage that you see starting to play out. The biosimilars business, Damayanti, has really been in a very good shape. The Biologics gross margins have held steady and Opex, as a percentage of revenue has started seeing an improving trend.
What is the current debt level at parent and BBL level, and why has interest expense gone up?
the debt, I think we have said that mainly it's at Biocon Biologics level. We have a net debt of roughly USD 1.1 billion in June at biosimilars level, approximately USD100 million at the Generics level and USD 120 million cash positive in Research. And the funds that we have raised through QIP, as you're aware, has been used partially to retire the OCD of Goldman Sachs and the interest that we were accruing on that OCD would start showing a reduction from quarter 2 onwards. But the bank interest will continue for a foreseeable future because these are primarily on the bonds, which are 5 years bond, which will be due for repayment in '29.
Should we assume interest burden goes down from Q2?
See, Q2 will definitely go down for Goldman Sachs, which had the 5% coupon on USD 180 million. So that would go down. And as I mentioned, Kotak and Edelweiss will be more later part of this fiscal.
What is the regional split of BBL revenues?
See, this quarter, Emerging Markets is about 23%. Advanced Markets is about 77%. But on a full year basis, you should factor 75%, 25%, Damayanti. And within 75% of the Advanced Markets, U.S., then North America will be 40% plus and the balance will be Europe.
What is consolidated gross debt level?
That's that USD 1.1 billion. So again, I'll repeat. Biocon Biologics has a net debt of USD 1.15 billion, USD 100 million debt in generics, USD 100 million cash in Syngene. So when you add the se 3, it's USD 1.15 billion, which is primarily the debt in Biocon Biologics.
Is there Revlimid contribution in Q1 and what's the facility cost impact on Generics EBITDA?
the Revlimid launch impact, as we mentioned, was in quarter 4 of last year, which had boosted the profits and revenue in fourth quarter of FY '25. We did have a very small component of sale in quarter 1 which, of course, did not have a significant impact. So Till the product is launched in an unlimited quantity, which is going to happen at the beginning of next calendar year, we are not going to have any more continuing sales of Lenalidomide for at least the first 3 quarters of this fiscal. And as far as the cost is concerned, we did have 3 facilities, as Kiran mentioned in her opening remarks, which were capitalized in last fiscal. The impact of all these facilities operating costs is in the P&L, which is going to be on an ongoing basis. The impact is roughly INR 60 crores a quarter.
With QIP proceeds and Goldman Sachs repaid — what is the BBL minority interest stake now?
we've raised INR 4,500 crores, of which we have used roughly USD 200 million to repay Goldman Sachs. The repayment has been done as of end of June. We have a commercial paper, which we had borrowed money to repay ADQ in January earlier this year, and that commercial paper is due in September. Now apart from that, the remaining funds will be used to repay Kotak and Edelweiss as their payments become due. But on a fully diluted basis, assuming all these I mean, Goldman and Kotak/ Edelweiss is paid out, we'll be up to 78% stake in Biocon Biologics.
Is there no compulsion on Biocon Biologics to go for a listing after retiring investor obligations?
No, there's no compulsion. I think we have said that IPO is -- I mean the commitment to Viatris that we had was the best effort, and we have time to give exit to investors, which is in few years. So there's no compulsion as such.
Any traction update on Yesintek in US and on Aspart dual-brand strategy with Civica — will pricing differ?
let me first talk about the bUstekinumab, Yesintek launch that we've had in the U.S., and it's been a very successful launch led by our U.S. team there. We've had very strong formulary coverage for this product. We've got all of the big commercial payers, whether it is CVS, United Health, Express Scripts, all of them have listed Yesintek on their main formularies. So that's a very strong positive sign. Two is we are also starting to see initial trends in terms of how prescriptions have moved. And we have seen that a very large share of the prescriptions have moved towards Yesintek, which is a good thing. Apart from the fact that it's actually an interchangeable product. On the second question that you asked about insulin Aspart, we are very proud of being the first and the only interchangeable rapid-acting insulin analogue in the U.S. market at this point.
Stelara IQVIA data shows strong trends but payer transitions happen progressively — is there more runway to improve share?
as the products continue to transition the Stelara from the payer starting July 1, you're starting to see what Shreehas said, early uptake of Ustekinumab. So these products will continue to see one full basis point that has contributed to that increase in June. Remember, most of these products where Stelara will come off of the payer starts in July and then will continue to accelerate as we go through the end of the year. So we've got a great start. We have a massive amount of coverage from the payer side, and our sales force are in tune out there already talking to health care providers.
How sticky is Biocon's Yesintek market share given competition could chip away in next payer cycle?
Look, we're early leaders like we are with Biocon. Doctors are getting used to writing Yesintek. And remember, interchangeability is not to each biosimilar. It's only to the brand. So as the patients and doctors get used to utilizing the Biocon Yesintek, it becomes very sticky. And I can tell you, we're in a great position, as we've spoken about before, being vertically integrated. We are well positioned to continue to compete and compete profitably in this market as the dynamics change and shift.
Oncology biosimilars — new competition returning, will margins be flat with Stelara gains offset by Oncology pressure?
I think first up, Neha, we can look at the data points that you're referring to, but we believe that the oncology franchise for us in the U.S. has been very, very strong. In fact, we still have over 1/4th of the market with the 2 biosimilars that we've launched and continues to be very, very profitable. It's seven years since we've launched these products, and they continue to hold value. As we bring Abevmy, which is our biosimilar bevacizumab into the market, it only further strengthens our oncology franchise.
When do we launch Aspart and what's the Bevacizumab launch timeline?
On the Aspart piece, we'll be launching immediately. We have approval. We'll start seeing more pull-through. As you remember, the U.S. is set on a July basis and a January basis. So aspart will be strategically launching between now and the end of the year and leveraging our relationships and our great franchise that we set up with Semglee. But that will be a ramp-up because of timing in regard to the payor cycles. And in regard to Bevacizumab, you'll see this launching towards the end of the summer around the October time frame.
Status of Liraglutide US filing and Semaglutide preparedness for emerging market launches?
So the Lira U.S. file is under review with the FDA, and we should hear back shortly. We definitely do expect the approval to come in sometime this fiscal. I cannot comment on the timing exactly, but we do expect a launch in the U.S. during this fiscal. And as far as Semaglutide is concerned, I think even in the last quarter, we had said that development is done. We are going to file in quarter 2, which is this quarter in many emerging markets in Canada. And we are expecting early approvals in some of the markets where we'll file this quarter by end of calendar '26/early calendar '27.
On Yesafili in Canada — how should we look at the launch?
we're ready, we're launching. We've already started working with key customers in which we're putting in bids now in Canada. Primarily, the business is in two spots, Quebec and Ontario, which we have our sales force, which we're very familiar with. We remain very optimistic in our opportunity, because of our position in that launch and being the first one of the first in the market in Canada.
Key generic launches for FY26 double-digit growth — is Lira in India significant? Is Sema the one to watch for next year?
the biggest growth driver is going to be Lira in Europe, where we have already supplied partially in quarter 1. We will continue to supply to Zentiva and to other markets where we are direct in quarter 2 onwards. And that would be the main growth driver. Apart from that, we do have a couple of other launches. I think we have spoken about Micafungin injection being launched in quarter 2. We also have Norepinephrine injection coming off a launch in quarter 2. We had received an approval for Everolimus Zortress, which is being launched in quarter 2. I mentioned about Entresto or Sacubitril Valsartan launched in quarter 2. And again, lira U.S is, of course, a big opportunity; still a very lucrative 700 million, 800 million market with limited number of players.
What's the timeline for Sema Canada approval?
best case would be by end of calendar '26. We'll be filing this quarter. And so far, let me remind you, Canada has not approved a single GLP-1, whether it is generic liraglutide as well. So Canadian health regulator is taking its own time to approve the GLP-1. We have been interacting with Health Canada on a Liraglutide file. We, of course, understand a little bit better in terms of what they are expecting. And our teams are addressing proactively now for Semaglutide as we file that drug this quarter. And the review cycle, while is short in Canada, it's post filing, it's 8 to 9 months, if it's a first cycle approval.
What is the Generics operational cost impact from new facilities and trajectory going forward?
the cost which is there in quarter 1 P&L relating to the three new facilities, roughly INR 60 crores. So on a full year basis, it's roughly INR 240 crores. Now we have a few more facilities which will get capitalized during the later part of this year. We will see some increase during the remaining quarters for the new facilities that will get capitalized. But not a significant change. But as I said, that the impact of all these new launches and increase in gross margin would offset these additional costs that have hit the P&L and more from H2 onwards.
Frost & Sullivan report mentions biosimilar market growing 3x by FY2029. Can Biocon grow better than the market?
the report that's been put out by Frost & Sullivan is very fair. Because it does cite two things. One is that the biologics opportunity itself is very large. But the report also establishes the fact that biosimilars are here to stay, and that's the next large opportunity where Biocon Biologics is very well placed in the current set of circumstances where we have one of the largest portfolios, one of the deepest in certain key therapy areas, which is in Oncology, in Diabetes, and in Autoimmune diseases. we've always said that we'll invest in debilitating diseases. We are getting products to market. We've got five products ready for launch in the next 12 to 18 months. 100% share your sentiment.