Q1-FY24 · Kiran Mazumdar-Shaw
We are tracking well ahead of this plan. On July 1, 2023, we successfully integrated over 70 countries in emerging markets into Biocon Biologics.
Biocon · tone and specificity signals across the available quarters.
Language signals
We are tracking well ahead of this plan. On July 1, 2023, we successfully integrated over 70 countries in emerging markets into Biocon Biologics.
Post-transition, by the end of this fiscal, core EBITDA margins are expected to return to the mid-thirties.
We are seeing very active growth and good growth in those other channels, like Semglee, trastuzumab, et cetera.
We expect the second quarter to continue to be relatively muted, with performance then building in the second half of the fiscal, led by new generic formulation launches across multiple markets.
We do not see this market as an 8, 9, 10-player market for a long time. We expect this market to consolidate, and we expect those players which will have the ability to endure over a period of time, which requires you to be fully integrated.
We are in constant conversation with the agency, and we will provide them with whatever is required for them to assess the readiness of this site to supply new products.
We are now in a very healthy financial state. I think the fact that we have done the QIP and the bond issue has made us far more financially robust.
The opportunity ahead is far more exciting than what we've seen at Biocon Biologics so far.
We are very proud of being the first and the only interchangeable rapid-acting insulin analog in the U.S. market at this point.
We are pleased with the accelerated progress in transitioning the acquired business and with the growth in market share of our commercialized products.
The market adoption of biosimilars has very clearly been slower than anticipated across the market, and of course, this has also affected Hulio.
We are fully aware of what has worked, what hasn't worked, and we will make sure that these things even out over time.
We maintain our outlook for a transition to accelerating growth in the H2 of the fiscal year, with Syngene returning to growth, maintained momentum in our biosimilars business, and a recovery in generics in the latter part of the H2, driven by the launch of our first GLP-1 generic in the UK.
We do not see any other biosimilar for Aspart at this point in time. We've said in the past as well that the agency has clearly given an indication that there is no outstanding question on the science or the dossier at this point in time on Aspart.
I know it can be frustrating, and it can be very, very difficult sometimes to see how these things evolve. Believe me, it's very frustrating for us as well. But we are committed to this, and we will continue to work with it to make sure that we get to that finish line sooner than later.
We are the first interchangeable biosimilar as far that the FDA has approved. It is indeed a very proud moment for us.
We are not in a rush. We will do this in a responsible manner.
We have a very balanced mix. There's no exposure in any one particular market.
We have now successfully completed the full transition of the acquired business in about 120 countries, fully 1 year ahead of schedule to become a globally scaled and vertically integrated lab-to-market biosimilar enterprise.
The market for Adalimumab is not going to open up in a big way in calendar 2024, and the expectation is that that will happen in a more structured fashion in calendar 2025.
We are awaiting the agency to come and inspect us. There is no outstanding question on the science. There is nothing that part is pending.
We maintain our outlook for a transition to growth in the second half of this year and into next fiscal with improved visibility across all businesses.
The only piece that was remaining was the site GMP status. With that achieved, we've responded to them saying that we've now completed this, and we want them to reconsider our application at the earliest.
I think the Viatris settlement deal was about the deferred payment that we had to work on. And like we've said, we've been able to close out the entire $335 million.
Q3 FY26 represents an important operational inflection point for Biocon. With major capex now largely behind us and operating leverage beginning to play out, we are progressing from a phase of balance sheet resilience into a cycle of sustainable growth, margin expansion and a cash flow-led value creation.
We've refrained from giving specific guidance for the future... but clearly the future is more exciting than what the past is, is a fair way to look at it.
We have four molecules in the zone of $200 million annualized revenues and adalimumab was one of that.
We were very pleased with our recent landmark success in our peptide portfolio through securing approval for liraglutide, a GLP-1 receptor agonist prescribed for diabetes as well as obesity in the U.K.
We see GLPs as the major growth driver of the business from fiscal 26 onwards.
We have signed a settlement and license agreement with Janssen Biotech and Johnson & Johnson, that clears the way to commercialize the product, in the U.S., subject to regulatory approval, no later than February 22, 2025.
We are now on a path of accelerating growth with a commitment to innovation, digital augmentation, and operational excellence.
We have over 70% market access with the payers in the U.S. at the beginning of the start. With that comes the opportunity for us to continue to pull the product through in the U.S.
The future clearly is far more exciting than what we have seen before.
We are now moving from a phase of integration and investment to one focused on execution, operating leverage, and value creation.
Growth is only when it's profitable. We've been very careful as we picked up market shares.
Every dollar that we generate out of free cash the first claim is going to be to reduce the debt.