Q1-FY24 · Jonathan Hunt
We have enough confidence in the demand for biologic CDMO that we've accelerated an internal growth program by 3 years by doing this.
Syngene International · tone and specificity signals across the available quarters.
Language signals
We have enough confidence in the demand for biologic CDMO that we've accelerated an internal growth program by 3 years by doing this.
What we tried to indicate is we've done well enough, better than expected, over the last 18 months, two years, in our biologic CDMO business, that we're currently in danger of running out of capacity.
The underlying base is just some really good innovation going on. On a global basis, you have aging societies and an ever-growing set of demographics that drive us to consume more healthcare.
What we're seeing most commonly is that these China switches, as we call them, are setting up pilots across a broad range of services, often placing them with a select short list of suppliers. They then intend to run these comparative pilots through the year and use this as a way of down-selecting to a longer-term partner.
The busy you are, the more creative people get in operational delivery. I think the team have done a really nice job over the last six months with finding some hidden capacity by being more operationally efficient.
We believe these investments are growth drivers that will deliver operating leverage when revenue growth returns as expected in the H2 of the year.
We framed our guidance at the end of last year, and we are encouraged by the positive start and the growth in Q1. We're twelve weeks into the year, and it's just too early for us to make adjustments at this stage. As the quarters unfold, we will revise or refine as we see it.
When we had guided towards single digit growth, there are a couple of things that we had called out. One, we were seeing an inventory adjustment that would come through the year on account of commercial manufacturing in our biologics plant. That is still to come.
Biotech funding... plays into early stage biotech companies, represent one of the inputs into our discovery services. But these pilots are one source of input. We continue to have a healthy pipeline from multinational and mid-sized biopharma companies who are looking to externalize some of their discovery services.
The really easy answer to your question is no, we've seen no impact whatsoever [from IRA], but I'm not sure that's particularly informative. I would expect this to play out over the next five, 10, 20 years.
We're a broad-based business. We've got 450+ active clients. They cover from, I think, the very largest pharmaceutical company in the world to the smallest, newest biotech startup. So we span that whole range.
If capital is harder to get and more expensive, you may well only get a smaller amount of investment, in which case you have to work hard to make it go further. And if you can get equivalent science, equivalent service, world-class regulatory compliance for a lower dollar amount, then yeah, it sharpens the value proposition we have.
I think it's a bit too soon to declare victory, so we'll have to wait and watch that for a little bit longer.
We have been indicating over the last couple of quarters that we are building up a healthy pipeline for all parts of our business. We do expect healthy growth of discovery services, both on sequential basis and year-on-year basis.
It's not an overnight sensation, but it's a really positive tailwind on the industry for those of us that have got capacity in this part of the world and outside of China.
FY 2026 being a transient year. On a reported basis and in constant currency, we guided to a mid-single-digit growth on revenue. We also guided towards a mid-20s EBITDA margin and a declining PAT. We continue to hold our guidance for the full year.
This trial will recruit patients across clinical sites both in India and the United States. This is an important milestone and reflects our growing capabilities in managing large, complex global trials. The economics of this trial will be spread out over three years, and the bulk of that will come in FY 2027 and 2028 as the trial recruits pick up.
We saw the impact of restocking happening in quarter two. That was in line with our anticipation or our expectations as well. We are working with the client to ensure that it is going as what we had anticipated it to be.
Trends outside of biotech, so Big Pharma, animal health, big biotech, other regions of the world other than the U.S., are much less affected. As I look across the global industry and at our peer groups, you can see these patterns are pretty widely reported, and I think that sort of suggests they're well understood.
We consider the slower growth in Discovery services as transient, and while the exact timing of recovery is uncertain, we will watch the uptick in RFP inflow that Jonathan mentioned closely in the coming weeks as an early indicator for increased growth in the next financial year.
We've only—we're only just digesting the Stelis acquisition. We've got a busy year ahead of turning that facility around, so that it's operating as an antibody plant rather than as a vaccines plant. And then simultaneously with that, we're out trying to sell that capacity.
The rate of stabilization in the biotech funding took longer in the year than what we'd included in our original guidance. I was hopeful that it would stabilize clearly in 2Q, and I think it stabilized more in 3Q.
Despite challenges faced in the first half year, we expect to close the full year with single-digit revenue growth and a flat EBITDA.
It's more structural. Here's a good word for you. It's more tectonic. You know, like plate tectonic. It's going in one direction. It's powerful, but it's slow-moving, steady-moving.
The key variable impacting our Q3 performance has been the ongoing impact related to a single commercial stage product from our largest large molecule biologics customer.
We expect the impact of this single product to play out in the coming quarters. It will go beyond Q4.
If I was to exclude the one-off product, the rest of the business is growing in high single digits, low double digits in constant currency terms.
We are looking to build a wide and diversified business across the platforms and build more large relationships so that exposure to these types of single product events would be minimized.
Q4 revenue from operations declined by 8% over the corresponding quarter last year. The quarter really marks the end to what was a tough year for many in the pharma-based research sector.
I'm pretty encouraged by some of the positive signals in the market. In the last 12 weeks, I think we've seen a marked improvement in that funding environment. $23 billion of new funding went into the US biotech sector in the last 12 weeks.
We expect the first half to be relatively flat to low single-digit growth year-on-year as we build the business pipeline. We expect a stronger second half and a better exit to the year.
Within the global CRDMO market, large molecule biologics development and manufacturing is the fastest-growing segment. The acquisition that we've made plays into this market opportunity, and Syngene's total single-use bioreactor capacity for production of monoclonal antibodies has now increased to around 50,000 liters.
We expect FY 2026 to be a transit year with uncertain short-term macro environment building in the recovery of biotech funding, big pharma restructuring, and tempering of urgency on the Biosecure Act.
The way to think about this is the fact that these are manufacturing sites, and we've given a direction of when these sites will become operational. As and when these sites get operationalized and its capacity starts getting utilized, you will start seeing the drag come down.
FY 2027 will be a transition year for Syngene, with important leadership changes already underway to position this company for its next phase of growth, particularly in CDMO, biologics, and emerging AI-enabled service lines.
With the investments that we've made in the modalities and the capabilities that we're building, and with the maturation of the pipelines that we're developing on the commercial side, we would expect to see those begin to play through and look beyond 2027 for a more sustainable and higher growth trajectory.
We expect, as Peter alluded a little bit, that the coming quarters, Q1 and Q2, will have almost no Librela. There is some minor Librela volumes towards the end of the year, but that's about it.