ARV guidance upgraded from INR2,500 cr to INR2,800 cr.
- Cdmo h2 seasonality vs — answer hedged.
- Global fund tender cycle — answer hedged.
- Immunoact capacity ramp foreign — answer hedged.
CDMO in Q1 is generally weaker. And as the year passes by, Q2 will be better, and Q3 will be much better and Q4 would be the top. And generally, H2 will be much better than H1. But this time, surprisingly, CDMO in Q1 is very, very strong. It is even better than last year's Q4. So on this base, do you still think H2 will be better than H1 for CDMO in FY '26 too?
The CDMO business, you can't count quarter-on-quarter. But we expect good growth over last year for sure. Our manufacturing and delivery depends on their clinical programs. So it will be bumpy, but we see we are in a good shape right now on our CDMO segment.
Currently, if you see the current cycle of Global Fund tender, which is generally for 3 years, it is going to end by end of December. May I know if Laurus has won the next tender cycle?
Generally, they will run the tender a little later, end of maybe September, October. See, if you see our trend, we are very successful in getting good share of that tender, and we don't see any challenges there.
On the ImmunoACT. How do you see the ramp-up in number of capacity, I understand it will come on stream by September. But in terms of the response from the market, how is the response from the market? Are we also seeing foreign national travelling to India to get this treatment done in India since the cost is much lower?
There are some more treatments offered to foreigners. That was based on the hospitals choi ce. What is also happening, we are also trying to build overseas presence by entering partnership with some Big Pharma in those regions. Maybe in the near future, we'll give you more details on our global expansion of CAR-T therapy using ImmunoACT.
Over the last 5 years, we've kind of come a long way and the product mix has changed and now we see the CDMO revenue contributing to 30-plus percent. At this point, we see the contributions from Bio division to be less than 5%. How do you see this product mix changing 5 years out? What is the vision of the company over there?
While we continue to focus on our core, which is APIs and integrated offerings in generics, we are also increasing our investments, capex, resources and technology platforms to offer a wide variety of services for late clinical and commercial Human health, Animal health and Crop science programs. As we've mentioned, currently, the CDMO contributes over 30% of our revenue. We expect it will continue to grow. In the near to medium term future, we expect it has the potential to touch 50%. That's our guesstimate.
Would it be right to assume that the gross margin improvement is driven by non-CDMO business significantly or largely because CDMO gross margins would largely be static in a range, maybe 5% deviation here and there. So would it be a right statement to make that the sharp improvement in gross margin over the last 6, 7 quarters that we are seeing is driven by the non-CDMO business?
If you look at our quarter -on-quarter performance, our revenue decline came from ARVs and other generics, whereas there was a growth from CDMO. So I think these 2 contributed to the gross margin expansion.
Is there further scope of improvement growth there? What is driving that non-ARV performance?
It's based on some shipments. As I mentioned, we expect the gross margins remain between 55% to 60%. Earlier we used to say around 55%. Now we are saying it will be between 55% to 60%. So that's very healthy, and we expect we'll be able to maintain that.
Any prebuying that you have witnessed or any indication of prebuying given the perpetual risk of some tariff that could come across?
I think it's a very difficult question to guess an answer because we have to wait. And as you have seen from our results. See our dependency on formulation sales to U.S. are not that significant. So yes.
In the context of Trump's make in America, Big Pharma is investing heavily in biologics, gene therapies, weight loss drugs, even diagnostics and more to expand capacity and strengthen their supply chain. Many of them from Roche to AstraZeneca to Eli Lilly have announced multibillion dollar capex in the U.S. How will these investments by innovators in the U.S. affect the outsourcing and CDMO industry?
These Big Pharmas have a very large pipeline. Maybe part of the supply chain will be located in U.S., part of the su pply chain located outside. We have to see how it evolves. Everybody is announcing a lot of investments in U.S. But we don't see beginning of impact. So as you mentioned, they will not move core chemistry to U.S. They may move cell and gene therapy, finishing steps. So the demand for intermediates will remain constant or increasing maybe.
Everybody is making in India and globally about peptides and the opportunity for GLP-1 and weight loss drugs basically and also other peptide products. Is there any opportunity that is available for Laurus also in this space?
We believe so.
Can I get a breakup of this INR5,000 crore capex, how much is going for the CDMO over the next 5 years?
No, we have not disclosed that. It will interchange based on the business opportunities.
On the non-ARV side, would it be a right statement that we are almost at the peak gross margins that we had in the past, say, around 2021? On the non-CDMO aggregate gross margin?
Yes, it's a difficult, but maybe closer.
Is our business mix changing that it can see a significant uptick from what was the historical peak on the gross margin because that will directly flow through EBITDA and PAT also in that sense. So is the business model changing where we can see a higher peak gross margin in non-CDMO piece?
I think there is no business mix change. There's only product change. In some products, w e get more margins, maybe we might shift in this quarter. So it is fundamentally the business is not changing significantly.
And for the APIs?
API, what is happening with that contract, we are doing more integrated. So we're making API and converting that into formulations. So we don't expect the contract manufacturing or API revenues will grow. It will not grow to the extent formulations are growing.
Because we've had 3 very strong consecutive quarters on the business. The growth has come through sequentially for the last few quarters on a Q-O-Q basis. On this base, how should we think about quarterly growth for this business? Is it going to be linear? Or we expect some lumpiness as we go forward?
Overall year, we can comment it's going to be a healthy growth.
Probably some volatility on a Q-o-Q basis as we go through the quarters?
We are not expanding that because of ARVs some business, we know very clear. See, it's not that we will get an order for CDMO in July and we deliver in September. It's not that. So this is a long lead time, we know very clear what molecule we're making, how much we are making, which is the customer, what price and all pretty well for this year. So w e see comfortable and we expect good growth in CDMO revenues overall for the year.
On the CDMO part, how many products are we supplying against which you're doing commercial supplies at this point of time. And typically, how should we think about how many new products can get commercial typically on an annual basis given the pipeline over the next couple of years?
It's difficult. We don't want to guess that number and confuse all the investors. So I think as you have mentioned, we have grown significantly in CDMO quarter -on-quarter for the last 5 quarters. And the numbers only will speak. That's what we don't want to forecast our partner products, yes. So when it comes to ARV, we are telling we'll be around INR2,500 crores plus or minus INR200 crores. We have visibility there. In CMO in generic, we have visibility. In CDMO, we don't want to guess and give a number.
In your opening comments, you made a few references to the fact that a lot of Big Pharma contracts supplies have started or are scaling up for our CDMO business. How should one read it when you highlight the Big Pharma part? Is it essentially leading to larger contracts or these are more strategic partnerships?
I think we cannot disclose more than what we have done.
There was one comment made on the CDMO side, which was very big, that the contribution is now 30% of the sales, and we expect it to touch 50%. So can you give some more clarity? By when can we expect this kind of contribution to come in from CDMO?
We mentioned it has a potential to go there. And we are not attaching any year to that.
Somewhere in 5 years down the line, can we expect this kind of potential run rate?
We are not giving any forecast there.
Quarter-on-quarter, we may see some decline in Q2, right, from this?
I don't say decline, but it will not have that kind of an increase.
I like some qualitative inputs in terms of CDMO business. Is it large volume sort of chronic drugs? Are they in the rare or orphan space? Secondly, also what could be our mix between, say, Big Pharma and small biotech on the CDMO business?
We can't give you therapeutic mix of our CDMO revenue. But the majority of revenues are coming from medium and Big Pharma, very less from small and virtual biotechs.
Are we the primary source in these cases? Are these projects where Big Pharma customers want to diversify the supply, and we are probably a second source?
I think those insights are very difficult to divulge. I'm sorry.
Are you looking at more opportunity because of this tariff tantrum that is happening around in the U.S.? In the other space more complex drug products, is there any opportunity that is coming about? Are there any meetings going on with the large companies?
No.
Is it possible to understand within CDMO revenue breakdown in terms of what is coming from commercial supplies and what is coming from Phase I, Phase II, Phase III and how that will evolve over the next 2, 3 years?
We are not dissecting those numbers into commercial Phase III, Phase II, Phase I and customer. That's we can't divulge customer and products. So I'm afraid, we can't give you that breakup.
There is a significant jump of gross margin in this quarter. It increased by around 500 basis points. We are now at 59.5%. Can we expect this kind of high gross margin will be maintained in future too as the share of CDMO increases? Or do you see it as a one-off and it's too early to expect this kind of high gross margin?
If you look at our gross margins over several quarters, we're always informing and also maintaining around 52%. Now you can say as the contribution from CDMO business increases, we expect the gross margins will remain between 55% to 60%. That's what we expect in the coming quarters.
On the bio side. On the food protein side. We are basically about to set up a facility for 2 million liter and then 4 million liters. So on the food protein side, what is the progress, sir? Are we now started putting any work there? If orders have been placed for the reactor?
As I mentioned, Jeevan, we are installing 400 kiloliters of fermentation capacity in Vizag greenfield project that's the Phase 1. As you mentioned, overall capacity at that site will go to 2 million liters in 2 more phases. In Phase II, Phase III put together, it will go to 2 million liters. And we have very good visibility about the utilization of that fermentation site, which product, which customer and all. Like we are gaining confidence and gaining visibility in our small molecule CDMO segment. We're also seeing a lot of visibility now what customer, what project, what price, what time lines on our large molecule CDMO. As you were talking about our focus on food proteins, we are focusing also on other proteins, cosmetic proteins, some polymers produced by fermentation. So the offerings are becoming very interesting, which are also at scale.
On the gene therapy, we are setting up a viral vector facility in Kanpur. Any update there?
So there is a change in our approach because our thought process changed fro m 2,500 square meter facility to 6,000 square meter facility. So there is no space available at Technopark in Kanpur. So we have moved idea of that facility to Hyderabad, Genome Valley, where we have broke the ground for a 6,000 square meter facility. And whatever gene therapy, viral vector and also that building houses antibody drug conjugate GMP facility as well. So because we have added another therapy ADCs, we thought to move to Hyderabad.
At any point in time, do you see these divisions becoming big to the extent that there may be a possibility of listing these as separate entities and business?
We don't have any plans for that.
Would it be a right statement that in gross margin -- in CDMO, your gross margin would reasonably be stable irrespective of the stage of project, whether it's an early stage or late stage? Or it materially varies gross margins on the stage of the project that you are?
You are right. Generally, the gross margins remain similar irrespective of stage and scale of the project.
Which part of the non-CDMO business has been contributing to margins? Because there is a significant improvement of almost 700 bps to 1,000 bps in non-CDMO gross margin. Is it the ARV part or FDF part which is driving?
It's majority came from non-ARV.
Now that the animal health facility is commissioned, even agrochemical. Has this contributed meaningfully for the CDMO business for the quarter? Or if you could break the CDMO business into Human health, Animal health and the Agrochemical and Ingredients?
The contributions from Human health and Animal health were there in this quarter. Nothing significant from crop sciences in this quarter.
Will meaningful revenues from crop sciences come up in the coming quarters?
We expect meaningful revenues from crop sciences will only come next financial year.
From a return on investment perspective, the KL facilities whether to utilize for the ingredients, for Human health or Animal health or Crop sciences. Is it the similar chemistry and hence, it's just a different application or how to think about it strategically for next 5 to 6 years?
So the facilities for animal health are segregated and dedicated. We can't use that for Human health or Crop sciences. Similarly, the Crop science facilities are also segregated and dedicated. So those can be us ed for only Crop sciences. So interchangeability of these 2 facilities are not possible. Whereas Human health, we have large capacity where we can do these projects in multiple sites at multiple scales.
On Bio side, where there has been certain issues with the customer. Probably if that customer comes back or if we have new customers, like tentative time line approximately for this business to sort of revive?
There is no challenge. It's only delay. The project now the bottleneck was resolved. Things are back to normal. And we don't see any big challenge achieving what numbers we thought at the beginning of the year.
Any progress update you can share regarding the Willow Bio and AI-driven bioengineering platform partnership we are progressing with? What advantages does bioengineering provided over conventional chemical synthesis in terms of efficiency, cost and sustainability?
Sajal what programs we are working with Willow using their AI -driven enzyme engineering platform, primarily hydroxylation platform. Adding hydroxy groups on stero idal backbones. That's the one we are working. There are multiple programs. Maybe in this financial year, one program will go from lab to pilot mode. And we expect 2 more programs in the next financial year.
Do we expect the learnings out of this program to be kind of integrated into some of our future ventures?
Our partnership with Willow is primarily meant for steroids and hormones. Our Bengaluru team is doing development, whereas Willow is doing research. I think they identify the enzyme and then they give it to Bengaluru team for optimization. So that partnership is working well. And currently, we are not intending to use that technology on any other program right now.
This new capex investment of over INR5,000 crores that you have announced in Andhra Pradesh, will be executed over multiple phases and years. Can we therefore anticipate maintaining a healthy net debt-to-EBITDA ratio despite this massive growth capex?
Yes. As we indicated before, we are going to invest INR5,000 crores in the next 5-year time. I think internal cash flows will be sufficient to take care of it. As we indicate, we don't want to make our net debt more than 50% of our revenue at any point of time.
You have mentioned that there is a pricing challenge in that particular slide for the Laurus Bio. Could you please share the details on the pricing challenge? And the second question is that how big it can become in the next 5 to 10 years at Laurus Bio itself?
See, the pricing challenge at Bio pertains to hiring reactor months to product billing. So that was the one shift happened b ecause in the trials since we don't know how many days fermentation will take, how many days the downstream processing happens. So customer used to pay per month or per batch. Once the product stabilizes, then the billing will go to per kg. So that's the pricing shift happening for them when the product mature. And the question regarding the opportunities in the next 5 years, we see significant potential. That is the reason we are investing a lot of money in greenfield projects. As we mentioned, the Phase I itself, we are creating 400 kiloliters capacity and eventually, it will go to 2 million liters fermentation capacity.
If you can see on a quarterly basis, there has been a reduction. The volatility in these numbers have been there for the last 4 quarters in the generic FDF. Is this going to continue? Is there any stability that is going to be there in the generic FDF and generic portfolio?
The majority delta in our sales in FDF is coming from how many millions of packs of antiretroviral we are shipping in the quarter. So overall, we are shipping the same numbers, but depending on the approvals from various countries to ship logistics and all, revenue recognition because most of them are sea shipments. So those are the factors contributing to the variation in the generic formulation sales.
Just a bookkeeping question on the ARV business, if you could give break up of formulation and API please?
Yes. Just give me 1 minute, we'll give you the ARV APIs is INR363 crores and formulations is INR284 crores. About INR640 crores both put together.
The non-ARV formulation we've seen a bit moderate run rate over the past maybe few quarters, if you could share how we sort of think of growing business in this segment?
We are expanding our capacity for non -ARV formulations and which will be qualified by end of this year. So we can expect non-ARV formulations should grow from Q4 onwards.
On the product approval side also, there has been bit slow, correct me if I'm wrong.
Revenue growth primarily comes from contract manufacturing of integrated formulations, both the API and FDF. We are doing tech transfers. Once the capacity is qualified, we don't see lag in revenues.
What are we doing from here on to improve that part, that piece of gross margin further?
As we grow our CDMO business, today, we haven't achieved operational efficiency, still a lot of unutilized capacities and all. As we grow our revenues, we are not going to grow our R&D and quality staff proportionately. We are going to increase other expenditure proportionately. If you look at when our revenue was less, our cost of employees went up to 16%, 17%. Sometimes it was around 10%. So we are at the beginning of that benefit to operational efficiency. Yes. Once we improve revenues, our percentage of expenditure will come down. So that is another metric, which will help us to improve our numbers, EBITDA as well as return on capital.
On the CMO business, which we have in both API and formulations, can you give us some color on when do you see momentum picking up on those pieces? Because we've seen sudden flattening out of the API business in the formulation business ex of ARVs also, we've not seem to have picked up much over the last few quarters.
It will pick up from Q4 onwards, Nitin, yes.
Is this driven by certain specific contracts? Or what will drive the timing from Q4 onwards on these businesses?
Right now, the tech transfer batches are going on in formulations. And the capacity enhancement is also going on parallelly. So both we expect will be handy to get higher supplies and higher revenue from Q4 onwards.
On the API business, ex of the ARVs, last year, we had a bit of a slump in the oncology part. How do we see the non-ARV API piece going forward? Are we seeing momentum coming in that business at some point in time?
Not in the next few quarters.
What is the reason because of which there has been some challenge on this piece over the last?
It's not a challenge is by choice, actually. The reason is we have allocated more resources to take up more CDMO projects instead of allocating to a significant number to generic API development. So we took that as a decision made by internal people. I think we are also expanding our R&D strength. Once that is done, we will put resources back in development, validation of generic APIs. We also need capacity to do that. So there are multiple things. So right now, we made an informed decision internally to allocate resources to CDMO projects.
On the ADC front, we have mentioned a couple of times that we endeavor to go into the ADC side also. May I ask which part of the ADC are we looking at? Is it the payloads, linkers, bioconjugation?
See, we already make payloads and linkers. And we don't want to make mabs. We'll do conjugation, purification and fill finish. That's the infrastructure resources we are building. Internally, we make payloads, linkers and then do bioconjugation, purification and fill finish. We will not make Mabs.
Out of this INR5,000 crore capex that we have announced, would it be possible to give some color there, like how much capex would go towards the ADC side?
This new INR5,000 crores capex is in Vizag, none of that capex will go to ADC.
This quarter, we've seen a significant jump in your employee expenses, almost 21% quarter-on-quarter, year-on-year. Any nonrecurring expenses here? Or this is the new base?
The part is nonrecurring in the sense, once in a year, actually, we are giving a long-term service awards for the people who stayed us for a longer period. And of course, there is an increment over the last year, last quarter. That's also reflected apart from the additional manpower.
On the ARV side, we've seen year-on-year growth in this quarter, but you're still maintaining your guidance of no growth for an overall full year basis. Any particular reason why still you're not seeing growth in this segment for the full year? Is it just uncertainty on the global tender?
We kept some margin. We have seen significant price drops in ARVs. If there is no price drop, we may go a little better. If there is a price drop, our incremental volumes will compensate the price drop. So we are keeping that cushion when we are committing INR2,500 crores ARV plus or minus INR200 crores.
The net debt for EBITDA right now is 1.8. What is the management's guidance for the debt over the next 2 years or next 3 years?
We are not expecting a significant increase in the debt. So as we have said We will try to manage with 50% of our revenue levels, the annual revenue levels. That means debt by EBITDA, maybe 2, 2.5 is max.
The INR5,000 crores that you're going to plan to do in the next, I presume next 3 to 4 years. What is the breakup? Are you going to do internal accruals or you are planning to do more JVs with other companies?
Mostly from the Laurus Labs side and majority of funding will be through internal accruals.
As the percentage of CDMO in your total sales rises and since CDMO is a higher gross margin business for you, is it reasonable to assume that it will take the aggregate or average margin -- overall margin trajectory of the company upward?
Yes. As the contribution and percentage from CDMO growth, we expect both gross margin and EBITDA margins should continue to go up.
On the ARVs, lenacapavir and cabotegravir, both have issued voluntary licenses. Even WHO today now seems to stand very strongly behind bringing in lenacapavir advocating for lenacapavir as probably the preferred treatment and bringing it in the emerging markets as well via the voluntary license route. Would Laurus have an opportunity in lenacapavir?
We are not part of the licensee of lenacapavir. And the Lenacapavir will be part of the guidelines for prevention rather than the treatment. That's one. And the cabotegravir, rilpivirine we have developed API. And we have a few partners using our APIs. Lenacapavir, we are not part of the licensee.