Cipla Limited
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On gross margin, it's mainly the product mix. Last year, we had some tender products with lower margins. This year, we have a better mix, leading to lower material costs.
Revlimid has increased quarter-on-quarter by some small margin.
We have answered the inspection queries and hope to implement remedial actions soon.
Yes, R&D activity will ramp up as some projects finished last year and early this year. Current clinical trials are not as extensive as before, but we expect an uptick in the coming quarters.
We expect R&D expenses to be around 5% to 6% of sales, with a maximum of about 6.5%.
We have external consultants assisting us, and we hope to hear back from the FDA by the end of September.
The Invagen filing is in progress, and we should file shortly. For the peptides, we expect to launch them after receiving approval, likely in Q3 or Q4.
The delta was driven by the Lanreotide ANDA launch and an increase in albuterol market share, along with a marginal increase in Lenalidomide.
We are not revising the EBITDA margin guidance. Gross margins depend on product mix, and while we expect similar margins in the coming quarters, tender business will dilute overall gross margin.
We had a 20%-22% market share before the ANDA launch, and we expect the ANDA to add to this share. The ramp-up will take time, and the ANDA is not substitutable for the brand.
In a market with abundant supply, that could happen, but in a slow supply ramp-up market, it's unlikely.
We are continuously looking at strategic opportunities mainly in India, focusing on growing therapies where we don't have leadership. We will look at both small and large opportunities. In the U.S., we would consider capability-linked opportunities such as sterile injectable facilities and specialty side 505(b)(2) in-licensing opportunities. We will also dedicate some capital to innovation, evaluating opportunities in areas like cell and gene therapy.
Price erosion can vary widely by product. On average, we see about 10% year-over-year erosion and around 5-6% quarter-over-quarter. Some products, particularly older ones, may experience larger erosions due to new contracts. However, we don't expect it to reach double digits going forward.
The impact will depend on the category they enter. Our current category has low prices, while others like ProAir and Ventolin are higher priced. The market for albuterol inhalers has been expanding significantly, growing from 58 million to nearly 70 million inhalers since we entered.
Yes, Q1 includes the benefit from the Sanofi transaction, although it may not reflect the full expected amount.
The launches are planned for later; not all will launch simultaneously. We have planned for staggered launches.
I don't believe there will be a market for GLP-1 products this year in India, but launches may happen next year. We expect to launch two peptides by the end of the year, with others following later.
Lanreotide's market share will depend on our supply ramp-up. The ANDA is a substitutable product, which may allow it to capture more share, but this is contingent on our supply plan.
Base growth can be difficult due to price erosion. However, we have other products like nanopaclitaxel and Advair that could provide meaningful opportunities.
The economics should be roughly the same, though there may be slight differences due to launch timing and pricing resets. The contracts with partners also affect the economics.
Yes, there is a supply constraint, and supplies will ramp up slowly. The current market is about 14,000 vials per month.
The current MR base is about 8,500, and we plan to increase it to close to 10,000 by quarter 1 '25, focusing on areas with growth potential.
The run rate has been about INR 1,000 to 1,200 crores, which may increase to about INR 1,500 to 1,800 crores due to strategic capex in the U.S. and India.
About 70% of the capex will be growth-related, while 30% will be compliance-related.