Glenmark Pharmaceuticals Ltd Q3 FY2025 Concall Summary

Key Takeaways

• India business surged 300% YoY, but Q3 was soft: India formulations hit ₹1,063.7 cr, yet the quarter slowed on acute respiratory weakness; management still expects to meet the full-year ~₹1,100 cr per quarter guidance.
• U.S. remains a drag, with a big FY '26–'27 pivot promised: No meaningful launches this quarter kept North America challenged, but two major respiratory launches in H1 FY '26 and a combined \$600–\$700 mn franchise coming to market in FY '27 underpin the recovery thesis.
• ISB 2001 data opened a partnering window: The 83% ORR in heavily pretreated multiple myeloma, presented at ASH, triggered partnering discussions; management aims to close a deal in calendar 2025, which would also end Glenmark's funding of IGI after FY '26.
• Currency took a ₹71 cr bite out of EBITDA: Emerging-market currency headwinds pushed the margin down; adjusted for that, EBITDA margin would be close to 19%, and management expects 1–1.5% YoY improvement going forward.
• What to watch next quarter: Whether the two respiratory ANDA approvals (Flovent 44 mcg MDI and fluticasone nasal spray) land in H1 FY '26 as guided, the pace of ISB 2001 partnering progress, and normalization of the working capital build that weighed on this quarter.

India Business: The Quarter's Engine, With a Respiratory Cough

• Topline surged on a weak base: India formulation sales grew ~300% YoY to ₹1,063.7 cr, though the base quarter included a one-time sales disruption that inflates the growth rate.
• Acute respiratory dragged Q3 sequentially: Respiratory acute, a large part of Glenmark's portfolio, slowed in Q3 after a very strong first half, making this a soft quarter relative to the run rate.
• Chronic respiratory and cardio-derma held up: Cardiovascular and dermatology continued to do exceedingly well, and the chronic respiratory segment grew faster than acute, partially offsetting the weakness.
• Diabetes saw molecule-level share loss, partly offset by LIRAFIT: Traditional molecules remogliflozin and teneligliptin lost share to newer DPP-4s and SGLTs; the LIRAFIT (liraglutide biosimilar) launch recaptured some of that ground and continues to do well.
• Full-year confidence intact: Management stated it will meet the 9–10% growth and ~₹1,100 cr per quarter average guidance, and "could be better than that."

Glenn Saldanha: "So in diabetes, we've traditionally had two molecules, remogliflozin, with the new -- remogliflozin and teneligliptin. With the new DPP-4s and SGLTs that have come into play, we've lost some share on both these molecules. But some of it has been offset with the launch of LIRAFIT, and LIRAFIT continues to do well."

U.S. Business: Waiting on the Respiratory Catalyst

• Q3 stayed challenged on a lack of launches: The U.S. business remained soft because no meaningful new products reached the market during the quarter; Travoprost Ophthalmic Solution and Lacosamide Oral Solution were the only launches.
• Q4 expected to improve on in-licensing launches: Some good in-licensed products are coming to market in February and March, which should help Q4 partially and the following quarter significantly.
• The FY '26 pivot rests on two respiratory approvals: Management anticipates approval of generic Flovent 44 mcg MDI (believed to carry an exclusive position) and fluticasone nasal spray in H1 FY '26; both are described as "very big products" that should contribute significantly to growth.
• FY '27 shapes up as the franchise year: The entire respiratory franchise of filings and launches this year has an estimated market potential of almost \$600–\$700 mn coming to market in FY '27, plus three sole 180-day exclusivities or first-to-file opportunities in FY '27 and '28 representing another \$800 mn market.
• Monroe plant is a longer-term geopolitical hedge: The injectables facility continues to take batches and file products while awaiting FDA inspection; management sees significant benefit longer term given the geopolitical situation.

Glenn Saldanha: "I mean all this put together, in FY '27, if you see the market potential of this entire franchise, the filings and the launches we are doing this year, you're looking at almost $600 million, $700 million of franchise coming to market in FY '27."

ISB 2001 & IGI: The Value-Unlocking Catalyst

• Phase 1 data reset the narrative: Data presented at ASH in December 2024 showed an 83% ORR and 22% CR or better in relapsed/refractory multiple myeloma, with a 75% ORR in patients pretreated with CAR-T or bispecific T-cell engagers; 80% of patients remain on treatment.
• Partnering discussions opened immediately: Post-ASH, the company held meetings at the JPM conference with many companies and reported "tremendous interest"; management has given itself until the end of calendar 2025 to close a deal, though it "could be earlier."
• A deal would end Glenmark's IGI funding: Management stated FY '26 will be the last year Glenmark has to put capital into IGI, with confidence in closing a transaction that funds IGI going forward; the long-term goal is to IPO the entity in the U.S.
• Next data readout at ASCO June 2025: Further Phase 1 dose escalation data will be presented, and the company hopes to start a dose expansion cohort in the next 3 to 6 months.

Glenn Saldanha: "So we are clearly on course to finding a partner to drive ISB 2001. So I mean, we've given ourselves till the end of this year, but it could be earlier."

RYALTRIS & Global Branded Business

• RYALTRIS tracking toward a \$200–\$300 mn peak: The product is in its second launch year, tracking to about \$80 mn, and management is "pretty much on track" to achieving the peak sales target over time; it carries better margins because Glenmark launched it directly in many geographies.
• Partner performance was solid across regions: Hikma (U.S.) recorded decent YoY performance in Q3; Menarini (Europe) saw steady market share increases; Yuhan (South Korea) is marketing well; Grand Pharmaceutical expects China approval sometime in FY '26.
• Europe branded business sustained its trajectory: Growth continued across all key markets, though the CEE region faced some seasonality; RYALTRIS gained market share.
• 12–15 additional market launches coming: The product will launch in another 12–15 markets over the next few quarters, with major markets including Brazil and China still ahead next year and the year after.
• ROW reported growth masked by currency: Reported growth of 3% was impacted by adverse currency movements in key markets; Russia recorded 16.6% secondary sales growth in constant currency.

Glenn Saldanha: "So I think RYALTRIS, over time, we are pretty much on track to achieving $200 million, $300 million of sales – peak sales over time."

Margins, Currency & Working Capital

• Currency took a ₹71 cr bite out of EBITDA: Adverse movements in emerging-market currencies (LATAM, South Africa, Russia) hit the margin; adjusted for that impact, EBITDA margin would be close to 19%.
• Working capital built up for launches: Inventory increased to support critical launches coming in the next couple of quarters; management expects normalization in the coming quarter and Q1.
• Other expenses on track for 27% full year: Some variation in sales and marketing timing occurred, but the full-year ratio is broadly as guided.
• 1–1.5% YoY margin improvement expected: Management guided to this improvement on the back of critical launches, while confirming it will hit both top-line and EBITDA guidance adjusted for currency.

V. S. Mani: "So on the full year, Nitin, we will hit both our top line as well as EBITDA guidance, adjusted for currency."

Pipeline & Upcoming Launches

• BeiGene oncology partnership adds two near-term launches: Tislelizumab and Zanubrutinib will launch over the next 3–4 months once regulatory approvals are received; expected to contribute significantly to the oncology business in India in FY '26.
• Envafolimab filing blitz underway: The subcutaneously injected PD-L1, licensed from Jiangsu Alphamab and 3D Meds, will be filed in over 20 markets this year, with the first market launch expected in FY '26.
• WINLEVI approved in the U.K., launching in FY '26: MHRA approval was received; the company plans to launch in the U.K. and other select European markets in FY '26.
• GLP-1 pipeline positioned for semaglutide: Glenmark is well positioned to launch semaglutide injectable and eventually oral in India, building on the LIRAFIT launch.
• Respiratory ANDA pipeline advancing: Two generic nasal spray ANDAs are filed and awaiting approval; generic Flovent 44 mcg MDI was filed in May 2024 and deficiencies have been responded to; other strengths of fluticasone MDI and one additional respiratory MDI will be filed in FY '26.
• Indore plant inspected after six years: The audit was thorough with no data-integrity observations; management is confident of addressing the observations received.

Glenn Saldanha: "Our view is FY '26 will be the last year where Glenmark will have to put capital into IGI."

Guidance & Commitments

Key Metrics