"Glenmark Pharmaceuticals Limited Q1 FY '26 Earnings Conference Call" August 18, 2025
Management: Mr. Glenn Saldanha - Chairman and Managing Director - Glenmark Pharmaceuticals Limited Mr. Anurag Mantri - Executive Director and Chief Financial Officer - Glenmark Pharmaceuticals Limited Mr. Utkarsh Gandhi - Senior General Manager, Investor Relations - Glenmark Pharmaceuticals Limited Moderator: Good morning, ladies and gentlemen, welcome to the Q1 FY '26 Earnings Conference Call of Glenmark Pharmaceuticals Limited. As a reminder, all participant lines will be in the listen-only mode and there will be an opportunity for you to ask questions after the presentation concludes. Should you need assistance during the conference call, please signal an operator by pressing star then zero on your touchtone phone. Please note that this conference is being recorded.
I now hand the conference over to Mr. Utkarsh Gandhi, Senior General Manager, Investor Relations for Glenmark Pharmaceuticals Limited. Thank you, and over to you, sir.
Starting with India sales for the formulation business in India were -- for Q1 FY '26 were at INR12,399 million, recording a growth of 3.7%. While Glenmark continued to deliver robust growth across the cardiac, respiratory and dermatology therapy areas, reported growth for the quarter was impacted on account of the discontinuation of some tail-end brands announced earlier and underperformance in the diabetes segment.
Glenmark India business continued to outperform the overall industry in terms of secondary sales growth. As per IQVIA June 2025 data, Glenmark India Formulation business recorded growth of 15.1% in the first quarter and 11.8% as of MAT June 2025 compared to 8.5% and 7.7%, respectively for the Indian pharma market.
As mentioned before, Glenmark continued its robust growth and outperformance in terms of key therapy areas like cardiac, dermatology and respiratory. Glenmark's India business continues to be ranked 13th with a market share of 2.3% as per IQVIA MAT June data. The company is ranked second in dermatology, third in respiratory and fifth in cardiac segment as per IQVIA MAT June 2025 data. And we continue to have 10 brands in the IPM top 300. Glenmark has improved its market share as well in -- especially in its core therapy areas.
In terms of key launches, Glenmark and BeOne Medicines have entered into an agreement for the marketing and distribution of Tislelizumab and Zanubrutinib in May 2024. Glenmark launched both these products towards the end of the first quarter under their respective brand names, TEVIMBRA and BRUKINSA. These launches mark an important milestone in expanding the innovative oncology portfolio in India and providing access to patients across multiple solid tumors as well as hematological malignancies. The company expects these 2 brands to gain momentum and meaningfully contribute to the India business over the next 2, 3 years.
Glenmark also had launched Empagliflozin towards the end of Q4. This is a widely recognized SGLT2 inhibitor in India. The drug was launched under the brand name GLEMPA, GLEMPA L and GLEMPA-M. And of course, LIRAFIT has been an important product launch for us in
the diabetes segment. Glenmark was the first to launch the biosimilar of Liraglutide under the brand name LIRAFIT. It has seen a strong traction with more than 50% market share in the molecule, and the company plans to launch other GLP-1 agonists as well.
Moving on to India's Consumer Care business. The Consumer Care business of the company operates in the Indian consumer health care market with a primary focus in dermatology and over-the-counter products and leading brands such as Candid, La Shield, Scalpe, Episoft and Elovera.
The business is well positioned for sustained growth, supported by rising consumer awareness and increasing adoption of self-care solutions. Primary sales for GCC in the quarter recorded a Y-o-Y growth of 20%. Candid Powder continued to lead its category with 60-plus percent market share and the other 2 key brands, La Shield and Scalpe also delivered a high growth in Q1.
Moving on to North America. The North America business registered revenues of INR7,780 million, which is about USD91 million for the first quarter of FY '26. This is a Y-o-Y -- sorry, a Q-o-Q growth of about 8.9%. Despite a relatively challenging environment, the company recorded Q-on-Q growth on the back of gaining share in its injectable product launches and other partnered products.
In the first quarter of fiscal year '26, Glenmark also launched 3 products, Mixed Amphetamines IR Tablets, which are generic to Adderall, Epinephrine Injection and Olopatadine Hydrochloride Ophthalmic Solution, OTC. While the company did not file any new NDAs in the Q1, Glenmark does plan to file 1 application in the forthcoming quarter and about 5 to 6 applications for the full year.
Glenmark is building out a large commercial portfolio in injectable products. We've mentioned this before. We already have 9 or 10 injectable products in the market today. The company expects approval of its generic respiratory NDAs as well starting H2 FY '26. And we are also working on filing the NDA for the other 2 strengths as well.
And the company continues to augment its commercial portfolio through partner product launches. Glenmark's marketing portfolio through June 30 consists of 208 generic products authorized for distribution. The company has 52 applications pending in various stages of the approval process, of which 24 are Para IV applications.
The company's subsidiary, Glenmark Pharmaceuticals Inc. USA was named in the multi-district
-- multiple antitrust and consumer protection lawsuits, including class actions consolidated in the Eastern District of Pennsylvania. These relate to the industry-wide allegations concerning price-fixing, market allocation and related anticompetitive conduct. Plaintiffs include reputative classes of direct purchases, and payers and indirect purchases of generic drugs as well as numerous private direct-action plaintiffs.
Glenmark USA continues to deny all allegations and has been defending these matters vigorously. With a view to resolve this dispute and avoid uncertainties, Glenmark USA has agreed into -- enter into a settlement with the putative direct purchaser class for a total of USD
37.75 million. The settlement is subject to approval by the court overseeing the litigation. The settlement makes it clear that Glenmark USA denies each and every of its allegations against it, and the settlement is not the basis of Glenmark USA having conceded or admitted any liability or illegality.
Moving on to Europe. Glenmark's Europe business has recorded more than 25% CAGR over the last 3 years and has gained significant scale across its branded products, particularly in the respiratory segment. Glenmark Europe operations revenue for the first quarter was INR6,678 million, recording a decline of Y-o-Y decline of 4%. The company anticipates the Europe region returning to double-digit growth from the second quarter onwards and expects to record double-digit growth in FY '26.
During the quarter, branded business growth, particularly in the respiratory segment remains strong. Branded respiratory products, including RYALTRIS, continued to grow on a month-on-month basis across owned and partner markets. The company continues to focus on sustaining the increasing contribution of branded products and portfolio from -- in the European markets, particularly from the pending respiratory product launches.
We've recently gotten approval for 2 additional respiratory products. And we have also launched WINLEVI in the U.K., and we are planning to launch it in other European markets as well by the end of this year, FY '26. Moving on to emerging markets. Glenmark's emerging market business has recorded 10% CAGR over the last 3 years and has recorded strong performance across all EM regions, particularly in the dermatology and the respiratory segment.
For the first quarter of FY '26, revenue from the emerging markets region was INR5,721 million, recording a Y-o-Y growth of 0.2%. While the first quarter was affected by lower seasonal demand in some Latin American markets, the rest of the EM regions grew 9% in the first quarter. The company anticipates double-digit growth in FY '26 for the emerging markets on a constant currency basis.
Talking about the individual regions in EM, as per IQVIA, Glenmark Russia secondary sales recorded growth of 21% in Q1. In terms of key therapeutic areas, Glenmark recorded 17.4% growth in value terms in dermatology versus overall market growth of 15%. Glenmark continues to be ranked ninth amongst dermatology companies and second in the Respiratory expectorants market in Russia. Key brands such as RYALTRIS, ASCORIL and CANDIBIOTIC have continued to gain and sustain high market share in their respective categories.
Glenmark's LatAm region, as mentioned, witnessed some challenges in Q1, mainly due to lower seasonal demand in key markets. Glenmark does maintain its top 10 rank amongst the companies in the covered market of chronic respiratory segment in Brazil. RYALTRIS has launched multiple differentiated products in the respiratory segment in the region, which will help business growth in future quarters. And RYALTRIS has been launched in Mexico and is awaiting approval in Brazil.
In Middle East, Africa regions, the company witnessed double-digit growth in secondary sales across major markets. RYALTRIS continues to be the leading nasal spray for allergic rhinitis in
South Africa and has seen successful launch in other key markets of the region. And Glenmark continues to be ranked third in the overall market in Kenya. Asia Pacific region recorded subdued performance in first quarter. Key markets such as Philippines, Malaysia recorded high single-digit secondary sales growth in the first quarter. RYALTRIS continues to do well in the Asia region. We recently received approval for Thailand as well. And Glenmark remains one of the leading players in the dermatology segment in the APAC region.
In terms of our key global brands, RYALTRIS, as of June, marketing applications for RYALTRIS have been submitted to more than 90 countries and product has been commercialized in more than 45 markets. It is expected to be launched in 10 to 12 additional markets over the next few quarters. As per IQVIA data, RYALTRIS continues to see robust performance in terms of both value and unit market shares across the key markets where the product has been launched, either by us or by our partners.
As mentioned before, Menarini has witnessed -- Menarini is our partner in the EU, has witnessed a steady increase in market share across all its licensed markets. Yuhan Corporation, Glenmark's partners in South Korean market also continues to perform well. And Glenmark's partner in Mainland China, Grand Pharma, expects to receive approval for RYALTRIS in China in FY '26.
QiNHAYO, which is Envafolimab. Glenmark has filed QiNHAYO in 15 markets in FY '25. First market launch is expected in FY '26. The company has received authorization from regulatory authority in Kenya for supply of QiNHAYO in -- via some early access programs.
And we have also initiated a global multicenter Phase III study in neo-adjuvant as well as adjuvant NSCLC. WINLEVI, which is partnered with Cosmo, Glenmark announced its approval for WINLEVI in the -- from the MHRA to market it in the U.K. Glenmark has launched WINLEVI in the U.K. and is expecting approval in other European markets by the end of FY '26.
Talking about IGI, IGI features a robust pipeline of innovative oncology molecules targeting multiple myeloma and solid tumors, of which ISB 2001 is in clinical development. Additionally, IGI has 2 autoimmune assets, which have been out licensed to leading companies and are also in clinical development currently. During the quarter, IGI presented promising full dose escalation results from its Phase 1 TRIgnite-1 study of ISB 2001 in relapsed/refractory multiple myeloma.
This data was presented as a rapid oral presentation at the ASCO 2025 Annual Meeting, demonstrating a sustained overall response rate of 79% and a high complete/stringent complete response rate of 30% across the 7 active doses in heavily pretreated patient population with a very favorable safety profile.
Recently, IGI also announced its global commercialization strategy for ISB 2001 following its landmark partnership with AbbVie under the terms of the agreement, IGI partnered with AbbVie and granted exclusive rights to globally develop and manufacture and commercialize ISB 2001 across North America, Europe, Japan and Greater China, while Glenmark will develop, manufacture and lead commercialization activities of ISB 2001 across emerging markets. This