R&D spend guidance maintained at ~6-7% of sales for FY24
Management reiterated full-year R&D guidance, with potential updates if needed. Concert Pharma costs are included.
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Sunpharma · forward-looking guidance across the available source record.
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What management said would happen.
growth
India business to grow in line with or better than market in coming quarters
CEO Kirti Ganorkar expressed confidence that India formulation growth will align with IPM growth, recovering from NLEM and sitagliptin impacts.
Lenalidomide sales expected to remain episodic
CFO noted that lenalidomide sales were significant in Q1 but will be episodic going forward, not a steady revenue stream.
Deuruxolitinib 8mg filing on track; no slowdown in OLE studies
Management confirmed that the partial clinical hold on 12mg has been lifted, and 8mg dosing continues as planned with no delays.
R&D spend to step up to 8-10% of sales for FY25
Management expects R&D investment to increase in subsequent quarters, with full-year guidance of 8-10% of sales.
Effective tax rate to increase on full-year basis
Tax rate expected to rise due to expiry of certain exemptions; should be viewed on an annualized basis.
Leqselvi launch pending court decision on preliminary injunction
Launch timing of Leqselvi will be governed by court ruling on Incyte's motion; company opposes and seeks early outcome.
ILUMYA PsA filing by end of CY2025
Sun Pharma plans to file for psoriatic arthritis indication for ILUMYA before end of calendar year 2025.
UNLOXCYT launch in H2 FY2026
UNLOXCYT will be launched in the U.S. in the second half of FY2026, pending label update.
Incremental $100M cost for Leqselvi and UNLOXCYT in FY2026
Management expects to incur approximately $100 million in direct costs (excluding amortization) for the launches of Leqselvi and UNLOXCYT during FY2026.
Effective tax rate around 25% for FY2026
CFO guided for an effective tax rate of approximately 25% for the full fiscal year, up from 16-17% last year.
R&D spend guidance maintained
Management expects R&D expenses to remain at similar levels or increase due to clinical trial ramp-up.
India business to grow higher than market
Management aims to grow India formulation business faster than the Indian pharmaceutical market on an annualized basis.
Tax rate to inch up on annual basis
Tax rate expected to be higher than last year's 8.8% due to profit mix across jurisdictions.
R&D spend to be 7-8% of sales for FY25
R&D spend for FY25 is expected to be in the range of 7-8% of sales, down from earlier guidance of 8-10%, due to delays in clinical studies.
Leqselvi launch readiness within weeks of favorable judgment
Management stated they would be ready to launch Leqselvi within a couple of weeks post a favorable court ruling on the patent litigation.
Ilumya PsA Phase III data expected H2 CY2025
Phase III data for Ilumya in psoriatic arthritis is expected in the second half of calendar year 2025, with launch shortly after approval.
R&D spend at lower end of 6-8% of sales
Management expects full-year R&D spend to be at the lower end of the guided 6-8% range.
Unloxcyt launch in H2 FY26
Unloxcyt remains on track for US launch in the second half of FY26, with sales force already in place.
Ilumya psoriatic arthritis filing in H2 FY26
Sun Pharma plans to file Ilumya for psoriatic arthritis indication in the second half of FY26.
Incremental specialty spend of ~$100M in FY26
The company expects to spend around $100M in FY26 to support Leqselvi and Unloxcyt launches, with increases in Q3 and Q4.
R&D spend to touch lower end of 7% guidance for FY24
Management indicated that R&D spend for the full year is expected to reach the lower end of the 7% of sales guidance.
Phase II/III trials for MM-II and GL0034 to start in H2 2024
Phase III for MM-II and Phase II for GL0034, initially expected early 2024, are now slated to begin in the second half of 2024.
Nidlegy filing with European authorities in H1 2024
Partner product Nidlegy is expected to be filed with European authorities during the first half of 2024.
FY25 R&D spend to be less than 7% of sales
Due to delays in clinical trial initiation, R&D expenditure for FY25 is expected to be below the earlier guidance of 7% of sales.
Leqselvi launch timeline dependent on litigation outcome
Oral arguments for Leqselvi patent litigation expected in April 2025; if favorable, launch could occur before patent expiry in December 2026.
Specialty sales growth to normalize after Q3 inventory build
Q3 specialty sales benefited from inventory build at a partner; next quarter sales are expected to be lower excluding milestones.
Semaglutide launch in India on patent expiry
Sun Pharma plans to launch generic semaglutide in India on day one of patent expiry for both chronic weight management and type 2 diabetes, under brands NovelTreat and SemaTrinity.
R&D spend guidance for next year
Management indicated they will provide R&D spend guidance for the next fiscal year in the next quarter's call.
Phase 2b trial for GL0034 to complete in 12-18 months
The phase 2b study for GL0034 in type 2 diabetes has started and is expected to complete within 12-18 months.
High single-digit consolidated revenue growth for FY25
Management expects consolidated top-line growth in high single digits for FY2025, driven by all business segments.
R&D spend to be 8-10% of sales in FY25
R&D investments will increase to 8-10% of sales for the next year, primarily for specialty pipeline.
Deuruxolitinib launch post-PDUFA date (July 2024)
Deuruxolitinib is on track for launch after the July 2024 PDUFA date, with pre-launch costs already being incurred.
FY26 revenue growth: mid-to-high single digit
Management expects consolidated top-line growth of mid-to-high single digits for FY2026.
Additional $100M investment in specialty launches
Approximately $100 million additional spend in FY26 for commercialization of new specialty products.
R&D spend guidance: 6%-8% of sales
FY2026 R&D spend expected to be 6%-8% of sales.
Leqselvi launch in Q2 FY26
Leqselvi to be launched in the US in the second quarter of FY2026.