Shilpa Medicare drops Aflibercept Europe trial, delays alopecia drug
The company shelved a costly European trial for one biologic and pushed back a Phase I for another, even as Q4 FY26 hit record revenue.
— 4 earlier stories on Shilpa Medicare Ltd. →What's new
- Shilpa Medicare will not pursue European Phase III trials for Aflibercept, citing high costs.
- Phase I studies for alopecia treatment SMLTOP09 delayed; now expected to start in FY27.
- Adjusted ROCE improved to 17.4% from 4% in FY23, excluding biologics investments.
Why this matters
Shedding the Aflibercept program and delaying SMLTOP09 narrows the pipeline right when revenue is peaking. It saves development cash but pushes meaningful biologic revenue further out, making the core API and formulation businesses carry the story alone for now.
What we're watching
- Whether the SMLTOP09 Phase I actually starts in FY27 as guided.
- FY27 growth trajectory for European formulations and the CDMO business.
- Any moves to backfill the dropped Aflibercept program.
The full read
Shilpa Medicare is cutting its losses. On the Q4 FY26 call, CEO Keshav Bhutada said the company will not pursue European Phase III trials for Aflibercept, citing prohibitive costs. Separately, the Phase I study for its experimental alopecia treatment, SMLTOP09, has been pushed back and is now expected to start in FY27. Both decisions narrow the near-term clinical pipeline, even as the company posted record quarterly revenue of ₹439 crore and a 40% rise in EBITDA. CFO Alpesh Dalal pointed to improving fundamentals, with adjusted ROCE reaching 17.4% from just 4% in FY23. Management offered no FY27 numbers, only talk of healthy growth in European formulations and the CDMO business. The result is a company in transition. Cash is flowing from the core business while meaningful biologic revenue gets pushed further out.
Questions answered
- Why is Shilpa Medicare giving up on Aflibercept in Europe?
- CEO Keshav Bhutada cited prohibitive costs for the Phase III program. The company is exiting the market rather than competing in a crowded biosimilar launch cycle, saving development capital.
- What is the new timeline for the alopecia drug SMLTOP09?
- The human clinical study has been pushed back. Global Phase I studies are now expected to begin in the current financial year, rather than sooner. No revised completion timeline was given.
- How did Shilpa's profitability change this quarter?
- Q4 FY26 delivered record revenue of ₹439 crore and a 40% rise in EBITDA. Adjusted ROCE, excluding biologics investments, improved to 17.4% from just 4% in FY23.
- Did management provide any numbers for FY27?
- No. Management declined to provide numerical guidance but indicated healthy growth in European formulations and the CDMO business. The open question is whether those segments can offset the pipeline setbacks.
Story so far
All notes on SHILPAMED →- 26 May 2026 · 1:51 PM IST Shilpa Medicare drops Aflibercept Europe trial, delays alopecia drug
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