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    Shilpa Medicare Limited

    SHILPAMED
    Healthcare·13 Aug 2025
    Management Summary

    Shilpa Medicare reported a strong Q1 FY26 with record EBITDA and significant gross margin expansion, driven by growth in API and Biologics segments. The company made progress in its oncology and non-oncology API pipeline, launched its first NCE (Nor-Ursodeoxycholic acid) in India, and advanced its Biologics programs. Capital allocation included ₹70 crores in capex for a fermentation plant and a proposed 1:1 bonus issue, while net debt stood at ₹550 crores.

    Highlights

    5
    • Achieved highest ever quarterly EBITDA of ₹98 crores, an 18% YoY growth, with EBITDA margins at 30%.

    • Gross margins improved by 700 basis points YoY to 76%, driven by better product mix and licensing fees.

    • API revenues grew 8% YoY to ₹187 crores, primarily due to portfolio rationalization and increased off-take from expanded capacities.

    • Biosimilars business recorded a revenue of ₹73 crores during the quarter.

    • Received NCLT approval for amalgamation of INM Technologies, expected to lower tax outflow, resulting in a 5.5% effective tax rate for the quarter.

    Concerns

    3
    • Unicycive contract commercialization delayed by one year to next financial year due to prior CMO partner issues.

    • Finance cost increased to ₹19 crores from ₹14 crores QoQ, primarily due to a non-cash mark-to-market impact of ₹6.5 crores on a euro-denominated interest swap loan.

    • Management was evasive on specific details regarding the Albumin signing amount from Orion due to confidentiality clauses.

    What Changed2

    vs Q2 FY26

    Guidance items27 → 26 (-1)Risks discussed4 → 3 (-1)

    Key financials

    Single quarter

    06 metrics
    1. 01Revenue₹328 Cr+9%YoY
    2. 02Gross Margin76%
    3. 03EBITDA₹98 Cr+18%YoY
    4. 04EBITDA Margin30%
    5. 05Finance Cost₹19 Cr

    Segment breakdown

    • API₹187 Cr52.2%
    • Formulation₹98 Cr27.4%
    • Biosimilars₹73 Cr20.4%
    Donut· Share of Revenue

    Capital allocation

    3
    high confidence
    CategoryHeadline
    Capex

    ₹70 crores

    Debt

    Net ₹550 crores

    M&A

    INM Technologies

    merger · closed

    Guidance & targets

    26
    CategoryTargetPriority
    API
    Oncology NCE programs commercialization
    Next financial year
    High
    API
    New oncology products DMF/CEP filing
    6 months
    High
    API
    Nor-Ursodeoxycholic acid commercial supplies
    Start from Q2 FY26
    High
    API
    Mycophenolate Mofetil DMF/CEP filing
    6 months
    High
    API
    Palbociclib DMF filing
    3 months
    High
    API
    Olaparib validation batches completion
    October of this financial year
    High
    CDMO
    Polymer segment commercial supplies completion
    2HFY26
    High
    CDMO
    NCE project (gall bladder indication) commercialization
    Next financial year
    High
    Peptides
    Liraglutide API/Formulation filing
    After 6-month stability (expected by end of September for batches)
    High
    Peptides
    Semaglutide registration batches start
    Q3 FY26
    High
    Peptides
    Semaglutide API/Formulation registration batch completion
    End of Q4 FY26
    High
    Peptides
    Tirzepatide scale-up
    Q3 FY26
    High
    Formulations
    Nor-Ursodeoxycholic acid launch
    October
    High
    Formulations
    Rotigotine transdermal patch approval (Europe)
    2HFY26
    High
    Formulations
    Rotigotine filing (U.S.)
    Q3 FY26
    High
    Formulations
    SMLINJ011 filing (India)
    Q3 FY26
    High
    Biologics
    NBE programs (Alveolus Bio, mAbTree) human studies entry
    Next year
    High
    Biologics
    Nivolumab (biosimilar) human studies entry
    End of this year
    High
    Biologics
    Albumin clinical study (EU) start
    End of year or early next year
    High
    Biologics
    Albumin clinical study (EU) completion
    12 to 15 months
    High
    Biologics
    Albumin approval (EU)
    1 year after filing
    High
    Biologics
    Albumin U.S. clinical study strategy submission
    Q3 FY26
    High
    Biologics
    Albumin U.S. clinical study strategy FDA response
    Q4 FY26
    High
    Biologics
    Aflibercept Phase III study completion (India/ROW)
    This financial year
    High
    Biologics
    Aflibercept commercialization
    Next year
    High
    Tax Rate
    Effective tax rate
    35-36%
    High

    API sales breakup excluding captive sales

    Next quarter
    CurrentNot provided separately
    TargetSeparate disclosure

    Why it matters

    This will provide clearer visibility into the core API business performance, distinct from internal consumption.

    Yes, we'll provide that. That should not be a problem, Krisha.

    How to verify

    key_financials.segment_breakdown[name='API']

    Risks & concerns

    3
    RiskSeverity

    Delay in Unicycive contract commercialization

    Commercialization of the Unicycive product was delayed by one year to next financial year due to issues with the previous CMO partner.Analyst acknowledged

    medium

    Forex impact on finance cost

    Finance cost increased by ₹5 crores QoQ, primarily due to a non-cash mark-to-market impact of ₹6.5 crores on a euro-denominated interest swap loan.Analyst acknowledged

    low

    FDA surprise inspections

    Management anticipates surprise FDA inspections for their formulation plant, indicating ongoing regulatory scrutiny.Management acknowledged

    medium

    Q&A highlights

    8

    “We are under confidentiality with our customer on this product. So, as we've mentioned before also, we are not allowed to disclose any numbers on this. Sorry, I'll not be able to tell anything on this.”

    Management refused to disclose specific financial details of the albumin deal, citing confidentiality, which limits investor visibility into a key revenue stream.

    asked by Krisha Kansara

    2 min read5 chapters

    Detailed Narrative

    01

    Q1 FY26 Financial Performance Highlights

    Shilpa Medicare reported a robust Q1 FY26, achieving its highest ever quarterly EBITDA of ₹98 crores, marking an 18% year-on-year growth with EBITDA margins at 30%. Total revenues for the quarter stood at ₹328 crores, a 9% increase YoY. Gross margins significantly improved by 700 basis points to 76%, primarily driven by a favorable product mix, profit sharing, and licensing fees. The company also saw its effective tax rate drop to 5.5% due to the amalgamation of INM Technologies, which allowed for the utilization of unabsorbed losses.

    02

    API Business Progress and Pipeline

    The API division contributed ₹187 crores to revenue, growing 8% YoY. The company is actively working on two main NCE programs in oncology, with the first expected to commercialize in the next financial year and the second in Phase III studies. Two new oncology products were validated, with DMF/CEP filings planned within six months. Capacity expansion for Tranexamic acid and Ursodeoxycholic acid has led to increased sales turnover, and commercial supplies for Nor-Ursodeoxycholic acid are expected to begin in Q2 FY26.

    03

    CDMO, Peptides, and Polymers Growth

    The CDMO segment has over 25 active projects, with two expected to commercialize next year. Commercial supplies for a polymer project started in Q1 and are anticipated to complete by 2HFY26, with replenishment orders expected. In peptides, liraglutide is ready for manufacturing validation, with formulation batches expected to complete by end of September. Semaglutide registration batches are planned for Q3 FY26, with completion by end of Q4 FY26, and tirzepatide scale-up will commence in Q3 FY26.

    04

    Formulations and Biologics Strategic Advancements

    In formulations, Shilpa launched Nor-Ursodeoxycholic acid, its first NCE, in India by October, marking a significant milestone. The Rotigotine transdermal patch is expected to receive European approval in 2HFY26, with US filing planned for Q3 FY26. The Biologics division saw ₹73 crores in revenue, driven by new CDMO deals and licensing income from the Orion albumin deal. Two NBE programs (Alveolus Bio and mAbTree) are slated to enter human studies next year, and the biosimilar Nivolumab will enter human studies by the end of this year.

    05

    Capital Allocation and Shareholder Returns

    Capital expenditure for the quarter was ₹70 crores, primarily directed towards a fermentation plant in Kadechur. The company's net debt stood at ₹550 crores as of June 30th, having refinanced ₹75 crores of high-cost NCD with lower-cost debt. The Board has proposed a 1:1 bonus issue to improve stock liquidity and reward long-term shareholders. Management indicated that future clinical studies would be funded through partnerships and licensing fees, minimizing the need for significant additional capex.

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