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    Shilpa Medicare Limited

    SHILPAMED
    Healthcare·17 Nov 2025
    Management Summary

    Shilpa Medicare delivered a strong Q2 FY26, achieving its highest-ever quarterly EBITDA of ₹110 crores on revenues of ₹372 crores, driven by robust performance in API and Formulation segments. The company successfully launched its first NCE program, NorUrsodeoxycholic acid, in India and continues to advance a complex pipeline across API, Formulations, and Biologics. Despite positive financial results and strategic progress, specific updates on the USFDA inspection for the Jadcherla plant remain undisclosed.

    Highlights

    5
    • Recorded highest ever quarterly EBITDA of ₹110 crores, marking a 21% growth YoY.

    • Achieved quarterly revenues of ₹372 crores, a 7% increase year-on-year.

    • Gross margin improved to 72% for the quarter, reflecting strong performance in core business.

    • Adjusted ROCE (excluding high-growth Biologics and NBE investments) significantly improved from 4% in FY23 to approximately 17% in H1 FY26.

    • Successfully launched the first NCE program, NorUrsodeoxycholic acid, in India, being the sole company globally to do so.

    Concerns

    2
    • Management provided no specific update on the USFDA inspection status for the Jadcherla plant, stating they would inform when an update is available.

    • Licensing income is noted to be 'lumpy' and varies depending on the stage of product development, making it less predictable quarter-on-quarter.

    What Changed2

    vs Q3 FY26

    Guidance items29 → 27 (-2)Risks discussed3 → 4 (+1)
    Key financials

    Metrics

    11

    Periods

    2

    Headline

    5
    • Revenue
      ₹372 Cr
      YoY+7.0%
    • Gross Margin
      72%
    • EBITDA
      ₹110 Cr
      YoY+21%
    • EBITDA Margin
      30%
      YoY+4%
    • PAT
      ₹44 Cr

    H1 FY26

    6
    • Revenue
      ₹700 Cr
      YoY+8%
    • Gross Margin
      74%
    • EBITDA
      ₹208 Cr
      YoY+20%
    • EBITDA Margin
      30%
      YoY+3%
    • PAT
      ₹91 Cr

    Segment breakdown

    Non-captive API
    ₹205 Cr Turnover
    Formulation
    ₹109 Cr Turnover
    Biologics
    ₹25 Cr Revenue (Q2)₹61 Cr Revenue (H1)
    Base Business (ex-licensing)
    60% Growth (Q2)67% Growth (H1)
    List

    Capital allocation

    2
    high confidence
    CategoryHeadline
    Capex

    ₹75 crores

    internal accruals

    Debt

    Net ₹569 crores

    Guidance & targets

    27
    CategoryTargetPriority
    Revenue
    API Business Growth
    double digit year-on-year
    High
    Revenue
    OLC Commercialization Revenue
    will be
    Medium
    Revenue
    European Business Growth
    continuously
    High
    Market Share
    NorUDCA Market Share (NAFLD patients)
    10-20%
    Medium
    Product Launch
    NCE Program (first product) Commercial Supplies
    start
    High
    Product Launch
    Ursodeoxycholic Acid Commercial Supplies
    start
    High
    Product Launch
    NorUrsodeoxycholic Acid (API) Commercial Supplies
    start
    High
    Product Launch
    Lanthanum Dioxycarbonate Commercial Launch
    expected
    High
    Product Launch
    Ondansetron Long-Acting Injection (India) Launch
    plan
    High
    Product Launch
    Aflibercept Launch
    expect to launch
    High
    Product Filing
    NCE Program (second product) Filing
    expected
    High
    Product Filing
    Transdermal Patches (US) Filing
    planning
    High
    Product Filing
    Ondansetron Long-Acting Injection (India) Filing
    plan
    High
    Capacity Utilization
    Tranexamic Acid Capacity Utilization
    full
    High
    Capacity Expansion
    Tranexamic Acid Additional Capacity
    100 metric tons
    High
    Facility Commissioning
    Lanthanum Dioxycarbonate Facility Commissioning
    commission
    High
    Facility Commissioning
    Dedicated Peptide Facility Commissioning
    commission
    High
    Product Development
    Semaglutide PV Campaign Completion
    complete
    High
    Product Approval
    Rotigotine (Europe) Approval
    expecting
    High
    Product Approval
    OLC of Unicycive Therapeutics Approval
    expected
    High
    Product Submission
    Transdermal Patches (US) Submission
    planning
    High
    Clinical Studies
    NBE Programs (mAbTree, Alveolus) Phase I Human Studies
    enter
    High
    Clinical Studies
    ADC Biosimilar Human Studies
    enter
    High
    Clinical Studies
    Androgenic Alopecia Phase III Clinical Studies
    starting
    High
    Clinical Trials
    Nivolumab Phase I/III Human Clinical Trial (India)
    likely to start
    High
    Clinical Trials
    Recombinant Human Albumin European Phase III Clinical Studies
    planning to start
    High
    Product Commercialization
    Peptide Project (MNC partner) Commercialization
    happen
    High

    NorUDCA Commercial Supplies & Revenue Traction

    Next financial year
    CurrentJust launched in India, initial supplies in Q3/Q4 FY26
    TargetSizable numbers from next financial year

    Why it matters

    NorUDCA is a key NCE program with significant market potential; its commercial ramp-up will be crucial for future revenue growth.

    Maybe in the current Q3 and Q4, it will be just supplies. But from the next financial year, we surely expect a sizable numbers from NorUDCA. This is our estimate.

    How to verify

    key_financials.segment_breakdown[name='Formulation'].metrics[label='Turnover']

    Risks & concerns

    4
    RiskSeverity

    USFDA inspection outcome for Jadcherla plant

    Management did not provide an update on the USFDA inspection, indicating potential uncertainty or ongoing process.Analyst not addressed

    medium

    Lumpiness of licensing income

    Licensing income is not consistent quarter-on-quarter, depending on product development stages, which can affect short-term revenue predictability.Management acknowledged

    low

    Competition in European generics market

    Europe is a very competitive market for me-too generics, requiring focus on complex, differentiated, and backward-integrated products to gain market share.Management acknowledged

    medium

    Late entry into Semaglutide market

    Analyst raised concerns about being late to market for Semaglutide, a competitive product, which management addresses with a differentiated, integrated approach.Analyst acknowledged

    medium

    Q&A highlights

    8

    “And with respect to clinical adoption dynamics, we expect at least we will get ~10% of the treated NAFLD populations, that will get convert to NorUDCA. This is what is our estimate over the next 3 to 5 years.”

    Analyst sought clarity on the market opportunity and competitive positioning for the newly launched NorUDCA, a key NCE product.

    asked by Krisha Kansara

    3 min read6 chapters

    Detailed Narrative

    01

    Strong Financial Performance and Margin Expansion

    Shilpa Medicare reported its highest-ever quarterly EBITDA of ₹110 crores in Q2 FY26, a 21% increase year-on-year, crossing the ₹100 crore mark for the first time. Revenues for the quarter stood at ₹372 crores, growing 7% YoY, while H1 FY26 revenues reached ₹700 crores, up 8%. Gross margin improved to 72% in Q2 and 74% in H1, driven by a stronger product mix. The EBITDA margin for both Q2 and H1 was 30%, reflecting a 4% and 3% improvement YoY, respectively. PAT for the quarter was ₹44 crores, with H1 PAT at ₹91 crores, surpassing the full-year PAT of FY25 (₹78 crores).

    02

    Strategic Focus on Complex and Differentiated Products

    The company emphasized its strategy of operating in advanced, complex, and high-entry barrier segments like API, Formulations, and Biologics. This approach is reflected in the improved adjusted ROCE (excluding Biologics and NBE investments), which rose from 4% in FY23 to approximately 17% in H1 FY26. Management highlighted a focus on better asset utilization and monetizing existing investments in Biologics, transdermal facilities, and fermentation facilities over the next 3-5 years, leveraging its technical know-how and R&D capabilities.

    03

    Key Product Launches and Pipeline Progress

    Shilpa Medicare successfully launched its first NCE program, NorUrsodeoxycholic acid, in India, being the only company globally to bring this product to market. Commercial supplies for another NCE program are expected from Q4 FY26, with a second NCE program filing anticipated in FY27. In the non-oncology segment, Tranexamic Acid is expected to reach full capacity utilization this year, with an additional 100 metric tons capacity planned for next financial year. Commercial supplies for Ursodeoxycholic Acid and NorUrsodeoxycholic Acid (API) are slated to begin in Q3 FY26.

    04

    Advancements in CDMO and Biologics

    The CDMO business shows good traction, with several programs advancing. The dedicated facility for Lanthanum Dioxycarbonate is set for commissioning in Q3 FY26, with commercial launch expected next financial year. On the peptide front, Semaglutide's PV batches are initiated, and a large dedicated peptide facility is planned for commissioning next financial year. In Biologics, two new NBE programs are expected to enter Phase I human studies in FY27, and the first ADC biosimilar is also planned for human studies in FY27. Aflibercept, the most advanced biosimilar program, is targeted for launch in FY27 after successful Phase III studies.

    05

    European Market Expansion and US Submissions

    In the European market, Nilotinib continues to gain market share, with limited generic competition expected. Approval for the complex Rotigotine transdermal patch is anticipated in Q4 FY26. For the US market, clinical studies for a transdermal patch have been completed, with submission planned for Q3 FY26, and filing for two other patches expected next financial year. The company is also planning to file for Ondansetron long-acting injection in India in Q4 FY26, with a launch targeted for next financial year, addressing a unique market need for advanced antiemetic patients.

    06

    Capital Expenditure and Debt Management

    The company incurred capex investments of ₹153 crores in H1 FY26. For the remainder of FY26, an additional capex of ₹75-100 crores is planned, primarily for the Albumin facility and API business expansion. Net debt at the end of September stood at ₹569 crores. Management stated that interest outgo has stabilized, and future capex programs are expected to be funded through internal accruals, indicating a focus on financial prudence and self-sufficiency.

    This is an AI-generated summary of a publicly available earnings call transcript. It is for informational purposes only and does not constitute investment advice, a recommendation, or an endorsement. inve.money is not a SEBI-registered investment advisor. Please consult a qualified financial advisor before making any investment decisions.