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    Shilpa Medicare

    SHILPAMED
    Healthcare·26 May 2026
    Management Summary

    Shilpa Medicare delivered strong Q4 and full-year FY26 results, achieving record revenues and significant EBITDA margin expansion driven by operating leverage. The company is actively diversifying its portfolio across APIs, formulations, biologics, and ADCs, with a robust pipeline of new products and strategic investments in CDMO capabilities. While US formulation revenue faced headwinds from product discontinuation, the focus has shifted to specialty products and global market expansion, with several key launches and regulatory milestones expected in FY27 and FY28.

    Highlights

    5
    • Revenue reached an all-time high of ₹439 crores in Q4 FY26, representing a 30% year-on-year growth.

    • EBITDA margins expanded to 28% in Q4 and 29% for the full year, driven by increased revenue and positive operating leverage.

    • Adjusted PAT for FY26 (before exceptional gain) surged by approximately 135% to ₹232 crores.

    • Adjusted ROCE, excluding investments in high-growth potential businesses, significantly improved from 4% in FY23 to 17.4% in FY26.

    • The company has a robust pipeline with key product launches anticipated in FY27 and FY28, including NorUDCA, Abraxane, Enzalutamide, and Rotigotine Transdermal Patch.

    Concerns

    3
    • US formulation revenue remained flat despite partner market share gains, attributed to the discontinuation of Azacitidine due to changing market dynamics.

    • Management declined to provide specific top-line and bottom-line guidance for FY27, citing the lopsided nature of licensing income and the need for continued investment.

    • The Phase III trials for Dutasteride were delayed due to additional preclinical study data requests from regulatory bodies, pushing back its development timeline.

    Key financials

    Metrics

    11

    Periods

    2

    Headline

    5
    • Revenue
      ₹439 Cr
      YoY+30%
    • EBITDA
      ₹121 Cr
      YoY+40%
    • EBITDA Margin
      28%
      YoY+2%
    • Adjusted PAT
      ₹87 Cr
    • Adjusted ROCE (excl. biologics/albumin)
      17.4%

    FY26

    6
    • Revenue
      ₹1,549 Cr
      YoY+18%
    • EBITDA
      ₹445 Cr
      YoY+30%
    • EBITDA Margin
      29%
      YoY+3%
    • Adjusted PAT
      ₹232 Cr
      YoY+135%
    • Net Debt
      ₹613 Cr

    Segment breakdown

    • API Business₹985 Cr56.2%
    • Formulation Revenue₹618 Cr35.3%
    • Biologics Segment₹150 Cr8.6%
    Donut· Share of FY26 Revenue

    Capital allocation

    3
    high confidence
    CategoryHeadline
    Capex

    ₹361 crores

    primarily funded by internal accruals

    Debt

    Net ₹613 crores

    Liquidity

    Liquidity disclosed

    Expect to fund capex programs broadly via internal accruals.

    Guidance & targets

    25
    CategoryTargetPriority
    API Business
    Overall API business growth
    steady growth
    Medium
    Formulations
    Overall growth possibility
    good growth possibility
    Medium
    Formulations
    Abraxane launch
    expecting launch
    High
    Formulations
    Enzalutamide tablets commercialization
    expected to get commercialized
    High
    Formulations
    Rotigotine Transdermal Patch Europe launch
    will be launched
    High
    Formulations
    Ondansetron extended-release injection India launch
    expecting to launch
    High
    Formulations
    NorUDCA Europe launch
    would be in FY29
    High
    Formulations
    NorUDCA ROW market revenues
    will start seeing revenues
    High
    Formulations
    Rotigotine Transdermal Patch ramp up
    will happen
    High
    Formulations
    Nilotinib ROW market launch
    will be launching
    High
    Biologics
    Growth figures
    lot of growth figures possible
    Medium
    Biologics
    Aflibercept launch
    on track for launch
    High
    Biologics
    Nivolumab EMA scientific advice response
    expecting response
    High
    Biologics
    Commercial revenues from Europe and ROW
    expect sometime in FY29
    High
    Biologics
    Adalimumab Europe and ROW market revenues
    will come in FY29
    High
    NCE Program
    Third U.S. NCE program approval
    expecting approval
    High
    NCE Program
    Initial development revenues from two new NCE programs
    expecting to start
    High
    Oncology Capacity
    New oncology block commissioning
    expected to get commissioned
    High
    Peptides Capacity
    New dedicated peptide large-scale manufacturing block commissioning
    expecting to commission
    High
    NBE Pipeline
    mAbTree Biologics Phase I studies
    planning to enter
    High
    NBE Pipeline
    Alveolus Bio human studies
    expecting to enter
    High
    NBE Pipeline
    Two NBE programs entering Phase I studies
    will be entering
    High
    ADC Biosimilar
    First ADC biosimilar human studies
    planning to enter
    High
    Recombinant Human Albumin
    IMPD submission for Europe study
    planned
    High
    Oncology Breakthrough Molecule
    Meaningful contribution
    should be meaningful
    High

    NorUDCA Commercial Traction and Volume Growth

    Q2 FY27
    CurrentSteep growth QoQ since November launch
    TargetClearer picture of trajectory and volumes

    Why it matters

    NorUDCA is a key new chemical entity, and its scaling will be a significant growth driver for the formulations segment.

    So we must see how the trajectory will be for the upcoming quarters because the disease curability duration is 6 months. So once the 6 months duration is completed, then we will have more data from doctors, from hospitals... So we will be able to give you a clearer picture in sometimes in second quarter of this year.

    How to verify

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

    Risks & concerns

    3
    RiskSeverity

    Sustainability of profit share from associate (Maaia)

    The INR 18 crores profit share from associate Maaia is due to improved performance, but management cannot guarantee its continuation as they do not control the entity.Analyst acknowledged

    medium

    Pending USFDA reaudit for Jadcherla facility

    The Jadcherla facility received FDA observations, compliance has been submitted, and the company is awaiting reaudit, though management states it does not significantly impact current US revenues due to reliance on third-party CMOs.Analyst acknowledged

    medium

    Raw material price volatility

    Raw material and solvent prices have increased significantly, but management confirmed that availability is not an issue.Analyst acknowledged

    low

    Q&A highlights

    8

    “So I think on the U.S. revenue front, as you rightly mentioned we have seen an increase in revenue, and that will most likely continue in the FY27 also. Only against last year, this year, we have stopped selling our generic product, which was azacitidine in U.S. Since the market dynamics have changed for the product we have discontinued. So now we are focusing more on selling super specialty products.”

    Analyst questioned the discrepancy between partner market share gains and flat US formulation revenue, leading to management clarifying a strategic shift away from certain generics like Azacitidine towards super specialty products.

    asked by Kiran D. (TableTree Capital)

    3 min read7 chapters

    Detailed Narrative

    01

    Strong Financial Performance Driven by Operating Leverage

    Shilpa Medicare delivered robust financial results in Q4 FY26, with revenue reaching an all-time high of ₹439 crores, marking a 30% year-on-year growth. For the full fiscal year, revenue stood at ₹1,549 crores, an 18% increase. EBITDA for Q4 grew 40% YoY to ₹121 crores, with the margin expanding to 28%, while full-year EBITDA was ₹445 crores (up 30% YoY) at a 29% margin, primarily due to increased revenue from key verticals and positive operating leverage. Adjusted PAT for FY26 (before exceptional gain📎) surged by approximately 135% to ₹232 crores, reflecting strong profitability.

    02

    Diversified Growth Across API, Formulations, and Biologics

    The company is strategically diversifying its platform across complex APIs, specialty formulations, biologics, and ADCs. The API business recorded ₹259 crores in Q4 and ₹985 crores for FY26, growing 16% YoY, supported by expanded capacities and strong captive demand from formulations. Formulations revenue surged 54% YoY in Q4 to ₹205 crores and 30% YoY for FY26 to ₹618 crores, with the European formulation business alone exceeding ₹200 crores (up over 100% YoY). The biologics segment also saw significant growth, with FY26 revenue of ₹150 crores, up approximately 100% YoY, driven by continued deal momentum in the CDMO business.

    03

    Robust Product Pipeline and Upcoming Launches

    Shilpa Medicare has a strong pipeline with several key product launches anticipated in FY27 and FY28. Nor Ursodeoxycholic acid (NorUDCA), a new chemical entity launched in Q3 FY26, is showing steep QoQ growth and is expected to gain further traction in FY27, with global expansion planned. Abraxane and Enzalutamide tablets are slated for commercialization in FY28, following successful completion of exhibit and registration batches in Q4 FY26. Additionally, the Rotigotine Transdermal Patch is set for a Europe launch in FY27, with a US FDA submission completed in Q4 FY26, and Ondansetron extended-release injection is expected to launch in India in FY27.

    04

    Strategic Investments in Biologics and CDMO Capabilities

    The company is making significant strides in its biologics and CDMO segments, with two new NBE programs set to enter Phase I studies in FY27, alongside ongoing development of a second ADC biosimilar. Shilpa is building its own integrated ADC manufacturing suite, which will encompass mAb, payload, linker, and conjugation, positioning it uniquely in India. The recombinant human albumin program received Global Phase III clinical study approval from CDSCO for its Europe study, with IMPD submission planned for H1 FY27, further solidifying its long-term growth strategy.

    05

    Capital Allocation Focused on Internal Accruals and ROCE Improvement

    Shilpa Medicare's capital expenditure for FY26 amounted to ₹361 crores, primarily funded through internal accruals and deployed in API, CDMO, and albumin facilities. The company expects capex to sustain at similar levels without significant growth compared to the previous year. Net debt increased to ₹613 crores from ₹550 crores in the previous year, aligning with business growth. The adjusted Return on Capital Employed (ROCE), excluding investments in high-growth potential biologics and albumin, significantly improved from 4% in FY23 to 17.4% in FY26, reflecting better operational efficiency and prudent capital management.

    06

    USFDA Audit Status and Strategic Shift in US Market

    The Jadcherla facility is currently awaiting reaudit by the USFDA after submitting compliance for observations received during a prior audit. Management clarified that this does not significantly impact current US revenues, as the majority of US products are now manufactured through third-party CDMO sites. The company has strategically shifted its focus in the US market from certain generic products, like Azacitidine (which was discontinued due to market dynamics), towards super specialty products, aiming for differentiated offerings and higher value realization.

    07

    Semaglutide and Oncology API Expansion

    Shilpa Medicare completed validation for Semaglutide GLP-1 in Q4 FY26, with DMF expected by H1 FY27. The company's differentiation in this competitive market lies in its ability to produce both synthetic and semisynthetic API, coupled with forward integration into its own formulations and global accreditations, primarily targeting the export market. Furthermore, a new oncology block is expected to be commissioned in FY27, increasing overall oncology API capacity and supporting the pipeline of over 15 new oncology products, including Methotrexate for which CEP was received in Q4 FY26.

    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.