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    Biocon Limited

    BIOCON
    Healthcare·7 Feb 2025
    Management Summary

    Biocon reported a progressive Q3 FY25 with 10% like-for-like operating revenue growth, driven by strong Biosimilars and Research Services performance. Key regulatory milestones were achieved, including VAI status for major facilities and multiple product approvals, setting the stage for future launches. However, Generics saw a marginal YoY decline and lower reported EBITDA margins due to new facility costs and R&D investments, while group core EBITDA growth was modest.

    Highlights

    6
    • Overall group operating revenue grew 10% YoY (like-for-like) to INR 3,821 crore.

    • Biosimilars revenue grew 14% YoY (like-for-like) to INR 2,289 crore.

    • Research Services revenue grew 11% YoY to INR 944 crore, with EBITDA margin improving to 31%.

    • Successful FDA audits across 3 sites (Bengaluru API, Biocon Park, Johor insulin facilities) received VAI status, paving way for US approvals of Bevacizumab and Aspart.

    • Completion of all BBL deferred milestones under the Viatris acquisition agreement.

    • Key product approvals for GLP Liraglutide in EU, Tacrolimus in China, and Yesintek (Ustekinumab biosimilar) in US/EU/Japan, with launches commencing in Q4 FY25.

    Concerns

    4
    • Generics revenue saw a marginal decline of 2% YoY, though it grew 10% QoQ.

    • Generics reported EBITDA margin was 5%, impacted by higher operating expenses linked to new facilities and increased R&D investments.

    • Group core EBITDA grew only 4% YoY to INR 1,007 crore, with a margin of 26%.

    • Biosimilars EBITDA margin was 22% (including non-cash Forex translation loss of INR 20 crores), which is lower than last year's reported EBITDA of INR 714 crore (which included BFI investment gains).

    What Changed2

    vs Q4 FY25

    Guidance items17 → 10 (-7)Risks discussed4 → 5 (+1)

    Key financials

    Single quarter

    08 metrics
    1. 01Operating Revenue (Like-for-like)₹3,821 Cr+10%YoY
    2. 02Total Group Revenue₹3,856 Cr+7.0%YoY
    3. 03Group Core EBITDA₹1,007 Cr+4%YoY
    4. 04Group Core EBITDA Margin26%
    5. 05Group Reported EBITDA₹787 Cr+16%YoY

    Segment breakdown

    Revenue from OperationsReported EBITDAReported EBITDA MarginProfit Before Tax
    Generics₹686 Cr₹39 Cr5%₹-14 Cr
    Biosimilars
    Research Services (Syngene)₹944 Cr₹302 Cr31%₹181 Cr
    Heatmap· 4 shared metrics

    Capital allocation

    4
    high confidence
    CategoryHeadline
    Debt

    Net USD 1.23 billion

    M&A

    Biocon Biologics (BBL)

    acquisition · closed

    M&A

    Cranbury oral solid dosage facility

    acquisition · integrated

    Liquidity

    Liquidity disclosed

    Viatris settlement funded through existing liquidity sources.

    Guidance & targets

    10
    CategoryTargetPriority
    Generics
    Revenue Growth
    mid-teens
    Medium
    Generics
    Revenue Growth
    growth
    High
    Generics
    Liraglutide Launch
    commercialization
    High
    Generics
    EBITDA Margin
    13-14%
    Medium
    Biosimilars
    EBITDA Margin
    22-23%
    High
    Biosimilars
    R&D Spend (% of Revenue)
    7-9%
    High
    Biosimilars
    New Product Launches
    5 in US, 3 globally
    High
    Biosimilars
    Ustekinumab (Yesintek) Launch
    February 2025
    High
    Biosimilars
    Denosumab Launch
    early FY26
    High
    Semaglutide
    Approvals
    some markets
    Medium

    What to watch in Q4 FY25

    5

    Generics Revenue Growth Trajectory

    Q4 FY25 and into next fiscal
    CurrentMarginal decline of 2% YoY, but 10% QoQ growth in Q3 FY25
    TargetContinued sequential growth, building towards mid-teens growth

    Why it matters

    Generics recovery is key for overall group performance and achieving mid-teens growth targets.

    Looking ahead, we expect performance in the fourth quarter and into the next fiscal to build upon the sequential revenue growth in Q3, driven by new product launches across markets, including the launch of our generic GLP, Liraglutide, in the UK and the EU, as well as additional new product launches, particularly in the United States.

    Risks & concerns

    5
    RiskSeverity

    Generics Pricing Pressures

    Pricing pressures have persisted in the Generics business, though some volume recovery was observed.Management acknowledged

    medium

    Market Dynamics in US Biotech

    Market dynamics, particularly in US biotech for Research Services, are stabilizing later than expected.Management acknowledged

    medium

    Biosimilar Price Erosion

    Competition in the biosimilar market leads to steady price erosion, which is in line with budgeted expectations.Management acknowledged

    medium

    Competition in Insulin Portfolio

    Innovators' increased focus on GLP-1s could potentially shift attention away from insulins, impacting market dynamics.Analyst acknowledged

    medium

    Complexity of Semaglutide Regulatory Approvals

    Regulatory review for Semaglutide varies by country, making approval timelines difficult to predict.Management acknowledged

    medium

    Q&A highlights

    8

    “As you can imagine, we are very excited about the upcoming launch for biosimilar, Ustekinumab. We will be amongst that wave of products that will be coming to the United States. But I also want to draw your attention that this is a global launch. So, we will be looking to bring this product to Europe as well. There is a huge opportunity that we are looking forward to. I do acknowledge what you said about the Part D and the past that has been the case with the biosimilar Adalimumab. obviously, we are very conscious of that. Our teams are working very hard with customers, both commercial as well as the government customers as well. We believe we will be very competitive in this space, both for Ustekinumab and even as we progress the Adalimumab asset as we go forward.”

    Analyst questioned potential uptake of the new Stelara biosimilar, considering it's a Part D product and past Adalimumab dynamics. Management confirmed excitement for global launch and confidence in competitiveness despite Part D challenges.

    asked by Damayanti Kerai (HSBC Securities and Capital Markets (India) Private Limited)

    3 min read6 chapters

    Detailed Narrative

    01

    Overall Group Performance and Outlook

    The Biocon Group delivered a progressive Q3 FY25, achieving a 10% year-on-year operating revenue growth on a like-for-like basis, reaching INR 3,821 crore. This performance was in line with expectations, driven by sustained growth in Biosimilars and a return to growth in Research Services. Group core EBITDA stood at INR 1,007 crore, up 4% YoY, with a margin of 26%. The company maintains its outlook for a transition to growth in the second half of FY25 and into the next fiscal year, with improved visibility across all businesses.

    02

    Generics Business Performance and Future Drivers

    The Generics segment reported revenue of INR 686 crore, experiencing a marginal 2% decline year-on-year but a healthy 10% sequential growth. This sequential improvement was primarily fueled by higher API sales and better performance in generic formulations. Core EBITDA for Generics was INR 102 crore (15% margin), though reported EBITDA was lower at INR 39 crore (5% margin) due to operating expenses for new facilities and increased R&D. Future growth is expected from new product launches, including the GLP Liraglutide in the UK and EU in Q4 FY25, and additional launches in the US.

    03

    Biosimilars Business Growth and Market Traction

    Biocon Biologics demonstrated strong performance with INR 2,289 crore in revenue, marking a 14% year-on-year like-for-like growth and 5% sequential growth. The segment's EBITDA was INR 487 crore, with a 22% margin excluding Forex impact. The company saw significant market share increases in the US, with Ogivri doubling to 22% and Fulphila rising to 23%. Stable market shares were maintained in Europe, with strong uptake in Germany and France, and positive traction in Japan and Australia through commercial partnerships.

    04

    Research Services (Syngene) Recovery and Market Dynamics

    Syngene International returned to growth in Q3 FY25, with revenue from operations reaching INR 944 crore, up 11% year-on-year and 6% sequentially. Reported EBITDA for Syngene was INR 302 crore, a 16% increase YoY, with the margin improving to over 31%. Profit before tax grew 27% YoY to INR 181 crore. The growth was broad-based across all divisions, suggesting that market dynamics, particularly in US biotech, are stabilizing, albeit slightly later than initially expected.

    05

    Regulatory Achievements and Product Pipeline

    Biocon achieved critical regulatory milestones, including successful US FDA inspections of its Bengaluru API sites and insulins facilities in Johor, Malaysia, both receiving Voluntary Action Initiated (VAI) status. This outcome is expected to pave the way for US approvals of biosimilar Bevacizumab and Aspart. The company also secured US FDA approval for Yesintek (biosimilar Ustekinumab), with launch planned for February 2025, and received EU approval for GLP Liraglutide, positioning it for commercialization in fiscal 2026.

    06

    Capital Allocation and Debt Management

    The group's net debt stands at approximately USD 1.23 billion. Biocon increased its stake in Biocon Biologics by 1.5% to meet an investor's liquidity option, bringing its holding closer to 72%. The remaining USD 160 million of deferred milestones under the Viatris acquisition agreement were fully settled using existing liquidity sources. Management reiterated its commitment to debt reduction, acknowledging it will be a balancing act with ongoing investments in future growth opportunities.

    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.