Shilpa Medicare Limited

Financial Performance Highlights

Q4 FY26 Performance:

  • Highest-ever quarterly revenues of INR439 crores, recording 30% year-on-year growth
  • Gross margin remained healthy at 68% for the quarter
  • Highest-ever quarterly EBITDA of INR121 crores, growing 40% year-on-year
  • EBITDA margin of 28%, improving approximately 2% year-on-year
  • Exceptional gain of INR30 crores from stake sale in JV company Sravathi Advance (sold 31% stake, now holds 34%)
  • Adjusted PAT (before exceptional gain) was INR87 crores for the quarter

Full Year FY26 Performance:

  • Historic revenue of INR1,549 crores, growing 18% year-on-year
  • Gross margin of 70% for the full year
  • Highest-ever yearly EBITDA of INR445 crores, reflecting 30% year-on-year growth
  • Yearly EBITDA margin of 29%, showing ~3% year-on-year improvement
  • Adjusted PAT (before exceptional gain) was INR232 crores for the full year, growing ~135% year-on-year
  • Interest outgo reduced year-on-year and has stabilized at current quarter run rate
  • Net debt increased to INR613 crores from INR550 crores in previous year
  • Capex of INR361 crores primarily funded by internal accruals, deployed in API, CDMO and albumin facilities
  • Adjusted ROCE (excluding investments in high-growth potential businesses) improved significantly from 4% in FY23 to 17.4% in FY26

Business Segment Performance

API Business:

  • Q4 revenue: INR259 crores
  • Full year revenue: INR985 crores, growing 16% year-on-year
  • Growth driven by improved uptake from newly expanded capacities and strong captive demand from formulation vertical

Formulations Business:

  • Q4 revenue: INR205 crores, growing 54% year-on-year
  • Full year revenue: INR618 crores, growing 30% year-on-year
  • Base business (excluding licensing income) reported robust growth of 64% for quarter and 75% for full year
  • European formulation business delivered revenues over INR200 crores, growing more than 100% year-on-year

Biologics Segment:

  • Full year revenue: INR150 crores, growing roughly 100% year-on-year
  • Strong growth driven by continued deal momentum in CDMO business

Operational and Product Updates

API Business Developments:

  • First U.S. NCE program launched in Q4 by big pharma company
  • Second U.S. NCE program supplying API for Phase III studies (ongoing)
  • Third U.S. NCE program developing API and formulation for Unicycive Therapeutics - submissions done, expecting approval in FY27
  • Dedicated manufacturing production blocks for OLC successfully commissioned in Q4 FY26, validation batches planned in Q1 FY27
  • Two new NCE programs completed client audits in Q4 FY26, expecting initial development revenues in FY27
  • Added more than 15 new oncology products to pipeline (top oncology blockbusters with patent expiry up to 2032)
  • One new non-oncology import substitute product completed process validation in Q4 FY26
  • Methotrexate complex import substitute oncology API received CEP in Q4 FY26
  • New oncology block added to existing setup, increasing overall oncology API capacity, expected commissioning in FY27
  • Peptides business continues optimistic growth working on multiple generic and CDMO peptides
  • New dedicated peptide large-scale manufacturing block equipment ordering completed, expected commissioning in FY27
  • Working on multiple payloads and linkers for ADC programs
  • Payload supplied to big pharma company completed registration batches in Q4 FY26

Formulations Developments:

  • Nor Ursodeoxycholic acid (NorUDCA) showing good clinical results and traction
  • Planning global expansion with scientific advice and submission in U.S. and Europe, planning human studies in FY27
  • Three commercial 505(b)(2) products approved in U.S., volumes expected to grow steadily quarter-on-quarter
  • Abraxane (paclitaxel albumin-bound) exhibit batches successfully completed in Q4 FY26, expecting launch in FY28
  • Enzalutamide tablets registration batches completed with non-infringing route, planning to file in U.S. and Europe in FY27, expecting commercialization in FY28
  • Rotigotine Transdermal Patch Europe launch expected in FY27
  • Rotigotine Transdermal Patch submitted to U.S. FDA in Q4 FY26
  • Ondansetron extended-release injection expected to launch in FY27 in India, planning global expansion with human studies in FY27

Biologics Developments:

  • Aflibercept human clinical study ongoing, on track for launch in FY27
  • Nivolumab human clinical study approval received for India, scientific advice submitted to EMA, expecting response in Q1 FY27
  • Four new biosimilars added to portfolio in Q4 FY26
  • First NBE program with mAbTree Biologics development completed, planning Phase I studies in FY27
  • Second NBE program partnered with Alveolus Bio, development work initiated, expecting human studies in FY27
  • Two NBE programs entering Phase I studies in FY27
  • 5 active CDMO and NBE programs ongoing
  • Phase I clinical study batches for one innovator program initiated in Q4 FY26, planning to finish supplies in FY27
  • First ADC biosimilar development completed using payload, linker and conjugation, planning human studies in FY27
  • Second ADC biosimilar product development initiated
  • Building integrated ADC manufacturing suite with mAb manufacturing, payload, linker and conjugation capabilities
  • Recombinant human albumin program received Global Phase III clinical study approval from CDSCO for Europe study
  • Planning IMPD submission for Europe study in first half of FY27

Q&A Highlights

U.S. Formulation Revenue:

  • Revenue grew from INR54 crores in FY25 to INR80 crores in FY26
  • Growth impacted by discontinuation of azacitidine generic product due to market dynamics
  • Now focusing on super specialty products

NorUDCA Scaling:

  • Launched in November (Q3), showing steep growth quarter-on-quarter
  • Disease curability duration is 6 months, clearer picture expected in second quarter of FY27

EBITDA Margins and Licensing Income:

  • Targeting 35% EBITDA margins but considered ambitious due to ongoing business growth investments
  • Licensing income expected to remain in similar range with robust pipeline of molecules

European Formulation Business:

  • Expecting healthy growth in FY27
  • Nilotinib impact expected in FY28 due to tender contract durations
  • Additional launches including Tadalafil oral disintegrating film, Axitinib and other generic products

Biologics Growth Drivers:

  • FY27 growth mainly from CDMO business and existing programs
  • Licensing for biosimilars in Europe and ROW markets
  • Commercial revenues from Europe and ROW expected in FY29

OLC (Unicycive Therapeutics):

  • No meaningful contribution projected in FY27
  • Approval timing and filing strategy confidential

Associate Company Profit Share:

  • INR18 crores share of profit from associate entity Maaia (35% stake)
  • Improvement based on significant performance improvement, value reinstated
  • Continuation not guaranteed as not a controlled entity

Facility and Regulatory Status:

  • U.S. FDA facility audit observations addressed, compliance done, waiting for reaudit
  • Facility has global accreditations (Europe, LatAm, Saudi), plant occupancy not an issue
  • No capacity crunch issues due to strong pipeline of differentiated products

Product Pipeline Timelines:

  • Global market entries for biologics portfolio expected in FY29
  • NorUDCA ROW market revenues expected in FY28, Europe in FY29
  • ADC and NBE products entering human global studies in FY27

Capex and Investment Strategy:

  • FY26 capex: INR361 crores
  • Focus on near-term and midterm revenue generation investments
  • No investments in long gestation projects

Raw Material Availability:

  • No major availability challenges
  • Significant price increases observed