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