Shilpa Medicare Limited has informed the Exchange about Investor Presentation
Shilpa Medicare Limited Corporate & Admin Office: “Shilpa House”, # 12-6-214/A-1, Hyderabad Road, Raichur – 584 135, Karnataka, India Tel: +91-8532-238704, Fax: +91-8532-238876 Email: info@vbshilpa.com, Web: www.vbshilpa.com CIN: L85110KA1987PLC008739
Date: 13th August, 2025
To,
Corporate Relationship Department, National Stock Exchange of India Limited BSE Limited Exchange Plaza, 5th Floor, Phiroze Jeejeebhoy Towers, Plot No.C/1, G Block Dalal Street, Fort, Bandra Kurla Complex, Bandra (E) Mumbai-400 001 Mumbai-400 051
Scrip Code: BSE-530549, Stock Symbol: NSE – SHILPAMED
Dear Madam/Sir,
Sub: Investor presentation of the Company for the quarter ended 30 June 2025 Ref: Disclosure under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015
With reference to the captioned subject, the Investor Presentation for the quarter ended 30 June 2025, on Company Overview, Business highlights, financial performance and other updates is enclosed herewith for your consideration.
A copy of this intimation is also being made available at:
https://vbshilpa.com/investor-presentation.php
We requesting you to take the above information on record.
Thanking you.
Yours faithfully, For Shilpa Medicare Limited
Ritu Tiwary Company Secretary & Compliance officer
Shilpa Medicare Ltd 1QFY26 Earnings Presentation
Date: 13th August 2025
Safe Harbour
Certain statements in this document may be forward - looking statements. Such forward looking statements are subject to certain risks and uncertainties like regulatory changes, local political or economic developments, and many other factors that could cause our actual results to differ materially from those contemplated by the relevant forward-looking statements. Shilpa Medicare Limited (SML) will not be in any way responsible for any action taken based on such statements and undertakes no obligation to publicly update these forward-looking statements to reflect subsequent events or circumstances.
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Shilpa Medicare at a glance
Established in 1987, we have 35+ years track record
Existing Business Segments: API , Formulation, CDMO, Biologics
Emerging Businesses: NDDS, ADC and Recombinant Human Albumin
10+ Regulatory approved manufacturing + R&D facilities (incl Analytical Lab)
400+ R&D Personnel
500+ Regulatory Filings across the world
Worldwide presence in 50+ countries
1Q FY26 Financials
Revenue INR 328 crores (+9% YoY) EBITDA INR 98 crores (+18% YoY)
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Key operating verticals
API
Formulations
Biologics
11%
1QFY26 Revenue contribution
59%
30%
Legal Entities
Areas of Operation
▪ Shilpa Pharma Lifesciences
▪ Oncology ▪ Non-Oncology ▪ Payloads and Linkers ▪ Peptides ▪ Polymers ▪ CDMO
▪ Shilpa Medicare ▪ Shilpa Therapeutics ▪ FTF Pharma
▪ Tablets/Capsules ▪ Injectables ▪ Oral Dissolving Films ▪ Transdermal patches ▪ CDMO
▪ Shilpa Biologicals ▪ Shilpa Biocare
▪ NBE ▪ Microbials Products ▪ Mammalian Products ▪ GLP-1 ▪ CDMO ▪ ADCs
API Includes others
4
Management Commentary
The first quarter of FY26 demonstrated steady progress and strong execution of our strategic priorities. Our partner successfully launched our second NDA in the U.S.—Bortezomib RTU— reinforcing our R&D-driven approach and delivering differentiated products that enhance ease of administration. Pemetrexed also gained momentum in the U.S., while Nilotinib continued to expand its presence in the EU. Additionally, we achieved a historic milestone with NorUDCA’s approval, making Shilpa the first global company approved for NAFLD treatment. These approvals, along with our robust NDA pipeline, positions us for sustained future growth.
Our API division(including captive) has reported growth ~25% YoY basis. New product launches, CDMO expansion, expanded capacities, and an improved product mix favoring regulated markets is expected to drive further growth for FY26.
In Biologics, our strategic investment in Alveolus Bio accelerates innovation and solidifies Shilpa’s position as a global biotech enabler—bridging cutting-edge science with scalable solutions. Our Novel Biological Entities (NBEs), developed in collaboration with mAbTree and Alveolus, remain on track for Phase I human trials in FY27. On the biosimilar front, Aflibercept has advanced to Phase III clinical trials in India, while Nivolumab has completed PCT, with Phase I trials expected to commence by the end of FY26. We have also received the initial milestone payment for Recombinant Human Albumin from Orion Corporation, and the program is progressing as planned.
On the regulatory front, we continue to achieve key accreditations for our facilities. During the quarter, Unit VI at Dabaspet, Karnataka—equipped with ODF & TDP manufacturing capabilities— received an EIR from the US FDA. This milestone will support the monetization of our differentiated product portfolio in the US market. Our focus remains on optimizing asset utilization across key verticals, and we are confident in delivering improved profitability in FY26.
— Mr. Vishnukant Bhutada Managing Director
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1QFY26 Performance
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1Q FY26 – Financial Highlights Highest Quarterly EBITDA
1Q FY26 (Consolidated)
Particulars (INR cr)
1QFY26
1QFY25
Total Revenue
Gross Profit
GP Margin
EBITDA
EBITDA Margin
PAT
PAT Margin
328
248
76%
98
30%
47
14%
302
209
69%
83
27%
14
5%
YoY
9%
19%
700 bps
18%
300bps
236%
900 bps
4QFY25
338
234
69%
84
25%
33*
10%
QoQ
(3%)
6%
700 bps
17%
500 bps
42%
400bps
Result commentary ▪ ▪ Highest quarterly EBITDA at INR 98crs growing 18% YoY; EBITDA Margins at 30%
Revenue grew by 9% on YoY basis, driven by growth in our API and Biologics verticals
Revenue Break-up (INR crs)
Biologicals, 37.0
Others, 7.0 2%
11%
Formulation, 98.0
1Q FY26
30%
#API, 187.0
57%
# API revenue (including captive sales) recorded revenue of INR 226 crores
All numbers are rounded off to nearest one
*Adjusted to Exceptional Item (net of tax)
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Consolidated Performance
Revenues
EBITDA and Margins
(INR in Cr.)
30%
98
302
1QFY25
338
4QFY25
328
1QFY26
1QFY25
4QFY25
1QFY26
27%
83
25%
84
PBT and Margins
PAT and Margins
13%
43
15%
50
10%
29
14%
47
10%
33
5%
14
1QFY25
4QFY25*
1QFY26
1QFY25
4QFY25*
1QFY26
*Adjusted to Exceptional Item
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Financial Summary
ROCE
Gross Block (INR crs)
8%
6.2%
8.8%
9.1%
1.0%
2.0%
1,538
1,587
1,670
1,991
2,004
FY21
FY22
FY23
FY24
FY25
1QFY26*
FY22
FY23
FY24
FY25
1QFY26
Net Debt to EBITDA (x)
6.7
5.8
3.4
3
Net Capex (INR crs)
1.6
1.6
331
225
172
216
70
FY21
FY22
FY23
FY24
FY25
1QFY26*
FY22
FY23
FY24
FY25
1QFY26
Note: 1QFY26 numbers are on TTM basis*
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API Business
10
Multiple growth drivers with strong order book
223
13 2
99
109
181
4 12
74
91
226
17 7
86
116
Oncology
Non-Oncology
CDMO
Others
4QFY25
1QFY25
1QFY26
(INR in Cr.)
▪
1QFY26 Revenue growth (including captive) came in at ~25% YoY. All our key segments reported healthy growth driven by strong order book and higher captive commitments
▪ Newly increased capacities for key products viz. UDCA, Tranexamic Acid, Azacitidine, Palbociclib and Nilotinib to contribute materially in FY26
▪
▪
The large Polymer contract commenced commercial revenue this quarter, marking a key milestone
Expanding product portfolio with launches in multiple complex APIs and Specialty portfolio
▪ Added new clients in various geographies
* Incl Captive sales (INR crs)
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API – Ongoing Developments
API Molecules
CDMO
▪ Commercial-Scale Manufacturing Capacities commenced operations for High-Demand Products – UDCA, Tranexamic Acid, and key Onco molecules
▪ New product introductions, optimized
production scale, and strong captive demand is expected to deliver consistent growth momentum
▪ Completed validation for 2 new products
▪ Initiated de-bottlenecking in various blocks
▪ 2 programs expected to commercialize in FY27, NDA filed
▪ Secured a new contract for the supply of a high-value specialty
chemical to a global healthcare leader
▪ As a CDMO in NDA program, partner obtained Phase II clearance
for new indication with fast-track status
▪ New dedicated block for OLC expected to be commercialized in
FY26
▪ 25+ programs are ongoing in different phases of development for
our clients
Polymer and Peptide ▪ Commercial supplies started of large polymer project
worth ~USD 4mn received from a US MNC for non pharma applications. Sole supplier from India, with order value expected to increase going forward.
▪ Initiated development of specialty polymers for eye care in
collaboration with U.S.-based partner
▪ GLP 1 - Liraglutide DMF readied and Semaglutide - Process
Qualification expected to be completed in 1HFY26
▪ Initiated scale-up to commercial batches for peptide APIs
with CEP approval
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48
API – DMF Filings
36
24
22
17
14
11
12
USFDA
EU/EMEA
GCC & ROW
MFDS
Canada
Australia
China
PMDA Japan
Russia
8
NZ
12
Brazil
New product introduction and increase in geographical coverage replicated with 264 DMF filings with major regulatory authorities Successfully completed US FDA inspection of Unit 2 with zero observations; received EIR Unit 1 successfully completed ANVISA (Brazil) and COFEPRIS (Mexico) regulatory audits
12
Formulations Business
13
Pipeline monetization to drive growth
132
103
24
7
44
48
9
57
4 11
19
12
98
18
9
36
31
4
US
Europe
RoW
Domestic
Licensing/ Services
4QFY25
1QFY25
1QFY26
(INR in Cr.)
▪ All 3 approved and launched NDAs have limited competition. More NDAs will be filed in coming quarters
▪
▪
Launched our 2nd NDA viz. Bortezomib RTU Subcutaneous in US, scale up expected in FY26
Pemetrexed gaining market share in US, with profit share upside expected to materialize in coming quarters
▪ Our partner continues to gain market share for Nilotinib; order book for Nilotinib remains strong
▪
▪
▪
Launched Axitinib in EU region via partner
Received approval NorUDCA, India’s first‐in‐class therapy for NAFLD, revenue to start from 3QFY26
Strong order book as the underlying demand for the products remains healthy
14
FDF – Update on key assets
SMLNUD07 NorUDCA
SMLTDP08 Rotigotine
SMLTOP09
SMLODF010 Tadalafil Film
SMLINJ011
SMLTDP012
SMLOSD014
▪ Received historic approval for NorUDCA, India’s first‐in‐class therapy for NAFLD—making Shilpa the first company globally to obtain approval for NAFLD.
▪ To Launch NorUDCA tablets in India, while advancing global regulatory efforts to bring vital therapy to patients internationally
▪ Transdermal Patch for
treatment of Parkinson’s disease ▪ US Study dosing has
been completed with results expected in 2QFY26
▪ US Submission
planned Q3 FY26 ▪ Europe submission completed by our partner and expecting a limited competition launch in FY26
▪ Topical lotion for treatment of Androgenic Alopecia
▪ Phase II concluded
with data submitted to Indian regulators - Phase III to commence upon receiving authorization ▪ EU regulators
validated our clinical development approach through Scientific Advice, significantly de-risking our regulatory pathway
▪ First company to
secure EU approval for multiple strengths of tadalafil films under hybrid application
▪ Expected to launch in European market in FY26
▪ Long Acting Injection for prevention of Acute and Delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, radiotherapy and other associated medication. Market Size is ~USD 375 mn (Global)*
▪ Dosing in Phase III
clinical trials in India has been completed
▪ Received positive Scientific Advice responses from both EU and US (pre-IND) regulators, planning clinical study designs
▪ An innovative delivery platform offering enhanced compliance and steady plasma levels for Alzheimer’s patients
▪ A unique patient-
friendly formulation enabling early market access in underserved anticoagulation segments
▪ A once-weekly
▪ Targeting earlier
transdermal patch delivery system enhancing patient adherence, compliance and convenience
▪ Preliminary clinical trials initiated; full development to be completed by end of FY26
market access in the US market compared to the conventional formulation
▪ Targeting a ~USD 10+ bn U.S. branded market with our enhanced delivery platform
▪ Exhibit batches
completed and BE Studies planned
*Source: IQVIA – MAT-March 25 Note: Our project numbering does not include #13
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Filings – Formulations
Formulations – Regulatory Filings
Pending
Approved
30
17
13
US ANDA and NDA
81
74
7
EU
10
6
4
Canada
618
291
327
ROW
Robust regulatory filings to strengthen the base for growth in the formulation segment Our ODF & TDP manufacturing Unit 6 received EIR approval from US FDA and SFDA, Saudi Arabia
16
CDMO Business
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CDMO – Strong capabilities in various technologies
Shilpa Medicare
Peer 1
Peer 2
Peer 3
Global Peer 1
Global Peer 2
Global Peer 3
Very strong capability
Strong capability
Developing capability
Negligible capability
Indian CDMOs
Global CDMOs
Specialized technologies
Small molecule
Peptide
Monoclonal Antibodies and Recombinant technology
Antibody – Drug conjugates
Fermentation
Offerings
Development
Manufacturing
▪ Early phase to late phase from AI/ML led discovery (target to hit, hit to lead and lead to NCE) to custom synthesis, scale up and clinical materials (for advanced intermediates,
RSMs
▪ “Clone-to-vial" capabilities makes us a preferred one-stop outsourcing partner, securing strong market position ▪ Leveraging expertise to offer interconnected tech platform for various fast growing opportunities in the areas of fermentation, Antibody-Drug Conjugates (ADCs), and GLP-1 ▪ Leveraging exquisite strengths in complex chemistry across pharma and specialty chemicals. Integrated CMC approach for delivering drug substance and drug product to pharma
customers
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Robust business model encompassing various stages
Value chain stages
Development & Clinical supplies
Late stage development & Commercial Manufacturing
Phases
Pre-Clinical Development
Clinical development & Supplies
Registration
Commercial Manufacturing
▪ Drug metabolism, pharmacokinetics (DMPK)
▪ Phase 3 clinical trials
Key steps
▪ Toxicology studies (Safety studies)
▪ Manufacturing clinical supplies
▪ Phase 1 and 2 clinical trails
▪ Drug filing with regulatory authorities
▪ Drug substance manufacturing (RSM, intermediates, APIs) and formulation
Number of projects
25+
3
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Comprehensive CDMO Development
Long term manufacturing and supply agreement with SML.
SML is receiving significant milestone income spanning over various stages viz. filing, approval and launch of the product
Unicycive Therapeutics Inc’s Oxylanthanum Carbonate (OLC) is a Potential best-in-class product being developed under FDA’s 505(b)(2) regulatory pathway for the treatment of hyperphosphatemia
NDA accepted by the US FDA
Product Profile1 ▪ Potential best-in-class product for the treatment of Hyperphosphatemia ▪ Advantages: (1) Potency: Shares high phosphate binding capacity of
lanthanum; (2) Pill Burden: Smaller and fewer pills; (3) Palatability: swallowed whole with water and not chewed
1. Source: Unicycive Presentation
Building back-end to develop & manufacture both API & Formulation
▪ A comprehensive CDMO contract for both API and formulation
development – a One-stop-Solution
▪ Unicycive received a Complete Response Letter (CRL) from the FDA,
citing deficiencies related to a third-party drug product manufacturer (unaffiliated with Shilpa Group).
▪ In response, the Company has proactively qualified an alternative supplier that has already successfully produced OLC drug product batches. This vendor will support resolving the CMC issues outlined in the CRL
▪ Expect commercialization in FY27
20
Biologics & NBE
21
Biologics – Growth envisioned on 4 pillars
Biologics
Novel Biologics
Integrated CDMO @Dharwad
ADC Platform
▪ Novel MAB (oncology): Term
sheet signed with mAbTree; cell line received and process development underway. Targeting investigator-led trials by late FY26.
▪ Novel Live Biotherapeutic
Product (LBP) Development & manufacturing contract signed with Alveolus Bio
▪ Alveolus and mAbTree NBE
projects are expected to enter Phase I studies in FY27
▪ Albumin - Global clinical trial
protocol submitted, aligned with EMA guidance
▪ Adalimumab: India market sees
growth, 24-month shelf life approved (from 18). Filing in progress in 15 RoW markets, with approvals expected in FY26. RoW approvals expected in this quarter
▪ Aflibercept: Ophthalmic biologic with a global market size of ~USD 5 bn1 . Enters Phase III, targeting FY27 launch; Out-licensed to two partners in India and Russia, with active discussions in MENA region
▪ Nivolumab (USD 11 bn) 1, Small-scale
development completed; PCT completed, targeting clinical initiation in 4QFY26.
▪ Pembrolizumab (USD 33 bn) 1 small scale development completed and PCT in progress
▪ Daratumumab (USD 13 bn) 1 and Dupilumab (USD 21 bn) 1 cell line development initiated; PCT targeted in FY26
▪ Trastuzumab (USD 3 bn) 1 process
development completed
1. Global Market share, Source: IQVIA – MAT-June 24
▪ Five active Novel Biologic Entity (NBE) programs advancing for multiple partners
▪ Increase in number of RFQs received from various global biotech
▪ Shilpa’s First ADC biosimilar is expected to enter human studies in FY27
▪ Dual-capability platform in both small molecules and biologics manufacturing provides global pharma partners with unmatched integration, simplifying their supply chain and development needs
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Why Recombinant Human Albumin ?
Predictable & assured supply – Product in yeast (Pichia pastoris) by fermentation
All raw materials used in the production are free from animal sources
High quality/Purity Meets Global standards
Freedom from potential contamination sources – inherently free from HIV, HBV, HCV, Prion contamination
Best in class productivity – makes the product competitive in comparison to plasma Albumin
23
Shilpa’s Recombinant Human Albumin
Key highlights
Shilpa’s novel rHA (Recombinant Human Albumin)
Regulatory filing status
Addressing the global unmet need
IP Positioning
▪ Entered into a strategic partnership with Orion Corporation for commercialization in Europe region for therapeutic use ▪ Under this agreement, Orion will be the exclusive partner for the distribution, marketing, and sales of Shilpa’s
Recombinant Human Albumin for therapeutic use in Europe
▪ Shilpa is entitled to receive from Orion certain development and regulatory milestone payments ▪ Shilpa has been investing in the development of this novel product for about 8 years and has also set-up a large-scale
fermentation facility for manufacturing
▪ India – Initiating Ph3 trials in FY26
▪ EU – Initiating Ph3 trials in FY26
▪ US – Pre IND to be filed 2QFY26
▪ Non-Therapeutic - Samples shared with few clients in US
▪ Shilpa has developed recombinant Human Albumin (rHA)
▪ Targets to fulfil growing demand of human serum albumin
▪ All the raw materials used in manufacturing are animal origin free (AOF)
▪ Shilpa’s Recombinant Human Albumin production technology is covered by patents in developed markets viz. US &
Europe
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Outlook
FDF
CDMO
API
Biologics
NDA – Pemetrexed and Bortezomib
Hybrid – Nilotinib (limited competition), Axitinib & Rotigotine
NorUDCA – First-In-Class for NAFLD in India, followed by launches in RoW
Two NCE projects to commercialize in FY27
Two NBE projects expected to enter human studies in FY27
Multiple complex API launches, growth in Specialty portfolio, coupled with capacity expansion for existing key products to drive API growth
Strong Biosimilar pipeline with various large assets completing clinical trails, coupled with niche CDMO Biologic offerings to drive Biosimilar revenue growth in significant manner from late FY26
Recombinant Albumin
Licensing income
Impending Operating Leverage
Margin Improvement
Ph3 trials for India and Europe to start in FY26
Strategic tie up with Orion Corporation for therapeutic use
Non – Therapeutic usage is being explored
Various assets where licensing income was received are moving towards commercial long term supply agreements
Substantial portion of current gross block remains under utilized having spread across high margin divisions viz. Biosimilar, CDMO and NDDS
Improved utilization is likely to drive meaningful improvement in revenue and EBITDA margins
25
Manufacturing Capabilities – API & Biocare
API Unit I - Raichur
API Unit II - Raichur
Biocare - Kadechur
Capabilities
Onco, Non-Onco NCE, APIs, Peptide and Polymers, Manufacturing proficiencies at gram- to-multi kilo and ton scales
Capacities
• 11 mfg blocks (4 onco and 7 non-onco) • Total reactor capacity of 650 KL
• Manufacturing and R&D Centre • Small molecule development, Linker, GalNAc Chemistry, Asymmetric synthesis, Chiral Chemistry, Peptides, Polymers, Enzymes, Purification, RP-separations CDMO services
• 10 mfg blocks (5 onco and 5 non onco) • Total reactor capacity of 510 KL
Regulatory Accreditation
• US FDA • EU GMP • ANVISA • COFEPRIS • TGA
• PMDA • Russian – GMP • WHO-GMP • KFDA • TPD
• US FDA • EU GMP • ANVISA • COFEPRIS • TGA
• PMDA • Russian – GMP • TDP • WHO-GMP • KFDA
• Fully automated integrated facility with DCS
control system
• Filtration system for protein separation
• 200KL+ Fermentation capacity • Capacities ranging from 5 KL to 50 KL for
product vessels and 5 KL to 15 KL for buffer vessels
• Audit ready
26
Manufacturing Capabilities – Formulations & Biologics
Formulations - Jadcherla
Formulations - Bangalore
Biologics - Dharwad
Capabilities
OSD tablets and capsules; Injectables – dry powder and liquid lyophilization
Fully automated facility for Transdermal patches and Oral Thin Films
Capacities
Injectable - ~3mn Liquid Vials Lyophilized - ~2mn Vials OSD – 25mn Tablets Capsules – 4mn Hard Capsules
ODF - ~50mn Units TDF - ~30mn Units
End-to-end services, from development to commercial manufacturing of microbial & mammalian-based drug substance and drug products. Having expertise in complex technologies viz. ADC, peptides and conjugated proteins
Upstream – 4,000LX2 Microbial Suite – SS 1,000LX2 PFS – 80 units/min
Regulatory Accreditation
EU GMP, ANVISA, COFEPRIS, TGA, WHO-GMP, SHAPRA, Health Canada, GHC
US FDA, WHO-GMP, UK-MHRA, EU GMP, TGA, SFDA
• EU GMP, DSIR Approved facility
27
Financials
28
Profit & Loss Consolidated
Particulars (INR cr)
1QFY26
1QFY25
Revenues
Gross Profit
Gross Margin %
Employee Cost
Other Expenses
EBITDA
328
248
76%
82
68
98
302
209
69%
72
54
83
EBITDA Margin %
30%
27%
Finance Cost
Depreciation
PBT
PAT
19
29
50
47
24
27
29
14
YoY
9%
19%
14%
26%
18%
-21%
7%
72%
236%
4QFY25
QoQ
338
234
69%
71
79
84
25%
15
29
43*
33*
(3%)
6%
15%
-14%
17%
27%
-
16%
42%
* 4QFY25 PBT & PAT are adjusted to Exceptional item All numbers are rounded off to nearest one
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Earnings call Details
Shilpa Medicare 1QFY26 Results Conference Call to be held August 13, 2025, Wednesday at 17:00 IST
Details of Earnings Conference Call
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THANK YOU!
Shilpa Medicare Limited
Monish Shah
+91 2249748754
monish.shah@vbshilpa.com
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