SHILPAMEDNSE10 February 2025

Shilpa Medicare Limited has informed the Exchange about Investor Presentation

Shilpa Medicare Limited

~ I Innovating for ~ affordable healthcare

Date: 10 February, 2025

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

To Corporate Relationship Department BSE Limited, 1st Floor, Rotunda Building, P.J. Towers, Dalal Street, Mumbai – 400 001.

To National Stock Exchange of India Limited Exchange Plaza, 5th Floor, Plot No.C/1, G Block Bandra Kurla Complex, Bandra (E) Mumbai – 400 051.

Scrip Code: BSE - 530549/ Stock Symbol: NSE – SHILPAMED

Dear Sir/Madam,

Sub: Investor Presentation of the Company for the quarter ended 31 December, 2024 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 31 December, 2024, on Company Overview, Business highlights, financial performance and other updates is enclosed herewith for your consideration.

This is for your information and necessary records.

For Shilpa Medicare Limited,

Ritu Tiwary Company Secretary & Compliance Officer

~ I Innovating for

. . affordable healthcare

Shilpa Medicare Ltd Shilpa Medicare Ltd 3QFY25 Earnings Presentation

Date: 10th Feb 2025

Safe Harbour

~ ~ -

•

I Innovating for affordable healthcare

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.

Shilpa Medicare at a glance

Established in 1987, we have 35+ years track record

L . . I Innovating for ~ affordable healthcare

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 30+ countries

9MFY25 Financials

Revenue INR 971 crores (+12% YoY) EBITDA INR 256 crores (+42% YoY)

Key operating verticals

API

Formulations

Biologics

9MFY25 Revenue contribution

58%

35%

Legal Entities

Areas of Operation

▪ Shilpa Pharma Lifesciences

▪ Oncology ▪ Non-Oncology ▪ HpAPI ▪ 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

API Includes others

CDMO – Strong capabilities in various technologies

L . . I Innovating for ~ affordable healthcare

Very strong capability

•

Strong capability

•

Developing capability

Indian CDMOs

Negligible capability

Global CDMOs

Shilpa Medicare

Peer 1

Peer 2

Peer 3

Global Peer 1

Global Peer 2

Global Peer 3

----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

•

• • • • • • • • •

• •

• • •

• • • •

• •

• • •

• • • • • • • •

Monoclonal Antibodies and Recombinant technology

Cell and Gene therapy

Shilpa’s CDMO offerings are a One – Stop – Shop covering various aspects including Biologics

Specialized technologies

HpAPI

Peptide

Flow chemistry

Antibody – Drug conjugates

PROTACs (Protein Degraders)

Fermentation

Small molecules

Discovery

Development

Manufacturing

Biologics/Large molecules

• • • • • • • • • • •

3Q & 9MFY25 Performance

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Management Commentary

.L... I Innovating for ~ affordable healthcare Our 3QFY25 performance reflects robust growth in profitability driven by improved business mix. The quarter witnessed healthy YoY growth in our key verticals of FDF & Biologics, which was partially offset by muted API performance.

As we focus on achieving significant milestones in all our verticals, our efforts remain towards monetizing existing key assets. During the quarter we have launched Nilotinib in EU region where we are a sole generic, on the Biologics front we have initiated Ph3 trials for Aflibercept, and we have initiated commercial launch quantities for OLC – a US CDMO opportunity. I am also highly optimistic on receiving approval for our NCE – NorUDCA in this financial year.

With positive traction on our new product launches in coming quarters I am confident of delivering strong revenue growth in each business vertical.

Going forward, our focus remains on scaling up API business, launch of approved NDAs in regulated markets and getting timely approvals on filed products. We continue to invest in future pipeline as well as focusing on resolutions on the regulatory front.

— Mr. Vishnukant Bhutada Managing Director

3Q FY25 – Financial Performance

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3Q FY25 (Consolidated)

Particulars (INR cr)

3QFY25

3QFY24

Total Revenue

Gross Profit

GP Margin

EBITDA

EBITDA Margin

PAT

PAT Margin

320

229

72%

26%

10%

289

192

67%

24%

YoY

11%

19%

500 bps

20%

200bps

588%

800 bps

Revenue Break-up (INR in cr.)

2QFY25

QoQ

349

227

65%

26%

-8%

700 bps

Formulation, 117.9

-10%

76%

500 bps

Biologicals, 18.3

Others, 1.0

Q3 FY25

37%

API, 183.2

57%

Revenue growth came in at 11% on YoY basis, driven by healthy performance in our fast-growing verticals viz. FDF and Biologics.

Result commentary ▪ ▪ Gross margins for the quarter came in at 72%, driven by healthy product mix ▪

PAT at INR 32crs showed a robust growth of ~588% YoY

All numbers are rounded off to nearest one

9M FY25 – Financial Performance

L . . I Innovating for ~ affordable healthcare

9M FY25 (Consolidated)

Revenue Break-up (INR in cr.)

Particulars (INR cr)

9MFY25

9MFY24

YoY (%)

Total Revenue

Gross Profit

GP Margin

EBITDA

EBITDA Margin

PAT

PAT Margin

971

665

69%

256

26%

866

555

64%

180

21%

12%

20%

500bps

42%

500bps

760%

600bps

Biologicals, 64.4

Others, 18.3

9MFY25

Formulation, 340.2

35%

API, 548.3

56%

Revenue growth came in at 12% on YoY basis, driven by healthy performance across our key verticals.

Result commentary ▪ ▪ Gross margins continue to improve at 69%, driven by better product mix ▪ ▪

EBITDA for 9MFY25 at INR 256crs is higher than the EBITDA of FY24, with EBITDA Margins of ~26% PAT stood INR 64crs, has nearly doubled of FY24 PAT of INR 32crs

All numbers are rounded off to nearest one

Consolidated Performance

L . . I Innovating for ~ affordable healthcare

(INR in Cr.)

Revenues

EBITDA and Margins

24%

26%

256

21%

180

289

349

320

866

971

3QFY24

2QFY25

3QFY25

9MFY24

9MFY25

3QFY24

2QFY25

3QFY25

9MFY24

9MFY25

PBT and Margins

13%

11%

107

PAT and Margins

10%

1.0%

3QFY24

2QFY25

3QFY25

9MFY24

9MFY25

Q3FY24

Q2FY25

Q3FY25

9MFY24

9MFY25

Financial Summary

L . . I Innovating for ~ affordable healthcare

ROCE

Gross Block (INR crs)

1,256

1,538

1,587

1,670

1,765

FY21

FY22

FY23

FY24

9MFY25*

FY21

FY22

FY23

FY24

9MFY25

Net Debt to EBITDA (x)

Capex (INR crs)

6.7

5.8

3.4

1.9

349

331

225

172

173

FY21

FY22

FY23

FY24

9MFY25*

FY21

FY22

FY23

FY24

9MFY25

Note: 9MFY25 Annualized *

API Business

L . . I Innovating for ~ affordable healthcare

API – Muted growth; order book remains healthy

L . . I Innovating for ~ affordable healthcare

203

194

182

■

Oncology

■

Non-Oncology

■

CDMO

■

Others

589

13 36

256

284

■

Oncology Non-Oncology

■

548

223

250

■

CDMO Others ■

3QFY24

2QFY25

3QFY25

9MFY24

9MFY25

▪

(INR in Cr.)

3QFY25 Revenue remained muted on account of lumpiness in client buying pattern.

Completed capacity expansion for key products viz. UDCA, Tranexamic Acid, Palbociclib and Nilotinib. Likely to drive incremental growth from 1QFY26 onwards

Expanding product portfolio with launches in multiple complex APIs and Specialty portfolio

▪ Added new clients in

various geographies

API – Ongoing Developments

API Molecules

CDMO

▪ Increased capacity for key products viz. Nor

UDCA, Palbociclib and Nilotinib. Commercialized expanded capacities of Tranexamic Acid

▪ Non-Infringing API of Nilotinib and Axitinib

approved in EU market

▪ CEP filed for Methotrexate – an import substitute

molecule

▪ Olaparib validation is expected to be complete in

4QFY25

▪ Successfully completed Mexican regulatory

authority audit for both units, for 7 products.

▪ Successfully Completed Phase II supply for a multi-step complex chemistry project, offering One-Stop-Solution for drug substance and drug product development for US client.

▪ Commenced commercial production for launch quantities of OLC

▪ Started plant scaleup of 2 ongoing CDMO programs.

▪ In our ongoing NDA program, where we serve as our partner’s

CDMO, has been given fast track classification

▪ Increase in number of RFQs received from various global biotech

companies

API – DMF Filings

Polymer and Peptide ▪ 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.

▪ Developed a process for synthesizing polymer with

varying molecular weights, widely used in biomedical applications, including drug delivery and tissue engineering

▪ GLP 1 - Liraglutide dossier readied by 4QFY25 and Semaglutide plant scaleup planned in 1QFY26.

USFDA

EU/EMEA

GCC & ROW

MFDS

Canada

Australia

China

PMDA Japan

Russia

New product introduction and increase in geographical coverage replicated with 246 DMF filings with major regulatory authorities

Formulations Business

L . . I Innovating for ~ affordable healthcare

New product launches drive FDF revenue growth

6 9

120

118

250

116

15 24

341

166

■

Europe

■

RoW Domestic ■

■

Licensing/ Services

■

Europe

■

RoW Domestic ■

■

Licensing/Services

3QFY24

2QFY25

3QFY25

9MFY24

9MFY25

L . . I Innovating for ~ affordable healthcare

(INR in Cr.)

▪

For the quarter, the division reported robust revenue growth of 64% on YoY basis

▪ Nilotinib Launch in EU region drove strong EU growth

▪

Received approval of our first ODF in EU region

Scale up in pemetrexed on expected lines. Faster pick up expected in FY26

Submitted remediation work with the US FDA for re- inspection of Jadcherla Unit

3 approved NDAs have limited competition. More NDAs will be filed in coming quarters

FDF – Update on key assets

L . . I Innovating for ~ affordable healthcare

NorUDCA SMLNUD07

▪ Phase III Studies for NAFLD completed and dossier submitted to Indian regulatory body

▪ Approval expected in FY25, with launch planned in 1HFY26. The product will be first NCE launch for NAFLD disease treatment for company.

SMLTDP08

SMLTOP09

SMLODF010

SMLINJ011

ODF & TDS

▪ Transdermal Patch for treatment of Parkinson’s disease ▪ US Study planned to initiate in 4QFY25 ▪ Europe submission completed in 2Q FY25 by our partner and expecting a limited competition launch in FY26.

▪ Topical lotion for treatment of Androgenic Alopecia ▪ Phase II completed and submitted to Indian regulatory body; Phase III study to start post approval

▪ EU Scientific advice

filed.

▪ European market

▪ Injection for

▪ Two new transdermal

launch expected in FY26

▪ Clinical trials for US will be initiated in 4QFY25

patch product development completed. Initiating human pilot study in 4QFY25 for our EU partner. The product is complex and uniquely positioned with no generic expected.

▪ Tadalafil ODF approved

in EU market and expected to launch in FY26

prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, radiotherapy and other associated medication. Market Size is ~$931 mn (Global)

▪ Phase I study

completed; Approval received for initiating Phase III studies

▪ EU Scientific advise filed; US Pre-IND filed and expect response in 4QFY25

*Source: IQVIA – MAT-June 24

Filings – Formulations

L . . I Innovating for ~ affordable healthcare

Formulations – Regulatory Filings

■

Pending

■

Approved

US ANDA and NDA

524

270

254

ROW

Robust regulatory filings to strengthen the base for growth in the formulation segment

As on 31st Dec 2024

Comprehensive CDMO Development Needs to be updated

L . . I Innovating for ~ affordable healthcare

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

:EliE: UnlCVCIVE

THERAPEUT I CS INC

NDA accepted by the US FDA with potential approval FY26

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

Binding purchase order for supply of OLC tablets by 1QFY26; Additional tablets to be delivered from 3QFY26 onwards

Building back-end to develop & manufacture both API & Formulation

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

▪ A comprehensive CDMO contract for both API and formulation

development – a One-stop-Solution

▪ Initial launch quantities to be delivered in 1QFY26 ▪ Unicycive announced successful trial results and FDA acceptance of its New Drug Application for OLC, with a target decision date of June 28, 2025, potentially easing treatment for hyperphosphatemia in CKD dialysis patients.

1. Source: Unicycive Presentation

Biologics

L . . I Innovating for ~ affordable healthcare

Biologics – Growth envisioned on 4 pillars

.£.... I Innovating for ~ affordable healthcare

Biologics

Novel Biologics

Integrated CDMO @Dharwad

Additional Products

▪ Adalimumab: India market growth based on approval of additional indications (Crohn’s disease and Ulcerative colitis in adults) from Indian agency

▪ Aflibercept: Ophthalmic biologic with

a global market size of ~$9 bn1 initiated into ph3. Expected launch in FY26. Two other Indian players (vial only) at launch.

▪ Albumin India: Permission for

▪ 3 CDMO projects in

India Phase III study received, trial starting in 1QFY26.

pharmaceutical segment are ongoing.

▪ Albumin Global: EU scientific advice for ph3 filed, expected feedback by 4QFY25; US advice to be filed subsequently, with feedback expected by 1HFY26.

▪ NBE asset in-licensing

opportunities under evaluation

▪ 1 large microbial-based project under advanced discussions. ▪ 1 New project in food sector

signed in Dec 2024. ▪ Extensive BD efforts are

planned for expanding business in this segment.

▪ Nivolumab ~($10 bn)1 ,

Pembrolizumab ~($26 bn)1 , Abatacept ~($4 bn)1 R&D initiated, PCT planned for all in 4QFY25 and target to start human studies in FY26. ▪ Wave 2 portfolio - 3 new

blockbusters added and PCT planned 2025-26. ▪ With this there are 6

biosimilars in total at various stages of development and pipeline, having multi billion dollars of cumulative market size.

1. Global Market share, Source: IQVIA – MAT-June 24

Outlook FY26 and beyond

L . . I Innovating for ~ affordable healthcare

FDF 6 key products (NDA- Pemetrexed, NDA – Bortezomib, Nilotinib, Axitinib, Rotigotine and NorUDCA) launches/Scale up to drive revenue materially

CDMO Commercial launch of OLC in US to kick start significant revenue from CDMO division

API Multiple complex API launches, growth in Specialty portfolio, coupled with capacity expansion for existing key products to drive API growth

Biologics Strong Biosimilar pipeline with various large assets completing clinical trails, coupled with niche CDMO Biologic offerings to drive Biosimilar revenue growth from late FY26 in a significant manner

Recombinant Albumin The product has moved to Ph3 trials for India and filed for EU advice on Ph3 trials. The non – therapeutic usage is also being explored with large vol clients

Licensing income Various assets where licensing income was received are moving towards commercial long term supply agreements

Impending Operating Leverage Substantial portion of current gross block remains under utilized having spread across high margin divisions viz. Biosimilar, CDMO and NDDS

Margin Improvement Improved utilization is likely to drive meaningful improvement in revenue and EBITDA margins

R&D Capabilities

R&D Spend (INR crs)

FY22

FY21

API

Biologicals

Formulation

Total

No. of Scientists

FY23

FY24

9MFY25

Regulatory Filings

246

524

780

400+

R&D Spend

% to sales

L . . I Innovating for ~ affordable healthcare

▪ 5 R&D sites across major cities in India

▪ Carefully crafted IP strategy for patent

challenges and 505(b)(2) filings

▪ API - Developed capabilities in peptide,

specialty and bio polymers manufacturing

▪ FDF- Differentiated Portfolio comprising of Onco and Non-Onco 505(b)(2) products. With key focus on ease of administration

▪ Developed products in difficult to

manufacture dosage forms viz. ODF & TDF

▪ Biosimilar – Capabilities to design and develop complex biologics with speed, quality, and innovation

▪ Developed molecule viz.

recombinant human albumin, an NBE, biosimilars product as well as vaccines ▪ Clone-to-Vial capabilities ▪ End-to-end biologics CDMO services for

drug substances (mammalian and microbial) and drug products

▪ Capabilities in high density fermentation

process development.

Manufacturing Capabilities – API & Biocare

L . . I Innovating for ~ affordable healthcare

API Unit 1 - Raichur

API Unit 2 - Raichur

Biocare - Kadechur

Capabilities

Onco, Non-Onco APIs and peptide, having competence for gram-to-kilo scale synthesis

Isolation, purification, separation techniques.

• • Asymmetric synthesis. • Chiral technology. • CDMO

• Fully automated integrated facility with DCS

control system

• Filtration system for protein separation

Capacities

• 11 mfg blocks (4 onco and 7 non-onco) • Total reactor capacity of 650 KL

• 10 mfg blocks (5 onco and 5 non onco) • Total reactor capacity of 510 KL

Regulatory Accreditation

• USFDA • EUGMP • TGA • PMFDA • KFDA

• WHO-GMP • TPD

• USFDA • EUGMP • TGA • PMFDA • KFDA

• 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

Manufacturing Capabilities – Formulations & Biologics

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I Innovating for affordable healthcare

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

Regulatory Accreditation

EU GMP, ANVISA, COFEPRIS, TGA, WHO-GMP, SHAPRA, Health Canada

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 – 4000LX2 Microbial Suite – SS 1000LX2 PFS – 80 units/min

WHO-GMP, UK-MHRA

• DSIR Approved facility

Financials

L . . I Innovating for ~ affordable healthcare

Profit & Loss Consolidated

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Particulars (INR cr)

3Q FY25

3Q FY24

YoY

2Q FY25

QoQ

9M FY25

9M FY24

Revenues

Gross Profit

Gross Margin %

Employee Cost

Other Expenses

EBITDA

320

229

72%

289

192

67%

EBITDA Margin %

26%

24%

Finance Cost

Depreciation

PBT

PAT

11%

19%

35%

20%

-55%

349

227

65%

26%

-8%

-4%

24%

-10%

-54%

971

665

69%

222

188

256

26%

107

866

555

64%

215

160

180

21%

All numbers are rounded off to nearest one

YoY

12%

20%

17%

42%

-10%

Earnings call Details

L . . I Innovating for ~ affordable healthcare

Shilpa Medicare 3Q and 9MFY25 Results Conference Call to be held February 11, 2025, Tuesday at 11:00 AM

Details of Earnings Conference Call

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18667462133 08081011573 8001012045 800964448

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THANK YOU!

~ \ Innovating for ~ affordable healthcare

Shilpa Medicare

Monish Shah

0 rn

+91 2249748754

monish.shah@vbshilpa.com

Ernst & Young IR

Runjhun Jain/Sneha Salian

0 rn

+91 98207 20993 / +91 98194 30437

runjhun.jain1@in.ey.com / sneha2.salian@in.ey.com

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