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

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

11 August 2023

Corporate Relationship Department, BSE Limited, Phiroze Jeejeebhoy Towers, Dalal Street, Fort, Mumbai-400 001

Dear Sir/Ma’am,

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

Sub: Investor Presentation of the Company for the Quarter ended 30 June 2023 Ref: Disclosure under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements)

Regulations, 2015

With reference to the captioned subject, the Investor Presentation of the Company for the Quarter ended 30 June 2023 with regard to Business highlights, financial performance and other updates is attached herewith for your consideration.

We request you to take the same on record and disseminate it to stakeholders of the Company.

Thanking you.

Yours faithfully, For Shilpa Medicare Limited

Ritu Tiwary Company Secretary & Compliance Officer

Shilpa Medicare Limited (SML)

Q1 FY’24 Results Presentation

1

2

API Units, Raichur

Disclaimer

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.

Table of content

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1

Company overview

2

Financial performance

3

Business highlights

4

Annexures

Company Overview

4

Company Overview

5

Established presence in Active Pharmaceutical Ingredients (APIs) and Formulations for domestic & international markets

Pursuing niche growth businesses like Biologics, Transdermal & Oral Dissolving Films Formulations

Affordable & Effective Pharmaceutical Solutions

Robust research orientation resulting in innovative products

Very strong R&D background including development, pathway engineering and characterization of biologics

Best in class manufacturing and supply of high-quality affordable drugs

Managing Director’s Message

6

Commenting on Q1 FY’24 performance, Mr. Vishnukant Bhutada, Managing Director Shilpa Medicare Limited said

“I am pleased to inform you that our relentless efforts on bringing operational efficiencies and strengthening our business has resulted in us bouncing back to profitability this quarter.

On the back of the introduction of Pemetrexed RTU in EU market, we are preparing to launch the product in the US market in collaboration with our partner. Backed by an attractive portfolio we are gearing to scale up engagements through other notable products, which is visible in the licensing revenues that we are able to generate for our portfolio. Complex product like Nilotinib filing in the European market is a step in that direction.

Our CDMO business has been receiving positive responses from customers. Additionally, we are exploring the non-oncology API segment, which has high growth potential or can serve as an import substitute API. We are committed to facilitating the successful introduction of novel products within APIs and Formulations, ensuring predictable cash flows. Our new product offerings are on the brink of making tangible contributions through product commercialization; where we expect significant contribution to augment our overall margin profile. As previously mentioned, we are actively streamlining R&D expenditures and expediting the monetization process. By concentrating our efforts there, we aim to consistently lower R&D costs, resulting in substantial savings that will positively impact our cash flow. Without affecting the niche product developments"

On biological front, we have secured marketing authorization for High concentration Adalimumab in India which is a crucial step into the realm of our biological offerings, aimed at enhancing patient comfort in treating Rheumatoid Arthritis. Piggybacking on India approval, our strategy extends to tapping into various international markets with this product. I am happy to inform you that we have also commenced phase 1 trials for recombinant Albumin, which is a pivotal move for this niche opportunity. Our large-scale fermenting facility is under erection and we expect the same to be completed before march 2024.“

Formulation update - Oncology

7

o New Drug Application for Pemetrexed Injection 1000 mg/100 ml, 500 mg/50 ml & 100 mg/10 ml, Ready to Use

formulation approved by US FDA

 First NDA product approval under 505(b)(2) application  Unique formulation supplied as ready to use product solution  Administered intravenously without any further dilution with product being stable at room temperature  Product approval from a third party manufacturing site  Commercialization arrangement in place with Amneal Pharmaceuticals LLC for the US Market

• Plan to launch under J code program by Q4 2023 • US market size approximately USD 735.3 million according to IQVIA MAT Q1 2023

o Filed Nilotinib Capsules 50mg, 150mg and 200mg DCP procedure from RMS Germany

 Product filled for Europe market  Tentative expected launch in Q2 2024  Partnered with two customers for the European market  EU market approximately USD 418 million according to IQVIA MAT Q1 2023 data  US Pivotal study ongoing

Formulation update – Non Oncology

o Shilpa Medicare’s SMLNUD07 enters into Phase III studies

8

 Received approval from CDSCO for proceeding further for Phase III studies of oral product SMLNUD07

 Phase III studies have been initiated for the indication of NAFLD (Non-alcoholic fatty liver disease)

 Tentative completion of the study Q2/Q3 2024

 About NAFLD

• Most common liver disease and it is estimated to affect up to 15% of the population in World (approx. 1.2

billion)

− About 188 Million people suffer from develop NAFLD in India

• The main characteristic of NAFLD is excessive accumulation of fat in hepatocytes

• In first stage NAFLD is characterized by simple hepatic steatosis (NAFL, non-alcoholic fatty liver)

Formulation update – Oral Films and Patches

9

o First partnership deal inked with a Europe based company for Transdermal Patch (SMLTDP08)

 Product Development completed and pilot studies have also been completed

 Pivotal studies are planned in Q2/Q3 2023

 Filed for EMA scientific advice for its skin irritation study, post approval the study shall be conducted

 Product has been partnered with a MNC for Europe and Emerging markets

 According to IQVIA MAT Q1 2023 data, the EU market is approximately USD 243 Million

o Launched dietary supplements/ OTC products portfolio in the USA market through a marketing partner

 Products available in USA market on store (Walmart) as well as online shopping (Amazon)

• Vitamin D3 Quick Dissolving Oral Strips – Dietary Supplement

• Melatonin Quick Dissolving Oral Strips . – Dietary Supplement

• Methyl Cobalamin (Vitamin B12) Quick Dissolving Oral Strips – Dietary Supplement

• Simethicone Quick Dissolving Oral Strips – OTC

• Green Tea Dissolvable Strips to Drink – Dietary Supplement

Biosimilar update

o Approval of High Concentration Adalimumab injection in India market

10

 Received the Marketing Authorization permission for Adalimumab 40 mg/0.4mL injection in prefilled syringe (PFS), a

biosimilar of Adalimumab higher concentration formulation (100mg/mL) in India

 Used for the treatment of Rheumatoid Arthritis (moderate to severe active RA & severe active and progressive RA) for

which the phase 3 clinical trial have been successfully completed in Q3 2022

 Results in increased patient comfort based on reduced injection volume  Planned launch in Q2 2023  Signed licence agreement with one big Indian company for commercialization in India along with own brand

o Recombinant Albumin

 Phase I initiated for the product  Product has been granted NBE (New Biological Entity) status

o Aflibercept

 Phase III approval received from CDSCO and plan to initiate a Phase 3 clinical trial, marking a significant milestone in the

development

 Pivotal trial is a crucial step towards advancing our commitment to delivering safe and effective solutions for various eye

conditions

Financial Performance

11

Financial Performance – SML Standalone

12

(INR in Cr.)

Particulars Q1 FY24 Q4 FY23 % change Q1 FY23 % change Revenues104.586.820%73.542%Gross Margin85.161.538%63.933%Gross Margin %81%71%87% Employee Cost27.826.36%27.9-1%Other Expenses21.228.7-26%18.912%EBITDA36.16.617.1EBITDA %35%8%23%Finance Cost6.76.62%2.7154%Depreciation12.312.02%10.418%PBT17.1-12.04.1Execeptional Item-(Income)/Exp6.315.00.0PAT7.9 -28.9 3.9105%Balance Sheet – SML Standalone

13

(INR in Cr.)

Particulars30-Jun-2331-Mar-2330-Jun-22Fixed Assets 598.3608.9613.1Tangible Assets509.1517.0541.2Intangible Assets89.292.071.9Capital WIP230.5226.4242.9Tangible Assets38.741.853.0Intangible Assets191.8184.6189.8Slump Sale Consideration Receivable249.0316.0486.3Other Non-current Assets1122.81047.0900.7Net Working Capital233.8242.1244.8Current Assets300.7314.4315.1Cash and cash equivalents11.84.523.8Current Liabilities-78.7-76.8-94.1Total Assets ( Net)2434.32440.52487.7Equity2125.32117.52175.0Borrowings (Current & Non current)271.8287.4260.3Other Non Current Liabilities37.235.652.3Total Liabilities2434.32440.52487.7Financial Performance Consolidated

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(INR in Cr.)

Particulars Q1 FY24 Q4 FY23 % change Q1 FY23 % change Revenues262.1265.7-1%269.3-3%Gross Margin174.2176.3-1%165.35%Gross Margin %66%66%61% Employee Cost72.972.41%72.9Other Expenses51.563.5-19%63.8-19%EBITDA49.940.423%28.674%EBITDA %19%15%11%Finance Cost18.217.72%9.689%Depreciation26.725.74%22.419%PBT5.0-3.0-3.4PAT1.2-8.12.3-49%Balance Sheet Consolidated

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Particulars30-Jun-2331-Mar-2330-Jun-22Fixed Assets 1,371.61,368.31,372.9Tangible Assets1,163.71,179.51,201.2Intangible Assets208.0188.9171.6Capital WIP657.0655.3515.3Tangible Assets374.9358.0231.0Intangible Assets282.2297.3284.3Other Non-current Assets123.8110.7144.1Net Working Capital459.6492.0614.7Current Assets733.3746.7851.2Cash and cash equivalents32.821.348.9Current Liabilities-306.4-276.0-285.4Total Assets ( Net)2,612.02,626.62,646.9Equity1,772.71,774.41,815.1Borrowings (Current & Non current)789.0795.7755.0Other Non Current Liabilities50.356.376.8Total Liabilities2,612.02,626.62,646.9 Consolidated Business Highlights

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Q1 FY’24 Consolidated Performance

Revenue

-1%

-3%

266

262.1

269.3

17

(INR in Cr.)

24%

74%

EBIDTA

49.9

40.4

28.7

Q4 FY'23

Q1 FY'24

Q1 FY'24

Q4 FY'23

Q1 FY'24

Q1 FY'23

5.0

PBT*

PAT

1.2

2.3

Q4 FY'23

Q1 FY'24

Q1 FY'23

-3.0

-3.3

*Before share of loss in associates/JV’s

-8.1 Q4 FY'23

Q1 FY'24

Q1 FY'23

Consolidated Revenue Break-up – Q1 FY’24

Q4 FY’23 INR 266 Cr.

Q1 FY’24 INR 262.1 Cr.

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(INR in Cr.)

Q1 FY’23 INR 269.3 Cr.

22.1, 8%

56.1 , 21%

Degrowth of -3% vs Q1 FY’23

4.8, 2%

12.2 , 4%

68.8 , 26%

API

Formulatio n

187.2 , 71%

91.8 , 35%

165.6 , 63%

188.3 , 70%

Degrowth of -1.5% vs Q4 FY’23

19

API Business

20

(INR in Cr.)

CDMO/Service

-2%

118%

8.5

8.3

3.8

Q4 FY'23 Q1 FY'24 Q1 FY'23

API Business-Highlights Q1 FY’24

Oncology

-5%

-18%

84.6

80.6

98.7

Q4 FY'23 Q1 FY'24 Q1 FY'23

Non Oncology

-14%

30%

84.4

72.7

55.8

Q4 FY’23 187.3

Degrowth 12%

Q1 FY’24 165.6

Degrowth 12%

Q1 FY’23 188.3

Others

-59%

-87%

30.0

9.8

4.0

Q4 FY'23 Q1 FY'24 Q1 FY'23

Q4 FY'23 Q1 FY'24 Q1 FY'23

*Numbers are excluding captive consumptions

DMF Filing update New product introduction and increase in geographical coverage replicated with 232 number of DMF filings done with major regulatory authorities

21

60

50

40

30

20

10

0

51

45

35

21

20

17

12

10

12

7

2

US FDA

EU/ EMEA

GCC / ROW

MFDS

TPD-Canada

TGA

CHINA

PMD

RUSSIA

MEDSAFE

WHO

As on 30-June-23

22

Formulation Business

23

(INR in Cr.)

Formulation Business-Highlights Q1 FY’24

Europe

22%

-28%

37.4

22.0

26.8

Q4 FY'23 Q1 FY'24 Q1 FY'23

US

-69%

-65%

13.7

12.3

4.3

Q4 FY'23 Q1 FY'24 Q1 FY'23

License Fees/ 211% 264% PDC

ROW

-38%

53.1

14.6

17.1

Q4 FY'23 Q1 FY'24 Q1 FY'23

Q4 FY’23 56.8

Growth 62%

Q1 FY’24 91.8

Growth 33%

Q1 FY’23 68.8

1050%

3.7

2.3

0.2

Q4 FY'23 Q1 FY'24 Q1 FY'23

Domestic

83%

194%

5.3

2.9

1.8

Q4 FY'23 Q1 FY'24 Q1 FY'23

Regulatory Filings

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

24

Approved

Pending

26

12

14

US ANDA (SML)

As on 30-Jun-23

31

10

21

EU Filings

444

243

201

ROW

3

1

2 US NDA (SML)

Annexures

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Manufacturing Excellence

Dharwad

Jadcherla Unit

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• Biologicals Manufacturing plant & R&D

Facility

• Formulations (Onco & Adjuvant Therapy of

Onco – Injectable & Oral)

Bengaluru Unit

Hyderabad

• TDS & ODF Manufacturing Facility &

Formulation R&D

• Formulations (Oral Dissolving Films) • Bio Analytical Lab, Pharmacovigilance Lab &

Quality control lab

Raichur Unit I & II

Ahmedabad

• API (Oncology – Non-Oncology) • API (Oncology – Non-Oncology) and R&D

API • CRAMS • Peptide • Polymer

• CRO & CDMO • R&D Formulation

About Shilpa Medicare Ltd.

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Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1989 at Raichur, Karnataka- India. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.

Shilpa Medicare has been on path of expansion ever since its inception. With a regulatory recognized manufacturing set up and excellent scientific expert team in place, Shilpa Medicare has since been on a steady growth path. Currently they are one of the leaders in the Oncology market and offer a complete range of products in this segment spanning to consolidate in field of across APIs, Oncology, API and formulations, they are striving to put in efforts in field of novel drug delivery systems and biotech products along with widening their focus to other therapy areas. Where Shilpa Medicare Ltd is today is the result of their constant endeavors for more than three decades.

formulations both in terms of R&D and manufacturing capabilities. Further

Siddharth Rangnekar Mit Shah

CDR India

+91 22 6645 1209 / 1217

siddharth@cdr-india.com mit@cdr-india.com

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Thank You