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
10 November 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 September 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 & Half year ended 30 September 2023 on Business highlights, financial performance and other updates is enclosed herewith for your consideration.
We request you to take the same on record.
Thanking you.
Yours faithfully, For Shilpa Medicare Limited
Ritu Tiwary Company Secretary & Compliance Officer
Shilpa Medicare Limited (SML)
Q2 & H1 FY24 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 Q2 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 is getting reflected in continuous improvement in our performance quarter after quarter. On the regulatory front, we have received approval for Betahistine Oral dispersible film for the UK market – our first product approval from our Bangalore Oral films plant and various other products are under filling. We have also received 3 product approvals for the Mexican market including the first generic approval of Axitinib. The launches in Mexico are planned in coming quarters.
Our Jadcherla facility recently received UAE GMP approval, Australia GMP approval and ANVISA Brazil approval with Nil observations. We have also concluded USFDA “for cause” inspection of our facility on 9th November with 10 observations. I would like to inform you that none of the observations relate to ‘data integrity’ or has been listed as ‘repeat observation’.
For API business, we have successfully completed PMDA Japan regulatory audit without any major or critical observations for our API facility. Our CDMO business has been receiving positive responses from customers and is on growing path. Additionally, in the non-oncology API segment we are exploring products which have high growth potential or can serve as an import substitute.
As an organization we are committed to facilitating successful introduction of novel products within APIs and Formulations, ensuring predictable cash flows. As previously mentioned, we are actively streamlining our R&D spends 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 launched High concentration Adalimumab in India under the brand name “ORIADALI™” 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 and launch, 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 by March 2024”.
Formulation update - Topical
7
Topical Lotion (SMLTOP09) for the Treatment of Androgenic Alopecia
▪ Phase II trial completed
▪ Phase III will be planned to be initiated in Q3 FY24
▪ Covered by granted patents in India, USA, China, Japan, Korea till June 2038
▪ Patent pending in Europe
▪ The global alopecia market is valued at $8.2 billion in 2022 and is expected to grow at the CAGR of 9% from 2023 to 2030
▪ Alopecia Disease Types:
Disease Subtype Alopecia Areata Androgenic Alopecia Cicatricial Alopecia, Traction Alopecia Alopecia Totalis, Alopecia Universalis And others
% of Market 34.3% 31.1%
Value in $billion (2022) $2.8 billion $2.5 billion
34.5%
$2.8 billion
▪ Scientific advice for EU successfully submitted and awaiting feedback in Q4 FY24
Formulation update – Non Oncology
8
SMLNUD07 :
▪ 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 Q1/Q2 FY25
▪ 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
Betahistine Dihydrochloride Orodispersible Films, 24 mg
▪ First company to receive approval for the 24 mg strength as a Film formulation in the UK
▪ Approval is a hybrid product application, which is bioequivalent to the reference product
▪ Indicated for the treatment of vertigo, tinnitus, hearing loss and nausea associated with Meniere’s syndrome
▪ Available in the form of tablets and oral liquid dosage forms in various strengths across UK, Europe
▪ The ODF formulation offers benefits with respect to patient compliance and ease of administration
▪ Approval from own manufacturing facility at Dabaspet, Bengaluru
Biosimilar update
Launch of High Concentration Adalimumab injection in India
10
▪ Used for the treatment of Rheumatoid Arthritis (moderate to severe active RA & severe active and progressive RA)
▪ Increased patient comfort based on reduced injection volume
▪ Launched Adalimumab under Shilpa own brand (“Oriadali™”) in Aug 2023
▪ Other marketing partner expected to launch in Q3 FY24
Recombinant Albumin
▪ Phase I initiated for the product
▪ Product has been granted NBE(New Biological Entity) status
Aflibercept
▪ Phase III approval received from CDSCO and plans to initiate a Phase 3 clinical trial in Q3FY24
CDMO
▪ First CDMO project for microbial fermentation from a client for the Korea Market
Financial Performance
11
Financial Performance – SML Standalone
12
(INR in Cr.)
Particulars Q2 FY24 Q1 FY24 % change Q2 FY23 % change Revenues97.4104.5-7%86.812%Gross Margin78.784.9-7%54.146%Gross Margin %81%81%0%62%30%Employee Cost26.327.8-5%29.6-11%Other Expenses22.421.07%30.8-27%EBITDA30.036.1-17%-6.4570%EBITDA %31%35%-7%Finance Cost5.26.8-23%4.95%Depreciation12.712.33%11.96%PBT12.217.1-29%-23.2153%Execeptional Item-(Income)/Exp0.26.3-97%0.6-64%PAT6.67.9-16%-17.2 Balance Sheet – SML Standalone
13
(INR in Cr.)
Particulars30-Sep-2330-Jun-2330-Sep-22Fixed Assets 598.9598.3603.0Tangible Assets512.5509.1529.8Intangible Assets86.489.273.2Capital WIP227.4230.5251.5Tangible Assets27.138.754.1Intangible Assets200.3191.8197.4Slump Sale Consideration Receivable0.0249.0435.3Other Non-current Assets1188.81122.8960.7Net Working Capital260.7228.8251.1Current Assets329.6300.7305.6Cash and cash equivalents6.711.836.4Current Liabilities -75.6 -83.7-90.9Total Assets ( Net)2275.82429.42501.7Equity2131.92125.32148.5Borrowings (Current & Non current)108.5271.8312.1Other Non Current Liabilities35.432.341.2Total Liabilities2275.82429.42501.7 Financial Performance Consolidated
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(INR in Cr.)
Particulars Q2 FY24 Q1 FY24 % change Q2 FY23 % change Revenues314.8262.120%267.318%Gross Margin189.0173.99%150.825%Gross Margin %60%66%56% Employee Cost73.172.90%73.6Other Expenses53.851.25%60.7-11%EBITDA62.149.825%16.5275.7EBITDA %20%19%6%Finance Cost23.218.228%13.572%Depreciation27.826.74%23.319%PBT11.15.0124%-20.2-155%PAT1.61.237%-18.6-109% Balance Sheet Consolidated
15
(INR in Cr.)
Particulars30-Sep-2330-Jun-2330-Sep-22Fixed Assets 1,361.01,371.61,353.7Tangible Assets1,160.01,163.71181.8Intangible Assets201.0208.0171.9Capital WIP681.2657.1602.9Tangible Assets389.1377.7302.3Intangible Assets292.1279.3300.6Other Non-current Assets136.8123.8117.3Net Working Capital501.6454.8587.6Current Assets801.4732.0851.7Cash and cash equivalents23.733.057.2Current Liabilities-323.5-310.2-321.3Total Assets ( Net)2,680.52,607.22,661.5Equity1,774.61,772.91787.9Borrowings (Current & Non current)863.5789.0800.9Other Non Current Liabilities42.445.372.8Total Liabilities2,680.52,607.22,661.5 Consolidated Business Highlights
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H1 FY 24 Consolidated Performance
Revenue
18%
20%
262.1 314.8 267.3
Q1 FY'24 Q2 FY'24 Q2 FY'23
8%
577.0
536.5
H1'24 H1'23
17
(INR in Cr.)
274%
24%
62.1
49.9
EBIDTA
148%
112.0
16.6
45.2
Q1 FY'24 Q2 FY'24 Q2 FY'23
H1'24
H1'23
H1 FY 24 Consolidated Performance
122%
11.1
5.0
PBT
16.1
18
(INR in Cr.)
33%
1.2
1.6
PAT
2.8
-20.2 Q1 FY'24 Q2 FY'24 Q2 FY'23
H1'24
-23.5 H1'23
-18.6 Q1 FY'24 Q2 FY'24 Q2 FY'23
H1'24
-17.8 H1'23
❖ PBT excluding share of loss in JV/Associates ❖ Excluding exceptional items
Consolidated Revenue Break-up – Q2 24
Q1 FY’24 INR 262.1 Cr.
Q2 FY’24 INR 314.8 Cr.
19
(INR in Cr.)
Q2 FY’23 INR 267.3 Cr.
4.8, 2%
9.0, 3%
91.8 , 35%
165.6 , 63%
85.7 , 27%
Growth of 18% vs Q2 FY’24
4.9, 2%
API
Formulation
Others
70.1, 26%
220.1 , 70%
192.3, 72%
Growth of 20% vs Q1 FY’24
Consolidated Revenue Break-up – H1 FY 24
20
(INR in Cr.)
H1’24
INR 576.9 Cr.
4.9, 1%
186.4 , 32%
385.7 , 67%
138.9, 26%
8% Growth
H1’23 INR 536.6 Cr.
20.9, 4%
376.8, 70%
API Formulation Others
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API Business
API Business-Highlights Q2 FY 24
Oncology
42%
16%
114.2
98.5
80.6
Q1 FY'24 Q2 FY'24 Q2 FY'23
Non Oncology
23%
14%
72.7
89.8
78.7
Q1 FY'24 Q2 FY'24 Q2 FY'23
*Numbers are excluding captive consumptions
22
(INR in Cr.)
CDMO/Service
-3%
48%
8.3
8.0
5.4
Q1 FY'24 Q2 FY'24 Q2 FY'23
Q1 FY’24 165.6
gwth 33%
Q2 FY’24 220.4
gwth 14.6%
Q2 FY’23 192.3
Others
108%
4.0
-14%
9.7
8.3
Q1 FY'24 Q2 FY'24 Q2 FY'23
API Business-Highlights H1 FY 24
Oncology
CDMO/Service
23
(INR in Cr.)
-1%
197.2
194.7
H1'24
H1'23
Non Oncology
21%
162.4
134.5
H1'24
H1'23
*Numbers are excluding captive consumptions
57%
16.3
10.4
H1'24
H1'23
-65%
34.7
12.3
H1'24
H1'23
Others
H1’24 385.7
Gwth 2%
H1’23 376.8
DMF Filing update
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New product introduction and increase in geographical coverage replicated with 237 number of DMF filings done with major regulatory authorities
70
60
50
40
30
20
10
0
45
28
20
61
2
24
22
17
10
8
US FDA
EU/ EMEA
TPD-Canada
PMDA-Japan
TGA
MEDSAFE-NZ
EDQM
KFDA Korea GCC & ROW
WHO
As on 30th September 2023
25
Formulation Business
Formulation Business- Highlights Q2 FY 24
Europe
-15%
-14%
26.8
26.5
22.8
License Fees/
-53%-38% 558%
ROW
70%
53.1
32.9
-51%
8.0
5.0
2.3
3.9
Q1 FY'24 Q2 FY'24 Q2 FY'23
Q1 FY'24 Q2 FY'24 Q2 FY'23
Q1 FY'24 Q2 FY'24 Q2 FY'23
26
(INR in Cr.)
US
402%
-16%
21.6
25.7
4.3
Q1 FY’24 91.8
Degwth 7%
Q2 FY’24 85.7
Gwth 21%
Q2 FY’23 70.6
Domestic
-15%
-17%
5.3
4.5
5.4
Q1 FY'24 Q2 FY'24 Q2 FY'23
Q1 FY'24 Q2 FY'24 Q2 FY'23
Formulation Business-Highlights H1 FY 24
Europe
License Fees
-36%289%
ROW
-22%
86.0
49.6
63.9
22.1
H1'24
H1'23
27
(INR in Cr.)
-24%
8.2
6.2
H1'24
H1'23
H1'24
H1'23
US
-32%
38.0
25.9
H1'24
H1'23
H1’24 177.5
Gwth 26%
H1’23 140.9
Domestic
13%
9.8
8.7
H1'24
H1'23
Regulatory Filings
Robust regulatory filings to strength the base for growth in the formulation segment
Approved
Pending
28
26
12
14
US ANDA (SML)
As on 30th September 2023
3
1
2 US NDA (SML)
65
22
43
EU Filings
446
236
210
ROW
Annexures
29
Manufacturing Excellence
Dharwad
Jadcherla Unit
30
• 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
32
Thank You