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
10 February 2022
National Stock Exchange of India Limited, Exchange Plaza, 5th Floor, Plot No. C/1, G Block, Bandra Kurla Complex, Bandra (E), Mumbai-400 051
Corporate Relationship Department, BSE Limited, Phiroze Jeejeebhoy Towers, Dalal Street, Fort, Mumbai-400 001
Dear Sir/Ma’am,
Sub: Investor Presentation of the Company for the Quarter ended 31 December 2021
Ref.: Disclosure under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements)
Regulations, 2015
Scrip Code: BSE - 530549/Stock Symbol: NSE – SHILPAMED
We wish to inform you that Investor Presentation of the Company for the Quarter ended 31 December 2021 with regard to financial performance, discussion on Business and other updates is attached herewith.
We request you to take the same on record.
Thanking you.
Yours faithfully, For Shilpa Medicare Limited
V.V. Krishna Chaitanya Company Secretary & Compliance Officer
Shilpa Medicare Limited (SML)
Q3 FY22 Results Presentation
1
2
API Units, Raichur
Disclaimer
are
subject
to certain risks
in this document may be Certain statements forward-looking statements. Such forward looking and statements uncertainties like regulatory changes, local political or economic developments, and many other factors to differ that could cause our actual materially from those contemplated by the relevant forward-looking Shilpa Medicare statements. 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.
results
Company Overview
3
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
Table of Contents
4
Financial Performance........................................05
Discussion on APIs/Formulations/New Segments……09/15/19
Other Updates.................................................21
Financial Performance
5
Abridged P&L Statement - Consolidated
6
(Rs. In Lakhs)
Particulars
Q3 Y22 Q3 FY21 Change (%) 9M FY22 9M FY21 Change (%)
Total Income (I+II) I. Total Revenue from Operations (A+B+C+D)
•API (A) •Formulations (B) •Service Revenue / Product License Fees (C) •Others (D) II. Other income Total Expenditure EBITDA EBITDA margin (%) Exceptional Income PBT PAT Share of Profit/(Loss) of Non-Controlling Interest
PAT after Share of profit/(loss) of Non controlling interest
27,778 27,230 18,195 7,823 711 501 548 22,724 5,054 18% - 1,996 1,025 (73)
19,986 19,125 13,533 4,071 1,185 337 861 17,028 2,958 15% - 1,106 814 (47)
956
767
39 42 34 92 (40) 49 (36) 33 71
- 81 26 -
25
81,368 80,493 50,216 25,715 2,876 1,686 875 67,487 13,881 17% 891 5,845 3,363 (255)
71,634 69,305 46,128 18,048 3,018 2,112 2,329 53,765 17,869 25% 6,084 18,803 13,998 (65)
3,111
13,936
14 16 9 42 (5) (20) (62) 26 (22)
(85) (69) (76) 292
(78)
Abridged P&L Statement - Standalone
(Rs. In Lakhs)
7
Particulars
Q3 FY22
Q3 FY21
Change (%)
9M FY22
9M FY21
Change (%)
Total Income (I+II) I. Total Revenue from Operations (A+B+C+D) •API (A) •Formulations (B) •Service Revenue / Product License Fees (C) •Others (D) II. Other income Total Expenditure EBITDA EBITDA margin Exceptional Income PBT PAT
28,964
27,664
18,195 8,276
383
810 1,300 22,008 6,956 24% - 4,835 3,677
17,990
17,129
12,782 3,509
502
337 861 14,061 3,929 22% - 2,487 1,687
61
62
42 136
(24)
140 51 57 77
- 94 118
83,476
80,284
50,216 26,895
1,487
1,686 3,192 64,204 19,272 23% 891 14,078 10,554
66,938
65,061
43,998 16,893
2,053
2,118 1,876 46,095 20,842 31% 5,295 22,031 15,780
25
23
14 59
(28)
(20) 70 39 (8)
- (36) (33)
In relation to the import alert issued by the USFDA for the Jadcherla unit, the Company has initiated extensive remedial measures. The incremental costs incurred on account of the USFDA import alert is Rs 474 Lakhs in Q3 FY22 & Rs. 2,760 Lakhs
Managing Director’s Message
8
Commenting on Q3 FY’22 performance, Mr. Vishnukant Bhutada, Managing Director Shilpa Medicare Limited said,
““Momentum in API business continues to improve in line with the measures we have taken, which is heartening. We have a deep pipeline of products that will help us maintain a positive outlook in this segment. In Formulation business, we are making progress in our engagement with the regulator and simultaneously have been carrying out new filings. Our team has been working collaboratively with the external consultants in order to achieve remediation. Meanwhile I am happy to share that we have successfully implemented site transfer for 2 products de-risking our business from single site dependency. We remain committed to normalize our US market operations at the earliest while we continue to enhance our reach in other key geographies.
I am pleased to share that we are working with Mylab Discovery Solutions Pvt Ltd to manufacture ‘Sputnik Light Drug Substance’ for them. Along with this we have initiated our manufacturing arrangements for the manufacture of ZyCoV-D. Additionally, we have made healthy progress on our own portfolio of products with very robust results in our clinical & animal trials for Adalimumab & Aflibercept respectively.
In a another significant development during the quarter, we have successfully raised Rs. 297 cr. through private placement of our shares to marquee investors. This fund raise has helped us in correcting the leverage position of the company while continuing with our growth impetus.”
Discussion of API Segment
9
Perspectives on APIs
10
Key strengths of the business
• Wide range of Oncology & Non oncology niche product portfolio • Building capacity & capability to improve efficiency & reach • Continuous improvement in process, operation & development to improve the yield , quality & compliance to maintain
leadership position in key molecules
• Positioned business development teams in all the regions globally • Strong R&D with focus on difficult to synthesize products including development of newer business segments
Way forward
• Separate business under a separate subsidiary to provide focused approach resulting in better operating efficiency with fund raising opportunity in the segregated business either from strategic investors through private placement or from investors at large through public issue
• Greater impetus to specialty areas of CDMO, Peptides, Polymers & intermediate with early success signs • Continuous efforts on process optimization & efficiency improvement
API REVENUE HIGHLIGHTS
11
Rs. In Lakhs
12,000
10,000
8,000
6,000
4,000
2,000
-
Q2 FY22 Q3FY22 Q3 FY21
Oncology 11,352 10,679 7,423
Non-Oncology 4,730 5,112 2,367
Crams 2,972 2,403 2,992
Product wise DMF filings as on December 31, 2021
12
Name of the API
US FDA
EU/ EMEA
TPD-Canada
PMDA Japan
TGA & Medsafe-NZ
EDQM
KFDA Korea
GCC & ROW
WHO Market
Ambroxol HCl Azacitidine Bicalutamide Bendamustine HCl Bortezomib Busulfan Capecitabine Decitabine Erlotinib HCl Fingolimod HCl Gemcitabine HCl Imatinib Mesylate Letrozole Irinotecan HCl Irinotecan HCl (Process-2) Melphalan HCl Oxaliplatin Pemetrexed Disodium Temozolomide Zoledronic Acid Pemetrexed Dipotassium (Nonahydrate) Anastrozole
Product wise DMF filings as on December 31, 2021
13
Name of the API
US FDA
EU/ EMEA
TPD-Canada
PMDA Japan
TGA & Medsafe-NZ
EDQM
KFDA Korea
GCC & ROW
WHO Market
Clofarabine Dimethyl Fumarate Axitinib Enzalutamide Pirfenidone Gemcitabine Hydrochloride (Process-2) Ibrutinib Teriflunomide Pomalidomide Tranexamic Acid Thalidomide Sunitinib Malate Lenvatinib Mesylate Tenofovir Alafenamide Fumarate Praziquantel
Tenofovir Disoproxil Fumarate
Cyclophosphonamide Prucalopride succinate Lenalidomide Acebrophylline Sorafenib (Base) Sunitinib (Base)
Product wise DMF filings as on December 31, 2021
1414
Name of the API
US FDA
EU/ EMEA
TPD-Canada
PMDA Japan
TGA & Medsafe-NZ
EDQM
KFDA Korea
GCC & ROW
WHO Market
Nifedipine Phenylephrine hydrochloride Nilotinib Varenicline tartrate Cabazitaxel Glycopyrronium bromide
Discussion of Formulations Segment
15
Perspectives on Formulations
16
Key strengths of the business
• Vertically integrated backed by in-house R&D and innovative APIs with sharp cost competencies • Range includes liquid and lyophilized injectable, sterile dry powder injections and oral solids in onco & adjuvant
therapies
• Strong portfolio of NDDS/value added product pipeline • Targeted sales of complex products in key regulated/RoW markets
Way forward
• Partial remediation towards USFDA import alert complete
• Submission of MCAP (Compliance Plan) to FDA in Q4 • Continue the hedging strategy to de-risk against single site operations • Continue focus on niche and value-added products portfolio development
• Strong strategic partnership model to enhance reach
Formulation - Highlights
Revenue Split
(Rs. In Lakhs)
17
Q3 FY22
50 , 1% 450 , 5%
210 , 3% Q2 FY22
377 , 4%
2,246 , 27%
USA'
EUROPE
ROW
DOMESTIC
5,529 , 67%
3,220 , 37%
USA'
EUROPE
ROW
DOMESTIC
4,925 , 56%
Q3 FY21
91 , 2%
21 , 1%
427 , 12%
2,969 , 85%
USA'
EUROPE
ROW
DOMESTIC
Rs. 8,276
Rs. 8,732
Rs. 3,509
• Completed 2 site transfer projects • Won 2 year tender for supply of Dimethyl Fumurate in Saudi Arabia through partner • Received approval for Pemetrexed RTU for the EU market • Remote record review by USFDA of QC Lab at Bangalore successfully completed without any observations
Formulation Product Pipeline as on December 31, 2021
18
Regulatory Submissions
- US ANDA: SML
- US NDA: SML
- US ANDA: Customers
TOTAL (In US)
- EU Filing
- Row Filling
TOTAL (In EU & ROW)
GRAND TOTAL
Filings
Approved
(Including Tentative)
Pending
26
03
18
47
25
279
304
351
13
01
13
27
19
95
114
141
13
02
05
20
06
184
190
210
18
Discussion of Biologicals
19
Perspectives on Formulations
20
Key strengths of the business
• Strong R&D with focus on difficult products • World class manufacturing facility • Development of 1 NBE and 6 biosimilars in limited competition space with significant cost advantage • 2 products in human clinical & 1 in animal clinicals • Strategic partnerships in vaccine manufacturing
Way forward
• First product launch in India expected in Q3/Q4 of FY22-23 • Strategic tie-ups for the international market • Capture low hanging fruits exploring additional vaccine / MABs manufacturing tie-ups
Other Updates
21
Patents Status as on December 31, 2021
22
Patents
Filings
Granted
Pending
-
-
-
-
API
Formulation*
Films Topical & Transdermal
Biologicals
-
Others
TOTAL
208
182
61
12
22
485
45
35
6
5
5
96
163
147
55
7
17
389
* Formulation numbers includes the Patents of FTF Pharma Pvt Ltd Ahmedabad, a wholly owned subsidiary of Shilpa Medicare Ltd
Manufacturing Excellence
Dharwad
Jadcherla Unit
23
• Biologicals Manufacturing plant &
R&D Facility
• Formulations (Onco & Adjuvant
Therapy
• of Onco – Injectable & Oral)
Bengaluru Unit
Hyderabad
• TDS & ODF Manufacturing Facility
& Formulation R&D
Raichur Unit I & II
Ahmedabad
• API (Oncology – Non-Oncology) • API (Oncology – Non-Oncology)
and R&D API
• CRAMS • Peptide • Polymer
• Formulations (Oral Dissolving Films) • Bio Analytical Lab,
Pharmacovigilance Lab & Quality control lab
• CRO & CDMO • R&D Formulation
About Shilpa Medicare Ltd.
24
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 to complete range of products in this segment spanning across APIs, consolidate in field of 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 Karl H Kolah
CDR India
+91 22 6645 1209 / 1220
siddharth@cdr-india.com karl@cdr-india.com
25
Thank You