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
Dated: 29th October, 2021
To Corporate Relationship Department BSE Limited 01st Floor, Routunda Building, PJ Towers, Dalal Street, Mumbai – 400001
To National Stock Exchange of India Limited. Exchange Plaza, 05th Floor, Plot No: C/1, G Block, Bandra Kurla Complex, Bandra € Mumbai - 400051
Dear Sir/Madam
Sub: Presentation made to analysts and investors. Reg: Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015
Scrip Code: BSE: 530549 Stock Symbol: NSE: Shilpamed
Pursuant to Regulation 30 of Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015, please find enclosed herewith the copy of presentation made to analysts and investors in connection with Un-Audited Standalone & Consolidated Financial Results for quarter and half year ended 30th September, 2021.
Kindly take the same into your records.
For Shilpa Medicare Limited. V V Krishna Chaitanya V V Krishna Chaitanya Company Secretary & Compliance Officer.
Digitally signed by V V Krishna Chaitanya Date: 2021.10.29 21:05:38 +05'30'
Shilpa Medicare Limited (SML) Q2 FY22 Results Presentation
1
2
API Unit, 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 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
actual
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 of Select Business Segments................... 09
Other Updates.................................................12
Way Forward……….........................................20
Financial Performance
5
Abridged P&L Statement - Consolidated
(Rs. In Lakhs)
6
Particulars
Q2 FY22
Q2 FY21
Change (%)
H1 FY22
H1 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 (%) to Total Income Exceptional ( Income )/Expenses (Net of Taxes) Finance Costs Depreciation and Amortization Tax Expenses Effective Tax Rate (%)
PAT (incl. exceptional item & before Non - Controlling Interest (net))
PAT Margins (%)
Share of Profit/(Loss) of Non-Controlling Interest (net)
PAT after Share of profit/(loss) of JV/Associates & Non controlling interest PAT Margins (%)
29,655
29,527
19,055
9,105
1,144
223
128
24,211
5,444
18%
(891)
1,158
1,918
1,156
35%
1,989
7%
(7)
1,996
7%
28,814
27,894
16,508
10,119
1,073
194
920
21,025
7,789
27%
-
395
1,270
1,599
26%
4,521
16%
(17)
4,538
16%
3
6
15
(10)
7
15
(86)
15
(30)
-
-
193
51
(28)
-
(56)
-
(57)
(56)
-
53,590
53,263
32,170
18,510
2,165
417
327
44,759
8,831
16%
(891)
2,190
3,681
1,512
39%
2,150
4%
(5)
2,155
4%
51,648
50,180
32,556
15,221
1,827
576
1,468
36,737
14,911
29%
(6,084)
796
2,502
4,514
26%
13,119
25%
(50)
13,169
25%
4
6
(1)
22
18
(28)
(78)
22
(41)
-
(85)
175
47
(67)
-
(84)
-
(91)
(84)
-
Abridged P&L Statement - Standalone
7
(Rs. In Lakhs)
Particulars
Q2 FY22
Q2 FY21
Change (%)
H1 FY22
H1 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 (%) to Total Income Exceptional ( Income )/Expenses (Net of Taxes) Finance Costs Depreciation and Amortization Tax Expenses Effective Tax Rate (%)
PAT Period/year from continuing operations incl. exceptional item
PAT Margins (%)
29,498 28,587 19,055 8,732
577
223 911 22,194 7,304 25% (891) 785 1,313 1,736 28%
4,362
15%
27,020 26,268 16,508 8,641
925
194 752 18,130 8,890 33% - 334 984 2,095 28%
5,478
20%
9 9 15 1
(38)
15 21 22 (18) (25) - 135 33 (17) 3
(20)
(27)
54,512 52,620 32,170 18,930
1,103
417 1,892 42,194 12,318 23% (891) 1,484 2,481 2,367 26%
6,877
13%
48,947 47,931 31,216 14,727
1,551
437 1,016 32,035 16,912 35% (5,295) 688 1,975 5,452 28%
14,092
29%
11 10 3 29
(29)
(5) 86 32 (27) (35) (83) 116 26 (57) (8)
(51)
(56)
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.465.02 Lakhs in Q2 FY22
Managing Director’s Message
8
Commenting on Q2 FY’22 performance, Mr. Vishnukant Bhutada, Managing Director Shilpa Medicare Limited said
“I am pleased to share we have improved our growth trajectory over the past quarters with a growth of 3%. Revenues for the quarter stood at Rs.
29,655 lakhs as against Rs. 28,814 lakh in the corresponding period last year. APIs continues to be the backbone of our business and our strategy
of focusing on long-term opportunities through niche business of peptides, polymers & CDMO services will bear fruit in the coming periods.
Formulation sales sustained momentum given higher traction in EU and rest of the world markets in addition to the sale of exempted products
into the US.
I am furthermore happy to share that through SML’s wholly owned subsidiary, Shilpa Biologicals entered into a definitive agreement with Cadila
Healthcare Ltd (CHL) for production and supply of the ZyCov-D, a vaccine drug substance. ZyCov-D is the first DNA plasmid vaccine in the
world for human use developed indigenously by CHL against the Covid-19 virus. It is also the first COVID-19 vaccine for adolescents in the 12-
18 age group. SML has taken another step towards supporting the nation battle the pandemic.
We believe that our attractive pipeline in formulations and investments in Biologics including our potential technology product of recombinant
albumin will serve as a strategic growth lever, allowing us to expand meaningfully in the future.”
Discussion of Select Business Segments
9
API - Highlights
Segment wise sales (including service revenue)
10
(Rs. In Lakhs)
Q2 FY22
398 , 2%
2,972 , 15%
4,730 , 24%
11,352 , 59%
Q1 FY22
307 , 2%
Q2 FY21
405 , 3%
3,671 , 27%
9,443 , 71%
3,593 , 21%
3,383 , 20%
Oncology
Non-Oncology
Crams
Others
9,531 , 56%
Rs. 19,453
Rs. 13,422
Rs. 16,913
•
Growth of 45% over Q1’FY22
• •
Including CRAMS business of Rs. 2,972 lakh Excluding CRAMS business – growth of 23%
• •
Capacity enhancements have resulted in incremental sales in Q2 FY22 Gemcitabine supplies for Phase III clinical trials commenced
Formulation - Highlights
11
Revenue Split (including service revenue)
(Rs. In Lakhs)
Q2 FY22
390 , 5%
377 , 4%
Q1 FY22
91 , 1%
385 , 4%
Q2 FY21
351 , 4%
3,220 , 36%
4,925 , 55%
5,419 , 52%
4,522 , 43%
780 , 8%
4,396 , 48%
3,634 , 40%
USA
EUROPE
ROW
INDIA
Rs. 8,912
Rs. 10,417
Rs. 9,161
•
•
Actively worked on hedging strategy to de-risk the current USDFA challenges • Out of six product site transfer, one product successfully completed
Requesting a meeting with USFDA in Q3 FY22
Other Updates
12
Contribution towards combating to Covid-19 pandemic
13
Entered in an agreement with Cadila Healthcare Ltd (CHL) for production-supply of the ZyCov-D vaccine drug substance
o The Company will manufacture the drug in its integrated Biologics R&D cum Manufacturing center at Dharwad, Karnataka through its
wholly owned subsidiary Shilpa Biologicals
o The targeted production of the ZyCoV-D vaccine from this facility will be mutually agreed upon by both parties
o ZyCoV-D is the first DNA plasmid vaccine in the world for human use which was developed by CHL and is also the first COVID-19 vaccine
for adolescents in the 12-18 age group
o SML has identified the biologics business as a key strategic growth lever and continues to make significant investments in Shilpa Biologics
Contribution towards combating to Covid-19 pandemic
14
Sputnik V vaccine update
o Shilpa Biologicals Pvt Ltd, (SBPL) has entered in a 3-year definitive agreement with Dr. Reddy's Laboratories for the production-supply of
SputnikV vaccine from its integrated Biologics R&D cum manufacturing center
o The targeted production of the dual vector Sputnik V for the first 12 months is 50 million doses (50 million of dose 1 and 50 million of dose
2), from the start date of commercial production
o DRL conducting Bridging studies for India for Sputnik Light in Q3 FY22 which would include product manufacturing by SBPL
Current Status on USFDA Warning Letter
15
USFDA updates on formulation facility
o Completed gap assessment and ongoing remediation in place for the two major areas of concern cited by the USFDA
▪ Handling of complaints and
▪ Handling of laboratory investigations
o A Master Compliance Action Plan will be submitted to FDA in Q3FY22
o Requesting a meeting with USFDA in Q3FY22
o Filing of new ANDA/NDA applications continues and the review from Agency is ongoing
o Site transfer batches of one product have been successfully made at a CMO and shall be filed in the Q3/Q4 FY22
o Remedial actions in various areas are in full swing with the help of 3rd party consultants
Patents Status as on September30, 2021
16
Patents
Filings
Granted
Pending
-
-
-
-
API
Formulation *
Films Topical & Transdermal
Biologicals
-
Others
TOTAL
207
182
61
12
22
484
43
28
6
4
5
86
164
154
55
8
17
398
* Formulation numbers includes the Patents of FTF Pharma Pvt Ltd Ahmedabad, a wholly owned subsidiary of Shilpa Medicare Ltd
Formulation Product Pipeline as on September 30, 2021
17
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
25
03
18
46
25
254
279
325
13
01
13
27
18
79
97
124
12
02
05
19
07
175
182
201
17
Manufacturing Excellence
18
Facility Location FacilityType
Dharwad
Biologicals Manufacturing plant & R & D Facility
Bengaluru Unit
TDS & ODF Manufacturing Facility & Formulation R & D
Raichur Unit I
API (Oncology – Non-Oncology)
a i d n I
Raichur Unit II
API (Oncology – Non-Oncology) and R & DAPI
Jadcherla Unit
Formulations (Onco & Adjuvant Therapy of Onco – Injectable & Oral)
Hyderabad Unit
Formulations (Oral Dissolving Films)
Hyderabad
Ahmedabad
Bio Analytical Lab, Pharmacovigilance Lab & Quality control lab
R & D Formulation
Company’s Headquarters at Raichur, Karnataka, India
Manufacturing Facilities
2 API plants at Raichur, India
4 R & D units ( Bengaluru, Dharwad, Raichur and Ahmedabad, India)
1 Manufacturing site for Biologicals at Dharwad, India
3 Formulation plants at Jadcherla, Hyderabad and Bengaluru, India
India
Ramping Up Capacities
Biologicals & Biosimilars
ODF & Transdermal
19
API
9 dedicated blocks for Oncology & 4 blocks for Non- Oncology
Multi-product capability for Oncology & Non-Oncology
Expansion of various API capacities
Peptide and Polymer divisions added which lends further capacity
CDMO introduced to existing business sector to expand capacities
2 independent lines - single use lines (Expanded to 4000L each) for production of MABS, vaccines and other recombinant proteins from mammalian cells
1 single use line (200L bioreactor) pilot scale – for clinical material production of MABS and other recombinant proteins from mammalian cells
Currently 2 nos Robotic filling lines for PFS and Vials, 3rd , 4th high speed vial and PFS line will be commissioned by 4th quarter of FY 22
CDMO business to kick started from Sep-21 with ZyCov- D deal, Biosimilar out licensing opportunities being pursued
State-of-art mfg. facility to develop and manufacture novel tech-based products at Bengaluru facility for global market
Combo line for ODF/TDS has been commissioned and exhibit batches of ODF Products have been initiated - 7 products execution completed and few more products in pipeline. Nutraceutical products introduction under planning
Complete in-house characterisation of TDS and ODF formulations using validated methods and high-end analytical instrumentations
2 dedicated lines for ODF formulations at Hyderabad facility to cater Domestic and ROW market
Optimal use of both Sites depending on product and market is being done
Established Business
Formulation
Growth Business
Novel Biologics
Niche Opportunities
Dermatological
2 self contained Oncology & Adjuvant Therapy Manufacturing lines for Oral Solids products
3 self Isolated Oncology & Adjuvant Therapy manufacturing lines for Injectable products (Liquid & Lyophilized)
New centralized QC laboratory and Bio-Analytical labs in Hyderabad
2 lines each of 1,000L fermentation capacity for production of trial material and formulation grade material was commissioned in April-21
the NBE to cater
to clinical
CDMO opportunities in production of vaccines being pursued and completed a deal in May-21and Sep-21. Further deals being pursued
Sputnik Vaccine (100 m doses pa) will be manufactured in tie-up Dr. Reddy’s Laboratories – tech transfer ongoing from RDIF, targeting Dec 21/Jan 22 production
R&D is carried out at Shilpa Medicare’s in-house R&D Facility
Exhibit batches are taken at a Contract Manufacturing Organization
One ANDA filed in US market and one product clinical phase 1 studies in progress.
Way Forward
20
Way Forward…
21
o Separate business under Shilpa Lifesciences Pvt. Ltd to provide focused approach resulting in better operating efficiency
o Greater impetus to specialty areas of CDMO, Peptides & Polymers
API
o One Production block likely to get commissioned in next quarter and also planning to increase the batch size of various
products to improve efficiency
o Partial completion of major remedial measures towards USFDA import alert by Q3 of FY22
o Submission of MCAP (Compliance Plan) to FDA by Q3 of FY 22
Formulations
o Continue the hedging strategy to de-risk against single site operations
o Focus on niche and value-added products portfolio
o Expand transdermal patches & thin film portfolio – increase geographic reach
o Focus on turning cash flow positive – capture low hanging fruits
Biologics
•
Exploring other vaccine / MAbs manufacturing tie-ups
o Completion of clinical trials for Adalimumab & Human Recombinant Albumin
About Shilpa Medicare Ltd.
22
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
23
Thank You