Shilpa Medicare Limited has informed the Exchange about Investor Presentation
I Innovating for
affordable healthcare
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 14 August 2021
To Corporate Relationship Department BSE Limited, 1 st 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/l, G Block Bandra Kurla Complex, Bandra (E) Mumbai - 400051.
Dear Sir/Ma'am,
Sub: Presentation made to analysts and investors.
Ref: Regulation 30 of the SEBI (Listing Obligations & 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 ended 30 June 2021.
This is for your information and Records.
v V Krishna Chaitanya Company Secretary and Compliance Officer
Shilpa Medicare Limited (SML) Q1 FY22 Results Presentation
1
2
Jadcherla Unit, Telangana
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 Transdermal, Oral Dissolving Films and Dermatological 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.................................................14
Way Forward……….........................................22
Financial Performance
5
Abridged P&L Statement - Consolidated
6
(Rs. In Lakhs)
Particulars
Q1 FY22
Q1 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 Share of Profit / (Loss) of Joint Venture and associates, net of tax Exceptional ( Income )/Expenses Finance Costs Depreciation and Amortization Tax Expenses Effective Tax Rate (%) PAT (incl. exceptional item) PAT Margins (%)
Share of Profit /(Loss) JV/ Associated & Non-Controlling Interest (net)
PAT (after Share of profit/(loss) of JV/Associate & non controlling interest
PAT Margins (%)
23,935 23,736 12,967 9,364 1,021 384 199 20,547 3,388 14% (75) 0 1032 1763 356 60% 161 1%
(3)
159
1%
22,835 22,286 14,708 6,208 755 616 548 15,712 7,123 31% (62) (6,084) 400 1233 2914 25% 8598 38%
33
8,631
38%
5 7 (12) 51 35 (38) (64) 31 (53) - - - 158 43 (88) - (98) -
-
(98)
-
Abridged P&L Statement - Standalone
7
(Rs. In Lakhs)
Particulars
Q1 FY22
Q1 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 Finance Costs Depreciation and Amortization Tax Expenses Effective Tax Rate (%)(continued operations)
PAT Period/year from continuing operations incl. exceptional item (E)
PAT Margins (%)
25,012 24,033 12,967 10,274 526 266 979 19,998 5,013 20% - 699 1,169 631 20%
2,515
10%
21,928 21,664 14,708 5,619 723 614 264 13,905 8,023 37% (5,295) 354 991 3,358 28%
8,615
39%
14 11 (12) 83 (27) (57) 271 44 (38) - - 97 18 (81) -
(71)
-
In relation to the import alert issued by the USFDA for our Jadcherla unit, the Company has initiated extensive remedial measures. The incremental costs incurred on account of the USFDA import alert is Rs.1,821.60 Lakhs in Q1 FY22
Managing Director’s Message
8
Commenting on Q1 FY’22 performance, Mr. Vishnukant Bhutada, Managing Director Shilpa Medicare Limited said
“I am pleased to share we have witnessed a recovery in performance and delivered an encouraging set of results in Q1 even as the macro environment
continues to remain volatile. The Company has registered a revenue growth of 5% yoy at Rs. 23,935 lakhs when compared to Rs. 22,835 lakhs in the
corresponding period last year. We continue to maintain our focus on improving the core API and Formulations business offerings as we build on newer
opportunities in untapped markets. I am glad to share that we recently undertook a vital decision of segregation of API business into a separate subsidiary
which will allow us to provide the desired strategic impetus to each business separately and in turn tap their full potential.
A very important development during the quarter, I am pleased to share with you that we are the Second Company in India that has received an approval
from the Defence Research & Development Organisation (DRDO) for the manufacture and sale of 2-Deoxy-D-Glucose (2DG). 2DG stops
virus growth and is the first medicine in India termed as anti-Covid drug which will treat Covid-19 and its variants.
With no end in sight to Covid-19 and its variants, the world has begun to adjust and live with it. It is our earnest endeavor to continue our efforts to
combat this disease. In this regard, I am pleased to share that the progress on the production-supply of Sputnik V vaccine is on track and we expect
commercial production to commence in Q3FY22. Over the years, we have prudently invested in high-quality human capital and deployed teams across
international markets.We believe that our investments in Biologics will act as a strategic growth lever which will enable future growth.”
Discussion of Select Business Segments
9
API - Highlights
Segment wise sales
10
(Rs. In Lakhs)
Q1 FY22
307 , 2%
- , 0%
Q4 FY21
877 , 7%
94 , 1%
Q1 FY21 414 , 3%
3,671 , 27%
2,559 , 21%
9,443 , 71%
8,789 , 71%
3,244 , 21%
2,828 , 19%
8,674 , 57%
Oncology
Non-Oncology
K-Product
Others
Rs. 13,422
Rs. 12,320
Rs. 15,161
o Increased offtake in Japan for Temozomide o Non Onco Sales driven by UDCA
o Recently receivedWHO approval for Tenofovir o Increased production capacity in Tranexamic acid
Formulation - Highlights
Revenue Split
11
(Rs. In Lakhs)
91 , 1%
5,419 , 52%
Q1 FY22
385 , 4%
Q4FY21
30 , 0%
Q1FY21
52 , 1%
923 , 17%
702 , 13%
4,522 , 43%
198 , 4%
3,505 , 66%
2,140 , 35%
USA
EUROPE
ROW
INDIA
3,968 , 64%
Rs. 10,417
Rs. 5,328
Rs. 6,190
o US business gaining traction again backed by sale of 3 products that have been exempted from the Import Alert
•
Azacitidine for Injection, Cyclophosphamide Capsules and Erlotinib Tablets
o Actively worked on hedging strategy, resulting in significant growth in other international markets as well
• One Product site transfer successfully completed
Investing in future Growth Businesses – New Launch
12
Launched fast dissolving oral films of Paracetamol brand name as Molshil®
o Shilpa Medicare Ltd. recently announced the launch of Oral Thin Film
Formulation, a Infant /pediatric dose of Paracetamol, under the
Brand name Molshil®
o The Company received the approval for Molshil® Oral Thin Films after
sufficiently complying with bioequivalence requirements
o These Paracetamol Oral Thin Films are patent protected and are
first of its kind in the world
o The Company has introduced these Paracetamol Oral Thin Films in
Orange Flavour in 60 mg and 120 mg strengths
o The Company is manufacturing these oral
films
in its own
manufacturing facilities
Investing in future Growth Businesses – New Launch
13
In Insomnia & Sleep Disorders
In Erectile Dysfunction ( Majorly through Retail Plan )
In Seasonal Allergic Rhinitis, Asthma, EIB, Perennial Allergic Rhinitis
Other Updates
14
Contribution towards combating to Covid-19 pandemic
15
Sputnik V vaccine update
o Shilpa Biologicals Pvt Ltd, (SBPL) the wholly owned subsidiary of Shilpa Medicare Ltd. 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 Technology Transfer ongoing currently with commercial production expected to start in Oct-Nov 2021
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 View Biologics as a strategic growth area and made significant investments in setting up a high end, flexible Biologics facility in Dharwad to
cater to the requirements of the fast-growing biologics field, that include, the Adenoviral, Subunit & DNA vaccines, Monoclonal antibodies
& fusion proteins
Contribution towards combating to Covid-19 pandemic
16
Received approval from DRDO for the manufacture and sale of 2-Deoxy-D-G1ucose (2DG)
o Recently received an approval from the Defence Research & Development Organization (DRDO) for the manufacture and sale of 2-Deoxy-
D-Glucose (2DG).
o Shilpa Medicare is only the second Company in the country to enter in a similar arrangement with DRDO.
o The Drug Controller General of India has given 2DG an emergency approval to treat COVID-19 patients in the country.
o The Company has been continuously striving to contribute towards the fight against COVID-19 and this is yet another step by it after it
recently announced the arrangement for manufacture and supply of SputnikV vaccine.
o Applied another two products for Covid-19 therapy
Current Status on USFDA Warning Letter
17
USFDA updates on formulation facility
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.
A Master Compliance Action Plan Company already prepared
Planning a meeting with USFDA in Q3FY22
Filing of new ANDA/NDA applications continues and the review from Agency is ongoing
Site transfer batches of one product have been successfully made at a CMO and shall be filed in the Q3/Q4 of FY22
Patents Status as on June 30, 2021
18
Patents
Filings
Granted
Pending
-
-
-
-
API
Formulation *
Films Topical & Transdermal
Biologicals
-
Others
TOTAL
205
179
59
12
22
477
40
26
6
4
5
81
165
153
53
8
17
396
* Formulation numbers includes the Patents of FTF Pharma Pvt Ltd Ahmedabad, a wholly owned subsidiary of Shilpa Medicare Ltd
Formulation Product Pipeline as on June 30, 2021
19
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
24
03
18
45
24
228
252
297
13
01
12
26
17
65
82
108
11
02
06
19
07
163
170
189
19
Manufacturing Excellence
20
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
21
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 start from Sep-21, 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 - 6 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
Site transfer of ODF products from Hyderabad Unit to Bengaluru Unit is planned
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-21. Further deals being pursued Sputnik Vaccine (50m 1st dose + 50m 2nd dose) will be manufactured in tie-up Dr. Reddy’s Laboratories – tech transfer ongoing from RDIF, targeting Oct/Nov 21 production
R&D is carried out at Shilpa Medicare’s in-house R&D Facility
Exhibit batches are taken at a Contract Manufacturing Organization
Way Forward
22
Way Forward…
23
o Separate business under Shilpa Lifesciences Pvt. Ltd to provide focused approach resulting in better operating efficiency
API
o Greater impetus to specialty areas of CDMO, Peptides & Polymers
o Completion of remedial measures towards USFDA import alert by Q2/Q3 of FY22
o Continue the hedging strategy to de-risk against single site operations
Formulations
o Focus on niche and value added products portfolio
o Expand transdermal patches & thin film portfolio – increase geographic reach
o Developing dermatology and ophthalmic pipeline
o Focus on turning cash flow positive – capture low hanging fruits
Biologics
•
Exploring other vaccine manufacturing tie-ups
o Exploring more biologicals to pursue in R&D
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