Shilpa Medicare Limited · NSE:SHILPAMED
Shilpa Medicare — Q4 FY21 Earnings Presentation
43 slides from Shilpa Medicare's earnings presentation, May 31, 2021
Slide 1: Cover letter to stock exchanges
Shilpa Medicare Limited Corporate & Admin Office: I Innovating for "Shilpa House", # 12-6-214/A-1, Hyderabad Road, affordable healthcare Raichur-584 135, Karnataka, India Tel: +91-8532-238704, Fax: +91-8532-238876 Email: info@vbshilpa.com, Web: www.vbshilpa.com CIN: L85110KA1987PLC008739 Dated 31.05
Slide 2: Q4 & FY21 Results Presentation
Shilpa Medicare Limited (SML) Q4 & FY21 Results Presentation 1
Slide 3: Disclaimer
2 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 m
Slide 4: Table of Contents
Table of Contents 3 Company Overview...........................................04 Financial Performance........................................16 Discussion of Select Business Segments................... 23 Business Update…………………………………...33 Way Forward................................................
Slide 5: Company Overview
Company Overview 4
Slide 6: Company Overview
Company Overview 5 Pursuing niche growth businesses like Transdermal, Oral Dissolving Films and Dermatological Formulations Established presence in Active Pharmaceutical Ingredients (APIs) and Formulations for Affordable & Robust research domestic & international markets Effective orientation result
Slide 7: Established Business
Established Business 6 API Formulation Manufacturing API products with high precision Portfolio includes liquid and lyophilized Isolator Technology & operated with zero injectable, sterile dry powder injections and oral discharge solids Portfolio contains technically challenging Global reach in the
Slide 8: Growth Business
Growth Business 7 Biologicals & Biosimilars Novel Biologic Company is pursuing a dedicated IP strategy for Molecule pipeline is patent protected globally Biosimilar and NBE assets 6 of the top 15 Biological products are in the Clinical trials should start by Jun-Sept 21 pipeline Strengths in the dev
Slide 9: Niche Opportunities
Niche Opportunities 8 Dermatological ODF & Transdermal Portfolio includes liquid and lyophilized 1 product is ready to be filed in the US market - injectable, sterile dry powder injections and oral Niche Generic solids Swatchshil launched in domestic market in Mar Global reach in the US, EU and the
Slide 10: SML's Key Strengths
9 R&D SML’s Key Strengths Manufacturing Excellence
Slide 11: Research & Development
Research & Development 10 o Pathway Engineering of cells – Novel cell lines with novel characteristics, high yield o HT Biologics characterization – Potential to reduce the iterations/cost in the latter stages of development and clinic o Multi-parallel Bioprocessing platforms with incorporation of c
Slide 12: Research & Development
Research & Development 11 o Analytical lab equipped with all sophisticated instruments for analytical development of transdermal patches and oral films as per current US/EU Guidance o R&D capability to conduct In-Vitro adhesion characterization like Peel, Tack, Shear and Release force; In-Vitro Perm
Slide 13: Manufacturing Excellence
Manufacturing Excellence 12 Facility Location Facility Type Dharwad Biologicals Manufacturing plant & R & D Facility TDS & ODF Manufacturing Facility & R & D (All Bengaluru segments except Biologics) Raichur Unit I API (Oncology – Non-Oncology) India India Raichur Unit II API (Oncology – Non-Oncolog
Slide 14: Established Business - Capacities
Established Business - Capacities 13 o 9 dedicated blocks for Oncology & 4 blocks for Non-Oncology o Multi-product capability for Oncology & Non-Oncology API o Expansion of various API capacities o Peptide and Polymer divisions added which lends further capacity o CDMO introduced to existing busines
Slide 15: Growth Business - Capacities
Growth Business - Capacities 14 o 2 independent lines - single use lines (1,000L Bioreactor each) for production of MABS, vaccines and other recombinant proteins from mammalian cells o 1 single use line (200L bioreactor) for production of MABS and Biologicals & other recombinant proteins from mammal
Slide 16: Niche Opportunities - Capacities
Niche Opportunities - Capacities 15 o R&D is carried out at Shilpa Medicare’s in-house R&D Facility Dermatological o Exhibit batches are taken at a Contract Manufacturing Organization o State-of-art mfg. facility to develop and manufacture novel tech-based products at Bengaluru facility for global m
Slide 17: Financial Performance
Financial Performance 16
Slide 18: Abridged P&L Statement - Standalone
Abridged P&L Statement - Standalone (Rs. In Lakhs) 17 Particulars Q4 FY21 Q4 FY20 Change (%) FY21 FY20 Change (%) Total Income (I+II) 19,485 20,090 (3) 86,422 81,724 6 I. Total Revenue from Operations (A+B+C+D) 17,971 19,793 (9) 83,032 80,598 3 •API (A) 12,226 13,304 (8) 56,319 50,181 12 •Formulatio
Slide 19: Abridged P&L Statement - Consolidated
Abridged P&L Statement - Consolidated (Rs. In Lakhs) 18 Particulars Q4 FY21 Q4 FY20 Change (%) FY21 FY20 Change (%) Total Income (I+II) 21,494 22,890 (6) 93,127 92,485 1 I. Total Revenue from Operations (A+B+C+D) 20,803 21,999 (5) 90,113 90,791 (1) •API (A) 12,250 15,240 (20) 60,862 55,441 10 •Formu
Slide 20: Results Snapshot (Standalone)
Results Snapshot (Standalone) 19 REVENUE BREAKUP (IN LAKHS) Key Highlights Q4FY21 Q4FY20 13,304 12,226 • Despite challenging last 2 quarters, both API & Formulation businesses 4,856 4,812 witnessed robust growth during the year 323 624 566 1,054 API Formulation Others Service Income & • Q4 performan
Slide 21: Capital Investment & Debt Details - Standalone
Capital Investment & Debt Details - Standalone 20 (Rs. In Lakhs) As on As on Particulars 31.03.2021 31.03.2020 Capital Investments Fixed Asset Gross Block 89,699 73,392 Tangible Assets (Project Under Progress) 29,719 24,418 Intangible Assets Under Development 18,516 12,863 Total Capital Investment 1
Slide 22: Historical Revenue Statement – Standalone
Historical Revenue Statement – Standalone 21 TOTAL REVENUE –14% CAGR IN LAST 3 YEARS R CAG % 14 2019 2020 2021 (Rs. In Lakhs) 45,614 38,821 34,817 R % CAG 1 7 22,776 -7% 19,115 CAG 16,596 R 8,968 3,027 2,619 2,5532,3341,318 3,390 1,5531,126 API (excluding CRAMS Formulations Service & License Income
Slide 23: Historical R&D Expenditure Trends
Historical R&D Expenditure Trends 22 (Rs. In Lakhs) Particulars FY18 FY19 FY20 FY21 Total R&D Expenditure 7,813 8,751 12,883 13,675 R&D Revenue Expenditure 5,386 4,004 6,948 6,836 R&D Intangible Assets(incl. CWIP) 2,427 4,747 5,935 6,839 R&D as a % of Revenue 10% 13% 16% 16% Strong orientation on R&
Slide 24: Discussion of Select Business Segments
Discussion of Select Business Segments 23
Slide 25: New Launches in India's Pharmaceutical Market
New Launches in India’s Pharmaceutical Market 24
Slide 26: New Launches in India's Pharmaceutical Market
New Launches in India’s Pharmaceutical Market 25
Slide 27: New Launches in India's Pharmaceutical Market
New Launches in India’s Pharmaceutical Market 26 Highlighting the advantages of Shilpa’s Green Tea over traditional green tea through communication Publishing engaging content on social media Focusing on creating more brand awareness and reaching out to new consumers Increasing the follower base on
Slide 28: New Launches in India's Pharmaceutical Market
New Launches in India’s Pharmaceutical Market 27 Vitamin Supplementations B12 Film – Methyl Cobalamin 1500 mcg Cholcal – Vitamin D3 2000 IU PDE Inhibitor TFL – Tadalafil 5mg, 10mg, 20mg
Slide 29: New Launches in India's Pharmaceutical Market
New Launches in India’s Pharmaceutical Market 28 Ondansetron Simethicone 62.5mg Gastrip Vomistrip – 2mg, 4mg, 8mg
Slide 30: API Progress in FY 2021
API Progress in FY 2021 29 New Products Introduced Business Segment Name of the Product Therapeutic Area Geography Total Market Size Nilotinib * Oncology Global $ 1.64 Billion Pazopinib HCL * Oncology Global $ 568 Million API $ 1.72 Billion (Single and in Phenylephrine HCL Non-Oncology Global combin
Slide 31: Formulation Progress in FY 2021
Formulation Progress in FY 2021 30 Products launched Business Segment Name Shilpa’s Brand Name Therapeutic Area Geography Total Market Size Lenvatinib Lenshil Oncology India $ 777 K Dastinib Dasashil Oncology India $ 1.8 Million Sunitinib Sunishil Oncology India $ 1.3 Million Axitinib Axishil Oncolo
Slide 32: Investing in future Growth Businesses
Investing in future Growth Businesses 31 Recently tied up with Dr. Reddy's Laboratories for the production of Sputnik V vaccine 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
Slide 33: Managing Director's Message
Managing Director’s Message 32 Commenting on Q4 & FY’21 performance, Mr. Vishnukant Bhutada, Managing Director Shilpa Medicare Limited said “I am pleased to share with you that we have been able to maintain our revenues during the year despite facing a volatile macro environment and other regulatory
Slide 34: Business Update
Business Update 33
Slide 35: Current Status on USFDA Warning Letter
Current Status on USFDA Warning Letter 34 o SML’s Jadcherla Unit received the Import Alert in Feb 2021 o After the Warning Letter in October 2020, the Company has undertaken a systematic and wholesome remediation plan with the help of a Third-Party Consultant to address the concerns of the Agency o
Slide 36: USFDA Exempted Formulation Sales - Largest Revenue Source
USFDA Exempted Formulation Sales - Largest Revenue Source 35 (Rs. In Lakhs) Year FY21 FY20 FY19 Total Formulation Sales 21,308 19,436 17,104 Exempted Formulation Sales* 18,608 13,426 14,467 % of total Formulation Sales 87% 69% 85% * Includes all products permitted for sales in the US Exempted Formul
Slide 37: Patents Status as on March 31, 2021
Patents Status as on March 31, 2021 36 Patents Filings Granted Pending - API 204 40 164 - Formulation * 168 21 147 - Films Topical & Transdermal 57 5 52 - Biologicals 11 3 8 - Others 22 5 17 TOTAL 462 74 388 * Formulation numbers includes the Patents of FTF Pharma Pvt Ltd Ahmedabad, a wholly owned s
Slide 38: Formulation Product Pipeline as on March 31, 2021
Formulation Product Pipeline as on March 31, 2021 37 Approved Regulatory Submissions Filings Pending (Including Tentative) - US ANDA: SML 23 13 10 - US NDA: SML 2 0 2 - US ANDA: Customers 18 12 6 TOTAL (In US) 43 25 18 - EU Filing 21 16 5 - Row Filling 209 52 147 TOTAL (In EU & ROW) 230 68 152 GRAND
Slide 39: Way Forward
Way Forward 38
Slide 40: Way Forward
Way Forward 39 o Completed debottlenecking of 1 Oncology block & 1 Non-Oncology started the manufacturing the product API o Initiated debottlenecking of all the production blocks o 2 major Oncology products batch size increased by 5 times and 7 times respectively o New Tranexamic block commissioned
Slide 41: Way Forward
Way Forward 40 o Diversification in other therapeutic areas like Biologics, portfolio expansion to Transdermal Dosage Forms and Oral thin films formulations. The manufacturing unit at Bengaluru has delivered exhibit batches for additional products o Launch of Shilpa’s branded products for ODF in the
Slide 42: About Shilpa Medicare Ltd.
About Shilpa Medicare Ltd. 41 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 marke
Slide 43: Thank You
Biological Facility Temple - Dharwad 42 Thank You