Shilpa Medicare Limited · NSE:SHILPAMED
Shilpa Medicare — Q3 FY21 Earnings Presentation
39 slides from Shilpa Medicare's earnings presentation, Feb 13, 2021
Slide 1: Cover letter to stock exchanges on results presentation
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 13th
Slide 2: Shilpa Medicare Limited Q3 & 9M FY21 Results Presentation
1 Shilpa Medicare Limited (SML) Q3 & 9M FY21 Results Presentation
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 Discussion of Select Business Segments................... 13 Financial Performance........................................16 Business Update…………………………………...22 Marketing Update…..........................................
Slide 5: Company Overview
Company Overview 4 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 6: Established Business Segments
Established Business Segments 5 APIs Formulations o Products include liquid and lyophilized injectable, o Manufacturing API products with highly précised sterile dry powder in the facility approved by USFDA Description Isolator Technology & EUGMP o Facility is approved by USFDA, WHO-GMP, EUGMP, o De
Slide 7: Established Business Segments
Established Business Segments 6 Biologicals & Biosimilars Novel Biologic o Molecule pipeline is patent protected globally o Company is pursuing a dedicated IP strategy for o Clinical trials should start by June-21 Biosimilar and NBE assets o Low risk with diverse applications catering to o 6 of the
Slide 8: Established Business Segments
Established Business Segments 7 Dermatological Oral Dissolving Films & Transdermal Formulations Products o Company engaged in R&D in various Dermatological o Transdermal Therapeutic systems facilitate better products treatment for the patient o 2 products are ready to be filed under which 1 o Enhanc
Slide 9: SML's Key Strengths
8 R&D SML’s Key Strengths Manufacturing Excellence
Slide 10: Research & Development - Clinical Affairs & QC
Research & Development - Clinical Affairs & QC 9 Experienced in: o Bioequivalence / Bioavailability o Qualified, experienced and well- o Core medical team comprises trained staff for the design of o Phase II- IV trials physicians and pharmacologists clinical studies & quality control o PK / PD studi
Slide 11: Research & Development – Bio Analytical at Hyderabad
Research & Development – Bio Analytical at Hyderabad 10 o The Bio Analytical Laboratory is o Can handle liquid-liquid o Team of qualified and equipped with the state-of-the- extractions, solid-phase experienced researchers with art equipment and tools extractions & protein experience in method requi
Slide 12: Research & Development - Pharmacovigilance operations
Research & Development - Pharmacovigilance operations 11 SML delivering end to end Global Pharmacovigilance Activities ICSR Case Processing Medical Review ICSR reporting Handling Market Safety Monitoring Complaints of Health Authority Handling of Websites Regulatory Collection of ICSRs Communication
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 (Onco – Non-Oncology) India India Raichur Unit II API (Onco – Non-Oncology) and R
Slide 14: Discussion of Select Business Segment
Discussion of Select Business Segment
Slide 15: Green Tea Film product advertisement
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Slide 16: Pharmashil New Launches in India's Pharmaceutical Market
Pharmashil New Launches in India’s Pharmaceutical Market 15
Slide 17: Financial Performance
Financial Performance
Slide 18: Abridged P&L Statement - Standalone
Abridged P&L Statement - Standalone (Rs. In Lakhs) 17 Particulars Q3 FY21 Q3 FY20 Change (%) 9M FY21 9M FY20 Change (%) F.Y 2019-20 Total Income (I+II) 17,991 21,936 (18) 66,938 61,633 9 81,724 I. Total Revenue from Operations (A+B+C+D) 17,130 21,693 (21) 65,061 60,804 7 80,598 •API (A) 12,783 11,93
Slide 19: Abridged P&L Statement - Consolidated
Abridged P&L Statement - Consolidated (Rs. In Lakhs) 18 Particulars Q3 FY21 Q3 FY20 Change (%) 9M FY21 9M FY20 Change (%) F.Y 2019-20 Total Income (I+II) 19,985 24,011 (17) 71,634 69,882 3 92,485 I. Total Revenue from Operations (A+B+C+D) 19,125 23,685 (19) 69,305 68,776 1 90,791 •API (A) 13,534 13,
Slide 20: Results Snapshot (Standalone)
Results Snapshot (Standalone) 19 REVENUE BREAKUP (IN LAKHS) Key Highlights 12783 Q3 FY 21 Q3 FY 20 • Decrease in Formulation revenue 11,938 in Y-o-Y i.e., Q3 FY21 V/s Q3 FY20 due to WL from USFDA & commitment given to FDA for remediation measures, 6,486 commercial production was delayed/temporarily
Slide 21: Capital Investment & Debt Details - Standalone
Capital Investment & Debt Details - Standalone 20 (Rs. In Lakhs) As on As on Particulars 31.12.2020 31.03.2020 Capital Investments Fixed Asset Gross Block 78,439 73,392 Tangible Assets (Project Under Progress) 36,112 24,418 Intangible Assets Under Development 16,625 12,863 Total Capital Investment 1
Slide 22: Historical Revenue Statement – Standalone
Historical Revenue Statement – Standalone 21 Total Revenue –13.66% CAGR in last 3 years (Rs. In Lakhs) 2018 2019 2020 38,821 36,511 34,817 19,115 16,596 8,909 8,968 3,602 3,027 3,117 2,553 2,334 2,332 1,553 1,126 API (Excluding CRAMS Revenue) Formulations Service & License Income Others Other Income
Slide 23: Business Update
Business Update
Slide 24: Corporate Updates
Corporate Updates 23 API Formulations Future Growth Businesses o Stringently adhering and o Following products were commercialized o R&D facility at Bengaluru is now complemented with a complying with global safety ▪ Axitinib Tablets - Domestic Pilot Plant and an Extractable/Leachable Lab guidelines
Slide 25: Current Status on USFDA Warning Letter
Current Status on USFDA Warning Letter 24 o SML’s Jadcherla Unit was served a Warning Letter from USFDA in Oct-2020 o The Company has undertaken a systematic remediation plan with the help of a Third-Party Consultant to address the concerns of the Agency o SML has regularly updated the Agency's stat
Slide 26: Marketing Updates
Marketing Updates
Slide 27: Proficient Marketing Team Across Geographies - API
Proficient Marketing Team Across Geographies - API 26 V. Prakash Rajkumar Janak Kastia Dilip Chavan Guruprasad Anna Somani Chaturvedi • 29+ years of • 29+ years of • 30+ years of • 24+ years of • 24+ years of • 8+ years of work overall work overall work overall work overall work work experience expe
Slide 28: Proficient Marketing Team Across Geographies - Formulation
Proficient Marketing Team Across Geographies - Formulation 27 Sundeip Bhatia Shankar Michel Roy Pramod Pandey Ramakrishna Iyer • 34+ years of • 32+ years of • 25+ years of • 22+ years of overall work overall work overall work overall work experience experience experience experience • Designation: •
Slide 29: Proficient Marketing Team Across Geographies - Formulation
Proficient Marketing Team Across Geographies - Formulation 28 Harco Giling Adam Levitt Abhishek Banerjee Rajeev Kumar • 11+ Years of • 30+ years of • 20+ years of • 14+ years of overall overall work overall work overall work work experience experience experience experience • Designation: Head • Desi
Slide 30: Product Dossier submissions in ROW Market
Product Dossier submissions in ROW Market 29 Products Under Products Submitted to Region Products Approved Assessment with MOH Customer Australia 9 -- 2 MENA 26 1 20 LATAM 94 26 29 Asia 43 8 46 CIS 6 2 18 Africa 25 5 24 Total 203 42 139
Slide 31: Patents Status as on December 31, 2020
Patents Status as on December 31, 2020 30 Patents Filings Granted Pending - API 203 37 166 - Formulation * 166 15 151 - Films Topical & Transdermal 49 2 47 - Biologicals 10 2 8 - Others 22 4 18 TOTAL 450 60 390 * Formulation numbers includes the Patents of FTF Pharma Pvt Ltd Ahmedabad, a wholly owne
Slide 32: Formulation Product Pipeline as on December 31, 2020
Formulation Product Pipeline as on December 31, 2020 31 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 13 8 - Canada Filing 1 0 1 TOTAL 65 38 27 3 1
Slide 33: Way Forward
Way Forward
Slide 34: Way Forward
Way Forward 33 o Plan to commercialize 3-4 molecules each year API o Completed debottlenecking of one Oncology block & started the manufacturing the product o Initiated debottlenecking of two Oncology blocks o New Tranexamic block commissioned which is an expansion block o Expanding reach by enterin
Slide 35: Way Forward
Way Forward 34 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 further products o Launch of Shilpa’s branded products for ODF in the do
Slide 36: Annexure
Annexure
Slide 37: Historical R&D Expenditure Trends
Historical R&D Expenditure Trends 36 (Rs. In Lakhs) Particulars FY18 FY19 FY20 9M-FY21 Total R&D Expenditure 7,813 8,751 12,883 10,793 R&D Revenue Expenditure 5,386 4,004 6,948 5,870 R&D Intangible Assets(incl. CWIP) 2,427 4,747 5,935 4,923 R&D as a % of Revenue 10% 13% 16% 17% Strong orientation on
Slide 38: About Shilpa Medicare Ltd.
About Shilpa Medicare Ltd. 37 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 39: Thank You
Innovating for affordable healthcare Thank You Innovating for affordable healthcare