Wockhardt Ltd — Regulatory Filings 2023

Feb 21, 2023

21[th] February, 2023

WOCK/SEC/SE/2022-23/068

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	BSE Limited Corporate Relations Department P J Towers, Dalal Street Mumbai - 400 001 Scrip Code: 532300		National Stock Exchange of India Limited Listing Department Exchange Plaza Bandra Kurla Complex, Bandra (E), Mumbai - 400 051 NSE Symbol– WOCKPHARMA

Dear Sir/Madam,

Subject: Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) – Regulations, 2015 Investor Conference recording and Investor Presentation

Pursuant to Regulation 30 of SEBI (Listing Obligation and Disclosure Requirements) Regulations, 2015 and further to our communication dated February 14, 2023, we enclose herewith the Investor Presentation discussed during Investor Call held today i.e. Tuesday, February 21, 2023 at 16:00 hrs IST through VC. The Investor Presentation is also available on the website of the Company at below link.

https://statutory.wockhardt.com/stock_exchange_disclosures.htm

Dr. Habil Khorakiwala (Chairman) and Dr. Murtaza Khorakiwala (Managing Director) participated in the Investor Call. The audio - video recording of the Investor Call has been uploaded on the Company’s website and the same can be accessed at below link:

https://statutory.wockhardt.com/stock_exchange_disclosures.htm

You are requested to kindly take it on record.

Thanking you,

Yours Sincerely,

Digitally signed by Debashis Dey Debashis Dey Date: 2023.02.21 18:29:52 +05'30'

Debashis Dey

Company Secretary

Encl.: A/a.

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Project Liberty Opportunity to invest in US pharma business

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Investor’s Presentation February 2023

Safe Harbor Statement

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The Presentation is to provide the general background information about Wockhardt Limited’s (the “ Company’s ”) activities as at the date of the Presentation. The information contained herein is for general information purposes only and based on estimates and should not be considered as a recommendation that any investor should subscribe / purchase the company shares. The Company makes no representation or warranty, express or implied, as to, and does not accept any responsibility or liability with respect to, the fairness, accuracy, completeness or correctness of any information contained herein. This presentation may include certain “forward looking statements”. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties which could cause actual outcomes and results to differ materially from these statements. Important factors that could cause actual results to differ materially from our expectations include, amongst others general economic and business conditions in India, ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currencies, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global pharmaceuticals industries, increasing competition, changes in political conditions in India or any other country and changes in the foreign exchange control regulations in India. Neither the company, nor its directors and any of the affiliates or employee have any obligation to update or otherwise revise any forward-looking statements. The readers may use their own judgment and are advised to make their own calculations before deciding on any matter based on the information given herein. No part of this presentation may be reproduced, quoted or circulated without prior written approval from Wockhardt Limited.

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Snapshot of Wockhardt : 9M FY23

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11 manufacturing facilities across world Revenues : INR 1,973 Cr . 2 R&D centres one each in India, UK, USA EBITDA: INR 86 Cr. ~ 520 scientists with >80 PhD’s, Drug Discovery team > 150 associates[1] Long term external D/E Ratio 0.16x >20% of the 5,400 global associates based outside India[1] International business ~ 75%* 3,214 patents filed; 793 patents granted

* Excludes Promoter loans

Strictly confidential | Page 3

Global Footprint : Significant Regulated market presence

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Global Footprint Capability – across different segments
► Generics
► 5,000 employees
► Branded
► Across US, EU, India &
► OTC
Emerging Markets
► Hospital
► Solids, ► Liquids
► Injectables, ► Nasal Sprays
► Biotechnology ► Complex technologies
► Antibiotics Drug Discovery
► Biotechnology
Direct operations Through Partners ► Pharma Generics
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United Kingdom Emerging Markets India Ireland United States of America
►Leading Indian ►Presence in ►1 [st] Indian ►Amongst TOP 5 ►Generics
generic company Latin America, Company to Generic Cos ►Hospital segment
in Retail & CIS, Africa, launch NCE ►Largest Generic ►Pediatrics
Hospital Asia and MENA ►800 field force Cos in hospital
products
segments
Share 32% 20% 25% 6% 13%
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Key highlights

1 Business performance 2 Restructuring of US Business 3 Agreement with Serum for vaccine manufacturing in UK 4 Novel Antibiotics

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2 US Business Restructuring

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US Cost Improvements
Site transfer from in-house Chicago site to CMOs
In-house Manufacturing Post re-structuring
$
Canada (CMO)
$
USA CMO
$$$
MGP Chicago
$
GCC (CMO)
US$ 25 Mn fixed cost US$ 6 Mn variable cost
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Restructuring Business

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Shut down of manufacturing facility at Morton Grove

Few products with high margin manufactured by 3[rd] party Continue to maintain sales with ~ 40% gross margins Annual savings of ~US$ 12 Mn

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3

Agreement with Serum for vaccine manufacturing at UK Facility

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• Joint venture of 51:49 in favor of Wockhardt

• Received £ 10 million as contribution for reserving capacity- 150 million doses across 15 years

• Serum has identified two vaccines

Wockhardt plans to manufacture post regulatory approvals and exhibit batches in next 8 - 12 months

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4

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Novel Antibiotics

20 years

Committed to Novel Antibiotics research

Probably only company to have comprehensive end to end drug discovery programs in Antibiotics

#1

Programs granted QIDP status by US FDA denoting unmet needs; faster trials, quicker approvals by US FDA

6

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4
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Nurturing aspiration for global leadership in antibiotic space

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Launched
5 NCEs launched or in advanced-clinical development
Pipeline
O
2 2 2
WCK
4873
WCK RECAR ZOLIFLO
1 1 1 1 1 BAXDELA
4282 BRIO DACIN
WCK DURLOB TANIBOR GEPOTID VABO-
AVYCAZ ZERBAXA NUZYRA FETROJA
5222 ACTAM BACTAM ACIN MERE
Wockhardt Pfizer Merck Paratek Entasis VenatoRx Shionogi GSK Melinta
Shrinking pipeline - A result of scientific challenge and missing discovery talent base
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Novel Antibiotics- WCK 4873

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• Signed licensing deal with Jemincare, China for development and Licensing commercialization in Greater China in China

• Received first milestone from Jemincare

India • Phase 3 clinical trial concluding by September 2023 Phase III • Marketing in India in 2024 post DCGI approval trials

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Novel Antibiotics- Emrok/Emrok-O

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• India Already marketed Emerging • Expect approvals in 8 emerging markets in next 6-9 months Markets

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WCK 5222- Flagship novel antibiotic

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Increase in • 2022 CDC report highlights rise in Anti-microbial Resistance during COVID-19 • potential Heightened vigilance reveals the rising level of threat

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WCK 5222
90% 78%
80%
70%
https://www.cdc.gov/drugre
60%
WCK 5222 sistance/pdf/covid19-
impact-report-508.pdf
50% WCK 5222 WCK 6777
WCK 4282
32% 35%
40% 32%
Emrok /
30% Emrok O
13%
20%
10%
0%
MDR CR CR ESBL MR S. aureus
Pseudomonas Acinetobacter Enterobacterales Enterobacterales
rates during COVID
Rise in antibiotic resistance
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MDR: Multi-drug resistant; CR: Carbapenem resistant; MR: Methicillin resistant

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WCK 5222- Flagship novel antibiotic

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• Global Global Phase III clinical trial initiated in August 2022 and expected to Phase III complete in next 15-18 months. • progress Expect to market product in USA, Europe, China & India in 2025

• 3 critical patients; all other antibiotics options exhausted including recent global innovation product

Saving lives • Post DCGI approval for compassionate use, successfully cured and discharged on completion of treatment with WCK 5222

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Compassionate use of WCK 5222

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Recently under DCGI Permission 3 patients in India with life-threatening infection received WCK 5222 on compassionate ground since available antibiotics were not efficacious

Patient 1 (Sep. 2022)

• 50 y, female admitted in Medanta, Hospital Lucknow, treated by Dr. Dilip Dubey

Patient 2 (Nov-Dec. 2022)

• 11 y, boy admitted in Global Hospital, Chennai, treated by Dr. Ponni/Subramanian

Patient 3 (under treatment)

• 18 y, male admitted in AIG Hospital, Hyderabad, treated by Dr. Balasaheb

• Post-abdominal surgery sepsis

• Infection of XDR Pseudomonas, resistant to ceftazidime/avibactam

• Though susceptible to colistin, even 4 weeks of therapy didn’t improve the clinical condition

  • Necrotic fasciitis after chemotherapy for acute leukemia

• Post bone-marrow-transplant febrile neutropenia

• Infection of XDR E. coli , resistant  Infection of XDR Pseudomonas, to ceftazidime/avibactam resistant to ceftazidime/avibactam

• Last-line therapies were not  Last-line therapies were not efficacious efficacious

• 10 days of therapy with WCK 5222 rescued the patient paving for discharge in stable condition

• 2 weeks of WCK 5222 eradicated  10 days of WCK 5222 eradicated the pathogen; discharged in stable the pathogen; being treated for condition cytopenia

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WCK 6777

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• Funding By National Institute of Health, USA • Stage In Phase I US development

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Financial / Business Highlights

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Deleveraging: Reducing Long term external Debt

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Long term external Debt position
3,218
(INR Cr.)
2,982
2,487
India External Debt
2,070 2,085
1,998 International External Debt
1,509 1,287
1,348
812
743 608
251
1,149 984 978 253
737 544 561
355
FY17 FY18 FY19 FY20 FY21 FY22 December 2022
0.96 0.93 Long term external Debt to Equity
0.83
0.68
0.34
0.19 0.18 0.17 0.16
FY17 FY18 FY19 FY20 FY21 FY22 Q1, FY23 Q2, FY23 Q3, FY23
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Promoters commitment

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Promoter Loans
(INR Cr.)
INR 709
Quasi- equity
Cr.
709
518
469
208
Rights Issue
~INR 500
- Conversion of Promoter Debt
Cr. March 2020 March 2021 March 2022 December
into Equity 2022
Promoter is fully committed to support the Company
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Key Metrics Performance – Sales Revenues

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Sales excl. Vaccines (INR Cr.)
699
673
578
Q1 FY23 Q2 FY23 Q3 FY23
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Key Metrics Performance – Steady improvement in EBITDA

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EBITDA excl. Vaccines (INR Cr.) 59 39 -27 Q1 FY23 Q2 FY23 Q3 FY23

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Cash Flow Movement

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Q3 FY23 (INR Cr.)

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Positive Deleveraging Promoter Investments
OCF commitment
Opening Cash from Total Debt Promoter Total Funds R&D Closing
Balance Ops Repayment Infusion Balance
& Interest
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UK Business

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Revenue Performance
Key Highlights:
•
Comprehensive, FDA-approved manufacturing facility
for sterile injectables.
•
Present in key therapies across Cardiac, Pain &
Analgesics, Vitamins, Respiratory & Diabetes,
Oncology, Anti-Infectives
223
•
Collaboration with UK Government and Astrazeneca
220
manufacture COVID-19 Vaccines.
208
Accelerated new filings
12 12
Q3 FY22 Q2 FY23 Q3 FY23 9 8
6
FY20 FY21 FY22 FY23 FY24e
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• Collaboration with UK Government and Astrazeneca to manufacture COVID-19 Vaccines.

All values in INR Cr.

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India Business

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Revenue Performance
175
158
150
Q3 FY22 Q2 FY23 Q3 FY23
483
452
9M FY22 9M FY23
All values in INR Cr.
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Key Highlights:

• Therapeutic focus across Diabetes , Nephro, Anti-Infectives, Pain / Analgesics, Vitamins & Nutrients, Neuro / CNS and others.

• One of the few Indian Companies who are into Manufacturing of Insulin, Glargine & OSD in Diabetes

• Robust Distribution Network – CNF (20+)/ Stockiest / Distributors (~ 2000)

• Only Indian Pharma company to Launch novel NCE in India (Brand name – Emrok & Emrok O)

• On 9 months basis, Diabetes Biosimilar business grew >20%

• Launched Sitagliptin under brand name “Sitawok”

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Emerging Markets Business

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Revenue Performance
148
117 117
Q1 FY23 Q2 FY23 Q3 FY23
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9M FY23 3% [5%] 4%
Africa
Asia
31%
CIS 27%
LatAm
MENA
New Markets + Others 30%
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Key Highlights:

• De-risked model of Operations - partnerships & relationship building.

• Differential & end to end Business model from Research to Manufacturing to Distribution with backward integration of API manufacturing.

• Strong Presence in Diabetes Segment – Insulin, Glargine : both Vials & Cartridges

• Upcoming Focus – Presence in New Markets / New Segments with high growth potential

All values in INR Cr.

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Growth Drivers

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Wockhardt 2.0 - Strategic pillars which will drive growth

• Affordable, Complex Generics, Sterile Injectable

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Biologics
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• Focus on differentiated products, NDDS, Complex technologies

• Global Gx Market ~ $ 200 Bn

Vaccines (Currently Covid-19)

• Focus on Diabetes Biosimilar

Pharma

• Diabetes injectable Portfolio

• Drug Substance and Product Integrated Manufacturing

• Insulin Glargine, EPO, Patented devices

• Diabetes biologics market ~$ 50 Bn

• 10 Bn doses for EM

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New Drug
Discovery
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• Focus on global reach Antibiotics drug discovery

• Comprehensive end to end drug discovery

• 6 QIDP approval by USFDA with 4 drug in pipeline

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Short-term and Mid-term growth drivers

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Mid term growth drivers (2-3 years)

1 Novel drug discovery

Short Term growth drivers (1-2 years)

1 Diabetes Biosimilars for Emerging markets

2 Collaboration for Vaccines with Serum Institute

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3 Focus on improving profitability and Cash flow

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1 Growth Drivers – Diabetes Biosimilar (EMs)

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Focus on Human Insulin and Insulin Glargine > US$ 1.5 Increased market share
Billion market
Registered in emerging markets New market launches
> 25 markets
6-7 Sustainable competitive
Limited competition
advantage
players
API +
Manufacturing infrastructure ready Cost competitive
Formulation
Development to
Integrated end to end capabilities Own “IP”
marketing
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Competitive advantage by providing end to end solutions in 1 Diabetes Biosimilars

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R&D

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• Focus on Insulin analogues, GLP-1 analogues

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Manufacturing
► Pilot to large scale capabilities for API &
formulations
Integrated
Capabilities
Regulatory
► Registrations in 25+ countries 1
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formulations
Regulatory
► Registrations in 25+ countries 1
Patented delivery devices Vials Cartridges
(pen)
Devices
► Customised precision patented delivery devices
Enhanced competitive posture to help
penetrate markets
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Pipeline of Insulin Analogs including Insulin Aspart

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2 Collaboration for Vaccines

Contract with UK Govt. for fill-finish supply for AstraZeneca/University of Oxford Covid-19 vaccine

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Serum Institute

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Supplied >60% of all Covid-19 Vaccines in UK

14% of AstraZeneca Europe > 90 COVAX countries With Prince (now King) Charles and ex-Prime Minister Boris Johnson

Dedicated manufacturing in UK for up to 150 Million doses per annum ----------------------------------------------Multi-vaccines arrangement including for COVID-19 ----------------------------------------------Long-term profit-sharing arrangement

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3 Antibiotic-resistant bacteria [6 super bugs] – silent killer

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COVID-19 killed 5 million people in two years [1]
Strong
COVID-19
evidence
for
inadequacy
of current
In 2019, six super bugs killed 5 million people [2]
antibiotics
Super bugs
Deaths
0 500,000 1,000,000 1,500,000 2,000,000 2,500,000 3,000,000 3,500,000 4,000,000 4,500,000 5,000,000
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1.Nature, Vol 601, 20 January 2022; 2.Lancet. 2022 Feb 12;399(10325):629-655

3 Novel Antibiotics pipeline against Resistant Organisms

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Emrok / WCK 5222 WCK 4282 WCK 4873 WCK 6777 Emrok O Phase Phase III (Global) Phase III (Global) Phase III (EM) Launched in India Phase I Filing 2023 EM Filing underway Potential cUTI cUTI CABP / RTI ABSSSI cUTI Indication HABP / VABP HABP / VABP Partnered in China Partnered in Russia Funding by NIH Positioning Destination therapy for Empiric-use; Macrolide-resistant MDR Gram+ve Out-patient therapy for XDR Gram-ve Carbapenem- sparing Respiratory Pathogens, Anti-MRSA MDR Gram -ve Acinetobacter and Gram-ve Quinolone-Sparing Pseudomonas US$ 9.2 Bn US$ 5.6 Bn ~US$ 700 Mn ~US$ 3.4 Bn Current Market At current generics At current generics At current generics At current generics Size for target markets[1] price price price price | Page 32 Source: IQVIA MAT MARCH 2021

Our journey ahead – target key milestones

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FY 2024 FY 2025
Insulin Glargine
Insulin Aspart
Approval in MENA, LATAM & Other markets
Launch in India
Insulin Aspart
WCK 4873
India: Filing in 2024
Approved and launch in India
Emrok/Emrok O
WCK 5222
Approval in Emerging Markets
Filing and approval in US
WCK 4873
Phase III completion and filing in India US Business
Profitable
WCK 5222
Completion of global Ph III study conduct
PBT Positive
Serum Vaccines
Initiation of manufacturing in UK
US Business
In-house manufacturing shifted to third party
India
14 new launches targeting Diabetes & Nephro
Fund raising
For R&D & Capex
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Estimated timelines

Life wins !

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Impacting Life Saving Life
Affordability Stakeholders
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