Wockhardt Limited has informed the Exchange about Investor Presentation
WOCK/SEC/SE/2023-24/072
26th February, 2024
BSE Limited Corporate Relations Department P J Towers, Dalal Street Mumbai - 400 001
National Stock Exchange of India Limited Listing Department Exchange Plaza Bandra Kurla Complex, Bandra (E), Mumbai - 400 051
Scrip Code: 532300
NSE Symbol – WOCKPHARMA
Dear Sir/Madam,
Subject: Disclosure under Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015, as amended – Investor Presentation
Pursuant to Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015, as amended, please find enclosed herewith a copy of the Investor Presentation for your records.
The said Investor Presentation has also been uploaded on the Company’s website and can be accessed through the following link:
https://www.wockhardt.com/investors/analyst-investors/presentation/
You are requested to kindly take it on record.
Thanking you, Yours Sincerely,
Rashmi Mamtura Company Secretary
Encl.: A/a.
Investor presentation
2024
1
Disclaimer
This presentation and the accompanying slides (the “Presentation") contain selected information about the activities of Wockhardt Limited ("Company") and its subsidiaries (together, the “Group") as at the date of this presentation. It does not purport to present a comprehensive overview of the Group or contain all the information necessary to evaluate an investment in the Company.
The information contained in this presentation is for information purposes only and does not constitute an offer or invitation to sell or, the recommendation or solicitation of an offer or invitation to purchase any securities of the Company in India, the United States or any other jurisdiction. This presentation should not, nor should anything contained in it, form the basis of, or be relied upon in any connection with any contract or commitment whatsoever.
This presentation is not intended to be a “prospectus” or “ or “draft offer document” or “offer document” or “final offer document” or “offer letter” or “offering memorandum”(as defined or referred to, as the case may be, under the Companies Act, 2013 and the rules notified thereunder or any other applicable law, including the Securities and Exchange Board of India (Issue of Capital and Disclosure Requirements) Regulations, 2018, as amended). It is clarified that this Presentation is not intended to be a document or advertisement offering for subscription or sale of any securities or inviting offers or invitations to offer or solicitation to offer from the public (including any section thereof) or any class of investors. This document has not been and will not be reviewed or approved by a regulatory authority in India or elsewhere or by any stock exchange in India or elsewhere. The distribution of this presentation in certain jurisdictions may be restricted by law, and the recipients into whose possession the presentation come should inform themselves about and observe such restrictions. Any decision to purchase securities in the context of an offering of securities (if any) should be made solely on the basis of information contained in the offering documentation published in relation to such offering. You will be solely responsible for your own assessment of the market and the market position of the Group, and you will conduct your own analysis and be solely responsible for forming your own view of the potential future performance of the business of the Group.
This Presentation and the information contained herein, is strictly confidential and is intended only for the exclusive use of the recipients thereof, subject to the provisions stated herein, and may not be disclosed, reproduced, published, transmitted, summarized, distributed or furnished, in or whole or in part, or passed on directly or indirectly to any other person or persons whether within or outside your organization or firm, or published in whole or in part, for any purpose by recipients directly or indirectly to any other person. Any printed form of this Presentation must be returned to us immediately at the conclusion of this Presentation. This Presentation is being communicated to selected persons who have professional experience in matters relating to investments for information purposes only and does not constitute a recommendation regarding any securities of the Group. Other persons should not rely or act upon this Presentation or any of its contents.
The Group may alter, modify or otherwise change in any manner the contents of this presentation, without obligation to notify any person of such revision or changes. This presentation may contain forward looking statements that involve risks and uncertainties. Forward looking statements are based on certain beliefs, plans and expectations of the Group about the future. Forward looking statements are not guarantees of future performance including those relating to general business plans and strategy, future outlook and growth prospects, and future developments in businesses and/or competitive and regulatory environment No representation, warranty or undertaking, express or implied, is made or assurance given that such statements, views, projections or forecasts, if any, are correct or that any objectives specified herein will be achieved. Actual future performance, outcomes and results may differ materially from those expressed in forward looking
statements as a result of a number of risks, uncertainties and assumptions. Although the Group believes that such forward looking statements are based on reasonable assumptions, it can give no assurance that such expectations will be met. Representative examples of factors that could affect the accuracy of forward looking statements include (without limitation) the condition of and changes in India’s political and economic status, government policies, applicable laws, the industries relevant to the Group in India, and international and domestic events having a bearing on the Group’s business, and such other factors beyond the Group’s control. You are cautioned not to place undue reliance on these forward looking statements, which are based on current views of the Group’s management on future events.
If the Company should at any time make an offering of securities, any decision to invest in any such offer to subscribe for or acquire securities of the Company must be based wholly on the information contained in the offer document or offering circular, placement document, and/or any international offering memorandum (including the risk factors mentioned therein) issued or to be issued by the Company in connection with any such offer and not on the contents herein. Information contained in this presentation is qualified in its entirety by reference to an offering document for any potential transaction if it proceeds. Any potential transaction could be made available to the recipient of this document in accordance with applicable laws and regulations, including the distribution of any required documents for such potential transaction and such documents will supersede all prior information provided to the recipient, herein or otherwise.
No representation or warranty express or implied) is made as to, and no reliance should be placed on, the accuracy, completeness or correctness of any information, including any projections, estimates, targets and opinions contained herein, and no liability whatsoever is accepted as to any errors, omissions or misstatements contained herein and, accordingly, none of the Group, its directors, officers or employees or its affiliates, its advisors or representatives, or any such person's officers or employees accepts any liability (in negligence or otherwise) whatsoever arising directly or indirectly from the use of this presentation.
The contents of this presentation have not been independently verified and this presentation has been prepared by the Group, solely for informational purposes Neither the delivery of this presentation nor any further discussions with any of the recipients shall, under any circumstance, create any implication that there has been no change in the affairs of the Group. This presentation is a summary only and it is not the intention to provide, and you may not rely on these materials as providing, a complete or comprehensive analysis of the financial position or prospects of the Group.
Certain data contained in this presentation was obtained from various external data sources, and none of the Group, its advisers or representatives has verified this data with independent sources Accordingly, the Group, its advisers and representatives make no representation as to the fairness, accuracy, correctness, authenticity or completeness of that data, and this data involves risks and uncertainties and is subject to change based on various factors. The information contained in this presentation is not to be taken as any recommendation made by the Group or any other person to enter into any agreement with regard to any investment. You will be solely responsible for your own assessment of the market and the market position of the Group, and you will conduct your own analysis and be solely responsible for forming your own view of the potential future performance of the business of the Group.
By participating in this Presentation, attendees agree to be bound by the foregoing limitations Any failure to comply with these restrictions may constitute a violation of applicable securities law
2
Snapshot of Wockhardt
Net sales Revenues (9M FY24)
INR 2,129 Cr.
12 manufacturing facilities across world
EBITDA (9M FY24)
INR 173 Cr.
Net Debt: Equity Ratio (as on September 30, 2023)
International Business (9M FY24)
0.27x*
78%
e r u t c u r t s a r f n I
2 R&D centres one each in India, UK
~ 315 scientists with 55 PhD’s; Drug Discovery team ~ 125 associates
3,262 patents filed; 837 patents granted
Pharma Generics
Biotechnology (focus on Diabetes)
Vaccines
New Chemical Entity (focus on novel Antibiotics)
* Excluding promoter debt & preference capital & net of Cash & cash equivalents and other Bank balances
3
Global footprint
Global operations
Capability across different segments
► Branded
► OTC
► Hospitals
► Antibiotics Drug Discovery
► Biotechnology
► Pharma Generics
► Solids
► Injectables
► Liquids
► Nasal sprays
► Biotechnology
► Complex technologies
Direct operations
Through Partners
United Kingdom
Emerging Markets
India
Ireland
USA
► Retail & Hospital
segments
► Vaccine CMO
► Presence in
Southeast Asia, East Asia, Africa, the CIS region and Latin America countries
► Pain, Diabetes,
Nephrology, CNS portfolio
► >750** field force
► Branded Generic &
OTC
► Retail pharmacies,
wholesalers & hospitals.
► Restructuring -
facility shutdown
► Shift to third party manufacturing
► Defocusing Pharma R&D
36%
21%
22%
6%
6%
*9M FY 23-24 (Others: 9%) **as on 31st December 2023
% sales revenue contribution for 9M FY23 -24
4
Financial Highlights
Net Sales Revenues INR Cr.
EBITDA INR Cr.
307
328
3,239
489
2,840 130
2,693
26
7% growth
2,129
5
1,983
24
2,710
2,750
2,667
1,959
2,124
71 98
80% growth
173 5
168
143 19
124
96 17
79
FY21
FY22
FY23
9M FY23
9M FY24
FY21
FY22
FY23
9M FY23
9M FY24
FY Figures Excl. Vaccine
FY Figures for Vaccine
9M Figures Excl. Vaccine
9M Figures Vaccine
-27
-21
5
Reduction in External Term Loans
Reduction in external term loan* (INR Cr.)
2,054
1,262
825
555
438
Mar-20
Mar-21
Mar-22
Mar-23
Sep-23
*Excluding promoter debt & preference capital
6
Net Debt : Equity @ 0.27*
Total Equity INR Cr.
Total Borrowings* INR Cr.
Total Borrowings* Reduction by > INR 600 Cr.
3,759
4,202
3,662
3,432
FY21
FY22
FY23
6M FY24
1,568
FY21
882
FY22
975
933
FY23
6M FY24
Cash & cash equivalents and other Bank balances INR Cr.
Net Debt-Equity Ratio *
292
FY21
406
FY22
124
FY23
84
6M FY24
0.42
FY21
0.21
FY22
0.27
FY23
0.27
6M FY24
* Excluding promoter debt & preference capital & net of Cash & cash equivalents and other Bank balances
7
Additional Short-term and Mid-term growth drivers
3 years growth drivers
5 years growth drivers
Diabetes Biosimilars for India + Emerging markets – Human Insulin & Glargine
Novel drug discovery - WCK 5222, Nafithromycin, Emrok
1
2
Novel drug discovery – WCK 5222, Nafithromycin, WCK 6777
Diabetes Biosimilars for India + Emerging markets – New Insulin Analogs and GLP1 Agonists
Vaccines
1
2
3
8
New Chemical Entity (Antibiotics)
9
Anti-microbial resistance (AMR) could cause 10 million deaths by 2050 ‘Tackling Drug-Resistant infections globally’ chaired by JIM O’NEILL- Former Minister, UK Govt. & Former Chairman Goldman Sachs’
A failure to address the
problem of antibiotic
Deaths attributable to antimicrobial resistance every year compared to other major causes of death
AMR in 2050 10,000,000
resistance could result in
Tetanus 60,000
Cholera 100,000-120,000
Measles 130,000
AMR 700,000
10 Million deaths
globally by 2050,
costing £ 66 trillion
http://amr-review.org/
Road traffic accidents 1,200,000
Diarrheal disease 1,400,000
Diabetes 1,500,000
Cancer 1,400,000
10
Wockhardt’s Novel Antibiotics
~25 years
Focused commitment to Novel Antibiotics research leading to end-to-end Discovery & Development capabilities
6
Programs granted QIDP* status by US FDA denoting unmet needs; faster trials, quicker approvals by US FDA
* Qualified Infectious Disease Product (QIDP) status granted by US FDA eligible for fast track development process and priority review. QIDP status also grants five
year extension to the market exclusivity in the United States
11
Novel Antibiotics pipeline encompassing all the Resistant Organisms
Gram Negative Portfolio
Gram Positive Portfolio
WCK 5222
WCK 4282
WCK 6777
Emrok / Emrok O
Nafithromycin
Status
Global Phase III ongoing
Meropenem resistant pathogen study (India)
Phase III ready
Phase I In collaboration with NIH (US)
Launched in India; Filed in Emerging Markets
Phase III completion in India
Potential Indication
cUTI, HABP / VABP (Global) + Carbapenem Resistant infections (India)
cUTI HABP / VABP
cUTI
ABSSSI
CABP / RTI
Target Market
Global
Global
Global
Emerging Market
Emerging Market
Positioning
Destination therapy for difficult-to-treat Gram-ve Klebsiella, Acinetobacter and Pseudomonas
Empiric-use; Carbapenem- sparing Gram-ve
Out-patient therapy for MDR Gram -ve
MDR Gram+ve Anti-MRSA
Macrolide-resistant Respiratory Pathogens, Quinolone-Sparing
HABP: Hospital Acquired Bacterial Pneumonia; VABP: Ventilator Acquired Bacterial Pneumonia cUTI : Complicated urinary tract infections; CABP: Community-acquired bacterial pneumonia ; RTI: Respiratory Tract Infection; ABSSSI: Acute bacterial skin and skin structure infections; MDR: Multidrug resistance ; Gram –ve: Gram Negative ; Gram +ve: Gram Positive
12
WCK 5222 Development Status (Brand name: ZaynichTM *)
WCK 5222 (Cephalosporin + β-lactam enhancer) – Destination therapy for XDR Gram Negative Acinetobacter & Pseudomonas
Pre-clinical
Phase I
Phase II1
Completed
Global Phase III (on-going)
Regulatory filings
Global Launch
► Phase I studies completed
Unmet Need
► Pulmonary PK, renal impairment and cardiovascular
safety studies completed
► Phase III clinical study based on US FDA accepted
development path
► Global Phase III cUTI study ongoing: >50% patient
recruitment completed
► Meropenem-resistant clinical study set for first patient
recruitment for early launch in India
► Patents secured in key global markets; strong IP
protection
1. Phase II waiver *- Trademark filed in India
► Carbapenem resistant Pseudomonas and Acinetobacter (20-95%)
infections are desperately treated with efficacy and safety- compromised colistin/polymyxin/tigecycline.
► WCK 5222 would provide a safer and consistently efficacious
therapy for such life-threatening infections.
Compassionate Use
100% clinical and microbiological success thus far in 15 patients with extremely difficult to treat infections, where all the available therapies failed
13
WCK 5222: Compassionate use results in 15 patients (incl. 2 paediatric) (1/2)
#.
Patients with Life threatening infections
Failed treatment
Pathogen and Drug Resistance
1
2
3
4
5
6
7
8
Complicated intra-abdominal infection induced-sepsis Febrile neutropenia, Thalassemia major, failed bone marrow transplant, bloodstream infection Acute T cell lymphoblastic leukaemia, pneumonia, bloodstream infection Lung infection leading to empyema, lung part excision with chronic pulmonary TB
Bilateral sequential lung transplant, osteomyelitis,
Osteomyelitis + maxillary sinusitis & pneumonia
Polymyxin-B (2 weeks)
XDR
Pseudomonas aeruginosa
PIP/TAZ, Meropenem, CAZ/AVI & Aztreonam
XDR
Escherichia coli
Polymyxin-B & Meropenem therapy
XDR
Pseudomonas aeruginosa
CAZ/AVI & Aztreonam (3 weeks) as well as Colistin (1 week) Multiple rounds of Tigecycline, CAZ/AVI, Meropenem Colistin, Fosfomycin (6 weeks), Meropenem (2 weeks)
Pan- drug resistant
Pseudomonas aeruginosa
MDR
MDR
Serratia marcescens
Pseudomonas Resistant to>>
Pseudomonas Resistant to>>
Osteomyelitis (bone infection of chest wall)
Colistin therapy
MDR
Bronchopleural fistula, Ventilated Pneumonia
Polymyxin-B and ceftazidime/avibactam therapy
MDR
Pseudomonas & Acinetobacter
DRUG RESISTANCE
WCK 5222
1 g u r D
R
R
R
R
R
R
R
R
2 g u r D
R
R
R
R
R
R
R
R
3 g u r D
R
R
R
R
4 g u r D
R
R
R
R
Treat- ment Duration
y c a c i f f E
y t e f a S
Outcomes
10 days ✓ ✓ • Complete
20 days ✓ ✓
resolution of infection
32 days ✓ ✓
22 days ✓ ✓
• Patient’s Clinical condition improved
S
R
22 days ✓ ✓
R
R
R
R
R
R
70 days ✓ ✓
49 days ✓ ✓
10 days ✓ ✓
• Well tolerated
• WCK 5222 was well tolerated even at adult doses in paediatric patients
Drug 1: Carbapenems ; Drug 2. Ceftazidime/ Avibactam (CAZ/AVI) Drug 3.Imipenem/ Relebactam; Drug 4.Ceftolozane/ Tazobactam
R: Resistant; S: Susceptible
14
100% clinical and microbiological success
WCK 5222: Compassionate use results in 15 patients (incl. 2 paediatric) (2/2)
DRUG RESISTANCE
WCK 5222
Patients with Life threatening infections
Failed treatment
Pathogen and Drug Resistance
#
9
10
11
Liver Transplant, HTN, Hypothroidism, Hospital- acquired Pneumonia on Ventilation Endovascular Infection Post Arterial graft
Colistin and Doripenem therapy
MDR
Pseudomonas Resistant
Urosepsis & septic shock, on ventilation & inotropic support
Colistin, Meropenem, PIP/TAZ
Multiple rounds of CAZ/AVI+Aztreonam
MDR
MDR
Pseudomonas Resistant
Pseudomonas aeruginosa
12
Pancytopenia, abscess in liver , consistent fever spikes
Colistin, CAZ/AVI+Aztreonam, Meropenem
MDR
Klebsiella pneumoniae
13
14
15
Severe septic shock, fever spikes, lung infection and required inotropic support
Bone and Joint Infection: Left malignant otitis externa w/ lateral skull base osteomyelitis
Complicated Intra Abdominal Infection with Spleen abscess (Recurrent abscess/sepsis)
Fosfomycin, Colistin and Levofloxacin
Pan-drug resistant
Pseudomonas aeruginosa
No other antibiotics tried based on past experience of treating physician
MDR
Pseudomonas aeruginosa
with Fosfomycin
MDR
Pseudomonas aeruginosa
1 g u r D
R
R
R
2 g u r D
R
R
R
3 g u r D
R
R
R
4 g u r D
R
R
R
Treat- ment Duration
y c a c i f f E
y t e f a S
12 Days ✓ ✓
14 Days ✓ ✓
30 Days ✓ ✓
Isolate not available for WCK 5222 susceptibility testing. Patient treated with WCK 5222 empirically at the discretion of clinician
30 Days ✓ ✓
R
R
R
R
R
R
R
R
R
R
R
R
5 Days ✓ ✓
42 Days ✓ ✓
28 Days ✓ ✓
Drug 1: Carbapenems ; Drug 2. Ceftazidime/ Avibactam (CAZ/AVI) Drug 3.Imipenem/ Relebactam; Drug 4.Ceftolozane/ Tazobactam
R: Resistant; S: Susceptible
100% clinical and microbiological success
Outcomes
• Complete resolution of infection
• Patient’s Clinical condition improved
• Well tolerated
• WCK 5222 was well tolerated even at adult doses in paediatric patients
.
15
Pathogens inflicting infections and associated indications while treating 15 patients with WCK 5222 in compassionate setting
Complete clinical as well as microbiological cure attained in all patients
Indication wise split for patients treated under compassionate use
Pathogen
Bone & Joint Infection**
22-70 days
4
15 patients
1
5
2
3
Complicated Intra- Abdominal Infection
28-30 days
Blood Stream infection
5-20 days
Treatment duration
cUTI with Pseudomon as Sepsis
30 days
Pneumonia (HABP, VABP, empyema)*
10-32 days
* 1/5 patients also had cIAI, 1/5 patients also had cSSSTI & BSI ** 1/4 patients also had pneumonia
Pseudomonas aeruginosa
Acinetobacter baumannii + Pseudomonas aeruginosa
Escherichia coli
Serratia marcescens
Klebsiella pneumoniae
15 Patients treated
Treatment duration
11a
5 to 70 days
1b
1c
1d
1e
10 days
20 days
22 days
30 days
a.
b. c. d. e.
9/11 patients had Colistin / Polymyxin failure; 3/11 patients had CAZ/AVI & Aztreonam failure; 1/11 patients had Fosfomycin IV failure Patient had Polymyxin & CAZ/AVI failure Patient had CAZ/AVI + Aztreonam failure Patient had CAZ/AVI & Tigecycline failure Patient had CAZ/AVI + Aztreonam & Colistin failure
Polymyxin-B / Colistin therapy had already failed in 10 out of these 15 patients; WCK 5222 dose adjustment was required in only 4 out of these 10 patients
16
WCK 5222 differentiation
Strictly confidential. Not for further circulation
Activity against resistant infection
Best comparable Pipeline Drugs
Best available Approved Drugs
Organism/ Resistance Mech.
WCK 52221
Product 1
Product 2
Product 3
Product 4
Product 5
Product 6
Product 7
Product 8
Product 9
K. pneumoniae (ESβL)
K. pneumoniae (KPC)
K. pneumoniae (MβL)
E. coli (PBP3 insert+ESBL/Class C)
E. coli (MβL± PBP3 Insert)
Enterobacter (AmpC)
Proteus (ESβL, Class C)
P. aeruginosa (AmpC + oprD +Efflux)
P. aeruginosa (Oxa, oprD + Efflux)
P. aeruginosa (MβL)
A. baumannii (CHDL, OXA)
S. maltophilia MDR/XDR
1. WCK 5222: Wockhardt’s combination of Cefepime (Cephalosporin) with Zidebactam (β-lactam enhancer); Product 1.Cefepime/taniborbactam ; Product 2.Aztreonam/avibactam ; Product 3. Cefiderocol ; Product 4.Imipenem/relebactam ;Product 5.Meropenem/vaborbactam ; Product 6.Plazomicin ; Product 7.Ceftazidime/avibactam ; Product 8.Sulbactam/durlobactam ;Product 9.Imipenem or meropenem
17
Most Isolates Susceptible
Variable Susceptibility
Most Isolates Resistant
Top 6 Super bugs inflicting global mortality in 2019 - more than 3.5 Millions deaths
Number of deaths associated with Anti-Microbial Resistance*
829,000
642,000
748,000
596,000
423,000
334,000
Acinetobacter
Escherichia Coli
Klebsiella
Pseudomonas
Staphylococcus
Pneumococcus
WCK 5222 is designed to address all the major Super Bugs including Pseudomonas, Klebsiella, E. coli and Acinetobacter
* Lancet. 2022 Feb 12;399(10325):629-655
18
Nafithromycin (Brandname: MiqnafTM *): Broad spectrum novel lactone ketolide for Community Acquired Bacterial Pneumonia (CABP) and Upper Respiratory tract infections(RTI)
1
Increasing resistance and incomplete coverage for current treatment options: • •
Azithromycin resistance in S. Pneumonia of ~65% in India** Lack of atypical pathogen coverage by Amoxicillin/Clavulanic acid
2
Nafithromycin has broad spectrum (covers entire range of gram +ve, gram -ve & atypicals) enabling monotherapy; effective against Azithromycin resistant strains / multi-drug resistance bacteria with 100% coverage based on high lung concentrations
3
4
Successfully completed phase III study with 96.77 % of cure rate in CABP and other respiratory infections, with safety profile commensurate with community usage
Lung penetration profile - Human lung exposure 8 times higher than Azithromycin
5
Ultra short duration therapy (3 day) with Once Daily dosing treatment regimen for improved patient compliance
6
Phase I and Phase II conducted by reputed global CRO’s in US & EU. Phase III completed in India and commercialization expected in short term
*- Trademark filed in India *-AMR Surveillance Network, Indian Council of Medical Research, 2022. Susceptibility and resistance to Azithromycin is determined by testing Erythromycin as per CLSI
19
EMROK & EMROK O: Multi-spectrum anti-MRSA Drug
Emrok / Emrok O®: Launched in India and filed in select Emerging markets
New Age Antibiotic : Benzoquinolizine sub-class
Multi-spectrum activity: Safe Oral and IV antibiotic with coverage of MDR Gram Positive pathogens including MRSA, Gram Negative, Anaerobic & Atypicals
EMROK & EMROK O - Only rapidly bactericidal agent available for MRSA infections with excellent penetration in Biofilms associated with Bone and Joint infections, Prosthetic Joint infections and Catheter-associated infections
20
Biotechnology
21
Strategic pillars of Diabetes Biosimilars
Focus on Diabetes Injectable portfolio
Vertically integrated
Human Insulin, Insulin Glargine commercialized
Research and Development
Yeast, mammalian and bacterial platform
Robust Pipeline of Insulin Analogs and GLP1 Agonists under development
Drug substance manufacturing
4 facilities
Drug product manufacturing
2 facilities
Patented delivery device
Disposable Pen, Reusable Pen
Business Organization
Direct presence in 10 Emerging markets (incl. India)
22
Competitive advantage by providing end-to-end solutions in Diabetes Biosimilars
Integrated capabilities
R&D
Manufacturing
Regulatory
Devices
Focus on Insulin
Pilot to large scale
Registrations in 40+
Customised precision
analogues, GLP1
capabilities for API &
countries
patented delivery
agonists
formulations
devices
Pipeline of Insulin Analogs including Insulin Aspart & Lispro
Patented delivery devices (pen)
Vials
Cartridges
Enhanced competitive posture to help penetrate markets
23
Development status of Insulin analogues and GLP-1 agonist
Aspart R
Aspart 30/70
Lispro R
Lispro 25/75
Liraglutide
Process development
Process Scale Up
Drug substance validation batches
Drug product validation batches
PK/PD study
✓
✓
✓
✓
✓
Analytical similarity
Ongoing
E.Coli host cell as platform technology for all above products ✓ Completed * To be further scaled up
✓
✓
✓
✓
✓*
✓*
✓
✓*
✓*
Planned
Planned
Planned
✓
Ongoing
Planned
24
Diabetes Biosimilars for Emerging markets - Competitive scenario
1
Limited competition
6-7 players
2
Registered in emerging markets
> 40 markets
Competitive scenario
3
4
Manufacturing infrastructure ready
Integrated end to end capabilities
API + Formulation
Development to marketing
Barriers to entry- development time, dedicated manufacturing
Under registration in 7 countries
Low cost manufacturing
Own patented device
5
Focus on Human Insulin & Insulin Glargine
> US$ 1.5 Billion market
Potential for deeper market penetration
6
Pipeline: Aspart R & Aspart Mix
~ US$ 1.1 Billion market
PK/PD development stage
25
Vaccine: Supply & Collaboration agreement with Serum at UK Facility
• Profit sharing of 51:49 with Serum Life Sciences Limited in favor of Wockhardt
• 15 years arrangement
• Reserved capacity of 150 million doses per annum
26
Abbreviation
ABSSSI: Acute bacterial skin and skin structure infections; AmpC : AmpC beta-lactamases AMR: Antimicrobial resistance API: Active Pharmaceutical Ingredient CIS: Commonwealth of Independent States CABP: Community-acquired bacterial pneumonia CHDL: Carbapenem-hydrolyzing class D β-lactamases CLSI: Clinical & Laboratory Standards Institute CMO : Contract Manufacturing Organization CNS: Central Nervous System CRO : Clinical research Organisation cUTI : Complicated urinary tract infections EBITDA: Earnings before Interest, Tax, Depreciation and Amortization ESBL : Extended Spectrum Beta-Lactamase GLP1: Glucagon-like peptide 1 GMP: Good Manufacturing Practice HABP: Hospital Acquired Bacterial Pneumonia KPC : Klebsiella pneumoniae carbapenemase
MBL : Metallo-β-lactamases MDR: Multidrug resistance MENA: Middle East and North Africa MRSA : Methicillin-resistant Staphylococcus aureus NIH (US): National Institutes of Health (NIH), OD: Once a day OTC : Over the counter PBP3: Penicillin-binding protein 3 PK/PD study : Pharmacokinetic-Pharmacodynamic R&D: Research and Development RTI: Respiratory Tract Infection; USFDA : United States Food and Drug Administration. VABP: Ventilator Acquired Hospital Pneumonia WCK 4282: Cefepime/Tazobactam WCK 5222: Cefepime/Zidebactam WCK 6777: Ertapenem/Zidebactam XDR : Extensively Drug Resistant
27
Thank You
28