Zydus Lifesciences Limited has informed the Exchange about Investor Presentation
August 10, 2022
Listing Department BSE LIMITED P J Towers, Dalal Street, Fort, Mumbai–400 001
Listing Department NATIONAL STOCK EXCHANGE OF INDIA LIMITED Exchange Plaza, Bandra Kurla Complex, Bandra (E), Mumbai–400 051
Re:
Investor Presentation
Dear Sir,
Code: 532321
Code: ZYDUSLIFE
Please find attached the Investor Presentation on the unaudited financial results for the quarter ended on June 30, 2022.
Please find the same in order.
Thanking you,
Yours faithfully, For, ZYDUS LIFESCIENCES LIMITED
DHAVAL N. SONI COMPANY SECRETARY
Encl.: As above
Zydus Lifesciences Limited Earnings Presentation 10th August, 2022
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Disclaimer and Safe Harbor Statement
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THIS PRESENTATION (PRESENTATION) IS NOT AN OFFER TO SELL ANY SECURITIES OR A SOLICITATION TO BUY ANY SECURITIES OF ZYDUS LIFESCIENCES LIMITED OR ITS SUBSIDIARIES OR JOINT VENTURES (TOGETHER, THE “COMPANY”). The material that follows is a Presentation of general background information about the Company’s activities as at the date of the Presentation or as otherwise indicated. It is information given in summary form and does not purport to be complete and it cannot be guaranteed that such information is true and accurate. This Presentation has been prepared by and is the sole responsibility of the Company. By accessing this Presentation, you are agreeing to be bound by the trading restrictions. It is for general information purposes only and should not be considered as a recommendation that any investor should subscribe / purchase the Company shares. This Presentation includes statements that are, or may be deemed to be, “forward-looking statements”. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes”, “estimates”, “anticipates”, “projects”, “expects”, “intends”, “may”, “will”, “seeks” or “should” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, aims, objectives, goals, future events or intentions. These forward-looking statements include all matters that are not historical facts. They appear in a number of places throughout this Presentation and include statements regarding the Company’s intentions, beliefs or current expectations concerning, amongst other things, its results or operations, financial condition, liquidity, prospects, growth, strategies and the industry in which the Company operates.
By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. Forward- looking statements are not guarantees of future performance including those relating to general business plans and strategy of the Company, its future outlook and growth prospects, and future developments in its businesses and its 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 the objectives of the Company will be achieved. There are some important factors that could cause material differences to Company’s actual results. These include (i) our ability to successfully implement our strategy (ii) our growth and expansion plans (iii) changes in regulatory norms applicable to the Company (iv) technological changes (v) investment income (vi) cash flow projections etc.
The Company, as such, 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 or opinions contained herein. The information contained in this Presentation, unless otherwise specified is only current as of the date of this Presentation. The Company assumes no responsibility to publicly amend, modify or revise any forward looking statements, on the basis of any subsequent development, information or events, or otherwise. Unless otherwise stated in this Presentation, the information contained herein is based on management information and estimates. This document is just a Presentation and is not intended to be a “prospectus” or “offer document” or a “private placement offer letter” (as defined or referred to, as the case may be, under the Companies Act, 2013). It is clarified that this Presentation is not intended to be a document offering for subscription or sale of any securities or inviting offers from the Indian public (including any section thereof) or from persons residing in any other jurisdiction including the United States for the subscription to or sale of any securities including the Company’s equity shares. No part of it should form the basis of or be relied upon in connection with any investment decision or any contract or commitment to purchase or subscribe for any securities. None of the Company’s securities may be offered or sold in the United States without registration under the U.S. Securities Act of 1933, as amended, except pursuant to an exemption from registration there from. This document has not been and will not be reviewed or approved by a regulatory authority in India or by any stock exchange in India. This document and its contents should not be forwarded or delivered or transmitted in any manner to any person other than its intended recipient, and should not be reproduced in any manner whatsoever.
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Q1 FY23: Financial Performance
Total Revenues*
R&D
Key Highlights of Q1 FY23
Rs. 40,727 mn 2% YoY
Rs. 2,842 mn 7% of revenues
❑ Ex-COVID related business, total revenues grew 11% yoy.
❑ Branded portfolio of India formulations business continued to progress well (up 9% yoy, ex-COVID) with market share gain in key therapy areas.
EBITDA & Margin %
Rs. 8,330 mn 20.5% of revenues 14% YoY
Net Profit ex. Exceptional & Disc. Ops ^
❑ Consumer Wellness business rebounded on the back of robust performance of summer heavy brands viz. Glucon-D and Nycil.
Rs. 5,295 mn 11% YoY
❑ US formulations business grew on the back of volume expansion and
new launches during the quarter.
❑ Research & Development (R&D) spend: at Rs.2,842 mn (7% of revenues).
Revenue Break-up (Rs. mn) and YoY Growth
❑ Net cash: Rs. 5,628 mn (at 30-Jun’22) vs Rs. 569 mn (at 31-Mar’22).
3% -10% -6%
14%
Total 39,229 1%
9%
-17%
18%
❑ Capex for the quarter: Rs. 2,828 mn.
Moraiya USFDA Inspection Update
❑ USFDA inspected the facility from 26th July to 5th August,2022.
❑ Inspection concluded with four Form 483 observations, none of which
were related to data integrity.
Note: * Total Revenues include net sales and other operating income. ^ Adjusted for exceptional items and loss from discontinued operations.
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India Form11,251 ConsumerWellness6,916 US15,592 EM3,155 EU614 API1,224 Alliances477 Key Financial Metrics (1/2)
Total Revenues (Rs. mn)
Gross Profit (Rs. mn)
Total R&D (Rs. mn) and % to Revenues
EBITDA ex. one-offs (Rs. mn) and Margin %
7.3%
5.9%
7.0%
7.0%
7.0%
24.3%
25.0%
20.6%
22.3%
20.5%
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40,018 37,598 36,398 38,638 40,727 Q1FY22Q2FY22Q3FY22Q4FY22Q1FY2326,468 23,988 23,064 23,679 25,634 Q1FY22Q2FY22Q3FY22Q4FY22Q1FY232,935 2,222 2,553 2,697 2,842 Q1FY22Q2FY22Q3FY22Q4FY22Q1FY239,719 9,393 7,516 8,612 8,330 Q1FY22Q2FY22Q3FY22Q4FY22Q1FY23Key Financial Metrics (2/2)
PAT ex. Exceptional, One-offs and Discontinued ops.(Rs. mn)
Capex (Rs. mn)
Net Debt/ EBITDA
Net Working Capital* (Rs. mn)
*Net working capital includes Inventory, Trade receivables and Trade payables.
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5,972 6,697 5,069 5,250 5,295 Q1FY22Q2FY22Q3FY22Q4FY22Q1FY232,650 2,800 3,100 2,668 2,828 Q1FY22Q2FY22Q3FY22Q4FY22Q1FY230.87 0.11 0.09 -0.02 -0.18 Q1FY22Q2FY22Q3FY22Q4FY22Q1FY2342,786 46,054 48,765 49,219 51,218 Q1FY22Q2FY22Q3FY22Q4FY22Q1FY23India Formulations business
Focus on execution to accelerate growth
Highlights for the quarter
Q1 FY23 Revenue Contribution
▪ Branded prescription business grew by 9% YoY, ex-COVID opportunities, Gx portfolio and divested products,.
29%
▪ Gained market share and improved ranking in key
therapies viz. cardiovascular, gynecology, respiratory and pain management on a YoY basis#.
Q1 FY23 Gr.
YoY
QoQ
-17.1%
-3.3%
Large brands - a key growth driver
TA-wise Break-up*
Brand Value (Rs. Mn)*
1000+
500 to 1000
250 to 500
# of Brands
9
27
38
▪
Lipaglyn® stood at 66th position# in Indian Pharma Market (IPM) viz-a-viz 79th rank during Q4 FY22.
▪ On the Super Specialty front,
➢ Retained leadership position in Nephrology
segment* and
➢ Gained multiple ranks in Oncology segment and
are now amongst top two players in India.
*Source: AWACS MAT Jun 22 #Source: AWACS Apr – Jun 22
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13,566 12,134 10,785 11,640 11,251 Q1FY22Q2FY22Q3FY22Q4FY22Q1FY23India Formulations Sales (Rs. mn)Anti-infectives14%Cardiac15%Derma6%GI11%Gynae6%Pain10%Respi10%Others28%Consumer Wellness
The business rebounded and registered strong growth
Highlights for the quarter
Q1 FY23 Revenue Contribution
▪
Timely onset of summer and improved distribution reach helped to re-recruit consumers for summer heavy brands like Glucon-D and Nycil.
18%
Both brands grew in double digits during the quarter.
Q1 FY23 Gr.
YoY
QoQ
18.0%
9.3%
Key brands continued to hold dominant market share
▪ Gross margins improved sequentially on the back of price increase, cost improvement measures and product mix.
▪
Inflation showed signs of moderation as key input prices eased towards the end of the quarter.
Brand Name
Market Share#
60.4%
34.2%
95.5%
6.6%
41.8%
76.0%
4.8%
Facial Cleansing *
Scrub
Peel Off
#Source: Nielsen and IQVIA MAT June 2022 report * Facial cleansing segment includes Face wash, Scrub and Peel-off.
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5,862 3,774 3,822 6,330 6,916 Q1FY22Q2FY22Q3FY22Q4FY22Q1FY23Consumer Wellness Sales (Rs. mn)US Formulations business
Consolidating the position amidst challenging environment
Highlights for the quarter
Q1 FY23 Revenue Contribution
▪ Maintained top 3 ranking in ~ 60% of the product
families in the US.
$ 194 mn
$ 199 mn
$ 199 mn
$ 189 mn
$ 202 mn
40%
Q1 FY23 Gr.
YoY
QoQ
9.2%
10.0%
Continued investment to build the generics pipeline
ANDAs
Filings
Approvals
Q1 FY23
Cumulative
8
7^
428
315
▪
▪
▪
▪
▪
Received 7 new product approvals (incl. 1 tentative approval) and launched 8 new products.
Approvals for the quarter include 1 first cycle approval.
Filed 8 ANDAs during the quarter including 3 filings designated as Competitive Generic Therapies (CGT).
113 ANDAs pending approval with the USFDA.
On the Specialty front, commenced commercial shipment of NULIBRY® (Fosdenopterin for Injection) during the quarter.
^ includes 1 tentative approval.
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14,279 14,734 14,892 14,233 15,592 Q1FY22Q2FY22Q3FY22Q4FY22Q1FY23US Formulations Sales (Rs. mn)Emerging Markets Formulations business
Base business continued to display growth
Highlights for the quarter
Q1 FY23 Revenue Contribution
▪ With receding impact of pandemic, the business grew in double digit. The growth was broad based across most of the geographies.
8%
▪
Filed 1 new product dossier with ANVISA and received approval for 3 new products during the quarter.
Q1 FY23 Gr.
YoY
QoQ
13.9%
14.7%
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2,770 3,487 2,914 2,750 3,155 Q1FY22Q2FY22Q3FY22Q4FY22Q1FY23EM Formulations Sales (Rs. mn)Updates on Innovation
NCE: Saroglitazar Magnesium
• Global pivotal Phase II(b)/III CT viz. EPICS-IIITM to evaluate the efficacy and safety of the molecule in patients with PBC and
Phase II global CT for NASH/ Fibrosis are ongoing for the US market.
• Clinical trials are currently ongoing for PCOS and NAFLD indications.
• Completed hepatic impairment studies in NASH and normal PBC patients, results of which will be submitted in near-term.
NCE: Desidustat
• Completed Phase I(b) CT in the US for CIA in cancer patients.
• Pre-IND meeting with the USFDA is scheduled in current quarter to seek further guidance.
NCE: ZYIL1 (NLRP3 inhibitor)
▪ Completed recruitment of patients for Phase II CT in Australia.
▪ Plan to initiate global pivotal CT in the near-term.
▪ The molecule is targeted at Cryopyrin-Associated Periodic Syndrome (CAPS), a rare indication.
CT = Clinical Trial; NASH = Non-Alcoholic Steatohepatitis, PBC = Primary Biliary Cholangitis, CIA = Chemotherapy Induced Anemia
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Updates on Innovation
Biosimilars
• Received marketing approval for drug substance of biosimilar Adalimumab from the Russian regulatory authority.
• Continue to file new products in existing emerging market countries and enter new markets through partnerships to ensure
long-term, sustainable growth for the business.
505(b)(2) and Specialty initiatives
• Continue to run various programs to expand awareness and early diagnosis of Molybdenum cofactor deficiency (MoCD) type
A and Menkes diseases, both of which are life-threatening, paediatric genetic disorders.
• Recently, Nulibry® received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Nulibry®
for the treatment of patients with Molybdenum Cofactor deficiency (MoCD) Type A.
• The brand also received Industry Innovation Award, 2022 from the National Organization for Rare Disorders (NORD), US.
mAb= monoclonal antibody
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Zydus at a Glance
>$2 bn
Global Revenues1
5th
Largest generic Co. in US in terms of prescription3
7
R&D Centers For NCE, APIs, Gx formulations, Biosimilars and Vaccines
Over 50%
Revenues from branded business (India, EM and Wellness)
Among Top 3
In 60% of product families marketed in US4
1st
Approved product for NASH in India - (Bilypsa® - Saroglitazar)
$4.6 1st bn
Market Capitalization2
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Brands among Top 300 in India5
1st 1st
OSD formulation for anemia associated with CKD – OxemiaTM (Desidustat)
35 Mfg. sites Producing
Biosimilars (pipeline & launched) & 7 novel >28 bn pills annually products (pipeline)
23 K
Biosimilars (pipeline & Zydans globally incl. launched) & 7 novel 1400 scientists (R&D) products (pipeline)
22 Biosimilars in portfolio
Biosimilars (pipeline & including 13 launched in launched) & 7 novel India products (pipeline)
1. 2. 3.
In FY22, assuming exchange rate of Rs. 74.5 per USD As on 8th August, 2022, exchange rate of Rs. 79.5 per USD IQVIA Regulatory Insights, MAT June 2022 TRx
4. IQVIA Regulatory Insights, June 2022 TRx 5. As per AWACS MAT June 2022
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Consolidated Financial Performance (reported)
Comments for Q1 FY23:
•
•
•
YoY decline in GC is due to
pricing pressure in the US and
input cost increase.
QoQ growth in employee benefit
expenses
is
due
to
yearly
increments,
one-time
performance link reward and
actuarial valuation impact.
Net Profit adjusted for one-time
inventory provision,
loss from
disc.
ops.
and
exceptional
expenses was 5,295 mn, down
11% YoY and up 1% QoQ.
* Excludes Research related expenses # Discontinued operations refer to expenses incurred in connection with cessation of operations of one of the manufacturing facilities of Zydus Wellness Ltd.
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Rs. mnQ1 FY23Q1 FY22YoYgr.Q4FY22QoQgr.Total Income from Ops.40,727 40,018 1.8%38,638 5.4%Gross Contribution (GC)25,634 26,468 -3.2%23,680 8.3%Gross Margin %62.9%66.1%61.3%Employee benefits expenses *6,042 5,674 6.5%5,401 11.9%R&D expenses2,842 2,935 -3.2%2,697 5.4%Other operating expenses8,420 8,140 3.4%8,405 0.2%EBITDA8,330 9,719 -14.3%7,177 16.1%EBITDA Margin %20.5%24.3%18.6%Other Income659 316 108.5%791 -16.7%Finance cost343 273 25.6%385 -10.9%Depreciation and amortization1,807 1,733 4.3%1,854 -2.5%Profit before exceptional items6,839 8,029 -14.8%5,729 19.4%Profit after exceptional items6,810 8,029 -15.2%5,729 18.9%Tax expenses1,184 1,574 -24.8%1,092 8.4%Share of profit from JVs221 70 215.7%46 380.4%Profit from discontinued operations #-83 -100 17.0%-150 44.7%Minority Interest581 553 5.1%559 3.9%Reported Net Profit5,183 5,872 -11.7%3,974 30.4%Details of Exchange Rate Fluctuations
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Rs. mnQ1 FY23Q1 FY22YoYgr.A. On operating transactions (above EBIDTA line)-998 -481 -107.6%a. Included in other operating income-1,083 -527 -105.5%b. Included in COGS86 47 83.9%c. Included in other operating expenses- - B. On other income-149 -182 18.1%C. On foreign currency borrowings (part of finance cost)1 - Total Exchange Rate Fluctuations ('+' = loss, '-' = gain)-1,146 -663 -72.9%Thank you
For any queries, please contact Arvind Bothra Arvind.Bothra@zyduslife.com +91-79-71800839
For more information, please visit www.zyduslife.com
Registered Office:
Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej-Gandhinagar Highway, Ahmedabad – 382 481 Gujarat, India