Bengaluru, India, 23^rd August, 2025 : Zydus Lifesciences Limited (including its subsidiaries/affiliates hereafter referred to as “Zydus”) an innovation-led global lifesciences company held a health symposium at Bengaluru to create a convergence of leading healthcare professionals who spoke on the transition to a new influenza vaccination guideline, as recommended by the World Health Organisation (WHO) for Northern hemisphere 2025-26.

Global influenza remains a significant public health concern, causing an estimated 400,000 respiratory and 300,000 deaths across the world annually¹. In US and Europe almost 50% of the population is vaccinated for seasonal flu annually¹. India which successfully leads the universal immunisation programme (UIP), has been able to counter several debilitating childhood vaccine preventable diseases. However, in India the flu vaccination is an unmet need and has less than 1.5 % of the population getting vaccinated.

Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Limited said, “Good health starts with prevention, and vaccines play a key role in protecting people and improving health. Influenza continues to pose a recurring challenge, leading to seasonal outbreaks and placing a considerable burden on healthcare systems. Vaccination plays a vital role in reducing the spread of infection, lowering the severity of disease, and preventing complications, especially among high-risk and vulnerable groups. At Zydus, we are committed to advancing preventive healthcare by promoting timely vaccination and raising awareness about its importance in controlling influenza and safeguarding public health.”

As per WHO’s 2025-26 recommendations of NH strains, the persistent absence of naturally occurring B/Yamagata lineage viruses since March 2020 indicates a very low risk of infection². Consequently, the inclusion of a B/Yamagata antigen in quadrivalent influenza vaccines is no longer considered necessary. Aligning with this, the CDC has excluded the B/Yamagata component from all U.S. influenza vaccines starting with the 2024–25 season³. This decision reflects global surveillance data and aims to streamline vaccine composition for improved efficacy and production efficiency.

National Centre for Disease Control (NCDC), India has also recommended to follow the WHO guidelines to adopt the latest strain of the vaccine, to prevent influenza and influenza-like illnesses which is emerging as a serious health concern⁴. The disease disproportionately affects vulnerable populations such as infants, the elderly, and individuals with chronic conditions.

Seasonal influenza infections happen in India throughout the year, with twin peaks during the monsoon and winter seasons⁵. Every year influenza causes substantial disease and deaths, but estimating the number of deaths due to influenza is challenging as routine testing and robust surveillance for influenza is not carried out and it is rarely certified as a cause of death⁵. Significantly, out of 1.27 lakh deaths attributed to influenza per year, almost 65% of the deaths occurred among older persons above 65 yr and 15-20 per cent were among children under five⁵. This necessitates annual vaccinations of the nationally defined target groups with vaccine composition depending on the current circulating strains.

Zydus, which is one of the largest manufacturers of flu vaccines in India has been advocating preventive health and timely vaccination to prevent influenza, influenza like illnesses and other related complications in high-risk group in vulnerable population. Influenza is a highly contagious respiratory illness caused by influenza viruses which spreads from person to person, mainly through airborne respiratory droplets generated from coughing and sneezing or direct contact with an infected surface or individual.

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Bengaluru, August 7, 2025 : Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received NOC (Notice of Compliance) from Health Canada for ZDS-Varenicline tablets 0.5 &1 mg. This is the group’s first NOC approval in Canada.

Varenicline is used as an aid in smoking cessation. It is a partial nicotinic acetylcholine receptor agonist, designed to partially activate this system while displacing nicotine at its sites of action in the brain.

ZDS-Varenicline tablets will be produced at Zydus Lifescience Ltd, SEZ, Ahmedabad. Varenicline tablets had annual sales of 15 mn Canadian dollar in Canada (IQVIA MAT December 2024).

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Key Financial Highlights 

Q2 FY24 Highlights 

• Revenue from operations at Rs. 43,688 mn, up 9% over last year. 
• Research & Development (R&D) investments for the quarter stood at Rs. 3,225 mn  (7.4% of revenues).  
• EBITDA for the quarter was Rs. 11,461 mn, up 41% YoY. EBITDA margin for the quarter  stood at 26.2%, an improvement of 580 bps on a YoY basis. 
• Net Profit for the quarter was Rs. 8,007 mn, up 53% YoY. 
• Capex (organic) for the quarter was Rs. 2,162 mn. 

H1 FY24 Highlights 

• Revenue from operations at Rs. 95,084 mn, up 19% over last year. 
• Research & Development (R&D) investments stood at Rs. 6,464 mn (6.8% of  revenues).  
• EBITDA was Rs. 26,514 mn, up 61% YoY. EBITDA margin stood at 27.9%, an  improvement of 720 bps over the previous year. 
• Net Profit was Rs. 18,876 mn, up 81% YoY. 
• Capex (organic) for the half year was Rs. 4,365 mn. 

Consolidated Financial Results

Rs. mn                                      Q2 FY24      Q2FY23      % Gr. y-o-y     Q1  FY24     % Gr. q-o-q 

Revenue from Operations      43,688         40,055         9.1%               51,396          -15.0%

EBITDA                                      11,461          8,153           40.6%            15,053          -23.9%

EBITDA margin (%)                  26.2%           20.4%                                 29.3%  

PBT                                            10,072          6,428           56.7%            13,292          -24.2%

Net Profit                                   8,007            5,225           53.2%            10,869          -26.3% 

Rs.  mn                                         H1 FY24       H1 FY23      % Gr. y-o-y 

Revenue from Operations         95,084           79,698          19.3%

EBITDA                                         26,514           16,483          60.9%

EBITDA margin (%)                     27.9%            20.7%  

PBT                                               23,364           13,238          76.5%

Net Profit                                     18,876           10,408          81.4% 

Our Q2 FY24 result represents stable growth in our key businesses, as well as strong  profitability. We are on track to meet our growth objectives for the year. Going ahead,  differentiated launches in the US, in addition to a rebound in India business growth which  was constrained by delayed seasonality, will be critical drivers. We anticipate sustained  momentum in profitability and aim for EBITDA margins of more than 24% in the current  fiscal year. 

–  Dr. Sharvil Patel, Managing Director – Zydus Lifesciences Limited

Q2 FY24 Business-wise Sales Performance (Consolidated)

Rs. mn                                       Q2 FY24       Q2 FY23      % Gr. YoY      Q1 FY24      % Gr. QoQ 

India Geography:                     17,693          16,875         4.8%              19,206          -7.9%

Formulations                             13,341           12,648          5.5%              12,270            8.7%

Consumer Wellness                  4,352             4,227            3.0%               6,936            -37.3% 

US Formulations                      18,648          17,084         9.2%              24,541          -24.0%

EM & Europe Formulations     4,504            3,849          17.0%             4,893            -8.0%

APIs                                            1,402            1,117           25.5%            1,389             0.9%

Alliances & Others                   339                501             -32.3%           499                -32.1% 

Consolidated Revenues          42,586          39,426        8.0%              50,528           -15.7%

H1 FY24 Business-wise Sales Performance (Consolidated)

Rs. mn                                          H1 FY24           H1 FY23        % Gr. YoY 

India Geography:                        36,899              35,042            5.3%

Formulations                                 25,611              23,899            7.2%

Consumer Wellness                     11,288               11,143           1.3% 

US Formulations                          43,189              32,676          32.2%

EM & Europe Formulations        9,397                 7,618            23.4%

APIs                                                2,791                2,341            19.2%

Alliances & Others                       838                    978               -14.3% 

Consolidated Revenues              93,114              78,655         18.4% 

Q2 FY24 Business Updates

India Geography 

• Comprises of Formulations as well as Consumer Wellness businesses and  accounted for 42% of consolidated revenues. 
• Registered revenues of Rs. 17,693 mn, up 5% y-o-y.  

Formulations business 

• Registered revenues of Rs. 13,341 mn, up 6% y-o-y.  
• Branded formulations business grew in high single digit adjusting for NLEM  impact and was partly affected by delay in acute season. 
• The business accounted for 32% of consolidated revenues. 
• Gained market share and improved ranking in anti-diabetic and respiratory therapies during the quarter on a y-o-y basis (Source: IQVIA Jul – Sep 23 data). 
• On the super specialty front, retained leadership position in the Nephrology  segment while in the Oncology space, remained the fastest growing company.  

Consumer Wellness business 

• Registered revenues of Rs. 4,352 mn, up 3 % y-o-y. Consumer Wellness business  accounted for 10% of consolidated revenues. 
• Personal care segment, which comprises of Nycil and EverYuth brands,  registered robust growth driven by favorable season in many parts of the  country. 

US formulations business 

• Registered revenues of Rs. 18,648 mn, up 9% y-o-y and down 24% q-o-q. The  business accounted for 44% of consolidated revenues. 
• In constant currency terms, the business registered revenues of US$ 225 mn.  • Launched 8 new products during the quarter. 
• New launches include Indomethacin suppository which was granted 180 days of  Competitive Generic Therapy (CGT) exclusivity and Plerixafor injection which was  a Day 1 launch. 
• Filed 4 ANDAs and received approval for 9 ANDAs during the quarter. 

Emerging Markets (EM) and Europe formulations business 

• Registered revenues of Rs. 4,504 mn, up 17% YoY. The business accounted for  10% of consolidated revenues. 
• The business continued to deliver healthy growth with all major markets  contributing to the growth during the quarter. 

API business 

• Registered revenues of Rs. 1,402 mn, up 26% y-o-y. The business accounted for  3% of consolidated revenues. 

Alliances & Others 

• Registered revenues of Rs. 339 mn, down 32% y-o-y. The business accounted  for 1% of consolidated revenues. 

Updates on Operations and Compliance

• Received Establishment Inspection Reports (EIR) from the USFDA for the  inspections of Oral Solid Dosage (OSD) facilities I and II located in Ahmedabad  SEZ and Biologics fill-finish facility located at Zydus Biotech Park in Changodar (near Ahmedabad). 

Updates on Innovation Pipeline 

NCE: ZYIL1 

• Initiated Phase II clinical trials in patients with Amyotrophic Lateral Sclerosis  (ALS).  
• ALS is a rare, progressive and fatal neurodegenerative disease, with an average  life expectancy of 3 to 5 years from the time of symptom onset. 

NCE: PCSK9 inhibitor 

• Received approval from the CDSCO to initiate Phase I clinical trials to evaluate  the safety and tolerability. The molecule will be administered subcutaneously in  healthy human volunteers. 
• Dyslipidemia patients with high LDL cholesterol are at a high risk of  atherosclerotic cardiovascular disease (ASCVD), such as heart attack and stroke. 
• This PCSK9 inhibitor will regulate the levels of LDL receptors, which are  responsible for the uptake and clearance of cholesterol from the blood. 

Biotech R&D 

• Completed clinical trials for one monoclonal antibody (mAb) and completed  recruitment of patients for clinical trials for another mAb. 
• Received regulatory approval to initiate Phase III clinical trials for one more  product. 

Specialty Initiatives 

• Received final approvals from the USFDA for two New Drug Applications (NDAs)  viz. Sitagliptin tablets (ZITUVIOTM)and Sitagliptin and Metformin IR tablets  (ZITUVIMETTM) in the area of metabolic disorder management.  
• Filed one more NDA viz. Sitagliptin and Metformin ER tablets in the area of  metabolic disorder management.  

Other Updates

• Acquired UK headquartered LiqMeds Group of companies which has the  capabilities and specialization in development, manufacturing and supply of oral  liquid products for global markets. 
• LiqMeds has a rich pipeline of differentiated products which includes many  505(b)(2) and FTF/ FTM products. 
• The acquisition is in line with the strategy to expand the presence in the specialty  space and offer novel solutions to satisfy unmet medical needs. 

Q2 FY24 Earnings Call Details 

The Company will host its post results earnings call at 4:00 p.m. IST on 7th November,  2023 during which the leadership team will discuss the financial performance and  address questions from the participants. 

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