The Board of Jubilant Pharmova Limited met today to approve financial result for the quarter & year ended March 31, 2023.

Financial Results Overview Q4’FY23 - Consolidated (Rs Crs)

• Impairment: In Q4’FY23, the Company booked an impairment charge of Rs 171 Crs related to certain intangible assets.

• Impairment of Intangible Assets figure is included under the ‘Depreciation and Amortisation’ head in P&L
• Normalised Profit Before Tax / PAT is after adjusting for impairment of intangible assets charge

Financial Results Overview FY23 - Consolidated (Rs Crs)

Q4 & FY23 – Adjusted Financials (Rs Crs)

• Adjustments include non-recurring / one-off revenues related to Remdesivir sales, one-time customer settlement in Generics business and Covid related revenues in CDMO Sterile Injectables business

Key Ratios FY23 – Consolidated (Rs Crs)

Financial Highlights – Radiopharmaceuticals (Rs Crs)

Key Priorities – Radiopharmaceuticals

• Maintain leadership position in stable high margin core portfolio in North America, e.g., lung functional imaging and thyroid targeted radiotherapeutics
• Innovation leader in PET cardiac imaging through proprietary RUBY-FILL (best in class cardiac imaging product). Further accelerate Ruby-Fill installs in US and other global markets.
• Timely execution of roadmap to enable FY-25 launch of MIBG
  • Targeting pediatric patients with high-risk Neuroblastoma. Incidence in the US is 800 (orphan drug) cases per year
  • Peak potential market size for MIBG is around USD 240 Mn
• Continue launch of high-growth innovation products, e.g., MAG-3 Mertiatide

Financial Highlights – Radiopharmacies (Rs Crs)

Key Priorities – Radiopharmacies

• Accelerate sales of high growth new products, e.g., Ga-PSMA, and to further gain market share in existing SPECT products
• Maintain current momentum of strong growth in merchant sales
• Leverage existing cyclotrons to capture share of PET product growth
• Additionally, explore opportunity to further expand presence into PET radiopharmacies, due to strong demand of PET products, such as PET-PSMA
• Continue to enhance operational and procurement efficiencies leading to improvement in financial performance in FY24

Financial Highlights – Allergy Immunotherapy (Rs Crs)

Key Priorities – Allergy Immunotherapy

• #2 player in US Sub-Cutaneous Immunotherapy market (Venom and Non-Venom) of >$200M. High barriers to entry as products are branded biologicals with regulatory approvals grandfathered in
• Further strengthen the prescriber base for Venom immunotherapy in the US through continuous brand building. Sole supplier of venom in US
• Focus on increasing market share in Non Venom Allergenic extracts (e.g., Dog, Cat, Mite allergy) and Skin Testing Devices in US. #2 player in US
• Gain market share in Europe and other non-US markets across Venom product category

Financial Highlights – CDMO Sterile Injectables (Rs Crs)

Key Priorities – CDMO Sterile Injectables

• Global Fill and Finish Sterile Injectable markets of USD 13Bn, with double digit growth rate projected over next 5 years
• Focus is on-time and at-cost execution of USD 370Mn capacity expansion in Spokane and Montreal, to double the CMO capacity over next 5+ years in a phased manner
• Cooperative agreement with US Govt. for USD 149.6 Mn and concessional loan from Canadian Govt. for ~USD 48 Mn
• Leverage differentiated technical know-how to further build scale, e.g., Hormones, Ophthalmic, Vaccines etc.

Financial Highlights – Generics (Rs Crs)

Key Priorities – Generics

• Continue quality improvement initiatives and engagement with the US FDA for resolution of Import Alert at the Roorkee facility.
• Salisbury site is compliant with US FDA. Roorkee site is compliant with other key non-US markets, e.g., MHRA, Japan, South Africa, Canada.
• Focus on implementation of Rs 150 Cr cost optimization opportunities. Benefits will start reflecting in performance from Q1’FY24 onwards
• Re-prioritise geography-mix to accelerate growth in branded markets such as India and select International markets
• Continue to strengthen leadership position in select products across markets

Financial Highlights – Drug Discovery Services (Rs Crs)

Key Priorities – Drug Discovery Services

• Leverage state of the art infrastructure and differentiated technical know-how, e.g., Integrated Drug Discovery, DMPK to drive new customer acquisitions in drug discovery.
• Continue to invest in capabilities for improving productivity, speeding up time to market and lowering cost of innovation.
• Further strengthen the CDMO contract pipeline within existing and new technologies.
• Ensure timely and at-cost completion of the upcoming new block at the Greater Noida facility to cater to increasing customer demand

Financial Highlights – CDMO - API (Rs Crs)

Key Priorities – CDMO - API

• In March 2023, the API plant at Nanjangud saw reversal of OAI status to compliant VAI status from USFDA, driven by Quality Improvement Initiatives at site.
• Going forward, focus is to drive higher capacity utilization including through launch of new products and by acquiring new customers globally
• Operations transformation program underway to increase productivity while lowering costs. Benefits will start becoming visible from H2’FY24.

Key Priorities – Proprietary Novel Drugs

• Clinical stage precision therapeutics business advancing potent and selective small molecules to address unmet medical needs in oncology and autoimmune diseases
• Wholly owned assets; opportunities to explore institutional funding, as well as maximize partnerships to get non-dilutive funding
• Emphasis on cost optimized operating model with a focus on value creation
• Business’ most advanced program - first in class dual inhibitor of LSD1/HDAC6 in undergoing Phase I/II clinical trials
• Another program – PRMT5 Brain penetrant has received IND approval
• IND approval for another two programs are expected in FY24

Segment Financial Results - Consolidated (Rs Crs)

Jubilant Therapeutics Inc.’s Selective, Orally Administered PAD4 Inhibitor Demonstrates Activity in Rheumatoid Arthritis Preclinical Models

Research conducted in collaboration with Boston Children’s Hospital and published in the peer-reviewed journal - Scientific Reports

Bedminster, New Jersey, United States:  April 13, 2023 – Jubilant Therapeutics Inc., a clinical stage biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced publication of novel research demonstrating that a highly selective, non-competitive and orally administered inhibitor of Protein Arginine Deiminase 4 (PAD4), showed remarkable efficacy in two animal models of Rheumatoid Arthritis (RA). Correlative in vitro studies confirmed that PAD4 inhibition acts by inhibiting NETosis, a fundamental pathophysiological mechanism in the establishment of many autoimmune diseases. The research was conducted in collaboration with Prof. Denisa Wagner a pioneer in PAD4 target space, at the Boston Children’s Hospital.

The research was published in Scientific Reports (https://doi.org/10.1038/s41598-023-30246-2).

“We are evaluating several selective, oral PAD4 inhibitors that have emerged from our TIBEO discovery engine for the treatment of both autoimmune diseases and cancer,” said Luca Rastelli, Ph.D., Chief Scientific Officer, Jubilant Therapeutics Inc. “Previous research on PAD4 activity and the resulting citrullinated proteins has implicated this target in the genesis of autoimmune diseases, therefore making the development of selective, orally available PAD4 inhibitors a valuable option for patients. The results presented in this paper showed substantial improvement in symptoms, molecular biomarkers and in the bone and tendons damage that result from RA. They also confirmed the underlying mechanism of action building on earlier research on PAD4 inhibition. We are now planning to select a lead PAD4 inhibitor candidate and will be progressing it for IND enabling studies.”

PAD4 is an enzyme that catalyzes citrullination of proteins and the release of neutrophil extracellular traps (NETs). Its role in autoimmune diseases has been established through clinical genetics and gene knock out studies in mice. This study evaluated an oral, highly selective PAD4 inhibitor, both in vitro and in two RA animal models. In human and mouse neutrophils, PAD4 inhibitor inhibited NET formation, in vitro. In two RA mouse models, JBI-589 reduced several measures of RA and inflammation including joint erosion, RA clinical score and inflammatory markers.

About Jubilant Therapeutics Inc.

Jubilant Therapeutics Inc. is a clinical stage biopharmaceutical company developing precision oral medicines with enhanced therapeutic index to address unmet medical needs in oncology and autoimmune diseases for genetically defined patients. Its advanced structure based discovery engine, TIBEO (Therapeutic Index and Brain Exposure Optimization), has been validated through successful partnerships including with Blueprint Medicines for a brain penetrant EGFR Exon-20 program. The Company’s pipeline consists of a first in class dual coREST modifier, JBI-802, currently in a Phase I/II clinical trial in multiple tumors, a novel brain-penetrant modulator of PRMT5 for which an IND has been accepted, brain penetrant and gut restrictive PDL1 inhibitors, as well as PAD4 inhibitors for oncology and inflammatory indications. The Company is headquartered in Bedminster, New Jersey and guided by globally renowned scientific advisors.

For more please visit: www.jubilanttx.com
Twitter @JubilantTx, LinkedIn

Media Contact

Katie Mathioudakis / Robert Flamm, Ph.D.
klarch@burnsmc.com / rflamm@burnsmc.com

IR Contact

Monique Kosse
Monique@lifesciadvisors.com

Call for India’s Social Change Leaders: Applications invited for the Prestigious ‘Social Entrepreneur of the Year (SEOY) - India Award 2023’ Noida, Uttar Pradesh, April 10, 2023: Jubilant Bhartia Foundation and Schwab Foundation for Social Entrepreneurship, the sister organisation of the World Economic Forum, invite applications for the 14th edition of the annual competition - Social Entrepreneur of the Year (SEOY) India Award 2023. The application entry for the award will be accepted till April 30, 2023. Interested candidates may submit the application form available at www.jubilantbhartiafoundation.com or can email the filled form to jbf.seoy@jubl.com

The winner of the Social Entrepreneur of the Year (SEOY) India Award 2023 will be announced in the last week of August, 2023 by an eminent personality in a magnificent ceremony at New Delhi.

The winner of the SEOY Award - India will join the world’s largest and the first inter-sectoral community of social innovators in the world affiliated with the Schwab Foundation for Social Entrepreneurship to engage, build and sustain their social enterprises.  

The participating individuals and organisations are evaluated on the key parameters of Market-based, Technology-enabled, Sustainability, Direct Social Impact, Reach & Scope, Replicability. The finalists will be selected following an intensive search and selection process, including expert reviews, interviews and site visits. The winner is selected by a prominent jury consisting of eminent leaders and professionals from the Government, Business, Media, and Civil Society.

The Social Entrepreneur of the Year (SEOY) India Award aims to promote and celebrate leading social entrepreneurs and their unique ventures in India that help in addressing the various gaps in our society and country. Through providing recognition, the SEOY India Award hopes to inspire many other potential social entrepreneurs in India every year.

In 2010, the Schwab Foundation for Social Entrepreneurship and Jubilant Bhartia Foundation came together to promote social innovation in India through the Social Entrepreneur of the Year (SEOY) Award – India and they have since recognised and supported the growing field of social innovation in India. This year the SEOY Award – India celebrates its 14th year. Over the last decade it has established itself as one of the most respectable awards for social entrepreneurs in India.

The award recognises individuals and organisations who implement innovative, sustainable and scalable solutions to address pressing issues faced by under-served communities to make inclusive growth a reality in India. They work in diverse areas such as health, education, employment, water, clean energy, building identity & entitlements, financial literacy, access to information and technology among others.

Key Highlights

Who can participate: Accomplished social change leaders across diversity of large-scale, system change and social innovation models in society

How to participate: Submit application form available at www.jubilantbhartiafoundation.com or email filled form to jbf.seoy@jubl.com.

Last Date: April 30, 2023

Evaluation parameters: Market-based, Technology-enabled, Sustainability, Direct Social Impact, Reach & Scope, Replicability.

Benefits:

• Access to the world’s most influential network
• Showcase awardees’ solutions to the highest level of decision-makers
• Build leadership capacity of awardees by strengthening their organisational and business strategies through executive education programmes at top universities, practitioner-oriented research and curated programming at global and regional meetings
• Create spaces for reflection and peer-to-peer mentoring

Past winners:

Aniket Doegar from Haqdarshak Empowerment Solutions won the Social Entrepreneur of the Year (SEOY) Award - India 2022, presented by Shri. Anurag Singh Thakur, Hon. Union Minister for Information & Broadcasting and Minister for Youth Affairs & Sports, Government of India. Haqdarshak Empowerment Solutions is solving the information and access gap between citizens and the government’s welfare schemes at the last mile, through its tech-enabled intervention. Present in 24 states in India it has trained over 22,800 agents and provided benefits worth Rs 4,000 crore for over 20 lakh families and 35,000 micro businesses.

About

Schwab Foundation for Social Entrepreneurship was co-founded by Professor Klaus Schwab, Founder and Executive Chairman of the World Economic Forum, and his wife Hilde. For over twenty years, the Schwab Foundation for Social Entrepreneurship has supported the world’s leading social innovators in their efforts to create a more just, equitable, and sustainable world. The Schwab Foundation provides unparalleled platforms at the regional and global level to highlight and advance leading models of sustainable social innovation.

For more info please visit: www.schwabfound.org

Follow the Schwab Foundation for Social Entrepreneurship on:

Twitter: https://twitter.com/schwabfound

Facebook: https://www.facebook.com/schwabfound/

Jubilant Pharmova announces USFDA communication assigning inspection classification of ‘Voluntary Action Indicated’ for its API Manufacturing Facility

Jubilant Pharmova Limited today announced that, pursuant to the United States Food and Drug Administration (USFDA) inspection of its API manufacturing facility at Nanjangud during 05-13 December 2022, it received a communication from the USFDA through which the regulatory agency assigned the inspection classification of the API facility as “Voluntary Action Indicated (VAI)”.

Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP).

About Jubilant Pharmova Limited

Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is engaged in Radiopharma, Allergy Immunotherapy, CDMO of Sterile Injectable, Generics, Contract Research Development and Manufacturing (CRDMO) and Proprietary Novel Drugs businesses. With a network of 46 radio-pharmacies in the US, Jubilant’s Radiopharma business is engaged in manufacturing and supply of Radiopharmaceutical products and services. Its other businesses such as Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products and Generics (Solid Dosage Formulations) caters to major regulated markets (USA, EU and other geographies) through five manufacturing facilities. The CRDMO segment (through Jubilant Biosys) provides collaborative research and partnership for Drug Discovery through two world class research centers in India. The company is also involved in the manufacturing of Active Pharmaceutical Products (API) through a US FDA approved facility in Nanjangud, Karnataka. Jubilant Therapeutics (JTI) invested for in-house Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and auto-immune disorders. Jubilant Pharmova Limited has a team of over 5,700 multicultural people across the globe. The Company is well recognized as a ‘Partner of Choice’ by leading pharmaceuticals companies globally. For more information, please visit: www.jubilantpharmova.com

For more information, please contact:

For Investors

Vineet V Mayer
Ph: +91 120 436 1021
E-mail: vineet.mayer@jubl.com

Disclaimer

Statements in this document relating to future status, events, or circumstances, including but not limited to statements about plans and objectives, the progress and results of research and development, potential product characteristics and uses, product sales potential and target dates for product launch are forward-looking statements based on estimates and the anticipated effects of future events on current and developing circumstances. Such statements are subject to numerous risks and uncertainties and are not necessarily predictive of future results. Actual results may differ materially from those anticipated in the forward-looking statements. Jubilant Pharmova may, from time to time, make additional written and oral forward looking statements, including statements contained in the company’s filings with the regulatory bodies and its reports to shareholders. The company assumes no obligation to update forward-looking statements to reflect actual results, changed assumptions or other factors.

Jubilant Therapeutics Inc., a clinical stage biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced that the United States Food and Drug Administration (US FDA) has granted Orphan Drug Designation (ODD) for JBI-778 for the treatment of Glioblastoma Multiforme (GBM). JBI-778 is an oral, brain penetrant and substrate-competitive protein arginine methyl transferase 5 (PRMT5) inhibitor for the treatment of tumors with brain metastases and primary brain tumors including high-grade glioma.

JBI-778 is the Company’s second drug candidate to receive ODD along with JBI-802, which received ODD for the treatment of small cell lung cancer (SCLC) and acute myeloid leukemia (AML).

“JBI-778 is our highly differentiated, substrate competitive PRMT5 inhibitor in development for both systemic and brain tumors with certain genetic signatures. It is the second clinical stage oral drug candidate that has emerged from the TIBEO discovery engine,” said Syed Kazmi, Chief Executive Officer, Jubilant Therapeutics Inc. He further added, “JBI-778’s differentiated profile compared to other PRMT5 inhibitors in development addresses safety issues of first-generation PRMT5 inhibitors.  It also enables a balanced exposure in brain and plasma - for the treatment of GBM and brain metastases along with the systemic disease. We have identified a novel synthetic lethality approach for prospective patient selection in target indications. JBI-778 has already been cleared by the US FDA to initiate clinical trials, which we anticipate to start during the second half of 2023.”
The US FDA’s Office of Orphan Products Development (OOPD) grants orphan designation status to a drug that is intended to treat a rare disease or condition that affects fewer than 200,000 persons in the United States.
About JBI-778
JBI-778 is a potent and selective brain penetrant inhibitor of protein arginine methyl transferase 5 (PRMT5), which is overexpressed in many cancers. JBI-778 is in development for the treatment of advance cancers with specific genetic mutations, and patients with high-grade glioma, all of whom have limited treatment options. It has a unique mechanism of action compared to existing PRMT5 inhibitors by being substrate-competitive and S-adenosylmethionine (SAM) cooperative, combined with a high brain exposure that enables targeting of both primary brain tumors and CNS metastasis. The substrate competitive profile appears to provide enhanced selectivity in the biological system by not interfering with the functions of SAM and shows a good tolerability profile in toxicological studies. JBI-778 has a unique opportunity to address the unmet needs of patients with an enhanced therapeutic index.

The Board of Jubilant Pharmova Limited met today to approve financial result for the quarter ended December 31, 2022.

Commenting on Company’s performance, Mr. Shyam S Bhartia, Chairman and Mr. Hari S Bhartia, Co-Chairman & Managing Director, Jubilant Pharmova Limited said:

“During the quarter, Company reported higher revenues YoY led by increase in sales in Radiopharmacies, Allergy and CDMO-API businesses and stable revenues in Radiopharmaceuticals, CDMO Sterile Injectables and Drug Discovery Services businesses.

Company’s profitability stood lower in Q3’FY23 vs. YoY and QoQ due to lower Covid related deals in CDMO Sterile Injectables business, industry wide issue of generator supply outage that impacted Radiopharmacies business, lower production in CDMO-API business and lower volumes in Drug Discovery Services business.

In Generics, the Company has undertaken a large scale business transformation focused on turnaround through cost optimisations and driving growth in branded markets in India and select international markets.

In FY24, Company’s profitability is expected to improve driven by growth in Radiopharmaceuticals, Allergy Immunotherapy and CDMO Sterile Injectables businesses. Recovery in Generics, API businesses and Radiopharmacies will also contribute to better profitability.

The Company has several growth levers across its various businesses (Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, Generics and CRDMO), which shall drive sustainable growth for the company in the medium term. In our Proprietary Novel Drugs business we have several high potential programs, which are at the preclinical / clinical stage.”

Q3’FY23 Highlights

Consolidated financials

• Revenues were at Rs 1,553 Crore vs. Rs 1,311 Crore in Q3'FY22 and Rs 1,600 Crore in Q2’FY23.
• Reported EBITDA was at Rs 155 Crore vs. Rs 200 Crore in Q3'FY22 and Rs 232 Crore in Q2’FY23.
  • In Q3’FY23, we witnessed nil COVID related deals vs. Rs 89 Crore in Q3’FY22 and Rs 22 Crore in Q2’FY22
• Finance cost was at Rs 51 Crore vs. Rs 37 Crore in Q3'FY22 and Rs 42 Crore in Q2’FY23. Higher finance cost was on account of increase in global interest rate benchmarks. 1M SOFR has increased from 3.05% on Sep 30, 2022 to 4.36% on Dec 31, 2022
• Reported PAT was at –ve Rs 16 Crore as compared with Rs 51 Crore in Q3'FY22 and Rs 5 Crore in Q2’FY23
• EPS was at –ve Rs 0.98 vs. Rs 3.2 in Q3'FY22 and Rs 0.34 in Q2’FY23
• Capital expenditure for the quarter was Rs 218 Crore

Specialty Pharmaceuticals

• Revenues were at Rs 760 Crore vs. Rs 635 Crore in Q3'FY22 and Rs 814 Crore in Q2’FY23
• EBITDA was at Rs 117 Crore vs. Rs 116 Crore in Q3’FY22 and Rs 198 Crore in Q2’FY23 with a margin of 15.4% vs. 18.3% in Q3’FY22 and 24.4% in Q2’FY23
• Radiopharma revenues were at 613 Crore vs. 510 Crore in Q3’FY22 and Rs 658 Crore in Q2’FY23
  • Radiopharmaceuticals business reported stable performance YoY; sequentially revenues variation is due to customer order rescheduling for some products in Q3’FY23
  • Radiopharmacies business reported higher revenue resulting from rise in volumes of new products launched. Sequentially the business witnessed lower sales due to shortage of radioisotopes for around 3 weeks during the quarter
  • Turnaround plan on track to achieve break-even in Q4’FY24E
• Allergy Immunotherapy revenues were at Rs 147 Crore vs. Rs 124 Crore in Q3’FY22 and Rs 156 Crores in Q2’FY23
• Revenue and EBITDA growth were supported by better prices vs Q3 last year

CDMO Sterile Injectables

• CDMO Sterile Injectables’ revenues were at Rs 272 Crore vs. Rs 265 Crore in Q3'FY22 and Rs 299 Crore in Q2’FY23
• Business’ stable performance during the quarter was on account of higher sales of other products during the Q3’FY23 amid nil revenue from COVID deals
• EBITDA was at Rs 56 Crore vs. Rs 116 Crore in Q3'FY22 and Rs 71 Crore in Q2’FY23
• Reported EBITDA declined YoY due to substantially higher base of COVID related business in Q3’FY22
  • Business reported revenues of Rs 89 Crs and Rs 22 Crs from the deals related to the Covid products in Q3’FY22 and Q2’FY23, respectively and nil sales in Q3’FY23
  • QoQ variation in margin in Q2’FY23 and Q3’FY23 is due to plant shutdown (twice in a year) and COVID deals

Generics

• Generics revenues were at Rs 223 Crore vs. Rs 171 Crore in Q3'FY22 and Rs 161 Crore in Q2’FY23
• Reported EBITDA was at Rs (36) Crore vs. Rs (43) Crore in Q3'FY22 and Rs (82) Crore in Q2’FY23
• Q3’FY23 performance improvement was on account of higher production at Roorkee plant and sales in non-US markets. This was partially offset by shutdown at Salisbury plant to upgrade part of the HVAC systems
• Business performance includes a one time gain due to a legal award to settle customer dispute
• India: Excluding Remdesivir related sales and provisions, the India Domestic Business grew over 15% YoY
• RoW: Excluding Remdesivir related sales and provisions, and one time gain due to a legal award to settle customer dispute , the ROW Domestic Business grew over 100% YoY
• Continuing quality improvement initiatives and engaging with the US FDA for resolution of the regulatory situation at the Roorkee facility
• Company has undertaken a large scale business transformation focused on
  • Strategic re-organization of the generics business
  • Business wide cost optimization (direct and indirect)
  • Re-prioritising geography-mix to accelerate growth in branded markets such as India and select International markets

Cost Optimisations

• Company has identified annual savings of Rs 100 Crore in operating costs. The implementation of these cost optimisations is on track and expected to be completed by March 2023. Benefits of cost optimisation initiatives to reflect in our performance from Q1’FY24
• Further identified additional cost optimisation opportunities of Rs 50 Crore. Implementation of these to be completed in H1FY24

CRDMO

• Revenues were at Rs 291 Crore vs. Rs 236 Crore in Q3'FY22 and Rs 320 Crore in Q2’FY23
• EBITDA was at Rs 39 Crore vs. Rs 35 Crore in Q3’FY22 and Rs 68 Crore in Q2’FY23 with a margin of 13.4% vs. 14.9% in Q3’FY22 and 21.3% in Q2’FY23
• Drug Discovery Services business reported stable revenues amid slowdown in US and selective approach by clients
  • Demand growth likely to remain moderate in near from target clients for integrated drug discovery services and DMPK. Currently witnessing key clients adopting selective approach in launching new projects
  • Sequentially revenues were lower as Q2’FY23 had one-off revenues from fee-for-service (FFS) in Drug Discovery services
  • DMPK in-vitro facility at Greater Noida has received validation, which enables the site to provide comprehensive drug discovery service offerings
• API revenues were at Rs 168 Crore vs. Rs 116 Crore in Q3’FY22
  • Revenues higher due to increase in utilization and higher volumes as Q3’FY22 witnessed lower production due to plant upgradation
  • USFDA during its Dec 2022 audit of the Nanjangud facility issued a few observations. We are engaging with the US FDA to resolve the regulatory situation at the facility

Proprietary Novel Drugs

9M'FY23 Financial Highlights

• Revenues were Rs 4,604 Crore versus Rs 4,603 Crore in 9M'FY22.
• Reported EBITDA at Rs 591 Crore vs. Rs 923 Crore in 9M'FY22.
  • In 9M’FY23, we witnessed COVID related deals of Rs 92 Crore vs. Rs 471 Crore in 9M’FY22
• Finance costs at Rs 133 Crore vs. Rs 106 Crore in 9M'FY22. Higher finance cost was on account of increase in global interest rate benchmark (SOFR 1M)
• Exceptional cost of Rs 57 Crore included Rs 48 Crore of foreclosure charges related to bond repayment in Q2’FY23 and balance due to write-off of capitalized debt origination costs. We expect savings from lower interest rates pursuant to the refinancing will enable recovery of this cost over the tenor of the new facility.
• Reported PAT was at Rs 36 Crore as compared with Rs 354 Crore in 9M’FY22
• EPS was at Rs 2.32 vs. Rs 22.26 in 9M'FY22.
• Capital expenditure for 9M’FY23 was Rs 498 Crore

Specialty Pharmaceuticals

• Revenues were Rs 2,296 Crore vs. Rs 1,917 Crore in 9M'FY22
• EBITDA was at Rs 433 Crore vs. Rs 321 Crore in 9M’FY22 with a margin of 18.9% vs. 16.7% in 9M’FY22
• Radiopharma revenue at Rs 1,863 Crore vs. Rs 1,557 Crore in 9M’FY22
  • Radiopharmaceuticals business witnessed improvement in sales driven by normalization in demand as the pandemic’s impact eased off
  • Ruby-Fill installations in the US are gradually gaining momentum with encouraging installations trend
  • Radiopharmacies business witnessed growth due to higher volumes resulting from recovery in demand as the pandemic’s impact waned. Turnaround plan is working well reflected by volumes at pre-COVID levels, introduction of new products and lower losses. This was partially offset by impact of generators shortage for 3 weeks in Q3’FY23, which is now normalised
• Allergy Immunotherapy revenue at Rs 433 Crore vs. Rs 360 Crore in 9M’FY22. Segment reported healthy revenue and EBITDA growth as volumes remain robust at higher than pre-COVID levels

CDMO Sterile Injectables

• CDMO Sterile Injectables’ revenue at Rs 833 Crore vs. Rs 1,046 Crore in 9M'FY22.
• Revenue and profitability normalised vs. 9M’FY22 as business witnessed higher COVID related business during the corresponding period.
• Segmental EBITDA at Rs 259 Crore vs. Rs 535 Crore in 9M'FY22
• In 9M’FY22, we witnessed COVID related deals of Rs 471 Crore vs. Rs 92 Crore in 9M’FY23

Generics

• Generics revenue at Rs 563 Crore vs. Rs 936 Crore in 9M'FY22 with benefits from Remdesivir sales of Rs 259 Crore.
• Reported EBITDA was at Rs (191) Crore vs. Rs (32) Crore in 9M’FY22 with Rs 115 Crore of benefits in EBITDA from Remdesivir sales.
• Revenues and profitability lowered vs. Q3’FY22 due to pricing pressure in the US generics market, lower volumes resulting from Roorkee Import Alert and lower Remdesivir sales.
• Business performance included a one time gain booked in Q3’FY23 due to a legal award to settle customer dispute
• India Geography: Excluding Remdesivir related sales and provisions, the India Domestic Business grew over 7%
• RoW Geography: Excluding Remdesivir related sales and provisions, and one time gain due to a legal award to settle customer dispute , the ROW Domestic Business grew over 10%
• Continuing quality improvement initiatives and engaging with the US FDA for resolution of the regulatory situation at the Roorkee facility

CRDMO

• Revenue at Rs 891 Crore vs. Rs 687 Crore in 9M'FY22
• EBITDA at Rs 153 Crore vs. Rs 157 Crore in 9M’FY22 with a margin of 17.2% vs. 22.9% in 9M’FY22
• Drug Discovery Services (DDS) revenue were at Rs 391 Crore vs. Rs 315 Crore in 9M’FY22 as volume growth drove YoY revenue increase.
  • Capex plan underway for additional building block in the Greater Noida facility for integrated services and chemistry.
• CDMO – API revenues were at Rs 500 Crore vs. Rs 372 Crore in 9M’FY22 due to higher volumes and capacity utilisations.

Debt Profile

• Net Debt (constant currency) at Rs 2,407 Crore as on Dec 31, 2022 vs Rs 2,204 Crore on Sep 30, 2022
• Average blended interest rate for 9M’FY23 was at 5.06% vs 4.58% in 9M’FY22

Key Business Priorities

Business Outlook

Earnings Call details

The company will host earnings call at 4.00 PM IST on Feb 03, 2023

Participants can dial-in on the numbers below
Primary Number: + 91 22 6280 1141 / + 91 22 7115 8042
Toll Free Numbers:
USA: 1 866 746 2133
UK: 0 808 101 1573
Singapore: 800 101 2045
Hong Kong: 800 964 448

Replay: Feb 03 to Feb 10, 2023
Dial-in: +91 22 7194 5757 / +91 22 6663 5757
Playback ID: 41519

Income Statement – Q3 & 9M’FY23

Jubilant Pharmova Limited’s wholly owned subsidiary Jubilant Draximage Inc (‘Company’) today announced that it has received approval from the US FDA with regards to the Company’s  new drug application (NDA)
submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Kit for the Preparation of Technetium (Tc 99m) Mertiatide Injection.

The Tc 99m Mertiatide Injection is used in the diagnosis of congenital and acquired renal abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients aged 30 days and older. The product enables providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.

This approval is effective from Jan 30, 2023.

About Jubilant Radiopharma

Jubilant Radiopharma, a division of Jubilant Pharma Ltd., is an industry-leading radiopharmaceutical business that comprises development, manufacturing and commercialisation of products through Radiopharmaceuticals business and distribution through the Radiopharmacies business. Jubilant Radiopharma’s manufactured products are used in the diagnosis, treatment and monitoring of various diseases with specialisation in lung, thyroid, bone and cardiac imaging products as well as in thyroid disease therapy. The division’s Radiopharmacies business is the second largest radiopharmacy network in the US with 46 pharmacies distributing nuclear medicine products to the largest national Group Purchasing Organisations (GPOs), regional health systems, stand-alone imaging centres, cardiologists and hospitals. This business has over 30 years of experience in serving the US nuclear medicine community and its current geographical reach enables it to serve over four million patients yearly. The Radiopharmacies business complements the Company’s niche Radiopharmaceuticals business and provides it with direct access to hospital networks. Jubilant Radiopharma is focused on developing, manufacturing, commercializing and distributing high quality and sustainable diagnostic and therapeutic agents for the sole purpose of “Improving Lives Through Nuclear Medicine” on a global scale.

About Jubilant Pharma Limited

Jubilant Pharma Limited (JPL), a Company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Pharmova Limited, is an integrated global pharmaceutical company engaged in manufacturing and supply of Radiopharmaceuticals with a network of radio-pharmacies in the US, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products and Solid Dosage Formulations through five manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. The Company has a team of around 3,500 multicultural people across the globe and is committed to delivering value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceutical companies globally. For more info please visit www.jubilantpharma.com

About Jubilant Pharmova Limited

Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is engaged in Radiopharma, Allergy Immunotherapy, CDMO of Sterile Injectable, Generics, Contract Research Development and Manufacturing (CRDMO) and Proprietary Novel Drugs businesses. With a network of 46 radio-pharmacies in the US, Jubilant’s Radiopharma business is engaged in manufacturing and supply of Radiopharmaceutical products and services. Its other businesses such as Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products and Generics (Solid Dosage Formulations) caters to major regulated markets (USA, EU and other geographies) through five manufacturing facilities. The CRDMO segment (through Jubilant Biosys) provides collaborative research and partnership for Drug Discovery through two world class research centers in India. The company is also involved in the manufacturing of Active Pharmaceutical Products (API) through a US FDA approved facility in Nanjangud, Karnataka. Jubilant Therapeutics (JTI) invested for in-house Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and auto-immune disorders. Jubilant Pharmova Limited has a team of over 6,000 multicultural people across the globe. The Company is well recognized as a ‘Partner of Choice’ by leading pharmaceuticals companies globally. For more information, please visit: www.jubilantpharmova.com

For more information, please contact:

For Investors
Vineet V Mayer
Ph: +91 120 436 1103
E-mail: vineet.mayer@jubl.com

Bedminster, New Jersey, United States - January 05, 2023 - Jubilant Therapeutics Inc., a clinical stage biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced that the United States Food and Drug Administration (US FDA) has granted Orphan Drug Designation for JBI-802 for the treatment of small cell lung cancer (SCLC) and acute myeloid leukemia (AML).

JBI-802 is a dual epigenetic modulator engineered in a single pharmacophore to achieve optimal inhibition of the transcriptional regulator CoREST, which regulates the development of cellular lineages responsible for neuroendocrine tumors like SCLC and hematopoietic tumors like AML.

This unique profile has shown synergistic anti-tumor activity and it is expected to overcome tolerability limitations of first-generation, single target epigenetic modulators.

“JBI-802 is the lead product candidate from our TIBEO (Therapeutic Index and Brain Exposure Optimization) Discovery Engine. It is our unique approach of structure-based drug design to generate novel pharmacophores with improved target product profile compared to existing agents. The Orphan Drug Designations (ODD) were supported by several relevant preclinical models. In SCLC, JBI-802 showed unique activity not just in normal neuroendocrine models but also in the ‘variant’ models driven by MYC amplification. This data also supports the ongoing Ph I/II clinical trial in neuroendocrine tumor patients. In AML the activity was uniquely seen in models of erythroleukemia, a subset of leukemia, with a unique erythroid phenotype and a very high unmet need based on its aggressive nature and limited therapy. This designation and emerging clinical data from the ongoing fist-in-human JBI-802 study will now underpin expansion of our clinical activities in thrombocythemia, leukemia and other erythroid tumors like MPN”, said Syed Kazmi, Chief Executive Officer, Jubilant Therapeutics Inc

The US FDA’s Office of Orphan Products Development (OOPD) grants orphan designation status to a drug that is intended to treat a rare disease or condition that affects fewer than 200,000 persons in the United States.

About JBI-802

JBI-802 is an oral, potent and selective dual inhibitor of two epigenetic targets of the CoREST complex: LSD1 and HDAC6. It targets stem cell modulation by inhibiting LSD1 and modulates immune suppression with isoform selective HDAC6 inhibition. Preclinical research has demonstrated its synergistic anti-tumor activity, which is superior vs. either target alone inhibitors and has a favorable safety profile with no significant safety concerns or accumulation. It is being clinically evaluated in multiple neuroendocrine tumors including SCLC, with a goal to expand in to hematological cancers such as acute myelogenous leukemia, essential thrombocythemia, and other myeloproliferative cancers. Positive clinical data was recently reported for bomedemstat, a LSD1 only inhibitor, in essential thrombocythemia, thereby establishing a pivotal role of epigenetic modulators in hematological malignancies.

About Jubilant Therapeutics Inc.

Jubilant Therapeutics Inc. is a clinical stage biopharmaceutical company developing precision oral medicines with enhanced therapeutic index to address unmet medical needs in oncology and autoimmune diseases for genetically defined patients. Its advanced structure based discovery engine, TIBEO (Therapeutic Index and Brain Exposure Optimization), has been validated through successful partnerships including with Blueprint Medicines for a brain penetrant EGFR Exon-20 program. The Company’s pipeline, consists of a first in class dual epigenetic modifier, JBI-802, currently in a Phase I/II clinical trial in multiple tumors, a novel brain-penetrant modulator of PRMT5 for which an IND has been accepted, brain penetrant and gut restrictive PDL1 inhibitors, as well as PAD4 inhibitors for oncology and inflammatory indications. The Company is headquartered in Bedminster, New Jersey and guided by globally renowned scientific advisors.

For more: www.jubilanttx.com, Twitter @JubilantTx, LinkedIn

Media Contact
Katie Larch / Robert Flamm, Ph.D.
klarch@burnsmc.com / rflamm@burnsmc.com

IR Contact
Monique Kosse
Monique@lifesciadvisors.com

Bedminster, New Jersey, USA – November 02, 2022 – Jubilant Therapeutics Inc., a clinical stage biopharmaceutical company developing precision oral medicines with enhanced therapeutic index to serve genetically defined patients suffering from cancer and autoimmune diseases, today announced that Syed Kazmi, Chief Executive Officer, will be making a business update presentation and meeting with institutional investors at the following conferences in November 2022:

About Jubilant Therapeutics Inc.
Jubilant Therapeutics Inc. is a clinical stage biopharmaceutical company developing precision oral medicines with enhanced therapeutic index to address unmet medical needs in oncology and autoimmune diseases for genetically defined patients. Its advanced structure based discovery engine, TIBEO (Therapeutic Index and Brain Exposure Optimization), has been validated through successful partnerships including with Blueprint Medicines.   The Company’s pipeline, consists of a first-in-class dual epigenetic modifier, JBI-802, currently in a Phase I/II clinical trial to treat solid tumors, a novel brain-penetrant modulator of PRMT5 for which an IND has been accepted, brain penetrant and gut restrictive PDL1 inhibitors, as well as PAD4 inhibitors for oncology and inflammatory indications. The Company is headquartered in Bedminster, New Jersey and guided by globally renowned scientific advisors. For more: www.jubilanttx.com, Twitter @JubilantTx, LinkedIn

Media Contact
Robert Flamm, Ph.D. / Katie Larch 
rflamm@burnsmc.com / klarch@burnsmc.com

IR Contact
Monique Kosse
Monique@lifesciadvisors.com

The Board of Jubilant Pharmova Limited met today to approve financial result for the quarter ended September 30, 2022.

Commenting on Company’s performance, Mr. Shyam S Bhartia, Chairman and Mr. Hari S Bhartia, Co-Chairman & Managing Director, Jubilant Pharmova Limited said:

“During the quarter, the Company reported significant improvement in revenues sequentially due to strong performance in Specialty Pharmaceuticals, CDMO Sterile Injectables and CRDMO, which was offset by lower revenues in the Generics segment. On a YoY basis, however, the revenues were marginally lower as performance of the CDMO Steriles business normalized due to tapering of COVID deals and weaker performance in Generics segment.

In Specialty Pharmaceuticals, Radiopharmaceuticals business reported increase in revenues YoY driven by higher volumes with normalization in demand as pandemic eased-off. Our Allergy Business continued to grow with higher volumes. In CDMO sterile injectables, revenues normalised YoY due to tapering of one-off COVID-related revenues in the corresponding quarter. There was however sizeable improvement sequentially due to higher volumes. Generics business revenues impacted YoY with pricing headwinds and Import Alert related challenges. Management begins implementation of strategic reorganization, cost optimization and re-prioritization of geography-mix in generic business.

In CRDMO, our Drug Discovery Services continues to maintain momentum from strong order book and our API revenues stood higher on volume growth and is poised to gain further from the asset upgradation program at Nanjangud plant.

During the quarter, we refinanced our existing US$200m bonds and US$150m term loan with a 5-year US$350m term loan facility at favorable terms with lower interest costs. This enables us to optimize our finance costs. We incurred foreclosure charges in the refinancing transaction, which we expect to recover over the tenor of the new USD 350m facility.”

Q2’FY23 Highlights

Consolidated financials

• Revenues were at Rs 1,600 Crore vs. Rs 1,657 Crore in Q2'FY22 and Rs 1,452 Crore in Q1’FY23.
  • The higher volumes in Radiopharma, Allergy and CMO Sterile injectables, API and steady growth in Drug Discovery Services led to sequential revenue growth
• Reported EBITDA was at Rs 232 Crore vs. Rs 344 Crore in Q2'FY22 and Rs 204 Crore in Q1’FY23.
• Finance cost was at Rs 42 Crore vs. Rs 35 Crore in Q2'FY22 and Rs 40 Crore in Q1’FY23.
• Exceptional cost of Rs 57 Crore included Rs 48 Crore of foreclosure charges related to bond repayment and balance due to write-off of capitalized debt origination costs. We expect savings from lower interest rates pursuant to the refinancing will enable recovery of this cost over the tenor of the new facility
• Reported PAT was at Rs 5 Crore as compared with Rs 143 Crore in Q2'FY22 and Rs 47 Crore in Q1’FY23.
• Normalised PAT was at Rs 62 Crore as compared with Rs 143 Crore in Q2'FY22 and Rs 47 Crore in Q1’FY23.
• EPS was at Rs 0.34 vs. Rs 8.97 in Q2'FY22 and Rs 2.96 in Q1’FY23. Normalised EPS was Rs 3.88 vs. Rs 8.97 in Q2’FY22 and Rs 2.96 in Q1’FY23
• Capital expenditure for the quarter was Rs 128 Crore

Specialty Pharmaceuticals

• Revenues were at Rs 814 Crore vs. Rs 651 Crore in Q2'FY22 and Rs 722 Crore in Q1’FY23.
• EBITDA was at Rs 198 Crore vs. Rs 130 Crore in Q2’FY22 and Rs 117 Crore in Q1’FY23 with a margin of 24.4% vs. 19.9% in Q2’FY22 and 16.2% in Q1’FY23

a) Radiopharma

• Radiopharma revenues were at 658 Crore vs. 529 Crore in Q2’FY22 and Rs 592 Crore in Q1’FY23
  • Radiopharmaceuticals witnessed improvement in revenues YoY and QoQ driven by higher volumes. Higher sequential revenues were als
  • on account of customer order rescheduling in Q1’FY23
  • Radiopharmacies business witnessed growth due t
  • higher volumes resulting from recovery in demand as the pandemic’s impact waned. Turnaround plan working well as reflected by volumes at pre-COVID levels and lower losses
  • USFDA audit in the Montreal Radiopharma plant successfully completed with zero observation in early October 2022

b) Allergy Immunotherapy

• Allergy Immunotherapy revenues were at Rs 156 Crore vs. Rs 122 Crore in Q2’FY22 and Rs 130 Crores in Q1’FY23.
  • The healthy revenue growth was driven by volume growth, price increase and geographic expansion

CDMO Sterile Injectables

• CDMO Sterile Injectables’ revenues were at Rs 299 Crore vs. Rs 409 Crore in Q2'FY22 and Rs 263 Crore in Q1’FY23
• EBITDA was at Rs 71 Crore vs. Rs 203 Crore in Q2'FY22 and Rs 132 Crore in Q1’FY23.
• Reported EBITDA margin was 23.8% in Q2’FY23, in-line with our expectations of normalized CDMO-Sterile injectable business
• Reported EBITDA declined YoY due to substantially higher base of COVID related business.
  • In Q2’FY23, we witnessed about Rs 22 Crs of COVID deals, vs. about Rs 162 Crs in Q2’FY22 and about Rs 70 Crs in Q1’FY23
  • QoQ variation in margin in Q1’FY23 and Q2’FY23 is due to plant shutdown (twice in a year) and COVID deals

Generics

• Generics revenues were at Rs 161 Crore vs. Rs 333 Crore in Q2'FY22 and Rs 178 Crore in Q1’FY23.
• Reported EBITDA was at Rs (82) Crore vs. Rs (42) Crore in Q2'FY22 and Rs (74) Crore in Q1’FY23
• Revenues and profitability lowered vs. Q2’FY22 due to pricing pressure in the US generics market, lower volumes resulting from Roorkee Import Alert and lower Remdesivir sales.
• We have responded to the US FDA with a CAPA plan post audit of the Roorkee plant that resulted in six observations.
• To put the business on path of sustainable growth and profitability, we have kicked off a large scale business transformation focused on
  • Strategic re-organization of the generics business
  • Generics wide cost optimization (direct and indirect)
  • Re-prioritising geography-mix to accelerate growth in branded markets such as India
• We have identified and are in process of executing annualized cost opportunities worth around Rs 100 Crore across direct and indirect spend. These will be implemented by Q4’FY23, while we work on identifying additional cost savings opportunity.

CRDMO

• Revenues were at Rs 320 Crore vs. Rs 258 Crore in Q2'FY22 and Rs 280 Crore in Q1’FY23
• EBITDA was at Rs 68 Crore vs. Rs 69 Crore in Q2’FY22 and Rs 46 Crore in Q1’FY23 with a margin of 21.3% vs. 26.6% in Q2’FY22 and 16.3% in Q1’FY23
• Drug Discovery Services revenues were at Rs 150 Crore vs. Rs 108 Crore in Q2’FY22 led by robust volume growth YoY.
  • Strong demand from target clients for integrated drug discovery services, functional chemistry and DMPK. However, we register market is adopting more selective approach in launching new projects
  • Strong incremental order flow supported by the Greater Noida facility that was commissioned in Sep 2021.
  • Sequentially revenue higher, in-line with historical trends of Q2 being a stronger quarter
  • The commissioning and validation of the greater Noida DMPK in-vitro facility to enable comprehensive service capability from the site
• API revenues were at Rs 170 Crore vs. Rs 150 Crore in Q2’FY22 due to higher volumes and price. Sequentially, revenues were flat with expectation of growth from H2FY23.

Proprietary Novel Drugs

H1'FY23 Financial Highlights

• Revenues were Rs 3,051 Crore versus Rs 3,292 Crore in H1'FY22.
• Reported EBITDA at Rs 436 Crore vs. Rs 723 Crore in H1'FY22.
  • In H1’FY23, we witnessed COVID related deals of Rs 70 Crore vs. Rs 380 Crore in H1’FY22
• Finance costs at Rs 82 Crore vs. Rs 69 Crore in H1'FY22. Higher finance cost vs. H1’FY22 was due to increase in interest rates
• Exceptional cost of Rs 57 Crore included Rs 48 Crore of foreclosure charges related to bond repayment and balance due to write-off of capitalized debt origination costs. We expect savings from lower interest rates pursuant to the refinancing will enable recovery of this cost over the tenor of the new facility
• Reported PAT was at Rs 52 Crore as compared with Rs 303 Crore in H1’FY22
• Normalised PAT was at Rs 108 Crore as compared with Rs 303 Crore in H1’FY22
• EPS was at Rs 3.30 vs. Rs 19.06 in H1'FY22. Normalised EPS was Rs 6.81 vs. Rs 19.06 in H1’FY22
• Capital expenditure for H1’FY23 was Rs 226 Crore

Specialty Pharmaceuticals

• Revenues were Rs 1,536 Crore vs. Rs 1,282 Crore in H1'FY22.
• EBITDA at Rs 316 Crore vs. Rs 205 Crore in H1’FY22 with a margin of 20.6% vs. 16.0% in H1’FY22
• Radiopharma revenue at 1,250 Crore vs. 1,047 Crore in H1’FY22
  • Radiopharmaceuticals business witnessed improvement in sales driven by normalization in demand as the pandemic’s impact eased off.
  • Ruby-Fill installations in the US are gradually gaining momentum with encouraging installations trend
  • Radiopharmacies business witnessed growth due to higher volumes resulting from recovery in demand as the pandemic’s impact waned. Turnaround plan is working well reflected by volumes at pre-COVID levels and lower losses.
  • USFDA audit in the Montreal Radiopharma plant successfully completed with zero observation in early October 2022.
• Allergy Immunotherapy revenue at Rs 286 Crore vs. Rs 236 Crore in H1’FY22. Segment reported healthy revenue and EBITDA growth as volumes remain robust at higher than pre-COVID levels

CDMO Sterile Injectables

• CDMO Sterile Injectables’ revenue at Rs 562 Crore vs. Rs 782 Crore in H1'FY22.
• Revenue and profitability lower vs. H1’FY22 as business witnessed higher COVID related business during the previous quarter.
• Segmental EBITDA at Rs 203 Crore vs. Rs 418 Crore in H1'FY22
• In H1’FY22, we witnessed COVID related deals of about Rs 382 Crore vs. about Rs 93 Crore in H1’FY23

Generics

• Generics revenue at Rs 340 Crore vs. Rs 765 Crore in H1'FY22.
• Reported EBITDA was at Rs (155) Crore vs. Rs 11 Crore in H1’FY23
• Revenues and profitability lowered vs. Q2’FY22 due to pricing pressure in the US generics market, lower volumes resulting from Roorkee Import Alert and lower Remdesivir sales.
• We have responded to the US FDA with a CAPA plan post audit of the Roorkee plant that resulted in six observations.
• To put the business on path of sustainable growth and profitability, we have kicked off a large scale business transformation focused on
  • Strategic re-organization of the generics business
  • Generics wide cost optimization (direct and indirect)
  • Re-prioritising geography-mix to accelerate growth in branded markets such as India
• We have identified and are in process of executing annualized cost opportunities worth around Rs 100 Crore across direct and indirect spend. These will be implemented by Q4’FY23, while we work on identifying additional cost savings opportunity.

CRDMO

• Revenue at Rs 600 Crore vs. Rs 451 Crore in H1'FY22
• EBITDA at Rs 114 Crore vs. Rs 122 Crore in H1’FY22 with a margin of 19.0% vs. 27.1% in H1’FY22
• Drug Discovery Services (DDS) revenue at Rs 268 Crore vs. Rs 196 Crore in H1’FY22 as robust volume growth drove YoY revenue increase.
  • Higher demand from Biotech companies for integrated services, functional chemistry and DMPK.
  • Increase in the volume of the Chemistry services supported by the Greater Noida facility that was commissioned in Sept 2021.
  • Strong capex plan underway in view of robust demand conditions in the Integrated services, Chemistry and DMPK business
• CDMO – API revenue at Rs 332 Crore vs. Rs 256 Crore in H1’FY22 due to higher volumes.

Debt Profile

• Net Debt (constant currency) at Rs 2,204 Crore as on September 30, 2022 vs Rs 1,951 Crore as on June 30, 2022
• Average blended interest rate for H1’FY23 was at 4.81% vs 4.62% in H1’FY22

Key Business Priorities