Jubilant Pharmova wholly owned subsidiary Jubilant Pharma Limited, through one of its wholly owned subsidiaries, Jubilant HollisterStier General Partnership, (JHS) a leading Canada-based pharmaceutical contract manufacturer, announced today that the Government of Quebec, through its agent Investissement Quebec, is granting a loan of CAD 25 million, which includes a forgivable portion of CAD 6.3 million to fund the CAD 100 Mn capacity expansion at the CMO Montreal facility. The loan disbursement is subject to final agreement to be signed between the two parties.

This investment aims to modernize and augment the drug production capacity by over 100% at the Montreal, Canada facility. As part of this initiative, Jubilant HollisterStier will acquire new specialized equipment and equip the plant with a single-use sterile preparation room to maximize the filling process linked to the production of liquid sterile products.

The Minister of Economy and Innovation and Minister responsible for Regional Economic Development, Mr. Pierre Fitzgibbon, made the announcement today.

"This modernization project shows the effervescence that is being created in Montreal in the life sciences. To have a more efficient health network, we must increase our health autonomy. The pandemic has shown us how important it is to strengthen our supply chains, and that is exactly what we are doing today. said Mr Pierre Fitzgibbon.

Christian Dubé, Minister of Health and Social Services said, "Quebec has a strong industrial fabric in life sciences, and the modernization of Jubilant HollisterStier's facilities will further consolidate this key sector. This project will also generate contract development and manufacturing activities for other Quebec biopharmaceutical companies. With the new Québec Life Sciences Strategy, we want to create even more synergies like this between our companies to meet the major health challenges."

Speaking on the announcement, Mr Pramod Yadav, CEO, Jubilant Pharma Limited said, "Jubilant HollisterStier is excited to be chosen as a part of the eco-system being developed by Canada to make it self-dependent for its future needs of vaccines and treatments in case of a pandemic. This funding will enable our continued effort to expand our capabilities in Canada and create more jobs."

"This new agreement is a testament to the contributions of our organization during the current pandemic and public health emergencies over the past two decades. Jubilant HollisterStier's expansion will target large Pharmaceuticals and Biotech companies parenteral products as well as feature a flexible manufacturing platform able to produce several types of vaccines (live, mRNA and inactivated/subunit).," shared Mr Amit Arora, President, Contract Manufacturing Organization (CMO), Jubilant HollisterStier.

Bedminster, New Jersey, USA – June 1, 2022 – Jubilant Therapeutics Inc. a clinical stage precision therapeutics Company advancing small molecule therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced data to be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. The data report on the pharmacokinetic and in vitro and in vivo anti-cancer properties of JBI-2174, the Company’s lead oral, brain penetrant PD-L1 inhibitor, which is in IND-enabling studies for the treatment for solid tumors. The poster will be presented by Luca Rastelli, Ph.D., Company’s Chief Scientific Officer, during the Developmental Therapeutics—Immunotherapy session at 8:00 a.m. CDT on June 05, 2022. The abstract is available here.

“Checkpoint inhibitors, such as anti-PD-1 and anti-PDL1 antibodies, have revolutionized cancer treatment by enabling the immune system to attack tumor cells,” said Luca Rastelli. “However, these antibodies have poor brain penetrance and shown limited efficacy in brain cancers. Employing our structure-based drug design and computational algorithms, we have designed oral small molecule checkpoint inhibitors that address this limitation. We are focused on completing our IND-enabling studies and hope to initiate shortly the clinical trials with JBI-2174 in patients with specific brain tumors.” he further added.

The potency, pharmacokinetics and in vivo activity of rationally designed small molecule inhibitors of PD-L1 were evaluated. The Company’s lead anti-PD-L1 candidate, JBI-2174, demonstrated strong affinity for PD-L1 with an IC50 of approximately 1 nM. In selectivity assays for immune-oncology targets, JBI-2174 was highly selective for PD-L1 and also inhibited PD-L1/PD-1 mediated signaling essential for T-cell modulation.  In multiple animal models where tumor cells were injected in the brain, JBI-2174 demonstrated sustained brain exposure, efficacy equivalent to an anti-PD-L1 antibody and increased survival compared to control. The results suggest an orally administered brain penetrant small molecule PD-L1 inhibitor could achieve efficacy in brain tumors that do not usually respond to immune-checkpoint antibodies

Jubilant Pharmova Limited has announced today that Jubilant Pharma Limited, a wholly owned subsidiary of the Company, through one of its wholly owned subsidiaries, Jubilant HollisterStier LLC, (JHS) a leading US-based pharmaceutical contract manufacturer has entered into a cooperative agreement for $149.6 million (USD) with the Army Contracting Command, in coordination with the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) on behalf of the Biomedical Advanced Research and Development Authority (BARDA), within the US Department of Health and Human Services. The effort was funded under the American Rescue Plan, this agreement will enable the Company to double its injectable filling production capacity at a total cost of $193 million, at its Spokane, Washington manufacturing facility. This will be completed by 2025.

This agreement is in addition to the $92 million filling line expansion announced in November 2021, which will be commercially available by the end of 2024.

Speaking on the announcement, Pramod Yadav, CEO, Jubilant Pharma Limited said, “Jubilant HollisterStier LLC is committed to making the US pharmaceutical supply chain more resilient with domestic manufacturing facilities and less reliant on foreign suppliers. Jubilant HollisterStier has a long history of supporting the US Department of Health and Human Services (HHS) and Department of Defense (DOD) biodefense and medical countermeasure programs, including production for national preparedness efforts. We are proud to support the US government in their efforts of making the US more prepared and ready for future pandemics.”

“Jubilant HollisterStier LLC’s expansion will target large Pharmaceuticals and Biotech companies for parenteral products as well as feature a flexible manufacturing platform able to produce several types of vaccines (live, mRNA and inactivated/subunit). We are committed to investing in capability and capacity. This investment will ensure our ability and flexibility to speedily produce quality vaccines and treatments for our customers and be better prepared for any future threats to the country,” shared Amit Arora, President, Contract Manufacturing Organization (CMO), Jubilant HollisterStier LLC.

About Jubilant HollisterStier LLC

Jubilant HollisterStier LLC, a subsidiary of Jubilant Pharma Limited, is a leading integrated contract manufacturer of sterile injectables, ophthalmics, optics, sterile and non-sterile topicals and liquids. With facilities in North America, Jubilant HollisterStier LLC provides specialized manufacturing for the pharmaceutical and biopharmaceutical industries. Services include a full range of support to streamline manufacturing, from process qualifications through commercial release. For more info please visit www.jublhs.com

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, APIs and Solid Dosage Formulations through six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. The Company has a team of over 4,600 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 a company engaged in Pharmaceuticals, Contract Research and Development Services and Proprietary Novel Drugs businesses. Pharmaceuticals business through Jubilant Pharma Limited Singapore (JPL) is engaged in manufacturing and supply of Radiopharmaceuticals with a network of 48 radio-pharmacies in the US, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products, APIs and Solid Dosage Formulations through six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. Jubilant Biosys Limited provides contract research and development services through two world class research centers in Bangalore and Noida in India. Jubilant Therapeutics is involved in 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

About JPEO-CBRND

About the JPEO-CBRND: The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint Force by providing medical countermeasures and defense equipment against chemical, biological, radiological and nuclear (CBRN) threats. JPEO-CBRND’s goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. JPEO-CBRND facilitates the rapid response, advanced development, manufacturing and acquisition of medical solutions, such as vaccines, therapeutics, and diagnostics, to combat CBRN and emerging threats such as COVID-19. To learn more about JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus or follow JPEO-CBRND on social media at @JPEOCBRND.

The Board of Jubilant Pharmova Limited met today to approve financial results for the quarter ended March 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:

“In FY 2022, the Company reported stable revenues, despite COVID-19 challenges, due to the diverse range of our businesses. Improved performance in Specialty Pharma business and strong growth in the Contract Research business was offset by lower revenues in the CMO, API and Generics businesses.

In Q4’FY22, the Company witnessed healthy improvement in operating performance sequentially due to growth in both Pharmaceuticals and Contract Research businesses, however on a YoY basis performance stood lower due to weaker performance in the Pharmaceuticals segment.

The Pharmaceuticals segment sequentially witnessed healthy improvement in revenues in all businesses. On a YoY basis, we witnessed growth in Radiopharma and Allergy Immunotherapy businesses and lower performance in CMO business due to tapering of COVID related revenues, lower volumes in Generics business due to import alert and lower volumes in API business.

The Contract Research and Development Services business, continued to witness strong growth both on a YoY and sequential basis driven by robust demand from our customers for our Drug Discovery Services.

In the Proprietary Novel Drugs business, our lead program – LSD1/HDAC6 inhibitor has successfully started Phase I/ II trials. Additional IND filings with FDA for pipeline programs are expected to follow in FY 23

We are glad to share that the API demerger is progressing as per plan and is expected to be effective from July 2022 onwards with April 1, 2022 as the appointed date.  This demerger will enable to create Synergies between CRO & CDMO businesses and help in supporting our customers for their needs from early stage of research to commercialization of active ingredients, and will provide competitive edge to this business.

We are also glad to share that the Board has recommended a final dividend of 500% i.e. Rs 5 per equity share of face value of Re 1 each for the FY’22

We would like to mention that over the medium term, we have strong growth levers in all our businesses. To drive growth in these businesses, Company will continue to invest accordingly.”

1. All figures are in Rs Crore unless otherwise stated

2. Q4’FY21 and FY21 financials include only continuing business

Q4’FY22 Highlights

A. Consolidated financials

• Revenue was at Rs 1,528 Crore versus Rs 1,580 Crore in Q4'FY21
• Reported EBITDA at Rs 244 Crore versus Rs 381 Crore in Q4'FY21
• Finance costs at Rs 40 Crore vs. Rs 43 Crore in Q4'FY21
• PAT was at Rs 59 Crore as compared with Rs 173 Crore in Q4'FY21
• EPS is Rs 3.74 versus Rs 10.86  in Q4'FY21
• Capital expenditure for the quarter was Rs 87 Crore

Segment Wise Analysis

B. Pharmaceuticals Segment

• Pharmaceuticals revenue at Rs 1,380 Crore vs. Rs 1,486 Crore in Q4’FY21
• Radiopharma business witnessed improvement in sales both YoY and sequentially, driven by recovery from easing of COVID-19 pandemic and some customer order scheduling
  • Ruby-Fill installations shows encouraging trend, increased strongly during Q4’FY22 vs. Q3’FY22
  • Radiopharmacy business witnessed growth YoY due to higher volumes. Turnaround plan is working well reflected by higher volumes and lower losses
• Allergy Immunotherapy continued to report robust performance reflected by growth in volumes both YoY and sequentially. Business continues to operate at volumes higher than pre-COVID levels. In addition to robust growth in the US market, business witnessing healthy growth in Non-US markets as well
• CMO business is operating at normal pre-pandemic levels now, COVID related one-off deals tapered off as indicated earlier
• API business witnessed better performance sequentially however on YoY basis performance was lower due to decline in volumes resulting from stabilization issues after shutdown in Q3’FY22
• Generics Business performance was driven by
  • Lower volumes due to import alert at Roorkee plant
  • Pricing pressure in the US market
  • Lower Remdesivir sales due to fewer hospitalisations
• Business has relaunched impurity free Losartan HCTZ in the market and gaining market share. We have also recently launched impurity free Losartan and expect to gain market share in Q1’FY23
• With regards to Roorkee import alert, our remediation activities are ongoing as per plan and we expect to complete the same by mid of CY 2022
• EBITDA was recorded at Rs 223 Crore as compared with Rs 366 Crore in Q4'FY21. EBITDA margin of 16.2% as compared to 24.6% in Q4'FY21
• In Q4’FY22, on YoY basis while Radiopharma business’ profitability increased due to recovery from Covid-19, overall profitability in Pharmaceuticals segment was lower due to the impact of Import alert, lower volumes in API business, tapering of COVID related one-off deals in CMO business and pricing pressure in the US generics market

C. Contract Research and Development Services Segment

• Revenue at Rs 142 Crore increased by 51% YoY led by robust volume growth
  • Higher demand from biotech companies for integrated services, functional chemistry and DMPK, Discovery Biology and Clinical trial data management support trough Trial stat, Canada.
  • Volumes increase supported by the recently commissioned facility at Greater Noida
  • Strong capex plan underway in view of robust demand conditions in this business

• Reported EBITDA at Rs 53 Crore vs. Rs 41 Crore in Q4'FY21 with a margin of 37.6% vs. 43.7% in Q4'FY21

FY22 Highlights

A. Consolidated financials

• Revenue was Rs 6,130 Crore versus Rs 6,099 Crore in FY21
• Reported EBITDA at Rs 1,168 Crore versus Rs 1,414 Crore in FY21
• Finance costs at Rs 145 Crore vs. Rs 184 Crore in FY21
• Average blended interest rate for FY22 improved to 4.56% from 5.07% in FY21
• Effective Tax Rate of 34.5% vs. 34.1% in FY21.
• PAT was at Rs 413 Crore as compared with Rs 574 Crore in FY21
• EPS is Rs 26.0 versus Rs 36.05 in FY21
• Capital expenditure for the year was Rs 437 Crore

Segment Wise Analysis

B. Pharmaceuticals Segment

• Pharmaceuticals revenue at Rs 5,651 Crore vs. Rs 5,790 Crore in FY21
• Pharmaceuticals EBITDA at Rs 1,087 Crore vs. Rs 1,386 Crore in FY21. EBITDA margin of 19.2% as compared to 23.9% in FY21
• Radiopharmaceuticals business saw recovery in revenues during the year. Demand conditions yet to reach pre COVID levels
• Radiopharmacy business during FY22 close to pre-COVID levels and witnessed growth during the year. Turnaround plan is on track and is showing encouraging results
• Allergy Immunotherapy reported robust performance with strong recovery from COVID-19 backed by healthy growth in revenues resulting from volumes higher than pre COVID levels. In addition to robust growth in the US market, business witnessing healthy growth in Non-US markets as well
• CMO business reported marginally lower revenues due to decline in COVID-19 related revenue which tapered off in H2’FY22.
• API revenue was lower during the year, as performance was impacted due to lower volumes resulting from plant shutdown and pricing pressure in some key products
• Generics revenue during the period stood lower due to the impact of Import Alert, lower remdesivir sales in H2’FY22, one-time impact of voluntary withdrawal of some sartan products in Q2’FY22 and pricing pressure in the US market

C. Contract Research and Development Services Segment

• Revenue at Rs 457 Crore increased by 50% YoY led by robust volume growth
  • Higher demand from biotech companies for integrated services, functional chemistry and DMPK, Discovery Biology and Clinical trial data management support trough Trial stat, Canada.
  • Volumes increase supported by the recently commissioned facility at Greater Noida
  • Strong capex plan underway in view of robust demand conditions in this business
• Reported EBITDA at Rs 169 Crore vs. Rs 109 Crore in FY21 with a margin of 37.0% vs. 35.6% in FY21

Debt Profile

• Net Debt (constant currency) reduction of Rs 69 Crore in FY22
• Average blended interest rate for FY22 improved to 4.56% from 5.07% in FY21

Business Outlook

Pharma: In radiopharma, we continue to build a long term pipeline of diagnostic and therapeutic radiopharmaceuticals and are executing a turnaround plan of radiopharmacies, which is showing encouraging results. I131 MIBG clinical trials underway with launch expected in FY25. Medium-long term outlook remains robust. Allergy business well placed to grow strongly with healthy margins over the medium term. We expect the CMO business to operate at normal pre-COVID levels for next 2-3 years before new capacity comes upstream and drive volumes .Generics business’ performance to improve going forward as the sartans impurity issue stands resolved and exempted products sales in the US has restarted, however pricing pressure in the US market is an overhang. Resolution of regulatory issues to further improve performance  of this business.

Contract Research and Development Services (CRDS): The business will continue to grow especially with commissioning of the State of the art Greater Noida facility. DMPK expansion at the Greater Noida is underway. We are committing further investments towards capex in this business as we have high capacity utilizations amid strong demand climate. API business is planning asset replacement programs in H1’FY23 for plant upgradation and capacity expansion with volumes expected to normalize in H2’FY23

Investments and Growth: We are accelerating capacity expansions to create new capabilities in our businesses. We expect to incur capex of around Rs 700-750 Crore in FY23 primarily towards expansion in CMO business and enhancement of CRDS capabilities and capacities. In addition, we expect product development expenditure of Rs 250-300 Crore. In view of the strong demand from our customers, we have approved further expansion of the Greater Noida facility which will deliver both Chemistry and DMPK services

Proprietary Novel Drugs: Our lead program – Our lead program – LSD1/HDAC6 inhibitor has successfully started Phase I/ II trials in patients with solid tumors. Additional IND filings with FDA for pipeline programs are expected to follow in FY 23. We have transformed Jubilant Therapeutics to a clinical stage biotech with higher value creation opportunities driven by emerging data from first-in-human studies, including potential capital raise at portfolio level as well as individual asset partnering/ monetization.

Consolidated effective tax rate: ETR of Jubilant Pharmova Limited for FY22 is 34.5%. The company’s cash tax rate is estimated to be at approximately 25% for the next three years based on the current tax structure in key geographies.

Income Statement – Q4 & FY22^1,2

1. All figures are in Rs Crore unless otherwise stated

2. Q4’FY21 and FY21 financials include only the continuing business

Earnings Call details
The company will host earnings call at 5.00 PM IST on May 27, 2022

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: May 27 to June 03 , 2022
Dial-in: +91 22 7194 5757/ +91 22 6663 5757
Playback ID: 75517#

• JBI-802 is a first-in-class, orally administered, dual equipotent inhibitor of LSD1 & HDAC6
• JBI-802 demonstrated synergistic anti-tumor activity in animal models

Bedminster, New Jersey, April 26, 2022 – Jubilant Therapeutics Inc., a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced the dosing of the first patient in a Phase I/II clinical trial of JBI-802 in patients with advanced solid tumors. JBI-802 is a first-in-class, small-molecule, orally administered dual inhibitor of LSD1 and HDAC6 that has demonstrated synergistic anti-tumor activity in animal models.

The Phase I/II trial is an open label, two-part dose escalation and expansion study designed to define the safety and tolerability, explore predictive biomarkers and assess preliminary activity of JBI-802 in more than 100 study participants with advanced solid tumors. More information on the clinical trial can be found at NCT05268666.

Hari S Bhartia, Chairman, Jubilant Therapeutics Inc. shared on the announcement,“We have come a long way from drug discovery to first-in-human dosing. We look forward to making a difference in patients’ lives. Our expertise in structure-based drug design and medicinal chemistry enables us to create differentiated precision therapeutics with truly innovative properties.”

Syed Kazmi, Chief Executive Officer, Jubilant Therapeutics Inc. said, “JBI-802, effectively modulates two validated oncology targets with similar affinity and quick on/off exposure kinetics, leading to synergistic anti-tumour activity with a reduced risk of thrombocytopenia. This is our first internally developed product candidate to enter clinical development. Other advancing programs include an oral brain penetrant inhibitor of PRMT5, JBI 778, and an oral brain penetrant PDL1 inhibitor, JBI 2174, for neurological cancers among others.”

About JBI-802
JBI-802 is novel, 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 and a favorable safety profile with no significant safety concerns or accumulation. It will be evaluated in both solid tumors, such as small cell lung cancer and neuroendocrine prostate cancer and hematological cancers such as acute myelogenous leukemia, myelodysplastic syndrome, and other myeloproliferative cancers.

PAD4 inhibition a novel pathway to inhibit tumor metastasis and tumor growth

Data presented at the American Association of Cancer Research Annual Meeting 2022

BEDMINSTER, New Jersey – April 11, 2022 – Jubilant Therapeutics Inc. a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced data to be presented at the American Association of Cancer Research (AACR) Annual Meeting 2022. The data reports on the pharmacokinetic and anti-cancer properties of isoform-selective peptidyl arginine deiminase 4 (PAD4) inhibitors as potential therapeutics to treat cancer. The poster will be presented during the Novel Targets and Pathways session at 9 a.m. CDT on April 12, 2022. The abstract is available here.

PAD4 activity in tumor cells may play a significant role in cancer metastasis. The first-in-class mechanism of PAD4 inhibition reduces neutrophil extra-cellular traps (NETs) which stimulates cancer cell adhesion, migration and invasion. Therefore, inhibition of PAD4 could be a novel strategy to inhibit cancer progression and metastasis. Jubilant Therapeutics Inc’s  drug discovery platform created a number of lead molecules with b in vitro potency and high selectivity to PAD4 compared to PAD1, PAD2 or PAD3. Oral dosing with a mouse breast cancer model resulted in approximately 50% tumor growth inhibition versus approximately 35% with anti-PD1 antibody and was well tolerated. Molecular correlates of PAD4 inhibition were associated with tumor growth inhibition. These results were observed with additional breast and lung cancer animal models and with other lead PAD4 inhibitors developed by the Company.

“These results highlight the potential of PAD4 inhibition as a treatment for cancer,” said Luca Rastelli, Ph.D., Chief Scientific Officer, Jubilant Therapeutics Inc. and co-author of the poster. “We are characterizing lead candidates from distinct chemical scaffolds, that are orally available, highly selective for PAD4 to address unmet needs in both oncology and autoimmune disorders.”

About PAD4

Peptidyl arginine deiminase 4 (PAD4) is an enzyme that converts protein arginine or mono-methylarginine to citrulline. The PAD4-mediated hypercitrullination reaction in neutrophils causes the release of nuclear chromatin to form a chromatin network termed Neutrophil Extracellular Traps (NETs). NETs have been shown to be associated with several pathological processes including, fibrosis, ischemic stroke, preeclampsia, thrombosis, cancers and other autoimmune diseases. Jubliant Therapeutics Inc. is targeting PAD4 inhibition as a novel strategy to treat inflammatory diseases, cancer progression and metastasis.

About Jubilant Therapeutics Inc.

Jubilant Therapeutics Inc. is a patient-centric biopharmaceutical company advancing potent and selective small molecule modulators to address unmet medical needs in oncology and autoimmune diseases. Its advanced discovery engine integrates structure-based design and computational algorithms to discover and develop novel, precision therapeutics against both first-in-class and validated but intractable targets in genetically defined patient populations. The Company is progressing its most advanced program - first in class dual inhibitor of LSD1/HDAC6 to Phase I/IIa in 1H 2022, followed by additional INDs with novel brain-penetrant modulators of PRMT5 and PDL1, as well as PAD4 inhibitors in oncology and inflammatory indications. Jubilant Therapeutics Inc. is headquartered in Bedminster, NJ and guided by globally renowned key opinion leaders and scientific advisory board members. For more information, please visit www.jubilanttx.com or follow us on Twitter @JubilantTx and LinkedIn.

Noida, Uttar Pradesh, April 04, 2022: Jubilant Bhartia Foundation and Schwab Foundation for Social Entrepreneurship, the sister organisation of the World Economic Forum, invite applications for the 13th edition of the prestigious annual award - Social Entrepreneur of the Year (SEOY) India 2022.

The last date for receiving applications for the Social Entrepreneur of the Year (SEOY) India Award is April 20, 2022. Candidates can participate by submitting the application form available at www.jubilantbhartiafoundation.com or email the filled form to jbf.seoy@jubl.com.

The Social Entrepreneur of the Year - India Award is a joint initiative between the Jubilant Bhartia Foundation and the Schwab Foundation for Social Entrepreneurship (the sister organisation of the World Economic Forum). The award recognises individuals and organisations who implement innovative, sustainable and scalable solutions to address pressing issues faced by under-served communities in India. The winner of the Social Entrepreneur of the Year (SEOY) India Award 2022’ will be announced in September 2022. The winner is awarded by a prominent chief guest in a magnificent ceremony every year.

These promising and successful social entrepreneurs with excellence in large-scale system change models work in diverse areas such as health, education, employment, water, clean energy, building identity & entitlements, financial literacy, access to information and technology, among others.

A Global Platform: The Indian Social Entrepreneur of the Year Award gives the winner and finalists of the award an introduction to a global community of fellow entrepreneurs so that they can engage with public figures as peers, directly influence decision making, draw funding and enable further partnerships, hence helping them to extend their reach and impact exponentially.

Benefits to winners through a three-year core programme:

• Access to the world’s most influential network: Opportunity to connect with key partners at regional and global summits and Schwab Foundation’s digital platform TopLink and to learn sector-specific best practices and scale solutions through partnerships
• Showcase awardees’ solutions to the highest level of decision-makers through award ceremonies, media campaigns, videos and speaking roles
• Build the 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 to equip awardees with the support systems to lead their organisation and drive trust-based collaborations

Parameters for Selection: The participating individuals and organisations are evaluated on the critical parameters of Market-based, Technology-enabled, Sustainability, Direct Social Impact, Reach & Scope, Replicability. The finalists every year are selected through a rigorous process, including expert reviews and site visits. The winner is chosen 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 address the gaps in society and the country. The SEOY India Award not only inspires existing social entrepreneurs to further amplify their work and impact so as to become a part of this select community of social innovators but also inspires individuals with a penchant to bring change to choose the path of social entrepreneurship.

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. Learn about us at www.schwabfound.org and follow us on Twitter: https://twitter.com/schwabfound

Jubilant Therapeutics Inc. (‘Jubilant’), a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, announced today that it will present data on inhibitors of peptidyl arginine deiminase type-4 (PAD4), a potential therapeutic target to treat cancer and autoimmune diseases.The meeting will be held at the American Association of Cancer Research Annual (AACR) in New Orleans between April 8 to 13, 2022, both in person and virtually.

Details of the presentation are as follows:

Title: Novel, isoform selective PAD4 inhibitors for the treatment of Cancer
Presentation Type: Poster
Presenters: Luca Rastelli, Chief Scientific Officer
Dhanalakshmi Sivanandhan, Vice President – Discovery Biology
Session: Novel Targets and Pathways
Time and Date: 12th April 2022, 9:00 AM - 12:30 PM
Link to Abstract: https://www.abstractsonline.com/pp8/#!/10517/presentation/15071

About PAD4
Peptidyl Arginine Deiminase type-4 (PAD4) is an enzyme that converts protein arginine or mono-methylarginine to citrulline. The PAD4-mediated hypercitrullination reaction in neutrophils causes the release of nuclear chromatin to form a chromatin network termed Neutrophil Extracellular Traps (NETs). NETs have been shown to be associated with several pathological processes including cancer metastasis, fibrosis, ischemic stroke, preeclampsia, thrombosis and other autoimmune diseases. Jubliant Therapeutics Inc. is targeting PAD4 inhibition as a novel strategy to treat cancer progression & metastasis and autoimmune diseases without inducing immunosuppression as seen with most other agents approved for autoimmune diseases.

The Board of Jubilant Pharmova Limited met today to approve financial results for the quarter ended December 31, 2021.

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

"The Company's performance during the quarter was affected by headwinds witnessed in Pharmaceuticals segment, which was partly mitigated by continued robust performance in the Contract Research and Development Services (CRDS) segment.

In the Pharmaceuticals segment, while the Radiopharma business witnessed improved performance, Generics business was affected by lower volumes due to Import Alert at Roorkee plant, latest sartan impurities issue and pricing pressure in the US generics market. Tapering of COVID related opportunities led to lower revenue and profitability in the CMO business. API business was affected due to lower volumes resulting from an unplanned plant shutdown during the quarter. Performance of API business expected to normalize in Q4'FY22.

In our Contract Research and Development Services business, we continue to witness strong growth on a YoY basis driven by robust demand from our customers for our Drug Discovery Services.

In the Proprietary Novel Drugs business, our lead program – LSD1/HDAC6 inhibitor has successfully received FDA clearance for IND filing and is on track for initiation of Phase 1 trials in Q4'FY22. Additional IND filings for pipeline programs to follow in FY 23.

I would like to mention that over the medium term, we have strong growth levers in all our businesses. To drive growth in these businesses, Company will continue to invest accordingly."

1. All figures are in Rs Crore unless otherwise stated

2. Q3'FY21 and 9M'FY21 financials include only continuing business

Q3’FY22 Highlights

A. Consolidated financials

• Revenue was at Rs 1,311 Crore versus Rs 1,771 Crore in Q3'FY21
• Reported EBITDA at Rs 200 Crore versus Rs 496 Crore in Q3'FY21
• Finance costs at Rs 37 Crore vs. Rs 46 Crore in Q3'FY21
• Effective Tax Rate of 27.7% vs. 35.6% in Q3'FY21. Current quarter benefited from reversal of certain deferred tax liabilities.
• PAT was at Rs 51 Crore as compared with Rs 219 Crore in Q3'FY21
• EPS is Rs 3.2 versus Rs 13.75 in Q3'FY21
• Capital expenditure for the quarter was Rs 112 Crore

Segment Wise Analysis

B. Pharmaceuticals Segment

• Pharmaceuticals revenue at Rs 1,186 Crore vs. Rs 1,692 Crore in Q3'FY21
• Radiopharma business witnessed improvement in sales YoY, however on a sequential basis performance was lower due to customers order scheduling and the surge in COVID cases in North America, especially in Dec 2021
  • We continue to maintain majority market share
  • Spike in COVID cases impacted Ruby-Fill installations during the quarter and pushed out new installs to the fourth quarter. Strong performance on new installs expected in Q4 as it generally witnesses higher installations
  • NDA for I131 MIBG clinical trials both for phase II and phase III is progressing satisfactorily.
  • Radiopharmacy business witnessed steady performance YoY. Turnaround plan is on track with positive outcome over the last 2-3 quarters, subject to continuing Covid ups and downs.
• Allergy Immunotherapy reported robust performance YoY and stable performance sequentially. Business continues to operate at volumes higher than pre-COVID levels
• CMO business revenue was affected as revenue related to COVID related one-off deals tapered off and also because of customer scheduling
• API business was affected due to lower volumes resulting from an unplanned plant shutdown during the quarter
• Generics business performance was driven by
  • Impurity issue in certain sartan products, which is an industry wide issue
  • Lower volumes due to import alert at Roorkee plant
  • Pricing pressure in the US market
  • Lower Remdesivir sales due to fewer hospitalisations
• With regards to Roorkee import alert, our remediation activities are ongoing as per plan and we expect to complete the same in H1CY2022
• EBITDA was recorded at Rs 178 Crore as compared with Rs 499 Crore in Q3'FY21. EBITDA margin of 15.0% as compared to 29.5% in Q3'FY21
• Lower profits in Pharma business due to the impact of Import alert, voluntary withdrawal of Losartan, continued tapering of COVID related one-off deals in CMO business and pricing pressure in the US generics market

C. Contract Research and Development Services Segment

• Revenue at Rs 120 Crore increased by 51% YoY led by robust volume growth
  • Higher demand from biotech companies for integrated services, functional chemistry and DMPK,
  • Discovery Biology and Clinical trial data management support trough Trial stat, Canada.
  • Volumes increase supported by the recently commissioned facility at Greater Noida
  • Continue to witness strong demand conditions in this business
• Reported EBITDA at Rs 46 Crore vs. Rs 29 Crore in Q3'FY21 with a margin of 38.5% vs. 36.4% in Q3'FY21

9M'FY22 Highlights

A. Consolidated financials

• Revenue was Rs 4,603 Crore versus Rs 4,519 Crore in 9M'FY21
• Reported EBITDA at Rs 923 Crore versus Rs 1,033 Crore in 9M'FY21
• Finance costs at Rs 106 Crore vs. Rs 141 Crore in 9M'FY21
• Average blended interest rate for 9M'FY22 improved to 4.58% from 5.15% in 9M'FY21
• Effective Tax Rate of 32.6% vs. 34.8% in 9M'FY21. Current period benefited from reversal of certain deferred tax liabilities in Q3'FY22.
• PAT was at Rs 354 Crore as compared with Rs 401 Crore in 9M'FY21
• EPS is Rs 22.26 versus Rs 25.19 in 9M'FY21
• Capital expenditure for the period was Rs 350 Crore

Segment Wise Analysis

B. Pharmaceuticals Segment

• Pharmaceuticals revenue at Rs 4,271 Crore vs. Rs 4,304 Crore in 9M'FY21
• Pharmaceuticals EBITDA at Rs 864 Crore vs. Rs 1,020 Crore in 9M'FY21. EBITDA margin of 20.2% as compared to 23.7% in 9M'FY21
• Radiopharmaceuticals business saw recovery in first nine months.
• Radiopharmacy business came close to pre-COVID levels with pick up in nuclear medicine procedures in Q1'FY22 but was again impacted by COVID-19 in Q2'FY22 and Q3'FY22. Turnaround plan is on track
• Allergy Immunotherapy reported robust performance with strong recovery from COVID-19 backed by healthy growth in revenues resulting from volumes higher than pre COVID levels
• Growth in CMO business led by strong demand witnessed from customers as we leveraged our capabilities to meet significant COVID-19 related demands. However, COVID-19 demand tapered off in Q3'FY22
• API revenue lower during the period, as Q3'FY22 performance was impacted due to lower volumes resulting from an unplanned plant shutdown.
• Generics revenue during the period stood lower due to the impact of Import Alert, lower remdesivir sales in Q3'FY22, one-time impact of voluntary withdrawal of some sartan products in Q2'FY22 and pricing pressure in the US market

C. Contract Research and Development Services Segment

• Revenue at Rs 315 Crore increased by 49% YoY led by robust volume growth
  • Higher demand from biotech companies for integrated services, functional chemistry and DMPK, Discovery Biology and Clinical trial data management support trough Trial stat, Canada.
  • Continue to witness strong demand conditions in this business
• Reported EBITDA at Rs 116 Crore vs. Rs 67 Crore in 9M'FY21 with a margin of 36.7% vs. 31.9% in 9M'FY21

Debt Profile

• Net Debt (constant currency) reduction of Rs 137 Crore in 9M'FY22
• Average blended interest rate for 9M'FY22 improved to 4.58% from 5.15% in 9M'FY21

Business Outlook

Pharma: In radiopharma, we continue to build a long term pipeline of diagnostic and therapeutic radiopharmaceuticals and are executing a turnaround plan of radiopharmacies. Medium-long term outlook remains robust. Allergy business well placed to grow strongly with healthy margins over the medium term. We expect the CDMO segment to witness near term correction as COVID related product demand has subsided. Performance of API business expected to normalize in Q4'FY22. Generics business' performance to improve going forward as the sartans impurity issue stands resolved and exempted products sales in the US has restarted, however pricing pressure in the US market is an overhang. Resolution of regulatory issues to further improve performance of this business.

Contract Research and Development Services (CRDS): The business will continue to grow especially with commissioning of the State of the art Greater Noida facility. DMPK expansion at the Greater Noida is underway. We are committing further investments towards capex in this business as we have high capacity utilizations amid strong demand climate.

Investments and Growth: We are accelerating capacity expansions to create new capabilities by almost tripling the investment over previous year. We expect to incur capex of around Rs 500 Crore in FY22 that includes expansion at Spokane site by 50% by end of CY 24 and enhancement of CRDS capabilities and capacities. In view of the strong demand from our customers, we have approved further expansion of the Greater Noida facility which will deliver both Chemistry and DMPK services

Proprietary Novel Drugs: We are on track to take our lead drug candidate to Phase I clinical trials in Q4'FY22 and have received FDA clearance of IND filing for same. Additional IND filings for pipeline programs expected in 2022. We are transforming Jubilant Therapeutics to a clinical stage biotech with higher value creation opportunities through potential partnering deals/ capital markets access subject to the emerging scientific results.

Consolidated effective tax rate: ETR of Jubilant Pharmova Limited for 9M'FY22 is 32.6%. The company's cash tax rate is estimated to be at approximately 25% for the next three years based on the current tax structure in key geographies.

Income Statement – Q3 & 9M'FY221,2

1. All figures are in Rs Crore unless otherwise stated

2. Q3'FY21 and 9M'FY21 financials include only the continuing business

Earnings Call details
The company will host earnings call at 5.00 PM IST on February 04, 2022

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: February 04 to February 11, 2022
Dial-in: +91 22 7194 5757/ +91 22 6663 5757
Playback ID: 139608#

Jubilant Therapeutics Inc, a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced U.S. Food and Drug Administration (FDA) clearance of the investigational new drug application (IND) for JBI-802, a novel, oral, potent and selective dual inhibitor of LSD1 and HDAC6, for the treatment of small cell lung cancer (SCLC), treatment-induced neuro-endocrine prostate cancer (NEPC) and other mutation-defined neuroendocrine tumors.

The Phase 1/2a trial is an open-label, two-part dose escalation and expansion study designed to define the safety profile and preliminary activity of JBI-802 in participants with advanced solid tumors. The study population will include patients with locally advanced or metastatic solid tumors whose disease has failed prior standard therapy.  Expansion cohorts of participants with SCLC, NEPC, and other neuroendocrine-derived cancers will be enrolled to obtain additional safety and efficacy data.

Mr. Hari S Bhartia, Chairman, Jubilant Therapeutics said “We are proud to see our fully in-house discovered program lead our transformation to a clinical stage biotech. This validates the powerful biotech platform that we have built. Jubilant’s objective is to leverage our decades of internal drug discovery and development expertise to create important new medicines by advancing novel molecules against validated targets or first-in-class molecules against newly discovered targets”

“JBI-802 is our most advanced drug candidate and our first to enter into clinical development from a broad pipeline of truly innovative molecules. Our chosen tumor types have high unmet medical needs that can translate to faster approval paths” said Syed Kazmi, Chief Executive Officer of Jubilant Therapeutics.

About JBI-802

JBI-802 is a novel, 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 compared to inhibiting either target alone, and has a favorable safety profile with no significant safety concerns or accumulation. It will be evaluated in both solid tumors, such as small cell lung cancer and neuroendocrine prostate cancer, and hematological cancers such as acute myelogenous leukemia, myelodysplastic syndrome, and other myeloproliferative cancers.