Presented by Shri. Anurag Singh Thakur, Hon. Union Minister for Information & Broadcasting and Minister for Youth Affairs & Sports, Government of India

Noida, September 15, 2022: The Schwab Foundation for Social Entrepreneurship, the sister organisation of the World Economic Forum and the Jubilant Bhartia Foundation of Jubilant Bhartia group today conferred Aniket Doegar of Haqdarshak Empowerment Solutions with the prestigious 'Social Entrepreneur of the Year Award - India 2022'. The award was presented by Shri. Anurag Singh Thakur, Union Minister for Information & Broadcasting and Minister of Youth Affairs & Sports Government of India, at a grand ceremony in the presence of eminent personalities.

Congratulating the winner and finalists and lauding the work of social entrepreneurs, Shri. Anurag Singh Thakur, Union Minister for Information & Broadcasting and Minister for Youth Affairs & Sports Government of India, said, “In a world driven by uncertainties, geo-political upheavals, the role of social entrepreneurs is increasingly becoming critical to nation building. It is imperative to know investments in environment, sustainability and governance will play a crucial role in not only meeting our shared goal of 5 trillion dollar economy, but also sustainable development goals by 2030 and achieving net zero emissions by 2070.” He further added, “Social Entrepreneurs put their innovative ideas to action, build a team, align beneficiaries and stake-holders, raise necessary funds and drive the organisations with their passion and energy towards solving critical issues, be it reduction of poverty, education of children, empowerment of women, climate change mitigation, healthcare etc.”

The SEOY India Award 2022 winner, Aniket Doegar of 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.

Ms. Hilde Schwab, Co-Founder and Chairperson, Schwab Foundation for Social Entrepreneurship, and Professor Klaus Schwab, Founder & Executive Chairman of World Economic Forum and Co-Founder of the Schwab Foundation for Social Entrepreneurship applauded the work of the social entrepreneurs and congratulated the winner & finalists. They shared, “Over these last challenging years, we have seen such depth of civic action, entrepreneurialism and innovation in India. Social entrepreneurs are the driving force behind innovations that improve the quality of life of individuals not only in India but around the world. Their role in creating a just, inclusive and sustainable COVID-19 response and recovery is pertinent. The Schwab Foundation for Social Entrepreneurship has been proud to partner with Jubilant Bhartia Foundation in recognising the exceptional work of Indian social entrepreneurs in alleviating environmental and social problems over the past 13 years. This year’s winner and finalists of the Social Entrepreneur of the Year India Award represent the ethos of social innovation and entrepreneurship.”

Congratulating the winner and the finalists, Mr. Shyam S Bhartia, Chairman and Founder and Mr. Hari S Bhartia, Chairman & Co-Founder, Jubilant Bhartia Group and Founder Directors of Jubilant Bhartia Foundation, shared, "The last two and a half years of the COVID-19 pandemic have showcased social entrepreneurs across the world as a different breed of individuals, going beyond the realm of possibility and serving humanity with all their might. Their creativity, resilience, commitment, potential and reach have been simply outstanding. Today we are proud to celebrate and felicitate all our finalists as extraordinary individuals with remarkable achievements and contributions towards society. We are proud of our 13 years of unique and rewarding partnership with the Schwab Foundation for Social Entrepreneurship. Through our partnership, we have been able to give the social entrepreneurs in India a global platform to showcase their work, scale-up their initiatives and cross-learn from an enriching alliance of similar high-spirited individuals from across the world."

Aniket Doegar, Haqdarshak Empowerment Solutions on winning the SEOY Award India 2022, shared, “I want to thank all our Haqdarshaks on-ground. This award will go a long way in supporting us as a young tech company. A big thanks to the Jubilant Bhartia Foundation and the Schwab Foundation for Social Entrepreneurship. With this recognition we hope to achieve our goal of reaching 100 million citizens.”

The winner of SEOY Award India, Aniket Doegar 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.

The other finalists for SEOY Award India 2022 were Osama Manzar from Digital Empowerment Foundation (DEF), Ajaita Shah from Frontier Markets, Wilma Rodrigues from Saahas Zero Waste and Meera Shenoy from Youth4jobs. The winner and finalists of SEOY Award India will also get an opportunity to apply for the Hindustan Times Fellowship for the Stanford Seed Transformation program.

This year the SEOY Award – India celebrates its 13th year. Over the last decade it has established itself as one of the most respectable awards for social entrepreneurs in India. 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 has since recognised and supported the growing field of social innovation in India.

This year's jury members for the SEOY Award India included Shobhana Bhartia, Chairperson & Editorial Director, HT Media Ltd; Hilde Schwab, Chairperson & Co-Founder, Schwab Foundation for Social Entrepreneurship; T V Narendran, CEO & Managing Director, Tata Steel Limited;  Sudha Pillai, Former Member Secretary, Planning Commission, Government of India; Aashti Bhartia, Non-Executive Director, Jubilant FoodWorks Limited; P R Ganapathy, Regional Director, Stanford Seed, India; Pranshu Singhal, Founder - Karo Sambhav, Winner SEOY 2021.

About the winner:

Haqdarshak Empowerment Solutions was formed with the objective to address the information and access gap related to the various government schemes at the last mile. The heart of all Haqdarshak’s innovative methods lies in their app-based technology platform. Haqdarshak digitizes information on schemes in 11 simple vernacular regional languages makes it available to intended beneficiaries through it’s various B2C channels and an agent-led model. All its products and services are available in 24 states of India. Over the last six years they have unlocked benefits worth Rs 1788 crore for over 16 lakh families.

To achieve their objective, Haqdarshak uses a two-pronged approach- i.e. by creating awareness about the applicable schemes for citizens and by training rural entrepreneurs in using their app and providing application support for the citizens. The entrepreneurs trained by Haqdarshak are local agents, who screen the family/citizen to determine the eligible welfare schemes applicable to them. They also have a proprietary ‘scheme eligibility engine’ that can identify entitled schemes based on the profile information provided by the beneficiaries. Haqdarshaks or the field agents track the applications and follow up with the government offices till the benefits are received by the citizens. Haqdarshaks earn a stipend during an initial program funded by philanthropic or corporate sponsors and are gradually able to earn a sustainable livelihood by using the app and charging a small fee to citizens. Haqdarshak has also built a similar platform to support the 63.5 million micro businesses in India, who form the backbone of the MSME sector. It has developed a curated list of schemes and documentation requirements for MSMEs along with a dedicated web & mobile platform too. Entrepreneurs can access the schemes’ information including benefits, application process and documentation required to apply, and check their eligibility. It has reached more than 20,000 micro-businesses in the last 12 months.

Note to the Editors:

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

Follow on:
Twitter: https://twitter.com/schwabfound;
Facebook: https://www.facebook.com/schwabfound/
LinkedIn: https://www.linkedin.com/company/schwab-foundation-for-social-entrepreneurship

 Jubilant Bhartia Foundation (JBF), established in 2007, is the not-for-profit organisation of the Jubilant Bhartia Group. It focuses on conceptualising and implementing the Corporate Social Responsibility initiatives (CSR) for the Group. The Jubilant Bhartia Foundation’s activities include various community development work, healthcare programs, cultural and sports events, environmental preservation initiatives, vocational training, women empowerment, educational activities, and promotion of Social Entrepreneurship.
Learn more at www.jubilantbhartiafoundation.com

Follow on:
Twitter: https://twitter.com/indiaseoy
Facebook: https://www.facebook.com/IndiaSEOY
LinkedIn: https://in.linkedin.com/company/jubilantbhartiafoundation

For media queries, please contact:
Vivek Prakash
Jubilant Bhartia Foundation;
Ph: +91 120 436 1804/ 1811;
E-mail: vivek.prakash@jubl.com

Philadelphia, September 07, 2022 - Researchers in the laboratory of Yulia Nefedova, M.D., Ph.D., at The Wistar Institute and collaborators at the Jubilant Therapeutics Inc. have uncovered a novel mechanism by which protein arginine deiminase 4 (PAD4) in neutrophils promotes cancer progression. The paper also found that inhibition of this function of PAD4 reduces primary tumor growth and metastasis and enhances checkpoint inhibitor treatments. Jubilant Therapeutics Inc. is developing a novel small molecule PAD4 inhibitor that directly targets this mechanism. The findings appear in Cancer Research, a journal of the American Association for Cancer Research.

“Development of metastases remains a leading cause of death from cancer. Tumor-associated neutrophils have long been implicated in cancer progression. Understanding the mechanisms by which these cells promote tumor growth and metastatic spread is critically important for the development of new treatments,” shares Yulia Nefedova, M.D., Ph.D., associate professor, Immunology, Microenvironment & Metastasis Program, Ellen and Ronald Caplan Cancer Center of The Wistar Institute.

This research revealed the importance of PAD4 protein in the migration of neutrophils, specialized white blood cells that serve as the first line of immune defense in the body, directly impacting both primary tumor growth and secondary malignant tumor spread. Both genetic deletion of PAD4 and pharmacological inhibition of PAD4 using Jubilant Therapeutic Inc’s novel inhibitor dramatically down-regulated chemokine CXCR2, reduced immune suppressive polymorphonuclear myeloid derived suppressor cells (PMN-MDSCs) at tumor and metastatic sites, activated T cells, and synergized with immune checkpoint blockade.

All results point to a potent anti-tumor effect of PAD4 inhibition to target PMN-MDSCs in the tumor microenvironment. This finding is being further investigated in Wistar’s Nefedova laboratory.

“These results highlight the potential of PAD4 inhibition as a novel treatment approach for cancer in addition to the previously established role of this pathway in autoimmune diseases," said Luca Rastelli, Ph.D., Chief Scientific Officer, Jubilant Therapeutics Inc. "We are developing several highly selective oral, small molecule PAD4 inhibitors, with the goal of bringing this novel mechanism to the clinic as potential therapeutics for tumor metastasis in colorectal and pancreatic cancers, patients with liver metastasis as well as for both acute and chronic autoimmune/inflammatory diseases.”

These findings were only made possible through the supportive collaboration between Wistar, a Philadelphia based nonprofit biomedical research institute, and Jubilant Therapeutics Inc., a clinical-stage precision therapy company developing new therapies to treat oncology and autoimmune disease. 

“Only working together, we are able to efficiently translate our fundamental research discoveries into clinical realities,” states Heather Steinman, Ph.D., MBA, The Wistar Institute vice president for Business Development & executive director of Technology Transfer.

Co-authors: Hui Deng, Cindy Lin, Laura Garcia-Gerique, Shuyu Fu, Zachary Cruz, Erin Bonner Matthew Rosenwasser, Sridharan Rajagopal, M. Naveen Sadhu, Chandru Gajendran, Mohd Zainuddin, Ramachandraiah Gosu, Dhanalakshmi Sivanandhan, Miriam A. Shelef, Brian Nam, Dan T. Vogl, and Dmitry I. Gabrilovich.

Publication Information: Regulation of tumor progression by PAD4-mediated neutrophil migration and its targeting with a novel selective inhibitor JBI-589. Cancer Research, 2022. Online publication.

About:

The Wistar Institute is an international leader in biomedical research with special expertise in cancer research and vaccine development. Founded in 1892 as the first independent nonprofit biomedical research institute in the United States, Wistar has held the prestigious Cancer Center designation from the National Cancer Institute since 1972. The Institute works actively to ensure that research advances move from the laboratory to the clinic as quickly as possible. Wistar’s Business Development Team is dedicated to advancing Wistar Science and Technology Development through creative partnerships. wistar.org.

Jubilant Therapeutics Inc. is a clinical stage precision therapeutics 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’s advanced 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, a brain penetrant PDL1 inhibitor, as well as PAD4 inhibitors for oncology and inflammatory indications. The Company is headquartered in Bedminster, New Jersey and guided by globally renowned key opinion leaders and scientific advisory board members. For more: www.jubilanttx.com Twitter @JubilantTx, LinkedIn

Contact – The Wistar Institute

Darien Sutton
(215) 898-3988
dsutton@wistar.org

Contact – Jubilant Therapeutics Inc.

PR Contact
Robert Flamm / Katie Larch
rflamm@burnsmc.com / klarch@burnsmc.com

IR Contact
Monique Kosse
Monique@lifesciadvisors.com

Bedminster, New Jersey, USA – August 03, 2022 – 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 (US FDA) clearance of the Investigational New Drug application (IND) for JBI-778, an oral, brain penetrant and selective protein arginine methyl transferase 5 (PRMT5) inhibitor, for the treatment of solid tumors with brain metastases and primary brain tumors including high-grade glioma.

The Phase I/II trial is an open-label, two-part dose escalation and expansion study designed to define the safety profile, pharmacokinetics, optimal dosing and preliminary activity of JBI-778. The study population in the dose escalation phase will include patients with stable brain metastasis whose disease has failed prior standard therapy. Expansion cohorts will include patients with active brain metastases and high-grade gliomas.

Hari S Bhartia, Chairman, Jubilant Therapeutics Inc. shared on the announcement, “JBI-778 will be our second, highly selective oral drug candidate to enter clinical development following JBI-802. These two programs, along with several others partnered or in preclinical development, highlight Jubilant Therapeutics’ proven discovery engine and structure-based drug discovery expertise.”

Syed Kazmi, Chief Executive Officer, Jubilant Therapeutics Inc. said, “JBI-778 was engineered by our drug discovery team to be a PRMT5 substrate-competitive and brain penetrant drug candidate to address primary brain tumors and brain metastases which currently have limited treatment options. The incidence of brain metastasis is increasing due to improved therapies, increased imaging of neurologically asymptomatic patients and patients living longer. Our team has developed a unique capability to optimize brain penetration for precision oncology therapeutics. In addition to JBI-778, we are also advancing an oral brain penetrant PDL1 inhibitor, JBI 2174, which is on the IND-track to potentially treat primary CNS cancers among others.”

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 patients with advanced cancer with brain metastasis, 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-adenosylmethoinine (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.

The Board of Jubilant Pharmova Limited met today to approve financial results for the quarter ended June 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 YoY improvement in sales in Specialty Pharmaceuticals and CRDMO, which was offset by CDMO Sterile Injectables and Generics segments.
In Specialty Pharmaceuticals, the Radiopharmaceuticals segment reported higher sales and profitability on account of recovery from COVID-19 impact, while Radiopharmacies business witnessed higher sales on account of recovery from pandemic and launch of new products. Our Allergy Business continues to perform strongly and witnessed healthy growth YoY. In the CDMO sterile injectables segment, revenue stood lower YoY as in Q1’FY22 the business realized higher revenue from COVID-19 related contracts as compared to this quarter. Generics segment’s performance was impacted by pricing pressure in the US market and Import Alert related challenges, which resulted in lower performance as compared to Q1’FY22.
In CRDMO, while our Drug Discovery Services segment continued to report robust growth led by higher volumes and stable pricing, the CDMO-API segment reported lower revenue as the Nanjangud plant is undergoing asset replacement and plant upgradation, which contributed to lower volumes.
We are glad to share that the API demerger has become effective 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 would like to inform that for better understanding of performance and outlook of our various businesses, the Company has reorganized the reporting segments from Q1’FY23 onwards and the details are covered in this quarter’s investor materials.”

Q1’FY23 Highlights

Consolidated financials

• Revenue was at Rs 1,452 Crore vs. Rs 1,635 Crore in Q1'FY22 and Rs 1,528 Crore in Q4’FY22
• Reported EBITDA at Rs 204 Crore versus Rs 379 Crore in Q1'FY22 and Rs 244 Crore in Q4’FY22
  • In Q1’FY23, we witnessed COVID related deals of Rs 70 Crore vs. Rs 220 Crore in Q1’FY22 and Rs 11 Crore in Q4’FY22
  • In Q1’FY23, we witnessed nil sales of Remdesivir vs Rs 133 Crore in Q1’FY22 and Rs 4 Crore in Q4’FY22
• Finance costs at Rs 40 Crore vs. Rs 35 Crore in Q1'FY22 and Rs 40 Crore in Q4’FY22 . Higher finance cost vs. Q1’FY22 was due to increase in interest rates
• PAT was at Rs 47 Crore as compared with Rs 161 Crore in Q1'FY22 and Rs 59 Crore in Q4’FY22
• EPS is Rs 2.96 versus Rs 10.09 in Q1'FY22 and Rs 3.74 in Q4’FY22
• Capital expenditure for the quarter was Rs 98 Crore

Specialty Pharmaceuticals

• Revenue at Rs 722 Crore vs. Rs 632 Crore in Q1'FY22 and Rs 695 Crore in Q4’FY22. Over 90% of the revenues are from the North America region
• EBITDA at Rs 117 Crore vs. Rs 75 Crore in Q1’FY22 and Rs 149 Crore in Q4’FY22 with a margin of 16.2% vs. 11.9% in Q1’FY22 and 21.5% in Q4’FY22

a) Radiopharma

• Radiopharma revenue at 592 Crore vs. 518 Crore in Q1’FY22 and Rs 566 Crore in Q4’FY22
  • Radiopharmaceuticals business witnessed improvement in sales driven by recovery from easing of COVID-19 pandemic. Sequentially sales lower due to some customer order scheduling in previous quarter
    • Ruby-Fill installations shows encouraging trend, sales increased both on a YoY and sequential basis in Q1’FY23
  • Radiopharmacies business witnessed growth YoY and sequentially due to higher volumes led by recovery from COVID-19 and launch of new products. Turnaround plan is working well reflected by volumes at pre-COVID levels and lower losses

b) Allergy Immunotherapy

• Allergy immunotherapy revenue at 130 Crore vs. 114 Crore in Q1’FY22
  • Allergy Immunotherapy reported healthy revenue growth YoY. Business continues to operate at volumes higher than pre-COVID levels.

CDMO Sterile Injectables

• CDMO Sterile Injectables’ revenue at Rs 263 Crore vs. Rs 373 Crore in Q1'FY22 and Rs 288 Crore in Q4’FY22. Over 85% of the sales come from North America with balance from Europe and Japan
  • Revenue and profitability lower vs. Q1’FY22 as business witnessed higher COVID related business during the previous quarter.
  • In Q1’FY23, we witnessed COVID related deals of Rs 70 Crore vs. Rs 220 Crore in Q1’FY22 and Rs 11 Crore in Q4’FY22
  • Sequentially revenue lower due to shutdown in Q4’FY22 and some stabilization issues in Q1’FY23 that led to lower volumes during the quarter
• egment’s EBITDA at Rs 132 Crore vs. Rs 216 Crore in Q1'FY22

CRDMO

• Revenue at Rs 280 Crore vs. Rs 193 Crore in Q1'FY22 and Rs 318 Crore in Q4’FY22
• EBITDA at Rs 46 Crore vs. Rs 53 Crore in Q1’FY22 and Rs 73 Crore in Q4’FY22 with a margin of 16.3% vs. 27.7% in Q1’FY22 and 23% in Q4’FY22
• Drug Discovery Services revenue at 118 Crore vs. 88 Crore in Q1’FY22 as robust volume growth drove YoY revenue increase.
  • Higher demand from Biotech companies for integrated services, functional chemistry and DMPK.
  • Chemistry Volume increase supported by the Greater Noida facility that was commissioned in Sep 2021.
  • Sequentially revenue lower in-line with historical trends of Q4 being a stronger quarter
  • Strong capex plan underway in view of robust demand conditions in the Integrated , Chemistry and DMPK business
• CDMO – API revenue at Rs 162 Crore vs. Rs 102 Crore in Q1’FY22 due to higher volumes. Sequentially revenue lower as there was a shutdown in one of the plants at the facility as part of the ongoing asset replacement programs for plant upgradation.

Generics

• Generics revenue at Rs 178 Crore vs. Rs 432 Crore in Q1'FY22 and Rs 221 Crore in Q4’FY22
• Revenue and profitability lower vs. Q1’FY22 due to:
  • Pricing pressure in the US market. During the quarter the business witnessed sharp fall in sartan prices that impacted performance
  • Lower volumes due to import alert at Roorkee plant
  • Lower Remdesivir sales due to fewer hospitalisations. In Q1’FY23, we witnessed nil sales of Remdesivir vs Rs 133 Crore in Q1’FY22 and Rs 4 Crore in Q4’FY22
• US FDA audited the Roorkee facility and has issued six observations. Company will submit action plan on same and will engage with US FDA
• Health Canada inspected Roorkee site in early June and gave compliance rating.
• In July 2022, the USFDA announced removal of Olanzapine, Spironolactone, and Valsartan from the list of excepted products w.r.t the Roorkee Import Alert post its review of the product supply situation and company’s compliance status
• Generics EBITDA at –ve Rs 74 Crore vs. Rs 53 Crore in Q1’FY22 and -ve Rs 24 Crore in Q4’FY22

Proprietary Novel Drugs

Debt Profile

• Net Debt (constant currency) at Rs 1,951 Crore as on June 30, 2022 vs Rs 1,951 Crore as on March 31, 2022
• Average blended interest rate for Q1’FY23 at 4.84% from 4.56% in FY22

Key Business Priorities

Business Outlook

Speciality Pharmceuticals: 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
CDMO Sterile Injectables: We expect the business to operate at normal healthy pre-COVID levels for next 2-3 years before new capacity comes upstream and drive volumes

CRDMO: The Drug Discovery Services 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. CDMO-API business is planning asset replacement programs in H1’FY23 for plant upgradation and capacity expansion with volumes expected to normalize in H2’FY23

Generics: Company hopeful of early resolution of the regulatory issue at the site and post that expect performance to improve led by new launches. In the meantime, emphasis is on shifting of production to CMOs and focus on Non-US strategic markets

Proprietary Novel Drugs: Phase I/II trial underway for our lead program – LSD1/HDAC6 inhibitor in patients with solid tumors. IND filing in Q2 FY23 for 2nd program – brain penetrant PRMT5 inhibitor – has been approved by FDA. Jubilant Therapeutics is now a clinical stage biotech with higher value creation opportunities driven by emerging data from first-in-human studies and additional IND filings.

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

Earnings Call details

The company will host earnings call at 5.00 PM IST on Aug 02, 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: Aug 02 to Aug 09, 2022
Dial-in: +91 22 7194 5757 / +91 22 6663 5757
Playback ID: 65703

Income Statement – Q1 FY23

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.