Sustaining growth momentum, EBITDA margin expansion & Net debt/EBITDA improvement

1. Normalised PAT is after adjusting for exceptional items

The Board of Jubilant Pharmova Limited met today to approve financial results for the quarter & half year ended Sep 30, 2024.

Q2’FY25 Financial Highlights

In Q2’FY25, Total income grew by 5% on a YoY basis to Rs. 1,774 Cr. on the back of growth in revenue in Radiopharma and drug discovery services. EBITDA grew by 19% on a YoY basis to Rs. 311 Cr. due to improved performance in CDMO Sterile Injectables, CRDMO and Generics. Generics business became profitable in the current quarter. EBITDA margins improved by 210 basis points on YoY basis to 17.5%. Q2’FY25 normalised PAT increased by 65% on a YoY basis to Rs. 103 Cr. on the back of improved operating performance and reduced finance cost. Net debt / EBITDA improved to 1.5x as on Sep’24 from 2.5x as on Mar’24.

H1’FY25 Financial Highlights

In H1’FY25, total income grew by 7% on YoY basis to Rs. 3,520 Cr. EBITDA grew by 32% on YoY basis to Rs. 577 Cr. due to improved performance in Radiopharma, CDMO Sterile Injectables, CRDMO and Generics. Normalised profit after tax increased by 153% to Rs. 172 Cr.

Signed Strategic partnership with Pierre Fabre

Earlier in this quarter, we announced a strategic partnership with Pierre Fabre, France. Under this partnership, Jubilant Biosys Innovative Research Services Pte Limited, Singapore (‘JBIRSPL’), subsidiary of Jubilant Biosys Limited, a wholly owned subsidiary of the Company would acquire 80% equity capital in Jasmin (new company incorporated in France, as a Société par Actions Simplifiée (SAS), 100% owned by Pierre Fabre). Jasmin shall acquire Pierre Fabre’s R&D Centre (Including R&D Site and R&D activities) at Saint Julien, France, upon closing of the transaction. This strategic partnership will enable Jubilant Biosys to expand its footprint in Europe in areas like Biologics (mAbs) and Antibody Drug Conjugate (ADC), in addition to its existing services including integrated drug discovery services from India.

Segmental Business Performance

Radiopharma - Leading Radiopharmaceutical manufacturer & 2nd largest Radiopharmacy network in the US

Radiopharmaceuticals Q2’FY25 revenue stood at Rs. 251 Cr. with EBITDA margins at 48%. The business continues to maintain a strong position in the high margin SPECT imaging product portfolio. Ruby-Fill® installations are accelerating. The dosing for Phase 2/3 clinical trial for MIBG has been completed. Overall, the business is on track to introduce multiple new products in the medium term.

Radiopharmacy Q2’FY25 revenue grew by 16% YoY to Rs. 568 Cr. and EBITDA remained stable (YoY) at Rs. 6 Cr. The proposed investment of US$ 50 million in PET radiopharmacy network is underway. This investment will take the overall radiopharmacy network to fifty two (52) sites, thereby solidly positioning Jubilant Pharmova’s radiopharmacy network as the second largest in the US and shall drive the future business growth.

Allergy Immunotherapy - No. 2 in the US Sub-Cutaneous allergy immunotherapy market

Allergy Immunotherapy business reported Q2’FY25 revenue at Rs. 170 Cr. and EBITDA at Rs. 46 Cr. As the sole supplier of Venom in the US, the business is expanding the overall market by increasing customer awareness. In the US Allergenic extracts, the business continues to maintain market share. The revenue was lower YoY due to a delay in product launches in the new (outside US) markets by our partners. The EBITDA margins came lower in the quarter on YoY basis due to lower revenue from the outside US markets and lower production. The margin is expected to normalise in the second half of the financial year.

CDMO Sterile Injectables

Q2’FY25 revenue remained stable at Rs. 302 Cr. and EBITDA grew by 59% YoY to Rs. 89 Cr. The capacity expansion program in Spokane, Washington, USA is on track. The technology transfer programs on Line 3 are underway. The commercial production shall start in FY26 or FY27, post FDA approvals.

CRDMO

In Q2’FY25, the Drug Discovery business revenue grew by 32% to Rs. 151 Cr and EBITDA grew by 39% to Rs. 36 Cr. Q2’FY25 revenue increased sharply YoY due to increase in revenue from new contracts from large Pharma customers and incremental revenues in CDMO business. Q2’FY25 EBITDA margins expanded YoY due to sharp revenue growth. The business onboarded one large pharma company as its client in Q2’FY25. Overall, the medium term outlook continues to be positive on the back of the increase in large pharma clients, CDMO revenues and the addition in new capabilities.

The API business reported revenues of Rs. 127 Cr. and EBITDA of Rs. 12 Cr. for Q2’FY25. Revenues decreased YoY due to focus on selling profitable products. EBITDA margins improved YoY due to cost optimisation efforts.

Generics

The business became profitable in Q2’FY25, sooner than our expectations. The success of the overall turnaround strategy was hinged on continuous quality improvement, reduction in overall cost and scaling up profitable products. Our large markets, US and non-US international business, both are now profitable. Q2’FY25 revenues remained stable YoY at Rs. 173 Cr. Reported EBITDA stands at Rs. 21 Cr. and with margins at 12%.

We plan to launch six to eight products per annum in our US and non-US international markets. We also plan to start the supply of approved products from Roorkee facility to the US market in H2’FY25. There are 35 ANDAs in the approval pipeline for the US. In our last update, we had communicated that following the status change of the solid dosage formulation facility at Roorkee, the exports to the US markets are expected to increase in a meaningful and gradual manner.

Proprietary Novel Drugs

We are happy to announce the dosing of first patients in global clinical trials involving both of our lead programs, Phase II trial for JBI -802 for Essential Thrombocythemia (ET) and other Myeloproliferative Neoplasms (MPN) and Phase I trial for JBI -778 for non-small cell lung cancer (NSCLC) and high grade Glioma.

• JBI-802 is a first-in-class, orally administered, inhibitor of CoREST complex
• JBI-778 is a potential best-in-class, orally administered, brain penetrant inhibitor of PRMT5

Yardley, Pennsylvania, Oct 25, 2024 – 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 first patients in global clinical trials involving two pipeline programs: Phase I/II clinical trial of JBI-802 in heme-oncology and Phase I clinical trial for JBI-778 in solid tumors.

“We are excited to take this significant step forward in our mission to transform the lives of patients through the development of easy to administer precision oral medicines with enhanced safety and therapeutic efficacy,” saidHari S Bhartia, Chairman, Jubilant Therapeutics Inc.

JBI-802 is a first-in-class, orally administered, small-molecule dual inhibitor of LSD1 (Lysine-specific histone demethylase 1A) and HDAC6 (Histone deacetylase 6) within the CoREST (Co-repressor of Repressor Element-1 Silencing Transcription) complex. In the earlier Phase I study conducted in advanced solid tumor patients, JBI-802 showed a dose-proportional increase in exposure across cohorts and a strong correlation between exposure and the on-target effect of platelet decrease. There were no reports of Dysgeusia and Anemia, typical adverse events seen with LSD1only inhibitors. The Phase I trial also showed anti-tumor activity in Non-Small Cell Lung Cancer (NSCLC) patients including a confirmed partial response. Overall, the study results provided human proof-of-principle for expanding the development of JBI-802 in Essential Thrombocythemia and Myelodysplastic Syndrome/Myeloproliferative Neoplasms (MDS/MPN) with thrombocytosis.

Essential Thrombocythemia is a chronic disease of excessive platelets with over 100,000 patients in the United States for whom the primary treatment is hydroxyurea, a therapy that poses sever limitations for patients in terms of both safety and efficacy.

The second clinical trial is to assess both safety and the recommended Phase II dose for JBI-778, an oral brain-penetrant inhibitor of PRMT5 (Protein arginine N-methyltransferase 5) in mEGFR Tyrosine Kinase Inhibitor (TKI) resistant NSCLC, IDH+ high-grade glioma (HGG) and Adenoid Cystic Carcinoma (ACC).

PRMT5, although a proven pathway for multiple cancers, has produced mixed results in terms of drug development due to safety concerns surrounding SAM competitive approach to PRMT5 inhibition and patient segment limitations of MTAP null tumor-focused approach PRMT5 inhibition. JBI-778 is a unique substrate competitive brain penetrant PRMT5 inhibitor that has shown no adverse effects in preclinical setting and can address both MTAP null and wild type tumors as well as brain tumors, catering to larger patient segment including those with brain metastases.  
“The two most advanced novel drug candidates at Jubilant Therapeutics Inc. were discovered in-house using our TIBEO [Therapeutic Index and Brain Exposure Optimization] Discovery Engine. It is our unique approach of structure-based drug design to generate novel pharmacophores with improved therapeutic index compared to existing agents. We are excited to advance both JBI-802 and JBI-778 in genetically-defined subsets of patients with select hematological and solid tumor indications with high unmet medical needs. Initial clinical data are expected to read out in 2025”, said Syed Kazmi, Chief Executive officer, Jubilant Therapeutics Inc.

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 compared to either target alone and with a favorable safety profile. JBI-802 is under evaluation in both hematological cancers such as acute myeloid leukemia, myelodysplastic syndrome and other myeloproliferative cancers as well as solid tumors, such as non-small cell lung cancer and small cell lung cancer.

About JBI-778

JBI-778 is novel, oral, potent and brain penetrant inhibitor of PRMT5. JBI-778 targets the substrate site and stabilizes SAM bound to PRMT5, providing high biological selectivity and has shown a superior safety profile as seen in animals. Preclinical research has demonstrated significant activity in Tyrokinase-Inhibitor resistant cell lines, brain tumor and NSCLC. JBI-778 is under evaluation in solid tumors such as NSCLC, High Grade Glioma and Adenoid Cystic Carcinoma.

Noida, October 09, 2024: Jubilant Biosys Innovative Research Services Pte Limited, Singapore (‘JBIRSPL’), subsidiary of Jubilant Biosys Limited, a wholly owned subsidiary of Jubilant Pharmova Limited and Pierre Fabre SA are entering in a strategic partnership. Pursuant to this, JBIRSPL would acquire 80% equity capital in Jasmin (new company incorporated in France, as a Société par Actions Simplifiée (SAS), 100% owned by Pierre Fabre). Jasmin shall acquire Pierre Fabre’s R&D Centre (Including R&D Site and R&D activities) at Saint Julien, France upon closing of the transaction.

This strategic partnership will enable Jubilant Biosys Limited to expand its footprint in Europe in areas like Biologics (mAbs) and Antibody Drug Conjugate (ADC), in addition to its existing services including integrated drug discovery services from India.

Speaking on the announcement, Giuliano Perfetti, CEO & Managing Director of Jubilant Biosys Limited said, “We are excited to embark on this new strategic partnership with Pierre Fabre. The facility in Saint Julien will serve as our European Centre of Excellence for Biologics and ADCs, located in the heart of Europe. This will enhance our footprint and collaboration with both biotech and large pharma companies in Europe and the USA. By combining the scientific expertise in Biologics and ADCs at our Saint Julien site with the capabilities of 1,200 scientists at our Centres of Excellence for Drug Discovery, Chemistry and CDMO in India, we can develop a unique delivery model tailored to our customers' needs, driving our company’s growth. With this strategic move, Jubilant Biosys continues to strengthen its position as a preferred “CRDMO Partner in Science,” committed to delivering innovative solutions to our customers.”

Sustaining growth momentum, EBITDA margin expansion & Net debt/EBITDA reduction

1.  Normalised PAT is after adjusting for exceptional items

The Board of Jubilant Pharmova Limited met today to approve financial results for the quarter ended June 30, 2024.

Q1’FY25 Financial Highlights

In Q1’FY25, Total income grew by 9% on a YoY basis to Rs. 1,746 Cr. on the back of growth in Ruby-Fill® and new product sales in radiopharmaceuticals, volume growth in radiopharmacies, continued growth momentum in Allergy Immunotherapy business and CDMO Sterile Injectables. EBITDA grew by 50% on a YoY basis to Rs. 266 Cr. due to improved performance across all businesses, Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, CRDMO and Generics. Q1’FY25 reported PAT stands at Rs. 482 Cr. Q1’FY25 normalised PAT increased by 1,055% on a YoY basis to Rs. 69 Cr. on the back of improved operating performance.

In June 24, consequent to the receipt of stake sale proceeds in Sofie Biosciences Inc., totaling up to USD 115.9 million, the company made a voluntary debt repayment of USD 75 million, equivalent to Rs. 626 Cr. Correspondingly, net debt has gone down to Rs. 1,869 Cr. from Rs. 2,509 Cr. as on Mar’24. Net debt/ EBITDA also improved to 1.7x from 2.5x as on Mar’24.

Driving future growth by investing USD 50 million to add six (6) sites in PET Radiopharmacy Network

Jubilant Draximage Inc., a subsidiary of the Company’s wholly owned subsidiary Jubilant Pharma Limited, announced an investment of USD 50 million to expand its PET radiopharmacy network by adding six (6) PET radiopharmacies in strategic locations throughout the United States. This investment shall position the company in the growing PET Imaging segment and shall also enable it to secure long term contracts with the leading PET radiopharmaceutical manufacturers. The new PET radiopharmacies shall be fully operational in FY28.

Investing in Green Energy

The Company has embarked on a renewable energy implementation journey across its facilities in India to enable a reduction in both, cost and carbon footprint. In Q1’FY25, the Company’s subsidiary, Jubilant Biosys Limited entered into a power purchase agreement and Security subscription and shareholder agreement with Isharays Energy Two Private Limited, for the purchase of renewable energy generated through captive power arrangement for its facilities located in Noida and Greater Noida. In January this year, the company approved a similar investment to access renewable power through a captive arrangement for its facilities located in Karnataka, India.

Segmental Business Performance

Radiopharma - Leading Radiopharmaceutical manufacturer & 2nd largest Radiopharmacy network in the US

Radiopharmaceuticals Q1’FY25 revenue grew by 28% YoY to Rs. 262 Cr. and EBITDA grew by 35% YoY to Rs. 126 Cr. The business continues to maintain leadership in the high margin SPECT imaging product portfolio. Ruby-Fill® installations are accelerating. A new product, Sulfur Colloid is getting traction. The dosing for Phase 2 clinical trials for MIBG has been completed. Overall, the business is on track to introduce multiple new products in the medium term. Radiopharmacy Q1’FY25 revenue grew by 17% YoY to Rs. 570 Cr. and EBITDA grew by 617% YoY to Rs. 13 Cr.  The proposed investment of USD 50 million will expand the company’s PET radiopharmacy network to nine (9) sites and overall radiopharmacy network to fifty two (52) sites, thereby solidly positioning Jubilant Pharmova’s radiopharmacy network as the second largest in the US and driving the future business growth.

Allergy Immunotherapy - No. 2 in the US Sub-Cutaneous allergy immunotherapy market

Q1’FY25 revenue grew by 11% YoY to Rs. 168 Cr. and EBITDA grew by 26% YoY to Rs. 63 Cr. As a sole supplier of Venom in the US, the business is expanding the overall market by increasing customer awareness. In the US Allergenic extracts, the business continues to gain market share. The business is also making inroads in the markets outside of the US.

CDMO Sterile Injectables

Q1’FY25 revenue grew by 27% YoY to Rs. 324 Cr. and EBITDA grew by 40% YoY to Rs. 57 Cr. The capacity expansion program in Spokane, Washington, USA is on track with respect to time and cost. Line 3 and Line 4 are expected to start commercial production in FY26 and FY28 respectively.

CRDMO

Q1’FY25 revenue stood at Rs. 243 Cr with EBITDA margins at 16 %.

In the Drug Discovery business, medium term outlook continues to be positive on the back of the anticipated Biosecure Act. In the short term, the business is trying to diversify its customer base and in the medium term, it is adding the ‘development’ capabilities in addition to research and manufacturing. As disclosed earlier, we added two large pharma companies as our clients in Q4’FY24. We expect the revenue from these two new large pharma clients to increase from H2’FY25 onwards.

In the API business, revenues decreased YoY due to change in the product mix. EBITDA margins improved YoY due to cost optimisation efforts.  

Generics

In the Generics business, the closure of manufacturing operations at the solid dosage formulation facility at Salisbury, Maryland, US has been completed in Q1’FY25. We are building a network of CMOs that shall support us in manufacturing select profitable products through low-cost & strategic locations.

Also, following the status change of the Solid dosage formulation facility at Roorkee, the exports to the US market are expected to increase in a meaningful and gradual manner. The business plans to launch 6 to 8 new products per annum in the US and other International markets. In Q1’FY25 revenue stood at Rs. 156 Cr. The company aims to reach EBITDA breakeven within FY25 and then further improve the profitability in the medium term.

Proprietary Novel Drugs

For JBI-802, our lead program, Phase 1 clinical data established safe dosage and further, dose dependent platelet effect was seen in the clinic at higher doses, establishing application in Essential Thrombocythemia (ET) and other Myeloproliferative Neoplasms (MPN). In light of these, we are starting a Phase II clinical trial to treat ET and MPN patients with thrombocytosis. The Phase I trial also showed an anti-tumour response in two lung cancer patients at the low dose of 10mg without platelet reductions. One patient with Non-small cell lung Cancer, having STK11 mutations showed significant response on JBI-802, while not responding to previously administered doublet IO therapy. Generally, the survival rate is very low in such cases, however, the patient has responded well to JBI-802. Additional investigator led clinical trials in NSCLC and post MPN AML are being discussed with multiple institutions to obtain larger patient data.

The Board of Jubilant Pharmova Limited met today to approve financial result for the quarter and financial year ended Mar 31, 2024. The board has proposed a dividend of Rs. 5 per equity share.

FY24 Financial Highlights

In FY24, Total income grew by 7% to Rs. 6,772 Cr. on the back of growth in Ruby-Fill® and new product sales in radiopharmaceuticals, volume growth in radiopharmacies, continued growth momentum in Allergy Immunotherapy business and growth in other income. EBITDA grew by 20% to Rs. 994 Cr. on YoY basis due to improved performance across segments led by Radiopharma, Allergy Immunotherapy and Generics. In line with the management’s guidance, Radiopharmacy business has pivoted to profitability in FY24. The generics business is also moving towards profitability. FY24 normalised PAT increased 63% YoY to Rs. 195 Cr. on improved operating performance. Net Debt/ Ebitda also reduced from 2.93x as on Mar’23 to 2.48x as on Mar’24.

New Product Launch: Received US FDA Approval for Technetium (Tc 99m) Sulfur Colloid Injection in FY24

During FY24, the Company’s subsidiary Jubilant DraxImage Inc. received the US FDA approval for kit, for the preparation of Technetium (Tc 99m) Sulfur Colloid Injection. Technetium Sulfur Colloid Injection is used in the localization of metastatic lymph nodes in patients with breast cancer and melanoma, imaging of areas of the liver, spleen and bone marrow, and studies of esophageal transit, gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents. Post approval, Sulfur Colloid was launched in Q3’FY24 and has contributed in the revenues in FY24.

Solid returns from Strategic Investment in PET Radiopharmacy business

Company’s wholly owned subsidiary ‘JPL’ plans to sell its 25.8% stake in Sofie Biosciences Inc. (‘Sofie’) at an aggregate value of USD 143.27 million. The solid returns made by this investment validated the company’s strategy to invest in PET radiopharmacy business. The proceeds from the stake sale shall be used to reduce debt, capex & other corporate purposes.

Segmental Business Performance

Radiopharma - Leading Radiopharmaceutical manufacturer & 2nd largest Radiopharmacy network in the US

Radiopharmaceuticals FY24 revenue grew by 9% to Rs. 952 Cr. and EBITDA grew by 3% to Rs. 477 Cr. The business continues to maintain leadership in high margin SPECT imaging product portfolio. Ruby-Fill® installations are accelerating. New products Mertiatide and Sulfur Colloid are getting traction. The dosing for Phase 2 clinical trials for MIBG has been completed. Overall, the business is on track to introduce multiple new products in the medium term. In line with the management’s expectations, the radiopharmacy business has pivoted to profitability on the back of increasing sales in new products and improvement in operational efficiencies. The business has reported 7% EBITDA margin in Q4’FY24. Radiopharmacy business grew at an impressive growth of 22% in FY24. Overall Radiopharma segment revenue and EBITDA stands at Rs. 3,001 Cr and Rs. 584 Cr, which includes EBITDA share & share of profits from Sofie.

Allergy Immunotherapy - No. 2 in the US Sub-Cutaneous allergy immunotherapy market

FY24 revenue grew by 13% to Rs. 679 Cr and EBITDA grew by 33% to Rs. 273 Cr. As a sole supplier of Venom in the US, the business is expanding the overall market by increasing the customer awareness. In the US Allergenic extracts, the business continues to gain market share. The business is also making inroads in the markets outside of the US.

CDMO Sterile Injectables

FY24 revenue stood at Rs. 1,117 Cr with EBITDA margins at 17%. The capacity expansion program in Spokane, Washington, USA is on track with respect to time and cost. Line 3 and Line 4 are expected to start commercial production in FY26 and FY28 respectively.

CRDMO

FY24 revenue stood at Rs. 1,093 Cr with EBITDA margins at 15%. In the Drug discovery business, revenue decreased YoY due to the headwinds faced by the US biotech industry. Medium term outlook continues to be positive. In the short term, the business is trying to diversify its customer base and for the medium term, it is adding ‘development’ capabilities in addition to research and manufacturing. In FY24, the business has added two large pharmaceutical companies as their customers.

In the API business, due to pricing pressure in the select products, revenues decreased marginally but the EBITDA increased significantly on the back of reduction in operating costs.

Generics

In the Generics business, Solid dosage formulation facility at Roorkee, India got its status changed to VAI from USFDA. Following this status change, the business expects the exports from the Roorkee facility to the US market to increase in a meaningful and gradual manner. The Generics business has plans to scale up revenues in the US and International markets through launch of new products. In FY24 revenue stood at Rs. 775 Cr with an improvement in EBITDA on YoY basis.

Proprietary Novel Drugs

For JBI-802, our lead program, Phase 1 clinical data established safe dosage and showed anti-tumor response in 2 lung cancer patients at the low dose of 10mg without platelet reductions. One patient with Non-small cell lung Cancer, having STK11 mutations showed significant response on JBI-802, while not responding to previously administered doublet IO therapy. Further, dose dependent platelet effect was seen in clinic at higher doses, establishing application in Essential Thrombocythemia (ET) and other Myeloproliferative Neoplasms (MPN). In light of these, we are starting Phase II clinical trial to treat ET and MPN patients with thrombocytosis in H1 2024. Along with that, investigator led clinical trials in NSCLC and post MPN AML are being discussed with multiple institutions.

Noida, Uttar Pradesh, March 01, 2024: Jubilant Bhartia Foundation and Schwab Foundation for Social Entrepreneurship, a sister organisation of the World Economic Forum, invite applications for the 15th edition of the annual competition - Social Entrepreneur of the Year – India Award 2024 (SEOY). The application for the award will be accepted till April 30, 2024. Interested candidates may submit the application form available at www.jubilantbhartiafoundation.com or can email the filled form to jbf.seoy@jubl.com

The winner of the Social Entrepreneur of the Year – India Award 2024 will be announced on 10th September 2024 in New Delhi.

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

The participating individuals and organisations will be evaluated on the key parameters of Market-based, Technology-enabled, Sustainability, Direct Social Impact, Reach & Scope and Replicability.

The finalists will be selected following an extensive search and selection process, including expert reviews, interviews and site visits. The winner is selected by a jury of eminent leaders and professionals from Government, Business, Media, and Civil Society.

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

In 2010, the Schwab Foundation for Social Entrepreneurship and Jubilant Bhartia Foundation came together to promote social innovation in India through the Social Entrepreneur of the Year – India Award, and they have since recognised and supported the growing field of social innovation in India. This year, the award celebrates its 15th year and has established itself over the last decade as one of the most respectable awards for social entrepreneurs in India.

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

Key Highlights

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

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

Last Date: April 30, 2024

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

Benefits:

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

Past winners:

Dr Shuchin Bajaj from Ujala Cygnus won the Social Entrepreneur of the Year Award - India 2023, presented by Mr Amitabh Kant, G-20 Sherpa, during its presidency, Government of India. Dr Shuchin Bajaj, through Ujala Cygnus’ chain of low-budget-and-patient-friendly tertiary-care hospitals, is enabling access to high-quality integrated healthcare infrastructure and services for underserved communities in tier 2 & 3 cities of India. It works with a mission of ‘Building trust by saving and caring for lives with dignity, affordability and quality’. Ujala is bringing the revolution of super-speciality tertiary health care to the untouched and un-served communities at the convenience of their home town and a basic cost. Ujala Cygnus is also mobilising the community on various facets of health awareness through health/medical camps for rural outreach. Ujala Cygnus has been a pioneer and champion of the Ayushman Bharat PMJAY initiative. All Ujala Cygnus are NABH accredited andempanelled with prominent TPAs and government panels, including ESI, increasing their accessibility. Ujala Cygnus hospitals are currently present in 18 districts and five states of Northern India, reaching a population of over 5 crore people. In FY 22-23, Ujala Cygnus treated 3,42,656 inpatients and 4,59,891 outpatients and undertook 61,516 surgeries. Ujala Cygnus envisions expanding to the farthest corners of North India and institutionalising at least 30 units of medical excellence by 2025. The organisation is currently present in 5 states in North India, including Delhi, Jammu and Kashmir, Uttar Pradesh, Uttarakhand, and Haryana. In the near future, it plans to expand to Odisha, Bihar, Madhya Pradesh, Himachal Pradesh and Rajasthan.

About

Schwab Foundation for Social Entrepreneurship: In partnership with the World Economic Forum, the Schwab Foundation for Social Entrepreneurship convenes a global pioneering community of social innovators who seek to advance the field of social innovation towards more systemic change. The Schwab Foundation supports these changemakers’ efforts to collectively create a more just, equitable and sustainable world. The Schwab Foundation's Global Alliance for Social Entrepreneurship is the largest multi-stakeholder coalition in support of the social innovation sector. Its 110+ members represent over 100,000 social entrepreneurs and bring together a growing ecosystem of corporations, investors, philanthropists, governments, researchers, media, and industry actors.

For more info please visit: www.schwabfound.org

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Sustaining growth momentum along with EBITDA margin expansion

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

Q3’FY24 Financial Highlights

Total income grew by 10% to Rs. 1,713 Cr. on the back of growth in Ruby-Fill® and new product sales in radiopharmaceuticals, volume growth in radiopharmacies, continued growth momentum in Allergy Immunotherapy business, growth in CDMO Sterile Injectables and growth in other income. EBITDA grew by 63% to Rs. 254 Cr. on YoY basis due to improved performance across segments led by Radiopharma, Allergy Immunotherapy, CRDMO and Generics. In line with the management’s guidance, Radiopharmacy business has pivoted to profitability in FY24. The generics business is also moving towards profitability. Q3’FY24 PAT increased YoY to Rs. 66 Cr. on improved operating performance and increased profit share from an associate, Sofie Biosciences Inc.

Received US FDA Approval for Technetium (Tc 99m) Sulfur Colloid Injection

During Q3’FY24, the Company’s subsidiary Jubilant DraxImage Inc. received the US FDA approval for kit, for the preparation of Technetium (Tc 99m) Sulfur Colloid Injection. Technetium Sulfur Colloid Injection is used in the localization of metastatic lymph nodes in patients with breast cancer and melanoma, imaging of areas of the liver, spleen and bone marrow, and studies of esophageal transit, gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents. Post approval, Sulfur Colloid was launched in Q3’FY24 and has contributed in the revenues for the quarter.

Investing in Green Energy

The Company and its subsidiary Jubilant Biosys Limited, have entered in a power purchase agreement and Security subscription and shareholder agreement with O2 Renewable Energy XVI Private Limited (‘O2 renewable’), for purchase of renewable energy generated from the Captive Generating Plant (CGP). This will help meet the 90% of electricity demand for the Company’s facilities located in Karnataka, India.

Segmental Business Performance

Radiopharma - Leading Radiopharmaceutical manufacturer & 2nd largest Radiopharmacy network in the US

Q3’FY24 revenue grew by 23% to Rs. 752 Cr and EBITDA grew by 153% to Rs. 161 Cr. The business continues to maintain leadership in stable, high margin SPECT imaging product portfolio. Ruby-Fill® installations are accelerating. New products Mertiatide and Sulfur Colloid are getting traction. The clinical trials for MIBG is progressing well. Overall, the business is on track to introduce multiple new products from FY24-28. In line with the management’s expectations, the radiopharmacy business has pivoted to profitability on the back of increasing sales in new products and improvement in operational efficiencies. Q3’FY24 and 9M’FY24 Radiopharma segment EBITDA includes EBITDA share from Sofie Biosciences Inc. of Rs. 25 Cr.

Allergy Immunotherapy - No. 2 in the US Sub-Cutaneous allergy immunotherapy market

Q3’FY24 revenue grew by 9% to Rs. 161 Cr and EBITDA grew by 16% to Rs. 62 Cr. As a sole supplier of Venom in the US, the business is expanding the market by increasing the customer awareness. In the US Allergenic extracts, the business continues to gain market share. The business is also making inroads outside of the US market.

CDMO Sterile Injectables

Q3’FY24 revenue increased by 11% to Rs. 303 Cr. Q3’FY24 margins were impacted due to planned extended shut down for maintenance and proactive remediation. Normalised operations have been resumed. The capacity expansion program in Spokane, Washington, USA is on track with respect to time and cost. Line 3 and Line 4 are expected to start commercial production in FY26 and FY28 respectively.

CRDMO

Q3’FY24 revenue stood at Rs. 252 Cr with EBITDA margins at 16%. In the Drug discovery business, revenue decreased YoY due to the headwinds faced by the US biotech industry. Medium term outlook continues to be positive. In the short term, the business is trying to diversify its customer base and for the medium term, it is adding ‘development’ capabilities in addition to research and manufacturing. In the API business, due to pricing pressure in the select products, revenues decreased YoY but the EBITDA increased significantly on the back of reduction in operating costs.

Generics

Q3’FY24 revenue stood at Rs. 199 Cr with an improvement in EBITDA on both YoY and QoQ basis. The business has implemented a Rs. 150 Cr. cost optimisation program. In addition to that, on the revenue side, the business is focussing to increase the revenue mix towards profitable segments and products.

Proprietary Novel Drugs

JBI-802, lead program in the business, initial phase 1 data suggests therapeutic potential in sensitizing immunotherapy resistant tumors and in Myeloproliferative Neoplasms with thrombocytosis.

About Jubilant Pharmova Limited

Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is a company with global presence that is involved in Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, Contract Research Development and Manufacturing Organisation (CRDMO), Generics and Proprietary Novel Drugs businesses.

In the Radiopharma business, the Company is involved in manufacturing and supply of Radiopharmaceuticals with a network of 46 radiopharmacies in the US. The Company’s Allergy Immunotherapy business is involved in the manufacturing and supply of allergic extracts and venom products in the US and in some other markets such as Canada, Europe and Australia. Jubilant through its CDMO Sterile Injectables business offers manufacturing services including sterile fill and finish injectables (both liquid and lyophilization), full-service ophthalmic offer (liquids, ointments & creams) and ampoules.

The CRDMO business of the Company includes the Drug Discovery Services business that provides contract research and development services through two world class research centers in Bengaluru and Noida in India and the CDMO-API business that is involved in the manufacturing of Active Pharmaceutical Ingredients. 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. The Company operates six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. Jubilant Pharmova Limited has a team of over 5,500 multicultural people across the globe. The Company is well recognized as a ‘Partner of Choice’ by leading pharmaceuticals companies globally.

• Jubilant Pharma Limited, Singapore (‘JPL’), a wholly owned subsidiary, in Nov’2020 invested USD 25 Million in Sofie Biosciences Inc., USA (‘Sofie’) and currently holds 25.8% stake
• Sofie is engaged in developing and delivering molecular diagnostics and therapeutics (theranostics). It has radiopharmaceutical production and distribution network, mature contract manufacturing services and high value theranostic intellectual property.
• Sofie has now entered into a definitive merger agreement with certain private equity funds managed by [Trilantic Capital Partners, North America (‘Trilantic North America’)], a US private equity firm. The merger transaction is expected to close by 30th June 2024, subject to customary conditions and regulatory approvals.
• Consequently, JPL plans to sell its entire 25.8% equity stake in Sofie for aggregate proceeds of about USD 139.43 Million, including certain preferred returns. Of this, USD 113.63 Million (subject to certain customary adjustments at closing) is expected to be received upon completion of the merger while receipt of balance sum of USD 25.8 Million is contingent upon achievement of certain future milestones. JPL plans to use these proceeds to reduce leverage and for capex and other corporate purposes.

Bedminster, New Jersey, United States, January 8, 2024:  Jubilant Therapeutics Inc.,a clinical-stage biotechnology company pioneering the development of a first-in-class CoREST (Co-repressor of Repressor Element-1 Silencing Transcription) inhibitor JBI-802 with the dual activity on LSD1 and HDAC6, today announced preliminary safety, pharmacokinetic and initial efficacy results of the Phase I trial in advanced cancer patients. Furthermore, the study results provide a human proof of principle for expanding the development of JBI-802 in Essential Thrombocythemia (ET) and related Myeloproliferative Neoplasms (MPN/MDS) with thrombocytosis.

The data from first 11 patients with advanced cancer revealed a dose-proportional increase in exposure across cohorts and a strong correlation between the exposure and the on-target effects of platelet decrease, indicating that pharmacological relevant level of LSD1 inhibition have been achieved. At the same time, platelet decrease is the only adverse event above grade 1 observed in these patients, which differentiates JBI-802 from LSD1-only inhibitors. Specifically, no AEs (Adverse Events) of anemia has been observed, which is potentially due to the positive benefit of inhibition of HDAC6 in erythrocytes. Also, there are no reports of Dysgeusia, an adverse event that has been observed with LSD1-only inhibitors.

Among the 11 patients, two were NSCLC (Non-small Cell Lung Cancer) patients, both had progressed on doublet immunotherapy, nivolumab+ipilimumab as first line treatment and both showed anti-tumor activity. Both the patients were treated at lower dose level (10mg) where no relevant decrease of platelets is seen, suggesting that in patients with sensitive tumors this dose can be pharmacologically active with a desirable safety profile.

Both NSCLC patients had failed first line treatment with doublet immunotherapy, nivoluman/ipilumab prior to enrolling in the JBI-802 study. The first patient had a STK11 mutation, known to decrease the effectiveness of immunotherapy, present in around 10% of NSCLC patients (higher frequency in lung adenocarcinoma). JBI-802 showed a confirmed partial response in this IO-refractory NSCLC patient with a 39% decrease in the target lung tumor mass. The tumor shrinkage outcome was accompanied by a complete resolution of pancoast syndrome (lung lesion affecting the nerves of brachial plexus). The response appears to be durable after nine cycles and the patient remains on JBI-802 therapy.

The second patient had both lung lesion and liver metastasis, which are known to confer resistance to immunotherapy and lead to poor prognosis.  Treatment with JBI-802 resulted in over 50% shrinkage of the patient’s liver metastasis and a complete resolution of related portal hypertension, edema and improvement of quality of life.

Dr. Alexander Starodub, The Christ Hospital - Cincinnati, treating physician for the above patients commented “The anti-tumor activity seen in these two NSCLC patients is remarkable given the poor prognosis based on their genetic and metastatic pattern. The 10 mg dose of JBI-802 was well-tolerated without any clinically significant adverse effects and the initial clinical data suggest a good therapeutic index for JBI-802”.

Preclinical studies showed a synergistic anti-tumor effect by combining immunotherapy and JBI-802 in xenograft models. In addition, the CoREST inhibition was reported to sensitize immunotherapy resistant tumors, especially those with STK11 mutations. Taken together, the preliminary efficacy data from the JBI-802 Phase I study suggest the opportunity that a combination between immunotherapy and JBI-802 could bring a new therapy option to such patient populations with limited treatment options.

In addition, the on-target dose/exposure-proportional decrease in platelet constitute a proof-of-principle that JBI-802 can be an active compound in  hematological malignancies like Essential Thrombocythemia (ET) and other MPN/ MDS characterized by thrombocytosis. A follow up Phase I/II study in MPN/ET and MPN/MDS with thrombocytosis is being planned in the first quarter of this year to investigate JBI-802 as potential novel treatment option.

The Board of Jubilant Pharmova Limited met today to approve financial result for the quarter ended Sep 30, 2023.

Financial Results Overview Q2’FY24 - Consolidated (Rs Crs)

1. Adjustments include non-recurring or one-off revenues related to Remdesivir, Covid related revenues in CDMO Sterile Injectables business and one-time discount to customers of Generics business in US market due to the pricing pressure and shelf stock adjustment in certain products

2. Adjusted Profit Before Tax and Adjusted PAT is after adjusting for exceptional items and adjustments factored in EBITDA

Financial Results Overview H2’FY24 - Consolidated (Rs Crs)

1. Adjustments include non-recurring or one-off revenues related to Remdesivir, Covid related revenues in CDMO Sterile Injectables business and one-time discount to customers of Generics business in US market due to the pricing pressure and shelf stock adjustment in certain products

2. Adjusted Profit Before Tax and Adjusted PAT is after adjusting for exceptional items and adjustments factored in EBITDA

Key Ratios – Consolidated

1. EBITDA is on TTM basis

2. Exchange rate: 1USD = INR 83.05 as on Sep 30, 2023 and 1USD = INR 82.17 as on Mar 31, 2023

Financial Highlights – Radiopharmaceuticals (Rs Crs)

Key Priorities – Radiopharmaceuticals

• Maintain leadership position in stable high margin core portfolio in North America, e.g., lung functional imaging and thyroid targeted radiotherapeutics
• Innovation leader in PET cardiac imaging through proprietary RUBY-FILL (best in class cardiac imaging product). Further accelerate Ruby-Fill installs in US and other global markets.
• Timely execution of roadmap to enable CY 25 launch of MIBG
• Targeting pediatric patients with high-risk Neuroblastoma. Incidence in the US is 800 (orphan drug) cases per year
• Peak potential market size for MIBG is around USD 240 Mn
• Continue launch of high-growth innovation products. Launched Technetium Mertiatide Injection in Q1’FY24. One more launch planned in FY24 subject to regulatory approvals

Financial Highlights – Radiopharmacies (Rs Crs)

Key Priorities – Radiopharmacies

• Accelerate sales of high growth new products, e.g., Ga-PSMA, and to further gain market share in existing SPECT products
• Maintain current momentum of strong growth in 3rd party sales
• Leverage existing cyclotrons to capture share of PET product growth
• Additionally, explore opportunity to further expand presence into PET radiopharmacies, due to strong demand of PET products, such as PET-PSMA
• Continue to enhance operational and procurement efficiencies leading to improvement in financial performance in FY24

Financial Highlights – Allergy Immunotherapy (Rs Crs)

Key Priorities – Allergy Immunotherapy

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

Financial Highlights – CDMO Sterile Injectables (Rs Crs)

Adjusted Revenue and EBITDA excludes the one-off COVID related business

Key Priorities – CDMO Sterile Injectables

• Global Fill and Finish Sterile Injectable markets of USD 13Bn, with double digit growth rate projected over next 5 years
• Focus is on-time and at-cost execution of USD 370Mn capacity expansion in Spokane and Montreal, to double the CMO capacity over next 5+ years in a phased manner
• Cooperative agreement with US Govt. for USD 149.6 Mn and concessional loan from Canadian Govt. for ~USD 48 Mn
• Leverage differentiated technical know-how to further build scale, e.g., Hormones, Ophthalmic, and Vaccines etc.
• CMO Montreal facility received OAI from the US FDA in May 2023. Engaging with the US FDA to address its observations and resolve the OAI status at the facility

Financial Highlights – Generics (Rs Crs)

Adjusted Revenue and EBITDA excludes the Remdesivir business and one-time discount to customers in US market due to pricing pressure and shelf stock adjustment in certain products

Key Priorities – Generics

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

Financial Highlights – Drug Discovery Services (Rs Crs)

Key Priorities – Drug Discovery Services

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

Financial Highlights – CDMO - API (Rs Crs)

Key Priorities – CDMO - API

• In March 2023, the API plant at Nanjangud saw reversal of OAI status to compliant VAI status from USFDA, driven by Quality Improvement Initiatives at site.
• Going forward, focus is to drive higher capacity utilization including through launch of new products and by acquiring new customers globally
• Operations transformation program underway to increase productivity while lowering costs. Benefits will start becoming visible from H2’FY24
• Clinical stage precision therapeutics business advancing potent and selective small molecules to address unmet medical needs in oncology and autoimmune diseases
• Wholly owned assets; opportunities to explore institutional funding, as well as maximize partnerships to get non-dilutive funding
• Emphasis on cost optimized operating model with a focus on value creation
• Business’ most advanced program - first in class dual inhibitor of LSD1/HDAC6 is undergoing Phase I/II clinical trials
• Another program – PRMT5 Brain penetrant has received IND approval
• LSD1/HDAC6 and PRMT5 have the potential to address high unmet medical needs globally with multi-billion-dollar market size

Segment Financial Results - Consolidated (Rs Crs)