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  • 20 October 2020

    Jubilant Therapeutics Strengthens Scientific Advisory Board

    BEDMINSTER, NJ, USA – October 20, 2020 – Jubilant Therapeutics Inc., a biopharmaceutical company advancing small molecule modulators to address unmet medical needs in oncology and autoimmune diseases,

    BEDMINSTER, NJ, USA – October 20, 2020 – Jubilant Therapeutics Inc., a biopharmaceutical company advancing small molecule modulators to address unmet medical needs in oncology and autoimmune diseases, today announced that three new thought leaders in the field of cancer genetics will join the Company’s Scientific Advisory Board. These thought leaders will provide external scientific review and advice to the Jubilant leadership team on research and development activities.

    “We are pleased to welcome these distinguished experts to our Scientific Advisory Board,” said Syed Kazmi, President and Chief Executive Officer of Jubilant Therapeutics Inc. “The depth of their collective expertise and experience will be extremely valuable as we work to progress our programs towards the clinic. We look forward to collaborating with these highly skilled and imaginative scientists” he further added.

    The Scientific Advisory Board will help support the advancement of Company’s differentiated portfolio, including a unique LSD1/HDAC6 dual inhibitor positioned to address hematological cancers and solid tumors, a next-generation, potential first-in-class PAD4 inhibitor targeting inflammation-driven diseases and autoimmune disorders, as well as novel small molecule PRMT5 and PD-L1 inhibitors for oncology.

    About the New Members

    Julian Downward, PhD, Associate Research Director, Division of Molecular Pathology at the Institute of Cancer Research at the Francis Crick Institute. Dr. Downward’s work focuses on the role played by major oncogenes such as RAS and EGFR in human cancer.

    William C. Hahn, MD, PhD, Chief Scientific Officer, William Rosenberg Professor of Medicine at the Dana-Farber Cancer Institute. Dr. Hahn’s discoveries have informed our current molecular understanding of cancer and formed the foundation of new translational studies. His laboratory pioneered the use of integrated functional genomic approaches to identify and validate cancer targets.

    Ross Levine, MD, Chief, Molecular Cancer Medicine Service, Human Oncology and Pathogenesis Program at Memorial Sloan Kettering Cancer Center. As a physician-scientist, Dr. Levine’s laboratory focuses on elucidating the genetic basis of myeloid malignancies.

    About Jubilant Therapeutics Inc.

    Jubilant Therapeutics Inc. is a patient-centric biopharmaceutical company advancing potent and selective small molecule modulators to address unmet medical needs in oncology and autoimmune diseases. Its advanced discovery engine integrates structure-based design and computational algorithms to discover and develop novel, precision therapeutics against both first-in-class and validated but intractable targets in genetically-defined patient populations. The Company’s entrepreneurial-minded leadership and scientific teams strive for speed and efficiency by employing a business model that leverages the proven and synergistic capabilities of Jubilant Life Sciences Limited’s value chain and shared services. Jubilant Therapeutics is headquartered in the U.S. and guided by globally renowned key opinion leaders and scientific advisory board members.  For more info please visit: www.jubilanttx.com

  • 04 September 2020

    JUBILANT LIFE SCIENCES – Q1’FY21 RESULTS

    The Board of Jubilant Life Sciences Limited, an integrated global pharmaceutical and life sciences company, met today to approve financial results for the quarter ended June 30, 2020.

    • Q1’FY21 Revenue at Rs 1,893 Crore vs. Rs 2,182 Crore in Q1’FY20;
    • Q1’FY21 EBITDA at Rs 310 Crore vs. Rs 444 Crore in Q1’FY20

    The Board of Jubilant Life Sciences Limited, an integrated global pharmaceutical and life sciences company, met today to approve financial results for the quarter ended June 30, 2020.

    Commenting on the Company’s performance, Mr. Shyam S Bhartia, Chairman and Mr. Hari S Bhartia, Co-Chairman & Managing Director, Jubilant Life Sciences said:
    “During the quarter, we worked diligently towards employees’ safety while continuing to serve our global customers by maintaining our operations.
    The company’s performance in the LSI business has been better in EBITDA as well as in margins on both year-on-year as well as quarter-on-quarter due to good demand and improved pricing of select products. We maintained business continuity in all the manufacturing sites. DDDS segment witnessed year-on-year growth in revenues as well as EBITDA led by healthy demand from customers.
    The Company’s performance in the Pharma business had a temporary negative impact due to production suspension at our API plant. This facility has resumed operations from the month of June 2020 and since then it has been operating at a normal capacity. We are witnessing strong demand conditions and improved pricing environment. Our Radiopharma and Allergy business saw an interim decline in revenues due to postponement of elective procedures led by COVID-19 related restrictions on hospital visitations. Adverse impact in these businesses was mitigated by growth in CMO and Dosage businesses.
    With the gradual opening of the US healthcare markets, demand conditions in our Radiopharma and Allergy business have started improving from second half of Q1’FY21 with substantial normalisation achieved June 2020 onwards. In our CMO business, we have entered into four separate clinical and commercial supply agreements for the GMP manufacture of novel COVID-19 treatment and vaccine candidates. Strong demand conditions in this business, along with our business development initiatives, promise upside to performance in the near term.
    Overall, barring unforeseen circumstances, we expect strong performance in our Pharma, LSI and DDDS business in the remaining three quarters of FY21. During Q1’FY21, the Company reduced net debt on a constant currency basis by Rs 343 Crore.
    In the first week of August 2020, the Company launched its remdesivir product in the India and other countries under the brand name ‘JUBI-R’.
    The Company has taken several measures to tide over the COVID-19 induced challenges. We are confident of delivering sustained growth in the medium term on back of our leadership position in various businesses and growth strategies.

    Q1’FY21 Highlights

    Consolidated

    • Revenue at Rs 1,893 Crore, as compared with Rs 2,182 Crore in Q1’FY20
    • Reported EBITDA at Rs 310 Crore as compared with Rs 444 Crore in Q1’FY20. EBITDA margin at 16.4% vs. 20.4% in Q1’FY20
    • Adjusted EBITDA after one-off expenses at Rs 318 Crore as compared with Rs 478 Crore in Q1’FY20. Adjusted EBITDA margin for the quarter was 16.8% vs. 21.9% in Q1’FY20
    • Finance costs at Rs 76 Crore vs. Rs 73 Crore in Q1’FY20
    • Net Profit at Rs 88 Crore versus Rs 185 Crore in Q1’FY20. EPS of Rs 5.53 vs. Rs 11.61 in Q1’FY20
    • Capital expenditure for the quarter was Rs 71 Crore
    • Net debt on a constant currency basis reduced by Rs 343 Crore during Q1’FY21

    Pharmaceuticals Segment

    A. Pharmaceuticals Segment

    • Pharmaceuticals revenue was at Rs 1,096 Crore vs. Rs 1,328 Crore in Q1’FY20
    • Pharmaceuticals EBITDA at Rs 179 Crore as compared with Rs 330 Crore in Q1’FY20 with a margin of 16.3% as compared to 24.8% in Q1’FY20
    • Pharmaceuticals adjusted EBITDA at Rs 184 Crore vs. Rs 355 Crore in Q1’FY20 with a margin of 16.8% as compared to 26.8% in Q1’FY20
    • R&D spent during the quarter of Rs 57 Crore – 5.2% to segment sales. R&D debited to P&L is Rs 43 Crore – 3.9% to segment sales
    • The Company launched its remdesivir product under the brand name ‘JUBI-R’ in India and other markets in the first week of August 2020

    B. Life Science Ingredients Segment

    • LSI revenue was at Rs 737 Crore against Rs 805 Crore in Q1’FY20
    • Strong growth witnessed in Nutritional Products business though Specialty Intermediates and Life Science Chemicals businesses faced headwinds due to temporary impact on demand during beginning of quarter due to COVID-19
    • EBITDA at Rs 124 Crore increased by 2% YoY with margin of 16.8% as compared to 15.1% in Q1’FY20
    • Strong improvement in profitability of Nutritional Products and Specialty Intermediates businesses, driven by better product prices including that of Vitamin B3

    C. Drug Discovery & Development Solutions1 Segment

    • DDDS revenue at Rs 60 Crore increased by 26% YoY led by growth in Drug Discovery Services business
    • EBITDA at Rs 15.7 Crore vs. Rs 8.5 Crore in Q1’FY20 with a margin of 26.0% vs. 17.7% in Q1 last year
    • In July 2020, the company announced completion of the merger of Jubilant Chemsys Limited with Jubilant Biosys Limited. The combined entity will operate as Jubilant Biosys Limited. The merger will simplify operations and provide customers with a single brand access for a wide range of discovery, IND and PR&D and GMP development services

    1. Drug Discovery & Development Solutions include the Drug Discovery Services (Jubilant Biosys) business and Proprietary Drug Discovery business (Jubilant Therapeutics)

    D. Business Outlook

    • We have seen substantial improvement in demand in most of our business segments from June 2020 onwards be it Specialty Pharma, CMO, API or Specialty Intermediates
    • Given the strong demand recovery and new business sign-ups, we believe COVID-19 is not likely to have a material impact on our overall performance during FY21, provided the pandemic situation does not materially deteriorate going forward
    • Overall, we expect strong performance in our Pharma, LSI and DDS business in the remaining three quarters of FY21
    • For Pharmaceutical business, we expect substantially better performance in the remaining three quarters of FY21
    • For LSI business, we expect to achieve close to double digit growth in revenues and significant growth in EBIDTA with higher margins and a very healthy cash generation in FY21.
  • 10 August 2020

    Jubilant Radiopharma and Navidea Biopharmaceuticals Sign Binding Memorandum of Understanding for Commercialization Partnership

    Yardley, PA and Dublin, OH - August 10, 2020 (BUSINESS WIRE) Jubilant Radiopharma, a business unit of Jubilant Pharma Limited and Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) announced today that both companies h ave si gned a binding memorandum of understanding (“MOU”).

    The MOU outlines the terms and framework for an Exclusive License and Distribution Agreement (“ELDA”) for Navidea’s diagnostic imaging agent Tilmanocept (technetium Tc 99m tilmanocept injection) in the United States, Canada, Mexico, and Latin America. In connection with the MOU, Jubilant Radiopharma also made a $1 million equity investment in exchange for a limited exclusivity period while final due diligence efforts are completed.

    Tilmanocept, which is entering Phase 3 clinical trials for approval by the United States Food and Drug Administration (FDA), will enable Nuclear Medicine departments to visually and quantifiably localize and monitor activated macrophages in patients suspected of having rheumatoid arthritis (RA). RA is a painful longterm autoimmune disorder that primarily affects joints in the human body resulting in long term damage if left untreated. In the Unites States over 1.3 million Americans suffer from this disease.

    “For many years oncologists, cardiologists, neurologists and many other medical specialties have benefited from the information nuclear medicine procedures provide them to guide the way they manage their patients” commented Sergio Calvo, President Radiopharmaceuticals Division, Jubilant Radiopharma, “We are confident rheumatologists will also benefit from these procedures creating an even greater demand for this valuable modality”.

    “Jubilant Radiopharma business is focused on developing, manufacturing, commercializing and distributing diagnostic and therapeutic radiopharmaceuticals” stated Pramod Yadav, CEO, Jubilant Pharma Limited. “Jubilant Radiopharma is committed to improving lives through Nuclear Medicine by providing healthcare professionals access to high quality, FDA approved products that enable better patient outcomes. We are pleased to partner with Navidea Biopharmaceuticals to create access to this important new diagnostic imaging agent.”

    “Correct characterization of this debilitating disease and having the ability to monitor therapeutic response to drug therapies is of significant importance to patients” said Dr. Michael Rosol, Chief Medical Officer at Navidea. “Visualizing disease processes at the cellular level will provide even greater information to health care providers ensuring the appropriate therapy is administered at the appropriate time yielding better patient outcomes.”

    "We're excited about the prospect ofthis partnership with Jubilant Pharma," said Jed Latkin, CEO of Navidea. "The combination of Jubilant’s large nuclear medicine footprint and commitment to expand its penetration in the radiodiagnostics market makes them the ideal partner for our Rheumatoid Arthritis diagnostic. Execution of the ELDA will be a monumental step forward for our company.”

    About Navidea

    Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision- making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts.

    About Jubilant Pharma Limited

    Jubilant Pharma Limited (JPL), a company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Life Sciences Limited, is an integrated global Pharmaceutical company engaged in manufacturing and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile Injectables and Non Sterile products through six USFDA approved manufacturing facilities in the US, Canada and India and a network of over 50 radiopharmacies in the US. The Company has a team of around 5,200 multicultural people across the globe and is committed to deliver value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceutical companies globally.

    Navidea Forward-Looking Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding Navidea’s ability to enter into the ELDA on terms acceptable to Navidea, if at all, potential benefits to Navidea under the ELDA, Jubilant’s ability to act as an effective commercial and distribution partner, and Jubilant’s expected expansion into the radio- diagnostics market. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our ability to negotiate and enter into the ELDA on acceptable terms, if at all; Jubilant’s ability to act as a successful commercial distribution partner; our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.

    Investors are urged to consider statements that include the words “will,” “may,” “could,” “should,”“plan,” “continue,” “designed,” “goal,” “forecast,” “future,” “believe,” “intend,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements

    You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.

    References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Navidea is not responsible for the contents of third-party websites.

  • 08 August 2020

    Shyam S. Bhartia calls on the Hon'ble Chief Minister of Uttar Pradesh | Remdesivir (‘JUBI-R’) presented to Shri Yogi Adityanath | Jubilant donates 1000 vials of Remdesivir to UP Government.

    The Hon'ble Chief Minister of Uttar Pradesh Shri Yogi Adityanath today, received Remdesivir (‘JUBI-R’) from Mr. Shyam S. Bhartia, Chairman, Jubilant Life Sciences Limited. This COVID-19 medicine was researched at Jubilant’s Noida R&D facilities.

    On the occasion, Shri Yogi Adityanath said, “Remdesivir is an effective medicine in the treatment of severe COVID-19 cases. In this critical situation, I am pleased that this medicine was made available by Jubilant in the quick time of two and a half months.” The Chief Minister noted that Jubilant has a large presence in UP and he also invited Jubilant to make further investments and look at the opportunities in the pharmaceutical sector.

    In May 2020, Jubilant entered into a non-exclusive Licensing Agreement with Gilead Sciences, Inc., that granted it the right to register, manufacture and sell Gilead’s investigational drug remdesivir in 127 countries including India. Jubilant, recently launched Remdesivir injection under the brand name ‘JUBI-R’ in the Indian market. The drug is being made available to over 1,000 hospitals providing COVID-19 treatment in India through the Company’s distribution network. Remdesivir is the only antiviral drug that has received Emergency Use Authorization (EUA) by the USFDA for treatment of suspected or laboratory confirmed COVID-19.

    “It gives us immense pleasure and satisfaction to present ‘JUBI-R’ the life-saving medicine to Hon'ble Chief Minister of Uttar Pradesh Shri Yogi Adityanath. We are delighted to support the Uttar Pradesh Government in its fight against COVID-19 by donating 1000 vials of JUBI-R (Remdesivir) through our CSR arm, the Jubilant Bhartia Foundation. We are thankful to the Uttar Pradesh Government for its support in producing this critical drug in a short span of time. Jubilant remains committed to the cause of providing leading healthcare solutions addressing the needs of the patients.” stated Mr. Shyam S. Bhartia, Chairman, Jubilant Life Sciences Limited.

  • 03 August 2020

    Jubilant Life Sciences Limited announces launch of ‘JUBI-R’ (remdesivir) in India for the treatment of COVID-19

    Jubilant Life Sciences Limited, an integrated global pharmaceutical and life sciences company, is pleased to announce that its subsidiary, Jubilant Generics Limited (“Jubilant”), has launched remdesivir for injection under the brand name ‘JUBI-R’ in the Indian market at a price of INR 4,700 per vial of 100 mg (lyophilized injection).

    Jubilant Life Sciences Limited, an integrated global pharmaceutical and life sciences company, is pleased to announce that its subsidiary, Jubilant Generics Limited (“Jubilant”), has launched remdesivir for injection under the brand name ‘JUBI-R’ in the Indian market at a price of INR 4,700 per vial of 100 mg (lyophilized injection). The Company will make the drug available to over 1,000 hospitals providing COVID-19 treatment in India through its distribution network. Jubilant’s 24 hour help line will enhance access to ‘JUBI-R’ during these pandemic times, where timely access to the drug may prove critical to treatment outcomes.

    In order to increase accessibility of ‘JUBI-R’ to patients below the poverty line and to front line paramedical staff, Jubilant Bhartia Foundation, a not-for-profit organisation of Jubilant Group, is launching unique programs in India aimed at distribution of the drug.

    In May 2020, Jubilant entered into a non-exclusive Licensing Agreement with Gilead Sciences, Inc. (NASDAQ: GILD) that granted it the right to register, manufacture and sell Gilead’s investigational drug remdesivir in 127 countries including India. Remdesivir is the only antiviral drug that has received Emergency Use Authorization (EUA) by the USFDA for treatment of suspected or laboratory confirmed COVID-19 in adults and children hospitalized with severe disease. On July 20, 2020, Jubilant received approval from the Drug Controller General of India (DCGI) to manufacture and market the investigational antiviral drug remdesivir (“JUBI-R”) for 100 mg/vial (lyophilized injection) for restricted emergency use in India for the treatment of severe COVID-19. ‘JUBI-R’ will require to be administered intravenously in a hospital setting under the supervision of a medical practitioner.

    “It gives us immense satisfaction to launch ‘JUBI-R’ as this drug has a potential to save precious lives across the globe. We have launched the product at affordable prices and strive to make it available in sufficient quantities to meet high demand for the drug in the Indian market and in other countries,” stated Mr. Shyam S. Bhartia, Chairman and Mr. Hari S. Bhartia, Co-Chairman & Managing Director, Jubilant Life Sciences Limited. “The Company’s ability to launch this product in such short timelines highlights our R&D and manufacturing capabilities and our continued commitment to provide leading healthcare solutions. Through the Jubilant Bhartia Foundation, we will distribute the drug on compassionate basis to save precious lives of people through unique programs.”

  • 28 July 2020

    JUBILANT BIOSYS LIMITED announces the merger with JUBILANT CHEMSYS LIMITED

    Jubilant Biosys Limited (“Biosys”), a wholly owned subsidiary of Jubilant Life Sciences Limited, today announced completion of the merger with its sister company Jubilant Chemsys Limited, based in Noida, India. The combined entities will now operate as Jubilant Biosys Limited.

    Jubilant Biosys Limited (“Biosys”), a wholly owned subsidiary of Jubilant Life Sciences Limited, today announced completion of the merger with its sister company Jubilant Chemsys Limited, based in Noida, India. The combined entities will now operate as Jubilant Biosys Limited.

    The merger will simplify operations and provide customers with a single brand access for a wide range of discovery, IND and PR&D and GMP development services. Biosys had earlier announced significant investment in building new state-of-the-art research facilities in Greater Noida and in Bengaluru, India to cater to increasing customer demand for its functional services (medicinal & synthetic chemistry, structural biology, DMPK, Biology & GMP scale-up) and notably integrated drug discovery services.

    Marcel Velterop, President- Jubilant Biosys Limited and CDMO, said: “We are delighted to make this merger happen and focus our investments for growth to expand both the chemistry as well as integrated drug discovery capabilities. It provides clarity to customers and enables us to better deliver on our “4D” promise of accelerating the discovery process through increased digitization of our operations and information flow.”

    About Jubilant Biosys Limited:

    Jubilant Biosys, a Bengaluru based wholly owned subsidiary of Jubilant Life Sciences Ltd, offers contract research & development services for global pharmaceutical innovators. Biosys has demonstrated expertise in functional services such as Biology, DMPK, Toxicology as well as Medicinal Chemistry, PR&D and GMP scale-up capabilities up to phase II. It has a proven track record of delivering over 75 integrated programs in multiple therapeutic areas including but not limited to Oncology, Metabolic Disorders, Pain & Inflammation, CNS and expanding into Rare Diseases. Its sister company, TrialStat Solution Inc., provides an advanced EDC platform to accelerate clinical trials’ data capture and processing. For more info, please visit www.jubilantbiosys.com.

  • 20 July 2020

    Jubilant Life Sciences Limited announces approval of ‘JUBI-R’ (remdesivir) in India for the treatment of COVID-19

    Jubilant Life Sciences Limited, an integrated global pharmaceutical and life sciences company, is pleased to announce that its subsidiary, Jubilant Generics Limited (“Jubilant”), has received approval from the Drug Controller General of India (DCGI) to manufacture

    Jubilant Life Sciences Limited, an integrated global pharmaceutical and life sciences company, is pleased to announce that its subsidiary, Jubilant Generics Limited (“Jubilant”), has received approval from the Drug Controller General of India (DCGI) to manufacture and market the investigational antiviral drug remdesivir for 100 mg/vial (lyophilized injection) for restricted emergency use in India for the treatment of severe COVID-19.
    Jubilant’s remdesivir product will be marketed under the brand name ‘JUBI-R’ in India and will be made available in 100 mg vials (injectable). It would be administered intravenously in a hospital setting under the supervision of a medical practitioner. The Company will distribute the drug in the Indian market through its distribution network and will be available by the first week of August 2020.

    In May 2020, Jubilant entered into a non-exclusive Licensing Agreement with Gilead Sciences, Inc. (NASDAQ: GILD) that granted it the right to register, manufacture and sell Gilead’s investigational drug remdesivir in 127 countries including India. Remdesivir is the only antiviral drug that has received Emergency Use Authorization (EUA) by the USFDA for treatment of suspected or laboratory confirmed COVID-19 in adults and children hospitalized with severe disease.

    “We are very pleased to launch ‘JUBI-R’, a drug with potential to save lives of people who have contracted COVID-19,” stated Mr. Shyam S. Bhartia, Chairman and Mr. Hari S. Bhartia, Co-Chairman & Managing Director, Jubilant Life Sciences Limited.  “At Jubilant, we are focused on quickly making this drug available in India in required quantities and at affordable prices. This milestone underscores our continued commitment to provide leading healthcare solutions as well as demonstrates our ability to leverage our broad capabilities to deliver important new medicines.”

  • 22 June 2020

    Jubilant Therapeutics Presents Preclinical Data at the American Association for Cancer Research, Reveals Unique Dual-Action Anti-Cancer Mechanism Underscoring First-in-Class Pipeline Asset in Hematological Tumors

    -- Findings indicate JBI-802 is a potent and selective oral dual inhibitor of LSD1 and HDAC6 with enhanced anti-tumor activity in hematological cancer and favorable safety profile.

    BEDMINSTER, NJ -- June 22, 2020 – Jubilant Therapeutics Inc., a biopharmaceutical company advancing small molecule modulators to address unmet medical needs in oncology and autoimmune diseases, today announced that preclinical data  of dual LSD1 and HDAC6 inhibitor JBI-802, will be presented in a poster session at the American Association for Cancer Research (AACR) 2020 Virtual Annual Meeting II. The preclinical data demonstrated that JBI-802 has strong efficacy in multiple in vivo cancer models mediated by LSD1 and HDAC6 inhibition, while demonstrating excellent selectivity against other HDACs and superior in vivo efficacy compared to single agents targeting LSD1 or HDAC6.

    “We are excited to reveal these new data from our study of JBI-802 whose first-in-class dual mechanism of action targets the overexpression of two proteins, while exhibiting a favorable tolerability profile,” said Syed Kazmi, President and Chief Executive Officer of Jubilant Therapeutics Inc. “These data support the additional development of this novel dual epigenetic inhibitor as a potential therapeutic agent for genetically-defined cancers.”

    A link to the e-poster, listed below, is available through the AACR website.

    Title: Novel Dual Small Molecule Inhibitor Targeting LSD1 and HDAC6
    Poster Number: 1756
    Date and Time: June 22, 2020 at 8:45 a.m. Eastern Daylight Time (EDT)
    Session Title: Epigenetic Targets
    Presenter: Dhanalakshmi Sivanandhan, et al.

    Key highlights from the study which examined anti-proliferative activity of JBI-802 on select acute myeloid leukemia (AML), chronic lymphocytic leukemia, small cell lung cancer, sarcoma and multiple myeloma cell lines as compared to single agents, include the following:

    • JBI-802 demonstrated strong tumor growth inhibition in erythroleukemia and multiple other hematological tumors as compared to single agents;
    • Syngeneic models showed single agent activity with unique mechanism of action and that JBI-802 can be combined with checkpoint inhibitors safely in this mouse model; and
    • The molecule showed a favorable tolerability profile at efficacious doses.

    JBI-802 is currently being evaluated in IND-enabling studies for the treatment of AML and other solid tumors and first-in-human clinical studies are expected in 1H 2021. Jubilant Therapeutics Inc. is developing a pipeline of novel, differentiated therapeutic assets; for partnership opportunity inquiries please contact BD@jubilanttx.com.

    About Jubilant Therapeutics Inc.

    Jubilant Therapeutics Inc. is a patient-centric biopharmaceutical company advancing potent and selective small molecule modulators to address unmet medical needs in oncology and autoimmune diseases. Our 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 entrepreneurial-minded leadership and scientific teams strive for speed and efficiency by employing a business model that leverages the proven and synergistic capabilities of Jubilant Life Sciences’ value chain and shared services. Jubilant Therapeutics is headquartered in the U.S. and guided by globally renowned key opinion leaders and scientific advisory board members.

    Media Contacts
    MacDougall
    Amanda Whelan or Susan Sharpe
    awhelan@macbiocom.com or ssharpe@macbiocom.com
    (781) 235-3060

    Link: Click here

  • 29 May 2020

    JUBILANT LIFE SCIENCES – Q4 & FY20 RESULTS

    The Board of Jubilant Life Sciences Limited, an integrated global pharmaceutical and life sciences company met today to approve financial results for the quarter ended March 31, 2020.

    • FY20 Revenue at Rs 9,154 Crore; Q4’FY20 Revenue at Rs 2,391 Crore
    • FY20 EBITDA at Rs 1,995 Crore up 12% YoY; Q4’FY20 EBITDA at Rs 556 Crore up 58% YoY

    The Board of Jubilant Life Sciences Limited, an integrated global pharmaceutical and life sciences company met today to approve financial results for the quarter ended March 31, 2020.

    Commenting on the Company’s performance, Mr. Shyam S Bhartia, Chairman and Mr. Hari S Bhartia, Co-Chairman & Managing Director, Jubilant Life Sciences said:
    “We are glad to report record profits in FY20 with improvement in margins across all the business segments. The Q4FY20 performance was impressive with EBITDA growth of 58% YoY. Despite the Covid-19 led challenges, we continue to experience strong demand across most of our businesses. Our leadership position in all the segments we operate in ensures positive outlook for business performance and healthy cashflow generation to reduce leverage.”

    Pharmaceutical segment recorded revenue of Rs 5,714 Crore during FY20 as against Rs 5,349 Crore in FY19. The 7% YoY revenue growth during the year was driven by better performance in all three key business lines. EBITDA was at Rs 1,555 Crore, up 13% YoY with margin at 27.2%, as compared with 25.7% in FY19.

    LSI segment’s FY20 revenue was at Rs 3,179 Crore as against Rs 3,545 Crore last year. LSI’s FY20 EBITDA was at Rs 431 Crore vs. Rs 445 Crore last year with margin at 13.6% vs. 12.6% last year.

    The Drug Discovery Services business’ FY20 revenue increased to Rs 262 Crore from Rs 217 Crore with 28.1% EBITDA margin in the current year as against 8.3% EBITDA margin in FY19. In view of the strong demand, we are making investments in this business to double capacities over the next 2-3 years.

    In our Proprietary Drug Discovery business, we are working on more than six programs targeting small molecule therapies in the area of oncology and auto-immune disorders with two programs moving to the clinic next year.

    During the year, the company reduced its Net Debt by Rs 514 Crore and is focused on further deleveraging by generating healthy levels of cashflows.

    Company signed Licensing Agreement with Gilead Sciences to register, manufacture and sell Gilead’s investigational drug, remdesivir, a potential therapy for Covid-19 in 127 countries including India, and is working towards launching the drug in July 2020.

    The Company has taken several measures to tide over the COVID-19 induced challenges. We are confident of delivering sustained growth in the medium term on the back of our leadership position in various businesses and growth strategies.
    Q4’FY20 Highlights

    Consolidated

    • Revenue at Rs 2,391 Crore, as compared with Rs 2,386 Crore in Q4’FY19
    • EBITDA at Rs 556 Crore increased 58% YoY and 8% sequentially. EBITDA margin at 23.3% vs. 14.7% in Q4’FY19 and 22.2% in Q3’FY20
    • Adjusted EBITDA after one-off expenses at Rs 568 Crore up 46% YoY from Rs 388 Crore in Q4’FY19. Adjusted EBITDA margin for the quarter was 23.7% vs. 16.3% in Q4’FY19
    • Finance costs at Rs 71 Crore vs. Rs 62 Crore in Q4’FY19 and Rs 72 Crore in Q3’FY20
    • Net Profit at Rs 260 Crore as compared with Rs (99) Crore in Q4’FY20. EPS of Rs 16.4 vs. Rs (6.4) in Q4’FY19
      • Q4’FY19 had an Exceptional charge of Rs 235 Crore related to settlement of IFC convertible loan
    • Normalised PAT at Rs. 260 Crore vs. Rs 135 Crore in Q4’FY19. Normalised EPS at Rs. 16.4 vs. Rs 8.5 in Q4’FY19
    • Capex in Q4’FY20 of Rs 89 Crore
    • Net debt on a constant currency basis lower by Rs 297 Crore during Q4’FY20
    • In Q4’FY20, Company announced and paid an Interim Dividend @ 500% i.e. Rs. 5 per share of Rs 1 paid up for FY20, which is the Final dividend for the year as well

     

    Segment Wise Analysis

    Pharmaceuticals Segment

    • Pharmaceuticals revenue at Rs 1,483 Crore, an increase of 6% YoY and 2% QoQ. Specialty Pharma and Generics segments increased by 13% YoY and 17% YoY, respectively. CDMO revenue decreased 13% YoY due to Covid-19 related disruption at the API plant in March
    • Pharmaceuticals EBITDA at Rs 429 Crore, an increase of 50% YoY with margin of 28.9% as compared to 20.3% in Q4’FY19 and 28.4% in Q3’FY20
    • Pharmaceuticals adjusted EBITDA at Rs 440 Crore increased by 37% YoY with a margin of 29.7% as compared to 22.9% in Q4’FY19
    • R&D spent during the quarter of Rs. 42 Crore – 2.9% to segment sales. R&D debited to P&L is Rs. 43 Crore – 2.9% to segment sales
    • During the quarter, the Company transferred the India Branded Pharmaceuticals business to its indirect subsidiary, Jubilant Generics Limited.

    Life Science Ingredients Segment

    • LSI revenue in Q4FY20 at Rs 823 Crore compared to Rs 912 Crore in Q4FY19
    • EBITDA at Rs 118 Crore increased by 17% YoY and 18% QoQ with margin of 14.4% as compared to 11% in Q4’FY19

     

    Drug Discovery & Development Solutions1 Segment

    • DDDS revenue increased by 25% YoY to Rs 85 Crore led by growth in Drug Discovery Services business
    • EBITDA at Rs 35 Crore as compared to Rs (1) Crore in Q4’FY19 with margin improved to 40.7% from (1.1)% in Q4’FY19.
    • Drug Discovery & Development Solutions include the Drug Discovery Services (Jubilant Biosys & Jubilant Chemsys) business and Proprietary Drug Discovery business (Jubilant Therapeutics)

     

    FY20 Highlights

    Consolidated

    • Revenue at Rs 9,154 Crore up from Rs 9,111 Crore in FY19
    • Reported EBITDA at Rs 1,995 Crore increased by 12% YoY. EBITDA margin at 21.8% against 19.5% in FY19, an increase of 231 bps
    • Adjusted EBITDA after one-off expenses at Rs 2,066 Crore vs. Rs 1,860 Crore in FY19, growth of 11% YoY. Adjusted EBITDA margin in FY20 was 22.6% vs. 20.4% in FY19
    • Finance costs at Rs 287 Crore as compared to Rs 220 Crore in FY19.
    • Net Profit at Rs 898 Crore up 56% YoY. EPS of Rs 56.4 vs. Rs 36.9 in FY19
      • FY20 exceptional charge of Rs 35 Crore was related to Rs 23.3 Crore charge for prepayment of high yield bonds and NCDs and Rs 11.3 Crore related to asset write-off. FY19 exceptional charge of Rs 280 Crore was related to settlement of IFC convertible loan
    • Normalised PAT at Rs. 933 Crore vs. Rs 855 Crore in FY19. Normalised EPS at Rs. 58.6 vs. Rs 53.7 in FY19
    • Capex in FY20 of Rs 516 Crore
    • Net debt lower by Rs 514 Crore during FY20

     

    Segment Wise Analysis

    Pharmaceuticals Segment

    • Revenue at Rs 5,714 Crore, increased by 7% YoY, led by growth in all three revenue segments with 7% growth in Specialty Pharma, 5% growth in CDMO and 10% growth in Generics
    • EBITDA at Rs  1,555 Crore up 13% YoY with a margin of 27.2% as compared to 25.7% in FY19
    • Adjusted EBITDA at Rs  1,619 Crore increased 11% YoY with a margin of 28.3% as compared to 27.2% in FY19
    • R&D spent during FY20 at Rs. 228 Crore – 4% to segment sales. R&D debited to P&L is Rs. 199 Crore – 3.5% to segment sales

    Life Science Ingredients Segment

    • LSI revenue at Rs 3,179 Crore vs Rs 3,545 crore during FY19. Strong growth witnessed in Specialty Intermediates and Nutritional Products
    • EBITDA at Rs 431 Crore with margin of 13.6% as compared to 12.6% in FY19.
    • Adjusted EBITDA at Rs 440 Crore, with a margin of 13.8% as compared to 12.6% in FY19

    Drug Discovery & Development Solutions Segment

      • DDDS segment revenue increased 21% YoY to Rs 262 Crore
      • EBITDA increased by over three times to Rs 73 Crore from Rs 18 Crore FY19; FY20 margin at 28.1% up from 8.3% in FY19
  • 12 May 2020

    Jubilant Life Sciences Limited enters into Licensing Agreement with Gilead for Remdesivir, a potential therapy for Covid-19

    Jubilant Life Sciences Limited, an integrated global pharmaceutical and life sciences company, is pleased to announce that its subsidiary, Jubilant Generics Limited.

    Jubilant Life Sciences Limited, an integrated global pharmaceutical and life sciences company, is pleased to announce that its subsidiary, Jubilant Generics Limited (“Jubilant”), has entered into a non-exclusive Licensing Agreement with Gilead Sciences, Inc. (NASDAQ: GILD) that will grant Jubilant the right to register, manufacture and sell Gilead’s investigational drug, remdesivir, a potential therapy for Covid-19 in 127 countries including India. These countries consist of nearly all low-income and lower middle-income countries, as well as several upper-middle and high-income countries that face significant obstacles to healthcare access. Under the licensing agreement, Jubilant will have the right to receive a technology transfer of the Gilead manufacturing process to scale up production to enable expedited access of the medicine to Covid-19 patients upon approvals by regulatory authorities in respective countries.

    Commenting on the partnership, Mr. Shyam S. Bhartia, Chairman and Mr. Hari S. Bhartia, Co-Chairman & Managing Director, Jubilant Life Sciences Limited, said, “We are very happy to strengthen our partnership with Gilead to license remdesivir, which, based on initial data, shows promise to be a potential therapy for Covid-19, a pandemic creating unprecedented health and economic crisis globally. We will be monitoring the clinical trials and regulatory approvals very closely and would be ready to launch the drug shortly after the required regulatory approvals. We also plan to produce the drug’s Active Pharmaceutical Ingredient (“API”) in-house helping its cost effectiveness and consistent availability.”

    Remdesivir, an investigational antiviral therapy developed by Gilead, received Emergency Use Authorization (EUA) by USFDA to treat Covid-19. The EUA will facilitate broader use of remdesivir to treat hospitalized patients with severe COVID-19 disease. The EUA is based on available data from two global clinical trials – US National Institute for Allergy and Infectious Diseases’ placebo-controlled Phase 3 study in patients with moderate to severe symptoms of COVID-19, and Gilead’s global Phase 3 study evaluating remdesivir in patients with severe disease. Multiple additional clinical trials are ongoing to generate more data on the safety and efficacy of remdesivir as a treatment for COVID-19. Remdesivir remains an investigational drug and has not been approved by USFDA.