On February 5, 2021 Bristol Myers Squibb (NYSE: BMY) reported that the U.S. Food and Drug Administration (FDA) has approved Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B (Press release, Bristol-Myers Squibb, FEB 5, 2021, View Source [SID1234574683]). Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma.1Breyanzi is a CD19-directed CAR T cell therapy with a defined composition and 4-1BB costimulatory domain. Breyanzi is administered as a defined composition to reduce variability of the CD8 and CD4 component dose. The 4‑1BB signaling enhances the expansion and persistence of Breyanzi. Breyanzi offers a potentially definitive treatment. A single dose of Breyanzi contains 50 to 110 x 106 CAR-positive viable T cells (consisting of 1:1 CAR-positive viable T cells of the CD8 and CD4 components). Please see the Important Safety Information section below, including Boxed WARNINGS for Breyanzi regarding Cytokine Release Syndrome (CRS) and Neurologic Toxicities (NT).

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"Breyanzi, a CAR T cell therapy, will have an important role in clinical practice, offering people living with relapsed or refractory large B-cell lymphoma the chance for sustained response with an individualized treatment experience," said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb. "Today’s FDA approvalreflects our deep commitment to advancing cell therapy research, developing innovative treatments and supporting patients at every step of their treatment journey."

Bristol Myers Squibb plans to manufacture Breyanzi for each individual patient at its state-of-the-art cellular immunotherapy manufacturing facility in Bothell, Washington. Breyanzi offers a 24-day target turnaround time, and inpatient or outpatient administration options. To help support broad patient access, Bristol Myers Squibb plans to launch Breyanzi across an expansive network of treatment centers. Treatment centers will be Risk Evaluation and Mitigation Strategy (REMS) certified to support the appropriate use of Breyanzi, which is available only through the Breyanzi REMS program. Healthcare facilities, including hospitals and associated outpatient clinics, must enroll and comply with REMS requirements and be trained on the management of CRS and NT. Bristol Myers Squibb is also supporting the patient and physician treatment experience by providing Cell Therapy 360, a digital service platform, which optimizes access to relevant information, manufacturing updates, patient and caregiver support, and outpatient management resources to support patients. BMS will offer patients disposable wearable technology during the initial post-infusion monitoring period, which will help them track their temperature in real time through a smartphone when away from the treatment center.

"In TRANSCEND NHL 001, Breyanzi produced sustained responses in a significant proportion of patients with relapsed or refractory large B-cell lymphoma. TRANSCEND also demonstrated feasibility of outpatient administration, which is meaningful for patients, physicians and the healthcare system," said Jeremy Abramson, M.D., M.M.Sc., director of the lymphoma program at Massachusetts General Hospital and principal investigator for TRANSCEND NHL 001. "With this approval, we now have an important new treatment option for patients with relapsed or refractory large B-cell lymphoma who have undergone at least two prior lines of systemic therapy."

Diffuse large B-cell lymphoma (DLBCL) is a rapidly growing, aggressive disease and the most common form of non-Hodgkin lymphoma (NHL), accounting for one out of every three cases diagnosed.2 Seventy-three percent of patients will not respond to or will relapse following second-line treatment or later.3 For patients who relapse or do not respond to initial therapies, conventional treatment options that provide sustained responses are limited and median life expectancy is about six months.3 The goal of treatment in DLBCL is curative intent with definitive therapy.3 Additional options are needed in R/R DLBCL to deliver sustained responses to these patients.

"People battling relapsed or refractory large B-cell lymphoma continue to face a challenging treatment journey, both physically and emotionally," said Meghan Gutierrez, chief executive officer, Lymphoma Research Foundation. "Breyanzi is an innovative treatment that offers a new option for patients, and another reason for this community to maintain hope for the future."

Bristol Myers Squibb offers various programs and resources to address the needs of patients and caregivers, and provide support that allows for access to therapies, including Breyanzi.

Breyanzi has been granted Priority Medicines (PRIME) designation for R/R DLBCL in the European Union and a Marketing Authorization Application (MAA) is currently under review by the European Medicines Agency.

TRANSCEND NHL 001 Pivotal Trial Results

The FDA approval of Breyanzi is based on data from the TRANSCEND NHL 001 (017001) trial in which 268 patients with R/R LBCL received Breyanzi, the largest pivotal trial in third-line plus R/R LBCL that included patients with a broad range of histologies and high-risk disease. In the trial, Breyanzi was administered in the inpatient and outpatient settings.1

In the study, 192 patients were treated with Breyanzi at the dose of 50 to 110 x 106 CAR-positive viable T cells and evaluated for efficacy. Of these patients, 73% achieved a response (95% CI: 67%-80%), including 54% who had minimal or no detectable lymphoma remaining following treatment (CR; 95% CI: 47%-61%) and 19% who achieved a partial response (PR; 95% CI: 14%-26%). Median duration of response was 16.7 months in all responders (95% CI: 5.3 – NR), and for patients who achieved a CR, median duration of response was not reached (95% CI: 16.7 – NR); for patients with a best response of PR, median duration of response was 1.4 months (95% CI: 1.1 – 2.2). Of 104 patients treated with Breyanzi who achieved a best overall response of CR, 65% had remission lasting at least six months and 62% had remission lasting at least nine months.

In the study, 268 patients treated with Breyanzi were evaluated for safety. Any grade CRS occurred in 46% (122/268) of patients using the Lee grading system.4 Grade ≥3 CRS occurred in 4% (11/268) of patients. One patient had fatal CRS and two had ongoing CRS at the time of death. The most common manifestations of CRS included fever (93%), hypotension (49%), tachycardia (39%), chills (28%) and hypoxia (21%). The median duration of CRS was five days (range: 1-30 days) and median time to onset was five days (range: 1-15 days). Any grade neurologic toxicities (NT) occurred in 35% (95/268) of patients receiving Breyanzi. Grade ≥3 NT occurred in 12% (31/268) of patients. Three patients had fatal neurologic toxicity and seven had ongoing neurologic toxicity at time of death. The most common NT included encephalopathy (24%), tremor (14%), aphasia (9%), delirium (7%), headache (7%), ataxia (6%), and dizziness (6%). Neurologic toxicities resolved in 81 of 95 patients (85%), with a median duration of 12 days (range: 1-87 days). The median time to onset of the first event was eight days (range: 1-46 days).1 Median duration of neurologic toxicity was 15 days (range: 1 to 785 days) in all patients, including those with ongoing neurologic events at the time of death or at data cutoff.

Serious adverse reactions occurred in 46% of patients. The most common nonlaboratory, serious adverse reactions (>2%) were CRS, encephalopathy, sepsis, febrile neutropenia, aphasia, pneumonia, fever, hypotension, dizziness, and delirium. Fatal adverse reactions occurred in 4% of patients. The most common nonlaboratory adverse reactions of any grade (≥20%) were fatigue, CRS, musculoskeletal pain, nausea, headache, encephalopathy, infections (pathogen unspecified), decreased appetite, diarrhea, hypotension, tachycardia, dizziness, cough, constipation, abdominal pain, vomiting, and edema.

Indication

BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.

Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.

Important Safety Information

BOXED WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids.
Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed.
BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS.
Cytokine Release Syndrome (CRS)

CRS, including fatal or life-threatening reactions, occurred following treatment with BREYANZI. CRS occurred in 46% (122/268) of patients receiving BREYANZI, including ≥ Grade 3 (Lee grading system) CRS in 4% (11/268) of patients. One patient had fatal CRS and 2 had ongoing CRS at time of death. The median time to onset was 5 days (range: 1 to 15 days). CRS resolved in 119 of 122 patients (98%) with a median duration of 5 days (range: 1 to 17 days). Median duration of CRS was 5 days (range 1 to 30 days) in all patients, including those who died or had CRS ongoing at time of death.

Among patients with CRS, the most common manifestations of CRS include fever (93%), hypotension (49%), tachycardia (39%), chills (28%), and hypoxia (21%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).

Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI. Sixty-one of 268 (23%) patients received tocilizumab and/or a corticosteroid for CRS after infusion of BREYANZI. Twenty-seven (10%) patients received tocilizumab only, 25 (9%) received tocilizumab and a corticosteroid, and 9 (3%) received corticosteroids only.

Neurologic Toxicities

Neurologic toxicities that were fatal or life-threatening, occurred following treatment with BREYANZI. CAR T cell-associated neurologic toxicities occurred in 35% (95/268) of patients receiving BREYANZI, including ≥ Grade 3 in 12% (31/268) of patients. Three patients had fatal neurologic toxicity and 7 had ongoing neurologic toxicity at time of death. The median time to onset of the first event was 8 days (range: 1 to 46 days). The onset of all neurologic events occurred within the first 8 weeks following BREYANZI infusion. Neurologic toxicities resolved in 81 of 95 patients (85%) with a median duration of 12 days (range: 1 to 87 days). Three of four patients with ongoing neurologic toxicity at data cutoff had tremor and one subject had encephalopathy. Median duration of neurologic toxicity was 15 days (range: 1 to 785 days) in all patients, including those with ongoing neurologic events at the time of death or at data cutoff.

Seventy-eight (78) of 95 (82%) patients with neurologic toxicity experienced CRS. Neurologic toxicity overlapped with CRS in 57 patients. The onset of neurologic toxicity was after onset of CRS in 30 patients, before CRS onset in 13 patients, same day as CRS onset in 7 patients, and same day as CRS resolution in 7 patients.

Neurologic toxicity resolved in three patients before the onset of CRS. Eighteen patients experienced neurologic toxicity after resolution of CRS.

The most common neurologic toxicities included encephalopathy (24%), tremor (14%), aphasia (9%), delirium (7%), headache (7%), dizziness (6%), and ataxia (6%). Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, have occurred in patients treated with BREYANZI.

CRS and Neurologic Toxicities Monitoring

Monitor patients daily at a certified healthcare facility during the first week following infusion, for signs and symptoms of CRS and neurologic toxicities. Monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 4 weeks after infusion; evaluate and treat promptly. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab or tocilizumab and corticosteroids as indicated.

BREYANZI REMS

Because of the risk of CRS and neurologic toxicities, BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS. The required components of the BREYANZI REMS are:

Healthcare facilities that dispense and administer BREYANZI must be enrolled and comply with the REMS requirements.
Certified healthcare facilities must have on-site, immediate access to tocilizumab.
Ensure that a minimum of 2 doses of tocilizumab are available for each patient for infusion within 2 hours after BREYANZI infusion, if needed for treatment of CRS.
Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer BREYANZI are trained on the management of CRS and neurologic toxicities.
Further information is available at www.BreyanziREMS.com, or contact Bristol Myers Squibb at 1-888-423-5436.

Hypersensitivity Reactions

Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO).

Serious Infections

Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion. Infections (all grades) occurred in 45% (121/268) of patients. Grade 3 or higher infections occurred in 19% of patients. Grade 3 or higher infections with an unspecified pathogen occurred in 16% of patients, bacterial infections occurred in 5%, and viral and fungal infections occurred in 1.5% and 0.4% of patients, respectively. Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines.

Febrile neutropenia has been observed in 9% (24/268) of patients after BREYANZI infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated.

Avoid administration of BREYANZI in patients with clinically significant active systemic infections.

Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. Ten of the 11 patients in the TRANSCEND study with a prior history of HBV were treated with concurrent antiviral suppressive therapy to prevent HBV reactivation during and after treatment with BREYANZI. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

Prolonged Cytopenias

Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion. Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 31% (84/268) of patients, and included thrombocytopenia (26%), neutropenia (14%), and anemia (3%). Monitor complete blood counts prior to and after BREYANZI administration.

Hypogammaglobulinemia

B-cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with BREYANZI. The adverse event of hypogammaglobulinemia was reported as an adverse reaction in 14% (37/268) of patients; laboratory IgG levels fell below 500 mg/dL after infusion in 21% (56/268) of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 32% (85/268) of patients. Monitor immunoglobulin levels after treatment with BREYANZI and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement as clinically indicated.

Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI.

Secondary Malignancies

Patients treated with BREYANZI may develop secondary malignancies. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol-Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing.

Effects on Ability to Drive and Use Machines

Due to the potential for neurologic events, including altered mental status or seizures, patients receiving BREYANZI are at risk for altered or decreased consciousness or impaired coordination in the 8 weeks following BREYANZI administration. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

Adverse Reactions

Serious adverse reactions occurred in 46% of patients. The most common nonlaboratory, serious adverse reactions (> 2%) were CRS, encephalopathy, sepsis, febrile neutropenia, aphasia, pneumonia, fever, hypotension, dizziness, and delirium. Fatal adverse reactions occurred in 4% of patients.

The most common nonlaboratory adverse reactions of any grade (≥ 20%) were fatigue, CRS, musculoskeletal pain, nausea, headache, encephalopathy, infections (pathogen unspecified), decreased appetite, diarrhea, hypotension, tachycardia, dizziness, cough, constipation, abdominal pain, vomiting, and edema.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision—transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

On February 5, 2021, Salarius Pharmaceuticals, Inc. (the "Company") reported that it entered into an At the Market Offering Agreement (the "Sales Agreement") with Ladenburg Thalmann & Co. Inc. (the "Agent"), pursuant to which the Company may issue and sell, from time to time, shares of its common stock having an aggregate offering price of up to $6,306,000 (the "Shares"), depending on market demand, with the Agent acting as the sales agent or principal (Filing, 8-K, Salarius Pharmaceuticals, FEB 5, 2021, View Source [SID1234574684]). Sales of the Shares may be made by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended (the "Securities Act"), including, without limitation, sales made directly on or through the NASDAQ Capital Market. The Agent will use its commercially reasonable efforts to sell the Shares requested by the Company to be sold on its behalf, consistent with the Agent’s normal trading and sales practices, under the terms and subject to the conditions set forth in the Sales Agreement. The Company has no obligation to sell any of the Shares. The Company may instruct the Agent not to sell the Shares if the sales cannot be effected at or above the price designated by the Company from time to time and the Company may at any time suspend sales pursuant to the Sales Agreement.

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The Company will pay the Agent a commission of up to 3.0% of the gross proceeds from the sale of Shares by the Agent under the Sales Agreement. The Company has also agreed to reimburse the Agent for the fees and disbursements of its counsel, payable upon execution of the Sales Agreement, in an amount not to exceed $50,000, in addition to certain ongoing disbursements of its legal counsel up to $2,500 per calendar quarter. In addition, the Company has agreed to provide customary indemnification rights to the Agent.

The Offering will terminate upon the earlier of (1) the issuance and sale of all shares of the Company’s common stock subject to the Sales Agreement, or (2) the termination of the Sales Agreement as permitted therein.

Any sales of Shares under the Sales Agreement will be made pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-231010), including the related prospectus, filed with the Securities and Exchange Commission (the "SEC") on April 24, 2019 and declared effective on May 17, 2019, as supplemented by the prospectus supplement dated February 5, 2021, and any applicable additional prospectus supplements related to the Offering that form a part of the Registration Statement. The aggregate market value of Shares eligible for sale in the Offering and under the Sales Agreement will be subject to the limitations of General Instruction I.B.6 of Form S-3, to the extent required under such instruction. The prospectus supplement filed with the SEC on February 5, 2021 is only offering Shares having an aggregate offering price of $6,306,000. The Company will be required to file another prospectus supplement in the event it determines to offer more than $6,306,000 of Shares in accordance with the terms of the Sales Agreement, to the extent then permitted under General Instruction I.B.6 of Form S-3. The Company intends to use the net proceeds from this offering for general corporate purposes and for working capital.

The foregoing description of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the Sales Agreement, which is filed as Exhibit 1.1 to this report and is incorporated herein by reference. A copy of the legal opinion of Pillsbury Winthrop Shaw Pittman LLP regarding the legality of the issuance and sale of the Shares is filed as Exhibit 5.1 to this report and is incorporated by reference herein.

This Current Report on Form 8-K does not constitute an offer to sell or the solicitation of an offer to buy any Shares, nor shall there be any offer, solicitation or sale of any Shares, in any jurisdiction in which it is unlawful to make the offer, solicitation or sale.

On February 5, 2021 Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, reported that it has priced the previously announced underwritten public offering of 7,780,000 shares of its common stock, at a public offering price of $4.50 per share (Press release, Oncocyte, FEB 5, 2021, View Source [SID1234574685]). The gross proceeds to the Company from this offering are expected to be approximately $35.0 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by the Company. The offering is expected to close on or about February 9, 2021, subject to satisfaction of customary closing conditions. The Company has granted the underwriters a 30-day option to purchase up to an additional 1,167,000 shares of its common stock at the public offering price.

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Piper Sandler & Co. is acting as Sole Book-Runner for the offering. BTIG, LLC and Needham & Company are acting as Co-Lead Managers.

Oncocyte intends to use net proceeds from the offering to promote commercialization of its lead diagnostic test DetermaRx; to complete development of DetermaIO; and for development of future tests in its pipeline, including the CNI Monitor test that OncoCyte expects to acquire through a merger with Chronix Biomedical, Inc. Proceeds may also be used for pending acquisitions and post-acquisition obligations related to the Chronix merger, the purchase of the outstanding shares of Razor Genomics, Inc. common stock, and the earlier acquisition of Insight Genetics, Inc. Net proceeds not used for the foregoing purposes may be used for general corporate and working capital purposes and to invest in or acquire businesses or technologies that the Company believes are complementary to its business, although the Company has no other binding agreements to acquire any such business or technology.

The offering is being made pursuant to a "shelf" registration statement on Form S-3 (File No. 333-231980) that became effective with the Securities and Exchange Commission ("SEC") on June 18, 2019, the base prospectus contained therein and a prospectus supplement. A preliminary prospectus supplement and accompanying base prospectus relating to the offering and the shares of common stock being offered has been filed with the SEC. Before you invest, you should read the prospectus in the registration statement, the preliminary prospectus supplement, and other documents the Company has filed with the SEC for more complete information about the Company and this offering. Copies of the registration statement, the preliminary prospectus supplement and accompanying base prospectus may be obtained, when available, on the SEC’s website at View Source or, when available, by contacting: Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation, or sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful.

On February 5, 2021 The Board of Jubilant Pharmova Limited reported to approve financial results for the quarter ended December 31st, 2020 (Press release, Jubilant Pharma, FEB 5, 2021, View Source [SID1234575193]).

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Commenting on the Company’s performance, Mr. Shyam S Bhartia, Chairman and Mr. Hari S Bhartia, CoChairman & Managing Director, Jubilant Pharmova said: "Q3’FY21 has witnessed a substantial improvement over the previous quarter despite continued adverse impact of the COVID-19 pandemic.

Pharma business delivered strong performance led by CDMO and Generics. We continue to see new business opportunities in CDMO, Generics and Specialty Pharma segments.

The company’s performance in the LSI business has been better due to good demand and improved pricing of select products.

Contract Research and Development Services business witnessed strong year-on-year growth in revenues led by healthy demand from customers.

We continue to expect strong performance in our businesses in Q4’FY21. During 9M’FY21, the Company reduced net debt on a constant currency basis by Rs 570 Crore. This is in addition to Rs 514 crore reduction in net debt during FY20.

We received the final NCLT order approving the demerger of our LSI business. The demerger is effective from February 1, 2021 and creates separate and focused entities: Jubilant Pharmova for pharmaceuticals, contract research and development services and proprietary novel drugs businesses and Jubilant Ingrevia for life science products and innovative solutions business; that will help in unlocking shareholder value."

Q3’FY21 Highlights
A. Consolidated
 Revenue at Rs 2,664 Crore, as compared with Rs 2,315 Crore in Q3’FY20; up 15% YoY
 Reported EBITDA at Rs 653 Crore as compared with Rs 513 Crore in Q3’FY20; up 27% YoY. EBITDA margin at 24.5% vs. 22.2% in Q3’FY20
 Finance costs at Rs 59 Crore vs. Rs 72 Crore in Q3’FY20
Net Profit at Rs 310 Crore versus Rs 203 Crore in Q3’FY20. EPS of Rs 19.5 vs. Rs 12.8 in Q3’FY20; up 52% YoY
 Capital expenditure for the quarter was Rs 104 Crore Jubilant Pharmova Limited 1A, Sector 16A, Noida – 201301, India Tel.: +91 120 4361000 www.jubilantpharmova.com Segment Wise Analysis B. Pharmaceuticals Segment
Pharmaceuticals revenue was at Rs 1,692 Crore vs. Rs 1,450 Crore in Q3’FY20
 Pharmaceuticals EBITDA recorded at Rs 499 Crore as compared with Rs 411 Crore in Q3’FY20 with a margin of 29.5% as compared to 28.4% in Q3’FY20
 R&D spent during the quarter of Rs 45 Crore – 2.6% to segment sales. R&D debited to P&L is Rs 47 Crore – 2.8% to segment sales
 CMO business’ revenue grew based on strong demand from customers as well as new deals
 Five separate clinical and commercial supply agreements for COVID-19 treatment and vaccine candidates signed in 9M’FY21. Remdesivir of Gilead approved by the US FDA has been contributing to CMO revenue growth
 Started contract manufacturing of Eli Lily’s Bamlanivimab, a drug that has been granted Emergency Use Authorization by the US FDA for treatment of COVID-19 and COVID-19 vaccine candidate NVX-CoV2373 of Novavax, biotechnology company developing next-generation vaccines for serious infectious diseases
 Revenue growth during the quarter was also led by strong performance in key products in Generics segment, especially in the US market and also by launch of Remdesivir in various countries including India C. Life Science Ingredients Segment
 LSI revenue was at Rs 893 Crore against Rs 797 Crore in Q3’FY20
 Strong growth witnessed in Nutrition and Health Solutions and Life Science Chemicals business driven by improved pricing in both the segments
 EBITDA at Rs 155 Crore increased by 55% YoY with margin of 17.4% as compared to 12.6% in Q3’FY20
 Strong improvement in profitability is driven by improvement in prices across several products as well as recovery in volumes in Nutrition and Life Sciences Chemicals D. Contract Research and Development Services Segment
 Revenue at Rs 79 Crore increased by 17% YoY
 Reported EBITDA at Rs 29 Crore vs. Rs 22 Crore in Q3’FY20 with a margin of 36.4% vs. 32.9% in Q3’FY20
 Higher demand from biotech companies for integrated services, functional chemistry and DMPK
 Company continues to witness strong demand conditions in this business 9M’FY21 Highlights E. Consolidated
 Consolidated Revenue at Rs 6,932 Crore vs. Rs 6,763 Crore in 9M’FY20
 EBITDA at Rs 1,457 Crore vs. Rs 1,438 Crore in 9M’FY20. EBITDA margin at 21.0% vs. 21.3% in 9M’FY20
 Finance costs at Rs 199 Crore down 8% YoY
 Net Profit at Rs 622 Crore vs. Rs 638 Crore in 9M’FY20. EPS of Rs 39.1 vs. Rs 40.0 in 9M’FY20  Capex of Rs 285 Crore in 9M’FY21
Net debt reduced by Rs 570 Crore during 9M’FY21 Segment Wise Analysis F. Pharmaceuticals Segment
Pharmaceuticals revenue at Rs 4,304 Crore vs. Rs 4,231 Crore in 9M’FY20
 EBITDA at Rs 1,020 Crore vs. Rs 1,127 Crore in 9M’FY20. Margin of 23.7% as compared to 26.6% in 9M’FY20 G. Life Science Ingredients Segment
 LSI revenue at Rs 2,413 Crore vs Rs 2,356 Crore in 9M’FY20
EBITDA at Rs 418 Crore up 34% YoY with margin of 17.3% as compared to 13.3% in 9M’FY20 H. Contract Research and Development Services Segment
 Revenues at Rs 211 Crore up 20% YoY
 EBITDA was at Rs 67 Crore up from Rs 52 Crore in 9M’FY20

I. Business Outlook
 We continue to see improvement in demand in most of our business segments be it CMO, Generics, API or Life Science Ingredients
 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 continue to see strong performance in our businesses in Q4’FY21
 For Pharmaceutical business, we continue to see strong performance in Q4
 For LSI business, we expect to achieve close to double-digit revenue growth and significant growth in EBITDA with higher margin and a very healthy cash generation in FY21

On February 5, 2021 Cardinal Health (NYSE: CAH) reported second-quarter fiscal year 2021 revenue of $41.5 billion, an increase of 5% from the second quarter of last year (Press release, Cardinal Health, FEB 5, 2021, View Source [SID1234574686]). Second-quarter GAAP operating earnings increased 38% to $461 million, primarily due to the beneficial comparison to the prior-year charge related to voluntary surgical gown recalls. GAAP diluted earnings per share (EPS) increased to $2.13, primarily due to the tax effect of a self-insurance loss.

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Non-GAAP operating earnings decreased 3% to $628 million in the quarter, and this decrease included a modest net negative impact from COVID-19. The Pharmaceutical segment was adversely affected by COVID-19, while the Medical segment experienced a net positive impact. Non-GAAP diluted EPS increased 14% to $1.74 in the quarter, benefiting from a lower non-GAAP effective tax rate.

"As we collectively navigate the pandemic, we remain committed to supporting customers, patients, and communities around the world," said Mike Kaufmann, CEO of Cardinal Health. "Our second-quarter results demonstrate our resilient business model, strong fundamentals, and the adaptability of our dedicated employees. We remain focused on optimizing our core businesses, investing in key areas, and efficiently deploying capital to drive long-term, sustainable growth."

Second-quarter revenue for the Medical segment increased 7% to $4.3 billion, driven by a net positive impact from COVID-19. This increase was primarily due to the impact of personal protective equipment (PPE) sales and higher volumes in our lab business, partially offset by the adverse effects of cancelled or deferred elective procedures.

Medical segment profit increased 21% to $236 million in the second quarter, due to the net positive impact from COVID-19 and cost savings, which included global manufacturing efficiencies. The net positive impact from COVID-19 was primarily due to higher volumes in our Lab business and an increased contribution from PPE, partially offset by the adverse effects of cancelled or deferred elective procedures.

Tax rate
During the second quarter of fiscal 2021, our wholly-owned insurance subsidiary recorded a self-insurance pre-tax loss in its fiscal 2020 statutory financial statements related to charges previously accrued in the company’s consolidated financial statements. This self-insurance pre-tax loss, which did not impact the company’s pre-tax consolidated results, is currently deductible on our fiscal 2020 consolidated federal income tax return, and contributed to a significant net operating loss for tax purposes. In addition, pursuant to the Coronavirus Aid, Relief and Economic Security Act enacted by the United States Congress in March 2020, this net operating loss will be carried back to fiscal years 2015-2018 to recover previously-paid Federal taxes at rates that were in effect at that time.

Accordingly, the second-quarter fiscal 2021 GAAP effective tax rate of (47.6)% reflects a benefit of $420 million associated with the net operating loss carryback. Additionally, we intend to file for a federal income tax refund of $974 million, primarily as a result of the net operating loss carryback, which we expect to receive within 12 months. The company has recorded a corresponding current asset on its second quarter fiscal 2021 consolidated balance sheet.

The second-quarter fiscal 2021 non-GAAP effective tax rate of 13.2% reflects the impact of certain discrete items.

Fiscal year 2021 outlook1
Cardinal Health raised its fiscal year 2021 guidance range for non-GAAP diluted earnings per share attributable to Cardinal Health, Inc. to $5.85 to $6.10, from the prior range of $5.65 to $5.95.

The company does not provide forward-looking guidance on a GAAP basis as certain financial information, the probable significance of which cannot be determined, is not available and cannot be reasonably estimated. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

Recent highlights

Cardinal Health Board of Directors approved a quarterly dividend of $0.4859 per share. The dividend will be payable on April 15, 2021 to shareholders of record at the close of business on April 1, 2021.
The company reached an agreement with the Centers for Disease Control and Prevention (CDC) to act as a network administrator in Phase 2 of the Federal Pharmacy Partnership Strategy for COVID-19. Additionally, the Cardinal Health OptiFreight Logistics business was selected by the Ohio Department of Health to support efforts to distribute COVID-19 vaccines.
For the 13th consecutive year, Cardinal Health was honored as one of the "Best Places to Work for LGBTQ Equality" by the Human Rights Campaign (HRC) Foundation, achieving 100% on the HRC’s 2021 Corporate Equality Index (CEI).
Upcoming webcasted investor events

Barclays Global Healthcare Conference at 8:35 a.m. Eastern, March 9
Webcast
Cardinal Health will host a webcast today at 8:30 a.m. Eastern to discuss second quarter results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available until February 4, 2022.