On August 6, 2020 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported its financial results and business highlights for the second quarter ended June 30, 2020 (Press release, Athenex, AUG 6, 2020, View Source [SID1234562973]).

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"So far, 2020 has been a very productive year at Athenex. We continued to make advancement in our two lead products, Oral Paclitaxel and tirbanibulin ointment, both of which we believe could be important and valuable medicines," stated Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex. "We are completing our commercialization infrastructure and our supply chain, further positioning Athenex as a commercial-stage biopharmaceutical company. We also added to our Board of Directors with the appointment of Robert J. Spiegel, MD, an industry veteran with extensive experience developing and securing approvals for oncology products."

"We have strengthened our balance sheet by accessing non-dilutive capital," continued Dr. Lau. "This provides us with the financial flexibility to continue advancing the development and commercialization of our lead drug candidates and to further invest in the lifecycle management of Oral Paclitaxel and additional pipeline development activities."

Second Quarter 2020 and Recent Business Highlights:

Clinical Programs:

Tirbanibulin Ointment for Actinic Keratosis (AK)

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The U.S. Food and Drug Administration (FDA) has set a PDUFA target action date for tirbanibulin ointment as December 30, 2020.

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A Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMA) by the Company’s partner Almirall and validated.

Oral Paclitaxel for Metastatic Breast Cancer

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Athenex will provide an update on its NDA submission after a response from the FDA becomes available.

Oral Paclitaxel in Cutaneous Angiosarcoma — ASCO (Free ASCO Whitepaper) 2020 Presentation

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Athenex presented interim data from an ongoing Phase II clinical trial of Oral Paclitaxel monotherapy in elderly patients with unresectable cutaneous angiosarcoma, an aggressive malignancy with no FDA approved treatment.

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The interim data showed a clinical benefit rate (CR+PR+SD) of 100% in 22 evaluable patients receiving Oral Paclitaxel treatment. All 22 patients experienced reduction in tumor size. Complete responses (CR) were observed in 27.3% of patients (6/22), partial responses (PR) were observed in 22.7% of patients (5/22), and stable disease was observed in 50% of patients (11/22).

Commercial Business:

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Product sales growth in the second quarter was driven by sales of specialty pharmaceutical products used to treat patients hospitalized with COVID-19.

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Athenex Pharmaceutical Division (APD) currently markets a total of 30 products with 56 SKUs.

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Athenex Pharma Solutions (APS) currently markets 6 products with 18 SKUs.

Corporate Highlights:

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Athenex entered into a $225 million loan agreement with funds managed by Oaktree Capital Management, L.P. ("Oaktree")

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Entered into a $50 million Revenue Interest Financing agreement with Sagard Healthcare Royalty Partners, LP. ("Sagard")

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Appointed Robert J. Spiegel, MD to the Company’s Board of Directors. Dr. Spiegel was most recently Chief Medical Officer of PTC Therapeutics, and had a 26-year tenure at Schering-Plough, where he attained the title of Chief Medical Officer.

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Promoted Teresa Bair, Esq. to Executive Officer as General Counsel and Senior Vice President, Administration.

Financial Results for the Second Quarter Ended June 30, 2020

Revenue from product sales increased to $40.2 million for the three months ended June 30, 2020, from $22.0 million for the three months ended June 30, 2019, an increase of $18.1 million or 82%. This increase was primarily attributable to a significant increase in specialty product sales of $24.6 million, driven by the impact of the global health pandemic which led to the increased demand for COVID-19 related drugs. We experienced an increase in purchases from our existing customers as well as obtained large, non-recurring orders of specialty products from new customers. Fluctuations in the infection rate and the spread of the global health pandemic and market demand can significantly affect our product sales in the future. If and when the COVID-19 pandemic recedes temporarily or is quelled, we expect to see a significant softening in demand for these products. This increase in specialty product sales was offset by a decrease in API and 503B products sales of $2.6 million, and $3.8 million, respectively, due to the suspension of production of commercial batches at our API facilities and the discontinued vasopressin sales.

Cost of sales for the three months ended June 30, 2020 totaled $33.0 million, an increase of $16.1 million, or 95%, as compared to $16.9 million for the three months ended June 30, 2019. Increase in cost of specialty product sales was in-line with that in revenue and we continued to incur fixed costs despite decreased production at our API and APS facilities.

Research and development expenses for the three months ended June 30, 2020 totaled $22.0 million, an increase of $3.5 million, or 19%, as compared to $18.5 million for the three months ended June 30, 2019. This was primarily due to an increase in regulatory costs, R&D related compensation, preclinical operations, and drug licensing costs. The increase in these R&D expenses was offset by a $2.6 million decrease in clinical study costs as both tirbanibulin Phase 3 studies wound down and a $0.4 million decrease in 503B development costs.

Selling, general, and administrative expenses for the three months ended June 30, 2020 totaled $17.5 million, an increase of $0.3 million, or 2%, as compared to $17.2 million for the three months ended June 30, 2019. This was attributed to an increase of $1.3 million related to professional fees and IT costs, offset by a $1.0 million decrease in certain operational costs.

In the three months ended June 30, 2020, we recognized a $7.2 million loss on the extinguishment of debt related to the termination of the senior secured loan agreement with Perceptive. We did not incur expenses of similar nature for the three months ended June 30, 2019.

Net loss attributable to Athenex for the three months ended June 30, 2020 was $40.5 million, or ($0.50) per diluted share, compared to a net loss of $32.0 million, or ($0.44) per diluted share, in the same period last year. Excluding the one-time debt extinguishment expenses of $7.2 million, the net loss attributable to Athenex for the three months ended June 30, 2020 was $33.2 million or ($0.41) per diluted share.

As of June 30, 2020, the Company had cash and cash equivalents of $105.9 million, restricted cash of $11.0 million and short-term investments of $10.4 million.

On June 19, 2020, Athenex entered into a senior secured loan agreement and related security agreements with funds managed by Oaktree Capital Management, L.P. to borrow up to $225.0 million in five tranches with a maturity date of June 19, 2026. The first tranche of $100.0 million was funded at closing, with $54.1 million used to repay in full the existing credit facility with Perceptive. Additional debt tranches of $125.0 million in aggregate are available, subject to achievement of certain regulatory and commercial milestones. Proceeds from the financing will be used to fund the commercial launch of Oral Paclitaxel, ongoing pipeline development, manufacturing infrastructure, and working capital and general corporate purposes.

On August 4, 2020 Athenex entered into a Revenue Interest Financing (RIF) agreement with Sagard Healthcare Royalty Partners, LP. The agreement provides Athenex with $50 million of capital upon FDA approval of Oral Paclitaxel for the treatment of metastatic breast cancer. In exchange for funding this capital, Sagard will receive quarterly payments equal to a mid-single digit royalty of worldwide net sales of Oral Paclitaxel. The Company expects that the proceeds from the financing will be used to fund the development and commercialization of Oral Paclitaxel and other general corporate purposes. Also, in connection with this agreement, Sagard and certain of its co-investors have purchased by assignment $50 million of outstanding loans and undrawn commitments from funds managed by Oaktree, becoming lenders under Athenex’s $225 million term loan facility entered into between Oaktree and Athenex in June 2020.

Financial Results for the Six Months Ended June 30, 2020

Revenue from product sales increased to $58.7 million for the six months ended June 30, 2020, from $47.2 million for the six months ended June 30, 2019, an increase of $11.5 million or 24%. This increase was primarily attributable to a significant increase in specialty product sales, driven by the impact of the global health pandemic which led to the increased demand for COVID-19 related drugs. We recognized $28.3 million in license revenue, net of $1.7 million VAT, for the six months ended June 30, 2020, pursuant to the license agreement entered into with Xiangxue Pharmaceutical in December 2019.

Cost of sales for the six months ended June 30, 2020 totaled $52.6 million, an increase of $15.8 million, or 43%, as compared to $36.8 million for the six months ended June 30, 2019. Increase in cost of specialty product sales was in-line with that in revenue and we continued to incur fixed costs despite decreased production at our API and APS facilities.

Research and development expenses for the six months ended June 30, 2020 totaled $39.2 million, a decrease of $3.8 million, or 9%, as compared to $43.0 million for the six months ended June 30, 2019. This was primarily due to a decrease in licensing fees, clinical operations, and preclinical operations. The decrease in these R&D expenses was offset by an increase of $6.4 million in regulatory costs in connection with our NDA preparations and compensation expenses.

Selling, general, and administrative expenses for the six months ended June 30, 2020 totaled $43.2 million, an increase of $10.8 million, or 34%, as compared to $32.4 million for the six months ended June 30, 2019. This was primarily due to an increase of $7.4 million related to the costs of preparing to commercialize our proprietary drugs, if approved, and an increase of $3.4 million of general administrative expense, including professional service fees and other operating expenses.

Net loss attributable to Athenex for the six months ended June 30, 2020 was $59.9 million, or ($0.73) per diluted share, compared to a net loss of $67.3 million, or ($0.96) per diluted share, in the same period last year. Excluding the one-time debt extinguishment expenses of $7.2 million, the net loss attributable to Athenex for the six months ended June 30, 2020 was $52.7 million or ($0.65) per diluted share.

Outlook and Upcoming Milestones:

FDA response to the NDA for Oral Paclitaxel for metastatic breast cancer.

PDUFA date of December 30, 2020 for tirbanibulin ointment for actinic keratosis.

Financial Guidance:

Athenex provides revenue guidance for product sales only. The Company is raising its product sales guidance for the full year 2020 from mid-single digit growth as previously communicated, to at least mid-teens percentage growth year-over-year, from $80.5 million of product sales revenue reported in 2019. This takes into account the Company’s sales performance year to date as well as the outlook for the remainder of the year. The Company’s product mix may continue to include products that are used to treat patients hospitalized with COVID-19, although the Company does not view these revenues as recurring in nature.

The Company believes that the existing cash, cash equivalents, restricted cash, and short-term investments will be sufficient to fund current operating plans into the second quarter of 2021. The Company plans to access additional milestone-based, non-dilutive capital available under the Senior Credit Agreement with Oaktree and Revenue Interest Financing Agreement with Sagard upon achievement of such funding milestones, and if such funding milestones are achieved, the additional capital provided by such is expected to extend the Company’s cash runway into 2022.

Conference Call and Webcast Information:

The Company will host a conference call and live audio webcast today, Thursday, August 6, 2020, before the market opens, and host a conference call and live audio webcast 8:00am Eastern Time to discuss the financial results and provide a business update.

To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13706637. The live conference call and replay can also be accessed via audio webcast at link and also on the Investor Relations section of the Company’s website, located at View Source

On August 6, 2020 -Bristol Myers Squibb (NYSE:BMY) reported results for the second quarter of 2020, which reflect strong product sales, continued advancement of the pipeline and robust operating performance (Press release, Bristol-Myers Squibb, AUG 6, 2020, View Source [SID1234562971]).

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"Our second quarter results reflect the passion and focus of our employees, who continue to introduce new medicines, support patients with serious diseases and deliver strong results during the COVID-19 pandemic," said Giovanni Caforio, M.D., chairman and chief executive officer, Bristol Myers Squibb. "Our teams drove strong commercial execution while continuing to progress our integration initiatives. With several new product launches and the achievement of multiple milestones from our late-stage pipeline, I am confident that we are building a leading biopharma with a renewed portfolio of transformational medicines. Our financial flexibility and continued opportunities to invest in innovation position us well to deliver for the long-term."

*The pro forma revenues assume the company’s acquisition of Celgene (Celgene Acquisition) and its divestiture of Otezla to Amgen Inc. (Otezla Divestiture) occurred on January 1, 2019 and exclude foreign currency hedge gains and losses. Management believes that measuring revenue rates on a comparable pro forma basis is an appropriate way for investors to best understand the underlying performance of the business. See "Worldwide Pro Forma Revenue" in Quarterly Package of Financial Information for this quarter, which is available on bms.com/investors/financial-reporting/quarterly-results, for information on the revenue of the company and Celgene on a stand-alone basis for the prior-year period. Otezla is a trademark of Amgen Inc.

SECOND QUARTER FINANCIAL RESULTS

All comparisons are made versus the same period in 2019 unless otherwise stated.

Bristol Myers Squibb posted second quarter revenues of $10.1 billion, an increase of 61% on a reported basis, or 63% when adjusted for foreign exchange. The increase was driven primarily by the impact of the Celgene Acquisition, which was completed on November 20, 2019. Revenues remained consistent on a pro forma basis, as sales were estimated to be negatively impacted by approximately $600 million due mainly to COVID-19 related channel inventory work downs from the first quarter, as well as lower demand resulting from reduced new patient starts and fewer patient visits to physicians in the pandemic.
U.S. revenues increased 77% to $6.5 billion in the quarter. International revenues increased 40% to $3.6 billion in the quarter. When adjusted for foreign exchange impact, international revenues increased 43%.
Gross margin as a percentage of revenue increased from 68.6% to 73.4% in the quarter primarily due to product mix, partially offset by the unwinding of inventory purchase price accounting adjustments.
Marketing, selling and administrative expenses increased 51% to $1.6 billion in the quarter primarily due to $600 million of costs associated with the broader portfolio resulting from the Celgene Acquisition.
Research and development expenses increased 90% to $2.5 billion in the quarter primarily due to $1.1 billion of costs associated with the broader portfolio resulting from the Celgene Acquisition.
Amortization of acquired intangible assets was $2.4 billion in the quarter primarily due to the Celgene Acquisition.
Income taxes were $1.7 billion on pre-tax earnings of $1.6 billion in the quarter primarily due to tax charges resulting from an internal transfer of certain intangible assets and the Otezla Divestiture and purchase price adjustments. The effective tax rate was 19.0% in the same period a year ago.
The company reported net loss attributable to Bristol Myers Squibb of $85 million, or $0.04 per share, in the second quarter, compared to net earnings of $1.4 billion, or $0.87 per share, for the same period a year ago. The results in the current quarter include costs and expenses resulting from purchase price accounting, contingent value rights fair value adjustments and other acquisition and integration expenses.
The company reported non-GAAP net earnings attributable to Bristol Myers Squibb of $3.8 billion, or $1.63 per share, in the second quarter, compared to net earnings of $1.9 billion, or $1.18 per share, for the same period a year ago. A discussion of the non-GAAP financial measures is included under the "Use of Non-GAAP Financial Information" section.
Cash, cash equivalents and marketable debt securities were $22.2 billion and debt was $46.7 billion, as of June 30, 2020.
*Products were acquired as part of the Celgene Acquisition.

**Pro forma product revenues assume the Celgene Acquisition and the Otezla Divestiture occurred on January 1, 2019 and exclude foreign currency hedge gains and losses. Management believes that measuring product revenue rates on a comparable pro forma basis is an appropriate way for investors to best understand the underlying performance of the business. See "Worldwide Pro Forma Revenues" in the Quarterly Package of Financial Information for this quarter, which is available on bms.com/investors/financial-reporting/quarterly-results, for information on the product revenue of the company and Celgene for the prior-year period.

*Products were acquired as part of the Celgene Acquisition.

**Pro forma product revenues assume the Celgene Acquisition and the Otezla Divestiture occurred on January 1, 2019 and exclude foreign currency hedge gains and losses. Management believes that measuring product revenue rates on a comparable pro forma basis is an appropriate way for investors to best understand the underlying performance of the business. See "Worldwide Pro Forma Revenues" in the Quarterly Package of Financial Information for this quarter, which is available on bms.com/investors/financial-reporting/quarterly-results, for information on the product revenue of the company and Celgene for the prior-year period.

SECOND QUARTER PRODUCT AND PIPELINE UPDATE

Cardiovascular

Eliquis

Patent Update

In August, the Bristol-Myers Squibb-Pfizer Alliance announced the U.S. District Court decision to uphold both the composition of matter patent (US 6,967,208) and formulation patent (US 9,326,945) covering Eliquis (apixaban). (link)
Oncology and Hematology

Opdivo

Regulatory

In June, the company announced the U.S. Food and Drug Administration (U.S. FDA) approval of Opdivo (nivolumab) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. (link)
In May, the company announced Opdivo plus Yervoy (ipilimumab) given with two cycles of platinum-doublet chemotherapy was approved by the U.S. FDA for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. This approval was based on the Phase 3 CheckMate -9LA study. (link)
In May, the company announced the U.S. FDA approved Opdivo plus Yervoy for the first-line treatment of adult patients with metastatic NSCLC whose tumors express PD-LI>1% as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. This approval was based on data from Part 1a of the Phase 3 Checkmate -227 study. (link)
Reblozyl

Regulatory

In June, the company and Acceleron Pharma Inc. announced the European Commission (EC) approved Reblozyl (luspatercept) for the treatment of transfusion-dependent anemia in adult patients with myelodysplastic syndromes (MDS) or beta thalassemia. (link)
ide-cel

Regulatory

In July, the company and bluebird bio, Inc. announced that the companies submitted the Biologics License Application (BLA) to the U.S. FDA for idecabtagene vicleucel (ide-cel; bb2121) for patients with heavily pre-treated relapsed and refractory multiple myeloma. This submission follows the company’s receipt of a Refusal to File letter from the U.S. FDA in May 2020 following the original BLA submission from March 2020. (link)
In May, the company announced that the European Medicines Agency (EMA) validated its Marketing Authorization Application (MAA) for ide-cel; bb2121, the company’s investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy co-developed with bluebird bio, Inc., for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. (link)
CC-486

Regulatory

In May, the company announced that the EMA validated its MAA for CC-486 for the maintenance treatment of adult patients with acute myeloid leukemia (AML), who achieved complete remission (CR) or CR with incomplete blood count recovery (CRi), following induction therapy with or without consolidation treatment, and who are not candidates for, or who choose not to proceed to, hematopoietic stem cell transplantation. (link)
Pomalyst

Regulatory

In May, the company announced that the U.S. FDA approved Pomalyst (pomalidomide) for patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy (HAART), or in patients with Kaposi sarcoma who are HIV-negative. (link)
Liso-cel

Regulatory

In July, the company announced that the EMA validated the MAA for liso-cel (lisocabtagene maraleucel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies. (link)
Medical Conferences

In May, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program, the company announced important new data and analysis across its cancer portfolio (link), including:
First disclosure of data from the Phase 3 CheckMate -9LA trial evaluating Opdivo plus Yervoy given concomitantly with two cycles of chemotherapy, for the first-line treatment of metastatic NSCLC. (link)
Three-year follow-up results from the Phase 3 Checkmate -227 trial, demonstrating that Opdivo plus Yervoy provided sustained improvements in overall survival (OS) and additional efficacy measures as a first-line treatment for patients with metastatic NSCLC. (link)
First presentation of data from the Phase 2 KarMMA study with bluebird bio, Inc. evaluating the efficacy and safety of the companies’ investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, idecabtagene vicleucel (ide-cel; bb2121), in patients with relapsed and refractory multiple myeloma. (link)
In June, at the 25th European Hematology Association (EHA) (Free EHA Whitepaper), the company announced important new data and analysis from 60 company-sponsored studies, highlighting the company’s approaches to treating blood cancers and other diseases. (link)
Immunology

Zeposia

Commercial

In June, the company announced the commercial launch and availability of Zeposia (ozanimod), a new oral treatment for relapsing forms of multiple sclerosis, in the U.S. Zeposia was approved by the U.S. FDA on March 25, 2020. (link)
Regulatory

In May, the company announced the EC approval Zeposia for the treatment of adult patients in the European Union with relapsing forms of multiple sclerosis. (link)
Clinical

In June, the company announced results from True North, a pivotal Phase 3 trial evaluating oral Zeposia as an induction and maintenance therapy for adult patients with moderate to severe ulcerative colitis. True North met both primary endpoints of clinical remission in induction at Week 10 and in maintenance at Week 52. (link)
Orencia

Clinical

In June, at the European E-Congress of Rheumatology (EULAR) 2020, the company announced results from the open-label switch period of Early AMPLE, a Phase IV exploratory biomarker study assessing the differences by which Orencia (abatacept) and adalimumab, interfere with disease progression in moderate-to-severe early rheumatoid arthritis (RA) patients who tested positive (seropositive) for certain autoantibodies. (link)
COVID-19 Pandemic Response

During the current world health crisis, the company continues to take all necessary actions to promote public health by carrying out its mission of providing life-saving medicines to the patients who depend on the company and supporting relief efforts across the globe. (link)

Financial Guidance

Bristol Myers Squibb is updating its 2020 GAAP EPS guidance range from $0.37 – $0.57 to ($0.06) – $0.09. In addition, the company is updating its 2020 non-GAAP EPS guidance range of $6.00 – $6.20 to $6.10 – $6.25. Adjusted 2020 GAAP and non-GAAP line items are:

The 2020 guidance assumes the peak impact of the current COVID-19 crisis on the business would occur in the second quarter of 2020, with a return to a more stable business environment in the third quarter and minimal impact from the fourth quarter of 2020 onwards. Additional key factors assumed in guidance now include:

Mid-July foreign exchange and interest rates apply.
Products that saw significant advanced buying at the end of the first quarter will see that inventory work-down during the rest of the year, mostly in the second quarter, which the company experienced, and to a lesser degree in the third and fourth quarters.
A reduction in new-to-brand prescriptions, and on physician administered product demand during the second quarter, recovering during the third quarter and fully recovered in the fourth quarter.
All clinical trial activities are planned to resume by the end of the year where local country restrictions have been lifted.
The financial guidance excludes the impact of any potential future strategic acquisitions and divestitures and any specified items that have not yet been identified and quantified. The 2020 non-GAAP EPS guidance further excludes other specified items as discussed under "Use of Non-GAAP Financial Information." A reconciliation of non-GAAP financial measures to the most comparable GAAP measure and the reasons why management believes the use of these measures is important are provided in supplemental materials available on the company’s website. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this press release.

Company and Conference Call Information

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram.

There will be a conference call on August 6 at 8:30 a.m. ET during which company executives will review financial information and address inquiries from investors and analysts. Investors and the general public are invited to listen to a live webcast of the call at View Source or by dialing in the U.S. toll free 800-458-4121 or international 786-789-4772, confirmation code: 8970168, or using this link, which becomes active 15 minutes prior to the scheduled start time and entering your information to be connected. Materials related to the call will be available at the same website prior to the conference call.

A replay of the call will be available beginning at 12:00 p.m. ET on August 6 through 12:00 p.m. ET on August 20, 2020. The replay will also be available through View Source or by dialing in the U.S. toll free 888-203-1112 or international 719-457-0820, confirmation code: 8970168.

Use of Non-GAAP Financial Information

This earnings release contains non-GAAP financial measures, including non-GAAP earnings and related EPS information that are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis. Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures are available on the company’s website at www.bms.com.

These non-GAAP items are adjusted after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of future operating results. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods, including amortization of acquired intangible assets beginning in the fourth quarter of 2019, including product rights that generate a significant portion of our ongoing revenue, unwind of inventory fair value adjustments, acquisition and integration expenses, restructuring costs, accelerated depreciation and impairment of property, plant and equipment and intangible assets, R&D charges or other income resulting from upfront or contingent milestone payments in connection with the acquisition or licensing of third-party intellectual property rights, costs of acquiring a priority review voucher, divestiture gains or losses, stock compensation resulting from accelerated vesting of Celgene awards, certain retention-related employee compensation charges related to the Celgene Acquisition, pension, legal and other contractual settlement charges, interest expense on the notes issued in May 2019 incurred prior to the Celgene Acquisition and interest income earned on the net proceeds of those notes, equity investment and contingent value rights fair value adjustments and amortization of fair value adjustments of debt acquired from Celgene in our 2019 exchange offer, among other items. Deferred and current income taxes attributed to these items are also adjusted for considering their individual impact to the overall tax expense, deductibility and jurisdictional tax rates. Certain other significant tax items are also excluded such as the impact resulting from internal transfer of intangible assets and the Otezla Divestiture. This earnings release also provides international revenues excluding the impact of foreign exchange.

Non-GAAP information is intended to portray the results of the company’s baseline performance, supplement or enhance management, analysts and investors overall understanding of the company’s underlying financial performance and facilitate comparisons among current, past and future periods. For example, non-GAAP earnings and EPS information are indications of the company’s baseline performance before items that are considered by us to not be reflective of the company’s ongoing results. In addition, this information is among the primary indicators that we use as a basis for evaluating performance, allocating resources, setting incentive compensation targets and planning and forecasting for future periods. This information is not intended to be considered in isolation or as a substitute for net earnings or diluted EPS prepared in accordance with GAAP and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.

Amortization of acquired intangible assets were previously included in non-GAAP earnings and EPS information. These amounts have become significant to the financial results subsequent to the Celgene Acquisition and as a result, have been excluded in the non-GAAP results to better reflect our core operating performance. Comparable prior period non-GAAP results have not been revised to include this adjustment as the related amounts were insignificant ($24 million and $48 million for the three and six months ended June 30, 2019, respectively).

Website Information

We routinely post important information for investors on our website, BMS.com, in the "Investors" section. We may use this website as a means of disclosing material, non-public information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investors section of our website, in addition to following our press releases, SEC filings, public conference calls, presentations and webcasts. We may also use social media channels to communicate with our investors and the public about our company, our products and other matters, and those communications could be deemed to be material information. The information contained on, or that may be accessed through, our website or social media channels are not incorporated by reference into, and are not a part of, this document.

On August 6, 2020 Cardinal Health (NYSE: CAH) reported fourth quarter fiscal year 2020 revenues of $36.7 billion, a decrease of 2 percent from the fourth quarter last year (Press release, Cardinal Health, AUG 6, 2020, View Source [SID1234562968]). GAAP operating earnings were $270 million and non-GAAP operating earnings were $442 million in the quarter, both of which include an estimated net negative impact of approximately $130 million due to the COVID-19 pandemic. GAAP diluted earnings per share (EPS) were $2.23, which included a pre-tax gain of $579 million related to the divestiture of a minority equity interest. Fourth quarter non-GAAP diluted EPS were $1.04.

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Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. (PRNewsfoto/Cardinal Health)

Fiscal 2020 revenues were $152.9 billion, an increase of 5 percent from fiscal 2019. GAAP operating loss of $4.1 billion includes a $5.6 billion accrual in the first quarter related to opioid litigation. Non-GAAP operating earnings were $2.4 billion for the year. GAAP diluted loss per share for fiscal year 2020 was $12.61, while non-GAAP diluted EPS were $5.45.

"In fiscal 2020, we delivered on our commitments, grew operating earnings and exceeded our EPS guidance, despite the unprecedented global environment," said Mike Kaufmann, CEO of Cardinal Health. "We play an essential role in healthcare, and I’d like to thank our employees, especially our frontline teams, for their dedication under the challenging circumstances of the past several months. Our strong performance in fiscal 20 and the unwavering commitment of our employees will enable us to manage the complexities ahead, serve our customers and their patients, and continue our growth."

COVID-19

The COVID-19 pandemic adversely affected fourth quarter and fiscal year 2020 results. The negative impact was primarily due to the decline in volumes in both segments related to the cancellation or deferral of elective procedures and physician office visits. The company estimates that the COVID-19 pandemic had a net negative impact to both GAAP and non-GAAP operating earnings of approximately $130 million in the fourth quarter and approximately $100 million in fiscal year 2020.

Fourth quarter revenue for the Pharmaceutical segment was flat at $33.2 billion. As expected, this reflects the reduced pharmaceutical demand as a result of the accelerated third quarter sales related to COVID-19.

Pharmaceutical segment profit decreased 20 percent to $359 million in the fourth quarter. This reflects expected COVID-19-related volume declines, which primarily affected Nuclear and Precision Health Solutions, as well as the company’s generics program. Pharmaceutical Distribution customer contract renewals also adversely affected segment profit.

Fourth quarter revenue for the Medical segment decreased 13 percent to $3.5 billion due to the adverse effects of cancelled or deferred elective procedures related to COVID-19, primarily on products and distribution.

Medical segment profit increased 24 percent to $120 million in the fourth quarter due to benefits from cost savings initiatives and the beneficial comparison to a supplier-related charge in the prior year. This was partially offset by the adverse effects of COVID-19, primarily on products and distribution.

Fiscal year 2021 outlook1

Non-GAAP earnings per share $5.25 – $5.65
Interest and other $190M – $215M
Non-GAAP effective tax rate 24.0% – 26.0%
Diluted weighted average shares outstanding 292M – 296M
Capital expenditures $400M – $450M
Fiscal year 2021 non-GAAP EPS guidance assumes an incremental net headwind related to COVID-19 of a similar year-over-year magnitude as experienced in fiscal 2020. The company expects the adverse impact from the deferral and cancellation of elective procedures and physician office visits to continue, primarily in the first half of the year. The company expects an eventual recovery of elective procedures and physician office visits to pre-COVID-19 levels exiting fiscal 2021. Additionally, demand for personal protective equipment (PPE) products is expected to continue to outpace available supply for the balance of fiscal 2021 due to ongoing global supply challenges. The company anticipates higher costs related to procuring PPE products for customers during the pandemic to be a headwind in fiscal 2021.

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 completed the divestiture of its remaining equity interest in naviHealth.
Cardinal Health announced that David Evans, former interim Chief Financial Officer of Cardinal Health, joined the board of directors effective July 1. Mr. Evans previously served as executive vice president and CFO of Battelle Memorial Institute, and as executive vice president and CFO of Scotts Miracle-Gro.
Cardinal Health board of directors approved a quarterly dividend of $0.4859 per share. The dividend will be payable on October 15, 2020 to shareholders of record at the close of business on October 1, 2020.
Cardinal Health was named to the Human Rights Campaign (HRC) Best Places to Work for LGBTQ Equality for the twelfth consecutive year based on ratings in HRC’s 2020 Corporate Equality Index.
Upcoming webcasted investor events

Morgan Stanley 18th Annual Global Healthcare Conference at 11:15 a.m. Eastern, Monday, September 14
Webcast

Cardinal Health will host a webcast today at 8:30 a.m. Eastern to discuss fourth quarter and fiscal year 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 August 5, 2021.

On August 6, 2020 GlaxoSmithKline plc (LSE/NYSE: GSK) reported the US Food and Drug Administration (FDA) has approved BLENREP (belantamab mafodotin-blmf) as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent (Press release, GlaxoSmithKline, AUG 6, 2020, View Source [SID1234562932]). This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. BLENREP is the first anti-BCMA (B-cell maturation antigen) therapy approved anywhere in the world.[i]

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Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "As the second most common form of blood cancer in the US, multiple myeloma is an incurable and devastating disease. BLENREP is the first approved anti-BCMA therapy and has the potential to transform the treatment of patients with relapsed or refractory myeloma who have limited treatment options today.’’

BLENREP is GSK’s fifth major medicine approval in 2020 across areas of significant unmet medical need such as cancer, HIV and chronic kidney disease. This approval marks the second FDA approval for GSK’s oncology portfolio in four months.

BLENREP employs a multi-faceted mechanism of action and is directed toward BCMA, a cell-surface protein that plays an important role in the survival of plasma cells and is expressed on multiple myeloma cells.[ii] The approval of BLENREP was based on six-month primary results from the pivotal DREAMM-2 study, which enrolled patients with relapsed or refractory multiple myeloma who had actively progressing disease that had worsened despite current standard of care.

Dr Sagar Lonial, MD, Chief Medical Officer, Winship Cancer Institute of Emory University in Atlanta, Georgia, Chair of Emory Department of Hematology and Medical Oncology and Principal Investigator for DREAMM-2, said: "While treatable, refractory multiple myeloma is a significant clinical challenge with poor outcomes for patients whose disease has become resistant to the current standard of care. Due to the limited options currently available, these patients are often retreated with drugs from the same classes after they relapse, which is why the approval of BLENREP, the first anti-BCMA therapy, is significant for both patients and physicians alike."

In the DREAMM-2 study, treatment with single-agent BLENREP 2.5 mg/kg every three weeks demonstrated a clinically meaningful overall response rate (ORR) of 31% (97.5% CI; 21-43) in patients who had received a median of seven prior lines of treatment (n=97). The median duration of response (DoR) had not been reached at the six-month analysis, but 73% of responders had a DoR equal to or greater than six months. The most commonly reported adverse events (≥20%) were keratopathy, decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions, and fatigue. Keratopathy is characterised as changes in the corneal epithelium as seen on eye examination, which can manifest with or without symptoms.

Ocular adverse reactions occurred in 77% of the 218 patients in the pooled safety population and included keratopathy (76%), changes in visual acuity (55%), blurred vision (27%) and dry eye (19%). Corneal adverse events were monitored with eye exams prior to each dose, allowing for dose reductions or interruptions as appropriate. Patients also used preservative-free eye drops. Keratopathy leading to treatment discontinuation affected 2.1% of patients in the 2.5 mg/kg cohort.[iii]

BLENREP is available through participation in the BLENREP Risk Evaluation and Mitigation Strategy (REMS), which was developed to ensure appropriate use of the medicine. The programme requires education for all physicians prescribing BLENREP and their patients regarding the ocular risks associated with treatment as well as monitoring. Additional information about the BLENREP REMS can be found at www.blenreprems.com or 1-855-209-9188.

Paul Giusti, President and CEO of the Multiple Myeloma Research Foundation (MMRF), said: "The approval of BLENREP is an important advancement for patients with relapsed or refractory multiple myeloma, as it brings a much-needed new treatment to patients who face limited options due to their progressing disease. We are grateful for GSK’s continued commitment to myeloma patients and their families."

In 2017, BLENREP was granted Breakthrough Therapy designation by the FDA, which is intended to facilitate the development of investigational medicines that have shown clinical promise for conditions where there is significant unmet need.

About multiple myeloma
Multiple myeloma is the second most common blood cancer in the US and is generally considered treatable, but not curable.[iv] In the US, more than 32,000 people are estimated to be diagnosed with multiple myeloma this year and nearly 13,000 people will die from the disease.[v] Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.[vi]

About B-cell maturation antigen (BCMA)
The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines.iii

About BLENREP (belantamab mafodotin-blmf)
BLENREP is an antibody drug conjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa.

IMPORTANT SAFETY INFORMATION FOR BLENREP

WARNING: OCULAR Toxicity

BLENREP caused changes in the corneal epithelium resulting in changes in vision, including severe vision loss and corneal ulcer, and symptoms such as blurred vision and dry eyes.

Conduct ophthalmic exams at baseline, prior to each dose, and promptly for worsening symptoms. Withhold BLENREP until improvement and resume, or permanently discontinue, based on severity.

Because of the risk of ocular toxicity, BLENREP is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BLENREP REMS.

WARNINGS AND PRECAUTIONS

Ocular Toxicity: Ocular adverse reactions occurred in 77% of the 218 patients in the pooled safety population. Ocular adverse reactions included keratopathy (76%), changes in visual acuity (55%), blurred vision (27%), and dry eye (19%). Among patients with keratopathy (n = 165), 49% had ocular symptoms, 65% had clinically relevant visual acuity changes (decline of 2 or more lines on Snellen Visual Acuity in any eye), and 34% had both ocular symptoms and visual acuity changes.

Keratopathy: Keratopathy was reported as Grade 1 in 7% of patients, Grade 2 in 22%, Grade 3 in 45%, and Grade 4 in 0.5% per the KVA scale. Cases of corneal ulcer (ulcerative and infective keratitis) have been reported. Most keratopathy events developed within the first 2 treatment cycles (cumulative incidence of 65% by Cycle 2). Of the patients with Grade 2 to 4 keratopathy (n = 149), 39% recovered to Grade 1 or lower after median follow-up of 6.2 months. Of the 61% who had ongoing keratopathy, 28% were still on treatment, 9% were in follow-up, and in 24% the follow-up ended due to death, study withdrawal, or lost to follow-up. For patients in whom events resolved, the median time to resolution was 2 months (range: 11 days to 8.3 months).

Visual Acuity Changes: A clinically significant decrease in visual acuity of worse than 20/40 in the better-seeing eye was observed in 19% of the 218 patients and of 20/200 or worse in the better-seeing eye in 1.4%. Of the patients with decreased visual acuity of worse than 20/40, 88% resolved and the median time to resolution was 22 days (range: 7 days to 4.2 months). Of the patients with decreased visual acuity of 20/200 or worse, all resolved and the median duration was 22 days (range: 15 to 22 days).

Monitoring and Patient Instruction: Conduct ophthalmic examinations (visual acuity and slit lamp) at baseline, prior to each dose, and promptly for worsening symptoms. Perform baseline examinations within 3 weeks prior to the first dose. Perform each follow-up examination at least 1 week after the previous dose and within 2 weeks prior to the next dose. Withhold BLENREP until improvement and resume at same or reduced dose, or consider permanently discontinuing based on severity. Advise patients to use preservative-free lubricant eye drops at least 4 times a day starting with the first infusion and continuing until end of treatment. Avoid use of contact lenses unless directed by an ophthalmologist. Changes in visual acuity may be associated with difficulty for driving and reading. Advise patients to use caution when driving or operating machinery. BLENREP is only available through a restricted program under a REMS.

BLENREP REMS: BLENREP is available only through a restricted program under a REMS called the BLENREP REMS because of the risks of ocular toxicity. Notable requirements of the BLENREP REMS include the following:

Prescribers must be certified with the program by enrolling and completing training in the BLENREP REMS.
Prescribers must counsel patients receiving BLENREP about the risk of ocular toxicity and the need for ophthalmic examinations prior to each dose.
Patients must be enrolled in the BLENREP REMS and comply with monitoring.
Healthcare facilities must be certified with the program and verify that patients are authorized to receive BLENREP.
Wholesalers and distributers must only distribute BLENREP to certified healthcare facilities.
Further information is available at www.BLENREPREMS.com and 1-855-209-9188.

Thrombocytopenia: Thrombocytopenia occurred in 69% of 218 patients in the pooled safety population, including Grade 2 in 13%, Grade 3 in 10%, and Grade 4 in 17%. The median time to onset of the first thrombocytopenic event was 26.5 days. Thrombocytopenia resulted in dose reduction, dose interruption, or discontinuation in 9%, 2.8%, and 0.5% of patients, respectively. Grade 3 to 4 bleeding events occurred in 6% of patients, including Grade 4 in 1 patient. Fatal adverse reactions included cerebral hemorrhage in 2 patients. Perform complete blood cell counts at baseline and during treatment as clinically indicated. Consider withholding and/or reducing the dose based on severity.

Infusion-Related Reactions: Infusion-related reactions occurred in 18% of 218 patients in the pooled safety population, including Grade 3 in 1.8%. Monitor patients for infusion-related reactions. For Grade 2 or 3 reactions, interrupt the infusion and provide supportive treatment. Once symptoms resolve, resume at a lower infusion rate. Administer premedication for all subsequent infusions. Discontinue BLENREP for life-threatening infusion-related reactions and provide appropriate emergency care.

Embryo-Fetal Toxicity: Based on its mechanism of action, BLENREP can cause fetal harm when administered to a pregnant woman because it contains a genotoxic compound (the microtubule inhibitor, monomethyl auristatin F [MMAF]) and it targets actively dividing cells. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with BLENREP and for 4 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with BLENREP and for 6 months after the last dose.

ADVERSE REACTIONS
The pooled safety population described in Warnings and Precautions reflects exposure to BLENREP at a dosage of 2.5 mg/kg or 3.4 mg/kg (1.4 times the recommended dose) administered intravenously once every 3 weeks in 218 patients in DREAMM-2. Of these patients, 194 received a liquid formulation (not the approved dosage form) rather than the lyophilized powder. Among the 218 patients, 24% were exposed for 6 months or longer.

The safety of BLENREP as a single agent was evaluated in DREAMM-2. Patients received BLENREP at the recommended dosage of 2.5 mg/kg administered intravenously once every 3 weeks (n = 95). Among these patients, 22% were exposed for 6 months or longer.

Serious adverse reactions occurred in 40% of patients who received BLENREP. Serious adverse reactions in >3% of patients included pneumonia (7%), pyrexia (6%), renal impairment (4.2%), sepsis (4.2%), hypercalcemia (4.2%), and infusion-related reactions (3.2%). Fatal adverse reactions occurred in 3.2% of patients, including sepsis (1%), cardiac arrest (1%), and lung infection (1%).

Permanent discontinuation due to an adverse reaction occurred in 8% of patients who received BLENREP; keratopathy (2.1%) was the most frequent adverse reaction resulting in permanent discontinuation.

Dosage interruptions due to an adverse reaction occurred in 54% of patients who received BLENREP. Adverse reactions which required a dosage interruption in >3% of patients included keratopathy (47%), blurred vision (5%), dry eye (3.2%), and pneumonia (3.2%).

Dose reductions due to an adverse reaction occurred in 29% of patients. Adverse reactions which required a dose reduction in >3% of patients included keratopathy (23%) and thrombocytopenia (5%).

The most common adverse reactions (≥20%) were keratopathy (71%), decreased visual acuity (53%), nausea (24%), blurred vision (22%), pyrexia (22%), infusion-related reactions (21%), and fatigue (20%). The most common Grade 3 or 4 (≥5%) laboratory abnormalities were lymphocytes decreased (22%), platelets decreased (21%), hemoglobin decreased (18%), neutrophils decreased (9%), creatinine increased (5%), and gamma-glutamyl transferase increased (5%).

USE IN SPECIFIC POPULATIONS
Lactation: There is no data on the presence of belantamab mafodotin-blmf in human milk or the effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with BLENREP and for 3 months after the last dose.

Females and Males of Reproductive Potential: BLENREP can cause fetal harm when administered to pregnant women. There are no available data on the use of BLENREP in pregnant women to evaluate for drug-associated risk. No animal reproduction studies were conducted with BLENREP.

Pregnancy Testing: Pregnancy testing is recommended for females of reproductive potential prior to initiating BLENREP.

Infertility: Based on findings in animal studies, BLENREP may impair fertility in females and males. The effects were not reversible in male rats but were reversible in female rats.

Geriatric Use: Of the 218 patients who received BLENREP in DREAMM-2, 43% were aged 65 to less than 75 years and 17% were aged 75 years and older. Keratopathy occurred in 80% of patients aged less than 65 years and 73% of patients aged 65 years and older. Among the patients who received BLENREP at the 2.5-mg/kg dose in DREAMM-2 (n = 95), keratopathy occurred in 67% of patients aged less than 65 years and 73% of patients aged 65 years and older.

Renal Impairment: No dose adjustment is recommended for patients with mild or moderate renal impairment (estimated glomerular filtration rate [eGFR] 30 to 89 mL/min/1.73m2 as estimated by the Modification of Diet in Renal Disease [MDRD] equation). The recommended dosage has not been established in patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2) or end-stage renal disease (ESRD) with eGFR <15 mL/min/1.73 m2 not on dialysis or requiring dialysis.

Hepatic Impairment: No dose adjustment is recommended for patients with mild hepatic impairment (total bilirubin ≤upper limit of normal [ULN] and aspartate aminotransferase (AST) >ULN or total bilirubin 1 to ≤1.5 × ULN and any AST). The recommended dosage of BLENREP has not been established in patients with moderate or severe hepatic impairment (total bilirubin >1.5 × ULN and any AST).

INDICATION
BLENREP is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

The full Prescribing Information, including BOXED WARNING and Medication Guide, will be available here.

GSK in Oncology
GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics, and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

On August 5, 2020, MicuRx Pharmaceuticals, a Biotech focusing on discovery and development of novel antimicrobials, officially reported the close of nearly $43M series D financing, led by Huagai Capital, and with participation from Sinopharm-CICC and Zero2IPO Asset Management (Press release, MicuRx Pharmaceuticals, AUG 5, 2020, View Source [SID1234647080]). The funds will be mainly used to promote and expand clinical pipeline, and to support the comprehensive independent commercialization in China market.

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"We are honored to be recognized and supported by the Chinese top investors. Completion of this round marks the official entry of MicuRx into a new stage of development. "said Dr. Yuan Zhengyu, founder and CEO of the company," The world’s public health system will face unprecedented challenges in 2020. At the same time, the world will continue to face the dual urgency of bacterial resistance and the shortage of new antimicrobial drugs. Shouldering the sacred mission of fighting infection, MicuRx will adhere to the enterprise spirit of "professionalism and innovation", and strive to bring more original, efficient and safe products to patients with severe infection in China and the world, so as to better benefit the society. "

As the leading investor of this round of financing, Xu Xiaolin, chairman of Huagai Capital, congratulated MicuRx on the successful completion of round D financing. "As a leading enterprise in the innovation and development of new antimicrobial drugs, MicuRx has a core R&D capability and unique product pipeline. Under the leadership of Dr. Yuan and the management, we believe that MicuRx will take the commercialization of the Chinese market as an opportunity to achieve a new take-off. "

Mr. Li Zhiming, chairman of Sinopharm-CICC, commented: "China is a big country in the world widely uses common antibiotics. The overuse of antibiotics has led to the increasingly serious problem of clinical drug resistance. It is an urgent strategic need for Chinese enterprises to develop "super antibiotics" against drug-resistant bacteria in China. We hope that with the efforts of the company’s founding team and all shareholders, we can achieve a breakthrough of China’s local super antibiotics."

The first product developed by MicuRx call contezolid, is a new generation of oxazolidinone antibiotics for the treatment of multi drug resistant Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin resistant Enterococcus (VRE). Since the discovery of the compound in 2008, MicuRx has spent 11 years in development. After successfully completing the first phase III clinical trial for Complex Skin and Soft Tissue Infections, MicuRx has submitted China’s new drug marketing application (NDA) at the end of 2019, and has granted the priority review by National Medical Products Administration (NMPA).

In order to comprehensively promote the independent commercialization of contezolid, MicuRx will establish an efficient and professional commercialization team. Zhao Dongming, VP of MicuRx, who has rich commercial experience in the field of anti-infection, said: "the company has completed the formulation of commercialization and marketing strategy for contezolid. We are confident that contezolid will be highly recognized by doctors and experts, meet the clinical needs of patients, and that the ultimate success of the commercialization of MicuRx new drug, return to shareholders and the society."