On March 12, 2020 China Biologic Products Holdings, Inc. (NASDAQ: CBPO, "China Biologic" or the "Company"), a leading fully integrated plasma-based biopharmaceutical company in China, reported its financial results for the fourth quarter and fiscal year of 2019 (Press release, China Biologic Products, MAR 12, 2020, View Source [SID1234555515]).

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Fourth Quarter 2019 Financial Highlights

Total sales in the fourth quarter of 2019 decreased by 9.6% in RMB terms and 11.1% in USD terms to $102.2 million from $114.9 million in the same quarter of 2018.
Gross profit decreased by 17.2% to $64.0 million from $77.3 million in the same quarter of 2018. Gross margin decreased to 62.6% from 67.3% in the same quarter of 2018.
Income from operations decreased by 56.2% to $18.6 million from $42.5 million in the same quarter of 2018. Operating margin decreased to 18.2% from 37.0% in the same quarter of 2018.
Non-GAAP adjusted income from operations decreased by 28.9% in RMB terms and 30.2% in USD terms to $27.8 million from $39.8 million in the same quarter of 2018.
Net income attributable to the Company decreased by 64.1% to $12.5 million from $34.8 million in the same quarter of 2018. Diluted earnings per share decreased to $0.32 compared to $0.87 in the same quarter of 2018.
Non-GAAP adjusted net income attributable to the Company decreased by 31.2% in RMB terms and 32.6% in USD terms to $20.7 million from $30.7 million in the same quarter of 2018. Non-GAAP adjusted earnings per diluted share decreased to $0.53 from $0.76 in the same quarter of 2018.
Fiscal Year 2019 Financial Highlights

Total sales in 2019 increased by 12.3% in RMB terms and 7.9% in USD terms to $503.7 million from $466.9 million in 2018.
Gross profit increased by 2.8% to $329.1 million from $320.1 million in 2018. Gross margin decreased to 65.3% from 68.6% in 2018.
Income from operations increased by 11.9% to $163.6 million from $146.2 million in 2018. Operating margin increased to 32.5% from 31.3% in 2018.
Non-GAAP adjusted income from operations increased by 16.6% in RMB terms and 11.6% in USD terms to $198.3 million from $177.7 million in 2018.
Net income attributable to the Company increased by 8.4% to $138.8 million from $128.1 million in 2018. Diluted earnings per share remained stable at $3.53 in 2019 as compared to 2018.
Non-GAAP adjusted net income attributable to the Company increased by 20.5% in RMB terms and 15.4% in USD terms to $168.4 million from $145.9 million in 2018. Non-GAAP adjusted earnings per diluted share increased to $4.28 from $4.02 in 2018.
NOTE: Detailed financial statements and information are available through this link: View Source

"We are pleased to report that China Biologic surpassed our upwardly revised guidance for the full year 2019. As anticipated, however, we saw a year-over-year decline in the fourth quarter after exceptionally strong results for the first nine months of the year," said Joseph Chow, Chairman and CEO of China Biologic. "During the fourth quarter we continued our various initiatives to transform our business, including improving our earnings quality, distribution network, and credit policy management. We saw encouraging progress in several areas including distribution channel consolidation, plasma collection expansion and improving accounts receivable turnover. In 2020, we expect to face challenges including increasingly strict industry regulations, intensified market competition and disruptions to our operations as a result of the coronavirus outbreak. Despite these challenges, we are confident our newly-reorganized management team will successfully implement our strategies as we pursue our mission of raising standards in China’s plasma industry and improving lives through the application of groundbreaking medical science."

Financial Outlook

The COVID-19 outbreak has impacted various aspects of CBPO’s operations, including plasma collection, production of certain products, and sales and marketing activities. The Company is actively evaluating the overall impact on CBPO’s business, and has decided to postpone the release of financial guidance for the full year 2020. The Company will provide financial guidance to the market when it has better visibility.

Conference Call

The Company will host a conference call at 7:30 a.m. Eastern Time on Friday, March 13, 2020, which is 7:30 p.m. Beijing Time on March 13, 2020, to discuss its fourth quarter and fiscal year 2019 results and answer questions from investors. Listeners may access the call by dialing:

US:

1 888 346 8982

International:

1 412 902 4272

Hong Kong:

800 905 945

Mainland China:

400 120 1203

A telephone replay will be available one hour after the conclusion of the conference all through March 20, 2020. The dial-in details are:

US:

1 877 344 7529

International:

1 412 317 0088

Passcode:

10139946

A live and archived webcast of the conference call will be available through the Company’s investor relations website at View Source

On March 12, 2020 Dendreon Pharmaceuticals, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, reported findings from a sub-analysis of data from its PROCEED registry comparing overall survival (OS) in African American (AA) and Caucasian (CAU) men with metastatic castrate-resistant prostate cancer (mCRPC) who were treated with PROVENGE (sipuleucel-T) in a real-world treatment setting (Press release, Dendreon, MAR 12, 2020, View Source [SID1234555513]).

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When comparing PSA-matched AA men to CAU men with a baseline PSA less than or equal to the median (29.48 ng/mL), AA men in the PROCEED registry demonstrated a median OS of over 4.5 years (54.3 months) versus over 2.7 years (33.4 months) for CAU men – an improvement of 20.9 months and a 48% relative risk reduction in death.1,2

"Racial differences in the effectiveness of treatments in mCRPC are well documented," said Oliver Sartor, M.D., co-lead author of the publication, associate dean for oncology at Tulane University School of Medicine and medical director of the Tulane Cancer Center. "The high percentage of AA men enrolled in PROCEED compared to other trials provided a unique opportunity to evaluate the effectiveness of immunotherapy in extending survival in this patient population."

The PROCEED registry enrolled nearly 2,000 patients with mCRPC who received PROVENGE between 2011 and 2014 in everyday treatment settings, and followed them for three years. Approximately 12% of patients enrolled in PROCEED were AA. This analysis compared OS in a subset of AA patients (n=107) and CAU patients (n=222) matched by baseline PSA.3

"Black men tend to present with aggressive prostate cancer and have twice the mortality rate as compared to white men," said Andrew J. Armstrong, M.D., co-lead author of the publication, professor of medicine at Duke University School of Medicine and member of the Duke Cancer Institute. "However, in the context of immunotherapy for men with mCRPC, we observe that black men have significantly improved overall survival as compared to similar white men. While we do not yet understand the reasons for this improved survival by self-identified race, these data provide evidence to support the early use of sipuleucel-T immunotherapy regardless of race in order to improve long-term survival."

PROCEED evaluated the real-world use of PROVENGE in men with asymptomatic or minimally symptomatic mCRPC. These data were published online in Prostate Cancer and Prostatic Diseases (PCAN), a peer-reviewed Nature Research journal. The publication in PCAN is the first time these sub-group data have been published in a peer-reviewed journal.

"These findings add to the growing body of published clinical evidence that PROVENGE extends life in men with mCRPC and underscore its added effectiveness in African American men," said Bruce A. Brown, M.D., chief medical officer at Dendreon. "No other prostate cancer treatment has shown this level of added benefit in African American men with mCRPC, so these findings are exciting."

About the PROCEED Registry

PROCEED (NCT01306890) was a multicenter, open-label, observational registry conducted at urology and medical oncology clinics in private practice and academic sites. PROCEED enrolled 1,976 patients with mCRPC, of whom 1,902 received PROVENGE between 2011 and 2014 in everyday treatment settings. Of these, approximately 12% were African American. In the entire PROCEED population, patients were followed for a median of 46.6 months. Their median age was 72 years and their median baseline PSA was 15.0 ng/mL. The sub-analysis published in PCAN compared OS in a subset of African American patients (n=219) and Caucasian patients (n=438) matched by baseline PSA.

About Prostate Cancer in African American Men

Prostate cancer is the most frequently occurring non-cutaneous cancer among men in the United States and is second only to lung cancer among the leading causes of cancer-related deaths. In 2020, an estimated 191,930 new cases of prostate cancer will be diagnosed in the United States and 33,330 men will die from the disease.4

African American men have the highest prostate cancer incidence rate of any racial or ethnic group in the world.5 In the United States, the risk of prostate cancer is 74% higher in black men than non-Hispanic white men.6 The incidence of prostate cancer is about 60% higher in blacks than in whites for reasons that remain unclear.4 Prostate cancer death rates in blacks are more than double those of every other racial and ethnic group in the United States.4

About PROVENGE (sipuleucel-T)

PROVENGE is the only FDA-approved immunotherapy made from a patient’s own immune cells for the treatment of prostate cancer. More than 30,000 men have been prescribed PROVENGE, and it has been clinically proven to extend life for certain men in advanced stages of the disease.

INDICATION

PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION

Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

On March 12, 2020 McKesson Corporation (NYSE:MCK) reported the final results of its offer to its stockholders to exchange their issued and outstanding shares of McKesson common stock for shares of PF2 SpinCo, Inc. ("SpinCo") common stock owned by McKesson as part of its split-off of its interest in Change Healthcare LLC ("Change Healthcare") and its agreement with Change Healthcare Inc. (NASDAQ:CHNG) ("Change") to merge SpinCo with and into Change (Press release, McKesson, MAR 12, 2020, View Source [SID1234555512]).

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The exchange offer expired at 11:59 p.m., New York City time, on March 9, 2020. Under the terms of the offer, 11.4086 shares of SpinCo common stock were exchanged for each share of McKesson common stock accepted in the offer. McKesson accepted 15,426,537 of the tendered shares in exchange for 175,995,192 shares of SpinCo common stock, which were immediately converted into an equal number of whole shares of Change common stock (with cash in lieu of fractional shares) upon completion of the merger, which closed on March 10, 2020. The exchange offer and merger are generally expected to be tax-free to participating McKesson stockholders for U.S. federal income tax purposes except to the extent of any cash received in lieu of fractional shares of Change common stock.

Because the exchange offer was oversubscribed, McKesson accepted tendered shares of McKesson common stock on a pro rata basis in proportion to the total number of shares validly tendered and accepted for exchange. Stockholders who owned fewer than 100 shares of McKesson common stock, or an "odd lot" of such shares, and who validly tendered all of their shares, were not subject to proration in accordance with the terms of the exchange offer. The final proration factor of approximately 14.82% was applied to all other shares of McKesson common stock that were validly tendered and not validly withdrawn to determine the number of such shares that were accepted from each tendering stockholder.

Based on the final count by the exchange agent Equiniti Trust Company, the final results of the exchange offer are as follows:

Total number of shares of McKesson common stock validly tendered and not validly withdrawn:

97,324,143

Shares tendered and not validly withdrawn that were subject to proration:

96,151,322

"Odd-lot" shares tendered that were not subject to proration:

1,172,821

Total number of shares of McKesson common stock accepted:

15,426,537

On March 12, 2020 Novocure (NASDAQ: NVCR) reported that preclinical data on Tumor Treating Fields in combination with anti-PD-1 therapy were published in the peer-reviewed journal, Cancer Immunology, Immunotherapy (Press release, NovoCure, MAR 12, 2020, View Source [SID1234555511]). The published study suggests that Tumor Treating Fields therapy can induce anticancer immune response and provide the first evidence for the immunostimulatory effects of Tumor Treating Fields-induced cell death.

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The published study evaluated whether Tumor Treating Fields-mediated cell death can elicit antitumor immunity. The data demonstrated that damage-associated molecular patterns were released in Tumor Treating Fields-treated cancer cells, and calreticulin was exposed on the cell surface. In addition, Tumor Treating Fields therapy promoted the engulfment of cancer cells by dendritic cells and dendritic cell maturation in vitro, as well as recruitment of immune cells in vivo. The combination of Tumor Treating Fields with anti-PD-1 therapy resulted in a significant decline in tumor volume and an increase in the percentage of tumor-infiltrating leukocytes in two animal tumor models.

The data demonstrated a potential therapeutic advantage for combining Tumor Treating Fields and anti-PD-1 therapy, highlighting that this combination may be a viable treatment regimen to enhance clinical outcomes. Novocure is currently testing the combination of Tumor Treating Fields with immune checkpoint inhibitors in its phase 3 pivotal LUNAR trial in patients with stage 4 non-small cell lung cancer who progressed during or after platinum-based therapy.

About Tumor Treating Fields

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with glioblastoma and in the U.S. for mesothelioma, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.

On March 12, 2020 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, reported that the Company will report full year 2019 financial and operating results on the evening of Tuesday, March 24, 2020 (Press release, Celyad, MAR 12, 2020, View Source [SID1234555510]).

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Following the press release, Celyad management will host a conference call on Wednesday, March 25 at 1 p.m. CET / 8 a.m. ET to discuss full year 2019 results and provide an update on the Company’s recent progress and upcoming milestones.

Participants may access the conference call by dialing +44 (0) 2071 928501. The conference ID for the call is 1392585. Alternatively, participants may access the conference call by dialing the following local numbers: Belgium 02 401 70 35, France 01 76 72 89 28, Netherlands 020 7188527 and United States 1 917 720 0181.

To access the subsequent archived recording, visit the "Events & Webcasts" section of the Celyad website.

Additionally, in consideration of growing concerns over the spread of coronavirus disease, COVID-19, the Company has decided to postpone its upcoming Research & Development Day, previously scheduled for March 18th, until later in the year.