On August 6, 2018 bluebird bio, Inc. (NASDAQ: BLUE) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported a collaboration to apply their respective technology platforms to the discovery, development and commercialization of novel immune cell therapies for cancer (Press release, bluebird bio, AUG 6, 2018, View Source [SID1234528455]). The collaborators will specifically leverage Regeneron’s VelociSuite platform technologies for the discovery and characterization of fully human antibodies, as well as T cell receptors (TCRs) directed against tumor-specific proteins and peptides, and bluebird bio will contribute its field-leading expertise in gene transfer and cell therapy.

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"The collaboration with Regeneron complements bluebird bio’s growing immuno-oncology development portfolio, which includes clinical and pre-clinical CAR T and T cell receptor programs," said Philip Gregory, D.Phil., Chief Scientific Officer of bluebird bio. "With Regeneron’s proven targeting technologies, in combination with our deep expertise in cell biology and vector technology, as well as clinical experience with leading CAR T cell drug products, we hope to rapidly advance novel cellular therapies with the potential to transform the lives of people with cancer."

"Like Regeneron, bluebird is a science-focused company looking to push the limits of what novel technologies can do in drug discovery and development," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "We believe that the tremendous synergies between Regeneron’s proven technologies and bluebird’s toolbox of advanced cell and gene therapy technologies create a promising opportunity to help people with cancer by developing innovative new treatments. This collaboration adds yet another dimension to our rapidly advancing portfolio of immuno-oncology candidates and combination approaches."

The collaborators have jointly selected six initial targets and will equally share the costs of research and development up to the point of submitting an Investigational New Drug (IND) application. Additional targets may be selected over the five-year research collaboration term. When an IND is submitted for a potential cell therapy product, Regeneron will have the right to opt-in to a co-development/co-commercialization arrangement for certain collaboration targets, with 50/50 cost and profit sharing. If Regeneron does not opt-in, the company is eligible to receive milestone payments and royalties from bluebird bio on any potential resulting products.

Regeneron will also make a $100 million investment in bluebird bio common stock at a price of $238.10 per share, which represents a premium of 59 percent over the $150 closing price on August 3, 2018. This approximately $37 million premium will be credited against Regeneron’s initial 50 percent funding obligation for basic collaboration research, after which the collaborators will fund ongoing research equally. The transaction is subject to preclearance by the Federal Trade Commission under applicable antitrust laws.

Cell-based immunotherapies such as chimeric antigen receptor T cells (CAR Ts) use human immune cells (typically T cells derived from the patient with cancer) that are modified and returned to the patient to serve as therapeutic agents that specifically target and kill cancer cells. In advanced clinical studies, researchers have shown that modified T cells are highly active therapies in patients with a variety of blood cancers even after other treatment approaches have failed, and there are existing FDA-approved medicines that utilize this approach.

bluebird bio’s technologies use a customized lentiviral vector to modify T cells so that they can recognize tumor-specific proteins expressed by cancer cells and kill them upon engagement. Regeneron’s VelociSuite technologies, including VelocImmune and Veloci-T, enable the creation of fully-human antibodies and T cell receptors. These complementary technologies have the potential to expand the types of tumors that modified T cells can safely and effectively target by enabling the T cells to reach both extracellular and intracellular tumor antigens.

On August 6, 2018 Cardinal Health (NYSE: CAH) reported fourth-quarter fiscal year 2018 revenues of $35 billion, an increase of 7 percent from the fourth quarter last year, and fiscal year 2018 revenues of $137 billion, an increase of 5 percent from fiscal 2017 (Press release, Cardinal Health, AUG 6, 2018, View Source [SID1234528478]).

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Fourth-quarter GAAP operating earnings were a loss of $1.1 billion due to a Medical segment non-cash, goodwill impairment of $1.4 billion, which was primarily due to the performance of the Cordis business. Non-GAAP operating earnings were $465 million for the quarter. The company reported GAAP operating earnings of $126 million for fiscal year 2018 and non-GAAP operating earnings of $2.6 billion.

For the quarter, GAAP diluted earnings per share (EPS) were a loss of $3.76, while non-GAAP diluted EPS were $1.01. GAAP diluted EPS for fiscal year 2018 were $0.81, and non-GAAP diluted EPS were $5.00.

"Fiscal ’18 was a challenging year, but we are making significant progress by taking decisive actions to drive growth, reduce costs and enhance profitability," said Mike Kaufmann, CEO of Cardinal Health. "We are on track, and Cardinal Health’s best-in-class products and services continue to distinguish us with our customers and their patients."

Tax rates
During the fourth quarter of 2018 and 2017, GAAP effective tax rates were 1.8 percent and 25.8 percent, respectively. During fiscal years 2018 and 2017, GAAP effective tax rates were 213.8 percent and 32.7 percent, respectively. The fiscal year 2018 effective tax rates were adversely affected by the non-deductible Medical segment goodwill impairment. This unfavorable impact was partially offset in both the fourth quarter and fiscal year 2018 by net discrete tax benefits. Also, as previously disclosed, the fiscal year 2018 GAAP effective tax rate benefitted from transitional tax benefits of $2.97 per share due to the enactment of the U.S. Tax Cuts and Jobs Act ("U.S. tax reform") and a lower U.S. federal income tax rate.

During the fourth quarter of 2018 and 2017, the non-GAAP effective tax rates were 11.8 percent and 27.0 percent respectively. During fiscal years 2018 and 2017, the non-GAAP effective tax rates were 29.3 percent and 32.6 percent. The non-GAAP effective tax rates for the fourth quarter and fiscal year 2018 benefitted from net favorable discrete items and the lower U.S. federal income tax rate due to U.S. tax reform.

Segment results
Pharmaceutical segment
Fourth-quarter revenue for the Pharmaceutical segment increased 6 percent to $31 billion due to sales growth from Pharmaceutical and Specialty Distribution customers. This was partially offset by the divestiture of the company’s China distribution business and expiration of a large, mail-order customer contract, both of which were previously announced.

Segment profit for the quarter decreased 18 percent to $416 million primarily due to the negative impact from the company’s generic program performance.

Medical segment
Fourth-quarter revenue for the Medical segment increased 14 percent to $4 billion, which was driven primarily by the acquisition of the Patient Recovery business.

Medical segment profit decreased by 17 percent, or $24 million, to $114 million in the fourth quarter driven by the performance of Cardinal Health Branded products, primarily Cordis, and compensation-related items. This was mostly offset by contributions from acquisitions.

Outlook
The company does not provide GAAP EPS outlook because it is unable to reliably forecast most of the items that are excluded from GAAP EPS to calculate non-GAAP EPS. These items could cause EPS to differ materially from non-GAAP EPS. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

The company’s fiscal year 2019 guidance range for non-GAAP diluted EPS from continuing operations is $4.90 to $5.15.

Recent highlights

Closed on partnership with Clayton, Dubilier & Rice to accelerate the growth of naviHealth, a market leader in post-acute care management. Cardinal Health retains approximately a 45 percent interest in naviHealth and, at closing, received net cash proceeds of $736 million and expects to record a pre-tax gain of more than $500 million in the first quarter of FY19.

The company exited its transition services agreements (TSA) with Medtronic for North America, Latin America and the Global Supply Chain during the last week of July and is on track for TSA exits in other regions in late calendar year 2018 and early 2019.

Awarded more than $3 million in grants to more than 70 nonprofit organizations to support local efforts to combat the opioid epidemic across Ohio, West Virginia, Kentucky and Tennessee. The grants were made through the Cardinal Health Foundation’s Generation Rx program and are funded by Cardinal Health’s Opioid Action Program.

FY18 awards and recognition highlights

Named as one of 2018 World’s Most Admired Companies by Fortune for the fourth consecutive year

Earned distinction as a 2018 "Top 70 Companies for Executive Women" by the National Association for Female Executives for the seventh consecutive year

Recognized by Becker’s Healthcare as one of the 150 Top Places to Work in Healthcare in 2018 for the fifth consecutive year

Named to the Human Rights Campaign (HRC) Best Places to Work for LGBT Equality for the tenth consecutive year based on ratings in HRC’s 2018 Corporate Equality Index

Webcast

Cardinal Health will host a webcast today at 8:30 a.m. Eastern to discuss fourth-quarter and year-end 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 on the Cardinal Health website at ir.cardinalhealth.com until August 5, 2019.

Upcoming webcasted investor events

Morgan Stanley 16th Annual Global Healthcare Conference on Friday, Sept. 14 at 8:45 a.m. Eastern in New York City

On August 3, 2018 Omeros Corporation (NASDAQ: OMER) reported that the company will issue its second quarter 2018 financial results for the period ended June 30, 2018, on Thursday, August 9, 2018, after the market closes (Press release, Omeros, AUG 3, 2018, View Source;p=RssLanding&cat=news&id=2361970 [SID1234528383]). Omeros management will host a conference call and webcast that day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results.

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Conference Call Details

To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 3989669. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 3989669.

To access the live and subsequently archived webcast of the conference call, go to Omeros’ website at www.omeros.com and go to "Events" under the Investors section of the website. Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

On August 3, 2018 bluebird bio, Inc. (Nasdaq: BLUE) reported that members of the management team will present at the 2018 Wedbush PacGrow Healthcare Conference, Tuesday, August 14, at 8:35 a.m. ET at the Parker New York Hotel, New York City (Press release, bluebird bio, AUG 3, 2018, View Source [SID1234528416]).

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To access the live webcast of bluebird bio’s presentation, please visit the "Events & Presentations" page within the Investors and Media section of the bluebird bio website at View Source A replay of the webcast will be available on the bluebird bio website for 90 days following the conference.

On August 3, 2018 Zenyaku Kogyo Co., Ltd. (Japanese-only website) and Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that Zenyaku filed an application for approval with the Ministry of Health, Labour and Welfare for the anti-CD20 monoclonal antibody RITUXAN injection 100 mg and 500 mg [generic name: rituximab (genetical recombination)] for the treatment of "CD20-positive chronic lymphocytic leukemia (CLL) (Press release, Chugai, AUG 3, 2018, View Source [SID1234528993]). RITUXIAN is co-marketed by the two companies in Japan.

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Zenyaku received a request from the MHLW to develop RITUXAN for the treatment of CD20-positive CLL issued on April 6, 2012, as a result of the evaluation by the "11th Review Committee on Unapproved Drugs and Indications with High Medical Needs" held on March 23, 2012, and has been preparing to file for the addition of this indication. On March 20, 2018, the orphan drug designation was granted for RITUXAN for CD20-positive CLL as the estimated number of newly diagnosed CLL patient per year is about 400.

CLL is a disease in which small mature B lymphocytes proliferate monoclonally and proliferate in peripheral blood, bone marrow, lymph nodes and spleen, many of which progress slowly. This rare disease is mostly prevalent in elderly people, and considered as difficult to cure with current treatments while many patients often experience recurrence and progression repeatedly. The number of patients in Japan is small, reportedly about 0.3 to 100,000 people per year. The age of onset is typically over 50 years, and rarely seen in people under 30 years of age. In patients with CLL, the ratio of females to males is higher at about 1.5 or 2 to 1*.

Zenyaku and Chugai will continue to work for the early approval of the product to provide RITUXAN for CLL patients and medical professionals who are waiting for a new treatment option.

* Center for Cancer Control and Information Services. Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma View Source (Japanese only)