Cardinal Health Reports Fourth-quarter and Year-end Results for Fiscal Year 2018

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

VBI Vaccines to Present at the Canaccord Genuity 38th Annual Growth Conference

On August 6, 2018 VBI Vaccines Inc. (NASDAQ: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that Jeff Baxter, President and CEO, will present at the Canaccord Genuity 38th Annual Growth Conference in Boston, MA, on Wednesday, August 8, 2018, at 9:30 AM ET (Press release, VBI Vaccines, AUG 6, 2018, View Source [SID1234528474]).

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A live webcast of the presentation and a subsequent replay may be accessed by visiting the Investors page of VBI’s website at: View Source A replay of the webcast will be archived on the company’s website for 90 days following the presentation.

Event: Canaccord Genuity 38th Annual Growth Conference
Date: Wednesday, August 8, 2018
Time: 9:30 – 9:55 AM ET
Event Website: View Source

Unum Therapeutics to Host Second Quarter 2018 Financial Results Conference Call and Webcast on August 13, 2018 at 5:00 P.M. ET

On August 6, 2018 Unum Therapeutics Inc. (Nasdaq:UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies based on its novel, universal Antibody-Coupled T-cell Receptor (ACTR) technology platform, reported that the company will host a conference call and live audio webcast on Monday, August 13, 2018 at 5:00 p.m. ET to discuss financial results for the second quarter of 2018 (Press release, Unum Therapeutics, AUG 6, 2018, View Sourcenews-releases/news-release-details/unum-therapeutics-host-second-quarter-2018-financial-results" target="_blank" title="View Sourcenews-releases/news-release-details/unum-therapeutics-host-second-quarter-2018-financial-results" rel="nofollow">View Source [SID1234528469]). Unum management will also provide an update on the Company’s recent progress and upcoming milestones.

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Participants may access the conference call by dialing 866-300-3411 (domestic) or 636-812-6658 (international) and refer to conference ID number 2367857. To join the live webcast, please visit the investor relations section of the Unum Therapeutics website at View Source at least 10 minutes before the event begins.

A webcast replay will be available at the same location on the Unum Therapeutics website beginning approximately two hours after the event, and will be archived for 90 days.

Exact Sciences to participate in Canaccord Genuity Growth Conference

On August 6, 2018 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will be presenting at the following investor conference during August and invited investors to participate by webcast (Press release, Exact Sciences, AUG 6, 2018, View Source [SID1234528468]).

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Canaccord Genuity 38th Annual Growth Conference, Boston
Presentation on Wednesday, Aug. 8, 2018, at 1 p.m. EDT

The webcast can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

Harbour BioMed and Glenmark Pharmaceuticals Sign Agreement for Greater China to Develop GBR 1302, a First-in-Class Bispecific Antibody for Treatment of HER2-Positive Cancers

On August 6, 2018 Harbour BioMed and Glenmark Pharmaceuticals S.A., reported that they have entered into an exclusive license agreement for the Greater China territory to develop, manufacture and commercialize GBR 1302, Glenmark’s bispecific antibody targeting HER2 and CD3 for the treatment of HER2-positive cancers (Press release, Harbour BioMed, AUG 6, 2018, View Source [SID1234528464]).

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Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed said: "We are looking forward to collaborating with Glenmark Pharmaceuticals to develop and commercialize this promising, novel bispecific antibody in Greater China to meet the significant unmet medical needs of Chinese cancer patients. This collaboration is aligned with our strategy to leverage our clinical development expertise by in-licensing highly innovative clinical stage assets. GBR 1302 is complementary to the internal portfolio we are building through our industry leading transgenic mouse platforms for generating innovative antibody-based therapeutics."

"We are very pleased to begin this strategic relationship with Harbour BioMed for the development and commercialization of our bispecific antibody, GBR 1302 in Greater China, where the predominance of certain HER-2 positive cancers presents a significant clinical need," said Glenn Saldanha, Chairman and Managing Director of Glenmark. "GBR1302 is representative of Glenmark’s commitment to the discovery and development of innovative therapeutics for unmet medical need, and the opportunity to work collaboratively with Harbour BioMed on this program, which brings extensive local experience, is very important to Glenmark."

Under the terms of the agreement, Glenmark will receive an upfront payment and is eligible to receive payments for achieving pre-specified development, regulatory and commercialization milestones, as well as tiered royalties on net sales for any approved products from Harbour BioMed. The agreement is potentially worth more than $120 million in addition to royalties for Glenmark. Harbour BioMed will lead the clinical development and commercialization of GBR 1302, with the option to manufacture GBR 1302 for the Greater China market. The companies will collaborate on the generation of clinical data to support the registration of GBR 1302 in HER2-positive indications in their respective territories.

GBR 1302, Glenmark’s lead immuno-oncology candidate, works by stimulating the patient’s immune system against HER2 overexpressing tumor cells. GBR 1302 is currently in a first-in-human study to determine maximum tolerated dose (MTD) in an all-comers population of patients with a variety of HER2-positive cancers. Enrollment for the GBR 1302 clinical study is currently ongoing in the U.S. and Germany.

Kurt Stoeckli, President and Chief Scientific Officer for Glenmark added, "Harbour BioMed represents a company that is dedicated to the same principles as Glenmark in pursuing highly effective, precision-medicine based immunotherapeutics for the benefit of cancer patients and we look forward to working closely with them to advance meaningful treatment options."

About Glenmark’s Oncology Pipeline and Proprietary BEAT Technology
Glenmark’s pipeline currently includes three immuno-oncology candidates being studied in a wide range of tumor types. These include three bispecific monoclonal antibodies (bsAbs). GBR 1302, a HER2xCD3 bsAb, targets HER2 expressing tumors, including those not responsive to standard of care; GBR 1342, a CD38XCD3 bsAb targeting CD38 positive tumors including hematologic malignancies and solid tumors; and GBR 1372, an EGFRxCD3 bsAb targeting EGFR positive tumors including those resistant to standard of care.

BEAT (Bispecific Engagement by Antibodies based on the T cell receptor) is Glenmark’s proprietary technology for the production of bsAbs. With BEAT technology, Glenmark’s scientists have been able to overcome past production obstacles encountered with bsAbs, and can efficiently manufacture these molecules at clinical and commercial scale. Preclinically, BEAT bsAbs demonstrate the potential for more potent activity compared to existing therapeutic antibodies. Additionally, structural similarity to naturally-occurring antibodies may result in a normalized IgG half-life and less immunogenicity. GBR 1302, GBR 1342 and GBR 1372 are based on BEAT technology.