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10-Q – Quarterly report [Sections 13 or 15(d)]

vTv Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, vTv Therapeutics, 2017, AUG 2, 2016, View Source [SID1234521331]).

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10-Q – Quarterly report [Sections 13 or 15(d)]

Idera Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Idera Pharmaceuticals, AUG 2, 2016, View Source [SID1234514177]).

T cells were genetically modified using DNA plasmids from the SB platform to stably express a second-generation CD19-specific CAR and selectively propagated ex vivo with activating and propagating cells (AaPCs) and cytokines (J Clin Invest. 2016 Sep 1;126(9):3363-76. doi: 10.1172/JCI86721. Epub 2016 Aug 2. View Source [SID:SID1234516349]). Twenty-six patients with advanced non-Hodgkin lymphoma and acute lymphoblastic leukemia safely underwent hematopoietic stem cell transplantation (HSCT) and infusion of CAR T cells as adjuvant therapy in the autologous (n = 7) or allogeneic settings (n = 19).
B-mediated genetic transposition and stimulation resulted in 2,200- to 2,500-fold ex vivo expansion of genetically modified T cells, with 84% CAR expression, and without integration hotspots. Following autologous HSCT, the 30-month progression-free and overall survivals were 83% and 100%, respectively. After allogeneic HSCT, the respective 12-month rates were 53% and 63%. No acute or late toxicities and no exacerbation of graft-versus-host disease were observed. Despite a low antigen burden and unsupportive recipient cytokine environment, CAR T cells persisted for an average of 201 days for autologous recipients and 51 days for allogeneic recipients.
CD19-specific CAR T cells generated with SB and AaPC platforms were safe, and may provide additional cancer control as planned infusions after HSCT. These results support further clinical development of this nonviral gene therapy approach.

Teva Completes Acquisition of Actavis Generics

On August 2, 2016 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Allergan plc (NYSE: AGN) reported that Teva has completed its acquisition of Allergan’s generics business ("Actavis Generics") (Press release, Teva, AUG 2, 2016, View Source;p=irol-newsArticle&ID=2191986 [SID1234516257]).

This strategic acquisition brings together two leading generics businesses with complementary strengths, R&D capabilities, product pipelines and portfolios, geographical footprints, operational networks and cultures. The result is a stronger, more competitive Teva, well positioned to thrive in an evolving global marketplace, to realize the opportunities the very attractive global and U.S. generics markets offer, and to deliver the highest-quality generic medicines at the most competitive prices, unlocking value to patients, healthcare systems and investors around the world.

"The acquisition of Actavis Generics comes at a time when Teva is stronger than ever—in both our generics and specialty businesses," said Erez Vigodman, President and CEO, Teva. "Through our acquisition of Actavis Generics, we are creating a new Teva with a strong foundation, significantly enhanced financial profile and more diversified revenue sources and profit streams backed by strong product development engines in both generics and specialty. This is a platform that is expected to generate multi-year top-line and bottom-line growth as well as significant cash flow."

Mr. Vigodman continued, "We are confident that we can realize the projected synergies and accretion inherent in this acquisition for our stockholders and quickly integrate Actavis Generics into Teva. Furthermore, as a result of our strengthened financial profile following this transaction, we will be even better positioned to reap the benefits of Teva’s R&D capabilities to support top-line growth and expand our portfolio across the business. The strong, combined company cash flow will allow for rapid deleveraging and give us the ability to continue capital allocation, with a focus on bolstering our specialty pipeline and product portfolio as well as strengthening shareholder returns."

With the acquisition, Teva now has approximately 338 product registrations pending FDA approval and holds the leading position in first-to-file opportunities with approximately 115 pending ANDAs in the U.S. In Europe, after divestitures; Teva will have a pipeline capable of over 5000 launches across the region. In Teva growth markets including, Asia, Africa, Latin America, Middle East, Russia and CIS, there are now approximately 600 pending product approvals. Overall, Teva is planning for 1,500 generic launches globally in 2017.

Teva’s products generated approximately $215 billion in savings in the last decade to the U.S. healthcare system; this number will continue to increase and even accelerate as a result of the acquisition.

"Teva now has some of the best assets, people and capabilities in the industry. We have a clear responsibility to turn those strengths into meaningful results for patients, customers and the communities we serve, as well as for our shareholders," said Siggi Olafsson, President and CEO, Global Generic Medicines, Teva. "We are pleased to welcome our talented new colleagues from Actavis Generics, including many first-class scientists and business leaders."

Increased Global Commercial Reach
Teva’s acquisition of Actavis Generics improves international commercial opportunities and significantly enhances the global scale of its sales and R&D platforms. Offering access to the world’s largest drug cabinet—with more than 1,800 medicines and 16,000 products—Teva now has a commercial presence across 80 markets, including a top-three leadership position in over 40 markets and global leadership in all key global markets.

Financial Highlights
Teva expects to achieve cost synergies and tax savings of approximately $1.4 billion annually by the end of 2019, by eliminating duplication and inefficiencies on a global scale and capturing economies of scale.
Allergan plc received $33.43 billion in cash and approximately 100 million Teva shares.
Strong Combined Global Leadership Team and Employees with Deep Experience across the Business

The two companies share a close cultural and strategic fit, and Teva is focused on leveraging both organizations’ competencies and talent. The combined company’s expanded senior management team is comprised of leaders from both Teva and Actavis. It is structured to leverage the strong talent from both organizations to ensure that the new company capitalizes on its expanded global commercial footprint and Teva’s continued strength as a world leader in generics. With this structure in place beginning on Day One, the company is immediately positioned to maximize growth across all of its global businesses.
Operational Integration and Readiness

Since the acquisition agreement was announced in July 2015, integration teams at Teva and Actavis Generics have worked diligently to plan for integration of the two companies in order to ensure that the combined company is fully operational immediately upon the closing of the transaction. As a result of these actions, Teva will begin to capitalize on the benefits offered by the acquisition of Actavis Generics starting immediately.

"Our ability to close a transaction of this size successfully and be operational on ‘Day One’ is a true testament to the dedication of the integration planning teams at both companies," said Richard Daniell, Teva Chief Integration Officer. "Because business continuity was a primary objective throughout the integration process, our leaders and colleagues are in a position to quickly build on Teva’s solid financial foundation, operational discipline and diverse product base to continue to improve our performance."

CARDINAL HEALTH REPORTS Q4 AND FISCAL 2016 RESULTS,
PROVIDES FISCAL 2017 OUTLOOK

On August 2, 2016 Cardinal Health reported fourth-quarter fiscal year 2016 revenues of $31.4 billion, an increase of 14 percent from the fourth quarter last year, and fiscal 2016 revenues of $121.5 billion, an increase of 19 percent from the same period last year (Filing, Q4/Annual, Cardinal Health, 2016, AUG 2, 2016, View Source [SID:1234514197]).

For the quarter, the company reported growth in GAAP operating earnings of 11 percent to $620 million and in non-GAAP operating earnings of 5 percent to $643 million. GAAP operating earnings for fiscal year 2016 were $2.5 billion, an increase of 14 percent, and non-GAAP operating earnings for the fiscal year were $2.9 billion, an increase of 17 percent from the prior fiscal year.
For the quarter, GAAP diluted earnings per share from continuing operations2 (EPS) increased 16 percent to $1.02, while non-GAAP diluted EPS increased 14 percent to $1.14. GAAP diluted EPS for fiscal year 2016 increased 20 percent to $4.32, and non-GAAP diluted EPS increased 20 percent to $5.24.
"We finished fiscal 2016 having generated the highest revenues, the largest GAAP and non-GAAP operating earnings, and the greatest operating cash flow in our company’s history. Our teams worked incredibly hard this past year while never losing sight of the ultimate goal – serving patients and their families," said George Barrett, chairman and CEO of Cardinal Health, Inc. "The Cardinal Health team is well-positioned to adapt, innovate and lead during a time of great change in the healthcare industry."

Q4 and Fiscal Year Summary

Q4 FY16

Q4 FY15

Y/Y

FY16

FY15

Y/Y
Revenue
$
31.4
billion

$
27.5
billion

14%

$
121.5
billion

$
102.5
billion

19%
GAAP Operating Earnings
$
620
million

$
558
million

11%

$
2,459
million

$
2,161
million

14%
Non-GAAP Operating Earnings
$
643
million

$
611
million

$
2,895
million

$
2,472
million

17%
GAAP Earnings from Continuing Operations2
$
333
million

$
293
million

14%

$
1,427
million

$
1,212
million

18%
Non-GAAP Earnings from Continuing Operations2
$
372
million

$
333
million

12%

$
1,732
million

$
1,469
million

18%
GAAP Diluted EPS from Continuing Operations2
$
1.02

$
0.88

16%

$
4.32

$
3.61

20%
Non-GAAP Diluted EPS from Continuing Operations2
$
1.14

$
1.00

14%

$
5.24

$
4.38

20%
SEGMENT RESULTS
Pharmaceutical Segment
Fourth-quarter revenue for the Pharmaceutical segment increased 14 percent to $28.2 billion due to growth from existing and net new Pharmaceutical Distribution customers and, to a lesser extent, performance from the Specialty business. Segment profit for the quarter increased 1 percent to $542 million due to contributions from acquisitions, largely offset by the loss of a large customer contract, which expired on March 31, 2016.
For the full year, revenue for the Pharmaceutical segment increased 20 percent to $109.1 billion, and segment profit increased 19 percent to $2.5 billion.

Q4 FY16

Q4 FY15

Y/Y

FY16

FY15

Y/Y
Revenue
$
28.2
billion

$
24.7
billion

14%

$
109.1
billion

$
91.1
billion

20%
Segment Profit
$
542
million

$
535
million

$
2.5
billion

$
2.1
billion

19%

Cardinal Health
Page 2

Medical Segment
Fourth-quarter revenue for the Medical segment increased 12 percent to $3.2 billion primarily due to contributions from acquisitions, and, to a lesser extent, growth from Cardinal Health Brand products. Segment profit increased 19 percent to $122 million due to contributions from acquisitions and Cardinal Health Brand products.
Full-year revenue for the Medical segment increased 9 percent to $12.4 billion, and segment profit increased 6 percent to $457 million.

Q4 FY16

Q4 FY15

Y/Y

FY16

FY15

Y/Y
Revenue
$
3.2
billion

$
2.9
billion

12%

$
12.4
billion

$
11.4
billion

9%
Segment Profit
$
122
million

$
103
million

19%

$
457
million

$
433
million

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 2017 guidance range for non-GAAP diluted EPS from continuing operations is $5.48 to $5.73, representing growth of approximately 5 to 9 percent from the prior year.

Cardinal Health typically does not provide quarterly earnings guidance. However, the company expects a year-over-year decline in its non-GAAP earnings per share for the first-quarter of fiscal year 2017 in the high-single- to low-double-digit-percent range. This expectation is largely due to an anticipated first-quarter decline in Pharmaceutical segment profit in a percentage range from the high teens to low twenties with full-year Pharmaceutical segment profit expected to be essentially flat to fiscal year 2016.

The expected first-quarter fiscal 2017 Pharmaceutical segment decline is largely based upon two factors: 1) less year-over-year incremental contribution from its generics program; and 2) a previously mentioned Pharmaceutical Distribution large customer loss, the impacts of which will continue through the third-quarter of fiscal year 2017.

More details can be found on the accompanying earnings presentation slides as well as on the company’s conference call.

SELECTED YEAR-END AND RECENT HIGHLIGHTS
•
Increased quarterly dividend by 16 percent to $0.4489 per share, or $1.80 on an annualized basis, and authorized new share repurchase program
•
Appointed Pamela O. Kimmet Chief Human Resources Officer following the retirement of Carole Watkins
•
Committed nearly $2 million in multi-year patient safety grants to help improve the effectiveness, efficiency and excellence of patient care
•
Announced distribution agreement with Biosensors enabling Cordis to sell Biosensors’ coronary stent portfolio in select countries in Europe, the Middle East, Africa, Australia and New Zealand
•
Convened 26th annual Retail Business Conference, presenting a record-setting 9,300 attendees with the industry’s largest lineup of continuing education opportunities, buying opportunities, and access to a broad array of Cardinal Health solutions to help diversify and improve their businesses
•
Demonstrated Cardinal Health’s commitment to the community by:
◦
Recognizing the essential contributions of medical laboratory professionals to patient care with the Cardinal Health urEssential Award
◦
Donating 11 million yen to Save the Children Japan to assist with restoration efforts for those families affected by the earthquakes earlier this year
◦
Contributing more than $85,000 in cash and health care products to aid those affected by the wildfires in Fort McMurray, Alberta, Canada

AWARDS AND RECOGNITIONS

Over the past year, Cardinal Health was recognized for the company’s culture and its commitment to diversity and sustainability. These accolades include:

•
Named on the 2016 "World’s Most Admired Companies" list by Fortune
•
Designated a 2016 Top Green Company in the U.S. by Newsweek
•
Named to the Human Rights Campaign (HRC) "Best Places to Work for LGBT Equality" for fourth consecutive year based on ratings in HRC’s 2016 Corporate Equality Index
•
Included in Becker’s Healthcare 150 Great Places to Work in Healthcare 2016 listing

Cardinal Health
Page 3

•
Named among the 2016 Best Companies for Leaders by Chief Executive
•
Included in the Dow Jones Sustainability North American Company Index for the 10th year in a row