8-K – Current report

On April 28, 2016 Cardinal Health today reported third-quarter results for fiscal year 2016, including a 21 percent increase in revenue to $30.7 billion and a 20 percent increase in non-GAAP operating earnings to $788 million (Filing, 8-K, Cardinal Health, APR 28, 2016, View Source [SID:1234511565]). Non-GAAP diluted earnings per share (EPS) increased 20 percent to $1.43. On a GAAP basis, operating earnings increased 11 percent to $656 million, and diluted EPS increased 7 percent to $1.17.

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"We had a strong financial and operational performance in our fiscal third quarter. At the same time, we continued to enhance and grow enterprise-wide service and product lines, which are important to our customers and address some of health care’s most difficult challenges," said George Barrett, chairman and chief executive officer of Cardinal Health. "We delivered double-digit growth in revenue and profit in both our Pharmaceutical and Medical reporting segments and had very solid performance across our lines of business."

The company tightened the range for its fiscal 2016 non-GAAP diluted earnings per share guidance to $5.17 to $5.27 from the prior range of $5.15 to $5.35.
Q3 FY16 SUMMARY

Q3 FY16

Q3 FY15

Y/Y
Revenue
$
30.7
billion

$
25.4
billion

21%
Operating earnings
$
656
million

$
591
million

11%
Non-GAAP operating earnings
$
788
million

$
657
million

20%
Net earnings attributable to Cardinal Health, Inc.
$
386
million

$
365
million

6%
Non-GAAP net earnings attributable to Cardinal Health, Inc.
$
472
million

$
396
million

19%
Diluted EPS attributable to Cardinal Health, Inc.
$
1.17

$
1.09

7%
Non-GAAP diluted EPS attributable to Cardinal Health, Inc.
$
1.43

$
1.19

20%
SEGMENT RESULTS
Pharmaceutical Segment
Third-quarter revenue for the Pharmaceutical segment increased 22 percent to $27.5 billion due to growth from new and existing customers as well as acquisitions.
Strong performance from both acquisitions and new and existing customers significantly contributed to segment profit growth of 16 percent to $660 million.

Q3 FY16

Q3 FY15

Y/Y
Revenue
$
27.5
billion

$
22.6
billion

22%
Segment profit
$
660
million

$
567
million

16%
Medical Segment
Third-quarter revenue for the Medical segment increased 13 percent to $3.1 billion due to the net contribution from acquisitions as well as solid growth from existing businesses.
Segment profit increased 26 percent to $128 million due to the contribution from acquisitions, net of divestitures, and from Cardinal Health-branded products. Segment profit includes the $21 million negative impact of the Cordis-related inventory fair value step-up.

Q3 FY16

Q3 FY15

Y/Y
Revenue
$
3.1
billion

$
2.8
billion

13%
Segment profit
$
128
million

$
102
million

26%

ADDITIONAL THIRD-QUARTER AND RECENT HIGHLIGHTS
• Announced agreement to acquire Curaspan Health Group Inc., a leader in discharge planning and care transitions technology for hospitals, health systems and post-acute providers

• Recognized as one of the Top Companies for Female Executives by the National Association for Female Executives

• Launched Cardinal Health MedSync Advantage, a custom-built medication synchronization program to help community pharmacists improve medication adherence and patient outcomes and increase pharmacy efficiency

• Announced winners of the sixth annual Generation Rx awards, recognizing student pharmacists from across the country and a clinical professor of pharmacy for their ongoing efforts to help prevent prescription medication misuse

Cytokinetics, Inc. Reports First Quarter 2016 Financial Results

On April 28, 2016 Cytokinetics, Inc. (Nasdaq:CYTK) reported total research and development revenues for the first quarter of 2016 were $8.4 million, compared to $4.4 million, during the same period in 2015 (Press release, Cytokinetics, APR 28, 2016, View Source;p=RssLanding&cat=news&id=2162959 [SID:1234511566]). The net loss for the first quarter was $12.5 million, or $0.31 per basic and diluted share. This is compared to the net loss for the same period in 2015 of $8.9 million, or $0.23 per basic and diluted share. As of March 31, 2016, cash, cash equivalents and investments totaled $108.6 million.

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"We made meaningful progress this quarter advancing our portfolio of muscle-biology directed programs," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "Notably, in partnership with Amgen we participated in several productive meetings with regulatory authorities which inform the potential Phase 3 development program for omecamtiv mecarbil. We also made strides in our ongoing skeletal muscle activator clinical development programs for tirasemtiv and CK-2127107 and decided with Astellas to move a next-generation skeletal muscle activator into IND enabling studies, further expanding our development pipeline."

Recent Highlights and Upcoming Milestones

Cardiac Muscle Program

omecamtiv mecarbil

Announced the start of a Phase 2 clinical trial of omecamtiv mecarbil in Japanese subjects with heart failure due to reduced ejection fraction. The primary objectives of the trial are to assess the pharmacokinetics, safety and tolerability of omecamtiv mecarbil. The secondary objective of the trial is to measure changes from baseline in systolic ejection time.

The manuscript, "Acute Treatment with Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure, The ATOMIC-AHF Study," published in the Journal of the American College of Cardiology. Results from this trial were first presented at the European Society of Cardiology Meeting in 2013.

Participated with Amgen in regulatory meetings with the FDA, EMA and Health Canada intended to inform the design of a potential Phase 3 development program for omecamtiv mecarbil.

Conducted various clinical, non-clinical and planning activities in collaboration with Amgen to support the potential advancement of omecamtiv mecarbil into a Phase 3 development program.

Expect to make a decision regarding the advancement of omecamtiv mecarbil to Phase 3 in the coming months.
Skeletal Muscle Program

tirasemtiv

Enrolled more than 50% of targeted patients in VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS), an ongoing, international Phase 3 clinical trial designed to assess the effects of tirasemtiv versus placebo on slow vital capacity (SVC) and other measures of skeletal muscle strength in patients with ALS.

Convened the first Data Monitoring Committee Meeting for VITALITY-ALS to review unblinded safety and efficacy data; Committee recommended continuing the trial without modifications or changes to the protocol.

Presented "Decline in Slow Vital Capacity Predicts Respiratory Insufficiency in Patients with ALS," at the Muscular Dystrophy Association’s 2016 National Clinical Conference.

The manuscript, "A Randomized, Placebo-controlled, Double-blind Phase IIb Trial Evaluating the Safety and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis," published in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration. Results from this trial were first presented at the Annual Meeting of the American Academy of Neurology in 2014.

Participated in the ALS Guidance Development Project and the Clinical Trial Guidelines Workshop Meeting in collaboration with ALS community stakeholders.

Announced a collaboration with Origent Data Sciences to refine and prospectively validate an Origent computer model to predict ALS disease progression leveraging data from our clinical trials of tirasemtiv.

Expect to complete target enrollment of 600 patients in VITALITY-ALS in the first half of 2016.
CK-2127107

Continued enrollment of Phase 2 clinical trial of CK-2127107 in patients with spinal muscular atrophy (SMA), in collaboration with Astellas.

Expect to complete enrollment of our Phase 2 clinical trial of CK-2127107 in patients with SMA in the second half of 2016.

Expect Astellas will initiate a Phase 2 clinical trial of CK-2127107 in patients with COPD in the first half of 2016.
Pre-Clinical Research

Continued research activities under our joint research program with Amgen directed to the discovery of next-generation cardiac muscle activators and under our joint research program with Astellas directed to the discovery of next-generation skeletal muscle activators. In addition, company scientists continued independent research activities directed to our other muscle biology programs.

Anticipate potential advancement of one next-generation compound from each joint research program into pre-clinical development in 2016.
Corporate

Announced Cytokinetics’ Vision 2020: Empowering Our Future, a strategic initiative designed to deepen and expand our pipeline over the next five years as well as advance a portfolio of muscle-biology directed drug candidates toward late-stage development and commercialization to address unmet needs of people living with conditions characterized by impaired muscle function.

Drew down the second, $15.0 million tranche from our growth capital loan with Oxford Finance LLC and Silicon Valley Bank.

Announced support of the European Organisation for Rare Diseases (EURORDIS) and the National Organization for Rare Disorders (NORD) to raise awareness of Rare Disease Day, an international campaign dedicated to elevating the public understanding of rare diseases.

In observance of ALS Awareness Month, Cytokinetics will ring the Nasdaq closing bell on Monday, May 2, 2016.
Financials

Revenues for the first quarter of 2016 were $8.4 million, compared to $4.4 million during the same period in 2015. Revenues for the first quarter of 2016 included $4.0 million of license revenues and $3.7 million of research and development revenues from our collaboration with Astellas, $0.6 million in research and development revenues from our collaboration with Amgen and $0.2 million in research and development revenues from our collaboration with ALSA. Revenues for the same period in 2015 were comprised of $1.6 million of license revenues and $2.1 million of research and development revenues from our collaboration with Astellas, and $0.7 million of research and development revenues from our collaboration with Amgen.

Total research and development (R&D) expenses for the first quarter of 2016 were $13.5 million, compared to $9.0 million for the same period in 2015. The $4.5 million increase in R&D expenses for the first quarter of 2016, compared with the same period in 2015, was primarily due to an increase of $4.2 million in outsourced clinical costs mainly associated with the ongoing VITALITY-ALS trial, and an increase of $1.0 million in personnel related expenses due to increased headcount, partially offset by a decrease of $0.6 million in outsourced preclinical costs associated with research activities conducted in 2015.

Total general and administrative (G&A) expenses for the first quarter of 2016 were $6.8 million compared to $4.4 million for the same period in 2015. The $2.4 million increase in G&A expenses for the first quarter of 2016, compared to the same period in 2015, was primarily due to an increase of $1.1 million in personnel related expenses due to increased non-cash stock compensation expense and increased headcount, an increase of $0.6 million in outsourced costs related to medical affairs and commercial development, and an increase of $0.6 million in corporate and patent legal fees.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s first quarter results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 29638364.

An archived replay of the webcast will be available via Cytokinetics’ website until May 5, 2016. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 29638364 from April 28, 2016 at 5:30 PM Eastern Time until May 5, 2016.

Functional activity of L-carnitine transporters in human airway epithelial cells.

Carnitine plays a physiologically important role in the β-oxidation of fatty acids, facilitating the transport of long-chain fatty acids across the inner mitochondrial membrane. Distribution of carnitine within the body tissues is mainly performed by novel organic cation transporter (OCTN) family, including the isoforms OCTN1 (SLC22A4) and OCTN2 (SLC22A5) expressed in human. We performed here a characterization of carnitine transport in human airway epithelial cells A549, Calu-3, NCl-H441, and BEAS-2B, by means of an integrated approach combining data of mRNA/protein expression with the kinetic and inhibition analyses of L-[(3)H]carnitine transport. Carnitine uptake was strictly Na(+)-dependent in all cell models. In A549 and BEAS-2B cells, carnitine uptake was mediated by one high-affinity component (Km<2 μM) identifiable with OCTN2. In both these cell models, indeed, carnitine uptake was maximally inhibited by betaine and strongly reduced by SLC22A5/OCTN2 silencing. Conversely, Calu-3 and NCl-H441 exhibited both a high (Km~20 μM) and a low affinity (Km>1 mM) transport component. While the high affinity component is identifiable with OCTN2, the low affinity uptake is mediated by ATB(0,+), a Na(+), and Cl(-)-coupled transport system for neutral and cationic amino acids, as demonstrated by the inhibition by leucine and arginine, as well as by SLC6A14/ATB(0,+) silencing. The presence of this transporter leads to a massive accumulation of carnitine inside the cells and may be of peculiar relevance in pathologic conditions of carnitine deficiency, such as those associated to OCTN2 defects.
Copyright © 2015 Elsevier B.V. All rights reserved.

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Efficacy of Continuous Dosing of Tadalafil Once Daily vs Tadalafil On Demand in Clinical Subgroups of Men With Erectile Dysfunction: A Descriptive Comparison Using the Integrated Tadalafil Databases.

Various factors play a role in the development of erectile dysfunction (ED).
To provide a descriptive comparison of erectile function response for tadalafil on-demand (PRN) and once-daily (OAD) dosing regimens in patients with common comorbid conditions, treatments, or risk factors that can be considered when treating ED.
In total, 17 PRN and 4 OAD placebo-controlled studies were included in the integrated database in these pooled analyses. Data were analyzed from patients treated with placebo, tadalafil 10 mg (low dose), and 20 mg (high dose) for the PRN studies and placebo, tadalafil 2.5 mg (low dose), and 5 mg (high dose) for the OAD studies.
The effects of tadalafil were measured using the International Index of Erectile Function administered from baseline to week 12. A descriptive comparison of the efficacy of tadalafil PRN vs OAD was examined in the clinical populations.
Baseline characteristics of 4,354 men were comparable between the PRN and OAD groups, with differences seen only in the variables of race, body mass index (BMI) of at least 30 kg/m(2), and alcohol use. Tadalafil was efficacious at improving erectile function for all clinical populations, except for the low-dose OAD group, which demonstrated a weaker effect vs placebo than the high-dose OAD group, and the low- and high-dose PRN groups vs placebo for patients with BMI of at least 30 kg/m(2) for patients without a cardiovascular disorder, smokers, patients with ED duration shorter than 1 year, and patients without previous phosphodiesterase type 5 inhibitor use. Tadalafil was efficacious for patients with or without diabetes mellitus, arterial hypertension, hyperlipidemia, and alcohol use at baseline.
Tadalafil OAD and PRN regimens showed efficacy in patients with ED. No clinical populations of patients with ED seemed to benefit overwhelmingly from one dose regimen over the other.
Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

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Metabolic response of prostate cancer to nicotinamide phophoribosyltransferase inhibition in a hyperpolarized MR/PET compatible bioreactor.

Metabolic shifts in disease are of great interest for the development of novel therapeutics. In cancer treatment, these therapies exploit the metabolic phenotype associated with oncogenesis and cancer progression. One recent strategy involves the depletion of the cofactors needed to maintain the high rate of glycolysis seen with the Warburg effect. Specifically, blocking nicotinamide adenine dinucleotide (NAD) biosynthesis via nicotinamide phosphoribosyltransferase (NAMPT) inhibition depletes cancer cells of the NAD needed for glycolysis. To characterize this metabolic phenotype in vivo and describe changes in flux with treatment, non-invasive biomarkers are necessary. One such biomarker is hyperpolarized (HP) [1-(13) C] pyruvate, a clinically translatable probe that allows real-time assessment of metabolism.
We therefore developed a cell perfusion system compatible with HP magnetic resonance (MR) and positron emission tomography (PET) to develop translatable biomarkers of response to NAMPT inhibition in reduced volume cell cultures.
Using this platform, we observed a reduction in pyruvate flux through lactate dehydrogenase with NAMPT inhibition in prostate cancer cells, and showed that both HP lactate and 2-[(18) F] fluoro-2-deoxy-D-glucose (FDG) can be used as biomarkers for treatment response of such targeted agents. Moreover, we observed dynamic flux changes whereby HP pyruvate was re-routed to alanine, providing both positive and negative indicators of treatment response.
This study demonstrated the feasibility of a MR/PET compatible bioreactor approach to efficiently explore cell and tissue metabolism, the understanding of which is critical for developing clinically translatable biomarkers of disease states and responses to therapeutics.
© 2015 Wiley Periodicals, Inc.

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