Abbott Reports First-Quarter 2016 Results

On April 20, 2016 Abbott (NYSE: ABT) reported financial results for the first quarter ended March 31, 2016 (Press release, Abbott, APR 20, 2016, View Source [SID:1234511137]).

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Abbott 2016 Q1 Performance at-a glance

Adjusted diluted EPS from continuing operations, which excludes specified items, was $0.41 in the first quarter, above Abbott’s previous guidance range. Reported diluted EPS from continuing operations under GAAP was $0.04 in the first quarter.
First-quarter worldwide sales of $4.9 billion increased 5.1 percent on an operational basis and decreased 0.2 percent on a reported basis.
Abbott is raising its full-year 2016 adjusted EPS guidance range for continuing operations to $2.14 to $2.24 from $2.10 to $2.20. Projected full-year 2016 EPS for continuing operations under GAAP is $1.36 to $1.46.
Abbott’s recent innovations and product launches contributed to sales growth in the first quarter. Select recently launched products include ElevaTM in the premium segment of the Chinese infant formula market; Abbott’s portfolio of infant and toddler non-GMO nutrition products in the U.S.; MitraClip, Abbott’s structural heart product for the treatment of mitral regurgitation; Freestyle Libre in Europe; Supera peripheral stent in the U.S. for treatment of blockages in the superficial femoral artery; and Abbott’s portfolio of TECNIS intraocular lenses for the treatment of cataracts.
In the first quarter, Abbott received European approval for use in children and teens of its revolutionary FreeStyle Libre Flash Glucose Monitoring System that eliminates routine finger sticks and finger-stick calibration. In Abbott Vascular, AbsorbTM, Abbott’s fully dissolving vascular stent, earned a positive review from an independent U.S. Food and Drug Administration advisory committee.
"We’re off to a good start to the year and are raising our full-year adjusted EPS guidance range," said Miles D. White, chairman and chief executive officer, Abbott. "All four of our businesses met or exceeded our growth expectations and underlying demand remains strong."

FIRST-QUARTER BUSINESS OVERVIEW

Following are sales by business segment and commentary for the first quarter:

Total Company
($ in millions)


% Change vs. 1Q15

Sales 1Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Operational

Reported

Operational

Reported
Total *

1,531

3,354

4,885

1.9

6.6

(1.2)

5.1

(0.2)
Nutrition

719

952

1,671

4.9

3.9

(3.2)

4.3

0.1
Diagnostics

339

779

1,118

3.7

8.2

1.8

6.9

2.3
Established Pharmaceuticals


888

888

n/a

11.0

(1.0)

11.0

(1.0)
Medical Devices

466

731

1,197

(3.9)

3.5

(1.3)

0.5

(2.4)

Note: Operational growth reflects percentage change over the prior year excluding the impact of exchange rates.
* Total Abbott Sales from continuing operations include Other Sales of $11 million.
n/a = Not Applicable.

First-quarter 2016 worldwide sales of $4.9 billion increased 5.1 percent on an operational basis and decreased 0.2 percent on a reported basis, including an unfavorable 5.3 percent effect of foreign exchange.

U.S. sales increased 1.9 percent, led by 9.2 percent growth in Point of Care Diagnostics, 7.5 percent growth in Medical Optics, and 4.9 percent growth in Nutrition.

International sales increased 6.6 percent on an operational basis and decreased 1.2 percent on a reported basis in the first quarter. International operational sales growth was led by 11.0 percent growth in Established Pharmaceuticals, 11.0 percent growth in Diabetes Care and 8.2 percent growth in Diagnostics.

Nutrition
($ in millions)


% Change vs. 1Q15

Sales 1Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Operational

Reported

Operational

Reported
Total

719

952

1,671

4.9

3.9

(3.2)

4.3

0.1
Pediatric

403

564

967

4.7

4.1

(2.3)

4.4

0.5
Adult

316

388

704

5.2

3.6

(4.6)

4.3

(0.5)

Worldwide Nutrition sales increased 4.3 percent in the first quarter on an operational basis and 0.1 percent on a reported basis, including an unfavorable 4.2 percent effect of foreign exchange.

Worldwide Pediatric Nutrition sales increased 4.4 percent on an operational basis and 0.5 percent on a reported basis in the quarter, including an unfavorable 3.9 percent effect of foreign exchange. In the U.S., above-market sales growth was led by recently launched infant and toddler non-GMO products, including Similac Advance Non-GMO and Go & Grow by Similac Non-GMO. International growth was led by market share expansion of Eleva in the premium segment of the Chinese infant formula market, as well as continued strong performance in Russia and across several countries in Latin America.

Worldwide Adult Nutrition sales increased 4.3 percent on an operational basis and decreased 0.5 percent on a reported basis in the quarter, including an unfavorable 4.8 percent effect of foreign exchange. International Adult Nutrition growth was led by continued strong growth of Ensure and Glucerna in Latin America and other priority geographies. U.S. Adult Nutrition sales growth of 5.2 percent was led by growth of Ensure in the retail and institutional market segments. During the quarter, Abbott launched Ensure Enlive, a nutrition drink that helps adults rebuild lost muscle and regain strength and energy.

Diagnostics
($ in millions)


% Change vs. 1Q15

Sales 1Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Operational

Reported

Operational

Reported
Total

339

779

1,118

3.7

8.2

1.8

6.9

2.3

Core Laboratory

190

695

885

2.4

8.6

2.1

7.3

2.1

Molecular

47

61

108

(2.1)

3.2

(3.4)

1.0

(2.8)

Point of Care

102

23

125

9.2

9.6

7.2

9.3

8.8

Worldwide Diagnostics sales increased 6.9 percent in the first quarter on an operational basis, driven by continued above-market growth globally, including strong growth in both emerging and developed markets. Sales increased 2.3 percent on a reported basis, including an unfavorable 4.6 percent effect of foreign exchange.

Core Laboratory Diagnostics sales increased 7.3 percent in the quarter on an operational basis and 2.1 percent on a reported basis, including an unfavorable 5.2 percent effect of foreign exchange. Operational sales growth in the quarter was driven by double-digit growth in emerging markets.

Molecular Diagnostics sales increased 1.0 percent in the quarter on an operational basis and decreased 2.8 percent on a reported basis, including an unfavorable 3.8 percent effect of foreign exchange. Strong operational sales growth in Abbott’s infectious disease testing business was offset, as expected, by the planned scale down of its genetics business.

Point of Care Diagnostics sales increased 9.3 percent in the quarter on an operational basis and 8.8 percent on a reported basis, including an unfavorable 0.5 percent effect of foreign exchange. Sales growth was led by continued adoption of Abbott’s i-STAT handheld system in the U.S. and international markets.

Established Pharmaceuticals
($ in millions)


% Change vs. 1Q15

Sales 1Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Operational

Reported

Operational

Reported
Total



888

888

n/a

11.0

(1.0)

11.0

(1.0)
Key Emerging Markets



634

634

n/a

11.9

(3.2)

11.9

(3.2)
Other



254

254

n/a

8.6

4.9

8.6

4.9

Established Pharmaceuticals sales increased 11.0 percent in the first quarter on an operational basis and decreased 1.0 percent on a reported basis, including an unfavorable 12.0 percent effect of foreign exchange.

Key Emerging Markets include India, Russia, Brazil and China, along with several additional emerging markets that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these key geographies increased 11.9 percent on an operational basis and decreased 3.2 percent on a reported basis, including an unfavorable 15.1 percent effect of foreign exchange.

Operational sales growth in Key Emerging Markets was led by continued double-digit growth in India, which comprises more than 20 percent of Abbott’s Established Pharmaceuticals sales. Sales growth in India was led by double-digit growth across several core therapeutic areas, including women’s health, gastroenterology, and cardio-metabolics. During the quarter, Abbott also achieved above-market growth in China and several countries in Latin America as it continues to expand its presence and portfolio in these key geographies.

Medical Devices
($ in millions)


% Change vs. 1Q15

Sales 1Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Operational

Reported

Operational

Reported

Total

466

731

1,197

(3.9)

3.5

(1.3)

0.5

(2.4)

Vascular

289

396

685

1.9

0.2

(4.5)

0.9

(1.9)

Diabetes Care

69

174

243

(31.6)

11.0

4.8

(5.2)

(9.1)

Medical Optics

108

161

269

7.5

4.2

0.5

5.4

3.2

Vascular Product Lines:

Coronary Devicesa)

194

336

530

4.9

(1.1)

(5.6)

0.9

(2.0)

Endovascularb)

73

60

133

9.5

8.6

2.9

9.0

6.4

a) Includes DES / BVS product portfolio, structural heart, guidewires, balloon catheters, and other coronary products.
b) Includes vessel closure, carotid stents and other peripheral products.

Worldwide Medical Devices sales increased 0.5 percent in the first quarter on an operational basis and decreased 2.4 percent on a reported basis, including an unfavorable 2.9 percent effect of foreign exchange.

Worldwide sales of Vascular products increased 0.9 percent in the quarter on an operational basis and decreased 1.9 percent on a reported basis, including an unfavorable 2.8 percent effect of foreign exchange. Sales of MitraClip, Abbott’s device for the treatment of mitral regurgitation, increased double-digits globally, as Abbott continues to build the market for this first-in-class device. Growth in Abbott’s Endovascular business was driven by vessel closure products and Supera, Abbott’s peripheral stent for the treatment of blockages in the superficial femoral artery and proximal popliteal artery in the upper leg. In March, Absorb, Abbott’s fully dissolving vascular stent, received a positive review from an independent U.S. FDA advisory committee.

Worldwide Diabetes Care sales decreased 5.2 percent in the quarter on an operational basis and 9.1 percent on a reported basis, including an unfavorable 3.9 percent effect of foreign exchange. Strong international sales growth was driven by continued consumer uptake of FreeStyle Libre, Abbott’s revolutionary Flash Glucose Monitoring System that eliminates routine finger sticks and finger-stick calibration. During the quarter, Abbott received European approval for use of FreeStyle Libre in children and teens. In the U.S., sales were impacted by competitive and market dynamics.

Worldwide Medical Optics sales increased 5.4 percent in the quarter on an operational basis and 3.2 percent on a reported basis, including an unfavorable 2.2 percent effect of foreign exchange. Operational sales growth was driven by continued market uptake of cataract products in the premium intraocular lens segment, including TECNIS Symfony and TECNIS Toric lenses.

ABBOTT RAISES FULL-YEAR ADJUSTED EARNINGS-PER-SHARE GUIDANCE RANGE

Abbott is raising its full-year 2016 guidance range for earnings per share from continuing operations, excluding specified items, to $2.14 to $2.24 from $2.10 to $2.20.

Abbott forecasts net specified items for the full year 2016 of approximately $0.78 per share. Specified items include intangible amortization expense, the impact of the Venezuelan currency devaluation, and charges associated with cost reduction initiatives and deal and other expenses, partially offset by the favorable resolution of various tax positions from prior years.

Including net specified items, projected earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) would be $1.36 to $1.46 for the full year 2016.

ABBOTT DECLARES 369TH QUARTERLY DIVIDEND

On Feb. 19, 2016, the board of directors of Abbott declared the company’s quarterly dividend of $0.26 per share. Abbott’s cash dividend is payable May 16, 2016, to shareholders of record at the close of business on April 15, 2016. This marks the 369th consecutive quarterly dividend paid by Abbott.

Abbott is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for 25 consecutive years.

Molecular Alterations and Everolimus Efficacy in Human Epidermal Growth Factor Receptor 2-Overexpressing Metastatic Breast Cancers: Combined Exploratory Biomarker Analysis From BOLERO-1 and BOLERO-3.

Two recent phase III trials, BOLERO-1 and BOLERO-3 (Breast Cancer Trials of Oral Everolimus), evaluated the addition of everolimus to trastuzumab and chemotherapy in human epidermal growth factor receptor 2-overexpressing advanced breast cancer. The current analysis aimed to identify biomarkers to predict the clinical efficacy of everolimus treatment.
Archival tumor samples from patients in BOLERO-1 and BOLERO-3 were analyzed using next-generation sequencing, immunohistochemistry, and Sanger sequencing.
Biomarker data were available for 549 patients. PIK3CA activating mutations and PTEN loss were reported in 30% and 16% of BOLERO-1 samples and in 32% and 12% of BOLERO-3 samples, respectively. PI3K pathway was hyperactive (PIK3CA mutations and/or PTEN loss and/or AKT1 mutation) in 47% of BOLERO-1 and 41% of BOLERO-3 samples. In both studies, differential progression-free survival (PFS) benefits of everolimus were consistently observed in patient subgroups defined by their PI3K pathway status. When analyzing combined data sets of both studies, everolimus was associated with a decreased hazard of progression in patients with PIK3CA mutations (hazard ratio [HR], 0.67; 95% CI, 0.45 to 1.00), PTEN loss (HR, 0.54; 95% CI, 0.31 to 0.96), or hyperactive PI3K pathway (HR, 0.67; 95% CI, 0.48 to 0.93). Patients with wild-type PIK3CA (HR, 1.10; 95% CI, 0.83 to 1.46), normal PTEN (HR, 1.00; 95% CI, 0.80 to 1.26), or normal PI3K pathway activity (HR, 1.19; 95% CI, 0.87 to 1.62) did not derive PFS benefit from everolimus.
This analysis, although exploratory, suggests that patients with human epidermal growth factor receptor 2-positive advanced breast cancer having tumors with PIK3CA mutations, PTEN loss, or hyperactive PI3K pathway could derive PFS benefit from everolimus.
© 2016 by American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

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TH-302 in Combination with Radiotherapy Enhances the Therapeutic Outcome and Is Associated with Pretreatment [18F]HX4 Hypoxia PET Imaging.

Conventional anticancer treatments are often impaired by the presence of hypoxia. TH-302 selectively targets hypoxic tumor regions, where it is converted into a cytotoxic agent. This study assessed the efficacy of the combination treatment of TH-302 and radiotherapy in two preclinical tumor models. The effect of oxygen modification on the combination treatment was evaluated and the effect of TH-302 on the hypoxic fraction (HF) was monitored using [(18)F]HX4-PET imaging and pimonidazole IHC stainings.
Rhabdomyosarcoma R1 and H460 NSCLC tumor-bearing animals were treated with TH-302 and radiotherapy (8 Gy, single dose). The tumor oxygenation status was altered by exposing animals to carbogen (95% oxygen) and nicotinamide, 21% or 7% oxygen breathing during the course of the treatment. Tumor growth and treatment toxicity were monitored until the tumor reached four times its start volume (T4×SV).
Both tumor models showed a growth delay after TH-302 treatment, which further increased when combined with radiotherapy (enhancement ratio rhabdomyosarcoma 1.23; H460 1.49). TH-302 decreases the HF in both models, consistent with its hypoxia-targeting mechanism of action. Treatment efficacy was dependent on tumor oxygenation; increasing the tumor oxygen status abolished the effect of TH-302, whereas enhancing the HF enlarged TH-302’s therapeutic effect. An association was observed in rhabdomyosarcoma tumors between the pretreatment HF as measured by [(18)F]HX4-PET imaging and the T4×SV.
The combination of TH-302 and radiotherapy is promising and warrants clinical testing, preferably guided by the companion biomarker [(18)F]HX4 hypoxia PET imaging for patient selection.
©2015 American Association for Cancer Research (AACR) (Free AACR Whitepaper).

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Celldex Therapeutics Presents Data Supporting the Clinical Development of Glembatumumab Vedotin and the Preclinical CD40 Program at the AACR Annual Meeting 2016

On April 20, 2016 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported three poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2016 in New Orleans (Press release, Celldex Therapeutics, APR 20, 2016, View Source [SID:1234511138]). The Company previously reported on four poster presentations at AACR (Free AACR Whitepaper), which included Phase 1 safety and immune response data from the ongoing study evaluating varlilumab and nivolumab in patients with advanced cancers. New presentations included data enhancing the understanding of glembatumumab vedotin’s mechanism of action and further validation of the overexpression of its target, gpNMB, in a wide range of tumor types. Additionally, the Company also presented research with lead agonist antibodies targeting the CD40 receptor, a promising target for immunotherapy, in a poster titled "Development and characterization of novel CD40 antibody agonists for cancer immunotherapy."

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Found on antigen presenting cells, such as dendritic cells, macrophages and B cells, CD40 is a key activator of immune responses. The Company has characterized two fully human antibodies that demonstrated potent agonist activity, such as activating human dendritic cells and B cells and indirectly inducing T cell proliferation. Importantly, Fc receptor interaction, which could cause signal amplification and is required for some CD40 agonist antibodies in development, was not required for agonist ability, enabling controlled, sensitive activation of CD40. Additionally, the drug candidates were shown to upregulate CD95/Fas, a receptor involved in apoptosis, on B cell lymphoma cell lines and to mediate potent anti-tumor activity against the lymphomas in vivo.

"The CD40 pathway has a unique and powerful role in bridging the innate and adaptive immune response, and if properly modulated, it could become a very important part of cancer immunotherapy. We have identified some promising and differentiated antibodies, from which we will select a lead clinical candidate to complement our growing immunotherapy pipeline," said Tibor Keler, Ph.D., Executive Vice President and Chief Scientific Officer of Celldex Therapeutics. "In addition, we are enthusiastic about new research demonstrating gpNMB overexpression in a broad set of tumor types, further reinforcing the wide potential clinical applicability of glembatumumab vedotin."

The CD40 poster is available on the "Publications" page of the "Science" section of the Celldex website.

Celldex and its collaborating investigators also presented two additional posters supporting the clinical development of glembatumumab vedotin:

Title: Glycoprotein NMB (gpNMB) overexpression is prevalent in human cancers: pancreatic cancer, non-small cell lung cancer, head and neck cancer, and osteosarcoma

gpNMB is the target of Celldex’s antibody-drug conjugate glembatumumab vedotin. Using a validated immunohistochemistry (IHC) assay to detect the expression of gpNMB, the Company examined tissues from multiple types of solid tumors and normal tissue. Overexpression of gpNMB in samples of tumor tissue versus normal tissue was found in squamous cell carcinoma of the lung (85%), osteosarcoma (62%), pancreatic cancer (55%), lung adenocarcinoma (45%) and squamous cell carcinoma of the head and neck (40%). These results support the potential broad applicability of gpNMB as a therapeutic target across a wide range of tumor types. Celldex is currently investigating glembatumumab vedotin in the pivotal METRIC study in triple-negative breast cancer and in a Phase 2 study in metastatic melanoma. Independent investigators are also studying glembatumumab vedotin in uveal melanoma and osteosarcoma. A Phase 1/2 study in squamous cell carcinoma of the lung is expected to commence in the second quarter of 2016.

The poster is available on the "Publications" page of the "Science" section of the Celldex website.

Title: Targeting gpNMB with 89Zr-CR011 for PET imaging of triple negative breast cancer
Abstract: 4209

Collaborating investigators used a radio-labeled form of the glembatumumab antibody to study uptake by tumor cells in vitro and in vivo. Using positron emission tomography (PET) imaging with xenograft models of triple-negative breast cancer (TNBC), the investigators detected specific localization of glembatumumab in the tumor and plan to perform similar studies with patient derived tumor samples. These studies contribute to understanding the mechanisms of action for glembatumumab vedotin, Celldex’s antibody-drug conjugate targeting gpNMB, and may provide a diagnostic approach for selecting patients with the greatest likelihood of clinical benefit.

About Glembatumumab Vedotin
Glembatumumab vedotin is a fully-human monoclonal antibody-drug conjugate (ADC) that targets glycoprotein NMB (gpNMB). gpNMB is a protein overexpressed by multiple tumor types, including breast cancer, melanoma, lung cancer, uveal melanoma and osteosarcoma. gpNMB has been shown to be associated with the ability of the cancer cell to invade and metastasize and to correlate with reduced time to progression and survival in breast cancer. The gpNMB-targeting antibody, CR011, is linked to a potent cytotoxic, monomethyl auristatin E (MMAE), using Seattle Genetics’ proprietary technology. Glembatumumab vedotin is designed to be stable in the bloodstream but to release MMAE upon internalization into gpNMB-expressing tumor cells, resulting in a targeted cell-killing effect. Glembatumumab vedotin is in development for the treatment of locally advanced or metastatic breast cancer with an initial focus in triple negative disease, stage III and IV melanoma, uveal melanoma and osteosarcoma.

The Molecular Registry of Pituitary Adenomas (REMAH): A bet of Spanish Endocrinology for the future of individualized medicine and translational research.

Pituitary adenomas are uncommon, difficult to diagnose tumors whose heterogeneity and low incidence complicate large-scale studies. The Molecular Registry of Pituitary Adenomas (REMAH) was promoted by the Andalusian Society of Endocrinology and Nutrition (SAEN) in 2008 as a cooperative clinical-basic multicenter strategy aimed at improving diagnosis and treatment of pituitary adenomas by combining clinical, pathological, and molecular information. In 2010, the Spanish Society of Endocrinology and Nutrition (SEEN) extended this project to national level and established 6 nodes with common protocols and methods for sample and clinical data collection, molecular analysis, and data recording in a common registry (www.remahnacional.com). The registry combines clinical data with molecular phenotyping of the resected pituitary adenoma using quantitative real-time PCR of expression of 26 genes: Pituitary hormones (GH-PRL-LH-FSH-PRL-ACTH-CGA), receptors (somatostatin, dopamine, GHRH, GnRH, CRH, arginine-vasopressin, ghrelin), other markers (Ki67, PTTG1), and control genes. Until 2015, molecular information has been collected from 704 adenomas, out of 1179 patients registered. This strategy allows for comparative and relational analysis between the molecular profile of the different types of adenoma and the clinical phenotype of patients, which may provide a better understanding of the condition and potentially help in treatment selection. The REMAH is therefore a unique multicenter, interdisciplinary network founded on a shared database that provides a far-reaching translational approach for management of pituitary adenomas, and paves the way for the conduct of combined clinical-basic innovative studies on large patient samples.
Copyright © 2016 SEEN. Published by Elsevier España, S.L.U. All rights reserved.

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