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Integra LifeSciences Reports First Quarter 2016 Financial Results

On April 27, 2016 Integra LifeSciences Holdings Corporation (NASDAQ:IART) reported its financial results for the first quarter ending March 31, 2016 (Press release, Integra LifeSciences, APR 27, 2016, View Source [SID:1234511480]).

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Highlights:

First quarter revenue increased 16.9% over the prior-year quarter to $236.8 million and organic revenue increased 8.9%;

Adjusted gross margins reached a record high;

Adjusted net income increased 15.3% over the prior year quarter to $27.6 million;

Expanded product portfolio with two new licensed tissue technologies, HuMend(TM) and VolTAC(TM);

Increasing ankle revenue expectations, inclusive of Salto Talaris (R) and Cadence(TM) Total Ankle System, to over $12 million for 2016;

Raising 2016 full year organic sales guidance to approximately 8%; Raising low end of total revenue guidance to the range of $985 million to $1.0 billion.

Total revenues for the first quarter were $236.8 million, reflecting an increase of $34.2 million, or 16.9%, over the first quarter of 2015. This reflects strong performance in both business segments, with Orthopedics and Tissue Technologies revenue increasing 37.0% and Specialty Surgical Solutions revenue increasing 7.9%.

Excluding the contribution of revenues from acquisitions, discontinued products and the effect of currency exchange rates, revenues increased 8.9% over the first quarter of 2015.

"Our Dural Repair, Precision Tools and Instruments, and Regenerative Technologies franchises posted strong performance in the first quarter and drove the organic growth results ahead of our previous guidance," said Peter Arduini, Integra’s President and Chief Executive Officer. "We are continuing to make investments in product development and commercialization, and plan to introduce new products such as Omnigraft(TM) for diabetic foot ulcers and Cadence(TM) for total ankle arthroplasty, later this year."

The Company reported GAAP net income of $11.6 million, or $0.31 per diluted share, for the first quarter of 2016 compared to GAAP net income of $11.7 million, or $0.35 per diluted share, for the first quarter of 2015.

Results for the first quarter of 2016 include the addition of 3.8 million shares issued in an equity offering in August 2015.

Adjusted measures discussed below are computed with the adjustments to GAAP reporting set forth in the attached reconciliation.

Adjusted net income for the first quarter of 2016 was $27.6 million, or $0.74 per share, compared to adjusted net income of $24.0 million, or $0.72 per share, in the first quarter of 2015.

Adjusted EBITDA for the first quarter of 2016 was $52.1 million, or 22.0% of revenue, compared to $43.6 million, or 21.5% of revenue, in the prior year’s first quarter.

Adjusted free cash flow conversion for the trailing twelve months ended March 31, 2016 was 55.2% versus 48.5% in the prior year trailing twelve-month period.

Outlook for 2016

Based upon the first quarter’s result, the Company is raising the low end of its full-year 2016 revenue guidance to a new range of $985 million to $1.0 billion, up from prior guidance of $975 million to $1.0 billion. The Company also is raising its full-year 2016 organic revenue growth to approximately 8% from its previous guidance of approximately 7%. The Company is adjusting the low end of its full-year adjusted earnings per share guidance range to $3.38 – $3.50 from $3.35 – $3.50. The Company’s GAAP EPS guidance is now $1.73 to $1.85.

"Our strong financial performance in the first quarter gives us the confidence to increase our organic revenue growth target for the full-year," said Glenn Coleman, Integra’s Chief Financial Officer. "We are also making significant selling, marketing, clinical and product development investments, concentrated in the first half of the year, which we expect will lead to greater margin expansion in the back half of 2016."

In the future, the Company may record, or expects to record, certain additional revenues, gains, expenses or charges as described in the Discussion of Adjusted Financial Measures below that it will exclude in the calculation of adjusted EBITDA and adjusted earnings per share for historical periods and in providing adjusted earnings per share guidance.

Astellas Co-sponsors C3 Prize

On April 27, 2016 Astellas Pharma Inc. (President and CEO: Yoshihiko Hatanaka, "Astellas") reported that its subsidiary, Astellas US LLC is co-sponsoring the C3 (Changing Cancer Care) Prize with the World Medical Innovation Forum, Stanford Medicine X and MATTER (Press release, Astellas, APR 27, 2016, View Source [SID:1234511478]).

The C3 Prize is a challenge designed to inspire non-medicine innovations that improve cancer care. While the C3 Prize selection will be judged in the United States according to the official rules, the application process is open to other markets on its official website.
The regulations and laws of the United States apply to the C3 Prize. For more information, visit www.C3Prize.com.

Through the C3 Prize, Astellas commits to providing solutions for patients, families and caregivers who are living with cancer, and improve cancer care.

Mitochondrial dysfunction-mediated apoptosis resistance associates with defective heat shock protein response in African-American men with prostate cancer.

African-American (AA) patients with prostate cancer (PCa) respond poorly to current therapy compared with Caucasian American (CA) PCa patients. Although underlying mechanisms are not defined, mitochondrial dysfunction is a key reason for this disparity.
Cell death, cell cycle, and mitochondrial function/stress were analysed by flow cytometry or by Seahorse XF24 analyzer. Expression of cellular proteins was determined using immunoblotting and real-time PCR analyses. Cell survival/motility was evaluated by clonogenic, cell migration, and gelatin zymography assays.
Glycolytic pathway inhibitor dichloroacetate (DCA) inhibited cell proliferation in both AA PCa cells (AA cells) and CA PCa cells (CA cells). AA cells possess reduced endogenous reactive oxygen species, mitochondrial membrane potential (mtMP), and mitochondrial mass compared with CA cells. DCA upregulated mtMP in both cell types, whereas mitochondrial mass was significantly increased in CA cells. DCA enhanced taxol-induced cell death in CA cells while sensitising AA cells to doxorubicin. Reduced expression of heat shock proteins (HSPs) was observed in AA cells, whereas DCA induced expression of CHOP, C/EBP, HSP60, and HSP90 in CA cells. AA cells are more aggressive and metastatic than CA cells.
Restoration of mitochondrial function may provide new option for reducing PCa health disparity among American men.British Journal of Cancer advance online publication, 26 April 2016; doi:10.1038/bjc.2016.88 www.bjcancer.com.

Prediction of remission and low disease activity in disease-modifying anti-rheumatic drug-refractory patients with rheumatoid arthritis treated with golimumab.

To create a tool to predict probability of remission and low disease activity (LDA) in patients with RA being considered for anti-TNF treatment in clinical practice.
We analysed data from GO-MORE, an open-label, multinational, prospective study in biologic-naïve patients with active RA (DAS28-ESR ⩾3.2) despite DMARD therapy. Patients received 50 mg s.c. golimumab (GLM) once monthly for 6 months. In secondary analyses, regression models were used to determine the best set of baseline factors to predict remission (DAS28-ESR &lt;2.6) at month 6 and LDA (DAS28-ESR ⩽3.2) at month 1.
In 3280 efficacy-evaluable patients, of 12 factors included in initial regression models predicting remission or LDA, six were retained in final multivariable models. Greater likelihood of LDA and remission was associated with being male; younger age; lower HAQ, ESR (or CRP) and tender joint count (or swollen joint count) scores; and absence of comorbidities. In models predicting 1-, 3- and 6-month LDA or remission, area under the receiver operating curve was 0.648-0.809 (R(2) = 0.0397-0.1078). The models also predicted 6-month HAQ and EuroQoL-5-dimension scores. A series of matrices were developed to easily show predicted rates of remission and LDA.
A matrix tool was developed to show predicted GLM treatment outcomes in patients with RA, based on a combination of six baseline characteristics. The tool could help provide practical guidance in selection of candidates for anti-TNF therapy.
© The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology.

Review of embryo-fetal developmental toxicity studies performed for recent FDA-approved pharmaceuticals.

Details of embryo-fetal development (EFD) studies were compiled from published FDA approval documents for 43 small molecule drugs (2014-2015) and 37 monoclonal antibodies (mAbs, 2002-2015). Anti-cancer agents were analyzed separately. Rats and rabbits were the species used for EFD studies on 93% of small molecule drugs. Overall, the rat and rabbit were equally sensitive to maternal and fetal toxicity (including teratogenicity). Dosages equivalent to more than 50-times the human exposure (or 10-times for mAbs) were frequently used, but were unnecessary for 90% of drugs. EFD studies were not required for several recently approved mAbs owing to pre-existing scientific knowledge. The cynomolgus monkey was used for developmental toxicity testing of 75% of mAbs, frequently using an ePPND study design. Studies in pregnant rodents using homologous murine antibodies supplemented or replaced monkey studies under some circumstances. Most anti-cancer small molecules and mAbs were tested for developmental toxicity in at least one species.
Copyright © 2016. Published by Elsevier Inc.