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.

New LTX-315 article published in Cell Death and Differentiation

On April 27, 2016 Lytix Biopharma reported that a new LTX-315 article was published in Cell Death and Differentiation (Press release, Lytix Biopharma, APR 27, 2016, View Source [SID:1234514844]).

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Title: The oncolytic peptide LTX-315 overcomes resistance of cancers to immunotherapy with CTLA4 checkpoint blockade

Authors: T Yamazaki, JM Pitt, M Vétizou, A Marabelle, C Flores, Ø Rekdal, G Kroemer and L Zitvogel

This preclinical study further provides strong rationale for combining LTX-315 with checkpoint inhibitor anti CTLA4.

Clinical and economic impact of rivaroxaban on the burden of atrial fibrillation: the case study of Japan.

Atrial fibrillation (AF) affects an estimated 1.5 million individuals in Japan, increasing their stroke risk and imposing considerable costs on the Japanese healthcare system. To reduce stroke incidence, guidelines recommend using anticoagulants in moderate-to-high risk non-valvular AF (NVAF) patients; however, many patients receive no treatment, aspirin only, or remain poorly-controlled on vitamin K antagonists (VKAs) due to high VKA discontinuation rates and non-adherence to guidelines. A prevalence-based Markov model was developed to estimate the clinical and budgetary impact of treating these patients with Xarelto(TM) (rivaroxaban, Bayer AG) in Japan.
Population, baseline risk of events, and associated management costs were estimated using data from Japanese publications where available. Treatment efficacy and safety were derived from published data and the J-ROCKET AF trial. Drug and physician visit costs were based on data from the Ministry of Health, Labour, and Welfare, the J-ROCKET AF trial, and Japanese clinical guidelines.
Our model demonstrates that increased use of rivaroxaban in inadequately-managed NVAF patients could avoid 456,081 non-fatal ischemic strokes (IS) and 76,975 cardiovascular deaths over 10 years in Japan. This clinical benefit offsets the increased incidence of myocardial infarctions and anticoagulant-related bleeding. Decreased event costs could lead to a ¥188.4 billion decrease in net spending over the analysis time horizon.
Introducing rivaroxaban may decrease the burden of NVAF in Japanese society. From a clinical perspective, the reduction in IS and embolic events outweighs the increased risk of anticoagulant-related bleeding; from an economic perspective, reduced event costs offset drug and physician visit costs, resulting in cost savings.

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Sobi publishes its report for the first quarter 2016

On April 27, 2016 Swedish Orphan Biovitrum AB (publ) (Sobi(TM)) reported its results for the first quarter 2016 (Press release, Swedish Orphan Biovitrum, APR 27, 2016, View Source;Media/News/RSS/?RSS=View Source [SID:1234511481]). Revenue for the quarter totalled SEK 1,273 M (865), an increase of 47 per cent compared to previous year. All parts of the business contributed to the result with Orfadin and Kineret delivering strong performance.

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Business Summary Q1 2016

Initiated commercial launch of Elocta in the first European countries; revenue in the quarter derived almost exclusively from Germany
European Commission approved transfer of marketing authorisation for Elocta to Sobi
Sobi and Biogen received recommendation from CHMP that marketing authorisation be granted for Alprolix for the treatment of haemophilia B
Received commercialisation rights to three products from PharmaSwiss
European patent granted for Orfadin oral suspension
Initiated clinical pipeline programmes for acute gout and Still’s disease, and a patent granted for a new formulation of Kineret
Financial Summary Q1 2016 (Q1 2015)

Total revenue was SEK 1,273 M (865), an increase of 47 per cent (48 per cent at CER)
Product revenue was SEK 1,108 M (632), an increase of 75 per cent (76 per cent at CER)
Revenues include a one-time credit from Biogen of SEK 322 M triggered by the first commercial sales of Elocta
Gross margin was 74 per cent (60)
EBITA was SEK 502 M (172)
Earning per share 1.13 SEK (0.28)
"2016 is off to a strong start with excellent financial results, new products added to our Partner Products portfolio, development of two new programmes for Kineret, the launch of Elocta in Europe, and positive opinions regarding Alprolix from the CHMP recommending that marketing authorisation be granted, and from the COMP recommending that the orphan designation be maintained," said Geoffrey McDonough, CEO and Pesident at Sobi. "In January we began the launch of Elocta in the first European countries, enabling people with haemophilia A in the region access to the first extended half-life factor treatment. Revenue from the quarter derives almost exclusively from Germany, the only market in the EU where pharmaceuticals are immediately reimbursed upon EU approval. We received positive reimbursement decisions late in the quarter in both the Netherlands and Ireland, and continue to advance discussions in Denmark, Sweden and the UK."

Financial Summary
Q1 Q1 Full year
Amounts in SEK M 2016 2015 Change 2015
Total revenues1 1,273 865 47% 3,228
Gross profit 944 519 82% 2,007
Gross margin 74% 60% 62%
EBITA 502 172 >100% 433
EBIT (Operating profit/loss) 410 102 >100% 146
Profit/loss for the period 301 75 >100% 68
1 Q1 2016 revenues include a one time credit of SEK 322 M relating to first commercial sales of Elocta.

Outlook 2016 unchanged
Sobi continues to expect total revenue for the full year to be in the range of SEK 4,800 to 5,000 M. Revenue will include one-time credits for Elocta of SEK 300 to 325 M and for Alprolix of SEK 300 to 325 M, which will not impact cash. Gross margin is expected be in the range of 68 to 70 per cent.

Sobi will continue to invest in the launches of Elocta and Alprolix, and will also take on incremental costs of SEK 250 – 300 M reflecting its 50 per cent share of Biogen’s ongoing development costs for the products. Sobi will assume these costs when it becomes marketing authorisation holder for Elocta, which occurred 24 March 2016; and for Alprolix expected in the second half of the year. These incremental costs are included in this outlook.

Sobi expects EBITA for the full year to be in the range of SEK 1,200 to 1,300 M.

Sobi’s report for the first quarter 2016 can be found on View Source;Media/Reports/.

Improved Detection of preclinical Colorectal Liver Metastases by High Resolution Ultrasound including Molecular Ultrasound Imaging using the targeted Contrast Agent BR55.

Purpose: Aim of the present study was to investigate the sensitivity of high resolution ultrasound (HRU), standard contrast-enhanced ultrasound (CEUS) and CEUS using a novel vascular endothelial growth factor receptor 2 (VEGFR2)-targeted contrast agent for the detection of hepatic metastases in a mouse model of colorectal cancer using clinical standard technology. Materials and Methods: The human colon cancer cell line HT29, transfected with luciferase cDNA for in vivo bioluminescence monitoring, was injected intrasplenically into CB17.SCID mice. Mice were monitored weekly by bioluminescence and after 2 and 4.5 weeks by HRU and CEUS. Contrast media (untargeted BR1, targeted BR55) was applied and digital cine loops from the arterial phase (15 - 45 sec), portal venous phase (50 - 120 s) and late phases (3 - 5 min, 1hour) of the whole liver were analyzed. Data were correlated with postmortem histopathology. Results: Without contrast enhancement, lesions > 4 mm were reliably detected. After use of untargeted CEUS, lesions > 2 mm were reliably detected and enhanced rim vascularization and late-phase wash-out was shown. With BR55, lesions > 0.8 mm were reliably detected with excellent documentation of vascularization. A persistent contrast enhancement was seen > 30 min after injection. Contrast-enhancement patterns with BR55 significantly correlated with CD31 (R2 = 0.74) and VEGFR2-immunohistochemistry (R2 = 0.66). Conclusion: Detection of metastases by HRU and CEUS was earlier and more accurate than monitoring via bioluminescence. In vivo monitoring of hepatic micrometastases can thus be performed without prior modification of cancer cells using standard technology.
© Georg Thieme Verlag KG Stuttgart · New York.

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