April 2016 – Page 11 – 1stOncology™: Cancer Intelligence Service

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.

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

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]).

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.

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Month: April 2016

Sobi publishes its report for the first quarter 2016

Integra LifeSciences Reports First Quarter 2016 Financial Results

Astellas Co-sponsors C3 Prize

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

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