On April 27, 2016 Varian Medical Systems (NYSE:VAR) reported non-GAAP net earnings of $1.09 per diluted share and GAAP net earnings of $1.01 per diluted share for the second quarter of fiscal year 2016 (Press release, Varian Medical Systems, APR 27, 2016, View Source [SID:1234511502]). Varian’s revenues totaled $759 million for the second quarter, equal to the year-ago quarter and up 2 percent in constant currency. The company ended the quarter with a $3.3 billion backlog, up 6 percent from the end of the second quarter of fiscal year 2015.

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"The company delivered solid results for the second quarter with strong gross order growth in our Oncology business and made promising progress in our Particle Therapy business," said Dow Wilson, CEO of Varian Medical Systems. "As expected, we continued to experience weakness in our Imaging Components business."

The company finished the second quarter of fiscal year 2016 with $961 million in cash and cash equivalents and $794 million of debt. Cash flow from operations was $32 million for the second quarter, bringing the total for the first half of the fiscal year to $109 million. During the quarter, the company spent $57 million to repurchase about 725,000 shares of common stock.

Oncology Systems

Oncology Systems’ second quarter revenues totaled $584 million, down 1 percent from the same quarter of fiscal year 2015 and up 1 percent in constant currency. Second-quarter Oncology gross orders were $618 million, up 6 percent from the year-ago quarter and up 8 percent in constant currency. In the Americas, Oncology gross orders increased by 2 percent in dollars and 3 percent in constant currency with 7 percent growth in North America offsetting a decline in Latin America. In EMEA, gross orders were up 19 percent in dollars and up 23 percent in constant currency. In APAC, gross orders rose 2 percent in dollars and 3 percent in constant currency, driven by robust growth in China.

"Oncology generated gross order growth with strategic wins in all three geographies," Wilson said. "Orders rose with the help of an expanding number of treatment rooms in China and India and demand for new products, including our VitalBeam accelerator, as well as our InSightive Analytics and RapidPlan software. Overall, we saw healthy global oncology demand during the quarter."

Imaging Components

Imaging Components revenues were $144 million for the second quarter, down 8 percent from the year-ago period. Gross orders were $138 million for the second quarter, down 12 percent from the year-ago period.

"The Imaging Components business continued to experience lower shipments of flat panels and tubes during the quarter," said Wilson. "Meanwhile, our new MeVis and Claymount businesses performed well in the quarter."

Other

The company’s Other category, including the Varian Particle Therapy business and the Ginzton Technology Center, recorded second quarter revenues of $31 million, up $16 million from the year-ago quarter. "We are continuing to build momentum in this business with growing interest in our single-room ProBeam Compact proton therapy system," Wilson said.

Outlook

"Including the results of the second quarter, we continue to believe that total company non-GAAP earnings will be in the range of $4.55 to $4.65 per diluted share for fiscal year 2016," said Wilson. "With expectations of a slower than anticipated recovery in our Imaging Components business due to high inventory levels at a major customer, we now believe revenues for fiscal year 2016 will increase by about 3 percent over fiscal year 2015.

"For the third quarter of fiscal year 2016, we expect non-GAAP earnings to be in the range of $1.16 to $1.20 per diluted share. We expect third quarter revenues to be about equal to the year-ago period with growth in our core businesses offset by a decline in our proton business versus the year-ago quarter when we booked the big University of Maryland project."

Please refer to "Discussion of Non-GAAP Financial Measures" below for a description of items excluded from expected non-GAAP earnings.

On April 27, 2016 Varian Medical Systems (NYSE: VAR), reported that its 3D volumetric imaging technology is now being used at a California proton therapy center to enhance the precision and quality of its treatments for cancer patients (Press release, Varian Medical Systems, APR 27, 2016, View Source [SID:1234511483]). The treatments with image-guided intensity modulated proton therapy (IMPT) are being delivered on Varian’s ProBeam system at Scripps Proton Therapy Center in San Diego.

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3D volumetric image-guided IMPT is enabled by Varian’s cone beam computed tomography (CBCT) technology and supports adaptive treatment planning and delivery wherein clinicians can revise plans based on what they see in images during the course of treatment. Volumetric imaging is particularly important for proton radiosurgery, an ultra-precise form of treatment. ProBeam cone beam imaging is based on the same leading technology used in Varian’s radiation oncology systems including the TrueBeam platform.

The unique combination of 3D volumetric imaging with controlled pencil beam scanning makes it possible to conform dose to the size, shape and location of the tumor while potentially reducing side effects. With proton therapy, the risk of damage to healthy tissues and potential side effects are reduced because proton beams can be controlled so that they deposit their energy within the tumor site rather than passing all the way through the patient.

"Volumetric imaging is enormously beneficial, because IMPT is very sensitive to anatomic changes," said Dr. Lei Dong, chief of Medical Physics, Scripps Proton Therapy Center. "For the optimum treatment we need to know of any changes, not only to the target, but also the anatomy outside of the target. The cone beam imaging on the Varian ProBeam System is excellent and stays true to the same high quality that I’ve seen on their photon systems."

"This is an important milestone for Varian where we are bringing the most advanced 3D imaging capability to the ProBeam system for proton therapy patients," said Dr. Moataz Karmalawy, general manager of Varian’s Particle Therapy division. "This should enable clinicians to deliver proton radiosurgery that will allow precise treatments for cancer patients to be completed in fewer sessions. It should be a win for everybody."

For more information on Varian’s proton therapy solutions, visit View Source

On April 27, 2016 Swedish Orphan Biovitrum AB (publ) (Sobi(TM)) reported its 2015 Annual Report, themed "A new chapter of our story" (Press release, Swedish Orphan Biovitrum, APR 27, 2016, View Source;Media/News/RSS/?RSS=View Source [SID:1234511482]). The integrated report summarises the business as well as financial highlights for 2015, and gives a deeper insight into the company’s strategic agenda and its patient-centric innovation model.

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The 2015 Annual Report is available both in print and as an interactive online version, in responsive design to enable viewing on all mobile devices. New features in the online version include pdf and excel downloads of the report and the financial results as well as video comments from CEO Geoffrey McDonough and stakeholders.

CEO and President Geoffrey McDonough wrote in his letter to the shareholders, "We believe that the culture of pioneering in the service of patients with rare diseases requires a small, agile, and human scale organisation that can stay responsive to the changing landscape of patient needs, science and society. We began our transition five years ago and over this period Sobi’s market capitalisation has increased more than sevenfold."

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To read the digital version of the report please follow this link.
To read or download the annual report in Swedish, please follow this link.
To read or download the annual report in English, please follow this link.
To order a printed copy, please send an email to [email protected].

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/.

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.