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20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

(Filing, Annual, Novartis, 2016, JAN 25, 2017, View Source [SID1234517556])

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Integra LifeSciences Commences Previously Announced Cash Tender Offer to Acquire Derma Sciences, Inc.

On January 25, 2017 Integra LifeSciences Holdings Corporation ("Integra") (NASDAQ:IART), a global leader in medical technology, reported that its wholly-owned subsidiary, Integra Derma, Inc. ("Offeror"), is commencing a cash tender offer to purchase all outstanding common and preferred shares of Derma Sciences, Inc. ("Derma Sciences") (NASDAQ:DSCI) at an offer price of $7.00 per share for Derma Sciences’ common stock, $32.00 per share for Derma Sciences’ Series A Convertible Preferred Stock and $48.00 per share for Derma Sciences’ Series B Convertible Preferred Stock (Press release, Integra LifeSciences, JAN 25, 2017, View Source [SID1234517586]). The tender offer is being made pursuant to an Offer to Purchase, dated January 25, 2017 (the "Offer to Purchase"), and in connection with the Agreement and Plan of Merger, dated January 10, 2017, among Integra, Offeror and Derma Sciences (the "Merger Agreement"), which Integra and Derma Sciences previously announced on January 10, 2017.

The tender offer will expire at 12:00 midnight, New York City time, on Wednesday, February 22, 2017, unless the offer period is extended or earlier terminated in accordance with the terms of the Merger Agreement (such date and time, as it may be extended, the "Expiration Date"). Offeror is required to extend the offer period for any period required by applicable law or rules and regulations of the SEC and for one or more periods of up to ten business days each until, and including, July 15, 2017, if at the Expiration Date any of the conditions to the tender offer have not been satisfied.

There is no financing condition to the tender offer. The obligation of Offeror to pay for shares tendered pursuant to the tender offer is conditioned on the tender and acceptance of that number of shares that, together with the number of shares (if any) then owned by Integra, represents at least a majority of (i) the voting power of all outstanding common and preferred shares, voting together as a single class, (ii) the outstanding shares of Series A Convertible Preferred Stock and (iii) the outstanding shares of Series B Convertible Preferred Stock, as well as other customary conditions. Following the completion of the tender offer, Integra expects to consummate a second-step merger at the same per-share price paid in the tender offer for shares not purchased in the tender offer.

D.F. King & Co., Inc. is acting as information agent and Broadridge Corporate Issuer Solutions, Inc. is acting as depositary and paying agent in the tender offer. Requests for documents and questions regarding the tender offer may be directed to information agent by telephone at (800) 290-6424.

Varian Medical Systems Reports Results for First Quarter of Fiscal Year 2017

On January 25, 2017 Varian Medical Systems (NYSE:VAR) reported GAAP net earnings of $0.22 per diluted share and non-GAAP net earnings of $0.75 per diluted share for the first quarter of fiscal year 2017, including $76 million in charges almost exclusively relating to a proton facility owned by California Proton Treatment Center, LLC (CPTC) in San Diego (Press release, Varian Medical Systems, JAN 25, 2017, View Source [SID1234517559]). These charges and the associated limited tax deductibility reduced Varian earnings in the first quarter of fiscal 2017 by $0.64 per diluted share on a GAAP basis or $0.34 per diluted share on a non-GAAP basis.

Varian’s first quarter revenues totaled $763 million, up 1 percent from the year-ago quarter in dollars and constant currency. The company ended the quarter with a $3.4 billion backlog, up 2 percent from the end of the first quarter of fiscal year 2016.

"Varian generated strong global order growth and margin gains in our oncology business as well as sales momentum in the imaging components business while recording an impairment of CPTC’s indebtedness to Varian," said Dow Wilson, CEO of Varian Medical Systems. "We remain on track with our previously announced plans to separate and establish the imaging components business as a new public company, Varex Imaging, at the end of this month."

Varian took a $76 million charge in the first quarter in response to certain actions in January by CPTC and its loan agent, ORIX Capital Markets, to address liquidity issues caused by lower than expected patient volumes that are insufficient to support CPTC’s capital structure. This led Varian to reserve $38 million in accounts receivable and to impair $38 million of its $98 million loan to CPTC, of which $29 million was accrued interest. The company is reporting additional information on this matter today in a Form 8-K filing with the Securities and Exchange Commission.

"We believe this center can get on a more solid financial footing by serving a broader patient population with additional healthcare providers locally and regionally," Wilson said. "We remain confident and committed to supporting all of our customers and to building a profitable proton business based on leading technology that is treating patients and performing at a high level. We are continuing to make good progress on 13 other installations and the sales funnel continues to look promising." The company’s Particle Therapy business, recorded first quarter revenues of $30 million.

Varian finished its first quarter of fiscal year 2017 with $815 million in cash and cash equivalents and $607 million of debt. Cash flow from operations was $82 million for the first quarter. During the quarter, the company spent $49 million to repurchase 500,000 shares of common stock.

Oncology Systems
Oncology Systems’ first quarter revenues totaled $581 million, down from the year-ago quarter by 1 percent in dollars and by 2 percent in constant currency. First-quarter Oncology gross orders were $586 million, up from the year-ago quarter by 10 percent in dollars and constant currency. In the Americas, Oncology gross orders increased by 5 percent in dollars and in constant currency, including 7 percent growth in North America. In EMEA, gross orders were up 8 percent in dollars and up 10 percent in constant currency. In APAC, gross orders rose 29 percent in dollars and by 24 percent in constant currency.

"Broad-based demand for new equipment as well as software and services drove the strong gross order growth in our Oncology business during the quarter," Wilson said. "Revenues declined versus a strong year-ago quarter due primarily to the timing of deliveries, but this business did a spectacular job of improving margins with the help of product mix, stable pricing and product cost reductions."

Imaging Components
First quarter revenues from Varian’s Imaging Components business were $152 million, up 7 percent from the year-ago period, and first quarter gross orders for this business were $132 million, up 4 percent from the year-ago period.

"Revenues from Imaging Components rose with gains in both the medical and industrial segments," said Varian Imaging Components President Sunny Sanyal, who will become CEO of Varex Imaging. "With our first quarter performance as well as our previously announced plan to acquire the Medical Imaging business of PerkinElmer this fiscal year, our business is on track to separate from Varian with solid momentum in orders and sales."

Varian Outlook
"Beginning with our fiscal second quarter, Imaging Components will be reflected as a discontinued operation for the first four months of fiscal year 2017," said Wilson. "The company is guiding for continuing operations for the second through the fourth quarters of the fiscal year 2017. For the balance of fiscal year 2017, we believe Varian revenues from continuing operations will grow in the range of 4 to 5 percent, bringing revenue growth for the year to 3 to 4 percent. Non-GAAP earnings per diluted share from continuing operations for the second through fourth quarters of the fiscal year will be in the range of $2.94 to $3.06."

"For the second quarter, we believe Varian revenues from continuing operations will grow in the range of 4 to 5 percent and non-GAAP earnings per diluted share will be in the range of $0.84 to $0.90," Wilson added. The company intends to repurchase 2 million shares of stock in its second quarter of fiscal year 2017. Varian will publish a historical annual breakdown of continuing and discontinued operations for fiscal years 2014-2016 on our website filing shortly following the separation. Separately, the company will make available quarterly pre-tax results for fiscal year 2016.

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

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Varian Medical Systems Reports Results for First Quarter of Fiscal Year 2017

New Published Research Reveals that Cervical Cancer Mortality Rates May Be Significantly Higher in the United States than Previously Reported

On January 25, 2017 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, reported research published in the journal Cancer which underscores the need for more access to screenings, improved clinical care and new therapeutic options for all women with cervical cancer (Press release, Advaxis, JAN 25, 2017, View Source [SID1234517558]).

These important research findings were covered by leading news outlets including The New York Times and CNN, as these data indicate that mortality rates of this deadly form of cancer are significantly higher in the United States than previously reported due to the inclusion of women who have had hysterectomies, highlighting racial and socioeconomic disparities. According to the research, the data revealed a U.S. cervical cancer mortality rate among women without hysterectomies of 10.1 per 100,000 black women and 4.7 per 100,000 white women, up from mortality rates of 5.7 and 3.2, respectively, which were previously reported in research among all women, including those who have had hysterectomies.

The publication of these data coincides with Cervical Health Awareness Month, a national effort designed to promote the need for cervical health education and screenings, which can lead to early detection of cervical cancer when therapies may be most effective.

Advaxis is the only biopharmaceutical company sponsoring global, phase 3 clinical research for advance stage cervical cancer. Last year, the company initiated its Phase 3 AIM2CERV (Advaxis IMmunotherapy 2 prevent CERVical recurrence) trial in high-risk, locally advanced cervical cancer (HRLACC). The company also announced positive, top-line data from the GOG-0265 Phase 2 trial that supports pursuing a global phase 3 study in metastatic recurrent cervical cancer.

"This research highlights disparities in outcomes in the cervical cancer community and underscores the need to work together with policy-makers, providers, academic institutions and the biopharmaceutical industry to raise awareness among minority groups about current treatment options and bring new treatment options forward," said Tamika Felder, Founder of Cervivor. "In doing so, hopefully we can close this gap."

Invasive cervical cancer occurs in women who have been infected by the human papillomavirus (HPV) and is the most common HPV-associated cancer in women. According to the American Cancer Society, approximately 12,000 women in the United States will be diagnosed with cervical cancer in 2017. While vaccines to prevent HPV infection may help prevent cervical cancer if given before exposure, only one-third of the U.S. population has been vaccinated against the virus and the vaccination rate is lower worldwide, which is the main cause of the nearly 500,000 new cases diagnosed each year. Cervical cancer largely affects women who have not received preventative vaccines or regular screenings.

Biota Pharmaceuticals, Inc. Announces Name Change to Aviragen Therapeutics, Inc. (NASDAQ: AVIR)

On April 12, 2016 Biota Pharmaceuticals, Inc. (NASDAQ:BOTA) reported that the Company has changed its name to Aviragen Therapeutics, Inc., ("Aviragen Therapeutics"), a pharmaceutical company focused on the development of the next generation of direct-acting antivirals that address infections that have limited therapeutic options (Press release, Aviragen Therapeutics, JAN 25, 2017, View Source [SID1234517553]).

"A meaningful transformation has taken place over the last two years as we transitioned from a drug discovery and early-stage licensing organization to one focused on drug development and progressing key late-stage product candidates in important viral diseases. Our name change reflects this transition and better defines our strategic initiatives moving forward," said Joseph Patti, PhD, President and Chief Executive Officer of Aviragen Therapeutics. "Specifically, our recent initiation of a Phase 2a efficacy study of BTA585 for the treatment of RSV infections highlights our focus on bringing new medicines to treat and prevent viral infections with limited therapeutics options. As Aviragen Therapeutics, we will continue to advance and expand our promising pipeline of anti-viral drugs."

The name change become effective on April 11, 2016 and the Company’s common stock will begin trading on the NASDAQ Stock Exchange under the new ticker symbol "AVIR" on April 13, 2016.