On October 26, 2016 Varian Medical Systems (NYSE:VAR) reported GAAP net earnings of $1.24 per diluted share and non-GAAP net earnings of $1.38 per diluted share for the fourth quarter of fiscal year 2016 (Filing, Q3, Varian Medical Systems, 2016, OCT 26, 2016, View Source [SID1234516023]). For the full fiscal year 2016, GAAP net earnings were $4.19 per diluted share, and non-GAAP net earnings were $4.68 per diluted share. Varian’s revenues totaled $912 million for the fourth quarter of fiscal year 2016, up 12 percent in dollars from the year-ago quarter and up 11 percent in constant currency. Varian’s revenues for the full fiscal year were $3.2 billion, up 4 percent in dollars versus fiscal year 2015 and up 5 percent in constant currency. The company ended the fourth quarter with a $3.5 billion backlog, down 1 percent from the end of fiscal year 2015 with a gain in Oncology business offset by declines in the Particle Therapy and Imaging Components backlogs.

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"The company finished the year on a strong note with solid growth in revenues and margins for both of its major businesses," said Dow R. Wilson, CEO of Varian Medical Systems. "For the fourth quarter, total company gross margin increased by nearly four percentage points over the year-ago quarter. Weak oncology orders in EMEA, where we had tough year-ago comparisons, offset gross order growth in the Americas and in Asia."

The company finished the fiscal year with $844 million in cash and cash equivalents and
$667 million of debt. Cash flow from operations was $152 million for the fourth quarter and $356 million for the fiscal year. During the quarter, the company spent $87 million to repurchase about 1 million shares of common stock.

Oncology Systems
Oncology Systems’ fourth quarter revenues totaled $678 million, up 7 percent in dollars from the same quarter of fiscal year 2015 and up 6 percent in constant currency. Annual revenues were $2.5 billion, up 5 percent in dollars from the prior fiscal year and up 6 percent in constant currency.

Fourth-quarter gross orders were $897 million, down 2 percent in dollars from the year-ago quarter and down 4 percent in constant currency. For the full fiscal year 2016, Oncology gross orders were $2.7 billion, up 1 percent in dollars and up 2 percent in constant currency. Oncology gross orders in the Americas rose 4 percent in dollars and increased 3 percent in constant currency for the fourth quarter. For fiscal year 2016, Americas gross orders rose 4 percent both in dollars and constant currency. Gross orders in Asia rose 8 percent in dollars and fell 1 percent in constant currency in the fourth quarter. For the fiscal year 2016, gross orders in Asia rose 5 percent in dollars and 3 percent in constant currency. Gross orders in EMEA fell 17 percent in both dollars and constant currency for the quarter. For the fiscal year, Oncology gross orders in EMEA fell 6 percent in dollars and 4 percent in constant currency.

"Oncology Systems generated healthy revenue growth, and strong gains in both its gross and operating margins with a favorable product mix and a sharp focus on product cost initiatives during the quarter," said Wilson. "We saw respectable gross orders growth in the Americas and in emerging markets during the quarter while facing challenging conditions in Western Europe where we had record-setting growth in the year ago period. Gross orders in North America were down 2 percent in the quarter but up 5 percent for the full fiscal year."

Imaging Components
Imaging Components revenues were $166 million for the fourth quarter, up 7 percent from the year-ago period, and $598 million for the fiscal year, down 2 percent from fiscal year 2015. Gross orders totaled $168 million for the fourth quarter, up 2 percent from the year-ago period, and totaled $571 million for the fiscal year, down 6 percent from fiscal year 2015.

"Our Imaging Components business continued to strengthen in the second half of the fiscal year with ongoing revenue growth driven in part by recent acquisitions and with solid improvements in its gross and operating margins," said Wilson. "This business has successfully weathered some severe challenges in the first half of the year and finished a fiscal year highlighted by two consecutive quarters of strong revenue growth and favorable product mix as well as several key new product introductions."

Varian intends to establish the Imaging Components business as a new, independent publicly-traded company, Varex Imaging Corporation, through a tax-free spin.

Other
The company’s Other category, including the Varian Particle Therapy business and the Ginzton Technology Center, recorded fourth quarter revenues of $68 million, up $38 million from the prior year period. Revenues for fiscal year 2016 were $163 million, up 13 percent from fiscal year 2015. During the quarter, the Particle Therapy business booked its first order for its Compact single room system. However, proton system gross orders were down from the prior year quarter and prior fiscal year when the company booked an unusually high number of orders. "While gross orders remain lumpy and timing is difficult to forecast, the sales funnel remains strong," said Wilson.

Outlook
"We believe that for the first quarter of fiscal year 2017, non-GAAP earnings for the total company, including the Imaging Components business and ramp-up costs for its separation, will be in the range of $1.03 to $1.07 per diluted share and revenues will increase by about 1 to 2 percent," said Wilson. "As we announced earlier, we will not give earnings guidance for the full fiscal year until after we have completed the separation of the Imaging Components business. For the full fiscal year 2017, we expect that Varian revenues, excluding the Imaging Components business, will rise by 3 to 4 percent. We expect that Imaging Components revenues for the full fiscal year 2017 will also rise by 3 to 4 percent."

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

On October 26, 2016 Active Biotech AB (NASDAQ OMX NORDIC: ACTI) and NeoTX Therapeutics Ltd. reported that they have entered into a licensing agreementfor Active Biotech’s investigational compound Naptomumab estafenatox ("ANYARA") for cancer immunotherapy (Press release, Active Biotech, OCT 26, 2016, View Source [SID1234523671]). NeoTX will be responsible for the worldwide clinical development and commercialization of the drug.This partnership is a key milestone in NeoTX’s strategy to bring tumor recognition enhancing therapeutics to the market.

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"We are very enthusiastic about our collaboration with Active Biotech. At NeoTX, we are strongly committed to developing innovative immunotherapies for unmet medical needs. "Active Biotech brings to our collaboration outstanding scientific and intellectual capital, and a powerful commitment to positively impact the treatment of cancer," said Asher Nathan, Chief Executive Officer of NeoTX.

Dr. Marcel Rozencweig, Chief Medical Officer of NeoTX and former Head of Global Clinical Oncology Research at BMS said "We are looking forward to developing ANYARA for immuno-oncology applications. We believe that the ANYARA technology is well suited to increase tumor recognition by the immune system and has demonstrated synergistic activity in combination with checkpoint inhibitors in animal models. As such, ANYARA would be attractive in combination with checkpoint inhibitors whose efficacy can be limited by poor tumor recognition".

"We are excited about the partnership with NeoTX, who we consider as an ideal partner for ANYARA. This partnership constitutes the next step in the clinical development, as well as the commercialization strategy, for the project." said Tomas Leanderson, President & CEO of Active Biotech.

About the agreement
Under the terms of the agreement, Active Biotech grants NeoTX exclusive rights to develop and commercialize ANYARA worldwide in cancer indications. The total deal value amounts to $71 million and is contingent upon achievement of clinical, regulatory and commercial milestones whereof Active Biotech will receive $250 000 as an initial payment upon signing. In addition, NeoTX will pay Active Biotech progressive, double-digit royalties on its net sales.

About ANYARA
ANYARA is a TTS (Tumor Targeting Superantigen) compound that increases the ability of the immune system to recognize the tumor. Synergy has been reported in vivo with a combination of ANYARA and a checkpoint inhibitor in an experimental tumor model. Clinically, the development of ANYARA has primarily been focused on cancer indications with a high unmet medical need. Positive data was reported from clinical Phase I trials in lung cancer, renal cell cancer and pancreatic cancer, where ANYARA was studied both as a single agent (monotherapy) and in combination with an established tumor therapy – docetaxel (Taxotere) – in patients with advanced cancer. The results showed that ANYARA was well tolerated both as monotherapy and in combination with docetaxel, and increased tumor recognition by T cells.

A Phase 2/3 trial of ANYARA in combination with interferon alpha in renal cell cancer demonstrated acceptable safety but did not meet its primary efficacy endpoint in the ITT population. The upcoming clinical trial will be done in combination with drugs that inhibit checkpoint dampening of the immune system, a combination strategy in line with the mode of action of ANYARA and supported by preclinical data.

On October 25, 2016 Onxeo S.A. (Euronext Paris, Nasdaq Copenhagen: ONXEO), an innovative company specialized in the development of orphan oncology therapeutics, reported its consolidated financials for the period ending September 30, 2016 and provided an update on major milestones achieved during the third quarter of 2016 (Press release, Onxeo, OCT 25, 2016, View Source [SID1234516029]).

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"The third quarter of 2016 was particularly eventful and productive for Onxeo. We made remarkable progress in terms of advancing our three key portfolio products as well as on the business development front. We announced results from two important preclinical studies, the first of which reinforces the rationale for developing Livatag as a potential new therapeutic option for HCC. Regarding the Livatag "ReLive" study, we are well on track to finalize the recruitment of patients in the near term, allowing the release of preliminary results in mid-2017 as planned. Data from another preclinical study confirmed the potential benefits of using AsiDNATM in combination with PARP inhibitors such as olaparib. This summer, we signed an exclusive licensing agreement with Pint Pharma for Beleodaq in South America, further expanding our product’s commercial potential. Lastly, our successful capital increase executed at the end of the third quarter has enabled us to increase our cash runway and strengthen our institutional shareholder base, including a number of US-based, specialized investors. We are well-equipped to address the opportunities expected in the coming months, as we work to deliver innovative therapeutic options that patients critically need, while creating value for our shareholders," commented Judith Greciet, CEO of Onxeo.

Continued advancement on key assets

Comprehensive preclinical and clinical work strengthening the products’ potential
Onxeo has progressed in the development of its key compound, Livatag (doxorubicin nanoformulation in Phase III trial for treatment of hepatocellular carcinoma). With more than 90% of the patients randomized as of September 30, 2016, the company is on track to deliver the preliminary results of the ReLive Phase III clinical study in mid-2017, in line with its development plan.

In an effort to expand the application of Livatag into other indications, Onxeo has also announced the first outcomes of its Livatag preclinical program, demonstrating enhanced efficacy effect in combination with immunotherapy, which validates its broader strategy for the product. Data from two in vivo studies have also confirmed the increased exposure and preferential affinity for the liver, supporting Onxeo’s current ReLive Phase III study rationale.

Onxeo has also made significant progress on Beleodaq, its pan-HDAC inhibitor already approved for PTCL (peripheral T-cell lymphoma). The company has started an initiative to develop an oral formulation of the compound, which would give a clear competitive advantage as well as expand the product’s potential application to indications for which such an oral formulation is appropriate. This development is on track, with prototypes designed and improved bioavailibity shown in an animal pharmacokinetic study.

Moreover, the company recently signed a promising new collaboration with the Royal College of Surgeons in Ireland (RCSI) for a research program on Beleodaq conjugate molecules, to improve product lifetime and stability properties, ultimately aiming to generate new patent opportunities.

Active preparation for the clinical development of first-in-class product AsiDNATM
Since the AsiDNATM acquisition, the Company has undertaken significant efforts to optimize the manufacturing process in terms of cost and duration, and is on track to manufacture its first clinical batch by the end of 2016, allowing for the initiation of a Phase I trial planned for 2017, after appropriate regulatory toxicologic assay.

The Company’s first objective is to show AsiDNATM activity when administered via the IV route, which would dramatically expand the potential of this compound. In parallel, preclinical research demonstrating the synergistic effect of Onxeo’s signal-interfering DNA product candidate in combination with various PARP (PolyADP-Ribose Polymerase) inhibitors has been published, confirming the interest of AsiDNATM compared to PARP inhibitors alone and the interest of the combination of these two DNA repair inhibitors.

Solid progress in business development and intellectual property

In the third quarter, Onxeo has strengthened its AsiDNATM intellectual property portfolio in the US with a new patent valid until 2031, confirming the innovative nature of the science behind its signal-interfering DNA product.

The company was also actively engaged in key operational and business development initiatives and achieved an important business development milestone, signing an exclusive license agreement with Pint Pharma for the commercialization of Beleodaq (belinostat) for PTCL in seven major South American countries.

Q3 revenue growth

Revenues for the third quarter of 2016 amounted to €1.23 million compared to €1.1 million in the third quarter of 2015 (+8%).

– €0.8 million of recurring revenues corresponding to product supplies to commercial partners and royalties on partners’ sales

– €0.4 million of non-recurring revenues, relating to the recognition under IFRS of upfront payments on certain licensing agreements

Over the first 9 months of the year, total revenues stood at €3.1 million, out of which €2.6 million were recurring revenues vs. €2.0 million in 2015 (+30%).

Long-term visibility reinforced with a successful €12.5 million capital increase

In early October, Onxeo successfully completed a capital increase of 5,434,783 new ordinary shares, raising gross proceeds of €12.5 million in a Private Placement. This capital increase strengthens and diversifies Onxeo’s shareholder base with the addition of prominent US-based healthcare institutional investors.

Proceeds from the capital increase, received on October 5, add to the €22.4 million consolidated cash balance at the end of September 2016, which extends Onxeo’s cash runway until Q2 2018. This capital will allow the company to pursue and accelerate the ongoing development of its pipeline assets, including the AsiDNATM and Livatag programs, as well as advance key preclinical programs, such as the combination therapy studies for AsiDNATM, Livatag, and Beleodaq.

Key near- and mid-term milestones

Livatag:
– Preclinical combination plan

– Next DSMB for Phase III trial: Q4 2016

– Preliminary Phase III trial results: expected mid-2017

AsiDNATM:
– Phase I initiation (monotherapy systemic) now expected in 2017, based on current CMC progress

Beleodaq:
– New oral formulation validated, ready to enter clinic: Q3 2017

– Preclinical combination study results: end of 2016 and onwards

– 1st-line PTCL Phase III initiation: end of 2016

On October 25, 2016 Baxter International Inc. (NYSE:BAX) reported results for the third quarter of 2016, and increased its earnings per share outlook for full-year 2016. Baxter’s third quarter worldwide sales totaled $2.6 billion, an increase of 3 percent on a reported basis and 4 percent on a constant currency basis as compared to the prior-year period (Press release, Baxter, OCT 25, 2016, View Source [SID1234515982]).

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"We are pleased with the continued strength across our core franchises as well as our improved financial performance, both of which are reflected in our third quarter results," said José (Joe) E. Almeida. "Given this progress, we are intensifying our focus on portfolio management and innovation to accelerate our efforts to introduce new products and therapies."

Financial Results

During the quarter, Baxter reported income from continuing operations of $127 million, or $0.23 per diluted share, on a GAAP (Generally Accepted Accounting Principles) basis. These results included net after-tax special items totaling $184 million, primarily related to business optimization initiatives, intangible asset amortization, debt extinguishment and Baxalta related spin-off costs.

On an adjusted basis, excluding special items, Baxter’s third quarter income from continuing operations totaled $311 million, or $0.56 per diluted share, exceeding the company’s previously-issued guidance of $0.43 to $0.45 per diluted share.

Baxter’s worldwide sales totaled $2.6 billion in the third quarter, an increase of 3 percent on a reported basis and 4 percent on a constant currency basis as compared to the prior-year period. Sales within the U.S. were $1.1 billion, advancing 6 percent, while international sales totaled $1.5 billion, representing a 1 percent increase on a reported basis, and an increase of 3 percent on a constant currency basis. Adjusting for the impact of foreign exchange, generic competition for cyclophosphamide, and 2015 PROTOPAM orders, Baxter’s sales increased 12 percent in the U.S. and rose 6 percent globally in the third quarter.

By business, Hospital Products sales of $1.6 billion in the third quarter increased 2 percent on a reported basis and 3 percent on a constant currency basis. Adjusting for the impact of foreign exchange, cyclophosphamide and PROTOPAM, Hospital Products sales advanced 7 percent from the prior-year period. Hospital Products performance in the quarter benefited from strong sales across the portfolio, driven by increased demand and favorable pricing in the U.S. for the company’s IV solutions, nutritional therapies, pharmacy injectables and IV access administration sets. Strength internationally in the company’s hospital pharmacy compounding services and cytotoxic contract manufacturing business also contributed to growth in the quarter.

Baxter’s Renal sales totaled $977 million in the third quarter, representing a 4 percent increase on a reported basis, and a 6 percent increase on a constant currency basis. Growth was driven by strong sales of peritoneal dialysis products as well as increased demand globally for continuous renal replacement therapies. Contributing to growth in the quarter were the recent launches of Baxter’s new Automated Peritoneal Dialysis (APD) systems, AMIA in the U.S. and HOMECHOICE CLARIA outside the U.S. Both of these systems utilize Baxter’s SHARESOURCE Connectivity Platform, which is the first and only two-way, remote patient management system for home dialysis therapy globally.

Financial Outlook

Based on the company’s strong performance in the first three quarters of the year, Baxter is raising its financial outlook for full-year 2016 including sales growth of approximately 2 percent on a reported basis or 4 percent on a constant currency basis, and earnings from continuing operations, before special items, of $1.88 to $1.91 per diluted share for the full year. Previous guidance called for reported sales of 1 to 2 percent (or 3 to 4 percent constant currency) and earnings of $1.69 to $1.74 per diluted share.

For the fourth quarter, the company expects sales growth of approximately 2 percent on both a reported and constant currency basis. Baxter expects earnings from continuing operations, before special items, of $0.49 to $0.52 per diluted share for the fourth quarter of 2016.

The earnings per share guidance for the fourth quarter and full-year 2016 excludes $0.05 and $0.22, respectively, per diluted share of intangible asset amortization expense; an estimated $0.01 and $0.07, respectively, per diluted share of Baxalta separation-related expense activities; an estimated $0.07 and $0.51, respectively, per diluted share of business optimization charges; and $7.84 per diluted share of asset impairment, debt extinguishment loss, product related reserve adjustments, and Baxalta retained stake gains for full-year 2016. These estimates are based on information reasonably available at the time of this release and future events or new information may result in different actual results. Reconciling for the inclusion of these items results in GAAP earnings of $0.36 to $0.39 per diluted share for the fourth quarter of 2016, and $8.92 to $8.95 per diluted share for full-year 2016.

A webcast of Baxter’s third quarter conference call for investors can be accessed live from a link on the company’s website at www.baxter.com beginning at 7:30 a.m. CDT on October 25, 2016.
Please see www.baxter.com for more information regarding this and future investor events and webcasts.

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

A Single Arm, Open-Label, Multi-Centre, Phase I/II Study Evaluating the Safety and Clinical Activity of AUTO2, a CAR T Cell Treatment Targeting BCMA and TACI, in Patients with Relapsed or Refractory Multiple Myeloma

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