Can Fite Reports on the Progress of its Phase II NASH Study with Drug Candidate Namodenoson

On February 28, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported an update on its Phase II clinical trial with drug candidate Namodenoson (CF102) in the treatment of NAFLD/NASH (Press release, Can-Fite BioPharma, FEB 28, 2018, View Source [SID1234524224]).

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The current Phase II study is being conducted in three Israeli sites including Hadassah Medical Center, Jerusalem and the Rabin Medical Center, Petach Tikva. Patients who suffer from NAFLD/NASH with evidence of active inflammation are treated twice daily with 12.5 or 25 mg of oral Namodenoson vs. placebo. The primary end point of the Phase II study is the anti-inflammatory effect of the drug, as determined by ALT blood levels, and the secondary end points include percentage of liver fat, as measured by MRI-PDFF (proton density fat fraction). The company anticipates the completion of patient enrollment toward the end of 2018 and data release in the first half of 2019.

Recent safety data showed that Namodenoson has a favorable profile and lack of hepatotoxicity in patients. Preclinical data demonstrate robust anti-inflammatory, anti-fibrogenic and anti-steatotic effects, supporting its development for the NAFLD/NASH indication.

Can-Fite CEO Dr. Pnina Fishman commented, "We are pleased with the progress so far in our clinical trial with Namodenoson for the treatment of NAFLD/NASH, and we look forward to data release later in H1/2019."

There is currently no U.S. FDA approved drug for the treatment of NASH, which is an addressable pharmaceutical market estimated to reach $35-40 billion by 2025.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

Bayer: business at prior-year level – on track with strategy

On February 28, 2018 Bayer reported group sales increased by 1.5 percent (Fx & portfolio adj.) to 35.015 billion euros (Press release, Bayer, FEB 28, 2018, View Source;parent=news-overview-category-search-en&ccm=001&presskit=1 [SID1234524316]).

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In 2017, Bayer’s operational business was at the prior-year level. The company made good progress strategically. "We took major steps toward the proposed acquisition of Monsanto," Management Board Chairman Werner Baumann said on Wednesday at the Financial News Conference in Leverkusen. Pharmaceuticals achieved another record year in business operations. Sales and earnings declined at both Consumer Health and Crop Science – in the latter case, however, this development was attributable to the difficult situation in Brazil. Animal Health posted an increase in sales and earnings. "We remain focused on our objectives and are convinced of our long-term perspective. We therefore have every reason to look to the future with optimism," said Baumann.

Bayer received further approvals last year for the proposed acquisition of Monsanto. "Only recently, the Brazilian antitrust authorities gave the green light. That is an important milestone on the road to closing this transaction. After all, Brazil is one of the world’s most important agricultural markets," Baumann said. Overall, more than half of the around 30 authorities worldwide have now approved the acquisition. Although Bayer is continuing to cooperate closely with the institutions involved, it is becoming evident that the examination procedures will require more time. "Our goal now is to be able to close the transaction in the second quarter of 2018," Baumann explained. "This does not affect our expectation of a successful conclusion to the regulatory review, nor our conviction that this is the right step."

Of importance last year in connection with the proposed acquisition of Monsanto and the associated merger control proceedings was the contractual agreement to sell certain Crop Science businesses to BASF. "We have now also committed to divest our entire vegetable seed business. Certain additional business activities of Bayer and Monsanto may also be sold or out-licensed," Baumann said. Thus Bayer is actively addressing observations expressed by antitrust authorities. Any sales and licenses would be subject to a successful closing of the proposed acquisition of Monsanto, which remains subject to customary closing conditions, including receipt of required regulatory approvals.

According to Baumann, the company last year took a big step toward its goal of achieving full separation from Covestro in the medium term by selling approximately 36 percent of the interest in that company for 4.7 billion euros. Bayer ceded de facto control of Covestro and deconsolidated the company at the end of September. Bayer’s direct interest in Covestro currently amounts to 14.2 percent. Another 8.9 percent is held by Bayer Pension Trust.

"Operationally, 2017 was a year of ups and downs," said the Bayer CEO. Sales of the Bayer Group rose by 1.5 percent on a currency- and portfolio-adjusted basis (Fx & portfolio adj.) (reported: 0.2 percent) to 35.015 billion euros. At 9.288 billion euros, EBITDA before special items was level with the previous year despite negative currency effects. EBIT rose by 2.9 percent to 5.903 billion euros after special charges of 1.227 billion euros (2016: 1.088 billion euros). The special charges comprised mainly impairment losses on intangible assets, expenses in connection with the proposed acquisition of Monsanto and efficiency improvement programs, and provisions for litigations and legal risks. EBIT before special items increased by 4.5 percent to 7.130 billion euros. Net income increased by 61.9 percent to 7.336 billion euros and core earnings per share from continuing operations by 1.0 percent to 6.74 euros.

Operating cash flow from continuing operations climbed by 2.7 percent to 6.611 billion euros. "We are pleased that we were able to substantially reduce our net financial debt in 2017," said Chief Financial Officer Johannes Dietsch. Net financial debt declined by 69.5 percent to 3.595 billion euros. There were cash inflows from operating activities and from the sale of Covestro shares. "We are therefore in a good position for the pending financing activities connected with the proposed acquisition of Monsanto," said Dietsch.

Pharmaceuticals: Earnings growth stronger than sales increase

Sales of prescription medicines (Pharmaceuticals) increased by 4.3 percent (Fx & portfolio adj.) to 16.847 billion euros – a new record. "The success of the division was once again driven by our key growth products," said Baumann. Total sales of the anticoagulant Xarelto, the eye medicine Eylea, the cancer drugs Stivarga and Xofigo and the pulmonary hypertension treatment Adempas advanced by 16.3 percent (Fx adj.) to 6.196 billion euros. The development in sales of Xofigo was particularly strong at 25.6 percent (Fx adj.), due mainly to its market launch in Japan in 2016 and to higher demand in the United States. Business with Xarelto expanded by 13.9 percent (Fx adj.), primarily on account of higher volumes in Europe, Japan and China. Bayer also posted gains for its license revenues – recognized as sales – in the United States, where Xarelto is marketed by a subsidiary of Johnson & Johnson. Sales of Eylea climbed by 18.5 percent (Fx adj.), due especially to expanded volumes in Europe, Canada and Japan.

Among the other leading pharmaceutical products, the hormone-releasing intrauterine devices of the Mirena product family posted sales growth of 9.2 percent (Fx adj.), benefiting from higher volumes of the low-dose intrauterine device Kyleena, particularly in the United States and Europe. Marked sales gains were also achieved with Aspirin Cardio for the secondary prevention of heart attacks (Fx adj. 10.5 percent) and the diabetes treatment Glucobay (Fx adj. 13.0 percent), mainly as a result of a continued positive business performance in China. Sales of the Kogenate/Kovaltry blood-clotting medicines were down by 15.9 percent (Fx adj.) due to lower order volumes being placed for the active ingredient by a distribution partner ahead of the planned contract termination at the end of the year. Adjusted for this development, sales of this product were at the prior-year level.

EBITDA before special items of Pharmaceuticals increased by 8.8 percent to 5.711 billion euros. Growth was mainly driven by higher volumes. By contrast, negative currency effects diminished earnings by 98 million euros.

Sales and earnings of Consumer Health down

Sales of self-care products (Consumer Health) declined by 1.7 percent (Fx and portfolio adj.) to 5.862 billion euros. "This was due to persistently weak business development in the United States," said Baumann. Furthermore, the Chinese authorities unexpectedly changed the legal status of two of Bayer’s medicated skincare brands from OTC to prescription, which led to sales declines in the fourth quarter of 2017. By contrast, business expanded slightly in Europe/Middle East/Africa, while sales in Latin America came in at the prior-year level (Fx adj.).

Business with the Bepanthen / Bepanthol wound and skin care products expanded by 6.6 percent (Fx adj.), with gratifying sales gains particularly in Europe/Middle East/Africa, and especially in Germany. Sales of the Canesten skin and intimate health products grew by 3.5 percent (Fx adj.), in a development that was mainly attributable to a positive business performance in China and the United Kingdom. There was a substantial 7.9 percent (Fx adj.) decline in sales of the analgesic Aleve, which had benefited in 2016 from a product line extension and faced intense competition in the United States in 2017.

EBITDA before special items of Consumer Health declined by 12.8 percent to 1.231 billion euros. This was largely due to lower volumes, in part as a consequence of the reverse switch in China and the associated EBITDA effect of around 50 million euros. Earnings were also held back by a higher cost of goods sold, primarily as a result of inventory impairments, as well as by currency effects of 25 million euros and higher selling expenses. Positive contributions came from one-time gains, including particularly 80 million euros from the divestment of noncore brands.

Crop Science held back by situation in Brazil

Sales in the agriculture business (Crop Science) moved back by 2.2 percent (Fx & portfolio adj.) to 9.577 billion euros. This was mainly due to the situation in the Brazilian crop protection business, where volumes were held back by unexpectedly high inventories in the market. "We have initiated a number of measures to normalize this situation. For example, we took back crop protection products from our distribution partners and concluded new agreements at amended terms," said Baumann. "We are now seeing that these measures are taking effect." When the Brazilian business is excluded, sales of Crop Science rose by 3.0 percent (Fx & portfolio adj.). Sales declined by 18.0 percent (Fx adj.) in Latin America but grew strongest, by 5.8 percent (Fx adj.), in North America, followed by Asia/Pacific and Europe/Middle East/Africa.

The Seeds business (seed and plant traits) posted positive development, with sales gains of 9.1 percent (Fx & portfolio adj.). Environmental Science, the business with products for nonagricultural applications, saw sales increase by an even more substantial 14.0 percent (Fx & portfolio adj.). By contrast, there was a decline of 5.3 percent (Fx & portfolio adj.) at Crop Protection. Fungicides (Fx & portfolio adj.: minus 9.9 percent) and Insecticides (Fx & portfolio adj.: minus 6.1 percent) saw disproportionate declines in sales – unlike Herbicides and SeedGrowth (seed treatment products), where the declines were much less marked at 1.6 and 0.3 percent (Fx & portfolio adj.), respectively.

EBITDA before special items of Crop Science declined by 15.6 percent to 2.043 billion euros. This decline is largely attributable to the situation in Brazil, which resulted in lower selling prices and volumes. Negative currency effects of 63 million euros were an additional factor.

Animal Health posts gains in Asia/Pacific and North America

Sales of Animal Health increased by 2.0 percent (Fx and portfolio adj.) to 1.571 billion euros. Business in the Asia/Pacific region developed especially positively due to higher demand and price increases. Sales also grew in North America. The Seresto flea and tick collar posted continued strong growth of 25.1 percent (Fx adj.). Sales of the Advantage family of flea, tick and worm control products decreased by 7.8 percent (Fx adj.) year on year. EBITDA before special items rose by 9.2 percent to 381 million euros. Price increases, the Cydectin business acquired by Bayer in January 2017 and lower selling expenses had a positive impact on earnings.

Core earnings per share increased in the fourth quarter of 2017

Sales of the Bayer Group in the fourth quarter of 2017 rose by 2.7 percent (Fx & portfolio adj.), to 8.596 billion euros. EBITDA before special items declined by 1.3 percent to 1.783 billion euros. By contrast, EBIT climbed by 6.7 percent to 625 million euros. Net income fell by 67.3 percent to 148 million euros. This included a negative special effect of 455 million euros that relates to the tax reform in the United States. By contrast, core earnings per share from continuing operations improved by 28.2 percent to 1.41 euros.

Sales and earnings in 2018 expected to be at the prior-year level despite currency losses

Based on the exchange rates as of December 31, 2017, Bayer expects sales of around 35 billion euros for 2018. Sales, EBITDA before special items and core earnings per share are expected to be at the prior-year level. On a currency- and portfolio-adjusted basis, Bayer expects sales to increase by a low- to mid-single-digit percentage, while EBITDA before special items and core earnings per share from continuing operations are each predicted to grow by a mid-single-digit percentage after adjusting for currency effects. The forecast takes into account temporary supply interruptions due to remediation measures in production. Bayer expects the impact on adjusted EBITDA to be about 300 million euros. The largest proportion of this amount is related to the Pharmaceuticals Division and a minor part to the Consumer Health Division.

For Pharmaceuticals, Bayer plans to generate sales of more than 16.5 billion euros. This corresponds to a low-single-digit percentage increase on a currency- and portfolio-adjusted basis. The division aims to raise sales of the key growth products Xarelto, Eylea, Stivarga, Xofigo and Adempas toward 7 billion euros. Bayer expects EBITDA before special items to decline by a low-single-digit percentage (Fx adj.: increase by a low-single-digit percentage) and anticipates a slight decline in the EBITDA margin before special items.

At Consumer Health, Bayer expects sales of more than 5.5 billion euros, which would be at the prior-year level on a currency- and portfolio-adjusted basis. Bayer expects EBITDA before special items to decline by a low-single-digit percentage (Fx adj.: increase by a low-single-digit percentage).

For Crop Science, Bayer sees sales coming in at more than 9.5 billion euros. This corresponds to a mid-single-digit percentage increase on a currency- and portfolio-adjusted basis. Bayer expects to increase EBITDA before special items by a mid- to high-single-digit percentage (Fx adj.: mid-teens percentage increase).

At Animal Health, Bayer expects a currency- and portfolio-adjusted increase in sales by a low-single-digit percentage. The company expects EBITDA before special items to decline by a mid-single-digit percentage (Fx adj.: at the prior-year level). Both sales and EBITDA before special items are negatively impacted by revised financial reporting standards (IFRS 15).

Through the expected acquisition of Monsanto in the second quarter of 2018, Bayer anticipates a significant increase in sales and EBITDA before special items. Based on current assumptions about the equity and financing measures to be undertaken, Bayer expects a moderate decline in core earnings per share. For the first full year following the acquisition, Bayer continues to expect a significant increase in sales and EBITDA before special items, and an increase in core earnings per share.

argenx reports fourth quarter business update and full year 2017 financial results

On February 28, 2018 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported its fourth quarter business update and full year results for 2017 (Press release, argenx, FEB 28, 2018, View Source;p=RssLanding&cat=news&id=2335501 [SID1234524272]).

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The full year results will be discussed during a conference call and webcast presentation today at 3 pm CET/ 9 am EST. To participate in the conference call, please select your dial in number from the list included below, and use the confirmation code 6683242. The webcast may be accessed on the homepage of the argenx website at www.argenx.com or by clicking here.

"2017 was a year of tremendous momentum for argenx as we made progress on our pipeline and increased value for our shareholders. As a result of this focused execution, we believe we are well-positioned to advance our pipeline through several key clinical milestones in the year ahead," commented Tim Van Hauwermeiren, CEO of argenx. "In December, we announced positive clinical data from our Phase 2 trial of ARGX-113 for the treatment of generalized myasthenia gravis and plan to advance ARGX-113 to Phase 3 in this indication. This also marked the first dataset from our Phase 2 program aimed at evaluating the role of ARGX-113 in indications where the reduction of pathogenic autoantibodies may mediate disease. We continue to evaluate the asset in two additional Phase 2 indications, immune thrombocytopenia and pemphigus vulgaris, and expect to report data from both in the second half of 2018. We also advanced our lead oncology asset and reported interim data from our Phase 1/2 trial of ARGX-110 in acute myeloid leukemia, which we expect to transition into a Phase 2 trial this year. We feel that our achievements in 2017 have further validated our disciplined and differentiated approach to antibody development and look forward to providing updates on several important catalysts from our wholly-owned pipeline and strategic collaborations in 2018."

FOURTH QUARTER 2017 AND RECENT HIGHLIGHTS

Reported positive topline results from Phase 2 proof-of-concept trial of ARGX-113 (efgartigimod) in generalized myasthenia gravis (MG) showing a strong clinical improvement over placebo throughout the entire duration of the trial as well as a favorable tolerability profile consistent with Phase 1 data.
Launched Phase 1 trial with subcutaneous formulation of ARGX-113 evaluating pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability.
Presented updates on Phase 1/2 clinical trials of ARGX-110 in acute myeloid leukemia (AML) and cutaneous T-cell lymphoma (CTCL) during American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.
Raised approximately $266 million in gross proceeds in an upsized U.S. public offering.

FINANCIAL HIGHLIGHTS (as of December 31, 2017) (compared to financial highlights as of December 31, 2016)

Operating income of €41.3 million (December 31, 2016: €17.2 million).
Net loss of €28.1 million (December 31, 2016: €21.4 million).
Cash position of €359.8 million (cash, cash equivalents and current financial assets) allowing us to pursue development of our pipeline as planned.

DETAILS OF OPERATIONAL RESULTS

Products in Clinical Development:

ARGX-113 (efgartigimod)

Reported positive topline results from Phase 2 proof-of-concept trial of ARGX-113 in generalized MG. ARGX-113 treatment resulted in a strong clinical improvement over placebo as measured by all four predefined clinical efficacy scales throughout the entire duration of the study. Among ARGX-113 treated patients, 75% had a clinically meaningful and statistically significant improvement for a period of at least six consecutive study weeks versus 25% of patients on placebo. Primary endpoint analysis revealed ARGX-113 to be well-tolerated in all patients and consistent with Phase 1 data.
Nearing complete enrollment in the Phase 2 clinical trial of ARGX-113 in immune thrombocytopenia (ITP). Amended ITP trial protocol to extend the follow-up period from eight weeks to 21 weeks. In addition, a one-year open label extension study was added as a second amendment to allow (re)treatment of the ITP patients from the first study (dosed at 10 mg/kg).
Launched Phase 1 trial to evaluate the PK, PD, safety and tolerability of a subcutaneously administered formulation of ARGX-113 in healthy volunteers.

ARGX-110

Provided updates on Phase 1/2 clinical trials of ARGX-110 in AML and CTCL during ASH (Free ASH Whitepaper) Annual Meeting.
Data from the Phase 1/2 clinical trial of ARGX-110 in combination with azacitidine in six newly diagnosed AML patients unfit for intensive chemotherapy showed signs of clinical activity, including complete remission (3/6 patients), complete remission with incomplete blood count recovery (1/6 patients) and partial response (2/6 patients). One of the patients that achieved a complete remission bridged to allogeneic stem cell transplant after five cycles. The preliminary data from the first set of patients suggest ARGX-110 is active both at the circulating and bone marrow blast levels and at the leukemic stem cell level. The data showed a favorable tolerability profile with no exacerbation of azacitidine toxicity.
Amended Phase 1/2 AML trial protocol to add a 20mg/kg dose cohort to the dose escalation to best inform the recommended dose for a Phase 2 study.
Data from the Phase 1/2 clinical trial of ARGX-110 in relapsed/refractory CTCL patients. Of the 22 CTCL patients under analysis, we observed one complete response, two partial responses and 10 patients with stable disease. ARGX-110 was observed to have a favorable tolerability profile in these CTCL patients.

Collaborations

Bird Rock Bio, Inc. (BRB) and argenx have mutually agreed to terminate BRB’s license agreement to develop and commercialize ARGX-109 (gerilimzumab). Genor, a sublicensee of Bird Rock Bio, will continue to develop ARGX-109 for the Chinese market.

Corporate

Intellectual property portfolio now includes 80 granted and 109 pending patents as of December 31, 2017.
Company expanded to 95 employees and consultants in support of the growth of the business.
Established argenx US, Inc., a subsidiary located in Boston, MA.
Nominated James Michael Daly as a new member of the Board of Directors, subject to approval by the shareholders at the annual general meeting.

OUTLOOK 2018
argenx continues to implement its business plan through advancing its deep pipeline of differentiated antibody-based therapies, including ARGX-113, ARGX-110, ARGX-115 and ARGX-112, the forging of collaborations with pharmaceutical companies and leading academic labs under its Innovative Access Program and the strengthening of its shareholder base.

In 2018, argenx aims to execute its ambitious business plan as follows:

Report full data from the Phase 2 proof-of-concept trial for ARGX-113 in generalized MG at the American Academy of Neurology conference (April 21-27, 2018,Los Angeles, CA)
Report topline data of the Phase 2 proof-of-concept trial for ARGX-113 in ITP and interim data of the Phase 2 proof-of-concept trial in pemphigus vulgaris in the second half of 2018. Report full data of the Phase 2 proof-of-concept trial for ARGX-113 in ITP before the end of the year.
Progress ARGX-113 into Phase 3 clinical development in generalized MG before the end of the year.
Report the full data of the Phase 1 healthy volunteer trial with the subcutaneous formulation of ARGX-113 during the second quarter of the year.
Provide an update on the Phase 1/2 clinical trial in AML in the second half of the year.
Report the full data of the AML Phase 1/2 and CTCL Phase 2 clinical trials of ARGX-110 by the end of the year.
Launch the Phase 2 proof-of-concept trial for ARGX-110 in AML before the end of the year.

KEY FIGURES (CONSOLIDATED)
Year Ended
December 31,
in thousands of € 2017 2016 Variance
Revenue € 36,415 € 14,713 € 21,702
Other operating income 4,841 2,439 2,402
Total operating income 41,256 17,152 24,104
Research and development expenses (51,740) (31,557) (20,183)
Selling, general and administrative expenses (12,448) (7,011) (5,437)
Operating loss € (22,932) € (21,416) € (1,516)
Financial income 1,250 73 1,177
Financial expenses – – –
Exchange losses (5,797) (31) (5,766)
Loss before taxes € (27,479) € (21,374) € (6,105)
Income tax income expense € (597) € – € (597)
TOTAL COMPREHENSIVE LOSS OF THE PERIOD € (28,076) € (21,374) € (6,702)

Net increase in cash, cash equivalents and current financial assets compared to year-end 2016 and 2015 263,047 54,402
Cash, cash equivalents and current financial assets at the end of the period 359,775 96,728

DETAILS OF THE FINANCIAL RESULTS

Cash, cash equivalents and current financial assets totaled €359.8 million for the year ended on December 31, 2017, compared to €96.7 million on December 31, 2016. The increase in the year-end cash balance on December 31, 2017 resulted primarily from €304.7 million of net proceeds received from the initial and follow-on U.S. public offerings of American Depositary Shares on the Nasdaq Global Select Market completed respectively in May and December 2017.

Operating income increased by €24.1 million for the year ended December 31, 2017 to reach €41.3 million, compared to €17.2 million for the year ended December 31, 2016. The increase primarily related to a €11.0 million increase in the recognition of upfront payments and a €9.2 million increase in milestone payments from our collaboration partners.

Research and development expenses totaled €51.7 million and €31.6 million for the years ended December 31, 2017 and 2016, respectively. The increase is mainly the result of higher external research and development expenses, reflecting higher clinical trial costs and manufacturing expenses related to the development of our product candidate portfolio.

Selling, general and administrative expenses totaled €12.4 million and €7.0 million for the years ended December 31, 2017 and 2016, respectively. The increase of €5.4 million in selling, general and administrative expenses for the year ended December 31, 2017 primarily resulted from higher personnel expenses, office costs and consulting fees incurred to support our growth and prepare the company to become and operate as a Nasdaq-listed company.

For the year ended December 31, 2017, financial income amounted to €1.3 million compared to €0.1 million for the year ended December 31, 2016. The increase of €1.2 million relates to (i) a €0.9 million realized gain on the sale of a participation in FairJourney Biologics LDA in December 2017 and (ii) an increase in the interest received on our cash, cash equivalents and current financial assets.

Exchange losses totaled €5.8 million for the year ended December 31, 2017 compared to €0.03 million for the year ended December 31, 2016. The increase is mainly attributable to unrealized exchange rate losses on our cash and current financial assets position in U.S. dollars due to the unfavourable fluctuation of the EUR/USD exchange rate.

The total comprehensive loss for the year ended December 31, 2017 was €28.1 million compared to €21.4 million for the year ended December 31, 2016.

U.S. SEC and statutory financial reporting
argenx’s primary accounting standard for quarterly earnings releases and annual reports is International Financial Reporting Standars (IFRS) as issued by the International Accounting Standards Board (IASB). Quarterly summarized statements of profit and loss based on IFRS as issued by the IASB are available on www.argenx.com.

In addition to reporting financial figures in accordance with IFRS as issued by the IASB, argenx also reports financial figures in accordance with IFRS as adopted by the European Union (EU) for statutory purposes. The consolidated statement of financial position, the consolidated statements of profit and loss, the consolidated statements of cashflow, and the consolidated statement of changes in equity are not affected by any differences between IFRS as issued by the IASB and IFRS as adopted by the EU.

The consolidated statement of profit and loss data of argenx SE as of December 31, 2017 presented in this press release are unaudited.

Annual Report 2017
argenx expects to publish its 2017 Annual Report based on IFRS as issued by the IASB and its 2017 Annual Report for statutory purposes based on IFRS as adopted by the EU on March 26, 2018. These Annual Reports will be available on www.argenx.com.

FINANCIAL CALENDAR:

May 8, 2018: Annual General Meeting
May 9, 2018: Q1 2017 Business Update and financial results
August 2, 2018: Half-year 2017 Business Update and financial results
October 25, 2018: Q3 2017 Business Update and financial results

Dial-in numbers:
Please dial in 5-10 minutes prior to 3 pm CET/ 9 am EST using the number and conference ID below.

Confirmation Code: 6683242
Belgium 0800 58228
Belgium +32 (0)2 404 0659
France 0805 101 219
France +33 (0)1 76 77 22 74
Netherlands 0800 023 1436
Netherlands +31 (0) 20 721 9251
United Kingdom 0800 358 6377
United Kingdom +44 (0)330 336 9105
United States 888-394-8218
United States +1 323-794-2149

A question and answer session will follow the presentation of the results. Go to www.argenx.com to access the live audio webcast. The archived webcast will also be available (90 days) for replay shortly after the close of the call from the "Downloads" section of the argenx website.

Valeant Announces Fourth-Quarter And Full-Year 2017 Results And Provides 2018 Guidance

On February 28, 2018 Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) ("Valeant" or the "Company" or "we") reported its fourth-quarter and full-year 2017 financial results (Press release, Valeant, FEB 28, 2018, http://ir.valeant.com/news-releases/2018/02-28-2018-120240355 [SID1234524266]).

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"2017 was a year of strong progress for Valeant as we delivered organic growth2 across nearly 75 percent of the Company while significantly reducing our debt and investing in our Bausch + Lomb, Salix and Ortho Dermatologics businesses," said Joseph C. Papa, chairman and CEO, Valeant.

"Since the end of the first quarter of 2016, we’ve reduced our total debt by more than 20 percent, and we will continue to address our debt, as well as reduce expenses. Additionally, we’re committed to growth through strategic investment in our core businesses, key products and late-stage pipeline. Altogether, these will get us to the final phase of our strategic plan – the transformation of Valeant," Mr. Papa continued.

Company Highlights

Executing on Core Businesses

The Bausch + Lomb/International segment comprised approximately 56% of the Company’s revenue in 2017
Reported revenue decreased by 1% compared to 2016; excluding foreign exchange and divestitures, revenue grew organically2 by 6% compared to 2016
Generated mid-single digit organic growth2 during each of the four quarters of 2017
The Salix business, which is reported within the Branded Rx segment, comprised approximately 18% of the Company’s revenue in 2017
Reported revenue grew by 2% and revenue grew organically2 by 5%, compared to 2016
Generated mid-single digit or higher organic growth2 during the second, third and fourth quarters of 2017
Continued to focus on stabilizing the dermatology business, which is reported within the Branded Rx segment
Recruited new leadership team and rebranded the business as Ortho Dermatologics
Increased dermatology sales force by more than 25% in January 2018

Launching New Products and Advancing Pipeline

Launched more than 100 new products globally in 2017
Launched AQUALOX contact lenses in Japan
Introduced Biotrue ONEday for Astigmatism daily disposable contact lenses in 20 countries in Europe
Received CE Mark from the European Commission for the Stellaris Elite Vision Enhancement system, including Vitesse
Received approval from the U.S. Food and Drug Administration (FDA) for and launched VYZULTA, a treatment option for glaucoma
Received FDA approval for SILIQ and launched it as the lowest-priced injectable biologic for moderate-to-severe plaque psoriasis in the United States based on total annual cost
Received FDA approval for LUMIFY, the only over-the-counter eye drop with low-dose brimonidine for the treatment of eye redness
Obtained 510(k) clearances from the FDA for Thermage FLX System, Stellaris Elite Vision Enhancement System and Vitesse
The FDA accepted New Drug Applications for:
DUOBRII3 (IDP-118), a topical treatment for plaque psoriasis; PDUFA action date of June 18, 2018
ALTRENO3 (IDP-121), an acne treatment in lotion form; PDUFA action date of Aug. 27, 2018
JEMDEL3 (IDP-122), a topical treatment for plaque psoriasis; PDUFA action date of Oct. 5, 2018

Reducing Debt, Extending Maturities and Resolving Legacy Issues

As of Feb. 28, 2018, reduced total debt by more than $6.7 billion since the end of the first quarter of 2016
Reduced total debt by more than $4.4 billion in 2017
Exceeded $5 billion commitment to pay down debt from divestiture proceeds and free cash flow earlier than the previously stated timing of February 2018
Reduced debt repayment requirements through 2020 by more than $10.8 billion since Dec. 31, 2016; eliminated all long-term debt maturities until 2020 and all mandatory amortization requirements
Completed 13 divestitures since the beginning of 2016, including skin care brands (CeraVe, AcneFree and AMBI), Dendreon Pharmaceuticals, iNova Pharmaceuticals, Obagi Medical Products and Sprout Pharmaceuticals
Achieved dismissals or other positive outcomes in resolving and managing litigation and investigations in more than 80 historical matters since the beginning of 2017
Agreed to resolve the Allergan securities litigation, subject to court approval
Agreed to resolve the SOLODYN antitrust litigations in February 2018, with the class settlement ($58 million) being subject to court approval

Fourth-Quarter and Full-Year Revenue Performance
Total revenues were $2.163 billion for the fourth quarter of 2017, as compared to $2.403 billion in the fourth quarter of 2016, a decrease of $240 million, or 10%.

Total revenues were $8.724 billion for the full year of 2017, as compared to $9.674 billion for the full year of 2016, a decrease of $950 million, or 10%. The decline was primarily driven by the impact of divestitures, and lower volumes in the U.S. Diversified Products segment, attributed to the previously reported loss of exclusivity for a basket of products, and the Ortho Dermatologics business. Revenues were also negatively affected by the unfavorable impact of foreign exchange. The decline was partially offset by higher volumes in our Bausch + Lomb/International segment, primarily the U.S. Consumer Products business, and increased international pricing in our Bausch + Lomb/International segment.

Revenues by segment were as follows:

Fourth-Quarter 2017

(in millions)

4Q 2017

4Q 2016

Reported
Change

Reported
Change

Change at
Constant
Currency4

Organic2

Change

Segment











Bausch + Lomb/International

$1,226

$1,261

($35)

(3%)


(5%)


4%

Branded Rx

$602

$744

($142)

(19%)


(19%)


(8%)

U.S. Diversified Products

$335

$398

($63)

(16%)


(16%)


(12%)

Total Revenues

$2,163

$2,403

($240)

(10%)


(11%)


(2%)

Full-Year 2017

(in millions)

FY 2017

FY 2016

Reported
Change

Reported
Change

Change at
Constant
Currency4

Organic2

Change

Segment











Bausch + Lomb/International

$4,871

$4,927

($56)

(1%)


0%


6%

Branded Rx

$2,475

$2,828

($353)

(12%)


(12%)


(6%)

U.S. Diversified Products

$1,378

$1,919

($541)

(28%)


(28%)


(27%)

Total Revenues

$8,724

$9,674

($950)

(10%)


(9%)


(4%)

Bausch + Lomb/International Segment
Bausch + Lomb/International segment revenues were $1.226 billion for the fourth quarter of 2017, as compared to $1.261 billion for the fourth quarter of 2016, a decrease of $35 million, or 3%. Excluding the impact of divestitures and foreign exchange, the Bausch + Lomb/International segment grew organically2 by approximately 4% compared to the fourth quarter of 2016.

Bausch + Lomb/International segment revenues were $4.871 billion for the full year of 2017, as compared to $4.927 billion for the full year of 2016, a decrease of $56 million, or 1%. Excluding the impact of divestitures of $240 million, primarily the skin care divestiture5, and foreign exchange, the Bausch + Lomb/International segment grew organically2 by approximately 6% compared to the full year of 2016, driven primarily by our International Rx, Global Consumer and Global Vision Care businesses.

Branded Rx Segment
Branded Rx segment revenues were $602 million for the fourth quarter of 2017, as compared to $744 million for the fourth quarter of 2016, a decrease of $142 million, or 19%. The Salix business grew revenue by 3% and generated organic growth2 of 5% compared to the fourth quarter of 2016.

Branded Rx segment revenues were $2.475 billion for the full year of 2017, as compared to $2.828 billion for the full year of 2016, a decrease of $353 million, or 12%. The decrease primarily reflects lower volumes in the Ortho Dermatologics business, and the impact of divestitures of $194 million, particularly from the divestiture of Dendreon Pharmaceuticals. Compared to the full year of 2016, the Salix business grew revenue by 2% and generated organic growth2 of 5%.

U.S. Diversified Products Segment
U.S. Diversified Products segment revenues were $335 million for the fourth quarter of 2017, as compared to $398 million for the fourth quarter of 2016, a decrease of $63 million, or 16%.

U.S. Diversified Products segment revenues were $1.378 billion for the full year of 2017, as compared to $1.919 billion for the full year of 2016, a decrease of $541 million, or 28%. The decline was primarily driven by decreases attributed to the previously reported loss of exclusivity for a basket of products.

Operating Income/Loss
Operating loss was $322 million for the fourth quarter of 2017, as compared to an operating income of $150 million for the fourth quarter of 2016, a decrease of $472 million.

Operating income was $102 million for the full year of 2017, as compared to an operating loss of $566 million for the full year of 2016, an improvement of $668 million. The improvement in our operating results for the full year of 2017 reflects gains from divestitures, lower operating expenses, the net decrease in non-cash charges for impairments and net favorable adjustments to acquisition-related contingent consideration. The improvement was partially offset by lower revenues coming from divestitures, the U.S. Diversified Products segment due to the loss of exclusivity for a basket of products, and the Ortho Dermatologics business.

Income Tax
In 2017 the Company recorded an income tax benefit of $4.145 billion, which was primarily attributed to an internal tax reorganization effort, which began in the fourth quarter of 2016 and was completed in the third quarter of 2017, and provisional benefits related to changes under the Tax Cuts and Jobs Act of 2017.

Net Income
Net income for the fourth quarter of 2017 was $513 million, as compared to a net loss of $515 million for the same period in 2016, an increase of $1.028 billion.

Net income for the full year of 2017 was $2.404 billion, as compared to a net loss of $2.409 billion for the full year of 2016, an improvement of $4.813 billion. The change in net income for the full year of 2017 is mainly attributed to an increase in the benefit from income taxes, as described above.

Adjusted net income (non-GAAP) the fourth quarter of 2017 was $347 million, as compared to $443 million for the fourth quarter of 2016, a decrease of $96 million. Adjusted net income (non-GAAP) for the full year of 2017 was $1.349 billion, as compared to $1.916 billion for the full year of 2016, a decrease of $567 million.

Operating Cash
Cash provided by operating activities was $578 million for the fourth quarter of 2017. Cash provided by operating activities was $2.290 billion for the full year of 2017, as compared to $2.087 billion for the full year of 2016, an increase of $203 million, or 10%. The increase in 2017 was primarily due to improvements in operating expenses and working capital.

EPS
GAAP Earnings Per Share (EPS) Diluted for the fourth quarter of 2017 was $1.45, as compared to ($1.47) for the fourth quarter of 2016. GAAP EPS Diluted for the full year of 2017 was $6.83, as compared to ($6.94) for the full year of 2016.

Adjusted EBITDA(non-GAAP)
Adjusted EBITDA (non-GAAP) was $875 million for the fourth quarter of 2017, as compared to $1.047 billion for the fourth quarter of 2016, a decrease of $172 million.

Adjusted EBITDA (non-GAAP) was $3.638 billion for the full year of 2017, as compared to $4.305 billion for the full year of 2016, a decrease of $667 million. The decline for the full year of 2017 was primarily driven by lower revenues coming from divestitures, the U.S. Diversified Products segment due to the loss of exclusivity for a basket of products, and the Ortho Dermatologics business. The decline was partially offset by organic growth2 in the Bausch + Lomb/International segment and the Salix business, and improved management of operating expenses.

2018 Financial Outlook

Valeant has provided guidance for the full year of 2018, as follows:

Full-Year Revenues in the range of $8.10 – $8.30 billion
Full-Year Adjusted EBITDA (non-GAAP) in the range of $3.05 – $3.20 billion

Other than with respect to GAAP Revenues, the Company only provides guidance on a non-GAAP basis. The Company does not provide a reconciliation of forward-looking Adjusted EBITDA (non-GAAP) to GAAP net income (loss), due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. In periods where significant acquisitions or divestitures are not expected, the Company believes it might have a basis for forecasting the GAAP equivalent for certain costs, such as amortization, which would otherwise be treated as non-GAAP to calculate projected GAAP net income (loss). However, because other deductions (such as restructuring, gain or loss on extinguishment of debt and litigation and other matters) used to calculate projected net income (loss) vary dramatically based on actual events, the Company is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income (loss) at this time. The amount of these deductions may be material and, therefore, could result in projected GAAP net income (loss) being materially less than projected Adjusted EBITDA (non-GAAP).

Additional Highlights

Valeant’s cash, cash equivalents and restricted cash (including non-current) were $797 million at Dec. 31, 2017
The Company’s availability under the Revolving Credit Facility was approximately $1.2 billion at Dec. 31, 2017
During the fourth quarter of 2017, Valeant’s corporate credit ratings were revised to stable by Moody’s Investors Service and remained unchanged by other ratings services

Portola Pharmaceuticals Reports Fourth Quarter and Full Year 2017 Financial Results and Provides Corporate Update

On February 28, 2018 Portola Pharmaceuticals, Inc. (NASDAQ:PTLA) reported financial results for the fourth quarter and full year ended December 31, 2017 and provided a corporate update (Press release, Portola Pharmaceuticals, FEB 28, 2018, View Source;p=RssLanding&cat=news&id=2335410 [SID1234524257]).

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"2017 was a year of significant achievement for Portola, highlighted by the FDA approval of our first medicine, Bevyxxa, and the regulatory application for FDA approval of our breakthrough-designated Factor Xa-inhibitor antidote, AndexXa," said Bill Lis, chief executive officer of Portola. "We are pleased with the early indicators of the U.S. commercial launch of Bevyxxa, which began in January, and the potential to have a major public health impact on millions of patients in the U.S. and beyond. We also are rapidly approaching the FDA action date for AndexXa, which, if approved, would position Portola with two first-in-class medicines in the field of thrombosis. In the meantime, we are working with European regulatory authorities on the path forward for both medicines and are continuing to advance our dual, oral Syk/JAK inhibitor, cerdulatinib, for hematologic cancers."

Recent Achievements, Upcoming Events and Milestones

Bevyxxa (betrixaban) – an oral, once-daily Factor Xa inhibitor approved for extended prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE.

Initiated U.S. commercial launch of Bevyxxa in January 2018
Received FDA approval for the manufacturing of betrixaban in Cork, Ireland
Completed an oral explanation to the European Committee for Medicinal Products for Human Use (CHMP); determining next steps in light of negative CHMP trend vote
New APEX trial results published in The American Heart Journal showing betrixaban’s effect on symptomatic VTE and VTE-related deaths; 12th major peer-reviewed publication

AndexXa (andexanet alfa) – an antidote for Factor Xa inhibitor treated patients with life-threatening bleeding; designated a Breakthrough Therapy and an Orphan Drug by the FDA.

The FDA set a new action date of May 4, 2018 for the Biologics License Application (BLA)
Successfully completed the first commercial campaign for Gen 2 product
Enrollment remains on track for the ongoing Phase 3b/4 ANNEXA-4 study in patients with acute major bleeding
Late-breaking clinical trial presentation on March 12, 2018 at the American College of Cardiology’s 67th Annual Scientific Session & Expo (ACC.18) featuring new interim data from ANNEXA-4
Successfully completed an oral explanation to the European CHMP; received a positive CHMP trend vote and are working with regulatory authorities to address their accompanying request for additional data

Cerdulatinib – an oral, dual-spleen tyrosine kinase (Syk) and janus kinase (JAK) inhibitor in development for the treatment of relapsed/refractory B-cell and other T-cell malignancies in patients who have failed multiple therapies.

Continued to enroll patients in a Phase 2a study evaluating the safety and efficacy of cerdulatinib in patients with relapsed/refractory B-cell and T-cell malignancies who have failed multiple therapies

Fourth Quarter and Full Year 2017 Financial Results
Collaboration and license revenue earned under Portola’s collaboration and license agreements with Bristol-Myers Squibb Company, Pfizer, Bayer Pharma, Janssen Pharmaceuticals, Daiichi Sankyo and Dermavant Sciences was $9.8 million for the fourth quarter of 2017, compared with $13.7 million for the fourth quarter of 2016. Collaboration and license revenue for the year ended December 31, 2017 was $22.5 million, compared with $35.5 million for the year ended December 31, 2016.

Total operating expenses for the fourth quarter of 2017 were $95.7 million, compared with $68.9 million for the same period in 2016. Total operating expenses for the fourth quarter of 2017 included $10.9 million in stock-based compensation expense, compared with $7.9 million for the same period in 2016. Total operating expenses for the year ended December 31, 2017 were $295.2 million, compared with $305.1 million for 2016. Total operating expenses for the full year ended December 31, 2017 included $43.3 million in stock-based compensation expense compared with $30.4 million for 2016.

Research and development expenses were $68.5 million for the fourth quarter of 2017, compared with $56.0 million for the fourth quarter of 2016. Research and development expenses were $203.7 million for the year ended December 31, 2017, compared with $246.9 million for 2016.

Selling, general and administrative expenses for the fourth quarter of 2017 were $26.9 million, compared with $12.9 million for the same period in 2016. Selling, general and administrative expenses for the year ended December 31, 2017 were $91.1 million, compared with $58.2 million for 2016.

For the fourth quarter of 2017, Portola reported a net loss of $91.8 million, or $1.41 net loss per share, compared with a net loss of $53.8 million, or $0.95 net loss per share, for the same period in 2016. Shares used to compute net loss per share attributable to common stockholders were $65.3 million for the fourth quarter of 2017 compared with $56.5 million for the same period in 2016. Net loss for the year ended December 31, 2017 was $286.1 million, or $4.81 net loss per share, compared with a net loss of $269.0 million, or $4.76 net loss per share, for the same period in 2016. Shares used to compute net loss per share attributable to common stockholders were $59.5 million for 2017 compared with $56.5 million for 2016.

Cash, cash equivalents and investments at December 31, 2017 totaled $534.2 million, compared with cash, cash equivalents and investments of $318.8 million as of December 31, 2016.

If the FDA approves andexanet alfa in Q2 2018, the Company will be entitled to receive an additional $100 million from its royalty-based financing with Health Care Royalty Partners.

2018 Annual Financial Guidance
For the fiscal year 2018, Portola expects total GAAP operating expenses to be between $390 million and $430 million, including stock based compensation. These expenses are primarily for manufacturing of both andexanet alfa and betrixaban, ongoing clinical trials, support for the commercial launch of Bevyxxa and preparation for the potential commercial launch of AndexXa.

Conference Call Details
Portola will host a conference call today, Wednesday, February 28, 2018, at 4:30 p.m. ET, during which time management will provide fourth quarter and full year 2017 financial results, updates on the U.S. launch of Bevyxxa and other matters. The live call can be accessed by phone by dialing (844) 452-6828 from the United States and Canada or 1 (765) 507-2588 internationally and using the passcode 4893459. The webcast can be accessed live on the Investor Relations section of the Company’s website at View Source It will be archived for 30 days following the call