On October 26, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Avastin (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin alone, for the front-line treatment of women with advanced ovarian cancer (Press release, Hoffmann-La Roche, OCT 25, 2017, View Source [SID1234521187]).

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“About 80 percent of women with ovarian cancer are diagnosed in the advanced stages when the disease is difficult to treat and options are limited,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are committed to working closely with the FDA to bring this potential new treatment option to women with newly diagnosed advanced ovarian cancer as soon as possible.”

This sBLA for Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, for the front-line treatment of people with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer, is based on data from the pivotal Phase III GOG-0218 trial. In newly diagnosed advanced ovarian cancer, the first treatment a woman receives after surgery is known as front-line treatment. The FDA is expected to make a decision on approval by June 25, 2018.

This is part of our broader development program for Avastin in ovarian cancer. Avastin is currently approved for treating two different forms of advanced disease that recurred after platinum-based chemotherapy. In addition, Genentech is evaluating Avastin in combination with Tecentriq (atezolizumab) and chemotherapy for the treatment of newly diagnosed advanced ovarian cancer in the Phase III IMagyn050 trial (NCT03038100).

About the GOG-0218 Study
GOG-0218 (NCT00262847) is a multi-center, randomized, double-blind, placebo-controlled Phase III study in 1,873 women with previously untreated advanced epithelial ovarian, primary peritoneal, or fallopian tube carcinoma who already had surgery to remove as much of the tumor as possible. Participants were randomized into one of three treatment arms: chemotherapy alone (carboplatin and paclitaxel), Avastin (15 mg/kg) plus chemotherapy followed by placebo alone, or Avastin plus chemotherapy followed by Avastin alone. Women who received Avastin in combination with chemotherapy, and continued use of Avastin alone for a total duration of 22 cycles, had a median progression-free survival (PFS) of 18.2 months compared to 12.0 months in women who received chemotherapy alone (HR=0.64; 95% CI 0.54 – 0.77, p<0.0001). Secondary endpoints of the study included overall survival (OS) and objective response rate (ORR). Adverse events were consistent with those seen in previous trials of Avastin across tumor types for approved indications. The study was conducted by the Gynecologic Oncology Group (GOG) and their initial results were previously published in the New England Journal of Medicine.

About Ovarian Cancer
Ovarian cancer causes more deaths among women than any other gynecologic cancer in the United States. In 2017, nearly 22,000 women will be diagnosed with ovarian cancer in the U.S. and more than 14,000 will die from the disease. About 80% of ovarian cancer cases are found at an advanced stage, when the cancer has spread beyond the ovaries. Early ovarian cancer often does not have any symptoms and when symptoms, such as abdominal swelling, bloating, abdominal pain, difficulty eating or feeling full quickly, and/or frequent urination, are present, they can be associated by other less serious conditions. Five-year survival rates worsen dramatically based on stage of diagnosis.

About Avastin
With the initial approval in the United States for advanced colorectal cancer in 2004, Avastin became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer.
Today, Avastin is continuing to transform cancer care through its proven survival benefit (overall survival and/or progression free survival) across several types of cancer. Avastin is approved in Europe for the treatment of advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer, ovarian cancer and cervical cancer, and is available in the United States for the treatment of colorectal cancer, non-small cell lung cancer, kidney cancer, cervical cancer and recurrent, platinum-resistant and platinum-sensitive ovarian cancer. In addition, Avastin is approved over 70 other countries worldwide for the treatment of patients with progressive glioblastoma following prior therapy. Avastin is approved in Japan for the treatment of the advanced stages of colorectal cancer, non-small cell lung cancer, breast cancer, ovarian cancer and malignant glioma, including newly diagnosed glioblastoma.
Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today. Over two million patients have been treated with Avastin so far. A comprehensive clinical programme with more than 300 ongoing clinical trials is investigating the use of Avastin in over 50 tumour types.

On October 25, 2017 Geron Corporation (Nasdaq:GERN) reported that it will announce its financial results for the third quarter ended September 30, 2017, on Wednesday, November 1, 2017, after the market close (Press release, Geron, OCT 25, 2017, View Source [SID1234521151]). Geron’s management will also host a conference call for analysts and investors on Wednesday, November 1, 2017, at 4:30 p.m. Eastern Time to discuss the company’s third quarter results and recent events.

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Participants can access the conference call live via telephone by dialing 877-303-9139 (U.S.); 760-536-5195 (international). The conference ID is 1056465. If accessing the conference call by telephone, please dial in at least 10 minutes early to minimize any delay in joining the call. A live audio-only webcast is also available at View Source or at www.geron.com on the Investors pages, under Events. The audio webcast of the conference call will be available for replay approximately one hour following the live broadcast through December 1, 2017.

On October 25, 2017 GlaxoSmithKline reported Q3 sales of £7.8 billion, +4% AER, +2% CER (Press release, GlaxoSmithKline, OCT 25, 2017, View Source [SID1234521165]).

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Financial highlights

Sales growth in Pharmaceuticals and Consumer Healthcare; Vaccines sales flat
Pharmaceuticals sales £4.2 billion +3% AER, +2% CER; Vaccines £1.7 billion +5% AER, flat at CER; Consumer Healthcare £2.0 billion +5% AER, +2% CER
Improved Total operating margin of 23.9% (+4.9 points, including 0.2 points currency benefit) and EPS (24.8p), primarily reflecting reduced transaction-related charges related to valuations of Consumer Healthcare and HIV businesses
Improved Adjusted Group operating margin of 31.5% (+1.0 point, no currency effect) primarily reflecting leverage from sales growth, focus on costs and benefits of restructuring. Pharmaceuticals 34.0% (-0.3 points, no currency effect); Vaccines 41.3% (+1.6 points, including 0.3 points adverse currency effect); Consumer Healthcare 20.0% (+3.9 points, including 1.3 points currency benefit)
YTD free cash flow £1.6 billion (9 months 2016: £1.3 billion)
19p dividend declared for quarter. Continue to expect 80p for FY 2017
Guidance for 2017 Adjusted earnings per share growth maintained at 3% to 5% CER
Product and pipeline highlights

New product sales of £1.7 billion, +44% AER, +40% CER, driven by continued strong performance from Tivicay/Triumeq in HIV, Relvar/Breo Ellipta and Nucala in Respiratory and meningitis vaccines
Trelegy Ellipta approved in the US for COPD and positive opinion received in Europe. Positive results from landmark IMPACT study show benefits of Trelegy Ellipta in reducing COPD exacerbations compared to dual therapies
Shingrix vaccine for shingles approved in US and Canada
Phase III results for Nucala (mepolizumab) in COPD published in New England Journal of Medicine with regulatory filings planned for this year
In Oncology, CHMP PRIME designation granted for 2857916 (BCMA antibody-drug conjugate) for relapsed and refractory multiple myeloma and new data to be presented at an upcoming scientific conference; option exercised from Adaptimmune to develop T-cell therapy (NY-ESO-1) for multiple tumour types
Q3 2017 results infographic
Emma Walmsley, Chief Executive Officer, GSK said:

“Performance in the quarter showed continued progress with sales growth and improved operating margins. This was driven by targeted cost savings and restructuring and integration benefits, which particularly benefited Vaccines and Consumer Healthcare, and also supported investment in our new products and R&D pipeline. Adjusted earnings per share for Q3 were 32.5p and we remain on course for our full-year earnings guidance, with cash generation continuing to improve. We are also pleased that we have secured major approvals for Trelegy Ellipta in COPD and Shingrix, our shingles vaccine.”

On October 25, 2017 Baxter International Inc. (NYSE:BAX) reported results for the third quarter of 2017 and updated its financial outlook for full-year 2017.
"Baxter’s solid performance in the third quarter reflects our continued focus on disciplined execution," said José (Joe) E. Almeida, chairman and chief executive officer. "We are advancing innovation and operational excellence across the organization to deliver positive results for our stakeholders — even as we respond to extraordinary challenges like the recent natural disasters across the Americas and the Caribbean. I’m proud of how our employees continuously step up to make a difference for our patients, healthcare providers, global communities and fellow colleagues."

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BAXTER REPORTS THIRD-QUARTER 2017 RESULTS AND UPDATES FINANCIAL OUTLOOK FOR FULL-YEAR 2017 — PAGE 2

Third-Quarter Financial Results
In the third quarter, worldwide sales totaled $2.7 billion, an increase of 6 percent on a reported, constant currency and operational basis as compared to the prior-year period. Operational sales adjust for the impact of foreign exchange, generic competition for U.S. cyclophosphamide, the Claris Injectables (Claris) acquisition and the previously communicated select strategic product exits the company is undertaking.
Sales within the U.S. were approximately $1.1 billion, advancing 8 percent. International sales totaled approximately $1.6 billion, representing a 5 percent increase on a reported basis and a 4 percent increase on a constant currency basis. Baxter’s operational sales rose 7 percent in the U.S. and 6 percent internationally.
Global sales for Hospital Products totaled $1.7 billion in the third quarter, advancing 7 percent on both a reported basis and constant currency basis and 6 percent operationally as compared to the prior-year period. Performance in the quarter benefited from continued strength in our U.S. fluid systems business as well as favorable demand for injectable pharmaceuticals reflecting a contribution of approximately $27 million of sales from the July 27 acquisition of Claris. Sales in the quarter also benefited from increased sales of anesthesia and critical care products as well as hospital pharmacy compounding services.
Baxter’s third quarter Renal sales were approximately $1 billion, representing an increase of 3 percent on both a reported basis and constant currency basis. Operationally, Renal sales advanced 6 percent in the quarter driven by improved performance across all major product lines and therapies globally.

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BAXTER REPORTS THIRD-QUARTER 2017 RESULTS AND UPDATES FINANCIAL OUTLOOK FOR FULL-YEAR 2017 — PAGE 3

Baxter reported income from continuing operations of $248 million, or $0.45 per diluted share, on a GAAP (Generally Accepted Accounting Principles) basis for the third quarter. These results included special items totaling $149 million ($108 million net after-tax), primarily related to business optimization, intangible asset amortization, product-related reserves, Claris integration expenses and Puerto Rico-related expenses post Hurricane Maria.
On an adjusted basis, excluding special items, Baxter’s third quarter income from continuing operations totaled $356 million, or $0.64 per diluted share, exceeding the company’s previously issued guidance of $0.58 to $0.60 per diluted share.
Business Highlights
In support of its strategy to accelerate profitable growth and deliver meaningful innovation for patients and healthcare professionals around the world, Baxter has achieved a number of recent operational, pipeline and commercial milestones.

•
Completed the acquisition of Claris Injectables Limited, a global generic injectables pharmaceutical company. The transaction significantly broadens Baxter’s presence in the generic pharmaceuticals space. Baxter is in the process of fully integrating Claris into its systems.

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BAXTER REPORTS THIRD-QUARTER 2017 RESULTS AND UPDATES FINANCIAL OUTLOOK FOR FULL-YEAR 2017 — PAGE 4

•
Enrolled the first patients in two new clinical trials for a unique expanded hemodialysis (HDx) therapy enabled by THERANOVA. HDx therapy extends the range of molecules that can be cleared from the blood during hemodialysis (HD), resulting in a clearance profile that more closely mimics the natural kidney.1 The U.S. trial will support submission for marketing authorization from FDA. THERANOVA is currently available in several markets worldwide, including Colombia, where the company also launched a second multi-center, prospective trial of the technology. These efforts are part of Baxter’s growing investment in generating compelling scientific evidence supporting the approval of and access to innovative therapies.

•
Launched the first 3-in-1 set for use in continuous renal replacement therapy (CRRT) and sepsis management protocols in select markets across Europe, Middle East and Africa. With this new indication, the oXIRIS set, which is used on the company’s leading PRISMAFLEX system, can now be employed to help remove excessive levels of cytokines, endotoxin and other inflammatory mediators from a patient’s blood.

Puerto Rico Update
In follow up to the company’s Oct. 12 press release, Baxter remains in limited production across all three manufacturing sites in Puerto Rico and is continuing to work with infrastructure providers to advance reliable restoration activities for power, communications and transportation.

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BAXTER REPORTS THIRD-QUARTER 2017 RESULTS AND UPDATES FINANCIAL OUTLOOK FOR FULL-YEAR 2017 — PAGE 5

The company remains focused on helping ensure patients have continued access to the products and therapies they need. To this end, Baxter has been working with FDA and has recently been granted regulatory discretion for temporary special importation of certain products from Baxter facilities in Ireland, Australia, Canada and Mexico to help support product supply for the U.S. market. While these actions will help mitigate some of the projected shortfall in supply, they will not be adequate to fully bridge the gap in the fourth quarter.
2017 Financial Outlook
Baxter currently projects fourth quarter revenues to be negatively impacted by approximately $70 million due to the temporary manufacturing disruptions resulting from Hurricane Maria.
For full-year 2017: Baxter now expects sales growth of approximately 4 percent on a reported basis, approximately 4 percent on a constant currency basis, and approximately 4 to 5 percent operationally. Earnings from continuing operations, before special items, are now expected to be $2.40 to $2.43 per diluted share.
For the fourth quarter: The company expects sales growth of 4 to 5 percent on a reported basis, approximately 2 percent on a constant currency basis and 1 to 2 percent operationally. The company expects earnings from continuing operations, before special items, of $0.56 to $0.59 per diluted share.
Please see the schedules accompanying this press release for reconciliations between the projected 2017 operational sales and adjusted earnings per diluted share to the projected GAAP sales and earnings per diluted share.

On October 25, 2017 Swedish Orphan Biovitrum AB (publ) (Sobi) reported its results for the third quarter 2017 (Press release, Swedish Orphan Biovitrum, OCT 25, 2017, View Source;Media/News/RSS/?RSS=View Source [SID1234521139]). Total revenues amounted to SEK 1,601 M, an increase of 37 per cent. Product sales amounted to SEK 1,459 M, an increase of 45 per cent. Elocta sales were SEK 417 M and Alprolix sales were SEK 98 M.

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Business highlights Q3 2017

Focus on future growth
37 per cent sales growth in the quarter
601 per cent product sales growth in Haemophilia
Solid development for Orfadin 20 mg and oral suspension in the US
Financial summary Q3 2017 (Q3 2016)

Total revenue was SEK 1,601 M (1,171), an increase of 37 per cent (41 per cent at CER)
Product revenue was SEK 1,459 M (1,009), an increase of 45 per cent (48 per cent at CER)
Gross margin was 70 per cent (67)
EBITA was SEK 536 M (282)
Cash position SEK 1,758 M (SEK 786 M as of 31 December 2016)
Earnings per share 1.20 SEK (0.50)
Financial summary Jan-Sep 2017 (Jan-Sep 2016)

Total revenue was SEK 4,636 M (3,913), an increase of 18 per cent (16 per cent at CER)
Product revenue was SEK 4,171 M (3,404), an increase of 23 per cent (20 per cent at CER)
Gross margin was 72 per cent (71)
EBITA was SEK 1,434 M (1,333)
Earnings per share 2.94 SEK (2.71)
Outlook 2017(1,2) – updated
Sobi now expects total revenues for the full year to be in the range of SEK 6,300 to 6,400 M (6,100-6,200).
Gross margin is expected to be around 70 per cent, unchanged.
Sobi now expects EBITA for the full year to be in the range of SEK 1,900 to 2,000 M (1,700-1,800).

(1) At current exchange rates.

(2) The latest outlook was published on 19 July 2017.

Guido Oelkers, CEO:
"A strong business performance was shown across the portfolio in the third quarter, with the main contributors being Elocta and Alprolix. Elocta sales increased more than 600 per cent compared to the same period last year and Alprolix sales increased with approximately 500 per cent. This strong growth momentum encourages us to be confident around the prospects of our Haemophilia franchise.

Our growth strategy has been designed to capitalise on the substantial potential in Haemophilia. Based on this solid platform we will further balance the business with a broader Specialty Care portfolio to ensure a sustainable company in both the short and long-term".

Financial summary
Q3 Q3 Jan-Sep Jan-Sep Full year
Amounts in SEK M 2017 2016 Change 2017 2016 Change 2016
Total revenues1 1,601 1,171 37% 4,636 3,913 18% 5,204
Gross profit2 1,129 782 44% 3,320 2,791 19% 3,651
Gross margin 70% 67% 72% 71% 70%
EBITA 536 282 90% 1,434 1,333 8% 1,543
EBIT (Operating profit/loss) 426 171 149% 1,092 1,033 6% 1,133
Profit for the period 324 135 141% 791 728 9% 801
(1)Jan-Sep 2016 revenues include a one-time credit received in Q1 of SEK 322 M relating to the first commercial sales of Elocta, and a one-time credit received in Q2 of SEK 386 M relating to first commercial sales of Alprolix.
(2)Jan-Sep 2017 includes a one-time inventory adjustment of SEK 59 M in Q1 due to delayed release of Kineret drug substance manufactured in 2016.
Telephone conference

Financial analysts and media are invited to participate in a telephone conference, which will include a presentation of the results, today at 14:00 CET. The event will be hosted by Sobi’s CEO and President, Guido Oelkers, and the presentation will be held in English.

The presentation can be followed live, or afterwards on www.sobi.com. Slides used in the presentation will be made available on Sobi’s website prior to the telephone conference.

To participate in the telephone conference, please call:

UK: +44 203 008 9809
SE: +46 8 566 426 94
US: +1 855 831 5948

Live audience URL:
View Source

(The recording will be made available via the audience URL within three hours after the live broadcast.)

Sobi’s report for the third quarter 2017 can be found on View Source;Media/Financial-Reports/