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.

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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

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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.

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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 2X Oncology, Inc. ("2X" or the "Company"), a precision medicine company developing targeted therapeutics to address significant unmet needs in hard-to-treat cancers, reported that the Company will participate in the Life Sciences Summit 2017 on November 1-2 in New York City and the Jefferies 2017 London Healthcare Conference on November 15-16 (Press release, 2X Oncology, OCT 25, 2017, View Source [SID1234526101]).

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Chief Executive Officer George O. Elston will participate in and hold 1x1s with investors at both conferences, joined by Chief Financial Officer Jarne Elleholm.

Additionally, Mr. Elston will present in the Emerging Company Showcase at the Life Sciences Summit on Thursday, November 2, 2017 at 3:30pm EDT, with a discussion period to follow.

Investors wishing to meet with 2X Oncology at or around either conference should notify the respective conference one-on-one desk, or contact Amy Raskopf to schedule a meeting.

On October 25, 2017 Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a clinical-stage biopharmaceutical company focused on developing and commercializing targeted therapies for safer myeloablation and conditioning of the bone marrow prior to a bone marrow transplant (BMT) and for the targeting and killing of cancer cells reported that the Company has successfully activated fifteen clinical trial sites in the pivotal Phase 3 SIERRA (Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia) trial (Press release, Actinium Pharmaceuticals, OCT 25, 2017, View Source [SID1234521146]).

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The SIERRA trial is planned to enroll 150 patients with relapsed or refractory acute myeloid leukemia (AML) who are age 55 and above and will compare Iomab-B and a BMT to physician’s choice of salvage chemotherapy. The primary end point is durable complete remission (dCR) of at least 6 months. Iomab-B is intended to provide safer myeloablation of the bone marrow prior to a bone marrow transplant, thus providing a potentially curative treatment option for this patient population and for patients with other leukemias, lymphomas, myelomas and other blood disorders. The following medical institutions are clinical trial sites in the Iomab-B Phase 3 clinical trials:

Center Location
MD Anderson Cancer Center Houston, Texas
Memorial Sloan Kettering Cancer Center New York, New York
Mayo Clinic Rochester, Minnesota
Mayo Clinic Jacksonville, Florida
Washington University School of Medicine Saint Louis, Missouri
Yale Cancer Center New Haven, Connecticut
Baylor Charles A. Sammons Cancer Center Dallas, Texas
The University of Kansas Cancer Center Westwood, Kansas
Roswell Park Cancer Institute Buffalo, New York
University Hospitals Cleveland Medical Center Cleveland, Ohio
The Ohio State University Comprehensive Cancer Center Columbus, Ohio
Penn State Hershey Cancer Institute Hershey, Pennsylvania
Loyola University Medical Center Maywood, Illinois
Banner MD Anderson Cancer Center Gilbert, Arizona
Fred Hutchinson Cancer Research Center Seattle, Washington
Dr. Mark Berger, Actinium’s Chief Medical Officer said, "I am delighted to be working with these world-renowned investigators and institutions in this important SIERRA trial for Iomab-B. Their interest and enthusiasm for Iomab-B further motivates my team as we work on this trial to bring Iomab-B to patients who could benefit from safer myeloablation prior to a bone marrow transplant. In many blood cancers and disorders a bone marrow transplant is the only potentially curative treatment option for patients and it is our goal to improve outcomes for these patients with Iomab-B by getting them to their transplant faster and with less complications than currently available myeloablative regimens allow. We are looking forward to adding additional clinical trial sites located in the U.S. and Canada to make this trial available to a greater range of patients and to expedite completion of the trial."

Actinium also announced that it will provide an update on the Iomab-B SIERRA trial by year end. The SIERRA trial will have three safety analyses by an independent Data Monitoring Committee when 25%, 50% and 75% patient enrollment has been reached. Also, two ad-hoc efficacy analyses may be requested by Actinium after 70 and/or 110 patients have engrafted and given enough time to achieve the primary endpoint of durable complete remission at six months post treatment.

Sandesh Seth, Actinium’s Chairman & CEO said, "Until this trial, Iomab-B had only been studied in a single center and Actinium is proud to have facilitated use of this important therapeutic option in most of the leading transplant centers in the U.S. via the SIERRA trial. These fifteen centers perform approximately a third of all AML related bone marrow transplants. Our ability to introduce Iomab-B in these centers bodes well for enrollment in the trial and also the commercial opportunity for Iomab-B as the top fifty centers account for approximately eighty percent of bone marrow transplants. There is no visible competition for Iomab-B from any drug or drug candidate that can provide safer myeloablation and enable improved outcomes of bone marrow transplant. Actinium intends to build on the clinical experience, infrastructure and supply chain capabilities that we have established thus far to complete the trial in accordance with prior guidance and, assuming a successful outcome, establish Iomab-B as the standard of care in providing safer myeloablation first in in AML and then in the other hematologic indications in which it has shown positive results."

About Iomab-B

Iomab-B is Actinium’s lead product candidate that is currently being studied in a 150-patient, multicenter pivotal Phase 3 clinical trial in patients with relapsed or refractory acute myeloid leukemia who are age 55 and above. Upon approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, which is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Iomab-B targets cells that express CD45, a pan-leukocytic antigen widely expressed on white blood cells with the monoclonal antibody, BC8, labeled with the radioisotope, iodine-131. By carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B will avoid the side effects of radiation on most healthy tissues while effectively killing the patient’s cancer and marrow cells. In a Phase 2 clinical study in 68 patients with advanced AML or high-risk myelodysplastic syndrome (MDS) age 50 and older, Iomab-B produced complete remissions in 100% of patients and patients experienced transplant engraftment at day 28. Iomab-B was developed at the Fred Hutchinson Cancer Research Center where it has been studied in almost 300 patients in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). Iomab-B has been granted Orphan Drug Designation for relapsed or refractory AML in patients 55 and above by the U.S. Food and Drug Administration and the European Medicines Agency.

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 26, 2017 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) and TESARO, Inc. (“TESARO”) reported a three-year integrated drug discovery collaboration to discover and develop novel small molecule product candidates against an undisclosed immuno-oncology (IO) target (Press release, Evotec, OCT 25, 2017, View Source [SID1234521186]).

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Under the terms of the collaboration, Evotec will apply its integrated drug discovery platform, from lead discovery through nomination of a pre-clinical development candidate, to TESARO’s translational research pipeline to advance best-in-class oncology therapies. In particular, Evotec will leverage its industry leading structural biology platform to identify novel start points to progress into a full-blown drug discovery programme.

“TESARO is excited to work with Evotec to expand our discovery capabilities against immuno-oncology targets”, said Jeffrey Hanke, Ph.D., Executive Vice President, Research and Development, and Chief Scientific Officer of TESARO. “Evotec has a proven track record of enhancing its partners’ drug discovery efforts in oncology. We look forward to working with Evotec to accelerate the identification of new therapies to help patients facing cancer.”

Dr Mario Polywka, Chief Operating Officer of Evotec, commented: “Oncology is one of Evotec’s core therapeutic areas of focus and we are pleased to enter into this exciting and innovative partnership with TESARO, a globally recognised oncology leader and one of the fastest growing biotech companies in the USA. This collaboration further demonstrates the value of our integrated research site in Toulouse and our world-leading structural biology group in Oxford. Using our integrated drug discovery platform, we are committed to helping TESARO drive innovation in this very important field of high-unmet medical need.”
No financial details of the collaboration were disclosed.