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 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/

On October 24, 2017 Asana BioSciences, LLC, an oncology focused, clinical stage biopharmaceutical company, reported that it will present updates regarding three of its lead molecules at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) to be held in Philadelphia, PA, October 26-30, 2017 (Press release, Asana BioSciences, OCT 24, 2017, View Source [SID1234521148]).

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“The presentations will highlight the well differentiated profile of our clinical and preclinical programs, including first disclosure on our next clinical candidate ASN007, a potent ERK1/2 inhibitor.”
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“We are very pleased with the progress made in advancing our oncology portfolio,” said Sandeep Gupta, PhD, Founder, President and Chief Executive Officer at Asana BioSciences. “The presentations will highlight the well differentiated profile of our clinical and preclinical programs, including first disclosure on our next clinical candidate ASN007, a potent ERK1/2 inhibitor.”

The presentation details are as follows:

1. A Phase 1 PK/PD study of ASN003, a novel, highly selective BRAF and PI3K dual inhibitor, in patients with advanced solid tumors.

Authors: Drew Rasco1, Nehal Lakhani2, Ryan Sullivan3, Monica Mita4, Jaimini Shah5, Helena Usansky5, Sanjeeva Reddy5, Niranjan Rao5, Louis J. Denis5, Anthony Tolcher1, Keith Flaherty3. 1START San Antonio, San Antonio, TX; 2START Midwest, Grand Rapids, MI; 3Mass Gen Hosp CC, Boston, MA; 4Cedars-Sinai Medical Center, Los Angeles, CA; 5Asana BioSciences.
Session: PO.B21 – Therapeutic Agents: Small-Molecule Kinase Inhibitors
Poster # B 147; Hall E
Date/Time: Sunday, October 29, 2017 at 12:30pm – 4:00pm EDT

2. ASN007, a novel oral ERK1/2 inhibitor, shows robust antitumor activity in RAS mutant cancer models.

Authors: Sanjeeva Reddy, Dhanalakshmi Sivanandhan, Purushottam Dewang, Niranjan Rao, Roger A. Smith and Scott Thompson.
Session: PO.B21 – Therapeutic Agents: Small-Molecule Kinase Inhibitors
Poster # B 150; Hall E
Date/Time: Sunday, October 29, 2017 at 12:30pm – 4:00pm EDT

3. ASN004, a novel 5T4-targeted Dolaflexin ADC, causes complete and durable tumor regressions in a variety of tumor xenograft models.

Authors: Roger A. Smith, David J. Zammit, Sanjeeva P. Reddy.
Session: PO.B19 – Therapeutic Agents: Biological
Poster # B 109; Hall E
Date/Time: Sunday, October 29, 2017 at 12:30pm – 4:00pm EDT

ASN003 is a potent and highly selective inhibitor of both B-RAF and PI3 kinases. RAS-RAF-MEK and PI3K-AKT-mTOR are two major pathways involved in tumor cell signaling and growth. Components of these pathways are frequently mutated in a broad range of tumors. Selective BRAF inhibitors induce dimerization of RAF proteins, leading to paradoxical activation of the RAF-MEK-ERK cascade. This activation is a major limitation for the clinical use of selective RAF inhibitors, as it leads to resistance and results in side effects in the skin limiting their use in patients with BRAF mutant tumors. In addition, elevated signaling through the PI3K/AKT pathway, with or without concomitant MAPK reactivation, represents an alternative path to resistance to BRAF inhibitors. Preclinical data with ASN003, demonstrates broad anti-proliferative activity in tumor cell lines and strong tumor growth inhibition in tumor xenograft models, including BRAF inhibitor resistant models. ASN003 is currently in Phase I clinical development in patients with advanced solid tumors, including melanoma, colorectal cancer and non-small cell lung cancer. ASN003 is well tolerated and shows the potential to be developed as a monotherapy or in combination with checkpoint inhibitors or standard of care.

ASN007 is a potent inhibitor of the extracellular-signal-regulated kinases, ERK1 and ERK2 (ERK1/2), key players in the RAS/RAF/MEK (MAPK) signaling pathway. This pathway is frequently hyper-activated in a wide range of cancers through mutations in upstream targets such as BRAF, RAS and receptor tyrosine kinases. Inhibition of ERK1/2 offers a promising therapeutic strategy for these cancers, particularly those driven by RAS mutations. ASN007 shows potent anti-proliferative activity in cancer lines that are selectively driven by the MAPK-pathway, including RAS mutant cell lines. Furthermore, ASN007 demonstrates strong inhibition of tumor growth in multiple BRAF and KRAS mutant patient-derived and cell line-derived xenograft models, including those that are resistant to BRAF and MEK inhibitors. The IND-submission is planned to evaluate safety and efficacy in patients with advanced solid tumors, including BRAF and KRAS mutant cancers.

ASN004 is an Antibody Drug Conjugate (ADC) that targets the 5T4 oncofetal antigen that is expressed in a wide range of malignant tumors, while very limited expression is found in normal tissues. ASN004 demonstrates robust antitumor activity leading to complete tumor regressions in multiple human tumor xenograft models with no development of resistance to ASN004 treatment. The IND-enabling program for ASN004 is near completion and a First-in-Human Phase 1 trial is being planned in 2018.

On October 24, 2017 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage biotechnology company with a fully human antibody discovery platform focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer, reported that the Company has filed a patent application for its series of HuMab-Tn fully-human monoclonal antibodies that target the tumor associated Thomsen-nouveau (Tn) antigen that will be developed as therapeutic and diagnostic products targeting ovarian, lung and breast cancers (Press release, MabVax, OCT 24, 2017, View Source [SID1234521277]). The Tn target is a carbohydrate antigen significantly expressed on the surface of cancer cells as a result of the transformation of normal cells into cancer cells. The Tn target is present on a broad array of tumor types but not found on normal tissues. This patent represents another valuable antibody asset brought forward by MabVax and the third patent filed on the antibody portfolio created through the Company’s unique discovery platform.

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The patent application covers the recovery of anti-Tn antibodies from patients who were vaccinated against their solid tumors with a vaccine that contained the Tn antigen. The discovery of fully human antibodies directly from vaccinated cancer patients is highly unique and has advantages including a potential for greater specificity and reducing the toxicities associated with non-human antibodies. The patent application also covers the additional work done by the Company’s antibody research and development team to optimize the recovered antibodies as well as detailing the resulting positive characteristics of the antibodies selected for patenting. The newly filed patent application, if issued by the U.S. Patent Office, will provide exclusivity for these antibodies until 2038.

“The filing of this patent is an important component of our broad strategy in expanding our robust patent estate. Importantly, this filing is timely as we look to select additional product candidates to fuel our pipeline that have the potential to address significant unmet therapeutic needs,” stated David Hansen, MabVax’s President and Chief Executive Officer.

The Company has demonstrated its ability to translate these discoveries through preclinical development and into clinical development with its HuMab-5B1 program, currently being evaluated in Phase 1 clinical trials as a therapeutic agent, an immunoPET diagnostic agent, and as a radioimmunotherapy (“RIT”). The Company envisions that the HuMab-Tn antibody portfolio has similar applicability, including as a bi-specific antibody, as an antibody conjugated with a payload to form an antibody drug conjugate (“ADC”), with a radionuclide as an immunoPET imaging agent or with a radionuclide as a RIT product.

Xspray Pharma AB presenterar idag resultaten av en klinisk pilotstudie avseende läkemedelskandidaten HyNap-Dasa (Press release, Xspray, OCT 24, 2017, View Source [SID1234523285]). Pilotstudien undersökte HyNap-Dasas biotillgänglighet av dasatinib som idag marknadsförs som Sprycel för behandling av kronisk myeloid leukemi (KML). För de undersökta HyNap-Dasa-kompositionerna låg de två kritiska parametrarna för absorption av dasatinib i kroppen, AUC och Cmax, nära de värden som observerades för Sprycel. Bolaget avser att med små justeringar ta en vald HyNap-Dasa-komposition vidare till en generisk produkt på den amerikanska marknaden (med regulatorisk ANDA-procedur).

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I den avslutade kliniska Fas I-studien deltog 12 friska försökspersoner. Biotillgängligheten för olika formuleringar av HyNap-Dasa testades i jämförelse med Sprycel. Resultaten är positiva och bekräftar validiteten av Xsprays formuleringsverktyg. De redan planerade studier som krävs för att kunna ta HyNap-Dasa till slutliga registreringsstudier kommer nu att utföras som planerat.

"Jag är mycket nöjd med att vi uppnått studiens primära syfte att få fram underlag för vår produktkomposition för planerade studier under första halvåret 2018. Studien visar att den uppnådda absorptionsprofilen av vår HyNap-Dasa komposition är lik originalets och att det verktyg vi har tagit fram fungerar för att justera både AUC och Cmax till de nivåer som krävs för att visa bioekvivalens. Detta är ett viktigt steg i utvecklingen av vårt generiska läkemedel baserat på vår RightSize teknologi. Vi har nu en klar bild av hur formuleringen ska vara sammansatt i kommande studier. Det gör att vi med stor sannolikhet kan hålla vår tidplan för de registreringsstudier som planeras framöver," säger Per Andersson, verkställande direktör.

De kliniska resultaten i sammandrag:

Den totala biotillgängligheten av dasatinib från den valda kompositionen av HyNap-Dasa, mätt som ytan under kurvan AUC, var 7% högre jämfört med Sprycel.
Den maximala koncentrationen av dasatinib i plasma, Cmax, var 13% högre för HyNap-dasa kompositionen jämfört med Sprycel.
Resultaten visar att formell bioekvivalens (Cmax och AUC inom området 80-125% av originalläkemedlet) kan uppnås med ett större antal försökspersoner.

Studieresultaten är i linje med bolagets plan för kliniska studier som finns presenterad i det prospekt som togs fram i samband med introduktionen på First North i slutet av september. Planen är att genomföra nödvändiga studier för att kunna ha en färdig produkt godkänd för försäljning på den amerikanska marknaden 2020 eller senast 2021.