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baxter international inc (BAX) Key Developments

Baxter International Inc. Announces Quarterly Dividend, Payable on April 1, 2015

The Board of Directors of Baxter International Inc. declared a quarterly dividend of $0.52 per Baxter common share. The dividend is payable on April 1, 2015 to shareholders of record as of March 11, 2015.

Baxter Provides Progress Update on Gene Therapy Program

Baxter International Inc. provided an update on its gene therapy program, including progress on the Phase I/II open-label clinical trial assessing the safety and optimal dosing level of BAX 335, an investigational factor IX (FIX) gene therapy treatment for hemophilia B, during a sponsored symposium at the 8th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD) in Helsinki, Finland. The trial is assessing the safety of ascending doses of BAX 335 to determine the optimal single dose in up to 16 adult patients with hemophilia B at treatment centers in the United States. The primary endpoint is the safety of a single dose of BAX 335 administered intravenously. Secondary endpoints include evaluation of the optimal dose to achieve stable therapeutic plasma FIX activity, as well as pharmacokinetics and immune response to treatment. As of the end of 2014, a total of six patients in three dosing cohorts have been treated in the trial with evidence of a dose-related response. No patients have developed FIX inhibitors to date. In the two higher dose cohorts, FIX activity levels around 10% or above have been observed in two patients, who also experienced no bleeding events. One of these patients showed elevated levels of liver enzymes indicative of an immune response, which is being treated with oral corticosteroids, per protocol. Immune responses have been reported in previous studies with gene therapy technology.

Baxter International Inc. Presents Additional Efficacy and Safety Data from the Phase III Pivotal Study of BAX 855

Baxter International Inc. presented additional efficacy and safety data from the Phase III pivotal study of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)] at the 8th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD) in Helsinki, Finland. The new data expand on the previously disclosed topline results from the pivotal trial, which found that BAX 855 met the study's primary endpoint in the control and prevention of bleeding episodes and routine prophylaxis. Patients in the twice-weekly prophylaxis arm of the trial experienced a 95% reduction in median annualized bleed rate (ABR) as compared to those in the on-demand arm (1.9 vs. 41.5, respectively). The study findings supported Baxter's December 2014 submission for approval of BAX 855 to the United States Food and Drug Administration. The prospective, global, multi-center, open-label, two-arm Phase III study evaluated BAX 855 among 137 previously treated hemophilia A patients (PTP) who were 12 years or older. Patients were assigned either to twice weekly prophylaxis (40-50 IU/kg, n=120) or on-demand treatment (10-50 IU/kg, n=17). In addition to a reduced ABR, BAX 855 was also effective in treating bleeding episodes, 96% of which were controlled with one or two infusions at a median dose of 29.0 IU/kg per infusion. Treatment was rated excellent or good for nearly all episodes (96.2%). In the prophylactic group (n=101), 40% of patients experienced no bleeds. The study also showed that BAX 855 pharmacokinetics offered a 1.4-1.5-fold extended half-life compared to ADVATE with a median infusion interval of 3.6 days, supporting the findings from the Phase I trial. No patients developed inhibitors to BAX 855 and no treatment-related serious adverse events, including hypersensitivity, were reported. Seven adverse reactions in six patients, including headache, diarrhea, nausea, and flushing were reported. Baxter's continuation study for patients who completed the pivotal trial and the Phase 3 study among previously treated patients under the age of 12 with severe hemophilia A remain ongoing. Upon completion of the pediatric study, Baxter expects to file for marketing authorization with the European Medicines Agency in 2016. BAX 855 is based on ADVATE, a full-length FVIII molecule with more than 11 years of real-world patient experience. Through a collaboration with Nektar Therapeutics, BAX 855 leverages proprietary PEGylation technology designed to prolong the amount of factor VIII available for use in the body. This proprietary technology has been used for 15 years in a number of approved medicines that treat chronic or serious conditions.

Baxter International Inc. Announces Unaudited Consolidated Earnings Results for the Fourth Quarter and Full Year Ended December 31, 2014; Provides Earnings Guidance for the First Quarter of 2015

Baxter International Inc. announced unaudited consolidated earnings results for the fourth quarter and full year ended December 31, 2014. For the quarter, the company reported net sales of $4,472 million compared to $4,322 million for the same period a year ago. Pre-tax income from continuing operations was $598 million compared to $524 million for the same period a year ago. Adjusted pre-tax income from continuing operations was $922 million compared to $941 million for the same period a year ago. Income from continuing operations before income taxes was $598 million compared to $524 million for the same period a year ago. Income from continuing operations was $524 million or $0.96 per diluted share compared to $409 million or $0.74 per diluted share, for the same period a year ago. Net income was $953 million or $1.74 per diluted share compared to $326 million or $0.59 per diluted share for the same period a year ago. Adjusted pre-tax income (excluding special items) was $922 million compared to $941 million for the same period a year ago. Adjusted net income from continuing operations, excluding special items was $733 million or $1.34 per diluted share compared to $720 million or $1.31 per diluted share for the same period a year ago. Adjusted net income was $745 million or $1.36 per diluted share compared to $727 million or $1.33 per diluted share for the same period a year ago. Cash flows from operations were $1,143 million compared to $1,083 million for the same period a year ago. Net debt, as at December 31, 2014 was $6,380 million compared to $6,433 million, as at December 31, 2013. Capital expenditures were $573 million compared to $488 million for the same period a year ago. For the full year, the company reported net sales of $16,671 million compared to $16,671 million for the same period a year ago. Pre-tax income from continuing operations was $2,439 million compared to $2,546 million for the same period a year ago. Adjusted pre-tax income from continuing operations was $3,427 million compared to $3,319 million for the same period a year ago. Income from continuing operations before income taxes was $2,439 million compared to $2,546 million for the same period a year ago. Income from continuing operations was $1,946 million or $3.56 per diluted share compared to $2,012 million or $3.66 per diluted share, for the same period a year ago. Net income was $2,497 million or $4.56 per diluted share compared to $2,012 million or 3.66 per diluted share for the same period a year ago. Adjusted pre-tax income (excluding special items) was $3,427 million compared to $3,319 million for the same period a year ago. Adjusted net income from continuing operations, excluding special items was $2.683 million or $4.90 per diluted share compared to $2,577 million or $4.69 per diluted share for the same period a year ago. Adjusted net income was $2,830 million or $5.17 per diluted share compared to $2,668 million or $4.86 per diluted share for the same period a year ago. Cash flows from operations were $3,215 million compared to $3,198 million for the same period a year ago. Net debt, as at December 31, 2014 was $6,380 million compared to $6,433 million, as at December 31, 2013. The company generated cash flows from operations of approximately $3.215 billion compared to $3.198 billion for the same period a year ago and invested record levels in research and development and capital improvements. The company’s investments in research and development grew 22% to more than $1.4 billion, while capital expenditures increased 24% to $1.898 billion against last year’s $1.525 billion, reflecting investments in manufacturing capacity to support future demand and growth opportunities across the company's global portfolio. The company also provided earnings guidance for the first quarter of 2015. For the first quarter of 2015, the company expects sales growth of approximately 2% to 3%, excluding the impact of foreign currency. Including the impact of foreign currency, the company expects sales to decline approximately 3% to 4%. The company also expects earnings from continuing operations, before special items, of $0.85 to $0.90 per diluted shaconsolidatedre, which reflects traditional seasonality, the impact of foreign currency, increased generic competition, and additional manufacturing and operational costs which are expected to be pronounced in the first quarter of 2015. The first quarter 2015 earnings guidance excludes approximately $0.09 per diluted share of projected intangible amortization expense. Reconciling for the inclusion of intangible asset amortization results in GAAP (Generally Accepted Accounting Principles), the earnings will be expected to be from $0.76 to $0.81 per diluted share, before other special items, for the quarter.

Baxter International Inc. Receives FDA Approval for LSolution for Electrolyte Management During Continuous Renal Replacement Therapy

Baxter International Inc. announced the United States Food and Drug Administration has approved PHOXILLUM Renal Replacement Solutions (BK4/2.5 and B22K4/0) as replacement solutions in continuous renal replacement therapy to correct electrolyte and acid-base imbalances, and in case of drug poisoning when CRRT is used to remove dialyzable substances. The FDA has granted PHOXILLUM orphan drug designation for use in CRRT. Hypophosphatemia (abnormally low concentration of phosphate in the blood) is a common electrolyte disturbance in patients treated with CRRT.1 PHOXILLUM is the only FDA approved pre-mixed solution containing phosphate in a 5L bag. It is designed to facilitate electrolyte management during CRRT by allowing use of a single type of solution across a wide clinical spectrum of acute kidney injury patients. Hemodynamic status and fluid, electrolyte and acid-base balance should be monitored. These abnormalities may be corrected by changing the formulations of replacement solution or by supplementation. The approval includes PHOXILLUM formulations containing different bicarbonate concentrations. CRRT is a dialysis modality used to treat disorders that develop as a result of AKI, especially toxin accumulation, fluid overload, and both acid-base and electrolyte disturbances. Due to its continuous nature, CRRT slowly corrects these abnormalities over time, allowing for treatment to be provided for unstable patients in the intensive care unit. AKI often occurs in hospitalized patients treated in an intensive care environment, and it typically occurs over a few hours to a few days. Patients losing the ability to filter waste products and excess fluid adequately require renal replacement therapy in most cases. Baxter anticipates PHOXILLUM phosphate-containing solutions will be available in the United States in the second quarter of 2015.

 

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