Jul. 1, 2014, 7:23 AM
- CTI BioPharma (CTIC) completes enrollment in the PERSIST-1 Phase 3 clinical trial of pacritinib, an oral JAK2/FLT3 inhibitor being evaluated as a treatment for myelofibrosis. Under the terms of the development and commercialization agreement with Baxter International (BAX), CTI expects to receive a $20M milestone payment when the last patient in the trial begins dosing. The payment should occur this quarter.
- There are approximately 320 patients enrolled in PERSIST-1. It is a randomized, open-label multicenter study comparing the safety and efficacy of pacritinib with best available therapy, other that JAK inhibitors, in patients with primary myelofibrosis without exclusion for low platelet counts. The primary endpoint is the percentage of patients achieving at least a 35% reduction in spleen volume measured by MRI or CT at 24 weeks of treatment.
May 19, 2014, 10:22 AM
- The U.S. Supreme Court declines to hear an appeal by Baxter International (BAX -0.1%) in a dialysis machine patent suit with Fresenius Medical Care (FMS -0.7%). The issue is whether a court can throw out a patent infringement judgement in a case where the patent office decides that a patent is invalid while the litigation is in process. The court's action means that the July 2013 ruling by the U.S. Court of Appeals remains intact whereby it threw out a $24M judgment in favor of Baxter.
- Biotech and pharma industry groups urged the court to hear the case because the appeals court ruling creates uncertainty due to the encouragement of time-wasting dual-track litigation.
- Fresenius originally challenged the Baxter patent in 2003. Baxter counter-sued and won a judgement in 2012 that required the former to pay for infringement. During the litigation, Fresenius asked the patent office to reconsider the validity of the patent which it did in 2010.
May 5, 2014, 4:45 PM
Apr. 17, 2014, 8:58 AM
- Q1 NI of $556M increased $4M (+0.7%) compared to Q1'13. NI ex-items was $652M up 8% from last year's $601M.
- Total revenue for the quarter was $3.95B. Revenue ex-Gambro was $3.55B (+3%). Bioscience revenue was $1.61B (+5%). Medical Products revenue was $2.34B (+22%).
- Q2 guidance calls for sales growth of 12% - 13% excluding foreign currency risk and EPS ex-items of $1.18 - $1.22.
- 2014 guidance includes revenue growth of 9% - 10% ex foreign currency risk and EPS ex-items of $5.05 - $5.25.
Apr. 17, 2014, 7:02 AM
Apr. 17, 2014, 12:05 AM
Apr. 16, 2014, 5:30 PM
Apr. 16, 2014, 9:28 AM
- Baxter International's (BAX) BAX 111 treatment met the primary endpoint in a Phase III trial of patients with von Willebrand disease, the most common type of inherited bleeding disorder.
- BAX 111 successfully treated 22 patients who experienced bleeding episodes during the trial.
- Secondary endpoints included those related to additional efficacy and safety measures, pharmacokinetics and health-related quality of life.
- Shares are +1.55% premarket. (PR)
Mar. 27, 2014, 9:11 AM
Mar. 27, 2014, 8:08 AM
- Baxter International (BAX) is splitting into two companies, with one focused on biopharmaceuticals and the other on medical products.
- Baxter will make a tax-free distribution of shares in the biopharmaceuticals business to its shareholders. The company expects to complete the transaction by mid-2015.
- The biopharmaceuticals business generated 2013 annual revenues of $6B and develops treatments for hemophilia and other bleeding disorders, immune deficiencies, burns and shock.
- The medical-products business earned annual sales of over $9B and provides intravenous (IV) solutions and nutritional therapies, drug-delivery systems and administration sets, and premixed and other injectable drugs, as well as inhalation anesthetics and hospital-based biosurgery products.
- Baxter CEO Robert Parkinson will head the medical-products company, which will retain the Baxter International name.
- Ludwig Hantson, who is president of BioScience, will run the biopharmaceuticals firm. (PR)
- Shares are +12.5%.
Mar. 26, 2014, 12:27 PM
Mar. 26, 2014, 8:33 AM
- Large cap pharma and biotech firms have regenerative therapy R&D programs underway according to a recent survey.
- 69% of respondents are focused on developing cellular-based therapies.
- Wound healing and burns have the greatest near-term potential.
- Long term areas of interest are cardiovascular disease, oncology, neurodegenerative disease, monogenic disorders and ocular disease.
- (AGN) (AMGN) (BAX) (BIIB) (CELG) (LLY) (GSK) (JNJ) (NVS) (NVO) (PFE) (RHHBY) (SNY) (MRK) (SHPG)
Mar. 17, 2014, 10:23 AM
- Goldman Sachs removes Baxter International (BAX) from its Conviction List and lowers its PT from $83 to $77 but maintains its Buy recommendation. Since the firm added BAX to its Americas CL in August it is off 7.7% versus the S&P 500's 8.5% gain.
- Analyst David Roman cites a higher risk profile due to heightened competition in the plasma business.
- Investors appear unconcerned. Shares are up a fraction in early trading.
Mar. 4, 2014, 4:49 PM
- Cell Therapeutics (CTIC) Q4 revenue balloons to $32.9M versus $0 a year ago. Almost all of the revenue is due to Baxter's (BAX) upfront payment of $32.4M for the license to develop and commercialize pacritinib.
- Product revenues for Q4 and FY13 were $.5M and $2.3M, respectively.
- Net income for the quarter was $10.2M ($.08/share) due to the Baxter payment. Net loss for the year was $49.6M ($.43/share).
- FY14 guidance projects a loss from operations of $45M - $50M.
- Consensus estimate for Q1 is a loss of $.23/share on revenues of $1.3M.
- Consensus estimate for 2014 is a loss of $.48/share on revenues of $23.9M.
- Mutual fund ownership has increased from 30 to 85 the past 4 quarters.
Feb. 18, 2014, 9:28 AM
Jan. 23, 2014, 8:45 AM
- Baxter (BAX) net profit -34% to $326M, hurt by expenses related to its $4B acquisition of Swedish dialysis product manufacturer Gambro, collaborations and other items.
- Gross margin dropped to 44.7% from 50.8%
- Sales breakdown: medical products +25% to $2.59B, including $413M from Gambro. Bioscience +5% to $1.78B, mainly boosted by solid demand for Baxter's hemophilia treatments.
- Guidance: Q1 adjusted EPS $1.06-1.09 vs consensus of $1.14; 2014 EPS $5.05-5.25 vs $5. (PR)
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Baxter International Inc is a healthcare company. It develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma and other chronic conditions.
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