Jul. 31, 2014, 2:17 PM
- The FDA's Blood Products Advisory Committee votes 15-1 supporting the risk/benefit profile of Baxter's (BAX -1.7%) HyQvia [Immune Globulin 10% (Human) with Recombinant Human Hyaluronidase].
- The product was approved in Europe in 2013 for the treatment of adult patients with primary immunodeficiency syndromes and myeloma or chronic lymphocytic leukemia with severe secondary hypogammaglobinemia and recurrent infections.
- The company expects an FDA decision this quarter.
- Related ticker: (HALO +6.2%)
Jul. 30, 2014, 9:35 AM
- Pfizer (PFE -1.7%) enters into a definitive agreement to acquire Baxter International's (BAX +0.7%) vaccine business for $635M. The transaction includes a portion of Baxter's manufacturing facility in Orth, Austria.
- The deal is expected to close by the end of 2014. Pfizer says that it will not impact its guidance for the year.
Jul. 29, 2014, 1:23 PM
- The FDA's Blood Products Advisory Committee meets on Thursday, July 31, 2014 to discuss Baxter International's (BAX +0.3%) BLA for HyQvia (Immune Globulin 10%) for the treatment for adult patients with primary and secondary immunodeficiencies. The European Commission cleared the product in May 2013.
- Related ticker: (HALO -0.9%)
- Briefing book
Jul. 22, 2014, 9:03 AM
Jul. 17, 2014, 8:10 AM
- Baxter International (NYSE:BAX) Q2 results: Total Revenues: $4,264M (+16.2%); BioScience: $1,751M (+6.9%); Medical Products: $2,513M (+23.7%).
- Bioscience Revenues: Hemophilia: $904M (+6.5%); BioTherapeutics: $548M (+6.8%); BioSurgery: $189M (+6.2%); Vaccines: $110M (+12.2%).
- Medical Products Revenues: Fluid Systems: $816M (+8.1%); Renal: $1,044M (+59.6%); Specialty Pharma: $404M (+10.4%); BioPharma Solutions: $249M (-2.7%).
- COGS: $2,041M (+5.3%); R&D Expense: $325M (+19.0%); SG&A Expense: $998M (+19.1%); Net Income: $520M (-11.9%); EPS: $0.95 (-11.2%); CF Ops: $599M (-21.5%). Gross Profit: $2,041M (+5.3%); COGS: 52.1% (+10.6%); Gross Margin: 47.9% (-9.4%); Operating Profit: $718M (-13.3%); Operating Earnings Yield: 16.8% (-25.4%); Net Earnings Yield: 12.2% (-24.2%).
- 2014 Guidance: Sales Growth: 10 - 11% up from 9 - 10%; EPS ex items: $5.10 - 5.20 versus $5.05 - 5.25; CF Ops: ~$3.5B (unch).
- Press release
Jul. 17, 2014, 7:04 AM
Jul. 16, 2014, 5:30 PM
Jul. 9, 2014, 9:16 AM
- Baxter International (BAX) acquires AesRx LLC, a private biopharmaceutical company focused on orphan drug targets. Its lead product candidate, currently in Phase 2, is Aes-103 (5-hydroxymethylfurfural) a small molecule compound being investigated as a prophylactic treatment for sickle cell disease. Financial terms are not disclosed.
Jul. 7, 2014, 9:51 AM
- Baxter International (BAX +0.3%) CFO Robert J. Hombach departs to assume senior operational responsibilities at the recently-spun-out biopharmaceuticals business. He will report to CEO Ludwig N. Hantson, Ph.D. Former Baxter treasurer James K. Saccaro rejoins the firm as CFO from Hill-Rom where he was SVP and CFO.
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
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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