Dec. 19, 2013, 3:44 PM
- Baxter (BAX -0.5%) gets another indication for the hemophilia treatment FEIBA.
- The FDA has approved the drug for the prophylactic treatment of patients with hemophilia A or B who have developed inhibitors.
- "This additional indication ... is aimed at reducing the number of bleeds among this patient population," the company's president of BioScience says. (PR)
Nov. 18, 2013, 3:12 PM
- Perhaps not surprisingly, Credit Suisse's Baxter (BAX +0.1%) upgrade is in part attributable to the expected three-month delay in FDA approval for Biogen's (BIIB -2.1%) long-lasting factor VIII therapy Eloctate.
- Concerns about looming competition in the hemophilia market have been a thorn in BAX's side over the past several months.
- In hiking his price target to $80 from $73, analyst Bruce Nudell also highlights "BAX's recent enrollment of its own long-acting rFVIII trial" (BAX 855) and points to "the potential for value creation should BAX split its Medical Products & Bioscience segment."
Nov. 18, 2013, 8:39 AM
Nov. 18, 2013, 7:39 AM
- Cell Therapeutics (CTIC) expects to spend $96M through mid-2017 on the development and commercialization of its Pacritinib treatment for myelofibrosis and acute myeloid leukemia.
- Cell Therapeutics expects to receive $67M from Baxter (BAX) in milestones until 2015 as part of a licensing agreement for Pacritinib, with further payments possible after that. Cell Therapeutics is also receiving a $60M upfront payment from Baxter. Cell Therapeutics reckons that it should receive enough money to avoid have to raise more equity financing.
- Cell Therapeutics and Baxter have been boosted by the failure of Sanofi's (SNY) Fedratinib treatment for myelofibrosis. Incyte (INCY) also develops a treatment for the rare bone-marrow cancer.
- Cell Thera is +7.5%.
Nov. 15, 2013, 10:15 AM
- Cell Therapeutics (CTIC +20.6%) soars as investors react to news the company has inked a licensing agreement with Baxter (BAX +0.9%) for the development and commercialization of pacritinib.
- As for Incyte (INCY +2.6%) — whose Jakafi also treats myelofibrosis — any downside the shares might have realized from the prospective competition appears to be taking a backseat to either a 13D filing by Baker Bros. or perhaps a price target hike at Brean.
Nov. 15, 2013, 7:56 AM
- Cell Therapeutics (CTIC) and Baxter (BAX) enter into a licensing agreement for the development and commercialization of pacritinib (the JAK2/FLT3 inhibitor that's currently in Phase 3 testing for myelofibrosis).
- Terms: Upfront payment to CTIC of $60M, $30M of which is an equity investment; CTIC eligible for milestone payments up to $112M and sales milestone payments assuming approval; CTIC gets royalties on sales outside the U.S., where BAX has assumed commercialization rights; the two companies will jointly commercialize the drug in the U.S.
- BAX will book a $30M pre-tax R&D charge in Q4.
- CTIC calls BAX "the ideal strategic partner." (PR)
- On watch today are shares of Incyte (INCY), whose Jakafi may see some competition from pacritinib, although it isn't clear how much of a dent pacritinib will make.
Nov. 13, 2013, 10:02 AM
- Baxter (BAX +0.3%) completes enrollment in a Phase 3 trial for the investigational extended half-life rFVIII hemophilia A treatment BAX 855.
- The study will evaluate BAX 855's efficacy in terms of reducing ABR "in both prophylaxis and on-demand treatment schedules."
- BAX says that while it is "focused first and foremost on strategies to address optimal efficacy and minimize patients bleeding episodes," the company is also "delivering on the convenience of less frequent dosing for this population with severe disease."
- The company expects to file for approval "late in 2014." (PR)
- For more on BAX, hemophilia, and the competitive environment, see here.
Nov. 12, 2013, 10:26 AM
Oct. 28, 2013, 1:49 PM
- "According to EMA documents, a review is going on regarding a potential data exclusivity decision and the agency looks likely to reach a conclusion by November. We expect the decision to be made public on November 22 after CHMP meeting," Deutsche's Robyn Karnauskas says, regarding regulatory data protection for Tecfidera in Europe. The decision will affect when the MS drug could face generic competition in the region.
- Karnauskas sees fair value of $250/share with EU exclusivity and $238/share without it — if there's no EU launch at all, Karnauskas sees $225/share. Adding in hemophilia estimates, Deutsche has a target of $270 on the shares assuming RDP for Tecfidera.
- Speaking of hemophilia, CEO George Scangos says approval for BIIB's Eloctate may be delayed. "The matter under discussion does not pertain to the safety or efficacy of the product or any of the clinical trial data," Scangos notes.
- Some analysts believe Eloctate is bad news for Baxter (BAX +2.1%) in terms of competition in the hemophilia space, although Goldman thinks the concerns are overblown.
Oct. 23, 2013, 2:49 PM
- Finally, a sell-sider comes to Baxter's (BAX -0.1%) defense amid escalating worries about competition in the hemophilia space.
- "Hemophilia is a highly nuanced condition in terms of patient-specific therapeutic regimens and requires intensive self-management," Goldman's David Roman says, noting that the firm has "undertaken a behavioral analysis to assess the dynamics around switching and the logistics involved."
- Goldman's conclusion: "Based on a review of physician office visits and a detailed patient demographic build, we think a reasonable rate of switching would approximate 10%-20% (of US Prophy patients) and could potentially reduce Baxter's 2015E EPS by 1-2%."
- BAX maintained at Conviction Buy with a price target of $80.
- More on the BAX hemophilia issue here
Oct. 18, 2013, 8:42 AM
Oct. 17, 2013, 7:48 AM
- Shares of Baxter (BAX) slip 3.8% in premarket trading as investors digest the company's quarter.
- Revenue of $3.8B is a 9% improvement from last year's quarter, although the top line fell slightly short of Street estimates (around 3% of the Y/Y growth is attributable to the Gambro acquisition).
- U.S. sales rose 9%, as did international sales.
- "Improved" demand for Advante and Feiba drove a 6% Y/Y increase in BioScience revenues
- Medical Products sales rose 10% (including Gambro).
- Outlook: Q4 sales growth of 14-15% (ex-currency impact) and EPS of $1.24-1.26 against consensus of $1.26/share on $4.31B in sales. FY13 sales growth of 7% (ex-currency impact and including Gambro) and EPS of $4.65-4.67 — the earnings outlook is consistent with previous guidance and is in line with consensus. (PR)
Oct. 17, 2013, 7:05 AM
Oct. 17, 2013, 12:05 AM
Oct. 16, 2013, 5:30 PM
Oct. 16, 2013, 1:15 PM
- "Snapping up market share in bleeding disorders won't be easy," Fierce Biotech's Tracy Staton notes, regarding FDA BLA approval for Novo Nordisk's (NVO +1.7%) NovoEight.
- Entrenched competitors in the hemophilia market include Baxter (BAX) — whose market position could come under pressure in the future thanks to competition from Biogen's (BIIB) long-acting clotting factor therapies (see here and here) — and Pfizer (PFE).
- Nevertheless, "NovoEight's approval is a step toward replacing [expected] lost revenues" from NovoSeven.
- Other relevant info cited by Staton: In June, the FDA "refused to approve rFXIII ... for the rare bleeding disorder congenital factor XIII deficiency [citing] problems with NVO's manufacturing, and last year, the drugmaker canned another potential entry in hemophilia, vatreptacog alfa, after some patients developed antibodies to the treatment."
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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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