There is good news from
Baxter International Inc.
). The Illinois-based global medical products and services
company announced receipt of the U.S. Food and Drug
Administration (FDA) approval for its FEIBA (Anti-Inhibitor
Coagulant Complex) treatment as well as CE marking in Europe for
the VIVIA hemodialysis (HD) system. The news resulted in a 2.7%
rise in the stock till yesterday.
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FEIBA is the first and only FDA-approved treatment for routine
prophylaxis that controls the frequency of bleeding episodes in
hemophilia A or B patients, who have developed inhibitors.
Inhibitors are antibodies produced by the body's immune system in
response to factor replacement treatment. About one-third of
previously untreated patients with hemophilia A are at risk of
Development of inhibitors is a major complication associated with
hemophilia treatment. Inhibitors lead to lack of response to
treatments and their presence increases the risk of developing
A pivotal Phase III study, FEIBA PROOF, is responsible for the
approval. The study showed a 72% reduction in median annual bleed
rate (ABR) compared to treatment with an on-demand regimen.
VIVIA Hemodialysis system
VIVIA hemodialysis system is capable of delivering frequent,
extended duration, short daily or nocturnal home HD therapy,
known as High Dose HD therapy1. It is designed with the patient
as the primary operator.
BAX will introduce VIVIA in a few number of European dialysis
clinics in 2014 to allow patients and healthcare providers become
familiar with the system. The company plans to expand launching
the product to other European nations in 2015.
Recent Other Development
Last month, Baxter entered a global licensing agreement with
Cell Therapeutics, Inc.
) to jointly develop and commercialize JAK2/FLT3 inhibitor
pacritinib that fights against genetic mutations linked to
myelofibrosis, leukemia and some tumors. As per the agreement,
BAX gained the commercialization rights for all indications for
pacritinib outside the U.S. while it jointly commercializes with
CTIC in the U.S. Following the announcement, shares of Baxter
rose 0.2% to $68.82 after the market closed yesterday.
According to the agreement, Baxter will provide an upfront
payment of $60 million, including a $30 million equity investment
in CTIC. Moreover, Cell Therapeutics will receive clinical,
regulatory, and commercial launch milestone payments of up to
$112 million ($40 million of which relates to clinical milestones
likely to be achieved in 2014) from BAX.
Baxter posted a 4% rise in third-quarter 2013 adjusted earnings
per share to $1.19, in line with the Zacks Consensus Estimate.
The third-quarter results were also within the company's earlier
stated guidance of $1.18-$1.21.
Revenues for the quarter went up 9% to $3,774 million but
slightly missed the Zacks Consensus Estimate of $3,795 million.
On an organic basis (excluding Gambro that contributed $100
million), revenues climbed 6%. Foreign currency did not impact
revenues in the quarter. On a geographic basis, revenues in the
U.S. as well as internationally improved 9% to $1,642 million and
$2,132 million, respectively.
For the fourth quarter of 2013, BAX expects revenue growth in the
range of 14% to 15% (12% to 13% at CER). This includes the impact
of the Gambro AB acquisition, amounting to $400 million. Adjusted
earnings per share are expected in the band of $1.24 to $1.26.
The Zacks Consensus Estimate for revenues and earnings per share
are pegged at $4,249 million and $1.25 respectively, for the
Baxter affirmed its earnings forecast for 2013, which includes
the impact of its Gambro acquisition. For 2013, the company
expects reported revenue growth of 6% (7% at CER). Excluding the
impact of foreign exchange rate and the Gambro acquisition,
Baxter continues to expect sales growth of approximately 4% (or
3% including the impact of foreign currency). The company expects
to generate revenues from the Gambro acquisition of approximately
$500 million for the year.
Moreover, the company anticipates adjusted earnings per share in
the range of $4.65 to $4.67 for 2013. The Zacks Consensus
Estimate for 2013 earnings per share of $4.66 lies within the
guided range. Baxter continues to expect cash flow from
operations to be $3,300 million for 2013.
The recent collaboration with Cell Therapeutics is expected to
benefit Baxter's oncology business. It will also strengthen its
position as a solution provider for hematology and rare diseases.
Currently, Baxter has a Zacks Rank #4 (Sell). Better-ranked
medical product stocks include
). NuVasive sports a Zacks Rank #1 (Strong Buy) while Chimerix
carries a Zacks Rank #2 (Buy).