Fri, Jun. 5, 4:45 PM
- Baxter International's (NYSE:BAX) Board of Directors approves the separation of its biopharmaceuticals business, known as Baxalta, and declares a special dividend distribution of 80.5% of Baxalta's common stock to Baxter shareholders who will receive one share of Baxalta for each BAX share owned. Baxter will retain a 19.5% stake.
- Baxalta will begin trading as an independent company on the New York Stock Exchange on July 1 under the symbol "BXLT."
Mon, Jun. 1, 10:13 AM
- CTI BioPharma (CTIC +17.5%) jumps in early trading in response to its announcement at ASCO (abstract #LBA7006) that patients with myelofibrosis treated with its lead product candidate, pacritinib, in a Phase 3 trial called PERSIST-1 met the primary efficacy endpoint of a statistically significant reduction in spleen volume compared to baseline at week 24. The results were originally reported in March.
- Fast Track-designated pacritinib, an oral tyrosine kinase inhibitor, is being co-developed with Baxter International (BAX -0.2%). Tyrosine kinase is an enzyme that serves as an "on/off" switch in many cellular functions. If stuck in the "on" position, unregulated cell growth occurs.
- Previously: CTI Bio up 19% premarket on Phase 3 results (March 9)
Thu, May 21, 11:18 AM
- Under the decentralized procedure, Baxter International (BAX -0.7%) submits a marketing authorization application to 17 authorities in Europe seeking approval of its 20% concentration subcutaneous immune globulin treatment for patients with primary immunodeficiencies. The company is advancing the 20% product in an effort to expand its treatment portfolio in primary immunodeficiencies.
Thu, May 21, 9:30 AM
- Alongside Goldman's list of 50 stocks appearing most as top holdings at hedge funds is its list of the 50 top shorts.
- New additions this quarter: Baxter Intl (NYSE:BAX), UPS, Marriott (NASDAQ:MAR), NextEra (NYSE:NEE), Ford (NYSE:F), National Oilwell Varco (NYSE:NOV), McDonald's (NYSE:MCD), M&T Bank (NYSE:MTB), CenturyLink (NYSE:CTL), Amgen (NASDAQ:AMGN), Pioneer Natural (NYSE:PXD), Duke Energy (NYSE:DUK), Seagate (NASDAQ:STX), AbbVie (NYSE:ABBV), Cisco (NASDAQ:CSCO).
- The full list (in order of $ value of short interest): AT&T (NYSE:T), Disney (NYSE:DIS), IBM, Verizon (NYSE:VZ), Intel (NASDAQ:INTC), Kinder Morgan (NYSE:KMI), Exxon (NYSE:XOM), Pfizer (NYSE:PFE), J&J (NYSE:JNJ), Deere (NYSE:DE), Caterpillar (NYSE:CAT), Exelon (NYSE:EXC), GE, Boeing (NYSE:BA), Halliburton (NYSE:HAL), Fox (NASDAQ:FOXA), Comcast (NASDAQ:CMCSA), UTX, Regeneron (NASDAQ:REGN), Merck (NYSE:MRK), salesforce.com (NYSE:CRM), AbbVie (ABBV), Conoco (NYSE:COP), Wal-Mart (NYSE:WMT), Eli Lilly (NYSE:LLY), Celgene (NASDAQ:CELG), Schlumberger (NYSE:SLB), AutoZone (NYSE:AZO), Wells Fargo (NYSE:WFC), Emerson (NYSE:EMR), McDonald's (MCD), Reynolds (NYSE:RAI), Target (NYSE:TGT), Accenture (NYSE:ACN), Coca-Cola (NYSE:KO).
Tue, May 19, 12:41 PM
- In this morning's Baxter International (BAX +1%) webcast, management said Baxalta's pro forma revenues this year should be close to $5.9B, a ~4% decline from 2014's $6.1B. In H2, gross margin should be 58 - 59%, operating margin should be ~29% and EBITDA margin ~33%.
- New product launches will drive over $300M in new sales.
- 2016 - 2020 outlook: annual sales growth: 6 - 8%; gross margin: 60 - 61%; annual operating earnings growth: 8%+; operating margin: 30 - 31% and EBITDA margin: 35 - 36%.
- The business will focus on three main areas: hematology, immunology and oncology. In hematology (2014 sales: $3.7B), the CAGR through 2020 is projected to be 3 - 5% led by inhibitors (5 - 7% CAGR) and hemophilia (1 - 3% CAGR). Blood disorders should contribute ~$200M in sales by 2020. In immunology (2014 sales: $2.2B), the CAGR through 2020 is expected to be at least 8% led by Immunoglobin at 8% and BioTherapeutics at 3 - 5% per annum. Biosimilars should contribute ~$150M in sales by 2020. Oncology is expected to ramp to $700M by 2020 based on the inclusion of Oncaspar ($500M without).
Mon, May 18, 3:59 PM
- In advance of the July 1 split-up of Baxter (BAX -1.6%) into two companies, the other named Baxalta, management announces key financial goals of the two independent organizations.
- Baxter's over-arching intent is to accelerate profit growth. It expects to grow sales ~4% per year through 2020 via deeper penetration of existing products, geographic expansion and new product introduction. It plans to expand operating margin 100 bps (1%) annually from ~9% in H2 2015 to ~14% by 2020 driving non-GAAP EBITDA from ~15% to ~20%. Cash flow from operations should grow more than 12% per year to greater than $2B by 2020. It expects to launch more than 20 new products over the next several years.
- Baxalta will implement a more focused and agile business model to drive its growth, led by new personalized treatments for patients with rare and orphan diseases in hematology, immunology and oncology. It expects to achieve sales growth of 6 - 8% per year and non-GAAP operating income growth of at least 8% per annum. Non-GAAP operating margin is expected to expand from ~29% to 30 - 31% by 2020 and non-GAAP EBITDA from ~33% to 35 - 36%. Cash flow from operations should be ~$2.1B by 2020.
- In conjunction with the separation, Baxter will receive ~$4B cash dividend from Baxalta and retain a 19.5% equity stake in the new firm. The monetization of the equity stake is expected to be tax-free and executed with 18 months of the split-off.
- Baxalta will host a conference call tomorrow morning at 8:00 am ET for investors.
Mon, May 18, 3:03 PM
- Goldman's sees the S&P 500 hitting a mid-year high of 2,150 by mid-year, but fading to 2,100 by year-end after the Fed hikes rates. Its 12-month forecast of 2,125 stands against the current level of 2,130.
- With appreciation returns expected to be nil, Goldman suggests having a look at its dividend growth portfolio - a sector-neutral basket of 50 stocks. They have a median yield of 2.5% and are expected to boost payouts by 16% this year and 12% in 2016. The group's P-E ratio is 15 vs. 17.3 for the S&P 500.
- The ten highest-yielding additions: Harley-Davidson (NYSE:HOG) - with a 2.3% yield, Home Depot (NYSE:HD) - 2.1%, Dr. Pepper Snapple (NYSE:DPS) - 2.5%, National Oilwell Varco (NYSE:NOV) - 3.6%, Regions Financial (NYSE:RF) - 2.3%, Baxter International (NYSE:BAX) - 3.1%, Cummins (NYSE:CMI) - 2.4%, Seagate Technology (NASDAQ:STX) - 3.9%, International Paper (NYSE:IP) - 3.1%, AES Corp (NYSE:AES) - 3%.
- Looking over a ten-year horizon, Goldman expects dividends to account for 46% of the S&P 500's 5% annualized return, up from 20% during the current bull market which started in 2009.
- ETFs: DVY, SCHD, ADX, SDOG, DLN, DHS, FDL, DTD, FVD, DVYL, SDYL
Tue, May 12, 11:31 AM
- With the aim of accelerating its commercialization efforts in cancer therapeutics, Baxter International (BAX -0.5%) acquires the Oncaspar (pegaspargase) product portfolio from Rome, Italy-based Sigma-Tau Finanziaria S.p.A. for $900M before expenses. The transaction should close in Q3.
- Oncaspar is a first-line biologic used as a component of a multi-agent chemotherapy regimen to treat acute lymphoblastic leukemia (ALL). It is an asparagine-specific enzyme that kills certain leukemic cells by depleting plasma asparagine. Some leukemic cells need exogenous asparagine to survive because they lack the essential enzyme to synthesize it themselves. It is approved for sale in the U.S., Germany, Poland and certain other countries and generates ~$100M in sales.
- The deal includes a lyophilized version on the product that is still in development. The current Oncaspar formulation is a solution with a short shelf life.
- Also included is the new chemical entity for the treatment of ALL, calaspargase pegol, a biologic in development that has an increased shelf life that should enable less frequent dosing.
- Baxter intends to explore new indications for Oncaspar, including acute myeloid leukemia.
Tue, May 5, 8:57 AM
Mon, May 4, 10:12 AM
- Baxter International (BAX +0.6%) files a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) seeking clearance for MM-398 (irinotecan liposome injection) for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. Merrimack Pharmaceuticals (MACK +3.5%), the original developer of MM-398, filed a New Drug Application (NDA) with the FDA in November.
- The companies inked an exclusive development and commercialization deal for MM-398 for ex-U.S. territories in September 2014. PharmaEngine has the rights in Taiwan.
- MM-398 is a nanotherapeutic consisting of the chemo agent irinotecan encapsulated in a liposomal sphere. It is being evaluated as a treatment of chemo-resistant tumors across multiple types of cancer.
- Previously: Merrimack pancreatic cancer product candidate Fast Track'd (Nov. 20, 2014)
Thu, Apr. 23, 8:47 AM
- Baxter International (NYSE:BAX) Q1 results ($M): Total Revenues: 3,764 (-2.2%); BioScience: 1,361 (+2.4%); Medical Products: 2,403 (-4.6%); Net Income: 430 (-22.7%); EPS: 0.78 (-22.8%); Operating Earnings: 486 (-22.2%).
- Q2 Guidance: Sales Growth: (9 - 10%); EPS ex items: $0.92 - 0.96 from $0.85 - 0.90; GAAP EPS: $0.84 - 0.88 from $0.76 - 0.81.
- The separation of the two companies, Baxter International and Baxalta, is expected to happen mid-year. Management will provide a strategic update and guidance for Baxter in the afternoon of May 18 and for Baxalta the next morning, May 19.
Thu, Apr. 23, 7:04 AM
Wed, Apr. 22, 5:30 PM
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Wed, Apr. 22, 12:16 PM
Mon, Apr. 20, 7:36 AM
- Additional data from a Phase 3 trial evaluating Baxter International's (NYSE:BAX) recombinant von Willebrand Factor (rVWF), BAX 111, for the treatment of patients with von Willebrand disease (VWD) show the trial met its primary efficacy endpoint of the number of patients who achieved treatment success for control of bleeding episodes. The data were presented during an oral session at the 2015 Scientific Symposium of the Hemostasis and Thrombosis Research Society in New Orleans.
- All patients treated in the full analysis set (n=22) experienced a 100% treatment success rating based on a four-point efficacy rating scale, comparing the estimated number of infusions needed to treat the bleeding episodes to the actual number of infusions administered. The median number of infusion required to treat bleeding episodes in the study (n=192) was one. The majority of events (81.8%) were resolved with a single infusion.
- The company submitted its regulatory application to the FDA in late 2014. It is designated an Orphan Drug by both the FDA and EMA for the treatment of von Willebrand disease, the most common form of inherited bleeding disorder, occurring in one - two percent of the general population. Many patients with VWD have minor symptoms, but some experience severe bleeding similar to patients with hemophilia.
Thu, Apr. 16, 10:03 AM
- Baxter International (BAX -0.1%) submits a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare seeking approval of BAX 855, an investigational extended half-life recombinant factor VIII treatment for hemophilia A patients at least 12 years old.
- BAX 855 is based on ADVATE, the company's recombinant factor VIII launched in 2003, that contains no blood-based additives. This eliminates the potential risk of transmitting pathogens.
- The firm filed an BLA in the U.S. in late 2014.
- Previously: Baxter submits BLA for extended half-life hemophilia treatment (Dec. 1, 2014)
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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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