Replies to post #73805 on Biotech Values

[DewDiligence]

Manhattan Dialysis Clinic May Have Infected Patients With Hepatitis C

[No wonder at-home peritoneal dialysis is catching on in a big way. The word “may” in the title of this article is patently superfluous.]

http://www.nytimes.com/2009/03/06/health/06clinic.html

›March 6, 2009
By RONI CARYN RABIN

At least nine kidney patients who now have hepatitis C may have been infected during treatment sessions at a Manhattan dialysis center that closed last year, according to the results of an investigation published on Thursday by the federal Centers for Disease Control and Prevention.

Four of the patients’ infections are genetically linked, the investigators said, indicating that those patients were almost certainly infected at the clinic, the Life Care Dialysis Center at 221 West 61st Street. The center was closed last year following allegations of unsanitary operating conditions.

According to the report, which appeared in the C.D.C.’s Morbidity and Mortality Weekly Report, still other patients may also have been infected at the clinic. But the investigation was confined to the 162 who were being treated as of September 2008, when the center closed.

Earlier statements from state health officials had confirmed only one infection with the virus among clinic patients. Hepatitis C is an often silent infection that can lead to cirrhosis, liver failure and cancer.

The patients whose infections were genetically linked came in for treatment on the same days of the week, and two had been hooked up to the same dialysis machines, the investigators reported.

The clinic tested patients occasionally for hepatitis C and was aware that some had tested positive for infection with the virus, but it never informed those patients or state health officials as required, the report said.

The investigation was triggered by a patient who called state health authorities in January 2008 to complain that the clinic was dirty, said Dr. Jenifer Jaeger, a C.D.C. officer assigned to New York State and the new report’s principal investigator.

The Office of Health Systems Management, part of the New York State Health Department, began an investigation in March, Dr. Jaeger said. It found, among other things, that the patient who made the phone call had tested positive for hepatitis C in January. “She had not been informed,” Dr. Jaeger said.

Dr. Walter Wasser, the physician who was the operator and medical director of the dialysis center, could not be reached for comment. He was fined $300,000 in September 2008 and surrendered the clinic’s operating certificate, but the state Office of Professional Medical Conduct has not taken formal action against him.

The dialysis center was described by the investigators as a filthy place where employees did not wash their hands properly, disinfect equipment or always wear gloves when treating patients. Dried blood was found on treatment chairs, bleach solution was not stored or prepared properly, and there was no separate clean area for storage or preparation of medications.

The dialysis center, located at a convenient spot near public transportation, operated at full capacity, and turnover time between patients was short, investigators said.

In one case described in the report, a single bleach-soaked gauze pad was used to clean an entire patient dialysis station, including the machine’s surfaces and equipment like the blood-pressure cuff and shared computer monitor and keyboard. Many staff members were unaware of the center’s written infection control policies about cleaning and disinfection.

Medical guidelines require strict testing and monitoring of dialysis patients for hepatitis C infection, both at the start of treatment and every six months afterward. The clinic tested patients erratically, sometimes once a month and sometimes every other year, according to the report.‹

[DewDiligence]

BAX Reports 2Q08 Results

[BAX has three operating divisions: BioScience, which includes recombinant and plasma-derived drugs; Medication Delivery, which includes low-tech and high-tech devices used by hospitals; and Renal, which consists of devices for peritoneal dialysis. With about 60% of sales outside the US, BAX has been adversely affected by the strong dollar relative to 2008. (BAX’s EU earnings are largely hedged for currency swings, but earnings in Asia and Latin America are not.) In 2Q09, BioScience, the largest and fastest-growing division, grew sales 13% in constant currencies; the overall company grew sales 8% in constant currencies, but exchange rates had a negative effect of 1,000 basis points resulting in a 2% sales decline in dollars. Nevertheless, 2Q09 EPS increased 13% to $0.96 due to operating leverage and share repurchases. For the full year, BAX raised EPS guidance slightly to $3.76-3.80. This figure excludes profits from the H1N1 vaccine, which are expected to be de minimis in 2009, due to high start-up costs, but could be material in 2010.

BAX has two development programs worthy of special note: i) an H1N1 pandemic vaccine using cell-based production that is almost ready for shipping; and ii) Gammagard (IGIV) for Alzheimer’s disease, which reported encouraging data in phase-2 (#msg-28594685) and is now in phase-3 with data expected in mid 2011 (http://clinicaltrials.gov/ct2/show/NCT00818662 ).]

http://finance.yahoo.com/news/Baxter-Reports-Strong-Second-bw-3454939368.html?x=0&.v=1

›Thursday July 16, 2009, 7:00 am EDT

DEERFIELD, Ill.--(BUSINESS WIRE)--Baxter International Inc. (NYSE: BAX ) today reported strong financial results for the second quarter of 2009 and raised its full-year financial outlook.

Second quarter net income of $587 million increased 8 percent from the $544 million reported in the second quarter of 2008. Earnings per diluted share of $0.96 increased 13 percent from $0.85 per diluted share reported in the prior-year period, and compares favorably to the guidance the company previously provided of $0.93 to $0.95 per diluted share. This performance was the result of strong underlying fundamentals across the portfolio, improved margins, and benefits derived from the company’s ongoing share repurchase program.

Baxter’s worldwide sales of $3.1 billion declined 2 percent in the second quarter. Excluding the impact of foreign currency, worldwide sales increased 8 percent. Sales within the United States increased 7 percent to $1.3 billion, while international sales declined 8 percent to $1.8 billion. Excluding the impact of foreign currency, Baxter’s international sales grew 9 percent.

In the second quarter, BioScience revenues totaled $1.4 billion, which represents a 2 percent increase over the prior-year period. Excluding foreign currency, BioScience sales advanced 13 percent, reflecting strong double-digit gains across several core franchises, which offset weak sales of the company’s FSME vaccine, primarily in Germany. Key drivers of this performance include robust growth of antibody therapies and other specialty plasma therapeutics, strong sales of recombinant therapies, including ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] for the treatment of hemophilia, as well as biosurgery products.

Medication Delivery sales of $1.1 billion declined by 3 percent and excluding foreign currency increased 8 percent. Renal sales of $550 million declined 8 percent and excluding foreign currency increased 4 percent. Contributing to these results was growth across multiple product categories including products used in peritoneal dialysis (PD) treatment, intravenous therapies, anesthesia products and injectable drugs.

Six-Month Results

For the first six months of 2009, Baxter’s net income totaled $1.1 billion, an increase of 13 percent, with earnings per diluted share of $1.79, an increase of 18 percent compared to $1.52 per diluted share reported in the prior-year period. On an adjusted basis, excluding a special item from 2008, Baxter’s net income increased 8 percent over the $1.0 billion reported in the same period last year. Adjusted earnings per diluted share for the six-month period increased 13 percent to $1.79 per diluted share, from $1.59 per diluted share in the prior-year period.

Baxter’s worldwide sales in the first half of the year totaled $5.9 billion, and declined 2 percent, from $6.1 billion in the prior-year period. Excluding the impact of foreign currency, sales growth for the first six months of 2009 was 7 percent. Sales within the United States totaled $2.6 billion, an increase of 6 percent over the same period last year, while international sales declined 7 percent (and excluding the impact of foreign currency increased 8 percent) to $3.4 billion.

Cash flow from operations totaled $1.0 billion in the first half of 2009, and the company has returned $1.2 billion to shareholders through both share repurchases and dividends during the first six months of the year. Baxter repurchased 16 million shares of common stock (or 13 million on a net basis) for approximately $866 million (or $743 million on a net basis), and paid dividends totaling $318 million, an increase of 16 percent versus the prior year.

“We continue to meet or exceed short-term financial goals, as reflected in the strong sales and earnings performance for the first half of 2009, while investing to create long-term value for shareholders,” said Robert L. Parkinson, Jr., chairman and chief executive officer. “These results and outlook validate the strength of the diversified healthcare model and reinforce our confidence in achieving longer-term objectives as we accelerate the pace of R&D investment.”

Advancing Innovation and Expanding Product Offering

The company continued to advance and expand its product pipeline across its business portfolio in the first half of 2009 with continued investment in research and development, augmented by new business development initiatives. Baxter’s investments in research and development through the second quarter totaled $443 million, reflecting an increase of 8 percent over the same period last year. Recent achievements include:

* Completing patient enrollment in Baxter’s pivotal Phase III study of GAMMAGARD LIQUID with rHuPH20 (PH20) hyaluronidase enzyme for the treatment of primary immunodeficiency disorder (PID). Patients will receive monthly subcutaneous injections of Halozyme Therapeutics, Inc.’s PH20 with Baxter’s GAMMAGARD LIQUID.

* Testing and evaluation of A/H1N1 influenza virus and the start of full-scale production of a commercial A/H1N1 pandemic vaccine using Baxter’s Vero cell culture technology.

* Initiation of a Phase III study following successful completion of a Phase II study evaluating TISSEEL fibrin sealant as a hemostatic agent in vascular surgery. These studies are being conducted for submission to the Food and Drug Administration (FDA) to support a broad hemostasis indication for this product in the United States.

* Signing a definitive agreement with Edwards Lifesciences Corporation for the acquisition of certain assets related to Edwards’ hemofiltration product line, also known as Continuous Renal Replacement Therapy (CRRT). CRRT provides a method of continuous yet adjustable fluid removal that can gradually remove excess fluid and waste products that build up with the acute impairment of kidney function, and is usually administered in an intensive care setting in the hospital.

Third Quarter and Full-Year 2009 Outlook

Baxter also announced today its guidance for third quarter 2009 and updated its guidance for the full year.

For the third quarter of 2009, Baxter expects sales growth, excluding the impact of foreign currency, of approximately 7 to 8 percent. Based on current foreign exchange rates, the company expects reported sales including the impact of foreign currency to be approximately flat over the prior-year period. Baxter also expects to achieve earnings per diluted share of $0.95 to $0.97, before any special items, in the third quarter.

For the full year, Baxter continues to expect sales growth, excluding the impact of foreign currency, to be approximately 7 to 8 percent. Based on current foreign exchange rates, Baxter expects reported sales growth to be approximately flat. In addition, the company now expects earnings per diluted share of $3.76 to $3.80, before any special items [the prior guidance was $3.70-3.78 (#msg-35023827)], and continues to expect cash flow from operations to total more than $2.6 billion.

A webcast of Baxter's second quarter conference call for investors can be accessed live from a link on the company's website at www.baxter.com beginning at 7:30 a.m. CDT on July 16, 2009. Please visit Baxter's website for more information regarding this and future investor events and webcasts, including the company’s Investor Conference to be held in Chicago on September 16, 2009.

Baxter International Inc., through its subsidiaries, 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 and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.‹

[DewDiligence]

Baxter’s biennial Investor Day presentation was held on on 9/16/09. The PR announcing the presentation included these notable excerpts (see the end of this post for the presentation slides):

http://finance.yahoo.com/news/Baxter-Hosts-2009-Investor-bw-3360789694.html?x=0&.v=1

Over its five-year long-range plan period , Baxter expects to increase sales approximately 7 to 8 percent (excluding the impact of foreign currency), grow earnings per share in the 11 to 13 percent range, and generate strong annual cash flow of approximately $4 billion by the year 2014. The company also plans to continue focusing on innovation and expanding its robust pipeline by increasing investments in R&D at a compounded annual rate of at least 8 to 10 percent.

Over the last 12 months, Baxter has initiated 14 Phase III clinical trials, and is advancing numerous earlier stage clinical trials of therapies that have the potential to profoundly impact the treatment and delivery of care for chronic diseases like Alzheimer’s, kidney failure, cardiovascular, diabetes, thrombotic thrombocytopenic purpura, multifocal motor neuropathy, as well as public health threats like pandemic and seasonal influenza.

The presentation slides are in seven separate pdf files at: http://investor.baxter.com/phoenix.zhtml?c=86121&p=irol-EventDetails&EventId=2026093 .