Wyeth Posts 4 Percent Drop in 2Q Profit
07.21.2004, 11:43 AM
Drug maker Wyeth reported a 4 percent drop in second-quarter profit Wednesday, citing increased research and development costs as the company works to improve its product offerings in the face of ongoing lawsuits over its former diet drugs. The Madison-based maker of antidepressant Effexor and injected arthritis drug Enbrel said net income was $827.3 million, or 62 cents per share. That compares with $864.4 million in the prior year, or 65 cents per share. Analysts surveyed by Thomson First Call had forecast earnings of 59 cents per share.
Worldwide net revenue increased 13 percent to $4.2 billion for the second quarter, although the increase would have been only 11 percent excluding the impact of favorable exchange rates. Wyeth's research and development costs during the second quarter were up 17 percent, president and CEO Robert Essner said. Over the last six months, those costs increased 27 percent over the same period in 2003.
More than a dozen projects are in late-stage human testing. "What you're seeing now is the emergence into a lot more visibility of a research effort that has been strengthened over the last several years," Essner said. Profit also was down compared to last year because of a one-time gain of $226 million in the second quarter of 2003, when Wyeth sold the rights to seven of its less-important medicines.
The company said Wednesday it continued to expect full-year earnings per share of $2.60 to $2.70, vowing "patience and perseverance" in defending itself against litigation from those who opted out of its national diet drug settlement. Wyeth, formerly known as American Home Products, made Pondimin, the fenfluramine half of fen-phen, and a chemical cousin, Redux.
"We think that we have very good positions in a very, very large majority of these cases," chief financial officer Ken Martin told analysts. "That's the focus right now. I would expect that the other side would love us to just kind of roll over and put money on the table but that's not where we're at right now."
Wyeth officials said Wednesday that there are currently 13 plaintiffs on trial. A Texas jury on April 27 awarded $1 billion to the family of a woman who died after taking one of the now-banned drugs, but Wyeth and legal experts say that award likely will be reduced.
How not to be a health fad junkie
If you think yo-yo dieting is a healthy quick fix, then you need to read this.
Anne Hart
912.652.0374 l anne.hart@savannahnow.com
Got cellulite-fighting sneakers? Excited about the latest research to develop ultrasound waves that bust up fat tissues? Ever popped a diet pill? Were you among the Americans who helped spend an estimated $9.4 billion nationally last year on cosmetic surgery and treatments like Botox and liposuction?
If you answered ''yes'' to any of the above, then chances are you're guilty of being a health fad junkie - someone who is quick to yo-yo diet, try the newest metabolism-boosting drug or shell out big bucks for body-shaping surgery.
Better to toss the TrimSpa now. Pam Steimle of Memorial Health University Medical Center takes a blood sample form 15 year old Krystle Lawrence at the corporate feel better challenge office in Savannah Mall. John Carrington Savannah Morning News
Health experts say the more effective, more affordable approach to a healthier body is to focus on much larger lifestyle changes.
Make a commitment to exercise regularly, for example, rather than spend $234 on MBT fat-busting sneakers from Swiss Masai, which promise a better-looking butt and thighs. Eat a diet rich in whole grains, fruits and veggies, take a multivitamin and quit eating after 8 p.m., rather than hit an overpriced low-carb store or down any of the multitude of high-protein bars on the market today. As a reformed yo-yo dieter, Yalonda Best of Savannah knows all this.
In the past few years, she lost pound after pound on Atkins and by taking diet pills such as Adipex Fastin and even the deadly Fen-Phen, before it was pulled from the market. "It all worked at first, every time, but then the weight came back on every time,'' Best said. "One time it came back double.'' She hopes participating in the ''feel better corporate challenge'' will help her stick to a healthy lifestyle - for good. Five Savannah teams are competing in the three-month corporate contest to be the most healthy business. The contest is different from the 20-month "feel better" campaign launched in February involving individuals rather than groups. The corporate effort involves teams of employees of sponsors for the "feel better" campaign - Clear Channel, the Savannah Morning News, WTOC, Savannah Mall and Memorial Health University Medical Center.
No quick fix
Exercising and eating right for a short period is easy. But within a year, most people are skipping Pilates class and heading back to the drive-thru. Yo-yo dieting not only doesn't have staying power, but has potential health consequences for people who repeatedly lose and regain pounds. ''It's easy to try to find a quick fix, because there are so many different diets rolling out. You're tempted to jump on the band wagon,'' Best said. "But you will only to be disappointed time and time again. The best way to go is to eat healthy, eat small portions, do not overindulge, exercise regularly and drink plenty of water.''
But despite the drawbacks, yo-yo dieting is still a viable option for people following that all-American pursuit - the quick fix. An estimated 50 percent of American women and 25 percent of American men are either dieting or thinking about dieting, The Associated Press reports. "You can't stay on a diet pill for the rest of your life,'' said Helen Hussey, clinical dietician at Memorial Health "It's for the short term. The problem is the people who get hooked on these fads don't have a good healthy, solid foundation for eating in the first place.''
The real challenge is not necessarily losing the weight, Hussey said. ''It's what you do after you lose the weight,'' she said. "They get this idea, 'I've lost this weight (so) I can afford to have this cake.' And they fall right back into their bad habits.'' Overweight people should instead strive to drop a pound a week. "If it comes off slowly, you are most likely to keep it off,'' Hussey said.
Educators at the University of California, Berkeley, report that women who began dieting before age 14 were not only heavier, but were also more than twice as likely to have dieted more than 20 times than women who began restricting calories later, The AP reports. Those who begin this pattern of losing and regaining pounds before puberty could disrupt their physical development.
Yo-yo dieting may also weaken the immune system, say researchers at the Fred Hutchinson Cancer Research Center in Seattle. In a study of 114 obese, sedentary women ages 50 to 75, researchers measured the effectiveness of natural killer cells, which attack viruses and cancers, AP said. Each woman was asked how many times she had taken off at least 10 pounds in the previous two decades. Among women who had lost weight at least five times, natural killer cell function dropped 30 percent, the researchers reported. The immune cells are part of the body's complex defense against illness and infection.
Yo-yo dieting may also leave some people worse off than they would be carrying excess weight, The AP reports. A 2001 article in the Journal of the American College of Cardiology showed yo-yo dieters had 7 percent lower levels of high-density lipoprotein, the good cholesterol. To help make weight loss a gradual and permanent change, communities are being built to get residents to automatically incorporate activity into their lifestyle. The suburban sprawl of strip malls, convenience stores, fast-food joints and subdivisions without sidewalks cause people to drive everywhere. To counter that trend, communities are being built nationally to force people to walk more by mixing housing and businesses.
Just look at the King Farm development outside Washington. It's one of the largest and newest ''walkable'' developments, consisting of a mix of townhouses and single-family homes on streets lined with wide sidewalks, according to an AP report. Common areas and parks are scattered throughout. Homes are constructed around a commercial center that mixes office buildings with a grocery store, restaurants and other businesses. Researchers chose King Farm as part of a four-year, $2 million federally funded study to evaluate the effects such communities have on how active residents are and how much they weigh.
Federal health officials are developing a model planning code that communities can adopt, using local zoning, ordinances and tax incentives to require sidewalks and other measures to promote walking. Investigators are studying about 2,400 people in 32 neighborhoods, half in Maryland and half in the Seattle area, conducting surveys about their habits and asking them to wear special meters that measure physical activity. Like the proper approach to weight loss, the study is expected to take a little time.
Company Completes Enrollment in STRIDE-4;
Conference Call Scheduled for 4:30 p.m. ET Today
HOUSTON, July 28 /PRNewswire-FirstCall/ -- Encysive Pharmaceuticals (Nasdaq: ENCY) today announced financial results for the second quarter ended June 30, 2004. The Company also announced that it has closed enrollment in STRIDE-4, a placebo controlled trial evaluating two dosages of Thelin(TM) versus placebo in patients with pulmonary arterial hypertension (PAH).
"We have made significant progress in the second quarter towards the completion of our comprehensive Thelin clinical program," said Bruce D. Given, M.D., President and Chief Executive Officer of Encysive Pharmaceuticals. "With STRIDE-4 and STRIDE-6 fully enrolled and our pivotal study STRIDE-2 on track to complete enrollment in the third quarter, the Company is successfully
advancing its commercialization strategy of marketing the first selective endothelin antagonist in PAH."
Second Quarter 2004 Financial Overview
For the second quarter of 2004, the Company reported a net loss of approximately $12.3 million, or $0.23 per basic and diluted share, compared to a net loss of approximately $14.1 million, or $0.32 per basic and diluted share, for the same period last year. The loss in 2003 included a one-time charge of $8.4 million related to acquiring full rights to Thelin(TM). After removing the $8.4 million charge in 2003, the increased loss in 2004 over 2003 in the second quarter is primarily the result of increased research and
development costs associated with our late-stage clinical trial program supporting Thelin(TM). Revenue for the second quarter of 2004 was approximately $3.4 million compared to $2.2 million for same period in 2003. In the second quarter, the Company's royalties on net sales of Argatroban by GlaxoSmithKline (GSK) increased to $2.0 million from $1.1 million earned in the same period in 2003, an increase of 76%. Cash, cash equivalents and investments at June 30, 2004, were approximately $60.6 million compared to approximately $85.5 million on December 31, 2003.
Updated Guidance
Previously, the Company had announced plans to license rights for marketing Thelin(TM) outside North America. In June 2004, the Company announced its intention to reserve all marketing rights for Thelin(TM). As a result of this change in strategy, the Company expects to incur additional development costs, including costs associated with regulatory filings in countries outside North America. Additionally, during the first six months of 2004, the Company elected to accept patients beyond its original expectations in certain of the clinical trials and added additional human pharmacology studies. The revised outlook for expenses in 2004, detailed below, reflects these additional Thelin(TM) development costs. Royalty revenues during the first six months of 2004 have exceeded original estimates due to higher-than-expected sales of Argatroban by GSK. Encysive has, therefore, revised royalties guidance, also detailed below.
Original Outlook Revised Outlook
Royalties $6.7 to $7.6 million $7.5 to $8.5 million Revenues (including royalties) $9.0 to $10.0 million $10.0 to $11.0 million
Expenses (net of Revotar minority interest) $55.0 to $58.0 million $64.0 to $67.0 million Investment income $0.8 to $1.0 million $0.8 to $1.0 million Net loss $(46.0) to $(48.0) million $(54.0) to $(57.0) million Cash and investments at year end $32.0 to $34.0 million $25.0 to $27.0 million
Second Quarter Highlights
* GlaxoSmithKline's dedicated hospital sales force continues to make sales inroads for Argatroban, increasing net sales by 76% for the quarter. Encysive is increasing its full-year guidance for Argatroban royalties from $6.7 - $7.6 million to $7.5 - $8.5 million.
* The Company presented new data on Thelin(TM) at the American Thoracic Society Meeting in May, including results from long-term exposure to Thelin(TM) and data demonstrating that 100 mg of Thelin(TM) was as effective as 300 mg.
* Enrollment was closed in STRIDE-6 (bosentan failure study) in June with top line clinical data expected in the fourth quarter of 2004.
* The Company announced its intention to reserve all marketing rights to Thelin(TM). It had previously planned to license rights for marketing the product outside of North America, while preserving for itself U.S. and Canadian rights. The Company intends to allow the market to continue to grow globally before making a final decision on any marketing plans outside North America.
* J. Kevin Buchi, Chief Financial Officer of Cephalon, Inc., joined Encysive's Board of Directors.
STRIDE-4 Closes Enrollment
The Company today also announced that STRIDE-4, a phase III, randomized double-blind, placebo controlled, 18-week safety and efficacy study in patients with PAH, has exceeded its target of enrolling 90 patients. In this trial, patients were randomized to receive one of three treatments: Thelin(TM) 50 mg once daily; Thelin(TM) 100 mg once daily; or placebo.
Upcoming Events
* Adams, Harkness and Hill Inc. investor presentation on August 5, 2004
* Thelin(TM) data to be presented at European Society of Cardiology meeting from August 28 - September 1 in Germany and the European Respiratory Society meeting from September 4-8, 2004, in Scotland.
* Closure of STRIDE-2 enrollment expected in the third quarter 2004
* Participation in UBS investor conference September 27-30, 2004
* Corporate presence at The American College of Chest Physicians, American Heart Association, American College of Rheumatology
* STRIDE-6 (bosentan failure study) top line clinical data
Conference Call Information
You may access the conference call scheduled for Wednesday, July 28, 2004, at 4:30 p.m. (ET) either through the call-in number or an audio webcast. The access number for the call is (612) 332-0720. Or, you may participate live online via Encysive's web site at
http://www.encysive.com . The webcast replay will be available, in addition to a call replay, beginning July 28, 2004, at 8 p.m. ET through August 2, 2004. The telephone replay can be accessed by calling (320) 365-3844 and entering passcode 738874.
About Thelin(TM) and PAH
Thelin(TM) is a small molecule that blocks the action of endothelin, a potent mediator of blood vessel constriction and growth of smooth muscle in vascular walls. Endothelin receptor antagonists may prove to be effective in the treatment of a variety of diseases where the regulation of vascular constriction is important. Thelin(TM) is 6,500 fold selective in the targeting of the endothelin A receptor. Pulmonary arterial hypertension is a condition that involves high blood pressure and structural changes in the walls of the pulmonary arteries, which are the blood vessels that connect the right side of the heart to the lungs. PAH causes shortness of breath, limits activity, and is eventually fatal unless treated successfully with heart and lung transplant. Primary and
secondary PAH are estimated to afflict approximately 80,000 to 100,000 people worldwide, many of whom are children and young women. Side effects of Thelin(TM) seen in the program to date, and which occurred more frequently than in placebo, include liver dysfunction (increased ALT and AST), headache, edema, constipation, nasal congestion and flushing. Because Thelin(TM) inhibits the metabolism of warfarin, the dose of warfarin should be adjusted downward when co-administered with Thelin(TM).
About Encysive Pharmaceuticals
Encysive Pharmaceuticals Inc., a biopharmaceutical company focused on the discovery, development and commercialization of novel drugs, is recognized for our expertise in small molecule drug development and vascular biology. Argatroban, our first FDA-approved product, is being marketed by GlaxoSmithKline for heparin-induced thrombocytopenia. Encysive Pharmaceuticals is in Phase III development of the endothelin antagonist, Thelin(TM), for pulmonary arterial hypertension. Our majority-owned affiliate, Revotar Biopharmaceuticals AG, is in Phase II development with the selectin antagonist, bimosiamose, in asthma, psoriasis and atopic dermatitis. Encysive Pharmaceuticals has several other research and development programs ongoing for a range of cardiovascular and inflammatory diseases. To learn more about Encysive Pharmaceuticals please visit our web site:
http://www.encysive.com .
To Prevent Heart Attack, Stroke, Amputation, and Death: A National 'PAD Coalition' Is Formed
Thursday August 5, 3:00 pm ET
DENVER, Aug. 5 /PRNewswire/ -- The Vascular Disease Foundation has taken the lead in creating a unique coalition in partnership with 14 other major national public health organizations and professional vascular societies. At its inaugural meeting, the Coalition identified as a top priority the need for a unified, long-term national public awareness campaign about peripheral arterial disease (PAD). Another priority area is to coordinate clinician PAD educational efforts. These activities will be designed to improve the clinical outcomes of individuals with PAD. The inaugural meeting of the PAD Coalition was held on the National Institutes of Health (NIH) campus in Bethesda, MD, on June 17, 2004, in cooperation with the National Heart, Lung, and Blood Institute (NHLBI) of the NIH.
This important day-long meeting brought together vascular healthcare professionals from around the country to create the structure of the Coalition. This structure was first conceived at a strategic planning meeting held in January 2003, at which initial consensus was reached and the rationale underlying the goals of such a national PAD awareness campaign was solidified. The PAD Coalition is co-chaired by Alan T. Hirsch, M.D., past-president of the Vascular Disease Foundation, and Marge Lovell, RN, CCRC, CVN, a current officer of the Foundation.
"Individuals with PAD have traditionally not enjoyed the healthcare opportunities afforded individuals with established heart disease. The beneficial impact of the Coalition and its public education campaign is thus expected to be particularly powerful," stated Dr. Hirsch. Members of every major PAD-focused healthcare organization will be working together to design accurate, science-based, PAD-focused educational messages. According to Ms. Lovell, "We should emphasize that the establishment of this unique vascular Coalition is precedent-setting, permitting us to amplify our common mission of serving the public."
In addition to the Vascular Disease Foundation, participating organizations included the American Association for Cardiovascular and Pulmonary Rehabilitation; American College of Cardiology; American College of Physicians; American Diabetes Association; American Heart Association; American Podiatric Medical Association; American Radiological Nurses Association; Peripheral Vascular Surgery Society; Society for Clinical Vascular Surgery; Society of Interventional Radiology; Society for Vascular Medicine and Biology; Society for Vascular Nursing; Society for Vascular Surgery; and the Society of Vascular Ultrasound.
PAD is a highly prevalent disease characterized by blockages in the arteries of the legs. Individuals with PAD face a markedly increased risk of heart attack, stroke, and death. The build-up of plaque is usually a result of atherosclerosis, or hardening of the arteries -- the same condition that leads to heart artery blockages and heart attack. PAD affects 8-12 million Americans, and one in every five people over the age of 70 has the disease. Advanced age, smoking, diabetes, high blood cholesterol and hypertension are key risk factors. The most common and easily recognized symptom of PAD is discomfort, fatigue, or pain that occurs in the buttock, thigh, or calf muscles when walking, and that is promptly relieved with rest. This symptom is called "claudication." Unfortunately, current data suggest that less than one-half of individuals with PAD know they have the disease and its corresponding increased risk of death. This is believed to be because many individuals with PAD do not experience typical leg symptoms. As well, the use of accurate and safe diagnostic tests for PAD, such as the inexpensive, noninvasive diagnostic examination, called an Ankle-Brachial Index (ABI), remains relatively uncommon in most primary office practices. Early diagnosis of PAD can offer an opportunity to treat risk factors that can slow the progression of the disease and decrease the chance of a heart attack or stroke. Other treatments can decrease leg symptoms, prevent amputation, and improve quality of life.
About the Vascular Disease Foundation
The Vascular Disease Foundation is a nonprofit, public educational organization dedicated to increasing awareness of the prevention, diagnosis, and management of vascular diseases. Its outstanding board of directors includes physicians, nurses, vascular sonographers, rehabilitation professionals, and clinical researchers who have been on the forefront of fighting vascular diseases for many years.
For more information on the Vascular Disease Foundation, or on vascular diseases, call 1-866-723-4636 or visit http://www.vdf.org.
CONTACT: Sheryl Benjamin, 303-949-8337
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