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Merck Announces Third-Quarter 2005 Earnings Per Share (EPS) of 65 Cents.


WHITEHOUSE STATION, N.J. -- Merck & Co., Inc.
--  Merck Anticipates Full-Year 2005 EPS Range of $2.47 to $2.51,
    Excluding Net Tax Charge, and Reported Full-Year 2005 EPS Range of
    $2.18 to $2.22

--  GARDASIL, Merck's Investigational Vaccine, Prevented 100% of
    Cervical Pre-cancers and Non-invasive Cervical Cancers Associated
    with HPV Types 16 and 18 in Phase III Study

--  U.S. Food and Drug Administration Approves PROQUAD, the First and
    Only Vaccine in the U.S. to Help Protect Children Against Measles,
    Mumps, Rubella and Chickenpox in One Shot


Merck & Co., Inc. today announced that earnings per share (EPS (Encapsulated PostScript) A PostScript file format used to transfer a graphic image between applications and platforms. EPS files contain PostScript code as well as an optional preview image in TIFF, WMF, PICT or EPSI, the latter being an ASCII-only format. ) for the third quarter of 2005 were $0.65, compared to $0.60 for the third quarter of 2004. Net income was $1,420.9 million, compared to $1,325.6 million in the third quarter of last year. Worldwide sales were $5.4 billion for the quarter, compared to $5.5 billion for the third quarter of 2004.

Total sales decreased 2% for the quarter, which reflects a decrease of 3% related to the VIOXX withdrawal, offset by other revenue growth of 1%.

For the first nine months of 2005, EPS were $1.59, including the impact of a $640 million net tax charge ($0.29 per share) recorded in the second quarter. Excluding the impact of the net tax charge, EPS for the first nine months of 2005 were $1.88. Net income was $3,511.6 million and worldwide sales were $16.2 billion for the first nine months of 2005. Total sales decreased 5% for the first nine months, which reflects a decrease of 9% related to the VIOXX withdrawal, offset by other revenue growth of 4%. Global sales performance includes a 1-point favorable effect from foreign exchange for the quarter and a 2-point favorable effect for the first nine months of the year.

"I am pleased to report that the quarter was consistent with our expectations," said Richard T. Clark, Chief Executive Officer and President. "We are focused on improving our core business fundamentals--specifically successfully launching our anticipated new products, advancing the progression of our pipeline and reducing our cost structure over and above what has been achieved to date. We must improve our performance over the long term, and I truly believe we can. By the end of the year, I'll provide details about our plans, as well as milestones and metrics that can be used to evaluate our progress against them."

Marketing and administrative expenses decreased 1% as compared to the third quarter of 2004. Excluding the VIOXX withdrawal costs of $141 million recorded in the third quarter 2004 as well as costs relating to relating to relate prepconcernant

relating to relate prepbezüglich +gen, mit Bezug auf +acc 
 ongoing global position eliminations of $80 million in the third quarter 2005 and $34 million in the third quarter 2004, marketing and administrative costs administrative costs,
n.pl the overhead expenses incurred in the operation of a dental benefits program, excluding costs of dental services provided.
 increased 5% for the quarter. The increase reflects activities required to prepare for the launch of four new investigational vaccines and maintaining activities in support of Merck's in-line products.

Research and development expenses were $943 million during the third quarter, a 3% increase from the third quarter of 2004.

Full-Year 2005 EPS Guidance

Merck anticipates full-year 2005 EPS of $2.47 to $2.51, excluding the net tax charge of $0.29 per share, reported in the second quarter, primarily relating to the American Jobs Creation Act. Merck anticipates reported full-year 2005 EPS of $2.18 to $2.22. Please see pages 12-13 of this news release for details of Merck's full-year 2005 financial guidance.

Merck's Key Franchises Maintain Leadership Positions

Merck's major franchises continue to rank either first or second in their classes, in terms of worldwide sales, and to benefit from new indications and treatment options, as well as clinical results that support their safety and efficacy profiles.

Worldwide sales of SINGULAIR, a once-a-day oral medicine indicated for the treatment of chronic asthma and the relief of symptoms of allergic rhinitis Allergic Rhinitis Definition

Allergic rhinitis, more commonly referred to as hay fever, is an inflammation of the nasal passages caused by allergic reaction to airborne substances.
, were strong, reaching $692 million for the third quarter and representing growth of 11% as compared to the third quarter of 2004. Sales for the first nine months were $2.2 billion, a 14% increase over the comparable 2004 period.

In August, Merck announced that the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) has approved SINGULAIR for the relief of symptoms of perennial allergic rhinitis (PAR), or indoor allergies, in adults and children six months of age and older. A convenient once-a-day tablet, SINGULAIR has been proven to help relieve a broad range of indoor and outdoor allergy symptoms for up to 24 hours.

Global sales of Merck's antihypertensive antihypertensive /an·ti·hy·per·ten·sive/ (-ten´siv) counteracting high blood pressure, or an agent that does this.

an·ti·hy·per·ten·sive
adj.
Reducing high blood pressure.

n.
 medicines, COZAAR and HYZAAR*, remained solid, reaching $751 million for the third quarter, representing growth of 6% as compared to the third quarter of 2004. Sales for the first nine months were $2.3 billion, a 9% increase over the comparable 2004 period.

COZAAR and HYZAAR belong to the AIIA AIIA Australian Information Industry Association
AIIA Australian Institute of International Affairs
AIIA Associazione Italiana per l'Intelligenza Artificiale
AIIA Associazione Italiana di Ingegneria Antincendio (Milan, Italy) 
 class, which remains the fastest growing class in the antihypertensive market. The AIIA class grew at 9.8% over the same period last year in the U.S. COZAAR/HYZAAR remained the number one branded AIIA in Europe and number two branded AIIA in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  in the third quarter. In early October, the FDA approved a new tablet, HYZAAR 100-12.5 mg, a new dosage offering the once-daily efficacy of COZAAR 100mg with a low-dose diuretic diuretic (dī'yərĕt`ĭk), drug used to increase urine formation and output. Diuretics are prescribed for the treatment of edema (the accumulation of excess fluids in the tissues of the body), which is often the result of underlying .

FOSAMAX remains the most prescribed medicine worldwide for the treatment of postmenopausal post·men·o·paus·al
adj.
Of or occurring in the time following menopause.


postmenopausal Change of life Gynecology adjective Referring to the time in ♀ when menstrual periods stop for ≥ 1 yr
, male and glucocorticoid-induced osteoporosis. FOSAMAX PLUS D, a new product that provides the proven power of FOSAMAX to reduce the risk of both hip and spine fractures plus the assurance of providing vitamin D vitamin D

Any of a group of fat-soluble alcohols important in calcium metabolism in animals to form strong bones and teeth and prevent rickets and osteoporosis. It is formed by ultraviolet radiation (sunlight) of sterols (see steroid) present in the skin.
 consistent with the recommended guidelines, became available in the United States earlier this year. On Aug. 25, the European Commission European Commission, branch of the governing body of the European Union (EU) invested with executive and some legislative powers. Located in Brussels, Belgium, it was founded in 1967 when the three treaty organizations comprising what was then the European Community  granted marketing authorization for this product, which is known in Europe as FOSAVANCE.

Additionally, new one-year extension results of the U.S. FACT study showed that FOSAMAX delivered significantly greater increases in bone mineral density bone mineral density
n.
See bone density.


bone mineral density A measurement of bone mass, expressed as the amount of mineral–in grams divided by the area scanned in cm2. See Bone densitometry.
 (BMD BMD

In currencies, this is the abbreviation for the Bermudian Dollar.

Notes:
The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion.
) at both the hip and spine than risedronate over two years. The increases in BMD seen with FOSAMAX were even greater compared to risedronate at year two than at year one. After two years, FOSAMAX also delivered superior reductions in bone turnover than risedronate, with a significantly greater effect after only three months of treatment.

Global sales for the franchise reached $777 million during the third quarter, which was comparable to the third quarter of 2004. Sales for the first nine months were $2.4 billion, a 3% increase compared to the first nine months of 2004.

On Oct. 17, Merck was notified that the U.S. Supreme Court would not review the previous court ruling where its claims regarding the patent covering once-weekly administration of FOSAMAX were found to be invalid. As a result, the earliest date for marketing of any generic alendronate alendronate /alen·dro·nate/ (ah-len´dro-nat) a bisphosphonate calcium-regulating agent used in the form of the sodium salt to inhibit the resorption of bone in the treatment of osteitis deformans, osteoporosis, and hypercalcemia related  in the United States continues to be February 2008.

ZOCOR, Merck's statin stat·in
n.
Any of a class of drugs that inhibit a key enzyme involved in the synthesis of cholesterol and promote receptor binding of LDL cholesterol, resulting in decreased levels of serum cholesterol.
 for modifying cholesterol, achieved worldwide sales of $1.0 billion in the third quarter, representing a decrease of 14% over the third quarter of 2004. Sales for the first nine months were $3.3 billion, a 15% decrease over the comparable 2004 period.

Merck's Other Promoted Medicines

Sales of Merck's other promoted medicines and vaccines were $1.6 billion for the third quarter, representing growth of 10% as compared with the third quarter of 2004. Sales for the first nine months were $4.4 billion, a 10% increase over the comparable 2004 period. These products treat or prevent a broad range of medical conditions See carpal tunnel syndrome, computer vision syndrome, dry eyes and deep vein thrombosis. , including infectious disease Infectious disease

A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions.
, glaucoma glaucoma (glôkō`mə), ocular disorder characterized by pressure within the eyeball caused by an excessive amount of aqueous humor (the fluid substance filling the eyeball). , benign prostate enlargement, migraine, arthritis and pain.

On Sept. 6, the FDA approved PROQUAD, a vaccine to help protect children against measles, mumps, rubella rubella or German measles, acute infectious disease of children and young adults. It is caused by a filterable virus that is spread by droplet spray from the respiratory tract of an infected individual.  and chickenpox chickenpox
 or varicella

Contagious viral disease producing itchy blisters. It usually occurs in epidemics among young children, causes a low fever, and runs a mild course, leaving patients immune. The blisters can scar if scratched.
 in a single injection. PROQUAD combines two well-established Merck vaccines -- M-M-R II and VARIVAX -- and builds on the tradition of these Merck vaccines in helping to protect children against these four potentially serious diseases.

Merck's vaccine for hepatitis A Hepatitis A Definition

Hepatitis A is an inflammation of the liver caused by a virus, the hepatitis A virus (HAV). It varies in severity, running an acute course, generally starting within two to six weeks after contact with the virus, and lasting no
, VAQTA Vaqta A vaccine against HAV made of killed hepatitis A virus to stimulate the body's immune system to produce antibodies against HAV. See Hepatitis A. , was approved by the FDA in August for use in children 12 months of age and older. Previously, VAQTA was approved for use in people two years of age and older.

Merck's Partnerships and Alliances

As reported by the Merck/Schering-Plough partnership, global sales of ZETIA and VYTORIN in the aggregate reached $630 million for the third quarter and combined new prescriptions reached 13.7% of the U.S. lipid-lowering market, according to according to
prep.
1. As stated or indicated by; on the authority of: according to historians.

2. In keeping with: according to instructions.

3.
 the most recent weekly IMS Health IMS Health (NYSE: RX) is an international consulting and data services company that supplies the pharmaceutical industry with sales data and consulting services. IMS Health was founded in 1954 by Bill Frohlich and David Dubow.  data. Sales for the first nine months were $1.7 billion.

Global sales by the Merck/Schering-Plough cholesterol partnership of ZETIA, the cholesterol-absorption inhibitor also marketed as EZETROL outside the United States, reached $356 million in the third quarter, an increase of 21% compared with the third quarter of 2004. Sales for the first nine months were $1.0 billion, a 39% increase over the comparable 2004 period. In the third quarter, ZETIA new prescriptions reached 6.4% of the U.S. lipid-lowering market, according to the most recent weekly IMS Health data.

Global sales of VYTORIN, also developed and marketed by the Merck/Schering-Plough partnership, reached $274 million in the third quarter. VYTORIN, marketed outside the United States as INEGY, is the first single cholesterol treatment to provide LDL cholesterol LDL cholesterol
n.
See low-density lipoprotein.


LDL Cholesterol
Low-density lipoprotein cholesterol is the primary cholesterol molecule. High levels of LDL increase the risk of coronary heart disease.
 lowering through the dual inhibition of cholesterol production and absorption. Sales for the first nine months were $673 million. In the third quarter, VYTORIN new prescriptions reached 7.3% of the U.S. lipid-lowering market, according to the most recent weekly IMS Health data.

Merck earns ongoing revenue based on sales of products that are associated with alliances, the most significant of which is AstraZeneca LP. Revenue from AstraZeneca LP recorded by Merck was $444 million in the third quarter and $1.2 billion in the first nine months of the year.

Merck's Pipeline Continues to Progress

Merck continued to make progress on its three investigational vaccines in late-stage development, two of which--ROTATEQ and ZOSTAVAX--are under review by the FDA and other regulatory agencies around the world. These vaccines represent significant new opportunities for Merck in the pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.

pe·di·at·ric
adj.
Of or relating to pediatrics.
, adolescent and adult vaccine markets.

On Oct. 7th, Merck presented the first Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA  data on an investigational vaccine, GARDASIL. These data, presented at the Infectious Diseases Society of America The Infectious Diseases Society of America (IDSA) is a medical association representing physicians, scientists and other health care professionals who specialize in infectious diseases.  (IDSA IDSA Infectious Diseases Society of America
IDSA Industrial Designers Society of America
IDSA Interactive Digital Software Association
IDSA Institute for Defense Studies and Analyses (India)
IDSA International Dark Sky Association
) annual meeting, reported that GARDASIL prevented 100% of high-grade cervical pre-cancers and non-invasive cancers (CIN CIN cervical intraepithelial neoplasia.
Cervical intraepithelial neoplasia (CIN)
A term used to categorize degrees of dysplasia arising in the epithelium, or outer layer, of the cervix.
 2/3 and AIS) associated with human papillomavirus human papillomavirus (HPV), any of a family of more than 60 viruses that cause various growths, including plantar warts and genital warts, a sexually transmitted disease. Detectable warts can be or removed, usually by chemicals, freezing, or laser, but often recur.  (HPV HPV human papillomavirus.

HPV
abbr.
human papilloma virus


Human papilloma virus (HPV) 
) types 16 and 18. CIN (cervical intraepithelial neoplasia cervical in·tra·ep·i·the·li·al neoplasia
n.
Dysplastic changes beginning at the squamocolumnar junction in the uterine cervix that may be precursor to squamous cell carcinoma.
) 2 is a moderate-grade lesion of the cervix cervix /cer·vix/ (ser´viks) pl. cer´vices   [L.]
1. neck.

2. the front portion of the neck.

3. cervix uteri.
 while CIN 3 represents both high-grade lesions and CIS Cis (sĭs), same as Kish (1.)


(1) (CompuServe Information Service) See CompuServe.

(2) (Card Information S
 (carcinoma in situ carcinoma in situ
n.
A neoplasm whose cells are localized in the epithelium and show no tendency to invade or metastasize to other tissues.


Carcinoma in situ 
), the immediate pre-cursor to invasive squamous cell squamous cell
n.
A flat, scalelike epithelial cell.
 cervical cancer Cervical Cancer Definition

Cervical cancer is a disease in which the cells of the cervix become abnormal and start to grow uncontrollably, forming tumors.
. AIS is the early development of adenocarcinoma adenocarcinoma: see neoplasm.  (or glandular cancer Noun 1. glandular cancer - malignant tumor originating in glandular epithelium
adenocarcinoma, glandular carcinoma

carcinoma - any malignant tumor derived from epithelial tissue; one of the four major types of cancer
) of the cervix.

The analysis compared GARDASIL to placebo in women who were not infected with HPV 16 and 18 at enrollment and who remained free of infection through the completion of the seven-month vaccination regimen. Women were followed for an average of two years after enrollment. No cases of CIN 2/3 or AIS were observed in the vaccine group (n=5,301) compared to 21 cases in the placebo group (n=5,258).

A secondary analysis, also presented at IDSA, evaluated the incidence of CIN 2/3 and AIS starting 30 days after the administration of the first dose in all of the women in the primary analysis group, as well as women who may have become infected with HPV 16 or 18 during the vaccination period. Women who may have violated the protocol in significant ways (for example, by missing certain protocol visits) were also included. On average, these women were followed for approximately two years. In this group, GARDASIL reduced the risk of developing high-grade pre-cancer and non-invasive cancer (CIN 2/3, or AIS) associated with HPV 16 and 18 by 97% (n=5,736); one case was observed in the vaccine group compared to 36 in the placebo group (n=5,766).

This trial is part of the ongoing Phase III program for GARDASIL, which involves more than 25,000 people in 33 countries worldwide. Merck remains on track to submit a Biologics License Application for GARDASIL to the FDA in the fourth quarter of 2005.

In other pipeline news, Merck presented two studies of Phase II data on Merck's DPP-4 inhibitor, sitagliptin (MK-0431), a potential new approach in the treatment of type 2 diabetes type 2 diabetes
n.
See diabetes mellitus.
, at the 41st annual meeting of the European Association for the Study of Diabetes (EASD EASD

See: European Association of Securities Dealers
) held in September. The studies showed that sitagliptin significantly improved glycemic Glycemic
The presence of glucose in the blood.

Mentioned in: Cholesterol, High


glycemic

pertaining to the level of glucose in the blood.
 control in patients with primarily mild-to-moderate hyperglycemia hyperglycemia: see diabetes.  and in patients with more severe hyperglycemia, as compared with placebo. In these studies, sitagliptin was generally well tolerated. The Phase III studies of sitagliptin are under way and Merck anticipates filing the New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) with the FDA in 2006.

Last week, Merck and Bristol-Myers Squibb Bristol-Myers Squibb (NYSE: BMY), colloquially referred to as BMS, is a pharmaceutical corporation, formed by a 1989 merger between pharmaceutical companies Bristol-Myers Company, founded in 1887 by William McLaren Bristol and John Ripley Myers in Clinton, NY (both were  jointly announced that the FDA issued an approvable letter for PARGLUVA, the companies' investigational oral medicine for the treatment of type 2 diabetes. The FDA requested additional safety information from ongoing trials, or those completed since the safety data from the last formal regulatory submission, to address more fully the cardiovascular safety profile of PARGLUVA. The companies are eager to begin discussions with the FDA to address this issue and to determine what additional information may be necessary.

In September, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted to recommend approval of PARGLUVA for use as monotherapy and in combination with metformin metformin /met·for·min/ (met-for´min) an antihyperglycemic agent that potentiates the action of insulin, used in the treatment of type 2 diabetes mellitus.

met·for·min
n.
 for type 2 diabetes.

Merck continues its strategy of establishing strong external alliances to complement our substantial internal research capabilities, including research collaborations, licensing pre-clinical and clinical compounds and technology transfers to drive both near- and long-term growth. This year to date, a substantial number of agreements have been executed or are in the final stages of negotiation.

In September, for example, FoxHollow Technologies and Merck announced the formation of a novel pharmacogenomics collaboration. The collaboration will focus on analyzing atherosclerotic plaque Atherosclerotic plaque
A deposit of fat and other substances that accumulate in the lining of the artery wall.

Mentioned in: Atherectomy

atherosclerotic plaque 
 removed from patient arteries as a means of identifying new biomarkers of atherosclerotic disease Atherosclerotic disease
The progressive narrowing and hardening of the arteries over time.

Mentioned in: Retinal Artery Occlusion
 progression for use in the development of cardiovascular compounds in Merck's pipeline. The agreement includes a research collaboration of up to three years.

Agensys, Inc., a cancer biotechnology company, and Merck announced last week that they have formed a global alliance to jointly develop and commercialize AGS-PSCA, Agensys' fully human monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing  (MAb) to Prostate Stem Cell stem cell

In living organisms, an undifferentiated cell that can produce other cells that eventually make up specialized tissues and organs. There are two major types of stem cells, embryonic and adult.
 Antigen (PSCA PSCA Profit Sharing/401(K) Council of America
PSCA Philippine School of Culinary Arts
PSCA Protein Sequence Comparative Analysis
PSCA Parts Stress Count Analysis (British Telecom) 
).

VIOXX Update

This update supplements information previously provided by the Company. Commencing with the Company's report on Form 10-Q Form 10-Q

See 10-Q.
 for the first quarter of 2006, the Company generally intends to give updates on VIOXX litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
 through its periodic filings with the Securities and Exchange Commission (SEC).

As previously disclosed, individual and putative class actions have been filed against the Company in state and federal courts alleging personal injury and/or economic loss with respect to the purchase or use of VIOXX. A number of these actions are coordinated in separate proceedings in a multidistrict litigation A procedure provided by federal statute (28 U.S.C.A. § 1407) that permits civil lawsuits with at least one common (and often intricate) Question of Fact that have been pending in different federal district courts to be transferred and consolidated for pretrial proceedings  in the U.S. District Court for the Eastern District of Louisiana The District of Louisiana or Louisiana District was an official United States government designation for the portion of the Louisiana Purchase that had not been organized into Orleans Territory. The area north of present-day Arkansas was also known as Upper Louisiana.  (the "MDL MDL - (Originally "Muddle"). C. Reeve, Carl Hewitt and Gerald Sussman, Dynamic Modeling Group, MIT ca. 1971. Intended as a successor to Lisp, and a possible base for Planner-70. Basically LISP 1.5 with data types and arrays. "), New Jersey state court, California state court, Texas state court and Philadelphia, Pennsylvania. As of Sept. 30, 2005 the Company has been served or is aware that it has been named as a defendant in approximately 6,400 lawsuits, which include approximately 11,700 plaintiff groups alleging personal injuries resulting from the use of VIOXX, and in approximately 160 putative class actions alleging personal injuries and/or economic loss (all of the actions discussed in this paragraph are collectively referred to as the "VIOXX Product Liability Lawsuits"). Of these lawsuits, approximately 2,900 representing approximately 6,300 plaintiff groups are or are slated to be in the federal MDL and approximately 2,750 representing approximately 2,750 plaintiff groups are included in a coordinated proceeding in New Jersey Superior Court before Judge Carol E. Higbee. In addition, as of Sept. 30, 2005, approximately 3,000 claimants had entered into Tolling Agreements with the Company, which halt the running of applicable statutes of limitations.

As previously disclosed, on Aug. 19, 2005, in a trial in state court in Texas, the jury in Ernst v. Merck reached a verdict in favor of the plaintiff and purported to award her a total of $253 million in compensatory and punitive damages Monetary compensation awarded to an injured party that goes beyond that which is necessary to compensate the individual for losses and that is intended to punish the wrongdoer. . Under Texas law, the maximum amount that could be awarded to the plaintiff is capped at approximately $26 million. The Company intends to appeal this verdict after the completion of post-trial proceedings in the trial court. The Company believes that it has strong points to raise on appeal and is hopeful that the appeals process will correct the verdict.

As previously reported, the trial in Humeston v. Merck is currently ongoing in New Jersey state Superior Court before a jury, with Judge Higbee presiding.

On Aug. 3, 2005, Judge Eldon E. Fallon issued an order setting the Evelyn Irvin Plunkett v. Merck case as the first case to be tried in the MDL. The trial currently is scheduled to begin on Nov. 28, 2005, in Houston, Texas “Houston” redirects here. For other uses, see Houston (disambiguation).
Houston (pronounced /'hjuːstən/) is the largest city in the state of Texas and the
 and has been brought by Evelyn Irvin Plunkett, on behalf of her late husband Richard Irvin, Jr., who died from an apparent heart attack. Plaintiff alleges that Mr. Irvin took VIOXX for approximately one month.

Judge Fallon has also scheduled three additional trials in the MDL which are currently scheduled to commence in February, March, and April 2006, respectively. In addition, there are other state court trials currently scheduled in the next six months and beyond, including Zajicek v. Merck and Guerra v. Merck, each in Texas, in March and April 2006, respectively.

Also, the Company has been named as a defendant in separate lawsuits brought by the Attorneys General of Louisiana The office of Attorney General of Louisiana existed from the colonial period to the present. Under Article IV, Section 8 of the Constitution of Louisiana, the Attorney General is elected state-wide for a four year term and is the chief legal officer of the state. , Mississippi, and Texas. These actions allege the Company misrepresented the safety of VIOXX and seek (i) recovery of the cost of VIOXX purchased or reimbursed by the state and its agencies; (ii) reimbursement of all sums paid by the state and its agencies for medical services for the treatment of persons injured by VIOXX; (iii) damages under various common law theories; and/or (iv) various remedies under state consumer fraud and fair business practices or Medicaid fraud Medicaid fraud The fraudulent billing of Medicaid by physicians or other health care providers, especially international medical graduates and psychiatrists. See Medicaid.  statutes, including civil penalties.

On Aug. 15, 2005, a complaint was filed in Oregon state court by the State of Oregon through the Oregon state treasurer The Oregon State Treasurer is a constitutional officer within the executive branch of the government of the U.S. state of Oregon, elected by statewide vote to serve a four year term.  on behalf of the Oregon Public Employee Retirement Fund against the Company and certain current and former officers and directors. The complaint, which was brought under Oregon securities law, alleges that plaintiff has suffered damages in connection with its purchases of Merck common stock at artificially inflated prices due to the Company's alleged violations of law related to disclosures about VIOXX.

In addition, as previously disclosed, on July 29, 2005, a New Jersey state trial court certified a nationwide class of third-party payors (such as unions and health insurance plans) that paid in whole or in part for the VIOXX used by their plan members or insureds. The named plaintiff in that case seeks recovery of certain VIOXX purchase costs (plus penalties) based on allegations that the purported class members paid more for VIOXX than they would have had they known of the product's alleged risks. Merck believes that the class was improperly certified. The trial court's ruling is procedural only; it does not address the merits of the plaintiff's allegations, which the Company intends to defend vigorously. The New Jersey state Superior Court, Appellate Division, has accepted Merck's appeal for review on an expedited basis.

As reported above, the Humeston v. Merck product liability trial is currently ongoing in New Jersey. Additional product liability trials have also been scheduled. The Company cannot predict the timing of any trials with respect to the VIOXX Shareholder Lawsuits. The Company believes that it has meritorious defenses to the VIOXX Lawsuits and will vigorously defend against them. In view of the inherent difficulty of predicting the outcome of litigation, particularly where there are many claimants and the claimants seek indeterminate damages, the Company is unable to predict the outcome of these matters, and at this time cannot reasonably estimate the possible loss or range of loss with respect to the VIOXX Lawsuits. As of Dec. 31, 2004, the Company had established a reserve of $675 million solely for its future legal defense costs related to the VIOXX Lawsuits and the VIOXX Investigations. In the third quarter, the Company did not increase the VIOXX legal defense reserve. The Company will continue to monitor its legal defense costs and review the adequacy of the associated reserves.

The Company has not established any reserves for any potential liability relating to the VIOXX Lawsuits and the VIOXX Investigations. Unfavorable outcomes in the VIOXX Lawsuits or resulting from the VIOXX Investigations could have a material adverse effect on the Company's financial position, liquidity and results of operations.

Merck's Response to Global Natural Disasters

Merck's facilities were not affected by Hurricanes Katrina or Rita. During the quarter, Merck assisted with the hurricane relief efforts by making cash grants and donations of medicines and vaccines totalling more than $12 million. The Company also committed to replacing prescription medicines for patients (through retail pharmacies or Merck's Patient Assistance Program) who may have lost their existing prescriptions as a result of Hurricanes Katrina and Rita. In addition, Merck and its employees have made contributions to the relief efforts in Pakistan and Central America.

Earnings Conference Call

Investors are invited to a live Web cast of Merck's third-quarter earnings conference call today at 9 a.m. EDT EDT
abbr.
Eastern Daylight Time


EDT Eastern Daylight Time

EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York

EDT 
, by visiting the Newsroom section of Merck's Web site (www.merck.com/newsroom/webcast). Institutional investors and analysts can participate in the call by dialing (706) 758-9927. Journalists are invited to listen by calling (706) 758-9928. A replay of the Web cast will be available starting at 1 p.m. EDT today through 5 p.m. EST on Oct. 31. To listen to the replay, dial (706) 645-9291 or (800) 642-1687 and enter ID # 9255693.

* COZAAR and HYZAAR are registered trademarks of E.I. DuPont de Nemours & Company, Wilmington, Del.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines in more than 20 therapeutic categories. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.

Forward-Looking Statement forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.


This press release, including the financial information that follows, contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the year ended Dec. 31, 2004, and in its periodic reports on Form 10-Q and Form 8-K Form 8-K

The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock.


Form 8-K

See 8-K.
, which the Company incorporates by reference.

Merck Financial Guidance for 2005

Worldwide net sales Net Sales

The amount a seller receives from the buyer after costs associated with the sale are deducted.

Notes:
This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight
 will be driven by the Company's major products, including the impact of new studies and indications. Sales forecasts for those products for 2005 are as follows:
WORLDWIDE
      PRODUCT                                   2005 NET SALES
      ZOCOR (Cholesterol modifying)         $4.2 to $4.5 billion
      FOSAMAX (Osteoporosis)                $3.1 to $3.4 billion
      COZAAR/HYZAAR (Hypertension)          $2.9 to $3.2 billion
      SINGULAIR (Respiratory)               $2.9 to $3.2 billion
      Other reported products*              $5.9 to $6.2 billion


*Other reported products comprise: AGGRASTAT, ARCOXIA, CANCIDAS, COSOPT, CRIXIVAN, EMEND e·mend  
tr.v. e·mend·ed, e·mend·ing, e·mends
To improve by critical editing: emend a faulty text.
, INVANZ, MAXALT, PRIMAXIN, PROPECIA, PROSCAR, STOCRIN, TIMOPTIC/TIMOPTIC XE, TRUSOPT, Vaccines and VASOTEC/VASERETIC.

--Under an agreement with AstraZeneca (AZN AZN Asian ), Merck receives revenue at predetermined pre·de·ter·mine  
v. pre·de·ter·mined, pre·de·ter·min·ing, pre·de·ter·mines

v.tr.
1. To determine, decide, or establish in advance:
 percentages of the U.S. sales of certain products by AZN, most notably NEXIUM. In 2005, Merck anticipates these revenues to be approximately $1.5 to $1.7 billion.

--The income contribution related to the Merck and Schering-Plough collaboration is expected to be positive in 2005. Equity Income from Affiliates includes the results of the Merck and Schering-Plough collaboration combined with the results of Merck's other joint venture relationships. Equity Income from Affiliates is expected to be approximately $1.5 to $1.7 billion for 2005.

--Merck continues to expect that manufacturing productivity will offset inflation on product costs.

--Product gross margin percentage is estimated to be approximately 77 to 78% for the full-year 2005.

--Research and Development expense (which excludes joint ventures) is estimated to decline at a low-to-mid single-digit percentage rate versus the full-year 2004 level. The full-year 2004 level referred to includes acquired R&D expenses in that year.

--Marketing and Administrative expense is anticipated to increase at a mid single-digit percentage growth rate over the full-year 2004 level. The full-year 2004 level excludes the costs related to the withdrawal of VIOXX and the charge taken in the fourth quarter related solely to future legal defense costs of VIOXX litigation. The full-year 2004 and full-year 2005 exclude the costs associated with position eliminations that occurred in 2004 and in the third quarter of 2005.

--The consolidated 2005 tax rate is estimated to be approximately 27.5 to 28.5% (excluding the net tax charge in the second quarter).

--Merck plans to continue its stock buyback Stock buyback

A corporation's purchase of its own outstanding stock, usually in order to raise the company's earnings per share.


stock buyback

See buyback.
 program in 2005. As of Sept. 30, $7.8 billion remains under the current buyback authorizations approved by Merck's Board of Directors.

Given these guidance elements, Merck anticipates full-year 2005 EPS of $2.47 to $2.51, excluding the net tax charge of $0.29 cents in the second quarter. Merck anticipates reported full-year 2005 EPS of $2.18 to $2.22.

This guidance does not reflect the establishment of any reserves for any potential liability relating to the VIOXX litigation.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines in more than 20 therapeutic categories. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.

Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2004, and in its periodic reports on Form 10-Q and Form 8-K, which the company incorporates by reference.
The following table shows the financial results for Merck & Co., Inc.
and subsidiaries for the quarter ended September 30, 2005, compared
with the corresponding period of the prior year.

                           Merck & Co., Inc.
                         Consolidated Results
            (In Millions Except Earnings per Common Share)
                      Quarter Ended September 30
                              (Unaudited)
                                                                 %
                                           2005      2004     Change
                                         -----------------------------
Sales                                    $5,416.2   $5,538.1       -2%

Costs, Expenses and Other
    Materials and production              1,238.8    1,364.2       -9
    Marketing and administrative (1)      1,741.2    1,752.9       -1
    Research and development                942.6      919.3        3
    Equity income from affiliates          (480.1)    (307.1)      56
    Other (income) expense, net             (24.7)      (4.2)      *

Income Before Taxes                       1,998.4    1,813.0       10

Taxes on Income (2)                         577.5      487.4

Net Income                               $1,420.9   $1,325.6        7

Average Shares Outstanding
   Assuming Dilution                      2,197.0    2,226.2

Earnings per Common Share
   Assuming Dilution                        $0.65      $0.60        8


* (Greater than) 100%


(1) Marketing and administrative expense includes $80 million and $34
    million for restructuring costs recorded in 2005 and 2004,
    respectively.

(2) The effective tax rate was 28.9% and 26.9% for the third quarter
    of 2005 and 2004, respectively.


The following table shows the financial results for Merck & Co., Inc.
and subsidiaries for the nine months ended September 30, 2005,
compared with the corresponding period of the prior year.

                           Merck & Co., Inc.
                         Consolidated Results
            (In Millions Except Earnings per Common Share)
                    Nine Months Ended September 30
                              (Unaudited)
                                                                 %
                                           2005     2004      Change
                                        ------------------------------
Sales                                   $16,246.0  $17,190.7       -5%

Costs, Expenses and Other
    Materials and production              3,670.9    3,676.2       --
    Marketing and administrative (1)      5,109.8    4,980.5        3
    Research and development (2)          2,736.0    2,901.6       -6
    Equity income from affiliates        (1,130.5)    (722.3)      57
    Other (income) expense, net              15.8     (240.0)      *

Income Before Taxes                       5,844.0    6,594.7      -11

Taxes on Income (3)                       2,332.4    1,882.4

Net Income                               $3,511.6   $4,712.3      -25

Average Shares Outstanding
   Assuming Dilution                      2,204.3    2,229.5

Earnings per Common Share
   Assuming Dilution                        $1.59      $2.11      -25

Adjusted Net Income and Earnings per
 Common Share
       Net Income (4)                    $4,151.9   $4,712.3      -12
       Earnings per Common Share
           Assuming Dilution (4)            $1.88      $2.11      -11
       Effective Tax Rate                    29.0%      28.5%

* (Greater than) 100%

(1) Marketing and administrative expense includes $95 million and $90
    million for restructuring costs recorded for the first nine months
    of 2005 and 2004, respectively.

(2) Research and development expense includes acquired research
    expense of $125 million resulting from the acquisition of Aton
    Pharma, Inc. in 2004 and licensing expense for research
    collaborations, including the initial payments of $100 million to
    Bristol-Myers Squibb and $70 million to Lundbeck in 2004.

(3) The effective tax rate was 39.9% and 28.5% for the first nine
    months of 2005 and 2004, respectively. Included in the second
    quarter 2005 is a net tax charge of $640 million primarily related
    to the American Jobs Creation Act. This net tax charge resulted in
    an increase of 10.9 percentage points to the effective tax rate
    for the first nine months of 2005.

(4) The difference between as reported net income and earnings per
    common share and adjusted net income and earnings per common share
    is the exclusion of $640 million of net tax charge, or $0.29 per
    share, as described in footnote (3).
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