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Article by DailyStocks_admin    (02-12-09 07:27 AM)

The Daily Magic Formula Stock for 02/12/2009 is ViroPharma Inc. According to the Magic Formula Investing Web Site, the ebit yield is 21% and the EBIT ROIC is >100%.

Dailystocks.com only deals with facts, not biased journalism. What is a better way than to go to the SEC Filings? It's not exciting reading, but it makes you money. We cut and paste the important information from SEC filings for you to get started on your research on a specific company.


Dailystocks.com makes NO RECOMMENDATIONS whatsoever, and provides this for informational purpose only.

BUSINESS OVERVIEW

ViroPharma Incorporated (“ViroPharma,” the “Company,” “we” or “us”) is a biopharmaceutical company dedicated to the development and commercialization of products that address serious infectious diseases, with a focus on products used by physician specialists or in hospital settings. We intend to grow through sales of our marketed product, Vancocin ® HCl capsules, through the continued development of our product pipeline and through potential acquisition or licensing of products or acquisition of companies.

We have one marketed product and multiple product candidates in clinical development. We market and sell Vancocin ® HCl capsules, the oral capsule formulation of vancomycin hydrochloride, in the U.S. and its territories. Vancocin is a potent antibiotic approved by the U.S. Food and Drug Administration, or FDA, to treat antibiotic-associated pseudomembranous colitis caused by Clostridium difficile infection (CDI), or C. difficile , and enterocolitis caused by Staphylococcus aureus , including methicillin-resistant strains. We are developing Camvia TM (maribavir) for the prevention and treatment of cytomegalovirus, or CMV, disease, and HCV-796 for the treatment of hepatitis C virus, or HCV, infection. We have entered into a licensing agreement for the rights to develop non-toxigenic strains of C. difficile (NTCD) for the treatment and prevention of CDI. We have licensed the U.S. and Canadian rights for a third product development candidate, an intranasal formulation of pleconaril, to Schering-Plough for the treatment of picornavirus infections. In addition, we have a discovery stage program in hepatitis C.

We intend to evaluate in-licensing or other opportunities to acquire products in development, or those that are currently on the market. We plan to seek products for diseases treated by physician specialists and in hospital settings, or to complement the markets that we hope our CMV and HCV programs will serve or in which Vancocin is prescribed.

We were incorporated in Delaware in September 1994 and commenced operations in December 1994. Our executive offices are located at 397 Eagleview Boulevard, Exton, Pennsylvania 19341, our telephone number is 610-458-7300 and our website address is www.viropharma.com. Information contained on our website is not incorporated into this Annual Report on Form 10-K or any other filings we make with the SEC.

Vancocin

In November 2004, we acquired all rights in the U.S. and its territories to manufacture, market and sell Vancocin, as well as rights to certain related vancomycin products, from Eli Lilly and Company (“Lilly”) for a $116 million upfront payment and additional purchase price consideration based on pre-defined sales levels through 2011, which, as of December 31, 2007, an aggregate of $23.1 million was paid. Lilly retained its rights to Vancocin outside of the U.S. and its territories.

Vancocin is approved by the FDA for treatment of enterocolitis caused by S. aureus (including methicillin-resistant strains) and antibiotic associated pseudomembranous colitis caused by C. difficile . Both are potentially serious infections of the gastrointestinal (GI) tract. S. aureus enterocolitis is rare; however, infection with C. difficile is the indication that accounts for the majority of Vancocin’s use.

Clostridium difficile infection (CDI) is an infection of the GI tract. The clinical manifestations, ranging from diarrhea to toxicmegacolon and sometimes death, are a result of toxins produced by the bacterium that cause inflammation in the colon. Hospitalized patients, those residing in long-term care centers, those greater than 65 years of age, and patients that have received broad-spectrum antibiotic therapy, are at greatest risk to acquire CDI.

CDI is not a nationally reportable disease and as such it is difficult to estimate the actual incidence of disease with precision. Based on reports from the Centers for Diseases Control and Prevention (CDC) and peer-reviewed publications, we estimate that at least 400,000 patients were affected by CDI in 2007. Many clinicians report treating increasing numbers of patients with severe CDI and increased mortality rates. Clinicians have also noted that patients are progressing from mild/moderate disease to severe disease or death more rapidly than previously observed. The incidences of CDI appear to be plateauing in 2007 relative to previous years.

Although the causes for this change in CDI remain under active investigation, the CDC has postulated that a combination of changes in antibiotic use and infection control practices, along with the emergence of a hypervirulent strain of C. difficile , are likely contributors. As of late 2007, this strain (referred to as the toxinotype III, BI, or NAP1/027 strain) has been identified in at least 36 states in the U.S.

Vancocin is the only drug approved by the FDA for the treatment of antibiotic-associated pseudomembranous colitis caused by C. difficile . Historically metronidazole, has been commonly used as first-line treatment for CDI, while Vancocin has been reserved for those patients who have failed metronidazole, have recurrent disease, or who are suffering from severe CDI. We believe that changes in the epidemiology of CDI, in particular the increasing frequency of severe disease, and data suggesting that failure or relapse occur more commonly in patients treated with metronidazole have led to an increase in the use of Vancocin. In October of 2007, the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of American (IDSA) presented draft new management guidelines for CDI at the IDSA annual metting. These draft guidelines are expected to be finalized in the spring of 2008

On March 17, 2006, we learned that the FDA’s Office of Generic Drugs, Center for Drug Evaluation and Research (“OGD”) changed its approach regarding the conditions that must be met in order for a generic drug applicant to request a waiver of in-vivo bioequivalence testing for copies of Vancocin. We are opposing this attempt. However, in the event this change in approach remains in effect, the time period in which a generic competitor may enter the market would be reduced and multiple generics may enter the market, which would materially impact our operating results, cash flows and possibly asset valuations.

Product Pipeline

We currently have three development programs. We have two programs in clinical development that target: (1) CMV with an initial focus on CMV disease in recipients of hematopoietic stem cell / bone marrow and solid organ transplants, and (2) HCV. These programs are within the transplant and hospital settings or focus on diseases treated by physician specialists, and are at the center of our strategic focus. Our third program is in preclinical development and targets the treatment and prevention of CDI utilizing the spore form of a non-toxin producing strain of C. difficle.

We have also engaged in a drug discovery program with Wyeth to identify back-up/follow-on molecules to HCV-796.

Intranasal pleconaril has been licensed to Schering-Plough and targets picornaviruses with intranasal pleconaril.

CMV Program

As of December 31, 2007, we continue to enroll patients in our phase 3 studies of Camvia for the prevention of CMV disease in allogeneic stem cell transplantation and liver transplantation. We expect that the phase 3 study in stem cell transplant patients will enroll a target of at least 620 patients at transplant centers in the U.S., Canada, and several European countries. The primary efficacy endpoint measures the incidence of CMV disease within six months post-transplant. Secondary endpoints include incidence of initiation of preemptive anti-CMV therapy, incidence of graft-versus-host disease, mortality and CMV disease-free survival. The study also will evaluate the pharmacokinetics of Camvia in this subject population.

The phase 3 study of liver transplant patients will enroll a target of approximately 350 patients in the U.S. and Europe who are at high risk of developing CMV diseases. The primary efficacy endpoint measures the incidence of CMV disease within six months post transplant. Secondary endpoints include time to onset of CMV infection and disease, the incidence and time to onset of anti-CMV therapy and survival without CMV infection or disease. Additionally, the incidence of adverse effects including those that limit the use of current therapies such as suppression of bone marrow function will be assessed.

We have completed several phase 1 clinical trials with Camvia to evaluate the potential for drug interactions, to evaluate the pharmacokinetics of Camvia in subjects with renal impairment and in subjects with hepatic impairment, and to evaluate the relative bioavailability of different tablet formulations. Additional clinical studies are either ongoing or planned for the future. We completed a phase 2 clinical trial with Camvia for the prevention of CMV infections in allogeneic stem cell transplant patients, which demonstrated that Camvia significantly reduces CMV reactivation in this population.


In 2008, the planned activities for the HCV-796 program include continuing monitoring and follow-up of patients enrolled in the phase 2 study. In addition, there will be extensive evaluation of available preclinical and clinical safety data in order to understand the potential risks to patients and whether further clinical studies are appropriate. No additional clinical studies with HCV-796 will be initiated until this evaluation is complete and the results are discussed with the FDA. The results of the investigation into liver enzyme findings observed in the phase 2 study, along with other predevelopment activities performed during the year, will significantly impact the timing and amount of expenses we will incur related to this program in future periods. In addition, discussions with the FDA regarding our plans may impact the timing, nature and cost of future planned studies. During 2008 we will continue with discovery activities to identify a follow-on/back-up molecule to HCV-796.

Hepatitis is an inflammation of the liver that is often caused by viruses, such as hepatitis A, B, or C. Hepatitis C virus is recognized as a major cause of chronic hepatitis worldwide. According to the CDC and the World Health Organization, about four million Americans and 170 million people worldwide, respectively, are infected with HCV. The acute stage, which occurs two weeks to six months after infection, usually is so mild that most people do not know they have been infected. About 75% of people who are newly infected with HCV progress to develop chronic infection. Liver damage (cirrhosis) develops in about 10% to 20% of persons with chronic infection, and liver cancer develops in 1% to 5% of persons with chronic infection over a period of 20 to 30 years. Liver damage caused by HCV infection is the most common reason for liver transplantation in the U.S.

CDI Program

In February 2006, we announced that we had entered into a licensing agreement with Dr. Dale Gerding, of the Hines VA for the rights to develop non-toxigenic strains of C. difficile (NTCD) for the treatment and prevention of CDI. We plan to initially focus our efforts on the opportunity to prevent recurrence of CDI following treatment with Vancocin. The concept behind this novel treatment approach aims to prevent disease recurrence, and involves the oral administration of non-toxin producing spores of C. difficile following initial treatment of acute CDI. The underlying concept of this approach is to first treat the disease with an effective product like Vancocin and eradicate the dangerous toxin-producing C. difficile which causes severe CDI. The treated patient could potentially then be dosed with oral NTCD to re-colonize the GI tract and prevent the ‘bad’ bugs from re-infecting the colon until normal GI flora returns and the patient is no longer susceptible to disease.

Common Cold and Asthma Exacerbations Program

Pleconaril is a proprietary, small molecule inhibitor of picornaviruses, which we licensed from Sanofi-Aventis in 1995. In preclinical studies, pleconaril has demonstrated the ability to inhibit picornavirus replication in vitro by a novel, virus-specific mode of action. Pleconaril works by inhibiting the function of the viral protein coat, also known as the viral capsid, which is essential for virus infectivity and transmission. Preclinical studies have shown that pleconaril integrates within the picornavirus capsid at a specific site that is common to a majority of picornaviruses and disrupts several stages of the virus infection cycle. In May 2002, the FDA issued a “not-approvable” letter in response to our new drug application for an oral formulation of pleconaril for the treatment of the common cold in adults. In contrast, the current formulation of pleconaril is delivered intranasally.

In November 2004, we entered into a license agreement with Schering-Plough under which Schering-Plough assumed responsibility for all future development and commercialization of pleconaril in the U.S. and Canada. Schering-Plough paid us an initial license fee of $10.0 million in December 2004 and purchased our inventory of bulk drug substance for an additional $6.0 million in January 2005. We understand that Schering-Plough is currently evaluating an intranasal formulation of pleconaril in phase 2 clinical trials.

Business Development

We intend to continue to evaluate in-licensing or other means of acquiring products in clinical development, and marketed products, in order to expand our current portfolio. Such products may be intended to treat, or are currently used to treat, the patient populations treated by physician specialists or in hospital settings.

Competition for products in clinical development, or that are currently on the market, is intense and may require significant resources. There is no assurance that we will be successful in acquiring such products, or that such products can be acquired on terms acceptable to us. Additionally, if we are successful in acquiring a marketed product, we may have to expand our marketing team and build a sales force. There is no assurance that we would be successful in expanding our commercial capabilities, that we would be able to penetrate the markets for any such products or that we could achieve market acceptance of our products.

Strategic Relationships

Vancocin Capsules and Lilly

In November 2004, we acquired all rights in the U.S. and its territories to manufacture, market and sell Vancocin, the oral capsule formulation of vancomycin hydrochloride, as well as rights to certain related vancomycin products, from Lilly. Vancocin is a potent antibiotic approved by the FDA to treat antibiotic-associated pseudomembranous colitis caused by C. difficile and enterocolitis caused by S. aureus , including methicillin-resistant strains. Lilly retained its rights to vancomycin outside of the U.S. and its territories.

We paid Lilly an upfront cash payment of $116.0 million. We are obligated to pay additional purchase price consideration based on annual net sales of Vancocin through 2011. As of December 31, 2007, we have paid an aggregate of $23.1 million to Lilly in additional purchase price consideration, as our net sales of Vancocin surpassed the maximum obligation level of $65 million in 2005, 2006 and 2007. The $23.1 million payment was based upon 35% of $17 million in 2007, 35% of $19 million in 2006 and 50% of $21 million in 2005.

For annual net sales during 2008 through 2011, we are obligated to pay additional amounts of 35% on net sales between $45 and $65 million. No additional payments are due to Lilly on net sales of Vancocin below or above the net sales levels. We account for additional purchase price consideration as contingent consideration and record an adjustment to the carrying amount of the related intangible assets and a cumulative adjustment to the intangible amortization upon achievement of the related sales milestones. See Note 6 of the Consolidated Financial Statements for additional information regarding intangible assets and amortization.

In the event we develop any product line extensions, revive discontinued vancomycin product lines (injectable or oral solutions), make improvements of existing products, or expand the label to cover new indications, Lilly would receive a royalty on net sales on these additional products for a predetermined time period.

In connection with the acquisition, we entered into a transition services agreement with Lilly. The transition period ended in January 2005 when we assumed responsibility for product inventory, warehousing, management services and distribution of the Vancocin brand in the U.S.

Cytomegalovirus and GlaxoSmithKline

In August 2003, we entered into a license agreement with GlaxoSmithKline (“GSK”) under which we acquired worldwide rights (excluding Japan) to an antiviral compound, Camvia, for the treatment of CMV disease. Camvia is a benzimidazole compound that was in development by GSK for the treatment of CMV retinitis in HIV positive patients.

Under the terms of the agreement, we have exclusive worldwide rights (excluding Japan) to develop and commercialize Camvia for the prevention and treatment of cytomegalovirus infections related to transplant (including solid organ and hematopoietic stem cell / bone marrow transplantation), congenital transmission, and in patients with HIV infection. The patents covering Camvia expire in 2015. We paid GSK a $3.5 million up-front cash licensing fee and will pay additional milestone payments based upon defined clinical development and regulatory events. In the third quarter of 2006, we recorded a $3.0 million milestone payment due to GSK associated with the initiation of the phase 3 study of Camvia, which was paid in February 2007. No additional amounts were recorded in 2007. We also will pay royalties to GSK and its licensor on product sales in the U.S. and rest of world (excluding Japan). We will be dependent on GSK to prosecute and maintain the patents related to Camvia, and to file any applications for patent term extension. We also may be dependent on GSK to protect such patent rights. We have the right to sublicense our rights under the agreement, which under certain circumstances requires consent from GSK.

CEO BACKGROUND

ELECTION OF CLASS III DIRECTORS

Our board of directors currently consists of eight (8) directors. The board consists of three classes of directors, with each director serving a three-year term. Each year, one class of directors comes up for election. At the annual meeting, stockholders will vote on the election of three Class III directors. The Class III directors elected at the annual meeting of stockholders will serve until the 2011 annual meeting of stockholders and until each such director’s successor has been elected and qualified, except if the director resigns, is removed or dies before such time.

The Class III nominees for election to the board of directors at the annual meeting are John R. Leone, Vincent J. Milano and Howard H. Pien. The Class I directors presently are Paul A. Brooke, Robert J. Glaser and Michael R. Dougherty. The Class II directors presently are Dr. William D. Claypool and Michel de Rosen.

The affirmative vote of a plurality of shares of the common stock present or represented by proxy at the annual meeting and entitled to vote is required for the election of each of John R. Leone, Vincent J. Milano and Howard H. Pien. If any of these nominees should become unable or unwilling to accept nomination or election, a circumstance which we do not expect, the proxy holders intend to vote for any alternate nominees designated by the board of directors or, in the discretion of the board, the position(s) may be left vacant.

Described below is certain information regarding each director, including the nominees. Each of the members of the board of directors, including the director nominees, is independent under applicable NASDAQ rules other than Mr. de Rosen who served as our Chief Executive Officer until March 31, 2008 and Mr. Milano who currently serves as our Chief Executive Officer. The Class III director nominees were recommended by the unanimous vote of the independent directors and nominated by the unanimous vote of the entire board of directors.

Class III—Director with Term Continuing until 2011

John R. Leone. Mr. Leone has served as a member of our board of directors since January 2006. From 2007 until the present Mr. Leone is a Partner in Paul Capital Partners. From August 2004 to January 2006, Mr. Leone was President, Chief Executive Officer and member of the board of directors of Cambrex Corporation. From 2000 to 2004, Mr. Leone was Senior Vice President and Chief Operating Officer for U.S. commercial operations of Aventis Pharmaceuticals. Prior to 2000, Mr. Leone held a variety of senior positions at Rhone-Poulenc Rorer, American Home Products Corporation and Pfizer. Mr. Leone is 60 years of age.

Vincent J. Milano. Mr. Milano became a member of our board of directors in February 2008 and has served as the Company’s Chief Executive Officer and Chief Financial Officer since the end of March 2008. He served as the Company’s Vice President, Chief Financial Officer and Chief Operating Officer from January 2006 until March 2008. He served as Vice President, Chief Financial Officer and Treasurer from 1997 to 2006, after joining the Company in 1996. Prior to joining the Company, he was with KPMG LLP. Mr. Milano received his bachelor of science degree in accounting from Rider College. Mr. Milano is 44 years of age.

Howard H. Pien. Mr. Pien has served as a member of our board of directors since January 2004. Mr. Pien is the CEO and President of Medarex, a biotechnology company, since June 2007. Mr. Pien served as the President and Chief Executive Officer and a Director of Chiron from April 2003 until Chiron’s merger with Novartis. Mr. Pien was elected Chairman of the board of directors of Chiron in May 2004. He joined Chiron from GlaxoSmithKline, where he held roles of increasing responsibility for the commercial operations of the company’s worldwide pharmaceuticals business, culminating in his tenure as President, Pharmaceuticals International from December 2000 to March 2003. Mr. Pien previously held key positions in SmithKline Beecham’s pharmaceuticals business in the United States, the United Kingdom, and North Asia, culminating in his tenure as President, Pharmaceuticals-North America. Prior to joining SmithKline Beecham, he worked six years for Abbott Laboratories and five years for Merck & Co., in positions of sales, marketing research licensing and product management. Mr. Pien previously served as a director of ViroPharma Incorporated from 1998 to 2003, and currently serves as a director of Medarex and Vanda, a public company engaged in drug development. Mr. Pien is 50 years of age.

Class I—Directors with Terms Continuing until 2009

Paul A. Brooke. Mr. Brooke has served as a member of our board of directors since February 2001. Mr. Brooke has served as Chairman of Alsius Corporation since its merger with Ithaka Acquisition Corp. in June 2007. Mr. Brooke previously served as Chairman and Chief Executive Officer of Ithaka Acquisition Corp. since its inception in April 2005. Since June 2000, Mr. Brooke has been the managing member of PMSV Holdings LLC, and a senior advisor of Morgan Stanley & Co. He was a managing director at Tiger Management LLC from April 1999 to May 2000. Mr. Brooke was a managing director at Morgan Stanley and was global head of healthcare research and strategy from March 1983 to April 1999. Mr. Brooke also is a director of WebMD.com, Incyte Corporation, Alsius Corporation, MPM Bioequities Fund, Cheyne Capital Management International, and Houston Pharma. Mr. Brooke is 62 years of age.

Michael R. Dougherty. Mr. Dougherty has served as a member of our board of directors since January 2004. Mr. Dougherty was elected as President and Chief Executive Officer of Adolor Corp. and a member of the board of directors on December 14, 2006. Mr. Dougherty joined Adolor in November 2002 as Senior Vice President of Commercial Operations and until his appointment as President and CEO in December 2006, served in a number of capacities, including Chief Operating Officer and Chief Financial Officer. From November 2000 to November 2002, Mr. Dougherty was President and Chief Operating Officer of Genomics Collaborative, Inc., a privately held functional genomics company. Prior to 2000, Mr. Dougherty served in a variety of senior positions at Genaera Corporation, formerly Magainin Pharmaceuticals, Inc. including, from August 1998 to November 2000, President and Chief Executive Officer. Mr. Dougherty is 50 years of age.

Robert J. Glaser. Mr. Glaser has served as a member of our board of directors since August 1997. Mr. Glaser is Chief Marketing and Sales Officer of Medsn, a medical education and e-learning company. During 2004, Mr. Glaser was Executive Vice President of Sales and Marketing of Ancillary Care Management, a healthcare management company. During 2003, Mr. Glaser was Senior Vice President, Caliber Associates. From 2001 to 2002, Mr. Glaser was a consultant to the biotechnology and pharmaceutical industries. From 1998 to 2001, Mr. Glaser was President of the McKesson HBOC Pharmaceutical Services division of McKessonHBOC. He was President and Chief Operating Officer of Ostex International from 1996 to 1997. Mr. Glaser was Senior Vice President of Marketing for Merck U.S. Human Health from 1994 to 1996, Vice President of Marketing from 1993 to 1994 and Vice President of Merck’s Vaccine Division from 1991 to 1993. Mr. Glaser is 56 years of age.

Class II—Nominees with Terms Continuing until 2010

William D. Claypool, M.D. Dr. Claypool has served as a member of our board of directors since December 2003. Since March 2008, Dr. Claypool serves as President of Phoenix Data Systems, Inc. Prior to Phoenix Data Systems, Inc. being acquired by Bio-Imaging Technologies, Inc. in March 2008, Dr. Claypool served as Chief Executive Officer and Chairman of the Board of Phoenix Data Systems, Inc. Dr. Claypool has been at Phoenix Data Systems since June 2001. From January 2001 to June 2001, he served as President and CEO of The GI Company. From 1991 to 2001 Dr. Claypool held a number of management positions with SmithKline Beecham Pharmaceuticals, serving from November 1998 to December 2000 as Senior Vice President and Director of Worldwide Clinical Development and Medical Affairs. Dr. Claypool is 57 years of age.

Michel de Rosen. Mr. de Rosen has served as the Chairman of our board of directors since September 2002, as President and Chief Executive Officer from August 2000 until the end of March 2008, and as a director since May 2000. In March 2008, Mr. de Rosen became the Chief Executive Officer of Saint Gobain Desjonqueres. From 1993 to 1999, Mr. de Rosen held several key positions in Rhone-Poulenc Pharma and Rhone-Poulenc

Rorer (now Sanofi Aventis), including Chief Executive Officer from 1995 until 1999, and Chairman and Chief Executive Officer from 1996 to 1999. Mr. de Rosen began his career at the French Ministry of Finance and subsequently served in several leading government positions. Mr. de Rosen also served in various executive roles in industry prior to 1993. Mr. de Rosen also is a director of ABB Ltd. and Endo Pharmaceuticals Holdings Inc. Mr. de Rosen is 56 years of age.

OUR BOARD OF DIRECTORS RECOMMENDS THAT YOU VOTE “FOR” THE NOMINEES FOR THE CLASS III DIRECTORS AS DESCRIBED IN PROPOSAL NO. 1 ABOVE.





MANAGEMENT DISCUSSION FROM LATEST 10K

Background

We are a biopharmaceutical company dedicated to the development and commercialization of products that address serious infectious diseases, with a focus on products used by physician specialists or in hospital settings. We intend to grow through sales of our marketed product, Vancocin ® HCl capsules, through the continued development of our product pipeline and through potential acquisition or licensing of products or acquisition of companies.

We have one marketed product and multiple product candidates in clinical development. We market and sell Vancocin ® HCl capsules, the oral capsule formulation of vancomycin hydrochloride, in the U.S. and its territories. Vancocin is a potent antibiotic approved by the U.S. Food and Drug Administration, or FDA, to treat antibiotic-associated pseudomembranous colitis caused by Clostridium difficile infection (CDI), or C. difficile , and enterocolitis caused by Staphylococcus aureus , including methicillin-resistant strains. We are developing Camvia TM (maribavir) for the prevention and treatment of cytomegalovirus, or CMV, disease, and HCV-796 for the treatment of hepatitis C virus, or HCV, infection. We have entered into a licensing agreement for the rights to develop non-toxigenic strains of C. difficile (NTCD) for the treatment and prevention of CDI. We have licensed the U.S. and Canadian rights for a third product development candidate, an intranasal formulation of pleconaril, to Schering-Plough for the treatment of picornavirus infections. In addition, we have a discovery stage program in hepatitis C.

We intend to evaluate in-licensing or other opportunities to acquire products in development, or those that are currently on the market. We plan to seek products for diseases treated by physician specialists and in hospital settings to complement the markets that we hope our CMV and HCV programs will serve or in which Vancocin is prescribed.

While we were profitable from operations since 2005, prior to the 2004 acquisition of Vancocin, our first commercial product, we incurred historical losses. Historical losses resulted principally from costs incurred in research and development activities, write-off of acquired technology rights, general and administrative expenses, interest payments on our outstanding debt and sales and marketing expenses.

During 2008 and going forward, we expect to face a number of challenges, which include the following:

The commercial sale of approved pharmaceutical products is subject to risks and uncertainties. There can be no assurance that future Vancocin sales will meet or exceed the historical rate of sales for the product, for reasons that include, but are not limited to, generic and non-generic competition for Vancocin and/or changes in prescribing habits or disease incidence. Additionally, period over period fluctuations in net product sales are expected to occur as a result of wholesaler buying decisions.

We cannot assure you that generic competitors will not take advantage of the absence of patent protection for Vancocin to attempt to market a competing product. We are not able to predict the time period in which a generic drug may enter the market. On March 17, 2006, we learned that the OGD changed its approach regarding the conditions that must be met in order for a generic drug applicant to request a waiver of in-vivo bioequivalence testing for copies of Vancocin. We are opposing this attempt. However, in the event this change in approach remains in effect, the time period in which a generic competitor may enter the market would be reduced and multiple generics may enter the market, which would materially impact our operating results, cash flows and possibly asset valuations. There can be no assurance that the FDA will agree with the positions stated in our Vancocin related submissions or that our efforts to oppose the OGD’s March 2006 recommendation to determine bioequivalence to Vancocin through in vitro dissolution testing will be successful. We cannot predict the timeframe in which the FDA will make a decision regarding either our citizen petition for Vancocin or the approval of generic versions of Vancocin. If we are unable to change the recommendation set forth by the OGD in March 2006, the threat of generic competition will be high.

We will face intense competition in acquiring additional products to expand further our product portfolio. Many of the companies and institutions that we will compete with in acquiring additional products to expand further our product portfolio have substantially greater capital resources, research and development staffs and facilities than we have, and substantially greater experience in conducting business development activities. We may need additional financing in order to acquire new products in connection with our plans as described in this report.

The outcome of our clinical development programs is subject to considerable uncertainties. We cannot be certain that we will be successful in developing and ultimately commercializing any of our product candidates, that the FDA or other regulatory authorities will not require additional or unanticipated studies or clinical trial outcomes before granting regulatory approval, or that we will be successful in gaining regulatory approval of any of our product candidates in the timeframes that we expect, or at all. For example, in August 2007, we and Wyeth decided to discontinue dosing with HCV-796 in a phase 2 study as a result of potential safety concerns. We and Wyeth continue to evaluate the observations that led to this decision in the hope of advancing this potential therapeutic agent in the future, however there can be no assurance that we will conduct additional HCV studies in the future as the FDA or other regulatory authorities may either prohibit any future studies with HCV-796 or alternatively may require additional or unanticipated studies or clinical trial outcomes before granting regulatory approval.

We cannot assure you that our current cash, cash equivalents and short-term investments or cash flows from Vancocin sales will be sufficient to fund all of our ongoing development and operational costs, as well as the interest payable on the senior convertible notes, over the next several years, that planned clinical trials can be initiated, or that planned or ongoing clinical trials can be successfully concluded or concluded in accordance with our anticipated schedule and costs. Moreover, the results of our business development efforts could require considerable investments.

Our actual results could differ materially from those results expressed in, or implied by, our expectations and assumption described in this Annual Report on Form 10-K. The risks described in this report, our Form 10-K for the year ended

December 31, 2007 are not the only risks facing our Company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results. Please also see our discussion of the “Risk Factors” in Item 1A, which describe other important matters relating our business.

The increase in net income for 2007 resulted primarily from the $37.2 million increase in sales, along with a $10.1 million reduction in the cost of sales. The $17.0 million increase in operating income resulted from factors described above, offset by the increased costs to support our CMV and HCV development programs. The year ended December 31, 2007 includes $7.6 million share-based compensation expense and $3.3 million of costs associated with our opposition to the OGD’s change in approach.

Revenue—Vancocin product sales

Our net product sales are solely related to Vancocin. We sell Vancocin only to wholesalers who then distribute the product to pharmacies, hospitals and long-term care facilities, among others. Our sales of Vancocin are influenced by wholesaler forecasts of prescription demand, wholesaler buying decisions related to their desired inventory levels, and, ultimately, end user prescriptions, all of which could be at different levels from period to period.

During the year ended December 31, 2007, net sales of Vancocin increased 22.3% compared to the same period in 2006 primarily due to an increase of units sold, the impact of a price increase during 2007 and wholesaler inventory levels which that were stable in 2007 compared to decreased levels in 2006. We believe, based upon data reported by IMS Health Incorporated, that prescriptions during the year ended December 31, 2007 exceeded prescriptions in the 2006 period by 4%.

Approximately 93% of our sales are to three wholesalers. Vancocin product sales are influenced by prescriptions and wholesaler forecasts of prescription demand, which could be at different levels from period to period. We receive inventory data from one of our three largest wholesalers through our fee for service agreement. We do not independently verify this data. Based on this inventory data and our estimates, we believe that as of December 31, 2007, the wholesalers did not have excess channel inventory.

Cost of sales

Vancocin cost of sales includes the cost of materials and distribution costs and excludes amortization of product rights. The decrease of $10.1 million over the prior year primarily results from the sale of units manufactured by NPI Pharmaceuticals (formerly OSG Norwich), which carry a lower inventory cost.

During 2007 and the second half of 2006, all of the finished product we purchased was produced by NPI Pharmaceuticals. As of June 30, 2006, Lilly no longer manufactured finished product for us because our third-party manufacturing supply chain was approved in the second quarter of 2006 and in July 2006, we began receiving regular shipments of product produced by NPI Pharmaceuticals. Our finished product that was sold in the second half of 2006 included product produced by both Lilly and NPI Pharmaceuticals. As such, our cost of sales began to steadily decrease in the second half of 2006 and remained consistent during 2007.

Since units are shipped based upon earliest expiration date, our cost of sales will be impacted by the cost associated with the specific units that are sold. Additionally, we may experience fluctuations in quarterly manufacturing yields and if this occurs, we would expect the cost of product sales of Vancocin to fluctuate from quarter to quarter.

Research and development expenses

For each of our research and development programs, we incur both direct and indirect expenses. Direct expenses include third party costs related to these programs such as contract research, consulting, cost sharing payments or receipts, and preclinical and development costs. Indirect expenses include personnel, facility, stock compensation and other overhead costs. Due to recent advancements in our clinical development programs, we expect future costs to exceed current costs.

Direct Expenses—Core Development Programs

Our direct expenses related to our CMV program increased significantly in 2007 as we advanced the program into larger Phase 3 clinical studies. Specifically, during the year 2007 we continued recruitment into an ongoing phase 3 study of Camvia in patents undergoing allogeneic stem cell transplant and began recruiting patients into a second phase 3 study in patients undergoing liver transplantation during the second quarter of 2007. We began executing on our pre-launch plans for our clinical, regulatory and commercial activities for the Camvia program in Europe. During the year 2006 we concluded analysis of data from our phase 2 clinical trial with Camvia, which demonstrated that Camvia significantly reduces CMV reactivation in patients who had undergone allogeneic stem cell transplantation. We initiated dosing in a phase 3 study of Camvia in the prevention of CMV disease in allogeneic stem cell transplantation and continued conducting and analyzing data from various phase 1 clinical trials. We also prepared for a second phase 3 study of Camvia in solid organ transplant patients. Included in the CMV expenses during 2006 was $3.0 million related to a milestone payment due to GlaxoSmithKline associated with the initiation of the phase 3 study of Camvia, which was paid in February 2007.

Related to our HCV program, costs in 2007 primarily represent those paid to Wyeth in connection with our cost-sharing arrangement related to discovery efforts to identify potential back-ups/follow-on compounds to HCV-796. Development activity for our HCV product candidate, HCV-796, during the year 2007 included completion of enrollment in the 500 mg BID arms of a phase 2 study of HCV-796 when dosed in combination with pegylated interferon and ribavirin and ongoing follow-up of patients in that study. In August 2007, we announced that elevated liver enzyme levels in a subset of patients in this study indicated a potential safety issue. Consequently, all dosing with HCV-796 was discontinued, although patients in the phase 2 study had the option of continuing to receive pegylated interferon and ribavirin as per standard of care. Therefore, monitoring and follow-up of patients in the phase 2 study will continue. During the year 2006, we conducted a phase 1b clinical trial which demonstrated the antiviral activity of HCV-796 in combination with pegylated interferon and began dosing in a phase 2 study of HCV-796. Wyeth pays a substantial portion of the collaboration’s predevelopment and development expenses.

Related to our Vancocin/ C. difficile program, costs in 2007 and 2006 related to research and development activities, including costs related to non-toxigenic strains of C. difficile .

Anticipated fluctuations in future direct expenses are discussed under “ Liquidity – Development Programs . ”

Direct Expenses—Non-core Development Programs

We incurred minimal direct costs related to our common cold program licensed to Schering-Plough.

Indirect Expenses

These costs primarily relate to the compensation of and overhead attributable to our development team, primarily due to increased personnel costs of $2.1 million.

Marketing, general and administrative expenses

Marketing, general and administrative (MG&A) expenses increased $12.5 million in 2007 to $37.1 million from $24.6 million in 2006. The largest contributors to this increase were medical education costs ($3.1 million), legal and consulting costs ($1.7 million), and compensation ($1.6 million) and share-based compensation expense ($1.5 million) due to increased personnel, Other contributors included corporate franchise taxes and commercial related expenses, which collectively increased by $2.3 million.

Included in the increased legal and consulting costs are expenses incurred related to our opposition to the attempt by the OGD regarding the conditions that must be met in order for a generic drug application to request a waiver of in-vivo bioequivalence testing for copies of Vancocin, which were $3.3 million in the year 2007 as compared to $2.3 million the same period in 2006. We anticipate that these additional legal and consulting costs will continue at higher levels in future periods.

Intangible amortization and acquisition of technology rights

Intangible amortization is the result of the Vancocin product rights acquisition in the fourth quarter of 2004. Additionally, as described in our agreement with Lilly, to the extent that we incur an obligation to Lilly for additional payments on Vancocin sales, we have contingent consideration. We record the obligation as an adjustment to the carrying amount of the related intangible asset and a cumulative adjustment to the intangible amortization upon achievement of the related sales milestones. Contingent consideration and Lilly related additional payments are more fully described in Note 6 of the Consolidated Financial Statements.

Intangible amortization for the years ended December 31, 2007 and 2006 were comparable at $6.1 million and $5.7 million respectively. The comparatives are impacted by cumulative adjustments, which were $0.6 million in 2007 and $0.4 million in 2006.

In March 2006, as a result of OGD’s change in approach relating to generic bioequivalence determinations, we reviewed the value of the intangible asset and concluded that there was no impairment of the carrying value of the intangible assets or change to the useful lives as estimated at the acquisition date. Additionally, on an ongoing periodic basis, we evaluate the useful life of these intangible assets and determine if any economic, governmental or regulatory event has modified their estimated useful lives. This evaluation did not result in a change in the life of the intangible assets during the year ended December 31, 2007. We will continue to monitor the actions of the OGD and consider the effects of our opposition efforts and the announcements by generic competitors or other adverse events for additional impairment indicators and we will reevaluate the expected cash flows and fair value of our Vancocin-related assets, as well as estimated useful lives, at such time.

Other Income (Expense)

Gain on sale of short term investments

During 2006, we sold our marketable securities investment in SIGA Technologies, Inc. for a gain of $1.7 million.

Net (loss) gain on bond redemption

On March 1, 2006, we redeemed the then remaining $78.9 million principal amount of our subordinated convertible notes for $79.6 million. This eliminated our long-term debt that was outstanding at December 31, 2005. The charge of $1.1 million related to this payment in the first quarter of 2006, represents a premium of $0.7 million and the write-off of deferred finance costs of $0.4 million at March 1, 2006.

Interest Income

Interest income for the years ended December 31, 2007 and 2006 was $24.3 million and $9.9 million, respectively. Interest income increased primarily due to increased short-term investments during 2007 and to a lesser extent, an increased rate of return.

Interest Expense

Interest expense and amortization of finance costs in 2007 relates entirely to the senior convertible notes issued on March 26, 2007, as described in Note 8 to the Consolidated Financial Statements.

Interest expense in 2006 relates entirely to the subordinated convertible notes, which were redeemed on March 1, 2006. In the third quarter of 2006, we recorded a credit to interest expense related to the beneficial conversion feature because we released the remaining liability associated with the auto-conversion provisions as the likelihood of payment was remote.

Income Tax Expense

Our effective income tax rate was 29.7% and 38.6% for the years ended December 31, 2007 and 2006, respectively. Income tax expense includes federal, state and foreign income taxes at statutory rates and the effects of various permanent differences. The decrease in the 2007 rate as compared to 2006 is primarily due to our current estimate of the impact of orphan drug credit for Camvia as well as a $4.0 million benefit for the valuation allowance adjustment primarily related to additionally deferred tax assets that management believes is more likely than not to be utilized. We currently anticipate an effective tax rate in the range of approximately 27% to 31% for the year ended December 31, 2008, which includes an estimate related to orphan drug credit based upon estimates of qualified expenses and excludes the impact of discreet items and any potential changes in the valuation allowance. We continue to evaluate our qualified expenses and, to the extent that actual qualified expenses vary significantly from our estimates, our effective tax rate will be impacted.

The decrease in net income for 2006 resulted from the $79.7 million change in income tax from a benefit in 2005 to a $41.9 million expense in 2006. The increase in operating income resulted from increased revenue, offset by the increased costs to support Vancocin and our CMV and HCV development programs. The year ended December 31, 2006 includes $5.0 million share-based compensation expense and $2.3 million of costs associated with our opposition to the OGD’s change in approach. Additionally, 2005 included $6.0 million of license fee revenue.

Revenue—Vancocin product sales

Our net product sales are solely related to Vancocin. We sell Vancocin only to wholesalers who then distribute the product to pharmacies, hospitals and long-term care facilities, among others. Our sales of Vancocin are influenced by wholesaler forecasts of prescription demand, wholesaler buying decisions related to their desired inventory levels, and, ultimately, end user prescriptions, all of which could be at different levels from period to period.

During the year ended December 31, 2006, net sales of Vancocin increased 32.4% compared to the same period in 2005 primarily due to the impact of price increases during 2006 and 2005. We believe, based upon data reported by IMS Health Incorporated, that prescriptions during the year ended December 31, 2006 exceeded prescriptions in the 2005 period by 23.2%. Our comparative period is also impacted by a decrease in wholesalers’ inventory levels during in the first four months of 2006, as compared to the 2005 period where wholesalers’ inventory levels increased.

Approximately 92% of our sales are to three wholesalers. Vancocin product sales are influenced by prescriptions and wholesaler forecasts of prescription demand, which could be at different levels from period to period. During the second quarter of 2006, we began receiving inventory data from two of our three largest wholesalers. We do not independently verify this data. Based on this inventory data, we believe as of December 31, 2006, the wholesalers did not have excess channel inventory.

Cost of sales

Vancocin cost of sales includes the cost of materials and distribution costs and excludes amortization of product rights. The increase of $1.0 million over prior year primarily results from increased volume, offset by the sale of units manufactured by NPI Pharmaceuticals (formerly OSG Norwich), which carry a lower inventory cost. As part of our November 2005 amendment of our manufacturing agreement with Lilly, we increased the amount of Vancocin that Lilly supplied to us, which increased our cost of sales in the first half of 2006 by $4.4 million, as specific units were sold.

During the second half of 2006, all of the finished product we purchased was produced by NPI Pharmaceuticals. As of June 30, 2006, Lilly no longer manufactured finished product for us because our third-party manufacturing supply chain was approved in the second quarter of 2006 and in July 2006, we began receiving regular shipments of product produced by NPI Pharmaceuticals. Our finished product that was sold in the second half of 2006 included product produced by both Lilly and NPI Pharmaceuticals. As such, our cost of sales began to steadily decrease during the second half of 2006.

Since units are shipped based upon earliest expiration date, our actual cost of sales will be impacted by the cost associated with the specific units that are sold. Additionally, we may experience fluctuations in quarterly manufacturing yields and if this occurs, we would expect the cost of product sales of Vancocin to fluctuate from quarter to quarter. Further, if we enter into fee-for-service or inventory management agreements with wholesalers in future periods, the fees would negatively impact our cost of sales expense.

Research and development expenses

For each of our research and development programs, we incur both direct and indirect expenses. Direct expenses include third party costs related to these programs such as contract research, consulting, cost sharing payments or receipts, and preclinical and development costs. Indirect expenses include personnel, facility, and other overhead costs. Due to recent advancements in our clinical development programs, we expect future costs to exceed current costs.



MANAGEMENT DISCUSSION FOR LATEST QUARTER

We are a biopharmaceutical company dedicated to the development and commercialization of products that address serious diseases, with a focus on products used by physician specialists or in hospital settings. We intend to grow through sales of our marketed product, Vancocin ® HCl capsules and Cinryze TM , through the continued development of our product pipeline and through potential acquisition or licensing of products or acquisition of companies. We have one marketed product, one product that has received FDA approval but has not been launched commercially, and one product candidate in clinical development.

We market and sell Vancocin ® HCl capsules, the oral capsule formulation of vancomycin hydrochloride, in the U.S. and its territories. Vancocin is a potent antibiotic approved by the U.S. Food and Drug Administration, or FDA, to treat antibiotic-associated pseudomembranous colitis caused by Clostridium difficile infection (CDI), or C. difficile , and enterocolitis caused by Staphylococcus aureus , including methicillin-resistant strains. We are developing maribavir for the prevention and treatment of cytomegalovirus, or CMV, disease, and non-toxigenic strains of C. difficile (NTCD) for the treatment and prevention of CDI. We have licensed the U.S. and Canadian rights for a third product development candidate, an intranasal formulation of pleconaril, to Schering-Plough for the treatment of picornavirus infections.

On October 21, 2008, we completed a merger under which ViroPharma acquired Lev Pharmaceuticals, Inc. (Lev), a biopharmaceutical company focused on developing and commercializing therapeutic products for the treatment of inflammatory diseases. As a result of the merger, we obtained Cinryze, which has been approved by the FDA and will be launched commercially in 2008. Based on discussions with FDA, we withdrew the portion of the Cinryze BLA referring to data for the acute treatment of HAE attacks. We intend to resubmit this data as a supplemental BLA later this year along with additional data from ongoing open label acute studies of Cinryze. Cinryze is a C1 inhibitor therapy for routine prophylaxis against hereditary angioedema (HAE), also known as C1 inhibitor deficiency, a rare, severely debilitating, life-threatening genetic disorder.

While we have been profitable from operations since 2005, prior to the 2004 acquisition of Vancocin, our first commercial product, we incurred historical losses. Historical losses resulted principally from costs incurred in research and development activities, write-off of acquired technology rights, general and administrative expenses, interest payments on our outstanding debt and sales and marketing expenses.

The commercial sale of approved pharmaceutical products is subject to risks and uncertainties. There can be no assurance that future Vancocin sales will meet or exceed the historical rate of sales for the product, for reasons that include, but are not limited to, generic and non-generic competition for Vancocin and/or changes in prescribing habits or disease incidence. Additionally, period over period fluctuations in net product sales are expected to occur as a result of wholesaler buying decisions.

We cannot assure you that generic competitors will not take advantage of the absence of patent protection for Vancocin to attempt to market a competing product. We are not able to predict the time period in which a generic drug may enter the market. On March 17, 2006, we learned that the OGD changed its approach regarding the conditions that must be met in order for a generic drug applicant to request a waiver of in-vivo bioequivalence testing for copies of Vancocin. We are opposing this attempt. In the event this change in methods to determine bioequivalnce remains in effect, the time period in which a generic competitor may enter the market would be reduced and multiple generics may enter the market, which would materially impact our operating results, cash flows and possibly asset valuations. There can be no assurance that the FDA will agree with the positions stated in our Vancocin related submissions or that our efforts to oppose the OGD’s March 2006 recommendation to determine bioequivalence to Vancocin through in vitro dissolution testing will be successful. We cannot predict the timeframe in which the FDA will make a decision regarding either our citizen petition for Vancocin or the approval of generic versions of Vancocin. If we are unable to change the recommendation set forth by the OGD in March 2006, the threat of generic competition will be high.

We also face risks associated with our ability to successfully integrate Lev into our company, and recognize value from the acquisition. Our inability to successfully integrate the companies could result in delays in the commercial launch of Cinryze and adversely affect the rate of the product’s adoption by patients and physicians ,or the failure to realize cost savings and any other synergies from the merger. The manufacture of Cinryze depends on obtaining adequate supplies of plasma. The plasma market has been constrained in recent years. We rely on a single manufacturer, Sanquin, for Cinryze. We outsource product distribution, and we will rely heavily on a single third party logistics company, as well as two specialty distributors and specialty pharmacy businesses. As a newly approved product, reimbursement for the Cinryze must be established and plays a significant role in our ability to realize product sales. Finally, as an Orphan Drug product, we intend to establish a robust patient access and patient assistance program, the success of which will play an important role in Cinryze. Moreover, the orphan drug business is a new field for ViroPharma, and we will rely on the expertise of selected employees that we expect to join us from Lev. Disruption of any one of these elements could make it more difficult to maintain relationships with suppliers, distributors, customers, payers, patients, patient advocacy groups or physicians, and could adversely affect our efforts to realize the potential value of the product.

We will face intense competition in acquiring additional products to expand further our product portfolio. Many of the companies and institutions that we will compete with in acquiring additional products to expand further our product portfolio have substantially greater capital resources, research and development staffs and facilities than we have, and substantially greater experience in conducting business development activities.

The outcome of our clinical development programs is subject to considerable uncertainties. We cannot be certain that we will be successful in developing and ultimately commercializing any of our product candidates, that the FDA or other regulatory authorities will not require additional or unanticipated studies or clinical trial outcomes before granting regulatory approval, or that we will be successful in gaining regulatory approval of any of our product candidates in the timeframes that we expect, or at all. For example, On April 14, 2008, the Company and Wyeth Pharmaceuticals, a division of Wyeth, jointly determined to discontinue the development of HCV-796 due to the previously announced safety issue that emerged in the ongoing Phase 2 trial in patients with hepatitis C. We also announced that the Company and Wyeth do not expect to continue to collaborate on future development of hepatitis C treatment candidates, however a decision to terminate the First Amended and Restated Collaboration and License Agreement dated June 26, 2003 has not been reached.

While we anticipate that cash flows from Vancocin, as well as our current cash, cash equivalents and short-term investments, should allow us to fund our acquisition of Lev, our investment in Lev’s common stock and substantially all of our ongoing development and other operating costs, as well as the interest payable on the senior convertible notes, we may need additional financing in order to expand our product portfolio. We cannot assure you that planned clinical trials can be initiated, or that planned or ongoing clinical trials can be successfully concluded or concluded in accordance with our anticipated schedule and costs.

Our actual results could differ materially from those results expressed in, or implied by, our expectations and assumption described in this Quarterly Report on Form 10-Q. The risks described in this report, our Form 10-K for the year ended December 31, 2007 are not the only risks facing our Company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results. Please also see our discussion of the “Risk Factors” in Item 1A, which describe other important matters relating our business.

The $4.9 million increase in operating income for the three month period ended 2008 as compared to 2007 resulted from the increased net product sales, offset by our higher costs to support our CMV and NTCD development programs as well as increased selling, general and administrative costs. The $14.7 million decrease in operating income for the nine month period ended 2008 as compared to 2007 is the result of increased costs to support our CMV and NTCD development programs, offset by higher net sales and a slight decrease in the cost of sales. The increase in net income for the three months ended September 30, 2008 resulted primarily from the factors discussed above along with a $4.8 million decrease in income tax expense offset by a $3.9 million reduction in interest income due to our portfolio shift from fixed income securities to cash equivalents. The decrease in net income for the nine months ended September 30, 2008 resulted primarily from the factors discussed above along with a $3.6 million decrease in interest income offset by a $13.2 million reduction in income tax expense.

evenue—Vancocin product sales

Our net product sales are solely related to Vancocin. We sell Vancocin only to wholesalers who then distribute the product to pharmacies, hospitals and long-term care facilities, among others. Our sales of Vancocin are influenced by wholesaler forecasts of prescription demand, wholesaler buying decisions related to their desired inventory levels, and, ultimately, end user prescriptions, all of which could be at different levels from period to period.

During the three and nine months ended September 30, 2008, net sales of Vancocin increased 29.4% and 16.8%, respectively, compared to the same periods in 2007 primarily due to the impact of a price increase during 2008 and an increase in the number of units sold to wholesalers. We believe, based upon data reported by IMS Health Incorporated, that prescriptions during the three and nine months ended September 30, 2008 exceeded prescriptions in the 2007 periods by 9.3% and 6.9%, respectively.

Approximately 94% of our sales are to three wholesalers. Vancocin product sales are influenced by prescriptions and wholesaler forecasts of prescription demand, which could be at different levels from period to period. We receive inventory data from two of our three largest wholesalers through our fee for service agreements. We do not independently verify this data. Based on this inventory data and our estimates, we believe that as of September 30, 2008, the wholesalers did not have excess channel inventory.

Cost of sales (excluding amortization of product rights)

Vancocin cost of sales includes the cost of materials and distribution costs and excludes amortization of product rights. The increase of $0.4 million in the three month period ended September 30, 2008 over the prior period is the result of increased units sold. The $0.1 million decrease for the nine-months ended September 30, 3008 over the respective prior year period is the result of increased efficiency in the manufacturing process.

Since units are shipped based upon earliest expiration date, our cost of sales will be impacted by the cost associated with the specific units that are sold. Additionally, we may experience fluctuations in quarterly manufacturing yields and if this occurs, we would expect the cost of product sales of Vancocin to fluctuate from quarter to quarter.

Research and development expenses

For each of our research and development programs, we incur both direct and indirect expenses. Direct expenses include third party costs related to these programs such as contract research, consulting, cost sharing payments or receipts, and preclinical and development costs. Indirect expenses include personnel, facility, stock compensation and other overhead costs. Due to advancements in our maribavir clinical development program and NTCD preclinical program, we expect future costs to exceed current costs.

Direct Expenses—Core Development Programs

Our direct expenses related to our CMV program increased significantly in the three and nine-months ended September 30, 2008 as we advanced through our two ongoing Phase 3 clinical studies. Specifically, we continued and in May 2008 completed recruitment into the phase 3 study of maribavir in patients undergoing allogeneic stem cell transplant at transplant centers in the U.S., Canada and several European countries. Data collection for the six month assessments will continue through the end of November 2008. We are continuing enrollment in our ongoing Phase 3 clinical study of maribavir in patients receiving liver transplantation in the U.S. and Europe. Additionally, we began executing on our pre-launch plans for our clinical, regulatory and commercial activities for maribavir in the U.S. and Europe as we move towards our planned 2009 initial NDA, MAA and NDS filings for maribavir in stem cell transplant patients. We intend to file a supplemental NDA, MAA and NDS for maribavir in liver transplant patients after approval of the initial NDA, MAA and NDS filings. During the first nine months of 2007 we continued recruitment into an ongoing phase 3 study of maribavir in patients undergoing allogeneic stem cell transplant and began recruiting patients into a second phase 3 study of maribavir in liver transplant patients.

Related to our HCV program, costs in the first nine-months of 2008 primarily represent those paid to Wyeth in connection with our cost-sharing arrangement related to discovery efforts to identify potential back-ups/follow-on compounds to HCV-796. During the first nine-months of 2007, costs included continued recruitment in the 500 mg BID arms of a phase 2 study of HCV-796 when dosed in combination with pegylated interferon and ribavirin and ongoing follow-up of patients in that study. In April 2008, we announced that ViroPharma and Wyeth, have jointly discontinued the development of HCV-796 due to the previously announced safety issue that emerged in the ongoing Phase 2 trial in patients with hepatitis C. We also announced that ViroPharma and Wyeth do not expect to continue to collaborate on future development of hepatitis C treatment candidates.

The increase in costs of NTCD in the first nine months of 2008 over 2007 relate to increased research and development activities and the costs associated with manufacturing NTCD spores.

Related to our Vancocin program, costs in the first nine months of 2008 and 2007 related to additional research activities.

Anticipated fluctuations in future direct expenses are discussed under “ Liquidity – Development Programs . ”

Indirect Expenses

These costs primarily relate to the compensation of and overhead attributable to our development team. The increase in 2008 as compared to 2007 is primarily due to increased personnel costs of $4.6 million resulting from additional hiring in the US and EU to support our clinical studies of maribavir and prepare for a regulatory submission and commercial expenses to support a potential future product launch.

Selling, general and administrative expenses

Selling, general and administrative expenses (SG&A) increased for the three and nine months ending September 30, 2008 $5.1 million and $18.7 million, respectively, comparative to the same periods in 2007. For the nine month period, the largest contributors to these increases were compensation costs, including share based compensation, as a result of increased headcount from the addition of our European operations and the Vancocin sales force ($8.6 million), medical education activities ($4.6 million) and marketing efforts ($3.0 million). Included in SG&A are legal and consulting costs incurred related to our opposition to the attempt by the OGD regarding the conditions that must be met in order for a generic drug application to request a waiver of in-vivo bioequivalence testing for copies of Vancocin, which were $2.8 million and $2.4 million in the first nine months of 2008 and 2007, respectively. We anticipate that these additional legal and consulting costs will continue at the current level, or possibly higher, in future periods as we continue this opposition. During the remainder of 2008, we anticipate continued increased spending in selling, general and administrative expenses, driven by increased compensation due to increased headcount, as well additional medical education and marketing expenses.

Intangible amortization and acquisition of technology rights

Intangible amortization is the result of the Vancocin product rights acquisition in the fourth quarter of 2004. Additionally, as described in our agreement with Lilly, to the extent that we incur an obligation to Lilly for additional payments on Vancocin sales, we have contingent consideration. We record the obligation as an adjustment to the carrying amount of the related intangible asset and a cumulative adjustment to the intangible amortization upon achievement of the related sales milestones. Contingent consideration and Lilly related additional payments are more fully described in Note 4 of the Unaudited Consolidated Financial Statements.

Intangible amortization, increased in all respective periods, with $1.5 million and $1.4 million for the three months ended September 30, 2008 and 2007, respectively and $5.3 million and $4.7 million for the nine months ended September 30, 2008 and 2007, respectively. The increase for each comparative period was primarily related to the $0.4 million increase in the cumulative adjustment, which was $1.0 million for the first nine months of 2008 and $0.6 million for the first nine months of 2007.

In March 2006, as a result of OGD’s change in approach relating to generic bioequivalence determinations, we reviewed the value of the intangible asset and concluded that there was no impairment of the carrying value of the intangible assets or change to the useful lives as estimated at the acquisition date. Additionally, on an ongoing periodic basis, we evaluate the useful life of these intangible assets and determine if any economic, governmental or regulatory event has modified their estimated useful lives. This evaluation did not result in a change in the life of the intangible assets during the quarter ended September 30, 2008. We will continue to monitor the actions of the OGD and consider the effects of our opposition efforts and the announcements by generic competitors or other adverse events for additional impairment indicators and we will reevaluate the expected cash flows and fair value of our Vancocin-related assets, as well as estimated useful lives, at such time.

Other Income (Expense)

Interest Income

Interest income for three months ended September 30, 2008 and 2007 was $3.1 million and $7.0 million, and for the nine months ended September 30, 2008 and 2007 was $13.5 million and $17.0 million, respectively. Interest income decreased for the three months ended September 30, 2008 primarily due to a decreased rate of returns as a result of our portfolio shift from fixed income securities to cash equivalents. Interest income for the nine months ended September 30, 2008 increased due to increased short-term investments, partially offset by decreased rate of returns.

CONF CALL
Will Roberts

Thank you, Debbie. Good morning and welcome to ViroPharma’s conference call and webcast to discuss ViroPharma’s third quarter 2008 financial results and other business matters. This call is scheduled for approximately one hour.

Certain statements regarding future demand for Vancocin; the timing of clinical studies data; and our ability to receive regulatory approvals in the U.S., Canada, and the E.U. and subsequently commercialize our drug candidates; our ability to successfully integrate our recent acquisition of Lev; our ability to successfully commercialize Cinryze; and all elements of our 2008 guidance made during this conference call, are forward-looking statements.

As you know, forward-looking statements involve substantial risks and uncertainties and actual results may differ materially from those projected in such forward-looking statements. The development, marketing, and sale of pharmaceutical products are subject to risks and uncertainties. As a result, our actual results could differ materially from those results expressed in or implied by this conference call.

Please refer to the press release issued this morning and to our filings with the SEC, for more information regarding the risks and uncertainties that could cause future results to differ materially from those expressed in this conference call.

With that, I’ll turn the call over to Vinnie Milano, ViroPharma’s President and Chief Executive Officer. Vinnie?

Vincent Milano

Thanks, Will. And good morning and welcome to everyone listening to ViroPharma’s conference call today. With me on the call this morning, in addition to Will, are Bob Doody, also of Corporate Communications; Rich Morris, our Controller and Chief Accounting Officer; and my team mates on the ViroPharma management team, Colin Broom, Dan Soland, Bob Pietrusko, Tom Doyle, and our newest addition, our new CFO, Charlie Rowland.

These are very exciting times at ViroPharma with, among other things, the near term launch of Cinryze and the near term completion of our Phase 3 study of maribavir in stem cell transplant patients.

For our call this morning, I will begin by providing some comments about our progress since the last financial call, including our acquisition of Lev Pharmaceuticals and Cinryze. Bob will discuss the new Cinryze indication and label, and Rich will discuss our financial results for the quarter and year-to-date.

Let me first acknowledge that with the current market conditions it is important for a biotech company such as ours to have a healthy balance sheet and conservative cash management practices. These are important differentiating points of ViroPharma compared to many other companies.

Through our continued successful execution of our business strategies, we are positioned to grow the Company. First, we completed dosing in our Phase 3 study of maribavir in stem cell transplant patients. The strong momentum throughout the global organization is evident as we are rapidly progressing toward our stated goals of providing top line data from that trial in the first quarter of 2009 and completing our initial regulatory approval filings for this indication in the U.S., Europe, and Canada, in the third quarter of 2009.

The second pivotal Phase 3 study of maribavir in solid organ transplant patients continues to enroll strongly. We look forward to providing specific timelines on the completion of enrolment, data disclosure, and supplemental submissions, soon.

Our Medical Affairs team and our regional medical scientists have continued to do an outstanding job of interacting with physicians who treat patients with C. difficile providing medical education and assisting in limiting the impact of a C. difficile infection outbreak on an institution by institution basis.

In addition, our financial performance during the third quarter was exceptional. Vancocin, our drug for severe CDI, had another record quarter of sales, netting $66 million during the third quarter of 2008. We believe that this continued growth can likely be attributed to the early adoption of the forthcoming CDI treatment guidelines and the impact of our sales force. Thanks to those robust sales, we have again increased and tightened our Vancocin net sales guidance for 2008 to be between $235 million and $245 million.

The third quarter of 2008 represents our fifteenth consecutive quarter of profitability and positive cash flows. We ended the third quarter of this year with cash and cash equivalents of $668 million and working capital of $672 million. Of course, we have invested some of these funds subsequent to the close of the quarter as a result of our acquisition of Lev Pharmaceuticals. Rich will comment on our balance sheet post-close in more detail in a few minutes. However, I do want to remind you that even after the close of our acquisition of Lev, our balance sheet remains very strong.

Eight days ago, we announced the close of our acquisition of Lev, following their October 21st shareholder vote in favor of the acquisition. Since then, all who owned Lev stock received $2.25 per Lev share in cash and $0.50 per share in ViroPharma stock.

Our immediate goals include fully integrating Lev into our business and launching our newly approved therapy, Cinryze, into the HAE prophylaxis market. Our focus this year is to identify as many prophylaxis patients as possible, starting with the conversion of patients in the open label studies on to commercial therapy.

Although we will not go into detail today about the commercialization strategy, next week on November 5, we will conduct another conference call to do just that. Our goal will be to provide you with much greater detail at that time of our commercial launch plans, our comprehensive patient access program, Cinryze Solutions, as well as our pricing strategy for Cinryze.

I want to remind everyone listening of the importance of this therapy to these patients suffering from hereditary angioedema. HAE is a genetic inflammatory disease that currently affects at least 4600 patients in the United States. The inflammation caused by HAE is disfiguring, debilitating, and, some times, life-threatening. The disease is directly linked to the reduced functional levels of C1 esterase inhibitor, which is a naturally occurring inhibitory protein in the blood that is involved in the regulation of the inflammatory process. Most people have more abnormal functional levels throughout their lives and therefore will never experience an episode of angioedema. However, when there is insufficient C1 inhibitor, either because of decreased production or a production of functionally impaired inhibitor, the patient may suffer the dangerous manifestations of this disease.

The most severe attacks of HAE include laryngeal and upper airway inflammation, which can be life threatening. Patients who experience a laryngeal attack often must undergo intubation or even tracheotomy. Death from asphyxiation may occur in as little as 20 minutes, and historically up to 40% of all HAE patients would die of an acute laryngeal attack in the absence of treatment.

Unfortunately, all patients, regardless whether they had had laryngeal attacks in the past, are at risk from asphyxiation. There is no relationship between previous history of HAE severity and the severity of future HAE attacks. And, there is no way to tell whether the next attack a patient will have could be deadly without emergency medical intervention.

Attacks last up to five days, resulting in between 20 and 100 days of incapacitation per year, including absences from work and school. HAE patients live in constant fear of their attacks and frequently find their ability to accomplish daily activities significantly reduced or even eliminated.

For many of these patients, prophylaxis is essential. In fact, today, approximately one-third of the diagnosed HAE patient population chooses prophylaxis with anabolic steroids, which do not directly address the underlying cause of the disease and have dangerous side effects, including virilization, carcinogenicity, and other serious adverse reactions. They have chosen this route because of their fear of HAE attacks, because they and their family members have had severe attacks and because their lives are significantly impacted by the disease. So these patients opted for prophylaxis despite the fact that until now the only available prophylactic option did not adequately target the cause of their disease.

For these patients, finally, there is a new option. On October 10th, the FDA approved our product, Cinryze, to prevent these attacks by increasing the plasma concentration of the C1 inhibitor that these patients cannot make themselves.

With that introduction, I will turn the call over to Bob Pietrusko for a review of the label. Bob?

Bob Pietrusko

Thanks, Vin, and good morning to everyone on the call. Today, I will review for you highlights of the Cinryze label. Cinryze is a human C1 inhibitor indicated for routine prophylaxis against angioedema attacks in adult and adolescent patients with hereditary angioedema, or HAE.

Consistent with our expectations, the label indicates that patients can receive Cinryze every three or four days to control their attacks or, on average, approximately two times per week. Cinryze targets the underlying cause of HAE – low levels of functional C1 inhibitor. By increasing plasma levels of C1 inhibitor activity, Cinryze prevents these attacks from recurring. C1 inhibitor activity also inactivates plasma kallikrein and factor XIIa and is thought to modulate vascular permeability by preventing generation of bradykinin.

I want to briefly review the details of the few approved package inserts to allow for a perspective on the role of Cinryze to prevent this dangerous and debilitating disease in these patients. As you know, the purpose of the package insert is to reflect the clinically meaningful data from the clinical trials to help guide appropriate usage. And we are pleased with the final version of the label. The broad indication in adolescence and adults is reflective of the clinical experience across this broad age group. It is important to note that the FDA agreed with the need to include adolescents in the label as puberty influences and increases the frequency and severity of attacks.

The safety and efficacy of Cinryze prophylaxis therapy to reduce not only the incidence of attacks but also the severity and duration of HAE attacks should they occur was demonstrated in a prospective randomized double-blind placebo-controlled multi-center crossover study of 24 patients. The efficacy determination was based on the number of attacks during the 12-week period while receiving Cinryze as compared to the number of attacks during the placebo treatment period.

Prophylaxis with Cinryze was associated with a reduction in the mean number of HAE attacks from 12.7 to 6.1 attacks during the treatment period. This treatment effect was highly significant. Patients treated with Cinryze also had a statistically significant 66% mean reduction in days of swelling and statistically significant decreases in the average severity and duration of attacks should they occur.

One of the important messages, which we will be delivering to patients, physicians, and third-party payers is that Cinryze truly transforms the lives of these patients who live in fear of HAE and are always concerned that their next attack could be their last. Not only does this therapy prevent HAE attacks in patients altogether, it also reduces the severity and duration of these attacks, if they do occur, taking much of the fear away from these patients.

The package insert clarifies that Cinryze was generally well tolerated throughout its clinical experience. The most common drug-related adverse reactions observed at a rate of greater than or equal to 5% were generally minor, including upper respiratory tract infections, Sinusitis, rash, and head ache. No serious adverse events were related to Cinryze.

Cinryze is contra – indicated in patients who have manifested life-threatening, immediate hyper-sensitivity reactions to the therapy, none of which have been seen in clinical trials of Cinryze to-date. Also, with any blood or plasma-derived product, there may be a risk of transmission of infectious agents by viruses and, theoretically, CJD. The risk has been reduced by screening all plasma donors for prior exposure to certain virus infections and by manufacturing steps taken to reduce the risk of viral transmission, including the use of pasteurization and nanofiltration.

Any blood or plasma-derived product will carry labeling statements about possible risk of virus transmission. This language is known as class labeling.

The FDA has asked us to conduct a Phase 4 trial designed to evaluate higher than the labeled dosage schedule of Cinryze to better define the safety profile of intensified dose schedules that may be used by patients who do not see acceptable clinical benefit at the labeled dose.

You will note that thrombotic events have occurred in neonates receiving high dose C1 inhibitor therapy for another use other than HAE and well above the approved and recommended treatment dosage range. As such, the label recommends that treating physicians monitor patients with known risk factors for thrombotic events. The Phase 4 requirement will help evaluate whether there is a risk of such thrombotic events the higher than approved doses of Cinryze.

Our label is strong and appropriate, reflecting the efficacy of Cinryze across a broad age group of patients and will allow prophylaxis with this therapy in any appropriate adolescent or adult HAE patient. This is an excellent and important therapy and we are thrilled to have recently received approval from the FDA.

One of our next steps will be toward the acute HAE indication. We expect to complete some additional analyzes of the existing acute data and add the open label acute study data to the package with a goal of submitting the supplemental BLA as soon as possible this year. At this point, we do not believe that the FDA will require an additional study though the FDA must agree.

With that, I will turn the call over to Rich for a review of the third quarter financial results. Rich?

Rich Morris

Thanks, Bob, and good morning, everyone. First, Vancocin’s performance during the third quarter and nine-month period of 2008. In the third quarter of 2008, net sales of Vancocin grew 29% over the third quarter of 2007 to $66 million. For the nine-month period, net sales were $182 million, 17% higher than the $156 million in net sales in the nine-month period of 2007.

Next, our expenses. During the third quarter of 2008, as expected, our investments in our clinical pipeline increased over last year’s third quarter. R&D expense for the third quarter of 2008 was $15 million compared to $11 million in the third quarter of 2007. For the year-to-date, our R&D expenses reached $45 million compared to $23 million in the nine months of 2007. The increases in both periods were driven primarily by the increased cost associated with our maribavir Phase 3 studies.

Our selling, general, and administrative expenses for the third quarter of 2008 were approximately $14 million compared to $9 million for the third quarter of 2007. Our SG&A expense has grown from $24 million in the nine-month period of 2007 to $43 million year-to-date through September 2008. The growth in both periods was primarily due to increasing compensation cost resulting from increased headcount for our European operations and Vancocin sales force, our marketing efforts, and an increase in our medical education activities.

Our effective tax rate of 21% for the third quarter of 2008 was down significantly from 36% in the third quarter of 2007. Our tax rate for the nine months of 2008 was 25%, down from 32% for the nine-month period of 2007. The decrease in the effective rate for both the quarter and nine-month period of 2008 as compared to 2007 is primarily due to an increase in our estimated orphan drug credit related to maribavir.

Also, impacting our effective tax rate is a reduction in the valuation allowance associated with our deferred tax assets in the third quarter of 2008. We believe it is more likely than not that we will realize the benefits of these deferred tax assets.

For the full year of 2008, we expect our effective tax rate will be between 25% and 30%, which excludes the potential impact of the Lev transaction, any additional potential changes in our valuation allowance, or any other discreet items.

We reported net income of $27 million for the third quarter of 2008 compared to $21 million in the third quarter of 2007. The increase is due to the increase in net sales and our lower effective tax rate.

For the third quarter of 2008, we reported earnings per share of $0.33 per diluted share compared to $0.26 per diluted share in the third quarter of 2007.

For the nine months ended September 30th, 2008, we reported net income of $69 million as compared to $75 million in 2007. This decrease largely due to lower operating income period-over-period because of the increases in R&D and SG&A, partially offset by increased net sales and our lower effective tax rate.

And we reported earnings per share of $0.84 per diluted share for the nine months ended September 30th, 2008, compared to $0.96 per diluted share for the same period in 2007.

Our balance sheet as of September 30th improved further over that of June 30th. Our cash, cash equivalents, and short-terms investments reached $668 million and working capital increased to $672 million. However, those numbers have since been reduced as a result of our acquisition of Lev. The net cash outlay for the acquisition of Lev was $385 million. So, by all financial measures the third quarter of this year was excellent.

I will now comment on our updated guidance for 2008. First and foremost, our Vancocin guidance assumes no generic competition. Also, our revenue guidance excludes revenue from Cinryze in 2008. Whatever product shipments do occur, they will be subject to the mechanics of revenue recognition for this product – this new product, which are being finalized. Our new expense guidance, however, does include the impact of expenses associated with Cinryze.

Regarding Vancocin net sales, we had increased our guidance and tightened our range. We now expect net sales to reach a range of $235 million to $245 million for the full year of 2008.

We have also increased our guidance for combined research and development and selling, general, and administrative expenses to account for the added expenses associated with Cinryze. These R&D and SG&A expenses, excluding the impact of FAS 123R, are expected to be between $115 million and $125 million.

We expect that the FAS 123R impact to the expenses I just described will be approximately $9 million. So, including the impact of FAS 123R expense, the R&D and SG&A expenses are expected to be between $124 million and $134 million.

In summary, we had a strong quarter and nine months and great momentum throughout our organization. And we expect this continue in the fourth quarter of 2008.

I will now turn this back over to Vin for some closing comments. Vin?

Vincent Milano

Thank you, Rich. ViroPharma is in a very different position today than we were at just the end of the second quarter of this year. With the acquisition of Lev, we have accelerated our evolution as a leading biotechnology company targeting dangerous diseases with few, if any, treatment options.

We are a unique and well positioned Company with two FDA-approved product in Vancocin and Cinryze; a clinical pipeline led by our anti-CMV compound, maribavir, which has important near-term milestones, including top line data from our Phase 3 stem cell transplant study in the first quarter of2009; and regulatory filings in the third quarter of 2009 for this syndication; and a strong cash position with now 15 sequential quarters of profitability and cash flow positivity [ph].

This is a very important time for ViroPharma and our stakeholders as we will soon launch Cinryze, which should, among other things, enable us to continue to deliver strong financial performance. However, that importance pales in comparison to the importance that this drug will play in the lives of many patients with HAE. Our goal is to ensure broad access to Cinryze for patients who may benefit from routine prophylaxis against HAE attacks.

For patients suffering from the life long ramifications of HAE, the approval of Cinryze marks the start of a new life with less fear and concern over this deadly disease. We will work closely with the medical community and with the key advocacy organizations, including the U.S. HAE Association, to increase the awareness of HAE and knowledge of this new prevention option as a way to reduce or eliminate the threat of these deadly attacks.

For ViroPharma, the acquisition and approval of Cinryze follows on the heals of a very successful nine-month period, with great momentum throughout our organization. Our ability to provide new avenues for growth has strengthened as has the commitment of all of our team at ViroPharma as we seek to change lives with the products we develop and commercialize.

Thank you for you attention this morning and your continued interest in ViroPharma. Let’s now open up the call for questions. Operator, are there any for us this morning?

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