Zest Invest: Viropharma - VPHM

Pharmaceuticals 8/1/07


Notes

"ViroPharma (VPHM) has one marketed product and multiple product candidates in clinical development. The Company markets and sells 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, or C. difficile, and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains.

"ViroPharma is developing CamviaTM (maribavir) for the treatment of cytomegalovirus, or CMV, infection and HCV-796 for the treatment of hepatitis C virus, or HCV, infection. The Company has licensed the U.S. and Canadian rights for a third product candidate, an intranasal formulation of pleconaril, to Schering-Plough for the treatment of picornavirus infections. "
http://www.viropharma.com/

Maribavir was renamed Camvia sometime in 2007. It has orphand drug status, which means there is a tax credit and some other benefits should the company market it. It is at the start of Phase 3 trials.
http://en.wikipedia.org/wiki/Orphan_drug

HCV-796 has FDA fast-track status, which helps speed the approval (or rejection) process with the FDA. It is at the start of Phase 2 trials.

From a quarterly report:
" We cannot assure you that generic competitors will not take advantage of the absence of patent protection for Vancocin to attempt to develop 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 asset valuations.

The number of shares outstanding increases 20%--and earnings per share decline 20%--when options and convertibles are considered.

20May07

Market-cap.: $1B
PEG: 0.8 (5yr expected):
PE: 13
Forward PE: 17 (2008)
Profit margin: 43%
Return on equity: 21%
Debt/equity: 0.6
Current ratio: 33 <--GOOD
Insiders: selling around $15.50
Estimates for 2008 are very low, and I'm not sure why. Five-year PEG is good.

1AUG07

From the recent quarterly report:

"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. Our net sales will also be impacted upon entering into any fee-for-service or inventory management agreements with wholesalers, which would require us to pay wholesalers for access to data and for their distribution and other services, reducing net sales.

"During the three and six months ended June 30, 2007, net sales of Vancocin increased 28.0% and 43.9%, respectively, compared to the same periods in 2006 primarily due to an increase in the number of units sold to wholesalers and the impact of a price increase during 2007. We believe, based upon data reported by IMS Health Incorporated, that prescriptions during the three and six months ended June 30, 2007 exceeded prescriptions in the 2006 periods by 5.6% and 9.0%, respectively. Our comparative periods are also impacted by a decrease in wholesalers' inventory levels during the first four months of 2006, as compared to the 2007 period where wholesalers' inventory remained relatively constant.

"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 that as of June 30, 2007, the wholesalers did not have excess channel inventory.

From the conference call:
The company is looking for an acquisition, but hasn't found any good deals yet.

Predicts revenue growth of 25% for Vancocin, and gross margin of 90%. No guidance for 2008. Research and development expenses will increase as the two drugs in the pipeline advance; Phase 3 testing is more expensive than Phase 2 testing.
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