VPHM - Sector: Healthcare---Industry: Biotechnology & Drugs

[la-onda]

ViroPharma Too Good to IgnoreThursday , October 30, 2008 07:10ET

Oct 30, 2008 (Zacks Investment Research via COMTEX) -- ViroPharma Inc. (VPHM) posted very strong financial results for the third quarter. Vancocin sales blew away expectations, coming in at $65.9 million, up 29%. Vancocin continues to benefit from impending treatment guideline changes and ViroPharma's new specialty salesforce. The acquisition and approval of Cinryze greatly strengthens the company's future prospects. We are excited to hear about the commercialization plans in early November. We expect management to be in position to launch the product before the end of the year. Besides strong Vancocin sales and the Cinryze approval, both phase III trials on maribavir are progressing on plan. ViroPharma's business fundamentals are strong. Sales and earnings are outpacing expectations and the company should exit the year with over $300 million in cash on hand. At this level, ViroPharma stock is too attractive to ignore. Our 2008 revenue forecast of $243.5 million yields a price to sales ratio of 3.2x. This is significantly below the biotechnology peer-group average of around 6.5x. We forecast 2008 EPS at $0.96. The price to earnings ratio is only 11.5x. As such, we rate the stock a Buy and are maintaining our price target at $16 per share.

[la-onda]

ViroPharma shares fall on rival's study data
Tuesday November 11, 4:24 pm ET
ViroPharma shares drop on positive infection drug study results from Optimer Pharmaceuticals

NEW YORK (AP) -- Shares of ViroPharma Inc. dove Tuesday after likely rival Optimer Pharmaceuticals Inc. said patients taking its developing gastrointestinal infection drug had a higher cure rate and were less likely to relapse.

Exton, Pa.-based ViroPharma saw shares fall $1.64, or 13 percent, to $10.93 in afternoon trading. The stock has traded between $7.78 and $15.16 over the past 52 weeks.

Meanwhile, shares of San Diego-based Optimer surged $4, or 87 percent, to $8.60 after having traded between $3.30 and $9.70 over the past 52 weeks.

In a statement Monday, Optimer said 92.1 percent of patients treated with OPT-80 in a late-stage study were cured, compared with 89.8 percent taking ViroPharma Vancocin, which is already on the market. Patients on OPT-80 also relapsed less than their counterparts on Vancocin.

"If (Optimer's) data is borne out by further study, we would welcome this as good news for patients," said ViroPharma President and Chief Executive Vincent Milano, noting that a significant reduction in relapse rate would be the primary area of potential improvement.

The gastrointestinal infection is called CDI, or clostridium difficile infection, and it affects the colon. It is most commonly obtained by patients in hospitals following treatment with antibiotics.

Vancocin sales rose 29 percent to $65.9 million during ViroPharma's third quarter and the company expects sales to reach between $235 million to $245 million in 2008. It is ViroPharma's only drug on the market, though the company plans next month to begin marketing the already-approved drug Cinryze, which treats a hereditary protein deficiency that can lead to dangerous swelling.

ViroPharma acquired Cinryze with its purchase of Lev Pharmaceuticals, which closed last month.

Despite the boost, Optimer's drug is still undergoing an additional late-stage study and is years away from reaching the market.

Cowen and Co. analyst Rachel McMinn reaffirmed a "Neutral" rating on ViroPharma, saying the possibility for generic versions of the drug have greater relevance than OPT-80.

"Additionally, the infectious disease community is notoriously slow to adopt novel therapies, and we expect OPT-80 to gain share slowly in the first few years of launch," she said.

Meanwhile, Thomas Weisel Partners analyst Stephen Willey reaffirmed an "Overweight" rating on ViroPharma, also saying the impact of generic drugs is more of a risk to Vancocin. He already expects generic competitors for Vancocin before 2010, meanwhile, OPT-80 likely wouldn't gain approval and hit the market until mid-to-late 2010, he added.

&

VPHM: CSFB Starts @ Outperform; Sets Tgt @ $15; Analyst Notes
Tuesday , November 11, 2008 10:43ET
Issuer: Viropharma, Incorporated (NasdaqNM: VPHM)
Analyst Firm:  Credit Suisse First Boston Corp.
Ratings Action: INITIATE
Current Rating: Outperform
Target Price Action: INITIATE
Target Price: $15.00

Analyst Comments: Credit Suisse views VPHM as a diversification story with two new produce coming to market with the ability to drive value above Vancocin, which has been an overhang.

&

VPHM: Short Interest UP 7.3% to 8.8M at the End of Oct 2008
Tuesday , November 11, 2008 16:22ET

According to new short interest data from NASDAQ, short interest for Viropharma, Incorporated (NasdaqNM: VPHM) INCREASED 7.3% to 8,757,350 shares as reported at month-end October, 2008.
Based on VPHM's 20-day average daily share volume of 1,359,310, it would require approximately 7 day(s) of buying to cover this short interest.

[la-onda]

ViroPharma submits supplemental biologics license application for Cinryze to treat acute attacks of hereditary Angioedema (VPHM):

Co announces that it submitted a supplemental Biologics License Application to the FDA for Cinryze C1 Inhibitor as a treatment for acute attacks of hereditary angioedema. The sBLA is based on a re-analysis and resubmission of data from a pivotal Phase 3 acute treatment study of Cinryze and interim data from an ongoing open label acute study of the drug.

The administration of Cinryze was effective in treating acute HAE attacks in these studies. The safety profile was similar to that observed with the use of Cinryze for routine prophylaxis of angioedema attacks in patients with HAE, the currently approved claim.

Overall, more than 9,000 doses of Cinryze have been administered to over 180 patients in all controlled and open label clinical studies of Cinryze for both acute treatment and routine prophylaxis against angioedema attacks. In the analysis of 447 acute attacks in 82 patients, open label Cinryze administration provided substantial relief of the defining symptom in 93.4% of the attacks within four hours of injection, with a median time to onset of relief of 30 minutes. There was no observed loss of effectiveness over multiple administrations of Cinryze for subsequent HAE attacks.

[la-onda]

ViroPharma: FDA draft guidance for generic Vancocin a near term negative- Oppenheimer
Oppenheimer says the FDA has issued draft guidance for generic Vancocin, effectively supporting in-vitro bioequivalence studies with no additional clinical trials, suggesting generic approval may be likely near term. The firm says resolution of the Vancocin overhang is a near-term negative, but it will shift focus to the Cinryze launch and upcoming Maribavir data. Firm lowers their 2009 EPS based on anticipated generic Vancocin approval in early 2009, to $0.62 vs $1.16 (consensus is $0.63).

&

ViroPharma Provides Update on Vancocin(R)
Monday December 15, 1:53 pm ET

EXTON, Pa., Dec. 15 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM - News) today provided the following update regarding Vancocin® (vancomycin hydrochloride capsules).


The Food and Drug Administration (FDA) has posted draft guidance for establishing bioequivalence (BE) to Vancocin. The new draft guidance is open for public comment, and if finalized as proposed would add new requirements for generic applicants beyond the in vitro dissolution testing originally proposed in March 2006. Under the draft guidance, generic applicants will also have to show that their products contain substantially the same inactive ingredients in substantially the same quantities as Vancocin. For generic versions of Vancocin that are not Ql and Q2 the same as Vancocin with respect to inactive ingredients, FDA is recommending in vivo BE studies with clinical endpoints in patients with Clostridium difficile.

Importantly, FDA has also called for public process specific to Vancocin, announcing that there will be a 60 day public comment period to review and comment on these draft guidance. FDA has acknowledged the complexity of the issues involved, and specifically stated that they will carefully consider such comments before responding to ViroPharma's Citizen Petition and finalizing BE recommendation for Vancocin.

Nowhere in the draft guidance does it indicate that FDA has correlated the described in vitro tests to an in vivo outcome, as required by FDA's regulation. A detailed description of this topic can be found at the following link (please cut and paste into your browser):

http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=090000648069607c

"After several years, FDA has agreed with ViroPharma on the need for public process in the development of BE methods for Vancocin," commented Vincent Milano, ViroPharma's president and chief executive officer. "We will actively participate in this process to appropriately address this important public health issue with the ultimate goal of ensuring the safety of patients. For example, we will work to ensure that the process considers the potential severity of Clostridium difficile infections and its effect on a patient's GI tract, and that in vitro lab-based tests are correlated with in vivo outcomes to avoid any potential danger to patients who suffer from this life-threatening disease."

C. difficile is a bacterium, which under certain circumstances, typically after antibiotic therapy, can colonize the lower gastrointestinal tract where it may produce toxins which cause inflammation of the colon and diarrhea. Without proper treatment, the associated complications of the disease can be deadly. Advanced age, gastrointestinal surgery/manipulation, long length of stay in healthcare settings, a serious underlying illness and compromised immunity are conditions associated with increased risk of disease. According to the U.S. Centers for Disease Control and Prevention (CDC), there are an estimated 400,000 to 500,000 CA-CDAD and HA-CDAD cases annually based on 2004 data.

[la-onda]

ViroPharma: New FDA guidelines are in line with our expectations, allowing for potential generic Vancocin approval without clinical trials - Rodman & Renshaw (11.31 )

Rodman and Renshaw notes that VPHM announced that the FDA has issued draft guidelines that provide a path to approval of a generic Vancocin without the need for clinical trials. Although the guidelines have come earlier than they had anticipated, their expectations had been that the FDA would try to find a way to approve generic versions of Vancocin primarily on the basis of in vitro bioequivalence data. On posting the new guidance to their website, the agency called for public comments to the documents over a 60 day period beginning today. They fully expect VPHM to respond to the FDA's guidance during this timeframe. Following the completion of the 60-day window, they expect the FDA to further review the guidelines in light of any comments submitted and therefore, in their view, there will be a further period of time before a generic is potentially approved. Although the increased likelihood of approval of a generic Vancocin in 2009 has resulted in headline pressure to VPHM shares, clarity as to a final resolution of this overhang will allow investors attention to become fully focused on Cinryze and maribavir, which we they as the key drivers to the stock in 2009.

[la-onda]

Love (of Biotech) Is the DrugBy JOHN JANNARONE

Cash-rich pharmaceuticals firms are on the hunt for acquisitions. But don't expect their war chests to bail out the weakest biotechnology firms.

Even though cash-strapped biotech companies offer potential acquirers the chance to snap up promising new drugs on the cheap, big pharma is likely to look elsewhere.
[Biotech heard on the street] Bloomberg News/Landov

Bristol-Myers Squibb's research institute in Hopewell, N.J.

The likes of Pfizer and Bristol-Myers Squibb already pour billions of dollars into annual research budgets. Rather than more early-stage opportunities, they need drugs with real near-term revenue potential to fill the gap as patents on existing blockbusters expire.

Both of those companies' top-selling drugs -- Pfizer's Lipitor and Bristol-Myers Squibb's Plavix -- will see patents expire in 2011, leading to lower revenues.

That makes companies such as ViroPharma, with a $1 billion market capitalization, as possible targets for big pharmaceuticals makers. The firm already has two drugs on the market and another is in the final stage of clinical trials. ViroPharma had $182 million in revenue for the first nine months of 2008 and posted a profit of $69 million.

A potential acquirer also might have to pay a healthy takeover premium. Viro-Pharma is no forced seller. With $250 million in debt and $613 million of cash, it can continue to operate without financial pressure.
Amylin Pharmaceuticals, a diabetes-drug developer valued at $1.5 billion, also could draw attention. It has two drugs now in production and generated revenue of $638 million in the first nine months of last year.

The company posted a loss of $211 million because of heavy research-and-development costs, and poor recent trials for a third drug hit the shares hard in 2008. But its $805 million in gross cash should be enough for a while.

Other firms are unlikely to be so lucky. Rigel Pharmaceuticals, for example, has a promising arthritis drug under development but is an unlikely fit for a large pharmaceuticals manufacturer. And the company's shares fell 68% last year partly because of concerns about its access to new funding.

The market hasn't punished pharmaceuticals firms that paid up for solid drugs. Eli Lilly's $6.5 billion acquisition of ImClone could cause Lilly to post a loss in the current fiscal year. But Lilly's shares fell 25% in 2008, similar to the performance of rivals.

Roche performed solidly despite its $45 billion unsolicited offer for the remaining 46% of Genentech it doesn't already own.

Doubts linger over the deal, including how easily Roche could finance it. But for smaller transactions, pharmaceutical companies have plenty of firepower. Pfizer has $9.7 billion in net cash. Bristol-Myers has about $1.2 billion and will receive another $1 billion for its stake in ImClone.

The cream of biotech firms, spared from the funding crisis, won't come cheap. But with revenue holes to fill, some pharmaceuticals giants might still be tempted to pay up.

Write to John Jannarone at [email protected]

[la-onda]

VPHM: Deutsche Bank Starts @ Hold; Sets Tgt @ $12; Analyst Notes
Tuesday , January 20, 2009 09:26ET
Issuer: Viropharma, Incorporated (NasdaqNM: VPHM)
Analyst Firm:  Deutsche Bank
Ratings Action: INITIATE
Current Rating: Hold
Target Price Action: INITIATE
Target Price: $12.00
Analyst Comments: Deutche Bank finds the stock fairly valued at current levels. Target $12.

[la-onda]

sold VPHM with a big loss 

ViroPharma - One-Trick Pony or One-Trick Thoroughbred?

We have been long-time bulls on ViroPharma, Inc. (NasdaqGS: VPHM -
News). Over the past year, ViroPharma's stock had been reacting well
to the uptick in Vancocin sales, and the Citizen's Petition strategy
to delay a generic alternative has worked beautifully to maintain an
exclusive market in 2007 and 2008.

Paramount to our investment thesis was that the continued strong sales
in Vancocin would allow for management to fully develop the next wave
of products, including HCV-796 and maribavir, as well as in-license
new candidates such as Cinryze. With HCV-796 and now maribavir gone,
and generic Vancocin most likely coming in mid-2009, too many
questions remain for us to recommend the shares.

It is our belief that ViroPharma will become a one-trick pony,
Cinryze, by the start of 2010. That's not necessarily a bad thing if
that pony turns out to be a thoroughbred. Some of the things that
could make Cinryze a thoroughbred include rapid uptake by the 200+
clinical trial patients and women and children actively seeking
treatment options.

Plus, Cinryze is the only viable treatment option for patients seeking
prophylactic therapy. Finally, approval for the acute indication in
June 2009 locks-up the entire C1-esterase inhibitor market and means
that Cinryze will most likely dominate the HAE landscape. That turns a
$250 million product into a $500 million product based on one FDA
regulatory decision.

But Cinryze will not carry the same sort of profitability that
Vancocin did. Vancocin had 95%+ gross margins and was being
effectively promoted by a very limited sales force. Sales totaled $232
million in 2008. Cinryze is a very different product. The product has
only a 65% gross margin and will require heavy promotion and safety
monitoring, along with the added costs of REMS and Cinryze Solution
registry.

Sales in 2009 will only be around $40 million. In fact, unless all the
pieces fall into place (DX-88 rejected, Cinryze approved for acute
use), it may not be until 2013 that Cinryze posts sales above $232
million. This means that ViroPharma's most profitable days are behind
them.

Management still holds $276 million in cash, but could owe future
potential milestones to Lev shareholders in the order of $175 million.
The first $87.5 million payment could be due in June 2009. The company
also has $250 million in convertible debt due in 2016. Given
management's need to maintain at least $200 million in cash reserves,
we do not expect another Lev-like acquisition anytime soon.

That leads us to the key investment question: Is ViroPharma a one-trick pony, or one-trick thoroughbred? At this time it is too early to tell, and we do not feel comfortable recommending the shares until visibility improves.


http://www.zacks.com/ZER/zer_get_pdf.php?r=Z427745&t=VPHM

[la-onda]

just an update 
cheers
Oliver

[setravis]

Strong Quarter for ViroPharma

ViroPharma Inc. (NasdaqGS: VPHM - News) posted third-quarter earnings of 48 cents per share, beating the Zacks Consensus Estimate by 17 cents and the year-ago figure by 20 cents. Increased product sales helped boost third quarter 2010 earnings.

Revenues

Quarterly revenue of $117.8 million was well above the Zacks Consensus Estimate of $106 million and 46% above the year-ago revenue of $80.6 million. Revenues were spurred by higher sales of Cinryze and Vancocin.

While Cinryze sales increased 69% to $49.1 million, Vancocin sales came in at $67.6 million, up 31%.

Sales of Cinryze increased during the quarter due to higher patient demand, while sales of Vancocin went up due to price increases.

Expenses

Selling, general and administrative (SG&A) expenses and research and development (R&D) expenses, taken together, increased during the quarter to $35.2 million from $31.2 million in the year-ago period.

Quarterly SG&A expenses increased 24.0% year over year as a result of a rise in compensation expense and marketing activities related to Cinryze, while quarterly R&D expenses declined 7.4% due to the discontinuation of the maribavir prophylactic program.

Outlook

For fiscal 2010, ViroPharma raised its Cinryze sales guidance to $170–$180 million from $165–$175 million.

Expenses, both R&D and SG&A taken together, are expected to range from $140–$145 million, up from the previous guidance range of $135–$145 million.

Our View

We currently have a Neutral recommendation on ViroPharma, which is supported by a Zacks #3 Rank (short-term Hold rating). We are pleased with the company's third quarter results. ViroPharma expects the European approval and launch of Cinryze to take place in the first half of 2011.

However, Vancocin, which is one of the primary revenue contributors at ViroPharma, is not protected by any patent. Vancocin generics are yet to hit the market with the FDA requiring generic companies to conduct a bioequivalence study to gain approval for their versions. We note that a proposed bioequivalence method for Vancocin is filed for approval with the FDA. If the method gets the regulatory body's nod, the time required for a generic manufacturer to get a copycat version of Vancocin approved will be reduced and multiple generics may enter the market, thereby leading to significant sales erosion of the drug.

Zacks Investment Research

[la-onda]

  new breeak out 
new 52 weeks high!