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Agreed. I just didn't have the patience. Who knows, I may jump back in for another go.
Best of luck to you.
with the CFO's massive insider sales and a likely to disappoint 10Q coming, this is headed over a cliff. Check out the Seeking Alpha piece on it.
Been holding May 17th puts on it for a few days and up nicely. Target is a 61.8% fib retrace to $65.61...
Covered 220 VRTX @ 79.74.
8:36AM Vertex Pharm announces new data that showed high viral cure rates with a total of 12 and 24 weeks of telaprevir combination treatment among people with genotype 1 hepatitis C who have the IL28B CC genotype (VRTX) 83.53 : Co announced new data from an interim analysis of the exploratory global Phase 3b CONCISE study evaluating the potential to shorten total treatment with telaprevir combination therapy to 12 weeks in certain people with genotype 1 chronic hepatitis C virus (HCV) infection who have the IL28B CC genotype. In the CONCISE trial, telaprevir was administered twice daily in combination with pegylated-interferon and ribavirin. Of the 239 people in the study, 159 people completed 12 weeks of telaprevir combination treatment and had undetectable hepatitis C virus at week four of treatment (rapid viral response, or RVR) and were eligible to be randomized. One hundred seven people were randomized to receive no further treatment and 52 people were randomized to receive an additional 12 weeks of treatment with pegylated-interferon and ribavirin alone, for a total of 24 weeks of treatment. In the 12-week total treatment group, of the 85 people with data available at the time of the interim analysis, 87 percent (74/85) had undetectable hepatitis C virus 12 weeks after the end of treatment (SVR12). In the 24-week treatment group, of the 30 people with data available at the time of the interim analysis, 97 percent (29/30) achieved SVR12.
Figures my call was damn close - wasn't payin attention to this one today - should of stuck to my call and shorted @87.00 ohh well
Cheers.
All luck, though. If it blows past 85, I'll be stopped out. Deutsche has a $100 target, but I was hoping for more profit-taking rather than covering today.
Let's see how the dice fall.
Good call - I thought for sure it was going to be pushed past $87
Too soon - powerful lil turd lol
I'm looking also ;)
April 18, 2013 7:27 EDT VRTX Vertex spikes higher after reporting phase 2 study results
Shares of Vertex are shooting higher in the after hours session after the company reported results from a phase 2 study of VX-661 and ivacftor that showed statistically significant results. WHAT'S NEW: A phase 2 study of VX-661 and ivacftor in adult patients with cystic fibrosis who have two copies of the most common mutation in the cystic fibrosis transmembrane conductance regulator gene showed statistically significant results. Patients in the 100mg and 150mg combination dose groups showed statistically significant mean relative improvements in lung function versus placebo, of 9% and 7.5%, respectively. In the study, Vertex said VX-661 was generally well-tolerated, both as monotherapy and in combination with ivacaftor. "This first study of VX-661 and ivacaftor provides further validation of the strategy of combining a corrector and potentiator to improve lung function in people with the most common type of cystic fibrosis," said Peter Mueller, Ph.D., chief scientific officer and executive VP of global research and development at Vertex. PRICE ACTION: Shares of Vertex are up $27.43, or 51.88%, to $80.30 in the after hours, a multi-year high for the stock, which is up more than 25% year-to-date.
Yup shorts are toasted!!!
Lol I agree - people must have screws loose to buy waaaaaay up here - shorts got fried on this bad boy
Up 51% @81.50 in AH.
Congrats longs. Don't get greedy and lock in the profit,
because after hitting the peak, it'll pull back 20 to 30% from the
top as they always do.
I missed the long play, so I'm looking to short eventually.
4:22PM Vertex Pharm announces initiation of pivotal Phase 3 program of VX-809 in combination with ivacaftor for the treatment of people with cystic fibrosis who have two copies of the F508del mutation (VRTX) 44.18 -0.68 : Co announced the initiation of a global pivotal Phase 3 development program for fixed-dose combinations of VX-809 (lumacaftor) and ivacaftor in people with cystic fibrosis (CF) who have two copies (homozygous) of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Vertex plans to conduct two 24-week Phase 3 studies to support approval of the combination of VX-809 and ivacaftor in people with CF ages 12 and older. The studies, TRAFFIC and TRANSPORT, will each include two treatment groups that will evaluate VX-809 (600mg QD or 400mg q12h) in combination with ivacaftor (250mg q12h) compared to a placebo group. Vertex expects to obtain 24-week safety and efficacy data from both studies and to submit a New Drug Application to the FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency, pending study results.
Co also plans to conduct a pharmacokinetics and safety study to evaluate VX-809 in combination with ivacaftor in children with CF ages 6 to 11 who have two copies of the F508del mutation. The company expects to use the data from this study for subsequent registration in children ages 6 to 11 in the United States and is continuing discussions with European regulatory agencies for patients in this age group.
Orphan Drugs & Value Propositions: Randy Explains
Make a comment
By Ed Silverman // January 17th, 2013 // 11:16 am
Earlier this month, NPS Pharmaceuticals announced that the price for its Gattex treatment for short-bowel syndrome would cost $295,000 a year, roughly three times what Wall Street had expected. This marked the fourth time in the past year that an orphan drug was approved and the price per patient was set at more than $200,000 annually. The move highlighted a growing debate about the calculations used for developing new medications designed for small patient populations and the ability of the healthcare system to afford these treatments and accommodate patients. We spoke with Randy Vogenberg, a principal at the Bentelligence consulting firm, which specializes in benefits consulting and strategic decision making, about the implications for drug makers and payers…
Pharmalot: Why are we seeing this kind of pricing?
Vogenberg: I think part of the reason is that we’re dealing with smaller patient populations than in the past and that’s the typical situation. There are hundreds instead of however many tens of thousands of patients and then we’re spreading cost among a smaller group. So unit costs rise dramatically. And there’s a Catch 22 around pricing – which is a little unique around specialty (drugs). You have a smaller number (of patients) and charging a higher price, so there’s a higher percentage of patients who can’t afford it. This means there’s greater need for unrestricted grants and patient assistant programs. So as a company, you end up paying more for your own product than in the older, traditional marketplace.
more...
http://www.biotechinvestorsnetwork.com/#!featured-article/c17ob
Might be the turn around here ?
Vertex Reschedules its Third Quarter 2012 Financial Results Conference Call and Webcast Due to Hurricane Sandy
-Company to announce third quarter financial results on Thursday, November 1, 2012-
Press Release: Vertex Pharmaceuticals Incorporated – Mon, Oct 29, 2012 9:11 AM EDT.. .
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
As a result of the effects of Hurricane Sandy and the related closure of the financial markets, Vertex Pharmaceuticals Incorporated (VRTX) today announced that it has rescheduled its third quarter 2012 earnings press release and conference call, which were originally scheduled for today, Monday, October 29. Vertex will now announce its third quarter 2012 financial results on Thursday, November 1, 2012 after the financial markets close. The company will host a conference call at 5:00 p.m. EDT on Thursday.
The conference call will be webcast live and a link to the webcast may be accessed from the ‘Events & Presentations' page of Vertex's website at www.vrtx.com. A replay of the conference call and webcast will be archived on the company's website until November 15, 2012. To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast.
About Vertex
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives.
Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases.
Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada. Today, Vertex has more than 2,000 employees around the world, and for three years in a row, Science magazine has named Vertex one of its Top Employers in the life sciences. Vertex's press releases are available at www.vrtx.com.
VRTX – GEN
4:00PM Vertex Pharm announces positive results from viral kinetic study of the nucleotide analogue ALS-2200 in people with hepatitis C (VRTX) 49.96 +0.64 : Co announced positive results from a viral kinetic study of the nucleotide analogue ALS-2200 for the treatment of hepatitis C. There was a median 4.54 log10 reduction in hepatitis C virus (HCV) RNA in people with genotype 1 chronic hepatitis C who were new to treatment (n=8) after seven days of dosing with 200 mg of ALS-2200 once daily. ALS-2200 was well-tolerated in this study, and no patients discontinued due to adverse events. Based on these data, Vertex plans to begin Phase 2 studies this year of 12-week all-oral regimens including ALS-2200 in people with genotype 1 hepatitis C, pending discussions with regulatory agencies.
Gift ?? They really love to hand out gifts.
http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0000875320&type=&dateb=&owner=include&start=0&count=40
Here’s your answer: #msg-77070399, #msg-77070752.
AH - ouch !!! $52.25
VRTX has now achieved one of its main business goals: #msg-75281415.
7:30AM Vertex Pharm: interim data from Phase 2 combination study of VX-809 and KALYDECO (ivacaftor) showed 'significant' improvements in lung function (FEV1) in people with cystic fibrosis who have two copies of the F508del mutation (VRTX) 37.41 : Co announced today an interim analysis of data from an ongoing Phase 2 study of VX-809 and KALYDECO (ivacaftor) that showed significant improvements in lung function (FEV1) among adults with cystic fibrosis (CF) who have two copies (homozygous) of the most common mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, F508del. A planned interim analysis was conducted after approximately half of the study patients had completed 56 days of treatment. Today's results are based on data from 37 homozygous F508del patients who completed treatment in the 56-day study and 11 patients with one or two copies of the F508del mutation who received placebo. There was a statistically significant improvement in lung function (absolute change in percent predicted FEV1) across the combined treatment groups relative to baseline compared to placebo (p=0.002). Of those who received VX-809 and KALYDECO (250mg, q12h), approximately 46 percent (17/37) experienced an absolute improvement from baseline to Day 56 in lung function of 5 percentage points or more, and approximately 30 percent (11/37) experienced an absolute improvement from baseline to Day 56 of 10 percentage points or more. None of the patients treated with placebo (0/11) achieved a 5-percentage point or more improvement from baseline to Day 56 in lung function. Most adverse events were mild or moderate in severity and comparable between treatment and placebo groups. The study is ongoing and complete data, including statistical analyses for all patient groups, will be available in mid-2012. Stock to resume trading at 7:50.
Vertex Pharm VRTX UBS Neutral $35 » $44
Read more: http://www.breifing.com/investor/calendars/upgrades-downgrades/#ixzz1qQSwyocl
Vertex Pharm reports data from Phase 2 Study of an INCIVEK combination regimen showed 74% of people co-infected with hepatitis C and HIV had undetectable hepatitis C virus 12 weeks after treatment ended (SVR12) (VRTX) 39.91 -0.52 : Co announced interim results from an ongoing Phase 2 study designed to evaluate the safety and tolerability of INCIVEK (telaprevir) tablets in combination with pegylated-interferon and ribavirin in people who are co-infected with genotype 1 hepatitis C virus and human immunodeficiency virus (HIV). Data showed 74 percent (28/38) of patients who were treated with INCIVEK combination therapy had undetectable hepatitis C virus (HCV RNA) 12 weeks after the end of all study treatment (SVR12) compared to 45 percent (10/22) who were treated with pegylated-interferon and ribavirin alone. INCIVEK was well tolerated with commonly used Atripla- and Reyataz-based HIV treatment regimens.
~ $VRTX ~ Earnings posted, pending or coming soon! In Charts and Links Below!
~ $VRTX ~ Earnings expected on Thursday *
This Week In Earnings: Earnings are coming or are already posted! This is what the charts look like! If you play the earnings these posts can be very helpful to you!
Want more like this? Search Keyword: MACMONEY >>> http://tinyurl.com/MACMONEY <<<
One or more of many earnings sites has alerted this security has or will be posting earnings on or around the day of this message.
http://stockcharts.com/h-sc/ui?s=VRTX&p=D&b=3&g=0&id=p88783918276&a=237480049
http://stockcharts.com/h-sc/ui?s=VRTX&p=W&b=3&g=0&id=p54550695994
~ Barchart: http://barchart.com/quotes/stocks/VRTX?
~ OTC Markets: http://www.otcmarkets.com/stock/VRTX/company-info
~ Google Finance: http://www.google.com/finance?q=VRTX
~ Google Fin Options: hhttp://www.google.com/finance/option_chain?q=VRTX#
~ Yahoo! Finance ~ Stats: http://finance.yahoo.com/q/ks?s=VRTX+Key+Statistics
~ Yahoo! Finance ~ Profile: http://finance.yahoo.com/q/pr?s=VRTX
Finviz: http://finviz.com/quote.ashx?t=VRTX
~ BusyStock: http://busystock.com/i.php?s=VRTX&v=2
~ CandlestickChart: http://www.candlestickchart.com/cgi/chart.cgi?symbol=VRTX&exchange=US
~ Investorshub Trades: http://ih.advfn.com/p.php?pid=trades&symbol=VRTX
~ Investorshub Board Search: http://investorshub.advfn.com/boards/getboards.aspx?searchstr=VRTX
~ Investorshub PostStream Search: http://investorshub.advfn.com/boards/poststream.aspx?ticker=VRTX
~ Investorshub Goodies Search: http://investorshub.advfn.com/boards/msgsearchbyboard.aspx?boardID=18582&srchyr=2011&SearchStr=VRTX
~ Investorshub Message Search: http://investorshub.advfn.com/boards/msgsearch.aspx?SearchStr=VRTX
~ MarketWatch: http://www.marketwatch.com/investing/stock/VRTX/profile
~ E-Zone Chart: http://www.windchart.com/ezone/signals/?symbol=VRTX
~ 5-Min Wind: http://www.windchart.com/stockta/analysis?symbol=VRTX
~ 10-Min Wind: http://www.windchart.com/stockta/analysis?symbol=VRTX&size=l&frequency=10&color=g
~ 30-Min Wind: http://www.windchart.com/stockta/analysis?symbol=VRTX&size=l&frequency=30&color=g
~ 60-Min Wind: http://www.windchart.com/stockta/analysis?symbol=VRTX&size=l&frequency=60&color=g
http://investorshub.advfn.com/boards/post_prvt.aspx?user=251916
*If the earnings date is in error please ignore error. I do my best.
Leerink cut sales estimates.
Vertex Pharmaceuticals: Great Pipeline, Valuation And Future
The past 6 months have proven that biotech mergers & acquisitions are soaring. Gilead (GILD) gobbled up Pharmasset (VRUS), and Bristol-Myers (BMY) bought Inhibitex (INHX), and dozens of companies are rumored to be next. The surge in M&A in this sector has inflated stock prices across the sector, as investors bet on the next deal. Yet one company has been ignored in this rally, and we think that it is time investors take note of it.
Vertex Pharmaceuticals (VRTX) is a biotech company that develops therapies for a wide range of diseases. Its primary product is Incivek, for the treatment of HCV (also known as HCV), and Lexiva, for HIV, which it sells in a partnership with GlaxoSmithKline (GSK). Incivek is one of the first new therapies for HCV in years, and it has been responsible for an almost 74% rise in Vertex's stock price over the last 10 years. Yet, as merger mania in the biotech sector heats up, Vertex has been left in the dust. We think that is a situation that cannot last for long, given the company's products and pipeline. Below we profile Vertex, its drugs, and its future.
Overview
Vertex received FDA approval to sell Incivek in May 2011, after nearly 15 years of development. The drug is on pace to break the record for the fastest product launch to reach sales of $1 billion. And just a quarter after launching the drug, Vertex announced that it has become profitable, posting EPS of $1.02 on revenues of $659 million in the third quarter of 2011. Many biotech companies spend years in the red even after launching their drugs. Yet despite all this, Vertex stock has languished over the past year.
click to enlarge images
Over the past year, Vertex has lagged both the S&P 500 and the broader biotech sector (XBI), falling over 9%. There are two factors at play here. The first is takeover mania in the biotech sector. The second is concerns with Incivek.
Takeover mania: After it was revealed Bristol-Myers was buying Inhibitex, both Achillion Pharmaceuticals (ACHN) and Idenix (IDIX) rallied sharply. Achillion rallied 16% and Idenix soared 34%. And what about Vertex, the only biotech company with an actual HCV drug on the market? Its shares rose a paltry 4%. With a surge in M&A action, it would make sense that the company most likely to be pursued by big pharma would be a company with a profitable drug on the market and a promising pipeline. Rumors would suggest that Johnson & Johnson (JNJ), Vertex's partner on the Incivek, would be a good fit for the company. In addition, Abbot Labs (ABT) could also be looking to expand its own HCV franchise. But with a market capitalization of over $7.5 billion, Vertex carries a hefty price tag, even without the premium necessary to seal an acquisition. The fact that it would take much more work to buy out Vertex than its peers in the HCV space has depressed the stock. Yet as each biotech's scarcity value increases, the chances of someone paying top dollar for Vertex increases.
Incivek: Multiple companies are developing the next generation of HCV therapies, including Pharmasset, Inhibitex, Achillion, and Idenix, as well as Merck (MRK). The mania surrounding the HCV developers is due to the fact these companies, while having no product on the market, are developing therapies that do not use interferon. Interferon has been a staple of HCV treatment for years, but it comes with a host of unpleasant side effects, some of them worse than the symptoms themselves. As such, many patients simply do not get treatment. But the next generation of therapies work far differently than current treatments. These nucleosides and nucleotides have proven themselves in many clinical trials. Gilead paid an 84% premium for Pharmasset precisely because its HCV treatment uses no interferon. The same goes for Inhibitex, Idenix, and Achillion. Incivek, on the other hand, is an improvement on existing treatments, yet must still use interferon, diluting its "value" relative to the other drugs in development. As such, Vertex has seen its stock depressed since the launch of Incivek, as investors fret that new treatments will render its drug useless.
These 2 factors have depressed Vertex's stock, and we think that this creates an ideal time to buy the stock. Vertex's future is nowhere near as grim as investors currently believe it to be. There are 2 primary reasons for this. The first is that pessimism about the company's HCV franchise is overdone. The second is that Vertex is rapidly diversifying away into new markets.
HCV
Medical data from a variety of biotech companies proves that interferon-free therapy is simply more effective than Incivek. That is a reality that Vertex investors must accept. Merrill Lynch, in cutting its estimates for Vertex, laid bare the situation. It slashed sales estimates for Incivek, citing competition from interferon-free therapies and waning demand due to the side effects of interferon.
Global Incivek Prescriptions: Merrill Lynch
Estimates have been slashed dramatically for Incivek's global potential, particularly in 2014 and beyond. This is due to the fact that 2014 is the projected date for interferon-free therapies to hit the market, led by Gilead's PSI-977, the primary driver of the Pharmasset deal. A variety of studies have shown that these therapies are superior to Incivek. There is no denying that. But, until 2014, Incivek will remain a leading choice for HCV patients, for it is an incremental improvement on prior therapies. Incivek has already demonstrated that it can allow Vertex to acheive profitability after just several months on the market. This allows Vertex to fund its research internally, without diluting its shareholders or weakening the balance sheet, something many other biotechs must resort to, even after starting sales of their drugs.
While Vertex was the first biotech to launch an HCV therapy, Incivek is certainly not its last drug in development for this disease. Vertex is fully aware that interferon-free therapies are the future, and it is planning accordingly. The company's 2012 business plan highlights its plans for the HCV franchise. Vertex is set to begin Phase III trials of VX-222, the successor to Incivek. VX-222, when given in combination with Incivek, cuts the maximum treatment time to 24 weeks, versus up to 48 weeks of treatment with Incivek alone.
In addition, Vertex is not sitting idly by in the interferon-free subsector. Vertex is collaborating with Alios BioPharma in developing interferon-free therapies. ALS-2200 and ALS-2158 are currently in Phase I trials. Data is expected in the second quarter of 2012, with Phase II trials set to begin in the second half of the year. Vertex has worldwide rights to these therapies, and in its deal with Alios it must pay royalties on future sales. At this point, readers may be wondering what good this will do Vertex, for these therapies are at least several years away from commercialization, and by then Incivek could be rendered irrelevant. However, we think investors are too focused on Incivek. Even in 2016, Incivek will be a profitable drug, despite the competition on the market. And by then, Vertex will have branched out into an entirely new area of medicine: cystic fibrosis.
Cystic Fibrosis
This is a disease that affects around 30,000 people in the United States and 70,000 worldwide. It is a rare and life-threatening disease with no current cure. So what is Vertex doing to address this? VX-770, to be marketed as Kalydeco, targets an extremely rare subset of cystic fibrosis patients, who have a specific mutation in the G551D gene. Only about 1.6% of all cystic fibrosis patients have this mutation, making it extremely rare. That is why Kalydeco has been given orphan drug status, and is on a fast track review at both the FDA and the EMA (European Medicines Agency). A target review date of April 18, 2012 has been set by the FDA, and all indications are that Kalydeco will be approved in both the US and Europe.
Orphan drugs are ones that treat extremely rare diseases. Given that they meet an unmet medical need, companies developing orphan drugs are given a variety of incentives for developing them, such as longer exclusivity, clinical research tax credits, and fast reviews at the FDA. The current poster child for the success of orphan drugs is Alexion (ALXN), whose Soliris drug treats several extremely rare diseases. Any Alexion investor can tell you that they are very happy with how the company has done, given its 1,300% rise over the last 10 years.
Credit Suisse estimates that while Kalydeco can ultimately address just 5% of the cystic fibrosis market, it can charge up to $250,000 per patient per year, which translates into annual sales of around $1.9 billion. Vertex plans to expand the market for Kalydeco beyond the G551D mutation, and multiple trials are planned for 2012 to determine if this is possible. While this is healthy on its own, a potential combination treatment of Kalydeco and VX-809, a new cystic fibrosis treatment, could expand Vertex's sales to around $5 billion in this market by targeting more common forms of the disease. But, current data has been underwhelming regarding the efficacy of this combination. Further data, set to be released in 2012, will show whether this upside can be realized. Either way, sales of around $1.9 billion are still very healthy, and the downside risk to Vertex in the cystic fibrosis market is limited. But HCV and cystic fibrosis are not the only diseases Vertex is targeting.
Arthritis, Epilepsy, and Influenza
Even while investing huge sums of capital into HCV and cystic fibrosis, Vertex is working on these 3 diseases as well. VX-509 targets arthritis as well as several other inflammatory diseases, and VX-765 targets epilepsy. VX-509 and VX-765 are both in Phase II trials. A 6-month Phase IIb study of VX-509 is set to begin in the first quarter of 2012, and VX-765 is set to enter new testing phases as well. While it is a bit too early to gauge the financial impact of these products, existing clinical data on VX-509 is promising, with patients showing significant improvements relative to existing therapies. As for VX-765, clinical data shows that the drug is well-tolerated, and Vertex is continuing to invest in it, though more data is needed to specifically determine its efficacy. Vertex is also initiating more trials of VX-787, its investigative influenza treatment for both swine (H1N1) and bird (H5N1) flu. VX-787 is currently in Phase I trials, and data is expected in the second quarter of 2012.
Financials
What many people seem to forget is that Vertex is already profitable, unlike many of its peers with new drugs on the market, such as Dendreon (DNDN) and Human Genome Sciences (HGSI). Vertex posted EPS of $1.02 per share last quarter, on revenues of more than $659 million. The company has more than $250 million in net cash on the balance sheet, and has no need to tap the debt or equity markets anytime soon. Vertex trades at just 8.1x 2012 earnings estimates ($4.48 per share), and we do not see any reason why the shares should be this cheap. Vertex is trading at the same multiples as big pharma trades, yet 2012 earnings are set to grow over 1,559% over 2011. Below we provide an overview of Vertex's earnings and revenue estimates for the next 5 quarters. Vertex is set to report fourth quarter 2011 earnings on February 2.
Vertex Earnings & Revenue Estimates
Vertex faces no profitability issues in 2012, and most estimates do not include revenues (or profits) from Kalydeco. Given the strong need for new cystic fibrosis treatments, we see no reason why Kalydeco could not see the same rapid uptake as Incivek did. 2012 will be a great year for Vertex financially. 2013 and beyond would be even better as Kalydeco ramps up and Vertex's other drug candidates enter the market. The current Reuters average price target for Vertex is $48.05, representing upside of over 32% from current levels. And considering how badly analysts missed the last quarter (predicting Incivek sales of $300 million versus $420 million in actual sales), we think analysts are likely to raise price targets and earnings estimates in 2012 as Vertex proves its skeptics wrong.
This company's future is far brighter than many would believe. And at 8.1x 2012 earnings, the shares are far too low relative to Vertex's potential. We think now is an opportune time to add to or initiate positions in Vertex Pharmaceuticals. This company has demonstrated that in can successfully launch a major drug into the market. It has a great pipeline and the financial strength to translate that into commercial success. We think that the skepticism surrounding this company is far too great, and that investors who have faith in the company and its products will be rewarded greatly for their loyalty.
Disclosure: We are long VRTX on its own, and are long GILD, ALXN, HGSI, and DNDN via the First Trust NYSE Arca Biotech Index Fund, an ETF that tracks a basket of 20 biotech stocks We are long ABT, JNJ, and MRK via the PowerShares Dynamic Pharmaceuticals Portfolio. In addition, a mutual fund we own grants ALXN a weighting of 1.19%.
http://seekingalpha.com/article/321131-vertex-pharmaceuticals-great-pipeline-valuation-and-future?source=yahoo
VRTX has 2 competitors in Hep C field:
Biotech, Hepatitis C, Drugs
Vertex Stock Drops 17% Over Two Days, As Potent Hep C Rivals Emerge
Luke Timmerman 11/8/11
Cambridge, MA-based Vertex Pharmaceuticals has seen its stock take a whopping 17 percent hit in the past two days at a scientific meeting, as investors have had time to think about the implications of new clinical trial data from a couple of competitors in the hepatitis C field.
Vertex (NASDAQ: VRTX) saw its stock tumble from $36.63 at Friday’s close to $30.41 at today’s close—a 17 percent drop over two days of trading—as investors absorbed a flurry of news stories at the annual meeting of the American Association for the Study of Liver Disease (AASLD) in San Francisco. Vertex’s decline coincided with a boost in the stocks of of Alpharetta, GA-based Inhibitex (NASDAQ: INHX) and Princeton, NJ-based Pharmasset (NASDAQ: VRUS).
Vertex has been the reigning king of hepatitis C for the past year. Its protease inhibitor drug telaprevir (Incivek) was FDA approved as a new treatment that boosts cure rates to almost 80 percent, while shortening the time people need to take interferon and ribavirin, a standard combination that causes significant side effects. The company has handily beaten Wall Street sales estimates for its first couple quarters on the market, and turned profitable, while fending off competition from a protease inhibitor from Merck (NYSE: MRK). But researchers are pushing hard now to fight hepatitis C with a combination of new antiviral medicines, much like how HIV is controlled, and Vertex’s existing drug could end up being less important over time than other treatments.
Pharmasset, which is developing a nucleotide polymerase inhibitor, saw its stock climb at the meeting when it said its drug had cured all 40 patients in a clinical trial. Importantly, the Pharmasset drug produced cures whether patients got interferon or not—and although the number of patients was small, it would be a big advantage if Pharmasset’s drug could eliminate the need for interferon. The company is still at least a couple years away from challenging Vertex on the market, but analysts see this new drug and potentially another one from Inhibitex as becoming potent new options that might be able to reach a goal that has so far eluded Vertex—the elimination of interferon, and the flu-like symptoms it causes, from the standard treatment regimen for hepatitis.
Thomas Russo, an analyst with Robert W. Baird, downgraded Vertex to “neutral” today after going over the results from the liver meeting. One of the bullet points in his note today was headlined “AASLD event reveals Vertex itself uncertain, lacking convincing strategy to defend position 2014+.”
Russo said he applauded Vertex management for “sincere, credible” comments about how Pharmasset may have changed the hepatitis C paradigm, but he isn’t sure Vertex can fend off the challenge through its own internal development, or through an acquisition.
“We remain positive on cystic fibrosis catalysts in the first half of 2012, but investors first need confidence in the HCV floor, and we’ve lost conviction this stock can “thread the needle” in an environment of new uncertainty (and resignation?) coming from the company itself,” Russo wrote.
Besides the nucleotide inhibitors in the works, other pharma companies are developing so-called non-nucleoside inhibitors as a third class of antiviral medicine that could go into combinations. Roche recently agreed to acquire San Diego-based Anadys Pharmaceuticals (NASDAQ: ANDS) for $230 million to get its “non-nuc,” while Abbott Laboratories is also pursuing a drug in that category.
http://www.xconomy.com/boston/2011/11/08/vertex-stock-drops-17-past-two-days-as-potent-hep-c-rivals-emerge/
9:35AM Vertex Pharm: Phase 3 study of KALYDECO in children ages 6 to 11 with a specific type of cystic fibrosis showed significant improvements in lung function and other measures of disease sustained through 48 weeks (VRTX) 37.28 -0.38 : Results from ENVISION showed that children who received KALYDECO experienced rapid and sustained improvements in lung function and other key measures of disease, including weight gain and a reduction in sweat chloride, throughout the 48-week study compared to those treated with a placebo. Patients in the study who received KALYDECO experienced a mean absolute improvement from baseline in lung function of 12.5 percentage points through week 24 and a mean relative improvement from baseline in lung function of 17.4 percent compared to placebo. Through 48 weeks, the mean absolute improvement in lung function for children treated with KALYDECO was 10 percentage points compared to placebo and the relative mean improvement was 15.1 percent from baseline compared to placebo. Phase 3 results and product labeling for currently available CF medicines generally describe relative improvements in lung function. The most commonly reported adverse events were respiratory in nature and comparable across treatment groups
Either CBS or NBC evening news had a nice segment on use of K to treat CF. I did not see VRTX identified. Patients were interviewed and expressed great improvement within a couple days of treatment inception, particularly ease of breathing.
5:09PM Vertex Pharm: New England Journal of Medicine publishes data from Phase 3 STRIVE study of KALYDECOTM in people ages 12 and older - Study shows that treating CF by targeting the underlying cause of the disease leads to significant clinical benefits (VRTX) 36.90 -0.88 : Co announced that the New England Journal of Medicine published data from a Phase 3 study of KALYDECO, a medicine in development that targets the defective protein that causes cystic fibrosis. In this study, called STRIVE, people with CF ages 12 and older with at least one copy of the G551D mutation who were treated with KALYDECO experienced significant improvements in lung function and other measures of disease. Improvements in lung function were seen as early as week two and were sustained throughout the 48-week study. The most commonly reported adverse events were respiratory in nature and comparable across treatment groups. Data from STRIVE will be published along with an accompanying editorial in the November 3, 2011 issue of NEJM.
Zacks Industry Outlook Highlights: Vertex Pharma, AstraZeneca, Abbott Labs, Allergan and Onyx Pharmaceuticals
For Immediate Release
Chicago, IL – September 23, 2011 – Today, Zacks Equity Research discusses the Pharmaceuticals, including Vertex Pharma (NasdaqGS: VRTX - News), AstraZeneca (NYSE: AZN - News), Abbott Labs (NYSE: ABT - News), Allergan (NYSE: AGN - News) and Onyx Pharmaceuticals (NasdaqGS: ONXX - News).
A synopsis of today’s Industry Outlook is presented below. The full article can be read at http://www.zacks.com/stock/news/61553/Pharmaceuticals+Stock+Outlook+-+Sept.+2011
Emerging markets are slowly and steadily gaining in importance, and several companies are now shifting their focus to these areas. Emerging markets should see strong sales thanks to increased demand for medicines. Several factors like government initiatives for healthcare, new patient population, and increasing use of generics should help drive demand. Growth in emerging markets could help stabilize the base business during the industry's 2010-15 patent cliff.
According to the IMS Institute, spending on medicines in emerging markets will double to $285-$315 billion in the next five years from $151 billion in 2010, driven by strong economic growth coupled with endeavors of concerned governments to expand access to healthcare. This will catapult "pharmerging" markets to the second position by 2015 where spending on medicines is concerned.
Branded Drugs Market Share to Decline
According to the IMS Institute, market share for branded drugs will continue declining over the next five years. Branded drugs market share, which declined from 70% in 2005 to 64% in 2010, is expected to decline to 53% by 2015. The decline will be driven by patent expiries, with generics accounting for a significant part of pharma spending. Spending on branded medicines in 2015 is expected to remain at the same level as in 2010.
OPPORTUNITIES
We currently have a Neutral outlook on large-cap pharma stocks (Zacks #3 Rank). While the companies will continue to face challenges like pricing pressure and genericization, growth in emerging markets and product approvals could help reduce the impact.
According to the IMS Institute, 44 new branded products were launched in 2010. However, the new product approval mix was more towards orphan drugs and medicines with the same mechanism of action as existing therapies.
Important product approvals in 2011 so far include the approval of Johnson & Johnson's prostate cancer therapy, Zytiga, Merck's hepatitis C virus (HCV) treatment, Victrelis, Bristol-Myers Squibb's melanoma treatment, Yervoy, and kidney transplant therapy Nulojix, Vertex Pharma's (NasdaqGS: VRTX - News) HCV treatment, Incivek and AstraZeneca’s (NYSE: AZN - News) blood thinner Brilinta, among others.
We currently have Neutral recommendations on companies like Abbott Labs (NYSE: ABT - News), Johnson & Johnson, Allergan (NYSE: AGN - News) and Pfizer. We believe that Allergan's presence across different segments and geographies will help maintain decent growth going forward.
In spite of the Neutral stance on the stock, we are positive on Bristol-Myers. Earnings estimates have been upped by majority of the analysts covering the stock after its strong second quarter results. 2011 has been a fruitful year for Bristol-Myers so far, with many key drugs getting approved. Growth in the coming quarters is expected to be driven by new product launches and acquisitions and deals.
WEAKNESSES
We recommend avoiding names that offer little growth or opportunity for a take-out. These include companies which are developing drugs that are likely to face regulatory hurdles. The US Food and Drug Administration (FDA) has been exercising more caution in granting approval to new products and several candidates are facing delays in receiving final approval.
We advise investors to avoid names such as Onyx Pharmaceuticals (NasdaqGS: ONXX - News) on which we have an Underperform recommendation. The company delivered lackluster results in the second quarter of 2011 due to lower revenues and higher operating expenses.
Zacks "Profit from the Pros" e-mail newsletter provides highlights of the latest analysis from Zacks Equity Research. Subscribe to this free newsletter today by visiting http://at.zacks.com/?id=2679.
7:35AM Vertex Pharm provides Interim Data from Phase 2 Study (VRTX) 49.45 : Co announces interim results from ZENITH, an ongoing Phase 2 study designed to assess the safety, tolerability and efficacy of multiple 12- and 24-week response-guided treatment regimens with VX-222, its lead polymerase inhibitor in development, in combination with INCIVEK tablets, pegylated-interferon and ribavirin in people with genotype 1 chronic hepatitis C who were new to treatment. This is an interim analysis from patients in the four-drug treatment arms and was conducted after these patients completed their assigned treatment. Results showed that 50% of people in the study who received VX-222 in combination with INCIVEK, pegylated-interferon and ribavirin were eligible to stop all treatment at week 12, and 93 percent of these patients had undetectable hepatitis C virus 12 weeks after treatment ended. Patients from the VX-222 treatment arm who were not eligible to stop all treatment at week 12 received an additional 12 weeks of pegylated-interferon and ribavirin alone for 24 total weeks of treatment. The hepatitis C virus was undetectable in 100% of these patients at the end of 24 weeks. In this study, VX-222, INCIVEK and ribavirin were given twice daily. Interim safety results from the four-drug treatment arms showed that mild gastrointestinal symptoms and mild fatigue were the most frequently reported adverse events. Side effects consistent with the known safety profile of INCIVEK combination treatment also were observed.
Vertex Pharmaceuticals
Reporting date: July 28, after market close.
Current consensus: Net loss of 95 cents a share on total revenue of $53.67 million.
The launch of Vertex's hepatitis C drug Incivek (and how well it competes against Merck's Hep C drug Victrelis) is a big-ticket event for the second-quarter earnings season.
It's hard to nail down one agreed-upon consensus estimate for Incivek U.S. sales during the second quarter. Vertex's own sell-side analyst survey came back with $21 million, but Thomson Reuters is at $23 million and Bloomberg is at $42 million. Some sell-side analysts have not published second-quarter estimates for Incivek sales, which explains the discrepancy.
Institutional investors surveyed last week expect Incivek sales of $35 million in the quarter, according to ISI Group biotech analyst Mark Schoenebaum, who conducted the survey of 224 investors, of which 25% were from long/short funds.
http://www.thestreet.com/story/11187316/3/5-biotech-drug-launch-stocks-to-watch.html
Vertex Pharmaceuticals (VRTX) and Alios BioPharma announced an exclusive worldwide licensing agreement that will add two distinct nucleotide analogues to Vertex's hepatitis C portfolio.
11:00AM Vertex Pharm reports Phase 3 STRIVE Study of VX-770 showed durable improvements in lung function and other measures of disease among people with a specific type of cystic fibrosis (VRTX) 48.53 +0.48 : Co announced the final results from its pivotal Phase 3 STRIVE study that evaluated VX-770, a medicine in development that targets the defective protein that causes cystic fibrosis (CF). STRIVE was designed to evaluate VX-770 among 161 people 12 years or older with a mutation known as G551D in the CF gene. Data from the study showed rapid improvements in lung function (FEV1) that were sustained through 48 weeks among those who received VX-770, compared to those treated with a placebo. Significant improvements in all key secondary endpoints were observed among people who received VX-770 compared to placebo. Adverse events that occurred more frequently among those treated with VX-770 compared to placebo were headache, upper respiratory tract infections, nasal congestion, rash, dizziness and bacteria in the sputum.
VRTX down $5 to $48 with data on fibrosis
Minyanville > Markets
Vertex Sinks on Cystic Fibrosis Study
By Brett Chase Jun 09, 2011 1:30 pm
The stock is oversold after a combination therapy for the chronic lung disease doesn't meet investors' expectations.
(0) Comments
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VRTX 47.96 -5.18 (-9.75%)
MRK 35.96 +0.17 (+0.47%)
The Vertex Pharmaceuticals (VRTX) press release this morning seemed to deliver promising news for cystic fibrosis patients. Two drugs in development were shown to attack the genetic cause of the chronic lung disease and were generally safe for the patients.
"These data open the door to the possibility of treating people with the most common form of cystic fibrosis by using two medicines together that target the defective protein that causes the disease," Vertex’s chief scientist Peter Mueller says in a statement.
The problem is the results don’t show a highly effective outcome and that’s why investors are selling off the shares today.
In midday trading, the stock is down 10% to $47.87 a share. It was down even more in earlier trading. The stock is up by more than a third this year on hopes for the company’s recently approved drug Incivek for hepatitis C. That drug is a potential blockbuster and it is, by far, the biggest catalyst for the stock. (See Vertex’s Hepatitis C Drug Approved.)
As for cystic fibrosis, Vertex expects to file an application later this year to sell one of its experimental drugs, VX-770, as a stand-alone treatment. Approval of that drug could be worth about $7 a share, estimates Robert W. Baird analyst Thomas Russo.
The company hopes to prove that it can treat a broader patient population by combining two of its cystic fibrosis drug candidates, VX-770 and VX-809. The study of that drug combination is in the middles stages of human trials. While the disappointing results of the study are hitting the stock hard, the shares may be oversold.
Russo recommends buying Vertex shares but not because he thinks the combination of those two developmental drugs will be a success.
“A longer-term view can find some encouraging data points here, but that requires patience and some leaps of faith,” Russo says of the Vertex study results released Thursday.
Rather, Russo points to the more likely near-term approval of VX-770 and the successful launch of Incivek. Vertex faces competition from Merck’s (MRK) rival drug Victrelis, which was approved for sale in the US the same week as Incivek.
Russo sets a 12-month price target of $62 a share for Vertex based mostly on Incivek’s success but partly on VX-770.
He’s not alone among analysts. Two other bullish analysts weighed in on the sell-off.
Leerink Swann analyst Howard Liang reiterated his buy recommendation with a $66 price target over the next 12 months.
RBC Capital Markets analyst Jason Kantor also recommends buying the shares and has a $59 price target. Kantor’s price target is based solely on Incivek and VX-770.
Date Research Firm Action From To
May 24, 2011 MP Advisors Downgrade Outperform Market Perform
May 4, 2011 Brean Murray Downgrade Buy Hold
Feb 24, 2011 Wedbush Upgrade Neutral Outperform
Jan 28, 2011 Brean Murray Initiated Buy
Oct 7, 2010 Dawson James Initiated Buy
Sep 8, 2010 JMP Securities Downgrade Mkt Outperform Mkt Perform
May 26, 2010 Wedbush Upgrade Underperform Neutral
May 26, 2010 Mehta Partners Upgrade Market Perform Outperform
May 4, 2010 Mehta Partners Initiated Market Perform
Apr 12, 2010 JP Morgan Downgrade Overweight Neutral
Vertex: With New Drug Approval Shares May Still Have Room to Run
http://seekingalpha.com/article/272523-vertex-with-new-drug-approval-shares-may-still-have-room-to-run?source=yahoo
7:03AM Vertex Pharm interim Phase 2 data showed a combination of VX-770 and VX-809 improved function of the defective protein that causes cystic fibrosis in people with the most common form of the disease (VRTX) 53.14 : Co announces interim results from the first part of a Phase 2 study designed to evaluate multiple combination regimens of VX-770 and VX-809, Vertex's lead medicines in development that aim to treat the defective protein that causes cystic fibrosis. The first part of the study met its two primary endpoints: (1) safety and tolerability of the combination regimen and (2) the effect of the combination of VX-770 and VX-809 on CFTR function as measured by sweat chloride, a key measure of the function of the CFTR protein. There were no serious adverse events reported, and the adverse event profile during the combination-dosing portion of the study (Day 14 to Day 21) was similar to that during the VX-809 monotherapy-dosing portion (Day 0 to 14). In the arm that evaluated VX-809 (200 mg) followed by dosing of VX-770 (250 mg) in combination with VX-809, a statistically significant reduction in sweat chloride of -13.17 mmol/L (p<0.001) was observed from baseline (Day 0) through Day 21. In this arm, a -9.10 mmol/L (p<0.001) reduction was observed after VX-770 (250 mg) was added to VX-809 (200 mg) for seven days (Day 14 to 21). Vertex intends to initiate the second part of this study in the fourth quarter of 2011 after the completion of further analyses of data from Part 1. The most commonly reported adverse events were respiratory in nature and occurred in approximately half of people across all arms of the study. One person receiving VX-809 in the monotherapy portion of the study discontinued treatment due to an increase in respiratory symptoms during the first 7 days of the study.
FDA approves Victrelis (boceprevir) with broad label:
#msg-63098013
Obviously not the best outcome for VRTX.
sorry a tad trigger happy lol,am sure it will
Not yet, but I'm sure it will be approved soon.
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