By Ed Silverman
Seven months after promising to start another Phase III trial of its solanezumab compound for Alzheimer’s in patients with a mild form of the disease, Eli Lilly took the unusual step of holding a teleconference to disclose details about the design of the forthcoming study, which is set to begin in the third quarter. …read more
Source: FULL ARTICLE at Forbes Health
By David Williamson, The Motley Fool
Filed under: Investing
Eli Lilly recently announced layoffs of roughly one-third of its U.S. workforce. In this video, David Williamson explains why this was both necessary and smart. Several of its key drugs will lose patent protection in the next two years, which represents a third of its revenue and Eli Lilly had to do something to compensate. Most likely, Lilly will expand its workforce once several of its new drugs receives FDA approval. In fact, diabetes drugs are looking like an Eli Lilly forte, with six different drugs in various clinical trials.
So if you have faith in Eli Lilly‘s product pipeline, don’t get rattled by the recent layoffs. Better times are ahead, so let its 3.5% dividend help tide you over.
Is Eli Lilly a buy or sell?
With two of its top three drugs poised to lose patent protection this year, is Eli Lilly a dividend stock headed nowhere fast? In a new premium report, The Motley Fool’s senior pharmaceuticals analyst breaks down all of Lilly’s moving parts, including an in-depth analysis of the company’s must-know opportunities and reasons to buy and sell today. To find out more click here to claim your copy today.
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From: http://www.dailyfinance.com/2013/04/12/hard-times-at-eli-lilly/
Filed under: Company News, Layoffs, Drug Companies, Stocks, Economy
INDIANAPOLIS — Eli Lilly plans to cut hundreds of workers from its U.S. sales force as the drugmaker prepares to deal with the loss of patent protection for two more top-selling drugs.
Lilly spokesman Scott MacGregor declined to disclose the specific number of cuts, which will happen by July 1, but did say it totals less than 1,000 full-time employees.
Eli Lilly and Co. (LLY), which is headquartered in Indianapolis, had about 17,150 U.S. employees at the end of last year and 38,350 total.
The company will lose U.S. patent protection for the antidepressant Cymbalta at the end of this year. The drug brought in $3.92 billion of Lilly’s $11.81 billion in U.S. sales last year, but the Cymbalta total will shrink quickly once cheaper generic competition hits the market.
Former top-seller Zyprexa, an antipsychotic, lost U.S. patent protection in the fall of 2011, and its U.S. sales plunged 83 percent last year to $360.4 million.
Lilly also loses patent protection for the osteoporosis treatment Evista in 2014. Evista rang up $699.5 million in U.S. sales last year.
The drugmaker has said it expects to cut costs to help make up for the loss of revenue from these expirations.
MacGregor said in an email that Lilly’s Bio-Medicines sales force, a category that includes neuroscience, cardiovascular and men’s health, will become smaller and more aligned with both business realities and the way customers want to interact with the company.
Lilly also will expand its diabetes sales force to prepare for the planned launches of two treatments in late-stage development.
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From: http://www.dailyfinance.com/2013/04/12/drugmaker-lilly-layoffs/
By Brian Orelli, The Motley Fool
Filed under: Investing
There goes the short-term bear thesis on ACADIA Pharmaceuticals .
I had recommended staying away from the company for now because it looked too risky with a long wait before the company could complete its second phase 3 trial for pimavanserin in patients with Parkinson’s disease psychosis.
But after talking to the Food and Drug Administration, ACADIA said today that the agency has agreed that the current data is “sufficient to support the filing of a New Drug Application.” That doesn’t guarantee the FDA is going to approve the drug, but it’s certainly a positive sign.
The FDA generally requires at least two successful phase 3 trials, but will accept a single trial in certain instances when there’s an unmet need. There aren’t any drugs approved to treat Parkinson’s disease psychosis, although atypical antipsychotics such as Johnson & Johnson‘s Risperdal, Eli Lilly‘s Zyprexa, Bristol-Myers Squibb‘s Abilify, and Pfizer‘s Geodon are used off label to treat Parkinson’s patients experiencing psychotic symptoms, which affects up to 60% of Parkinson’s patients.
Shares of ACADIA are up more than 50% as I write this. That’s well deserved.
Not having to do the study should speed things up a little — ACADIA hadn’t even started the second phase 3 trial — but not by the full length of the trial. There are still drug-drug interaction studies and chemistry and manufacturing tests that need to be completed; the company doesn’t expect to file the marketing application until near the end of next year.
So, why are shares up so much? Not having to run a confirmatory trial reduces the risk substantially.
Pimavanserin produced solid data in its most recent trial. Patients taking the drug saw their SAPS-PD score, a measurement of hallucinations and delusions, drop by 5.79 points while scores for placebo patients only dropped 2.73 points. The difference was statistically significant.
But this wasn’t the first trial testing pimavanserin, or even the second. ACADIA ran two previous trials, which both saw patients in the placebo group improve substantially based on the assessment scale. For the latest successful trial, the company modified the scale — that’s the PD in SAPS-PD — to include the nine items most relevant to patients with psychosis associated with Parkinson’s disease.
The modification clearly worked, but there are no guarantees that it could be repeated. Patients entering the confirmatory trial would know that the drug had succeeded, which could boost the scores of the placebo patients.
So, is ACADIA a buy now? With the risk removed, it’s more appealing, but you have to be willing to wait. We’re still a year and a half away from filing the application, and then there’s another eight to 12 months before pimavanserin will be approved.
With a market cap of $950 million, there’s some room to run once the drug hits the market in 2015. Pimavanserin shouldn’t have too much trouble taking away sales from Risperdal, Zyprexa, Abilify, Geodon, and the like since it’ll be approved
From: http://www.dailyfinance.com/2013/04/11/fda-throws-acadia-a-juicy-bone/
By Sean Williams, The Motley Fool
The typical treatment plan for bladder cancer entails surgery and/or chemotherapy and radiation after surgery in nearly all cases. Some earlier stage cases can be dealt with through immunotherapy and chemotherapy, while a combination of chemotherapy and/or radiation, as well as complete removal of the bladder can be used in more advanced cases.
Where investment dollars are headed
For lack of a better word, treatment options in bladder cancer are somewhat limiting. The same global chemotherapy treatments you often see employed in regional and advanced stages of many cancers are typically a patient’s “best shot.” Here’s a glimpse at some of the most common bladder cancer treatments.
Filed under: Investing
As I noted six weeks ago, cancer statistics are both staggering and disappointing. Although cancer deaths per 100,000 people have been on the downswing since 1991 thanks to access to more effective medications and better awareness about the negative health effects of smoking, there is still a lot of research and progress yet to achieve. My focus in this 12-week series is to bring to light both the need for continued research in these fields, as well as highlight ways you can profit from the biggest current and upcoming players in each area.
Over the past five weeks, we’ve looked at the four cancer types most expected to be diagnosed this year:
Today, we’ll turn our attention to the projected sixth-most diagnosed cancer: bladder cancer.
The skinny on bladder cancer
Bladder cancer is forecast to be diagnosed in 72,570 people this year, leading to an estimated 15,210 deaths. While the death toll isn’t anywhere near the totals we saw for lung cancer, it’s still much higher than the projected toll taken by melanoma.
In particular, bladder cancer tends to strike men with roughly four times greater frequency than women. It’s a particularly scary cancer because it rarely precludes many warning signs — outside of blood in the urine or potential irritation and the need to go to the bathroom more often — and there isn’t any tried-and-true simple diagnostic test to diagnose bladder cancer beyond obtaining cells from inside the bladder once a cause for concern exists.
Roughly half of all cases of bladder cancer are diagnosed when the cancer is in a non-invasive state. If caught early, survival rates are very high, with in-situ cases demonstrating 96% five-year survival rates. Once regional or distant, however, and the survival rates shoot down rapidly. The five-year survival for regional and distant cancer drop to just 33% and 6%, respectively, according to the American Cancer Society (link opens PDF).
Since 1975-1977, just as we’ve seen in previous cancer types, there have been improvements in the overall five-year survival rate, which has jumped from 73% to 80% in 2005-2009, but the biggest improvement has been a reduction in smoking — the primary risk factor for being diagnosed with bladder cancer — through better awareness campaigns of its dangers, and not through major treatment advances. In fact, bladder cancer diagnoses haven’t seen the same downtrend we’ve witnessed in numerous other cancer types.
Source: Surveillance, Epidemiology, and End Results Program & National Center for Health Statistics.
The typical treatment plan for bladder cancer entails surgery and/or chemotherapy and radiation after surgery in nearly all cases. Some earlier stage cases can be dealt with through immunotherapy and chemotherapy, while a combination of chemotherapy and/or radiation, as well as complete removal of the bladder can be used in more advanced cases.
Where investment dollars are headed
For lack of a better word, treatment options in bladder cancer are somewhat limiting.
Source: FULL ARTICLE at DailyFinance
By Alex Planes, The Motley Fool
Filed under: Investing
Investors love stocks that consistently beat the Street without getting ahead of their fundamentals and risking a meltdown. The best stocks offer sustainable market-beating gains, with robust and improving financial metrics that support strong price growth. Does Bristol-Myers Squibb fit the bill? Let’s take a look at what its recent results tell us about its potential for future gains.
What we’re looking for
The graphs you’re about to see tell Bristol’s story, and we’ll be grading the quality of that story in several ways:
What the numbers tell you
Now, let’s take a look at Bristol’s key statistics:
BMY Total Return Price data by YCharts.
|
Passing Criteria |
3-Year* Change |
Grade |
|---|---|---|
|
Revenue growth > 30% |
(6.3%) |
Fail |
|
Improving profit margin |
42.8% |
Pass |
|
Free cash flow growth > Net income growth |
64.3% vs. (81.5%) |
Pass |
|
Improving EPS |
(78.3%) |
Fail |
|
Stock growth (+ 15%) < EPS growth |
83.7% vs. (78.3%) |
Fail |
Source: YCharts. * Period begins at end of Q4 2009.
BMY Return on Equity data by YCharts.
|
Passing Criteria |
3-Year* Change |
Grade |
|---|---|---|
|
Improving return on equity |
(83.2%) |
Fail |
|
Declining debt to equity |
26% |
Fail |
|
Dividend growth > 25% |
9.4% |
Fail |
|
Free cash flow payout ratio < 50% |
35.8% |
Pass |
Source: YCharts. * Period begins at end of Q4 2009.
How we got here and where we’re going
A mere three out of nine passing grades isn’t particularly compelling for a well-established pharmaceutical leader. What looms over the horizon for Bristol? Are there drugs in the pipeline ready to bridge the inevitable patent cliff, or will investors be taken over the edge by a company with some wildly divergent financial fundamentals?
My fellow Fool Sean Williams pointed out valid reasons for optimism earlier this year, despite the big drop in net income of late. Most notably, the approval of stroke-prevention drug Eliquis, which was developed in tandem with Pfizer , is big news. The current stroke-prevention treatments don’t seem to hold a candle to Eliquis, which points to multibillion-dollar sales down the line. The oral SGLT-2 inhibitor drug Forxiga, developed with AstraZeneca , could also be a big step forward in diabetes treatments.
Bristol also appears to have a diverse enough pipeline to avoid a total patent cliff swan dive. Fool contributor Keith Speights notes that only Sanofi earns more of its revenue from its “other” drugs, the non-blockbusters that can still add up to big money over the course of a fiscal year. Until last year, Bristol actually initiated more clinical trials than Sanofi. It may need to pick up the pace in this regard, as it’s already lost a big chunk of revenue from the Plavix patent expiration, and only Eli Lilly …read more
Source: FULL ARTICLE at DailyFinance
By Business Wirevia The Motley Fool
Filed under: Investing
Teva-Handok Names Yoo Suk Hong as Chief Executive Officer
JERUSALEM & SEOUL, South Korea–(BUSINESS WIRE)– Teva-Handok today announced the appointment of Yoo Suk Hong as the first Chief Executive Officer of the business venture established between Teva Pharmaceutical Industries Ltd. (NYS: TEVA) and Handok Pharmaceuticals (KRX: 002390). This business venture was formed in February, 2013 and focuses on the Korean pharmaceutical market, currently valued at approximately USD 14 billion.
“As we prepare to officially launch Teva-Handok, we are very pleased to welcome Yoo Suk Hong as our CEO,” stated Prof. Itzhak Krinsky, Chairman of Teva Japan, Chairman of Teva South Korea and Head of Business Development Asia Pacific. “With his deep international experience coupled with his keen understanding of the Korean market, Yoo Suk will help us realize our goal of bringing high-quality and affordable medicines to patients in Korea.”
Handok Pharmaceutical’s Chairman and CEO Young Jin Kim stated, “CEO Yoo Suk Hong has had a variety of work experiences in both Lilly headquarter and Korea with remarkable achievements. I believe with his competencies developed through global leadership, he will help establish Teva Handok as a leader in the Korean market.”
Teva-Handok is expected to officially launch its first products in September 2013.
About Yoo Suk Hong
CEO Yoo Suk Hong graduated from Hankuk University of Foreign Studies and received an MBA from the Wharton School of Business, University of Pennsylvania. He worked as a financial analyst at Eli Lilly‘s headquarters in the US starting in 1992 and returned to Korea in 1995 first in new product marketing and then as the head of marketing and sales. In 2003, Mr. Hong was appointed as the global marketing manager of an osteoporosis medication at Lilly’s US headquarters. He was appointed as the CEO of Lilly Korea in 2007 and then sent again to the headquarters in 2008 as the marketing strategy director of emerging markets covering areas such …read more
Source: FULL ARTICLE at DailyFinance
By Max Macaluso, Ph.D., Brenton Flynn, and David Williamson, The Motley Fool
Filed under: Investing
From the impact of Obamacare to cutting-edge research, biotech buyouts to Big Pharma court battles, The Motley Fool’s health-care team sits down each week to discuss the most fascinating developments across the health-care industry, and their implications for long-term investors. In this week’s edition, the team talks about Novartis‘ patent dispute, stocks that have both popped and plummeted, and companies our analysts will be watching in the coming days.
In the following segment, health-care analyst Max Macaluso discusses President Obama‘s recent announcement of the $100 million “BRAIN Initiative” and how this project can help drugmakers, including Eli Lilly and Merck, that are developing new treatments for Alzheimer’s disease.
Is Eli Lilly a buy or sell?
With two of its top three drugs poised to lose patent protection this year, is Eli Lilly a dividend stock headed nowhere fast? In a new premium report, The Motley Fool’s senior pharmaceuticals analyst breaks down all of Lilly’s moving parts, including an in-depth analysis of the company’s must-know opportunities and reasons to buy and sell today. To find out more click here to claim your copy today.
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Source: FULL ARTICLE at DailyFinance
By Keith Speights, The Motley Fool
Filed under: Investing
Making money in business typically happens in one of two ways. You either sell a relatively low-cost product to a large number of customers. The other option is to sell a high-cost product to a small number of customers.
After years of going with the former approach, big pharma knows that to succeed in the future requires more of the latter. That’s why several major pharmaceutical companies have been building up their capabilities to tackle the red-hot market for drugs that treat orphan diseases affecting small numbers of patients. Here are three ways that the large drugmakers are seizing this “rare” opportunity.
1. The old-fashioned way
Several companies started from scratch by researching and developing drugs for orphan diseases. Eli Lilly actually began this process years ago. The company received approval from the Food and Drug Administration for Alimta in 2004. Alimta became the first drug approved in the U.S. for treating malignant pleural mesothelioma, a rare form of cancer with only around 2,000 new diagnoses each year.Lilly has experienced tremendous success with Alimta, which generated nearly $2.6 billion in sales last year
Sometimes drugs that originally focus on more common diseases can also help address orphan diseases. Lilly’s tabalumab, for example, is farthest along in development as a treatment for lupus. A phase 3 clinical study is currently under way with the drug targeting this disease. However, tabalumab was also designated by the FDA late last year as an orphan drug for treating multiple myeloma and is in a phase 2 trial for the more rare indication.
2. Making a big deal
Another approach for big pharmaceutical firms seeking to profit from the orphan drug market is to strike a big deal with a company that has products already far along in the pipeline. Merck took this path a year ago when it forged a partnership with Endocyte . The big pharmaceutical company paid $120 million upfront and could pay up to $880 million more if certain milestones are met with Endocyte’s star product, vintafolide.
Vintafolide received orphan drug status in March 2012 in Europe. The drug is currently in a phase 3 clinical trial targeting platinum-resistant ovarian cancer and is in a phase 2 trial focusing on non-small-cell lung cancer.
Merck’s possible $1 billion payout could prove to be a good investment if Wedbush analyst Gregory Wade is right. Wade estimates that vintafolide could hit peak sales in Europe of $400 million per year if approved later this year. He thinks another $500 million could be added to that annual total if the drug also receives approval in the U.S.
3. Thinking small
While Merck struck a big deal with Endocyte, smaller arrangements are more common. Pfizer , for example, licensed small biotech Repligen‘s spinal muscular atrophy program earlier this year. Under the terms of the agreement, Pfizer paid $5 million upfront with potential future milestone payments up to $65 million. Repligen’s RG3039 drug has received orphan designations in both the …read more
Source: FULL ARTICLE at DailyFinance
By Sean Williams, The Motley Fool
Filed under: Investing
With the tax deadline less than two weeks away, thinking about ways to reduce your tax liability and/or eliminate your future taxes by opening or contributing to an Individual Retirement Account, or IRA, should still be at the forefront of all investors’ minds.
Yesterday, I examined five great ideas for the conservative investor looking to contribute to their 2012 IRA. Today I’m going to mix things up and turn my attention to younger investors who are concerned less about capital preservation and dividends, and are more likely to seek out big growth potential and take on more risk. Here are five smart stock ideas to get younger investors started in building their perfect IRA.
1. Celgene : Biotechnology company Celgene isn’t going to offer investors a dividend, but it’ll make up for it in a number of ways.
To start with, Celgene’s management announced plans at the JPMorgan Healthcare Conference in January to double its sales and triple its total profit by 2017 with nothing but organic growth! Sales of the company’s multiple myeloma drug Revlimid remain strong, and its other cancer drug, Abraxane, gained FDA approval to treat non-small-cell lung cancer in October and has shown demonstrable efficacy in treating pancreatic cancer when combined with Eli Lilly‘s Gemzar.
It’s also all about Celgene’s pipeline. Pomalyst, the company’s newest multiple myeloma drug, was approved in February as an advanced-stage treatment and could fetch in excess of $1.1 billion in revenue by 2017 according to Piper Jaffray. Psoriasis drug apremilast is another pipeline contender worth watching, with the potential for $1.1 billion to $1.75 billion in peak sales if approved by the FDA, according to the company. Celgene is the type of biotech that could morph into what we now refer to as “big pharma” over the next decade.
2. Qualcomm : Market value is just a number; despite being valued at $113 billion, there’s absolutely no reason that Qualcomm can’t double in size over the next decade.
Qualcomm should be an attractive investment to all young investors, as it’s the only true vertically integrated mobile components supplier. The company’s CDMA wireless technology is found in a myriad of electronic devices from companies ranging from Apple to Nokia. It also introduced the RF360 in February, a chip able to process RF bands on the front end that could make RF chips obsolete in future 4G LTE models. Between its Gobi LTE modems and its dominant Snapdragon processors, there’s not a more dominant company in wireless technology.
The other half of the argument for why Qualcomm is a no-brainer buy is the sheer number of opportunities that exist in the emerging markets for Qualcomm to make its mark. Russia and its highly saturated market is yet to move beyond 3G capabilities, while Latin and South America are rapidly trying to upgrade their networks. Qualcomm’s dominance in wireless technologies is expected to span decades, not just this decade, and it could make for a …read more
Source: FULL ARTICLE at DailyFinance
By Max Macaluso, Ph.D. and David Williamson, The Motley Fool
Filed under: Investing
In honor of March Madness, the Motley Fool‘s health-care team assembled their own bracket consisting of the 16 largest and best pharmaceutical and biotech stocks on the market. The series kicks off with a tough matchup between two of the biggest players in the diabetes space: Sanofi and Eli Lilly . To learn the bull and bear cases for each stock — and to see which stock will move on to the Elite Eight — watch the following video.
Is Eli Lilly a buy or sell?
With two of its top three drugs poised to lose patent protection this year, is Eli Lilly a dividend stock headed nowhere fast? In a new premium report, The Motley Fool‘s senior pharmaceuticals analyst breaks down all of Lilly’s moving parts, including an in-depth analysis of the company’s must-know opportunities and reasons to buy and sell today. To find out more click here to claim your copy today.
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Source: FULL ARTICLE at DailyFinance
By Brian Orelli, The Motley Fool
Filed under: Investing
Recently, with the loss of patents causing generic competition, the main attraction to pharmaceutical companies has been their dividend. While there has been little to no revenue growth, at least they’ve offered a hefty dividend to justify holding them. The patent cliff won’t last forever. At some point, growth will return, and investors can get paid to wait.
That is, as long as there’s enough cash flow to support the dividend. For Eli Lilly the free cash flow, defined as cash from operations minus capital expense, decreased substantially last year.
|
Metric |
2010 |
2011 |
2012 |
|---|---|---|---|
|
Free Cash Flow (in millions) |
$6,163 |
$6,563 |
$4,399 |
|
YOY Increase (Decrease) |
73% |
6% |
(33%) |
Source: S&P Capital IQ. YOY=Year-Over-Year.
Ouch
It’s not quite as bad as it looks, though. Part of the decrease in free cash flow can be attributed to an increase in capital expenses, which jumped from $672 million in 2011 to $905 million last year. But 2011 was a multi-year low. In fact, the last time Eli Lilly had capital expenses that low was in 2000. I wouldn’t necessarily expect capital expenses to jump another 30% this year.
The rest of the drop in free cash flow was due to a 27% decrease in cash from operations. To calculate cash from operations, you start with net income and add back in depreciation and amortization expenses, other non-cash items, and changes in working capital.
Net income fell just 6%, matching a 7% decrease in revenue, but that’s a bit misleading. In 2012, Eli Lilly received a $788 million payment from Bristol-Myers Squibb after AstraZeneca and Bristol bought Eli Lilly‘s former partner Amylin Pharmaceuticals. When the companies ended their relationship, Amylin got full control of Byetta and Bydureon, and Eli Lilly got a royalty and milestones that Bristol paid off.
The one-time payment has to be subtracted out to calculate cash from operations since we want to know how the company is doing on a day-to-day basis. On that pro forma basis, net income fell about 24%. The rest of the change in cash from operations can be attributed to a change in inventories and accounts payable. Both tend to bounce around a lot, so there’s nothing to worry about unless we start to see a multi-year trend.
The decrease in income can be largely attributed to a 63% decrease in sales of Eli Lilly‘s top drug, the antipsychotic Zyprexa, after the drug lost patent protection.
Cash is king
Despite the massive decrease in free cash flow, Eli Lilly was sitting on a large enough cushion that it didn’t have any problems paying its dividend last year.
|
Metric |
2010 |
2011 |
2012 |
|---|---|---|---|
|
Dividends Paid (in millions) |
$2,165 |
$2,180 |
$2,187 |
|
Payout Ratio |
35% |
33% |
50% |
Source: S&P Capital IQ.
At 50% of its free cash flow, Eli Lilly‘s dividend seems safe and in line with other pharmaceutical companies. Johnson & Johnson paid …read more
Source: FULL ARTICLE at DailyFinance
By Brian Orelli, The Motley Fool
Filed under: Investing
Shares of Repros Therapeutics jumped 76% today, after announcing positive clinical trial data.
But investors still aren’t convinced that its testosterone-stimulating drug Androxal will be approved today. You can tell simply by the valuation — $300 million — they’re assigning to the company.
The testosterone market is a $2-billion annually and growing opportunity, thanks to direct-to-consumer advertising that big pharma is putting into it. You’ve probably seen the commercials for AbbVie‘s Androgel, with the huge 1.62% being brought in with cranes. It doesn’t get manlier than that.
The current testosterone boosters — Androgel, Eli Lilly‘s Axiron, Endo Pharmaceuticals Fortesta, and Auxilium Pharmaceuticals‘ Testim — are creams that have to be applied to the skin. Androgel’s selling point is that it’s more concentrated — 1.62% versus 1% — so men can apply less. But the area still has to be avoided by women and children, who could be exposed to the drug just by touching the skin.
Androxal, on the other hand, is taken orally, which would be a huge advantage. If approved, it’s not hard to see how the drug could easily capture a quarter of the market, or $500 million annually. Even at a very conservative price/sales ratio of three, Repros is potentially a $1.5 billion company. That’s five times where it is right now.
Investors are timid, because there’s still one more phase 3 trial to go, and the trial announced today had some issues. The company discovered one site where the site administrator fabricated data. And that wasn’t the site that had unusually low sperm counts disclosed back in January.
Repros says everything is fine. It’s thrown out the fabricated data, and the unusually low sperm counts are likely due to increased sexual activity. The drug worked as it’s supposed to, increasing testosterone levels, which increased the libido and, thus, decreased sperm counts.
It all sounds reasonable, but things that need to be explained tend to be frowned upon by the Food and Drug Administration. The agency turned down Johnson & Johnson‘s antibiotic ceftobiprole because the FDA deemed many of the clinical investigation sites unreliable.
A second positive trial without any complications will go a long way toward giving investors confidence that the drug can be approved by the FDA. Repros has a long way to run, but that’s because it’s still risky.
Another biotech with upcoming data
Will MannKind’s disruptive technology revolutionize the way diabetes is treated around the world — or will the FDA put the kibosh on this product before it even hits the market? In a new premium research report on MannKind, these complex issues are made crystal clear, in addition to showing you why to buy or sell the stock today. To find out more click here to grab your copy today.
By David Williamson, The Motley Fool
Filed under: Investing
In the following video, Motley Fool health-care analyst David Williamson takes investors through one possible boom for Eli Lilly , and one major potential bust. The company does have several major catalysts coming in the near term for drugs in its pipeline aimed both at stomach cancer and diabetes, but will these be enough to counteract losses from a major patent cliff coming up for the company? David gives his opinion on Eli’s pipeline, and just how bad the patent cliff could be.
Is Eli Lilly a buy or sell?
With two of its top three drugs poised to lose patent protection this year, is Eli Lilly a dividend stock headed nowhere fast? In a new premium report, The Motley Fool‘s senior pharmaceuticals analyst breaks down all of Lilly’s moving parts, including an in-depth analysis of the company’s must-know opportunities and reasons to buy and sell today. To find out more click here to claim your copy today.
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Source: FULL ARTICLE at DailyFinance
By David Williamson, The Motley Fool
Filed under: Investing
In the following video, Motley Fool healthcare analyst David Williamson takes a look at Eli Lilly‘s CEO, John Lechleiter, examining both how his background as a scientist makes him an a rarity in big pharma and highlighting his rise to the top of Eli Lilly. David then tells investors why Lechleiter’s background is both a strength for the company — and a potential weakness.
Is Eli Lilly a buy or sell?
With two of its top three drugs poised to lose patent protection this year, is Eli Lilly a dividend stock headed nowhere fast? In a new premium report, The Motley Fool‘s senior pharmaceuticals analyst breaks down all of Lilly’s moving parts, including an in-depth analysis of the company’s must-know opportunities and reasons to buy and sell today. To find out more click here to claim your copy today.
var FoolAnalyticsData = FoolAnalyticsData || []; FoolAnalyticsData.push({ eventType: “TickerReportPitch”, contentByline: “David Williamson“, contentId: “cms.26146”, contentTickers: “NYSE:PFE, NYSE:JNJ, NYSE:LLY”, contentTitle: “Is Eli Lilly‘s Management Charting the Right Course?”, hasVideo: “True”, pitchId: “126”, pitchTickers: “NYSE:LLY”, …read more
Source: FULL ARTICLE at DailyFinance
By Rich Duprey, The Motley Fool
Filed under: Investing
The EU’s decision to seize the bank accounts of ordinary Cypriot depositors was front and center again as concerns that the financial sector could come under tremendous pressure should the crisis ripple out from the island caused the Dow Jones Industrial Average to fall by 90 points yesterday. With Bank of America and JPMorgan Chase wobbling, the index pulled back from its recent high.
The three stocks below, however, were far removed from the scene of international intrigue rising on their own merits. Yet resist the urge to high-five everyone in the cubicles next to you. Smart investors won’t celebrate until they know why their stock surged, because without a fundamental basis for the bounce, these stocks could just as quickly make the return trip down.
|
Company |
% Gain |
|---|---|
|
Acadia Pharmaceuticals |
23.9% |
|
SUPERVALU |
11.7% |
|
Denison Mines |
9.5% |
Psychoanalyzing growth
Psych! Drug developer Acadia Pharmaceuticals said its drug pimavanserin met a series of secondary end points in a phase 3 clinical trial following previously reported results that it met its primary end point. The potential for FDA approval of what could become a first-in-class treatment has markedly improved and investors responded accordingly.
Pimavanserin is designed to treat psychosis in patients with Parkinson’s disease, a debilitating disorder that develops in up to 60% of Parkinson’s patients but for which there are no drugs currently approved in the U.S. to specifically treat it. Because there’s also the very real possibility it could be used to treat a similar disorder in patients suffering from schizophrenia and Alzheimer’s disease — and for which Acadia has the drug in phase 2 trials — this could be a huge winner for the pharmaceutical.
Of course, should it make it through the FDA‘s regulatory gauntlet it will have to compete with various anti-psychotic drugs like AstraZeneca‘s Seroquel, Eli Lilly‘s Zyprexa, Risperdal from Johnson & Johnson, and generic clozapine — all of which doctors prescribe off-label — but a drug specifically approved to treat the disorder just might gain a lot of traction .
Clean up in aisle 3!
Because it already owned 655 Albertsons stores from when SUPERVALU acquired the chain in 2006, Cerberus Capital Management was always the lead bidder to acquire the chain when it was put up for sale, but it was also out front because it was willing to accept the all the brands that the supermarket operator was selling as opposed to cherry-picking the ones it wanted.
In January, SUPERVALU said it would sell Albertsons, Acme, Jewel-Osco, and a number of other names to AB Acquisition, a Cerberus subsidiary, in a deal worth $3.3 billion. SUPERVALU would get $100 million in cash and have $3.2 billion in debt assumed and will also keep the Save-A-Lot banner that has 1,300 stores nationwide. Cerberus will also become a major shareholder owning more than 21% of SUPERVALU‘s stock and will get two seats on its board of directors.
Shares of SUPERVALU are up …read more
Source: FULL ARTICLE at DailyFinance
By Brian Orelli, The Motley Fool
Filed under: Investing
ACADIA Pharmaceuticals was on fire yesterday, up 24% after presenting data for its antipsychotic pimavanserin at the American Academy of Neurology annual meeting.
The data looked good. Pimavanserin passed its primary endpoint, lowering psychosis symptoms in patients with Parkinson’s disease. It even passed its secondary endpoints with flying colors.
There’s just one problem. We already knew that. The company released top-line data last November.
Were investors really that worried about the full data revealing some issue? I guess so.
I can’t really blame them. Pimavanserin failed two previous clinical trials in Parkinson’s disease psychosis because of high placebo effect. A little skepticism was in order.
Admittedly I didn’t see it coming, though. After the top-line data were released, I made an underperform call in CAPS with the comment, “No catalyst for awhile. And second phase 3 isn’t a sure thing. Placebo effect is hard to beat twice.”
That still seems to hold, especially with the full-data presentation — which I didn’t see as a catalyst — out of the way. ACADIA still has to run another clinical trial to confirm the first result. At this point, the biggest problem with owning ACADIA is time. You’re going to have to sit for awhile.
And after you wait, there’s the possibility that the second trial doesn’t match the first. My guess is the placebo effect increases in the second trial since patients entering the trial will know that the drug works. Fortunately pimavanserin beat placebo by a wide margin — the p-value for the primary endpoint was 0.001 — which gives ACADIA a little wiggle room since the p-value can go up as high as 0.05 for the second trial and still be considered statistically significant.
If it can get past a second trial, pimavanserin should be approved and sell well. Atypical antipsychotics such as Johnson & Johnson‘s Risperdal, Eli Lilly‘s Zyprexa, Bristol-Myers Squibb‘s Abilify, and Pfizer‘s Geodon are used off-label to treat Parkinson’s patients. But the atypical antipsychotics have side effects that can decrease motor function that’s already impaired in Parkinson’s patients. Pimavanserin doesn’t seem to have a meaningful effect on motor function, which should help ACADIA compete with the big boys.
But it’s hard to see why investors would buy ACADIA now at these inflated prices. Wait for a pullback to give you a little margin of safety in case the second trial doesn’t go as well as the first.
Is Eli Lilly a buy or sell?
With two of its top three drugs poised to lose patent protection this year, is Eli Lilly a dividend stock headed nowhere fast? In a new premium report, The Motley Fool’s senior pharmaceuticals analyst breaks down all of Lilly’s moving parts, including an in-depth analysis of the company’s must-know opportunities and reasons to buy and sell today. To find out more click here to claim your copy today.
By David Williamson, The Motley Fool
Filed under: Investing
Eli Lilly faces declining revenues, as major drugs reach their patent expiration. In this video, health-care analyst David Williamson explains the challenges facing Eli Lilly, and what it can do to confront them. While it has a compelling pipeline, purchasing late-stage or already approved assets would strengthen Eli Lilly‘s near-term competitiveness. Certainly, there are pitfalls involved with an acquisition, and Eli Lilly‘s current licensing strategy mitigates some of that risk. Watch and find out if Eli Lilly needs to make a big move, or if staying the course is the better option.
Is Eli Lilly a buy or sell?
With two of its top three drugs poised to lose patent protection this year, is Eli Lilly a dividend stock headed nowhere fast? In a new premium report, The Motley Fool’s senior pharmaceuticals analyst breaks down all of Lilly’s moving parts, including an in-depth analysis of the company’s must-know opportunities, and reasons to buy and sell today. To find out more, click here to claim your copy today.
var FoolAnalyticsData = FoolAnalyticsData || []; FoolAnalyticsData.push({ eventType: “TickerReportPitch”, contentByline: “David Williamson“, contentId: “cms.25615”, contentTickers: “NASDAQ:GILD, NYSE:BMY, NYSE:AZN, NYSE:LLY”, contentTitle: “Does Eli Lilly‘s Future Depend on Acquisitions?”, hasVideo: “True”, pitchId: “126”, …read more
Source: FULL ARTICLE at DailyFinance
By Sean Williams, The Motley Fool
Filed under: Investing
Whether you’ve decided to take notice, the biotechnology sector is rapidly evolving from the roll-of-the-dice gamble that it was in the early 2000s to an investor’s paradise. Better venture capital funding, vast improvements in clinical testing and drug development technologies, faster FDA approvals, and considerable amounts of cross-corporate collaboration have made the biotech sector a stomping ground for investor dollars.
However, take note that I didn’t say “trader’s dollars” — because there are numerous ways you can minimize your risk by investing in the biotech sector without sacrificing long-term gains. Here are three primary ways to reap the rewards of biotech without assuming the all-or-nothing misses often wrongly associated with the sector.
1. Target established biotechnology companies.
This one probably goes without saying, but by purchasing established biotechnology companies with actively growing pipelines, you tend to eliminate a lot of the downside risks associated with one-hit wonders.
Affymax is the perfect example of why biotech investors want to do their homework before investing. Even before its anemia drug Omontys was voluntarily recalled because of a number of deaths and hypersensitivity issues associated with the drug, it should have raised red flags to shareholders. Omontys was Affymax’s only approved drug, and it was being utilized as a combination therapy in its only other two clinical trials. Essentially, it was Omontys or nothing for Affymax — and in turn since the recall, its share price has gone from more than $20 to practically nothing!
Instead, I would encourage prospective long-term investors to turn to biotech companies with plenty of established drugs already on the market that also have numerous blockbusters plainly visible in their pipeline. I believe both Celgene and Gilead Sciences perfectly fit this bill.
Celgene’s superstar has been cancer drug Abraxane — which was first approved to treat metastatic breast cancer in 2005, but has been piling up additional indications and positive test results rapidly as of late. Abraxane added the indication of advanced non-small-cell lung cancer treatment in October, and, just a month later, Celgene noted that Abraxane when combined with Eli Lilly‘s Gemzar helped improve survival rates in patients with pancreatic cancer. On top of this, Celgene announced in January the possibility that it could double revenue and triple profits, organically, by 2017! Considering a multitude of possible new indications for Abraxane, the approval of Pomalyst for advanced multiple myeloma, and the potential for Apremilast to be approved for treating psoriasis, Celgene’s future as a long-term investment looks bright.
The same can be said for Gilead Sciences — which has a wide-reaching portfolio of products targeting cardiovascular and liver diseases, but headed most prominently by its established HIV/AIDS drug program. The scary thing is that Gilead’s pipeline could be the most robust of any biotech company. Stribild, the company’s new entirely in-house all-in-one HIV medication, was approved in August and will soon replace Atripla. Also, Sofosbuvir, the company’s experimental oral hepatitis-C …read more
Source: FULL ARTICLE at DailyFinance
By David Williamson, The Motley Fool
Filed under: Investing
Shares of ACADIA Pharmaceuticals shot through the roof today, up 30% as of this filming. In the video below, Fool health-care analyst David Williamson discusses news of some great phase 3 trial results for the company’s drug Pimavanserin, which treats psychosis in patients with Parkinson’s disease. David tells investors how good the results were, and what advantages this drug candidate could have over its competition if it reaches FDA approval.
Is Eli Lilly a buy or sell?
With two of its top three drugs poised to lose patent protection this year, is Eli Lilly a dividend stock headed nowhere fast? In a new premium report, The Motley Fool’s senior pharmaceuticals analyst breaks down all of Lilly’s moving parts, including an in-depth analysis of the company’s must-know opportunities, and reasons to buy and sell today. To find out more click here to claim your copy today.
var FoolAnalyticsData = FoolAnalyticsData || []; FoolAnalyticsData.push({ eventType: “TickerReportPitch”, contentByline: “David Williamson“, contentId: “cms.26139”, contentTickers: “NYSE:PFE, NYSE:BMY, NYSE:LLY, NASDAQ:ACAD”, contentTitle: “What Acadia Investors Need to Know About This Stock’s Pop Today”, hasVideo: “True”, pitchId: “126”, pitchTickers: “NYSE:LLY”, …read more
Source: FULL ARTICLE at DailyFinance
