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Why Now is Time to Buy Gilead

##Symbol##GILD ##Date##28 Dec 2015

Fundamentals

Written by Ophir Gottlieb, 12-28-2015 Follow @OphirGottlieb !function(d,s,id){var js,fjs=d.getElementsByTagName(s)[0],p=/^http:/.test(d.location)?'http':'https';if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src=p+'://platform.twitter.com/widgets.js';fjs.parentNode.insertBefore(js,fjs);}}(document, 'script', 'twitter-wjs'); PREFACE Gilead has the largest revenue and earnings in all of biotech. It drives the largest revenue per employee and highest operating margins. It has the single largest drug success in the history of the industry. While the stock is down nearly 20% from its highs, it just secured two massive FDA approvals to defend two separate $10 billion franchises. The charts we're about to look at are beyond breathtaking to borderline absurd. But after all that, the single most compelling reason to buy Gilead stock is even simpler, and perhaps, even more breathtaking.

CHARTS Here's a chart of revenue per employee in $millions on the y-axis for all bio/pharmas over $15 billion in market cap.

Gilead generates $3.5 million per employee and no other bio/pharma even generates $1.5 million per employee. But that's not the reason to buy the stock right now. Here's our second chart. We plot the amount of revenue generated per $1 of expense on the y-axis for all bio/pharmas over $15 billion in market cap.

Do you enjoy using visualizations to understand what's really going on in a company? Get Our (Free) News Alerts Twice a Week. Yeah. Gilead generates $3.06 of revenue for every $1 in operating expense. No other bio/pharma even generates $2. For context, Apple generates $1.40 in revenue per $1 of operating expense. Google generates $1.34 and Facebook generates $1.47. But this isn't the reason to buy Gilead stock right now. Next, let's turn to Gilead's trends. Here's the company's absurd all-time revenue (TTM) chart.

Do you thrive on seeing data that goes way beyond headlines and turns you into an expert? Try CML Pro. No credit Card. No Payment Info. Just the Power. We see 52% year-over-year growth in revenue and nearly 200% growth in two-years. But, this too, is not the reason to buy Gilead stock right now. While we have looked at revenue a lot, let's turn to actual earnings. Below we have plotted Gilead's net income (TTM) (after tax earnings).

We can see earnings have risen nearly 80% year-over-year and 400% over the last two-years. But, again, not the reason to buy Gilead stock right now. Biotech and technology data runs deeper than headlines and deeper than the data non-professionals have access to. That advantage is no longer acceptable to us. Get Our Free News Alerts Once a Day. CONCLUSION While Gilead's fundamentals are literally stronger than has ever been seen before in any biotech ever, these alone aren't the most compelling reason to buy the stock. Even further, the company defended two of the largest drug franchises ever in November with clinical trial data. While Hepatitis C is divided into six distinct genotypes, up until now Gilead had a treatment for four of the six types. But, on September 21, 2015 Gilead reported positive results from a Phase II trial on a combination treatment consisting of Sovaldi and an experimental drug. The opportunity is an "all-in-one treatment for all six genotypes of hep C." (Source: Forbes). But that's not the single most compelling reason to buy Gilead right now. Gilead also owns 87% of the HIV market which accounts for nearly $10 billion in sales. But, Gilead's HIV drugs have their critical patents expiring in the period 2018 to 2022. But, on November 8th, Gilead announced that its new HIV drug, Genvoya, was approved by the FDA. Genvoya is as effective as Stribild (the current drug) but has milder side effects. European Union regulators have already recommended approval of Genvoya. But that's not the most compelling reason to buy Gilead right now. 83% of Gilead stock is owned by institutions because the most compelling reason to to buy Gilead right now incredibly, is this: read the full research dossier in CML Pro. You see, the top 1% of wealth owners in the United States and their hedge fund managers are keenly aware of the data that will move markets; data that we have visualized in this article, and much more, like the data behind the most compelling reason to buy Gilead. If we're not using the same data and information, then we're trading against people that simply have more information then we do. That is a wealth losing strategy. The information asymmetry that exists between pros and non-pros has transferred massive wealth to the top 1% from the rest of us. That information asymmetry is no longer acceptable to us. This is just one of the fantastic reports CML Pro members get. For a (very) limited time we are offering CML Pro at a 90% discount for $10/mo. with a lifetime guaranteed rate. Join Us: Get the most advanced premium research delivered to your inbox along with access to visual tools and data that until now has only been made available to the top 1%. Thanks for reading, friends.

#$gild

Why This May Simply be the Best Biotech in the World

##Symbol##CELG ##Date##23 Dec 2015 Fundamentals Written by Ophir Gottlieb, 12-23-2015 PREFACE Celgene may simply be the most compelling biotech company in the world and a patent ruling it just received has pushed the stock up 10% overnight adding fully $10B to its market cap. BREAKING Celgene's largest drug is Revlimid and while it has been one of the greatest successes ever in biotechnology, it faced a patent lawsuit and decision that hung over the stock. News came out yesterday that an agreement had been reached where Celgene would allow for generic brands to sell starting in 2026. While that's a full year before the patent expires, we now can now rest assured that Revlimid will have more than another decade to grow and sell without competition. var page_count = 'off'; if (typeof OAS_rdl == 'undefined') { var OAS_rdl = ''; var OAS_CA = ''; page_count = 'on'; document.write(''); } var OAS_url = 'http://oascentral.investingmediasolutions.com'; var OAS_sitepage = 'CML_Mobile'; var OAS_pos = 'TopRight'; var OAS_searchterms = ''; var OAS_taxonomy = ''; if (typeof OAS_RNS == 'undefined'){ var OAS_RN = new String (Math.random()); var OAS_RNS = OAS_RN.substring(2, 11); } if (OAS_searchterms != '') { OAS_searchterms += '&'; } if (OAS_taxonomy != '') { OAS_taxonomy = '&' + OAS_taxonomy; } if (page_count != 'on') { OAS_taxonomy = '&oas_pv=no_analytics' + OAS_taxonomy; } document.write(''); PIPELINE For those that like to read children's books, borrowing from Roald Dahl, [Celgene is] "The Champion of the World." Before we get into the details of what does exist, let's look at the incredible pipeline for Celgene relative to all of biotechnology in the United States. In the image below, we have plotted the number of Phase III trials on the y-axis and ranked the largest biotechs on the x-axis. That's right, Celgene has more products in Phase III than any other biotech, save for AMGN, where it's tied. Now we can do the same thing with Phase II trials. There you have it. Celgene has the most Phase II trials and Phase II trials. Biotech data runs deeper than headlines and deeper than the data non-professionals have access to. That advantage is no longer acceptable to us. Try CML Pro. No credit Card. No Payment Info. Just the Power. CURRENT PRODUCTS In the last year, CELG has generated just over $8.7 billion in revenue. Here's a chart of Celgene's revenue (TTM) over the last sixteen years. That mountain of revenue is not only at an all-time high, it has increased consecutively to new all-time highs every quarter for the last ten years. Even given that fantastical streak, revenue is still up 20% year-over-year and 42% over the last two-years. We're talking about absurdly large growth in a mega cap biotech. We write one story a day to uncover new opportunities and break news. Try CML Pro. No credit Card. No Payment Info. Just the Power. PRODUCT MIX REVLIMID will account for $5.8 billion in sales this year, so we see why that patent agreement was so critical for the firm. Projections next year range around $6.5 billion, so solid growth for an enormous success. Growth is going to come from international markets. The Motley Fool points out risk that still lingers which is that in total the United States might start adopt a "pay-for-performance" reimbursement option for drugs. That's a legitimate risk for all of biotech, but it's not likely something we will see in 2016, if ever. But Celgene is not a one hit wonder. it's top five products are (1) Anemia and cancer treatment REVLIMID ($5.8B) (2) Breast, lung and pancreatic cancer treatment ABRAXANE (3) Myeloma drug POMALYST/IMNOVID (4) Bone marrow disorder myelodysplastic syndrome (MDS) drug VIDAZA and (5) Plaque psoriasis treatment OTEZLA. Here is a chart of Celgene's R&D expense through time. Innovation is coming. Do you enjoy understanding what's really going on in a company beyond the headline noise? Then Join Us: Get Our (Free) News Alerts Once a Day. SHAKING IT UP OTEZLA, the last drug we listed in the top five has massive room to grow because of a unique advantage the treatment has. Specifically... the full research is available in CML Pro. This reality could push the drug to potential blockbuster status. The drug hit nearly $140 million in sales the most recent quarter, which was more than 50% growth. Given it's unique advantage, there's every reason to believe that the growth will continue and OTEZLA has the potential to hit the "blockbuster" threshold of $1 billion in annual sales within a few years. THE PARTENRSHIP OF A LIFETIME Celgene and Juno (JUNO have entered into a ten-year collaboration that could generate a revenue base growth of 50%. Juno Therapeutics is a radical, promising and in the very sense of the word, transformational biotech. It has no revenue, but a market cap that tops $4 billion, and here's why: The firm is a clinical-stage company developing novel cellular immunotherapies. The company's stated goal is "to revolutionize medicine by re-engaging the body's immune system to treat cancer". And when the firm says "revolutionize," they aren't kidding. Check this out: Here's how this company works, in English, from The Motley Fool: "Juno's CAR-T therapeutics require the removal of a cancer patient's immune cells, selection and activation of the cells, and gene transfer to train the cells to attack the patient's tumor. At that point, the cells are grown in an incubator until there are enough to put back into the patient." (Source: Fool.com). That's right, the firm creates personalized cells and then reinserts them into the patient so she can attack the cancer herself. That's an attempt at curing cancer with no side effects. Here's what a recent FBR analyst wrote: "Investors' discussions focused on the company's products in development for leukemia, lymphoma, and solid tumors but also on the science behind the treatments with questions centering on manufacturing and cell persistence. The company's pipeline is deep with 10 candidates potentially in clinical trials [] by early 2016." (Source: Benzinga). Juno and Celgene could revolutionize medicine, and this is yet another potential blockbuster win for Celgene, but not at the $1 billion level, at the multi-billion level. The main stream media simply doesn't have the lexicon to understand breaking technology and biotech. It just doesn't. Get free news alerts twice a week from us from us and you will be the expert in the room. RECEPTOS ACQUISITION The Receptos acquisition did add a wall of debt to Celgene, as we can see in the chart below. But the careful analyst sees that this is a massive win for the company. The focal point of the acquisition was a drug called "ozanimod" that presents possible usage for multiple sclerosis and irritable bowel disorders. Upon acquisition of RCPT, Celgene made a bold case that the drug could ultimately yield $4-$6 billion in annual sales (remember, Celgene's total sales in the trailing-twelve-months is $8.7 billion). Yes, the initial forecasts from Celgene was a potential 50% growth in revenue from the acquisition. But, it gets more bullish if you believe Celgene's management. On the most recent earnings call Celgene... try the full research in CML Pro . This reality reflects a non-trivial possibility that this drug could run as high as Celgene's current total revenue in several years. CONCLUSION With the patent case out of the way, the largest pipeline in the world, growth in it's best selling product, growth in a new product, the partnership of a lifetime with JUNO and the massive monetization capacity of its acquisition, Celgene is very quickly becoming "The Champion of the World," and we just explained why. REALITY CHECK The top analysts, asset managers and hedge fund managers are keenly aware of the data that will move markets and if we're not using this data, then we're trading against people that simply have more information then we do (like Phase III and Phase II clinical trial data). That is a wealth losing strategy. This is just one of the fantastic reports CML Pro members get. For a (very) limited time we are offering CML Pro at a 90% discount for $10/mo. with a lifetime guaranteed rate. Join Us: Get the most advanced premium research delivered to your inbox along with access to visual tools and data that until now has only been made available to the top 1%. Thanks for reading, friends.

#$celg

Relypsa Just Had a Momentous Day

##Symbol##RLYP ##Date##21 Dec 2015

Relypsa, Inc.

Written by Ophir Gottlieb, 12-21-2015 Follow @OphirGottlieb !function(d,s,id){var js,fjs=d.getElementsByTagName(s)[0],p=/^http:/.test(d.location)?'http':'https';if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src=p+'://platform.twitter.com/widgets.js';fjs.parentNode.insertBefore(js,fjs);}}(document, 'script', 'twitter-wjs'); UPDATE The story surrounding Relypsa is one that seems so bullish but at the same time is so steeped in fact that it will feel almost impossible. So I will leave all opinion out of this piece. Friends, here come the facts, and they are not disputed.

Before we get into the incredible story, the firm just filed an 8-K on Monday December 21st, and here are the key takeaways: 1. On December 21, 2015, Relypsa, Inc. ("Relypsa") announced that VeltassaTM (patiromer) for oral suspension ("Veltassa") is now available for prescription to patients with hyperkalemia in the United States. 2. Relypsa has partnered with two national specialty pharmacies to fill and deliver Veltassa prescriptions to patients. Patients who have been prescribed Veltassa will receive the medicine via mail order directly from one of the authorized specialty pharmacies: * ACS Specialty Pharmacy, a CVS Pharmacy; or * Walgreens Specialty Pharmacy. 3. Veltassa will be distributed to hospitals through a network of authorized specialty distributors, including: * ASD Healthcare, a subsidiary of AmerisourceBergen; * Cardinal Health Specialty Distribution, a subsidiary of Cardinal Health; or * McKesson Plasma and Biologics, LLC. 4. All of Relypsa's sales representatives have now been hired and are calling on nephrologists, cardiologists and relevant hospitals to introduce them to Veltassa. Approximately one-third of Relypsa's sales representatives and all of Sanofi's nephrology sales force, pursuant to the Detailing Agreement between Sanofi and Relypsa, began calling on doctors following approval. By late November 2015, a second group of Relypsa representatives was hired and calling on doctors. The final group of Relypsa representatives started calling on doctors as of December 21, 2015. And of course, we can't forget that on Decemeber 4th this news broke:

Shares of Relypsa (NASDAQ:RLYP) exploded more than 30% higher after a rumor broke that Merck (NYSE:MRK) has plans to make an offer to buy out the company. Source: The Motley Fool

NOW: THE STORY Relypsa (RLYP) is a small-cap clinical stage biopharmaceutical company with a market cap of ~$850 million. The company has a single drug named Veltassa that treats hyperkalemia, which is a condition of fatal levels of potassium in patients with chronic kidney disease or heart problems. Veltassa is the first new medicine for hyperkalemia in more than 50 years with around 3 million people affected in the U.S. alone (Source: Seeking Alpha). The drug won its first FDA approval on October 21st, 2015 with actual sales expected to begin in the first week of January 2016. But, the stock dropped nearly 40% on the news. Yes, it dropped on the news. Here is the stock chart over the last year. Veltassa will be able to address about 2.4 million patients in the United States who suffer from high levels of potassium, Wedbush Pacgrow Lifesciences analyst Liana Moussatos said (Source: Reuters). We write one story a day to break news. Come on in: Get Our (Free) News Alerts Once a Day. Why the Stock Drop? Two reasons: First, the FDA approval came with a "black-box warning label" on the medication, which is the strongest warning that the FDA requires. For example, the FDA has required that boxed warnings be placed on all antidepressant medications because of the risk of suicide. For other medications, a boxed-warning may interfere with a drug's sales capacity. But, while most black-box labels warn of dangerous side effects and surround safety issues, this label did not. Here is the actual black-box label:

The boxed warning says that other oral medications should be administered at least 6 hours before or 6 hours after Veltassa is taken as the drug binds other oral drugs thereby reducing their absorption and reducing their effectiveness. Source: Seeking Alpha

So this is an inconvenience, but it is not a safety concern. This is critical as for the vast (vast) majority of people, this is a total non-issue. According to Oppenheimer, a market research survey of roughly 1000 patients charts indicates that ~95-98% of the patients currently take drugs daily or every twelve hours. "Overall, we're pleased with the label," spokeswoman Charlotte Arnold said in an emailed statement. "The indication is broad and supports use in both the hospital and outpatient settings" (Source: FiercePharma). That's right. Even if this warning even has an impact, 95% to 98% of the population will be totally unaffected. To further the point, Dr. Rodney Samaan said "from a cardiologist or nephrologist perspective, since most of the drugs we prescribe are BID or every twelve hours, or QD, daily, [this warning] will not be an issue." And Wedbush said the issue is:

"easily addressable, a minor issue" and that it has no impact on its billion dollar sales projections, which account for the United States alone.

What's really interesting here is that even though there was a negative reaction to the box-label, RLYP's drug is actually considered a vast improvement in terms of safety relative to the current treatment. Check this out:

Concordia Healthcare Corp's Kayexalate, the standard-of-care treatment approved in the United States for hyperkalemia, is not considered to be effective for long-term management by doctors and physicians. Ghenoiu said Kayexalate will soon be taken off the market due to its severe side effects, including constipation, death of intestinal cells and gastrointestinal bleeding. Veltassa has several advantages over Kayexalate, including better binding capacity, tolerability and compliance. Source: Reuters

It's not all good news for Relypsa. Morgan Stanley is quite bearish. Check out this quote after the FDA approval:

"This is likely to limit the demand for Veltassa, especially if ZS Pharma's competing drug ZS-9 is approved without a black box warning or similarly cumbersome dosing protocol. Given Veltassa's restrictive label, we believe ZS-9 is likely to emerge as the differentiated, best-in-class potassium binder, a significant commercial advantage." Source: Morgan Stanley

The main stream media doesn't have the vocabulary to understand breaking technology and biotech. But you can. Get free news alerts (once a day) from us and you will be the expert in the room. Get Our (Free) News Alerts. VALUATION Veltassa has a large addressable market and multiple analysts expect U.S. peak sales around $1 billion or higher with just a 5% penetration rate. The company has about $295 million in cash and a market cap of $850 million, making its equity worth about $550 million. Yes, the equity is worth about half of the potential U.S. sales or said differently, the price to future sales is 0.5. For context, the IBB Nasdaq Biotech Index has a price to sales ratio of 6.7. The stodgy S&P 500 has a price to sales of just under 2. Again, these are the facts, and they are not disputed. We write one story a day to uncover new opportunities and break news. Come on in: Get Our (Free) News Alerts Once a Day. COMPETITION Remember I wrote that there were two reasons the stock dropped. Here's number two: There is a competitor lurking. When news of the black-box warning broke, shares of ZS Pharma (ZSPH) gapped higher. This company's lead product candidate, ZS-9 is currently in late stage trials as another treatment for hyperkalemia. If the drug is approved, and if the drug doesn't get a black-label warning, perhaps it will hold a clinical advantage over Veltassa (Source: The Motley Fool). Of course those are a lot of "ifs" and Relypsa will have a full six-months (at least) of sales before ZSPH can even consider sales of its drug. The best news in the world is free. Get Our (Free) News Alerts. THIS IS WERE IT GETS CRAZY AstraZeneca (AZN) paid $2.7 billion to takeover ZS Pharma and its hyperkalemia drug. Yes, while we can play the "price-to-sales" game all we want, a major pharma company has said outloud with its pocket book, just the chance of a drug approved in a year to treat hyperkalemia is worth more than $2.7 billion. Remember, AZN didn't buy ZS Pharma to breakeven on the transaction, if its paying $2.7 billion, the firm believes it’s worth substantially more if approved. Again, Relypsa (RLYP) has a market cap of just $850 million with an approved drug (as opposed to a drug candidate) that will go on sale in a matter of weeks and it has $300 million in cash. These are the facts, and they are not disputed. International Relypsa has partnered with Vifor Fresenius Medical Care for an upfront cash payment of $40 million and up to $125 million in additional milestone payments and tiered double-digit royalties on net sales of up to 22%. Relypsa expects to submit an MAA with the European Medical Agency in the first half of 2016 and Veltassa should enter the EU market in 2017 (Source: Seeking Alpha). Do you thrive on really understanding companies and being a step ahead? Get Our (Free) News Alerts Once a Day. UPDATE 11-30-2015 Here is social sentiment from a Twitter poll I took: END UPDATE CONCLUSION Fact: AZN believes a drug candidate for hyperkalemia is worth north of $3 billion. Fact: Analysts abound believe that $1 billion in sales at just a 5% penetration rate in the United States alone is achievable for RLYP's Veltassa. Fact: RLYP has a market cap of $850 million including $300 million in cash, yielding an equity value of just $550 million. Fact: RLYP's drug is the first new medicine for hyperkalemia in more than 50 years with around 3 million people affected in the U.S. alone. Fact: RLYP will start selling its drug and realizing revenue in a matter of several weeks. Fact: RLYP's drug did get a "black-box" label warning but that warning does not surround safety indications, and several analysts and even doctors see no issue at all with the warning. Fact: A research study showed that 95%-98% of people will be totally unaffected by the 12-hour black-box safety indication. Fact: With the stock trading at $20 as of this writing, Wedbush has a price target of $75 and Oppenheimer has a price target of $55. Fact: Data coming out in early 2016 will demonstrate if Veltassa is binding with other medications. There is a possibility that the black-box is dropped or shortened to 3-hours. Fact: Without an approved drug, RLYP stock has traded over $40. As of this writing it's $20. Probably True: Within 18-months, RLYP will begin to generate revenue from European sales of its drug. That's it friends. Data like this, until now, has been kept away from retail investors, especially in a format that's so easy and so fast to digest. The information asymmetry that exists between pros and non-pros has transferred massive wealth to the top 1% from the rest of us. That information asymmetry is no longer acceptable to us. This is just one of the fantastic reports CML Pro members get. For a (very) limited time we are offering CML Pro at a 90% discount for $10/mo. with a lifetime guaranteed rate. Join Us: Get the most advanced premium research delivered to your inbox along with access to visual tools and data that until now has only been made available to the top 1%. Disclosure: I am long RLYP stock and call options and short put options.

#$rlyp

Update: Why JUNO is on the Brink of Curing Cancer

##Symbol##JUNO ##Date##12 Dec 2015 Juno Therapeutics Written by Ophir Gottlieb, 12-10-2015 Follow @OphirGottlieb !function(d,s,id){var js,fjs=d.getElementsByTagName(s)[0],p=/^http:/.test(d.location)?'http':'https';if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src=p+'://platform.twitter.com/widgets.js';fjs.parentNode.insertBefore(js,fjs);}}(document, 'script', 'twitter-wjs'); PREFACE Juno Therapeutics, if successful, would be an end-all-cure-all for cancer tumors. The firm may have as many as ten candidates in clinical trials by early 2016. Yes, it's on the brink of a cure, not a treatment. And here's a secret, the firm has over $1 billion in cash on hand. var page_count = 'off'; if (typeof OAS_rdl == 'undefined') { var OAS_rdl = ''; var OAS_CA = ''; page_count = 'on'; document.write(''); } var OAS_url = 'http://oascentral.investingmediasolutions.com'; var OAS_sitepage = 'CML_Mobile'; var OAS_pos = 'TopRight'; var OAS_searchterms = ''; var OAS_taxonomy = ''; if (typeof OAS_RNS == 'undefined'){ var OAS_RN = new String (Math.random()); var OAS_RNS = OAS_RN.substring(2, 11); } if (OAS_searchterms != '') { OAS_searchterms += '&'; } if (OAS_taxonomy != '') { OAS_taxonomy = '&' + OAS_taxonomy; } if (page_count != 'on') { OAS_taxonomy = '&oas_pv=no_analytics' + OAS_taxonomy; } document.write(''); STORY The company is focused on easily the most exciting biotechnology in the world, which is called CAR-T. Juno's technologies genetically engineer a patient's own T cells to recognize and kill cancer cells. Here's how it goes:

CAR-T therapeutics require the removal of a cancer patient's immune cells, selection and activation of the cells, and gene transfer to train the cells to attack the patient's tumor. At that point, the cells are grown in an incubator until there are enough to put back into the patient." (Source: Fool.com).

Get one stock gem a day: Get Our (Free) News Alerts Once a Day. UPDATE The annual meeting of the American Society of Hematology (ASH) just wrapped up and here's what happened with respect to Juno and CAR-T.

In a trial of JCAR014, 57% of leukemia patients and 64% of lymphoma patients who were given the most commonly used dosing regimen experienced complete responses. Another experimental T-cell-based therapy from Juno, JCAR015, achieved an 82% complete response rate in patients with ALL.

There was a ton of other data surrounding CAR-T, and most of it was quite good, if not downright shockingly good. Now get ready to fallout of your chair (CTL019 is Novartis' treatment):

Separately, researchers at the University of Pennsylvania reported that 55 out of 59 pediatric patients with acute lymphoblastic leukemia that had recurred or was not responding to treatment went into remission with CTL019. Of those, 18 were still in remission after a year and nine experienced remissions of more than two years. Source: Forbes

CAR-T is working, friends, It will be the technology, or at least a part of the technology, to cure cancer. Period. Now there are a lot of players getting into the CAR-T space, which is excellent news for the world, but makes stock picking a little harder. Kite Pharma is certainly one, and in a prior article I discussed how the company has essentially openly stated that they believe they have cured non-Hodgkin’s lymphoma and have bet the house on it. Other competitors include Novartis, Bellicum Pharma, Amgen and more. But let's focus on JUNO. The equity market certainly has, placing a $4.5 billion valuation on this company with zero revenue and zero FDA approvals. That's called confidence. Do you thrive on seeing data that goes way beyond headlines and turns you into an expert? Try CML Pro. No credit Card. No Payment Info. Just the Power. JUNO Juno was named to "MIT Technology Review's 50 Smartest Companies" for 2015 and for good reason. But, the stock has dipped hard in the recent 'risk-off' sell-off and appears to be in free fall. Here's a one-year stock chart -- note the recent move since the start of December.

It takes more than click bait and a 140 characters to be an expert and journalists aren't trained to understand breaking biotechnology. Get Our (Free) News Alerts. Be the Expert in the Room. Juno's website reads: "These cellular therapies have the potential to be effective regardless of the type of previous treatments patients have experienced and may avoid the long-term side effects associated with current treatments." Here's an image from Juno's website that illustrates this remarkable approach:

That's right, the firm creates personalized cells and then reinserts them into the patient so she can attack the cancer herself. We write one story a day to uncover new opportunities and break news. Come on in: Get Our (Free) News Alerts Once a Day. CONCLUSION Celgene and Juno have announced a ten-year collaboration, and that means JUNO has one of the most powerful mega cap biotechs in the world at its back, and even more so, that mega cap believes JUNO has cracked the code. After meeting with Juno's CEO and CFO, FBR analyst Ed White stated "[investors may be] unaware of the advancements that Juno is making in lymphoma," given their focus on leukemia and solid tumors (Source: Benzinga). He further went on to say:

"The company's pipeline is deep with 10 candidates potentially in clinical trials using either CAR or TCR by early 2016." (Source: Benzinga).

That's right, potentially 10 treatment candidates. The process itself is highly personal, which means the "manufacturing" process of cells is going to be expensive. The reality of medicine in the United States is that those that have, will receive. Those that do not have, very often times, will not receive. When democratic presidential candidate Hillary Clinton sent her tweet heard round the world surrounding costs of biotech medicine, the stock jolted down. Here's more from that same Motley Fool article:

"CAR-T therapeutics aren't going to have the typical high margins that come with most pharmaceutical drugs. If the government puts pricing controls on drugs, it may be difficult for Juno Therapeutics, and the rest of the companies developing CAR-T therapeutics, to profit from the therapies if the drugs are eventually approved by the Food and Drug Administration." (Source: Fool.com).

Keep in mind that the prices that specialty drug makers charge patients is very different than the price these drug manufacturers can charge insurance companies. For now, JUNO has a market cap above $4 billion and has only reported revenue once; last quarter it reported ~$12.5 million. The stock is a pure play speculation on an incredible and novel application of medicine to cure cancer rather than treat it, person by person. This is just one of the fantastic reports CML Pro members get. For a (very) limited time we are offering CML Pro at a 90% discount for $10/mo. with a lifetime guaranteed rate. Join Us: Get the Most Advanced Visual Tools, Data and Stock Research.

#$juno

Why Bellicum Pharma Has Enormous Upside

##Symbol##BLCM ##Date##09 Dec 2015

Bellicum Pharmaceuticals

Written by Ophir Gottlieb, 12-08-2015 Follow @OphirGottlieb !function(d,s,id){var js,fjs=d.getElementsByTagName(s)[0],p=/^http:/.test(d.location)?'http':'https';if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src=p+'://platform.twitter.com/widgets.js';fjs.parentNode.insertBefore(js,fjs);}}(document, 'script', 'twitter-wjs'); PREFACE Bellicum Pharmaceuticals is a small cap clinical stage biotech with potentially world changing treatments in the laboratory. This is a $490 million market cap firm, with $110 million in cash -- so while the risk of failure can't be ignored, this is also a company with enormous potential upside.

STORY BLCM is in clinical trials to treat both cancer and genetic blood diseases and it has a fascinating story behind it. The firm is trying to to craft next-generation therapies that empower the immune system to battle back against cancer and other rare blood disorders. Two if its critical trials are for products with unassuming names BPX-501 and BPX-601. On Saturday, December 5th, BLCM reported some high quality results from clinical trials. Here's what we now know: BPX-501 BPX-501 consists of T cells taken from a stem cell donor and "modified in a lab plus a molecular safety switch to turn off the modified T cells in the event of serious graft-versus-host disease" (Source: TheStreet.com). The great marvel of BPX-501, if it works, is that it will enable donors to save children's lives: it's a bridge to allow family members to save each others' lives.

A study enrolled 39 children and all of them underwent a haploidentical, T cell-depleted stem cell transplant. That's medical speak for transplants from donors with stem cells which are not an exact match to the patient (most of them were from family members). Mismatched stem cells can cause infections and something called graft-versus-host disease (or GVHD), both of which are potentially fatal. This is where BPX-501 comes in. Two weeks after the transplants, each of the children were infused with the trial drug and then data was compared to how these children did with how other children did that did not receive BPX-501. Here are the results:

On average, the immune system in patients treated with BPX-501 recovered 40 days faster and they were discharged from the hospital 21 days sooner than patients in the historical control. None of the BPX-501 patients died from transplant-related causes to date compared with three deaths from transplant in the historical control. The incidence GVHD, the most frequent and potentially deadly side effect of mismatched stem cell transplants, was also reduced by BPX-501 compared to historical controls.

So basically, in this interim trial, the treatment did quite well. The "safety switch" built into BPX-501 was never used because no severe cases of GVHD occurred. While we can all read these results, I think the most useful thing is to grab some quotes from doctors that focus on these diseases for a living, so here we go. Dr. Franco Locatelli from Italy's IRCCS Ospedale Pediatrico Bambino Gesù said, "these interim results present strong evidence that the addition of BPX-501 modified donor T cells provides important immune support and improves outcomes in patients undergoing a T cell-depleted haploidentical stem cell transplant." Do you enjoy discovering new companies and opportunities and really understanding them? Get Our (Free) News Alerts Once a Day. THE OPPORTUNITY It turns out that these haploidentical, T cell-depleted stem cell transplants are pretty rare, making up just 9% of total stem cell transplants every year -- that would be just over 2,000 of these transplants a year. As a stand alone business, this may truly be too small to matter in an economic sense. But, the potential goes much further. A strong and thoughtful argument is being made that if BPX-501 really does work, then doctors will opt for these "mismatched" stem cell donor operations more often. That is a hypothesis founded on solid ground. But there's actually more. Next year, Bellicum plans to meet with the FDA and European drug regulators to determine the steps necessary to seek approval for BPX-501 in transplant patients with non-malignant disease. One example the Bellicum's COO gave surrounded beta-thalassemia, a blood disorder that reduces the production of hemoglobin. The media isn't equipped to understand the stock market beyond headlines. Try CML Pro for free and watch yourself become the expert in the room. Try CML Pro. No credit Card. No Payment Info. Just the Power. Now, Beta thalassemia is a fairly common blood disorder worldwide. In fact, thousands of infants are born each year with the affliction according to the National Institute of Health (NIH). That expands the possible usage of BPX-501, and also puts it head to head with Bluebird Bio (BLUE), which has a gene therapy to treat the disease. We break news like this everyday. Discover the Undiscovered. Get Our (Free) News Alerts Once a Day. MORE OPPORTUNITY: CANCER & CAR-T Bellicum believes that the technology platform BPX-501 is built on can also be used to develop treatments for cancer, and now we're in a totally different league of disease, both in terms of its effects on society and its commercial viability. In fact, BPX-501 and BPX-601 may go hand in hand with CAR-T therapies. For those of you in the biotech world focusing on cancer cures, this is the game changer. I've covered CAR-T with JUNO and KITE, but a quick review goes like this:

In English, the goal is to reprograms a patient's T-cells — the kind that are supposed to fight disease — to seek and destroy only abnormal, cancerous lymph cells, not the healthy ones crucial for human life. You can see the reason for massive optimism, as this would be a cure for cancer, not a treatment. You can read our JUNO report here: Juno is Simply on the Brink of Changing the World You can read our KITE report here: This Biotech Just Bet the House that it Has Cured Cancer Bellicum is working on what they call "GoCAR-T Technology" which incorporates a "switch" that activates CAR T cells when triggered. This is the promise of Bellicum on a broader, billion dollar scale. Here's an illustration from the Bellicum website that shows how the company aims to improve the standard CAR-T process:

Do you thrive on understanding what's really going on in a company beyond headlines to find uncovered gems? Get Our (Free) News Alerts Twice a Week While JUNO and KITE battle it out to be the first to bring CAR-T to market, Bellicum stands firmly in the middle, to help either (or both) make their treatments safer and better. This is what Bellicum's website reads:

We believe these studies together provide proof-of-principle that GoCAR-T technology may turn[] CAR T cell therapy from an uncontrollable, and largely unpredictable class into a more predictable therapy which can be adjusted to the patient's therapeutic window. (Source: Bellicum Webiste).

The product called BPX-601 is Bellicum's GoCAR-T product candidate for solid tumors. The company writes, "we are currently conducting preclinical studies for the treatment of solid tumors overexpressing the prostate stem cell antigen (PSCA) antigen. We have obtained positive proof-of-principle data in an animal pancreatic tumor model, which we believe validate BPX-601's activity and rimiducid’s ability to modulate therapeutic effect. And perhaps the most important part: Although many product candidates are in development for these cancers, there are currently no approved products targeting prostate stem cell antigen (PSCA). We intend to file an IND for the initial indication of pancreatic cancer by the end of 2015. The main stream media doesn't have the vocabulary to understand breaking technology and biotech. Get free news alerts from us and you will be the expert in the room. Get Our (Free) News Alerts. CONCLUSION BLCM is moving down the line with positive results for multiple treatments. While the initial glance makes its BPX-501 product look tiny, a careful eye sees a massive opportunity. Add with that the movement into CAR-T, and this is a young biotech with explosive potential. The risk is that the company fails and that would mean it could literally go to zero. The upside is equally fantastical. The firm has a market cap of $490 million, with $110 million in cash. If it wins with either or both of its treatments, this is a multi-billion dollar firm. These are the risk and reward scenarios for this fascinating biotech. This is just one of the fantastic reports CML Pro members get. For a (very) limited time we are offering CML Pro at a 90% discount for $10/mo. with a lifetime guaranteed rate. Join Us: Get the Most Advanced Visual Tools, Data and Stock Research.

#$blcm

Morgan Stanley is Wrong: This Biotech May be Ready to Explode Higher

##Symbol##RLYP ##Date##18 Nov 2015

Relypsa, Inc.

Written by Ophir Gottlieb, 11-19-2015 Follow @OphirGottlieb !function(d,s,id){var js,fjs=d.getElementsByTagName(s)[0],p=/^http:/.test(d.location)?'http':'https';if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src=p+'://platform.twitter.com/widgets.js';fjs.parentNode.insertBefore(js,fjs);}}(document, 'script', 'twitter-wjs');

UPDATE 12-03-2015 News just broke that Merck plans to make a non-binding offer to acquire Relypsa according to a source claiming to have direct knowledge of the situation. A price could not be learned. FT Alphaville reports it a bit differently:" According to usually knowledgeable people, Relypsa has begun a process to consider strategic alternatives that includes a potential sale of the company. A full auction has begun with GlaxoSmithKline, Sanofi and Galenica of Switzerland among the potential bidders, the people said." We break news everyday. Be ahead, not behind. Get Our (Free) News Alerts Once a Day. UPDATE 11-30-2015 This article was originally published on November 19th. Updates have been added, which include safety assessments of the drug, size of the addressable market and social sentiment. Updates are denoted in the text. Before we get steeped in the incredible story, this is the fundamental investment thesis for RLYP: THESIS: Relypsa just received its first drug approval from the FDA, it will begin sales in a matter of weeks. The company has a market cap of just ~$850 million right (stock price is $21) now and several analysts forecast sales to reach $1 billion at just 5% market penetration. The average price to sales in the Nasdaq Biotech Index (IBB) is 6.7 to 1. I don't believe RLYP is worth $6.7 billion, not even close. But I do think the stock is worth north of $2 billion, which would put it at a price to sales equal to the stodgy S&P 500. That would be a stock price of $48. And for the record, the stock was trading above $42 in March of this year. Wedbush actually has a price target of $75 and Oppenheimer has a price target of $55. Further yet, biotech giant AstraZeneca (AZN) just paid $2.7 billion to purchase RLYP's competitor ZS Pharma for a drug that treats the same disease and it's not even FDA approved yet. Wall Street doesn't have the vocabulary to understand breaking technology and biotech. Get free news alerts (twice a week) from us and you will be the expert in the room.

PREFACE The story I'm going to tell you is one that seems so bullish and so steeped in fact that it will feel almost impossible. So I will leave all opinion out of this piece. Friends, here come the facts, and they are not disputed. Do you thrive on really understanding companies and being a step ahead? Get Our (Free) News Alerts Once a Day. STORY Relypsa (RLYP) is a small-cap clinical stage biopharmaceutical company with a market cap of ~$850 million. The company has a single drug named Veltassa that treats hyperkalemia, which is a condition of fatal levels of potassium in patients with chronic kidney disease or heart problems. Veltassa is the first new medicine for hyperkalemia in more than 50 years with around 3 million people affected in the U.S. alone (Source: Seeking Alpha). The drug won its first FDA approval on October 21st, 2015 with actual sales expected to begin in the first week of January 2016. But, the stock dropped nearly 40% on the news. Yes, it dropped on the news. Here is the stock chart over the last year. UPDATE 11-30-2015 Veltassa will be able to address about 2.4 million patients in the United States who suffer from high levels of potassium, Wedbush Pacgrow Lifesciences analyst Liana Moussatos said (Source: Reuters). END UPDATE We write one story a day to break news. Come on in: Get Our (Free) News Alerts Once a Day. Why the Stock Drop? Two reasons: First, the FDA approval came with a "black-box warning label" on the medication, which is the strongest warning that the FDA requires. For example, the FDA has required that boxed warnings be placed on all antidepressant medications because of the risk of suicide. For other medications, a boxed-warning may interfere with a drug's sales capacity. But, while most black-box labels warn of dangerous side effects and surround safety issues, this label did not. Here is the actual black-box label:

So this is an inconvenience, but it is not a safety concern. This is critical as for the vast (vast) majority of people, this is a total non-issue. According to Oppenheimer, a market research survey of roughly 1000 patients charts indicates that ~95-98% of the patients currently take drugs daily or every twelve hours. UPDATE 11-30-2015 "Overall, we're pleased with the label," spokeswoman Charlotte Arnold said in an emailed statement. "The indication is broad and supports use in both the hospital and outpatient settings" (Source: FiercePharma). END UPDATE That's right. Even if this warning even has an impact, 95% to 98% of the population will be totally unaffected. To further the point, Dr. Rodney Samaan said "from a cardiologist or nephrologist perspective, since most of the drugs we prescribe are BID or every twelve hours, or QD, daily, [this warning] will not be an issue." And Wedbush said the issue is:

"easily addressable, a minor issue" and that it has no impact on its billion dollar sales projections, which account for the United States alone.

UPDATE 11-30-2015 What's really interesting here is that even though there was a negative reaction to the box-label, RLYP's drug is actually considered a vast improvement in terms of safety relative to the current treatment. Check this out:

It's not all good news for Relypsa. Morgan Stanley is quite bearish. Check out this quote after the FDA approval:

END UPDATE The main stream media doesn't have the vocabulary to understand breaking technology and biotech. But you can. Get free news alerts (once a day) from us and you will be the expert in the room. Get Our (Free) News Alerts. VALUATION Veltassa has a large addressable market and multiple analysts expect U.S. peak sales around $1 billion or higher with just a 5% penetration rate. The company has about $295 million in cash and a market cap of $850 million, making its equity worth about $550 million. Yes, the equity is worth about half of the potential U.S. sales or said differently, the price to future sales is 0.5. For context, the IBB Nasdaq Biotech Index has a price to sales ratio of 6.7. The stodgy S&P 500 has a price to sales of just under 2. Again, these are the facts, and they are not disputed. We write one story a day to uncover new opportunities and break news. Come on in: Get Our (Free) News Alerts Once a Day. COMPETITION Remember I wrote that there were two reasons the stock dropped. Here's number two: There is a competitor lurking. When news of the black-box warning broke, shares of ZS Pharma (ZSPH) gapped higher. This company's lead product candidate, ZS-9 is currently in late stage trials as another treatment for hyperkalemia. If the drug is approved, and if the drug doesn't get a black-label warning, perhaps it will hold a clinical advantage over Veltassa (Source: The Motley Fool). Of course those are a lot of "ifs" and Relypsa will have a full six-months (at least) of sales before ZSPH can even consider sales of its drug. The best news in the world is free. Get Our (Free) News Alerts. THIS IS WERE IT GETS CRAZY AstraZeneca (AZN) paid $2.7 billion to takeover ZS Pharma and its hyperkalemia drug. Yes, while we can play the "price-to-sales" game all we want, a major pharma company has said outloud with its pocket book, just the chance of a drug approved in a year to treat hyperkalemia is worth more than $2.7 billion. Remember, AZN didn't buy ZS Pharma to breakeven on the transaction, if its paying $2.7 billion, the firm believes it’s worth substantially more if approved. Again, Relypsa (RLYP) has a market cap of just $850 million with an approved drug (as opposed to a drug candidate) that will go on sale in a matter of weeks and it has $300 million in cash. These are the facts, and they are not disputed. International Relypsa has partnered with Vifor Fresenius Medical Care for an upfront cash payment of $40 million and up to $125 million in additional milestone payments and tiered double-digit royalties on net sales of up to 22%. Relypsa expects to submit an MAA with the European Medical Agency in the first half of 2016 and Veltassa should enter the EU market in 2017 (Source: Seeking Alpha). Do you thrive on really understanding companies and being a step ahead? Get Our (Free) News Alerts Once a Day. UPDATE 11-30-2015 Here is social sentiment from a Twitter poll I took: END UPDATE CONCLUSION Fact: AZN believes a drug candidate for hyperkalemia is worth north of $3 billion. Fact: Analysts abound believe that $1 billion in sales at just a 5% penetration rate in the United States alone is achievable for RLYP's Veltassa. Fact: RLYP has a market cap of $850 million including $300 million in cash, yielding an equity value of just $550 million. Fact: RLYP's drug is the first new medicine for hyperkalemia in more than 50 years with around 3 million people affected in the U.S. alone. Fact: RLYP will start selling its drug and realizing revenue in a matter of several weeks. Fact: RLYP's drug did get a "black-box" label warning but that warning does not surround safety indications, and several analysts and even doctors see no issue at all with the warning. Fact: A research study showed that 95%-98% of people will be totally unaffected by the 12-hour black-box safety indication. Fact: With the stock trading at $20 as of this writing, Wedbush has a price target of $75 and Oppenheimer has a price target of $55. Fact: Data coming out in early 2016 will demonstrate if Veltassa is binding with other medications. There is a possibility that the black-box is dropped or shortened to 3-hours. Fact: Without an approved drug, RLYP stock has traded over $40. As of this writing it's $20. Probably True: Within 18-months, RLYP will begin to generate revenue from European sales of its drug. That's it friends. This is just one of the fantastic reports that CML Pro subscribers get several times a week. Get CML Pro and Be the Expert. Disclosure: I am long RLYP stock and call options as of 11-29-2015.

#$rlyp

Sarepta Could Crush It, Even with a Broken FDA

##Symbol##SRPT ##Date##18 Nov 2015 Sarepta Therapeutics Written by Ophir Gottlieb, 11-18-2015 Without getting paranoid, there is evidence (albeit circumstantial), that an FDA committee was pushed in a way that is at the very least odd, and at the very most, outright tampering and fraud. FIRST An Update The risk in SRPT stock is exploding as reflected by the option market. Here is the IV30® (via Livevol) which is a fancy way of saying the expected future volatility in the stock price for the next 30 calendar days. The risk is refelection of the news coming out in a matter of days from BMRN and this news: On November 17th, Sarepta Therapeutics revealed that a peer-reviewed medical journal, the Annals of Neurology, published the results, some of which had been announced, from a midstage trial testing its treatment for a fatal form of muscular dystrophy (Source: WSJ). The stock is finally rising after a catastrophic drop. The study found that at three years of treatment, patients experienced a slower rate of disease progression when compared to untreated matched historical controls and the investigational drug continued to be well-tolerated. Source: BusinessWire In English, SRPT is on the clock for an FDA committee meeting on January 22nd to recommend its drug to treat Duchenne muscular dystrophy (DMD), a disease which affects around 1 in 3,600 boys, which results in muscle degeneration and premature death. There are no cures or treatments available but SRPT has one and so does (maybe) BioMarin (BMRN). The incredible story is included below, and it's not only mind blowing, it may point to FDA member tampering, malfeasance and an incredible opportunity. Get one report a day just like this. Try free news alerts from us. There's just no ther way to say it, the stock market reaction for SRPT of late has been abrupt and utterly bizarre if not confounding. Here's the stock chart, and note the wild collapse in the stock. I originally posted an article on SRPT on July 9th, 2015 and October 15th. Get one report a day just like this. Try free news alerts from us. WHY SRPT Stock Collapsed Two things have happened. First, in an odd twist, the date expected for the FDA committee to meet was Nov. 23 and 24th and all parties believed that both BMRN and SRPT would both be reviewed on those days so the FDA could get a real handle on the two drugs and certainly approve at least one. But... It turned out BMRN will in fact meet with the FDA committee on Nov 23rd, but SRPT has been bumped to Jan. 22, 2016. That's not because the drug is less promising. Nothing has changed and tentative FDA schedules surprise people all of the time. In fact, by most accounts, SRPT's drug candidate is far superior to BMRN's. However, the fact that SRPT has been bumped back crushed the stock and does smell, even if it sounds paranoid, of some back channel FDA committee agreement. Parent and doctor advocacy groups almost immediately protested the date change, not because of the stock price, but because of the dire need for the medicine for children. Do you thrive on really understanding what's going on? Try free news alerts from us. The oddity and potential smoking gun of impropriety here is that the FDA committee had a wonderful opportunity to listen to and examine the data behind the only two drug candidates in the world to treat this disease at the same time, and make a recommendation based on all the data. But they didn't... and SRPT stock got hammered. Second, SRPT offered 3.25 million shares in a public offering at $39 per share. Sarepta plans to use the net proceeds from the offering for product and commercial development and general corporate purposes. That's a good thing. The main stream media simply doesn't have the lexicon to understand breaking biotechnology. It just doesn't. Get free news alerts (once a day) from us and you will be the expert in the room. THE Bizarre Over Reaction The market punished SRPT because its drug (if approved) will be two-months behind BMRN for release. Friends, this is a public company with a remarkable drug that will likely get approved and two-months means nothing to the stock price. This is not a one-time drug sale, it's a magnificent pipeline and treatment with decades of sales ahead of it. But again, all evidence points to SRPT having a superior drug, why has this date change happened, anyway? Even more bizarre, the PDUFA date (not the committee hearing date), which is the date that the drug gets an actual approval or disapproval status, was always going to be two-months behind BMRN. This was a known entity for now more than three-months and was never disputed. Yes, this two-month gap has always been known. I quote myself from the prior article in September: "BioMarin Pharmaceutical (BMRN) also has a drug under FDA review called drisapersen (from Prosensa in acquisition). Interestingly, Drisapersen's PDUFA date is Dec. 27, 2015 two months before SRPT gets its big day." Source: A Small Cap Biotech Ready to Explode The main stream media simply doesn't have the lexicon to understand breaking biotechnology. It just doesn't. Get free news alerts (once a day) from us and you will be the expert in the room. Since the PDUFA date was already behind BMRN, the changing of the dates for SRPT's FDA committee hearing feel yet more manipulated; in the bad and potentially illegal way. DETAILS about SRPT and its Drug Sarepta Therapeutics is a biopharmaceutical company that has no products out to market and no revenue, but has a market cap of $1.2 billion. SRPT has a drug candidate called eteplirsen that addresses Duchenne muscular dystrophy (DMD), a rare disease that affects the protective sheath surrounding muscle fibers and it's fatal. The FDA announced that it had in fact accepted Sarepta's new drug application filing for eteplirsen, granting it priority review status and setting its PDUFA decision date for Feb. 26, 2016. "Priority Review Status" is designated to drugs that offer benefit over existing therapies, or provide a treatment where no adequate therapy exists. It takes more than clickbait to understand breaking technology and biotech. Get free news alerts (once a day) from us and you will be the expert in the room. SRPT has had its ups and down, seeing its stock price trade as low as $11 and as high as $37 in the last year, alone. It's management appears to have totally botched an advisory committee request and in a rather unusual moment, the FDA itself clarified its points on the development timeline. But after a very (very) long trial for its DMD drug, things look good. When I say "good," I mean, it has reached the final endpoint and the data looks promising. An FDA advisory committee will judge the drug and the FDA will take that into account and make a final decision. The addressable market for this drug has been estimated to be about $700 million in sales which isn't quite blockbuster status, but it's a non-trivial win if it goes through and the $1.2 billion market cap as of today would represent less than a 2:1 price to sales. SRPT would instantaneously become a takeover candidate for any number of mega cap biotechs. The stock drop of off the FDA committee date change both apprears to be a bizarre over-reaction and feels like a nasty case of potential tampering with the FDA process. Disclosure: I am long SRPT shares. Get one report a day just like this. Try free news alerts from us.

#$srpt

The Hidden Gem Leading the Genomics Revolution

##Symbol##ILMN ##Date##13 Nov 2015

Fundamentals

Written by Ophir Gottlieb, 11-13-2015 Follow @OphirGottlieb !function(d,s,id){var js,fjs=d.getElementsByTagName(s)[0],p=/^http:/.test(d.location)?'http':'https';if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src=p+'://platform.twitter.com/widgets.js';fjs.parentNode.insertBefore(js,fjs);}}(document, 'script', 'twitter-wjs'); We could make an argument that Illumina is the single best stock to own to gain exposure to the biotechnology sector. The stock price has fallen hard from its all-time highs in the wave that has carried the entire market down but its core fundamentals continue to be overwhelmingly strong. 85% of revenues come from product sales while the remaining revenue stream comes from services. Here is the stock collapse.

The public knows little about this company, but in wonderfully written piece by Luke Timmerman from Forbes, he writes:

"Just as Intel INTC became the company that sparked so much of the computer revolution, Illumina has risen to prominence as a driver of the genomics revolution."

Do you thrive on understanding what's really going on in a company beyond headlines to find uncovered gems? Get Our (Free) News Alerts Once a Day. That's high praise, and better yet, it's true. The stock drop has been attributed to a valuation call for the entire biotech sector and a less than stellar earnings release on October 25th, 2015 when the company missed revenue estimates for the second straight quarter and both Citigroup and JP Morgan lowered price targets. Of course, those cuts happened at esentially the low of the price drop. We can always count on Wall Street to be a rather bumbling group. Wall Street simply doesn't have the vocabulary to understand breaking technology. It just doesn't. Get free news alerts (once a day) from us and you will be the expert in the room. The Marvel that is Illumina In an article written by Trey Thoelcke we get this: "The driving thematic force behind Illumina is that it is the leader in genetic sequencing and array-based solutions and the company is leading in the race toward genetic analysis for personalized medicine." In English, ILMN makes the tools that allow biotechs and pharmas to do their drug trials and get approvals. The company actually makes the machines that sequence genomes, so the company is the very backbone of all other biotech/pharmas hurrying to detect various illnesses or irregularities through DNA-based technology. It's almost impossible to get too excited about the firm's success so far and potential future. Of course, stock prices can get ahead of themselves, but the company itself is in fact a marvel. Check out this all-time revenue chart rolled up into trailing-twelve-month (TTM) periods.

Do you enjoy using visualizations to understand what's really going on in a company? We do too. Get Our (Free) News Alerts Once a Day. That's actually a real chart, not some made up fantasy of expectations. The green bar represents an all-time high. The company has generated over $2.1 billion in revenue in the last year and has realized 23% growth year-over-year and an astonishing 59% over the last two-years. For good measure, the company doesn't just produce revenue, it produces profits as well. Here's a history of the company's net income (TTM) (aka after tax profit) since 2008.

Biotech data runs deeper than headlines and deeper than the data non-professionals have access to. That advantage is no longer acceptable to us. Try CML Pro. No credit Card. No Payment Info. Just the Power. That green bar again represents an all-time high. ILMN has grown net income by over 80% year-over-year and 335% over the last two-years. New Products and Partnerhsips In the October 25th earnings release the company updated new products and partnerships. ILMN completed the acquisition of GenoLogics Life Science Software which was already been adopted by more than 120 genomic labs worldwide, and its Clarity LIMS software strengthens ILMN's industry leading portfolio of genetic analysis solutions. ILMN also focuses growth in reproductive and genetic health and oncology. The company has placed a lot of weight and had a lot of success with strategic partnerships including AstraZeneca, Janssen and Sanof. But perhaps its most exciting recent partnership is with Merck (MRK) to start developing an oncology diagnostic. Here's a chart if ILMN's R&D expense for all-time -- this is the guts of the future.

Yet again, we see that green bar, which represents and all-time high. R&D is up 40% over the last two-years. Do you thrive on seeing data that goes way beyond headlines and turns you into an expert? Try CML Pro. No credit Card. No Payment Info. Just the Power. With the addition GenoLogics, ILMN has become even yet more powerful. In the age of the biotech boom, where companies like Gilead, Celgene, Biogen, Alexion, Jazz and so many others are changing the world with cures for horrible diseases and afflictions, ILMN stands in the center. If the biotech boom today is the the rail road boom during the industrial revolution and the biotechs are the rail road companies, then ILMN is the steel that lines the rail road tracks. It takes more than click bait and a 140 characters to be an expert and journalists aren't trained to understand breaking technology. Get free news alerts (once a day) from us and you will be the expert in the room. You will be powerful. Get Our (Free) News Alerts. More Partnerships Illumina announced its collaboration with Memorial Sloan Kettering Cancer Center to focus research on the biology of circulating tumor DNA. Further, the company announced collaborations with Burning Rock and Amoy Diagnostics to develop clinical applications in China. Read that last sentence fragment again: "to develop clinical applications in China." The company also discussed new products. The Motley Fool reported that several new products were launched, including TruSight Tumor 15, which is a panel designed to identify potential cancer-related genetic variations, and Infinium arrays that help analyze genetic variation in populations. The Future Management took down full year forecasts to 18% revenue growth from 20%, but the company's CEO remains very positive. He said, "the fundamentals of our business remain strong, despite a 3% miss to revenue expectations." But, only a few people caught one very important change to an insurer's policy change, and I must give credit to The Motley Fool for sharing it. Check this out:

Giant health insurer Anthem changed its medical policy in August to allow non-invasive prenatal testing (NIPT) for most pregnancies. In the past, Anthem only reimbursed for genetic testing for high-risk pregnancies. Anthem is the first major insurer to make this move. If other insurers follow its lead, there should be higher demand for Illumina's NIPT technology. Source: The Motley Fool

We write one story a day to uncover new opportunities and break news. Come on in: Get Our (Free) News Alerts Once a Day. Conclusion Illumina is breaking all-time highs in revenue, earnings and R&D. It is the very backbone of perhaps the fastest growing sector (biotech) in the world outside of "The Internet of Things" (IoT) segment of technology. While growth forecasts have been taken down a bit, let's not lose the forest for the trees, friends. This company can't help but grow at double digit rates and there appears to be no real limit to that growth in the foreseeable future. The stock will also join the S&P 500 for its first day of trading on Thursday, November 19th. We write one story a day to uncover new opportunities and break news. Come on in: Get Our (Free) News Alerts Once a Day.

#$ilmn

Gilead Just Stunned the World and Did the Impossible, Again

##Symbol##GILD ##Date##04 Nov 2015

Fundamentals

Written by Ophir Gottlieb, 11-04-2015 Follow @OphirGottlieb !function(d,s,id){var js,fjs=d.getElementsByTagName(s)[0],p=/^http:/.test(d.location)?'http':'https';if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src=p+'://platform.twitter.com/widgets.js';fjs.parentNode.insertBefore(js,fjs);}}(document, 'script', 'twitter-wjs'); Update 11-12-2015 Gilead said on Thursday, November 12th that the U.S. Food and Drug Administration approved the expanded use of its blockbuster hepatitis C drug, Harvoni. The drug can now be used to treat patients with subtypes of chronic hepatitis C virus (HCV) and in patients who are co-infected with Human Immunodeficiency Virus (HIV), Gilead said in a statement (Source: Reuters). Update 11-8-2015 Gilead Sciences, Inc.’s GILD announced that the first tenofoviralafenamide (TAF)-based HIV drug, Genvoya, has been approved by the FDA (Source: ZACKS). I once called Gilead the greatest company in the world, but the impending risk of ending patents and competition from new drugs dulled that praise over the years. Friends, that praise may yet again be due. Gilead is simply unbelievable. First, we interrupt this discussion with ridiculous chart number one. Here's a chart of revenue per employee in $millions on the y-axis for all bio/pharmas over $15 billion in market cap.

Gilead generates $3.5 million per employee and no other bio/pharma even generates $1.5 million per employee. I mean, are you joking? OK, back to the analysis at hand. Do you enjoy using visualizations to understand what's really going on in a company? We do too. Get Our (Free) News Alerts Once a Day. Defending the Greatest Win Ever: Hepatitis C The bullish argument surrounding Gilead begins with the HCV franchise (Harvoni and Sovaldi). The hepatitis C drug combination is the single largest new drug success in the history of medicine and the combination drugs account for 90% of the Hep. C market. The Sovaldi / Harvoni mix requires patients take a pill for just 12-weeks and the result is a 90% chance that their Hepatitis C is cured. Hello? Gilead owns 90% of the market for Hep C and its "forever big" in that roughly 3 million Americans suffer from hepatitis C, with 150,000 new cases diagnosed annually. The global total is between 130 million and 150 million, according to the WHO (Source: Forbes). Do you enjoy understanding what's really going on in a company beyond the headline noise? Then Join Us: Get Our (Free) News Alerts Once a Day. The Bad Growth is slowing due to price push back from insurance companies for the very flagship hepatitis C drugs Harvoni and Sovaldi we just discussed. Further, The Motley Fool reported that AbbVie's competing combination drug, Viekira Pak, is starting to capture larger market share. To quote the article, "Put simply, we may have already seen the high-water mark for Gilead's hep C franchise." Scared yet?... Don't be. The Win Hepatitis C is divided into six distinct genotypes and up until now Gilead had a treatment for four of the six types. But, on September 21, 2015 Gilead reported positive results from a Phase II trial on a combination treatment consisting of Sovaldi and an experimental drug. The opportunity is an "all-in-one treatment for all six genotypes of hep C." (Source: Forbes). Gilead says it will file for US approval in the coming weeks. This regimen that spans all genotypes is also a part of Gilead's strategy to capture market share in developing countries that don't have the technology for genotype testing. Further, Market Realist revealed that in Europe "Harvoni has now been approved for patients that are co-infected with HCV and HIV, advanced liver diseases, post liver-transplant recipients, as well as patients who failed to respond to previous sofosbuvir therapies." It appears that Gilead has not only defended its $10 billion Hep. C franchise, it may have just expanded it. We interrupt this discussion with ridiculous chart number two. Here's a chart of the amount of revenue generated per $1 of expense on the y-axis for all bio/pharmas over $15 billion in market cap.

Yeah. Gilead generates $3.06 of revenue for every $1 in operating expense. No other bio/pharma even generates $2. For context, Apple generates $1.40 in revenue per $1 of operating expense. Google generates $1.34 and Facebook generates $1.47. OK, back to the analysis, again. Do you thrive on seeing data that goes way beyond headlines and turns you into an expert? Try CML Pro. No credit Card. No Payment Info. Just the Power. Defending the Largest HIV Franchise Ever Gilead owns 87% of the HIV market which accounts for nearly $10 billion in sales and it has dominated this market for nearly a decade. The Bad But, Gilead's HIV drugs have their critical patents expiring in the period 2018 to 2022. When patents expire, those same drugs become available under generic labels. The entire franchise is at risk. The Win In late October, Gilead reported positive test results for its new Genvoya HIV drug. Check this out. Genvoya is as effective as Stribild (current drug) but has milder side effects. According to Forbes, an FDA decision is imminent. Check this out:

A recent trial demonstrated that Genvoya suppressed HIV as well as Stribild, but unlike the other drug, it did not reduce a patient's bone mineral density as much. Genvoya also did not have the renal toxicity associated with Stribild. Source: MedScape

Update 11-8-2015 Gilead Sciences, Inc.’s GILD announced that the first tenofoviralafenamide (TAF)-based HIV drug, Genvoya, has been approved by the FDA (Source: ZACKS). We write one story a day to uncover new opportunities and break news. Come on in: Get Our (Free) News Alerts Once a Day. On September 25th, European Union regulators already recommended approval of Genvoya and a part of that approval surrounded the fact that the once a day treatment is gentler on a patient's bones and kidneys than an earlier version of the drug (Source: MedScape). Nausea is the most common adverse effect for Genvoya. Quite a change. It appears that Gilead has taken another $10 billion franchise that was in fact expiring, and has now bettered it and added a new patent cycle on top (that's about twenty years). Do you thrive on understanding what's really going on in a company beyond headlines? Get Our (Free) News Alerts Once a Day. More As if two massive franchises aren't enough, Gilead has entered the oncology market with its first drug, Zydelig, along with a number of its Phase III trials inside the cancer treatment realm. This is a firm with a history of unmatched innovation. Gilead also has 12 products in Phase II trials and 7 products in the Phase III trials, both numbers are the second largest of any biotech in the United States. Two of the Phase III treatments are pending FDA approval. Further, Gilead has an unmatched pile of cash to make acquisitions, if necessary. The media simply isn't equipped to understand the stock market beyond headlines. Try CML Pro. No credit Card. No Payment Info. Just the Power. Conclusion Gilead did the impossible twice with its two mega franchises for Hep. C and HIV. It appears it has topped itself by defending those franchises, not through acquisition, but through science and innovation. I suppose we need to ask again: Is Gilead the best company in the world? Do you thrive on understanding what's really going on in a company beyond headlines? Get Our (Free) News Alerts Once a Day.

#$gild

Valeant Collapse: It's Much Worse than We've Been Told

Valeant Pharmaceuticals

##Symbol##VRX ##Date##02 Nov 2015 Written by Ophir Gottlieb, 11-02-2015 Follow @OphirGottlieb !function(d,s,id){var js,fjs=d.getElementsByTagName(s)[0],p=/^http:/.test(d.location)?'http':'https';if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src=p+'://platform.twitter.com/widgets.js';fjs.parentNode.insertBefore(js,fjs);}}(document, 'script', 'twitter-wjs'); Valeant Pharma is collapsing on fraud allegations. That's what we've been told. But the stock's implosion goes ever further than that -- to facts that are not only undisputed, but openly admitted to by the company's CEO himself. I promise, you will leave this article with more knowledge than you came here with, including realities that nearly all of Wall St. has ignored. Here's one: Valeant's entire mode of operation (acquire drug companies, slashing jobs, costs, and R&D and then raising drug prices) is over. Period. The company can no longer acquire any more companies nor can it raise prices. Quick Recap First, the accusations are actually pretty simple and they read like this in plain English: Accusation: Valeant has literally booked revenue that didn't exist by creating a secret network of specialty pharmacies that it owned, then went ahead and sent drugs to them and counted those transfers as sales. Yes, an outright fraud. That's it. Now, let's get to the issues before, during and after this crisis that are breathtaking. Before the Accusations I. Fact: Valeant is Not a Drug Company CEO Michael Pearson reportedly believed that drug companies were terribly inefficient spending money on research and development that often went no where (Source: Fortune). Instead, Valeant become focused on distribution, letting other firms do the R&D and then implemented a strategy of rapid acquisitions. After companies were acquired, staff was laid off and R&D was dismissed and prices on all drugs were raised. The end result was a company with an enormous amount of debt, but a stock price that was rising. Here's the problem, debt is now an issue, and it could take Valeant down. A thorough discussion of debt is included below, below. But to give you taste, it looks like this (debt through time):

What can Valeant do if it can't borrow anymore? Do you thrive on understanding what's really going on in a company beyond headlines? Get Our (Free) News Alerts Once a Day. II. Fact: Congress Was Already Investigating Valeant August 14th: Even before this saga began, Valeant became the subject of vitriol due its immense price increases on two drugs to the tune of 525% and 212% that came overnight. Senator Bernie Sanders and Congressman Elijah Cummings requested information on the two price hikes but the company refused to furnish the documents saying the requested information was "highly proprietary and confidential" (Source: WSJ). September 28th: A month and a half later, 18 Democrats on the House Committee on Oversight and Government Reform called for a subpoena of the company. The stock dropped ~15% in a day. It takes more than click bait and a 140 characters to be an expert. Get free news alerts (once a day) from us and you will be the expert in the room. You will be powerful. Get Our (Free) News Alerts. III. Fact: Price Gauging Was Massive On October 5th, a Deutsche Bank analyst revealed that it wasn't just two two drugs but rather 54 other medicines in 2015 alone and by an average of 66%. Aside from the accusations, Wall St. analysts started noting that a revenue growth strategy based on price hikes of this magnitude was not sustainable. Again, this is all before the fraud accusations. IV. Fact: Board Members of Largest Valeant Shareholders Resign The $7.5 billion Sequoia fund had a nearly 30% weight in Valeant as of the end of June. The Wall Street Journal reports that Vinod Ahooja and Sharon Osberg stepped down from Sequoia Fund's independent board of directors and that the two "had raised concerns in recent months about whether Sequoia should have such a large position in the embattled pharmaceutical company" (Source: Barron's). Biotech and technology data runs deeper than headlines and deeper than the data non-professionals have access to. That advantage is no longer acceptable to us. Get Our Free News Alerts Once a Day. V. Fact: Debt Has Exploded There's another issue, an inarguable issue, and issue openly admitted to and signed off by the CEO of Valeant. Here it is: Valeant has nearly $31 billion in debt and just $1.4 billion in cash. The company's total market cap as of this writing is just $34 billion. The company has a additional "revolving credit facility" (think of it like a credit card) of $1.5 billion. Here's where it all falls apart: Whatever happens to these fraud allegations, Valeant will not be raising prices again in the near future. The company has $2 billion in debt due in 2016, and other $2 due in 2017 and $4 billion due in 2018. Yes, that's $8 billion just in debt payments and bond redemptions (Source: Fortune). If you're wondering whether this debt situation is normal for Valeant, the answer is unambiguously, no. Here's how the debt has exploded through time.

The main stream media doesn't have the vocabulary to understand breaking biotechnology. Get free news alerts (once a day) from us and you will be the expert in the room. Get Our (Free) News Alerts. Debt is up 90% year-over-year. S&P downgraded Valeant on October 30th down to B+ from BB-. Here's what S&P said along with the downgrade:

"Given the multitude of legal, regulatory, and reputational issues that Valeant faces, we are revising our assessment of management and governance to 'weak' from 'fair,' Source: MarketWatch.

VI. Allegation: WHOA! The accusation of specialty pharmacies that were owned by Valeant making fake orders to book false sales when drugs moved from one room to another room is the allegation. Here's how it is accused of going down: R&O pharmacy is accusing Valeant of fraud and on a grand (grand) scale. The quick and dirty is that a sole proprietor, 64 year-old Russell Reitz, sold his pharmacy for $350,000 and even before the sale was completed, other pharmacies began using an R&O identification number to bill for prescriptions that R&O hadn't filled, sometimes for drugs the store didn't stock, turning in revenue of $230 million according to the court documents (Source: Bloomberg). Before the sale was actually done, Reitz asked why Valeant had signed an insurance-company audit for the pharmacy that Reitz still controlled. The next day, Reitz received surprise visitors from a firm called Philidor RX Services.

Reitz's effort to learn who was selling drugs in his name -- peeling back, along the way, layers of corporate structures -- emerges in e-mails, letters and other documents filed in state court in Los Angeles, as well as in a lawsuit R&O filed against Valeant in federal court there early this month. Source: Bloomberg.

And thus the fraud allegations took off. The media simply isn't equipped to understand the stock market beyond headlines. Try CML Pro. No credit Card. No Payment Info. Just the Power. VII. Fact: Philidor Failed California's Sniff Test Philidor is a mail-order pharmacy with licenses in 46 states But one state, California, said no, and here's why: "The board, on its website, said Philidor had made misleading statements about its ownership, failing to include information on four out of five partners." For context, fewer than 1% of such applications are denied, according California's board executive officer, Virginia Herold. VIII. Fact: Valeant Cuts Ties with Philidor Valeant has cut ties with Philidor a week ago but the announcement only came hours only after the nation's two largest pharmacy benefit providers, CVS Health and Express Scripts, said that they had ended all interactions with the company, citing its business practices (Source: NBC). Conclusion Now you decide. Is this company a fraud? Given the debt and price hike situation which disrupts its entire mode of operation, does it matter any more? Or, is this the greatest buying opportunity in a biotech in years? Do you thrive on understanding what's really going on in a company beyond headlines? Get Our (Free) News Alerts Once a Day. Note: The author owns a small put spread in Valeant which earns a profit if shares decrease.

#$vrx

The Secret is Out: This is the Marvel Powering Biotech

Fundamentals

##Symbol##MDVN ##Date##31 Oct 2015 Written by Ophir Gottlieb, 10-31-2015 Follow @OphirGottlieb !function(d,s,id){var js,fjs=d.getElementsByTagName(s)[0],p=/^http:/.test(d.location)?'http':'https';if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src=p+'://platform.twitter.com/widgets.js';fjs.parentNode.insertBefore(js,fjs);}}(document, 'script', 'twitter-wjs'); Six years ago Medivation (MDVN) was on the fringes of established medicine but now it is the foundation powering mega biotech drug discovery. Wall Street is trying its best to stay quiet about the firm, but with 96% of the stock owned by institutions, the secret is out. Medivation is a truly unique opportunity with a simple strategy: generate revenue and speed up the process of getting new drugs to market while mitigating the enormous risk associated with drug discovery.

Medivation has taken a remarkably compelling and differentiated strategic approach to the biotech and drug discovery business.

The company searches the rare and serious disease spaces, with a focus on cancer, for drugs that are ready for development for human testing in 12-18 months (Source: InvestorPlace). In English:

"In essence, MDVN is a biotech head-hunting firm, but instead of looking for biotech research talent, Medivation is looking for the most talented drugs it can find to get into human trials." Source: InvestorPlace

Biotech and technology data runs deeper than headlines and deeper than the data non-professionals have access to. That advantage is no longer acceptable to us. Get Our Free News Alerts Once a Day. What's Going On While the stock is down 30% in the last six-months, it's up nearly 1,300% over the last five years (yes, 13-fold). But, the market cap is still 'just' $6.8 billion, and this company may very well have legs to grow substantially larger. Earnings are due out Thursday 11-5-2015 after the market closes. Let's take a look at a fascinating chart of trailing-twelve-month revenue in the bars and price to sales in the orange line for MDVN, below:

Do you enjoy using visualizations like the one above to understand what's really going on in a company? We do too. Get Our (Free) News Alerts Once a Day. That's what revenue looks like for a stock up 1,300% in five-years, and that's what the valuation measure looks like when a stock has come down so quickly off of its highs. The critical product for MDVN is cancer drug Xtandi. After approval by the FDA in 2012 as a treatment for previously treated patients with metastatic castration-resistant prostate cancer, Xtandi achieved a potentially more lucrative label expansion last year when it was given the green light by the FDA as a first-line indication prior to chemotherapy (Source: The Motley Fool). David Hung, M.D., president and CEO said:

"XTANDI's performance, in both the U.S. and outside the U.S., demonstrates continued traction toward becoming a foundation of therapy for the treatment of metastatic castration-resistant prostate cancer." Source: StreetInsider

The drug is already a smash success and the extended usage could mean more than a double in sales, making it legitimately a billion dollar drug (actually, more like $1.5 billion). The growth prospects for MDVN due to this extended labelling are remarkable and should ease some fears of a company relying on a single product to drive everything. Louis Navellier writes it better than I can, so I'll just quote him and cite that same InvestorPlace link, above. The main stream media doesn't have the vocabulary to understand breaking technology and biotechnology. Get free news alerts (once a day) from us and you will be the expert in the room. Get Our (Free) News Alerts. Here is MDVN's straightforward three-part strategy:

1. Build a portfolio of four to six product candidates that have the potential to be in clinical development within 12 to 18 months after acquisition. 2. Develop those product candidates as rapidly and efficiently as possible; and 3. Consider partnering or selling successful programs to large pharmaceutical, biotechnology or medical device companies for late-stage clinical studies and commercialization. Source: InvestorPlace.

Biotech data runs deeper than headlines and deeper than the data non-professionals have access to. That advantage is no longer acceptable to us. Try CML Pro. No credit Card. No Payment Info. Just the Power. Diversification of Revenue On August 25th of 2015, MDVN purchased PARP inhibitor (a group of pharmacological inhibitors developed for multiple indications; the most important is the treatment of cancer) 'Talazoparib' from BioMarin (BMRN) for $410 million with additional milestone payments of up to $160 million. Talazoparib selectively targets tumor cells with certain gene mutations. It is being explored across a variety of solid tumors, and is furthest along in development as a treatment for patients with breast cancer. Quoting Medivation's CEO, David Hung, again:

"Acquiring all worldwide rights to Talazoparib provides Medivation with a transformational opportunity to diversify and expand our proprietary portfolio and global oncology franchise. PARP inhibitors are an exciting class of oncology therapeutics that have been associated with promising activity across multiple tumor types, including breast and prostate cancer." Source: OncLive.

The drug is in the midst of several FDA trials, all of which are piggy backing on positive initial results. And just to be totally clear, this drug is aimed at treating breast, prostate and lung cancer. The main stream media doesn't have the vocabulary to understand breaking technology. Get free news alerts (once a day) from us and you will be the expert in the room. Get Our (Free) News Alerts. Conclusion Medivation can (and has) brought products to market and is also trying to become the single most trusted place for mega cap biotech companies to go to for potential drug candidates, especially in the oncology (cancer) realm. MDVN sells the drugs, or partners with the larger firms. It reduces its risk of the costly FDA approval process and continues to grow a pipeline at speed that is virtually unmatched (and unmatchable). If it succeeds in this venture, the firm's growth potential is staggering. Try CML Pro for free and become the expert in the room. You will be powerful because you will have knowledge that to this point Wall Street has held for itself. That advantage is no longer acceptable to us. Try CML Pro. No credit Card. No Payment Info. Just the Power.

Amgen Eyes One Goal: Cure. Cancer. Now.

##Symbol##AMGN ##Date##26 Oct 2015

Fundamentals

Written by Ophir Gottlieb, 10-26-2015 Follow @OphirGottlieb !function(d,s,id){var js,fjs=d.getElementsByTagName(s)[0],p=/^http:/.test(d.location)?'http':'https';if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src=p+'://platform.twitter.com/widgets.js';fjs.parentNode.insertBefore(js,fjs);}}(document, 'script', 'twitter-wjs'); Update 10-28-2015 Amgen Inc said on Tuesday that the U.S. Food and Drug Administration approved its cancer immunotherapy, Imlygic, for use in patients with the most deadly type of skin cancer (Source: Reuters). If there's one megacap biotech aiming to be the end-all cure-all for cancer, it's Amgen. And it's getting frighteningly close and several fronts. Amgen has the largest pipeline in late stage trials of all biotechs and while the stock price was actually down from 2005 through 2011, since then it has nearly tripled and if we look at the company as of today, there's no reason it can't keep rising. Let's learn about this remarkable company which has earnings due out 10-28-2015 after the close and an FDA decision on a cancer treatment due out 10-27-2015 with Europe right behind it. Overview First, let's start with revenue over the last 15-years and then we'll get to the transformational treatments it has for cancer.

Amgen is now generating over $20.7 billion in annual sales. But there's more coming... It takes more than click bait and a 140 characters to be an expert and journalists aren't trained to understand breaking technology. Get free news alerts (once a day) from us and you will be the expert in the room. You will be powerful. Get Our (Free) News Alerts. If we plot all of the large cap biotechs with the number of Phase II trials on the x-axis and the number of Phase III trials on the y-axis, we can see that AMGN does in fact have themost Phase III trials. Here's that chart.

The main stream media doesn't have the vocabulary to understand breaking technology and biotechnology. Get free news alerts (once a day) from us and you will be the expert in the room. Get Our (Free) News Alerts. Let's Cure Cancer, Why Don't We? Before we get into exiting products, let's cure cancer, why don't we? Amgen is at the forefront of oncology with its first-of-a-kind cancer therapy, talimogene laherparepvec (T-Vec). The final decision will be handed down by the FDA on October 27, with a likely European approval coming in the next few months (Source: 24/7 Wall St.) The way an FDA approval works is after all of the trials and data, an independent committee will meet with the company and that committee will make a recommendation to the FDA. It is often the case that the recommendation is accepted, but it's not a sure thing. In this case, the United States panel voted 22 to 1 in favor of approving T-Vec in April of 2015. here's how T-Vec is described:

"The company's T-Vec is a so-called oncolytic immunotherapy, using a genetically modified strain of the herpes virus to invade tumors and replicate itself, killing cancer cells along the way and spurring an immune response to double its effect." Source: 24/7 Wall St.

There was some troubling data from T-Vec in a Phase 3 trial where it fell short of its secondary (not primary) endpoint of overall survival. Take from that what you will. The primary endpoint was durable response rate, and that showed statistically significant improvement. Update: 10-28-2015: This drug was approved by the FDA:

"Imlygic, which is the first-of-its-kind to win approval in the United States, is an engineered version of a herpes virus that kills cancer cells when injected directly into tumors, destroying them from the inside, while also priming the immune system to attack the disease." Source: Reuters

New to This Site? Get News Notifications; Be The Expert in the Room. The REALLY Big Cancer Pipeline Amgen has a ten year collaboration with Kite Pharma, and friends, this is where we all get really excited. Here we go: Kite Pharma (KITE) is approaching cancer not to treat it, but to cure it in a radical, revolutionary, promising and in the very sense of the word, transformational way. In an incredibly bold step, Kite management, though a year away from completing clinical trials, has just signalled its unambiguous belief that it has in fact found a cure for non-Hodgkin's lymphoma (NHL), a cancer which affects half a million people right now and more than 70,000 new cases every year. Keep in mind, the clinical trials will conclude at the end of 2016, meaning even the most optimistic projections are for a yet to be FDA approved treatment to generate revenue in early 2017. But, if you're wondering how bullish management is regarding the current clinical trials check this out:

"Although it could be a year or longer before the FDA approves its treatment for non-Hodgkin's lymphoma, the clinical results are so promising that Kite has forged ahead with constructing a 44,000-square-foot facility that would become its cancer-fighting nerve center." Source: Los Angeles Times

Yes, there is no other way to say this: The company is basically saying out loud that it believes it has cured non-Hodgkin's lymphoma (NHL). Period. Biotech data runs deeper than headlines and deeper than the data non-professionals have access to. That advantage is no longer acceptable to us. Try CML Pro. No credit Card. No Payment Info. Just the Power. Amgen has provided $60 million to KITE upfront for covering early-stage development costs and could contribute up to $525 million if milestones are met. While Amgen has a huge pipeline of drugs, this is one of the most exciting parts of its future and reminds us that Amgen is committed to curing cancer. The main stream media simply doesn't have the vocabulary to understand breaking technology. It just doesn't. Get free news alerts (once a day) from us and you will be the expert in the room. More Cancer Pipeline As if we needed more, Amgen and Merck have a collaboration in place to combine their drugs to cure carcinoma of the head and neck. And yes, again, both treatments are immunotherapies, which use the body's immune system to destroy tumors. There is a Phase I trial in place to test Amgen's talimogene laherparepvec with Merck’s Keytruda. There is also a Phase III trial set to evaluate the drug combination in melanoma patients (Source: WSJ). More Pipeline Believe or not, cancer treatments aren't necessarily the biggest part of the pipeline. Kyprolis is Amgen's multiple myeloma drug. While sales rose 53% to just under $120 million last quarter, we must note that the drug is actually only being sold on its third line indication. In English, the FDA requires strict labelling of the drug for usage. The Motley Fool did a wonderful job summarizing the addressable market of the drug as the FDA expands its label for second-line status.

"There are some 5,900 potential patients in the third-line and 1,200 in the fourth-line for Kyprolis to reach each year. As a second-line therapy Kyprolis has an opportunity to reach [an additional] 16,400 patients. It's a big opportunity for Kyprolis to expand and reach its full potential of perhaps $3 billion in annual sales." Source: The Motely Fool

Yes, this $199 million drug has the potential to be a mega-billion hit. The one thing to note is that JNJ also has a myeloma drug which seems to be presenting significant competition to Amgen and of course, Celgene's Revlimid. When earnings come out for Amgen, pay attention to details on Kyprolis for its second line indication -- this is a game changer if it goes well. In any case, the market has room for more multiple drugs and the upside is enormous. Try CML Pro for free and become the expert in the room. You will be powerful because you will have knowledge that to this point Wall Street has held for itself. That advantage is no longer acceptable to us. Try CML Pro. No credit Card. No Payment Info. Just the Power. What's Going on Right Now Alright, the pipeline is the fun stuff, but the guts are still the actual sales results, and they are very impressive. As of right now, the company's revenue is driven by several products: Chemotherapy infection fighter Neulasta®/ NEUPOGEN®, Rheumatoid arthritis drug ENBREL, Anemia drug EPOGEN, Osteoporosis drugs XGEVA®/ Prolia®, another anemia drug Aranesp and a long list of others. Here's a breakdown of sales for existing products from the company's quarterly report.

In its latest earnings release Amgen reported $5.37 billion in revenue and raised its guidance for the full year from $20.3B - $20.9B to $21.1B - $21.4B. The company also crushed EPS estimates by $0.15 ($2.57 actual vs. $2.42 expected), which, for those of you that follow Amgen know is basically the standard at this point. It's number one drug, Neulasta® saw revenue drop ever so slightly but still brought in a robust $1.4 billion for the quarter. Number two drug ENBREL grew 8% year-over-year, much of which was due to price increases. The company reiterated its guidance that ENBREL will drive $5 billion in annual sales this year. Biotech and technology data runs deeper than headlines and deeper than the data non-professionals have access to. That advantage is no longer acceptable to us. Get Our News Alerts. Exciting Current Product Growth Amgen's newest products Prolia and Xgeva saw strong growth and then some really (really) good news. Prolia revenue rose 29% year-over-year and Xgeva grew revenue 11% year-over-year. But here's where it gets interesting. Prolia is an Osteoporosis drug and the first approved therapy that specifically targets RANK Ligand, an essential regulator of bone-removing cells (osteoclasts) and is often used for patients who have failed or are intolerant to other available osteoporosis therapy. More Good News on Prolia On October 11th AMGN announced the findings from a Phase 4 study. The study found that Prolia caused higher gains in bone material density than the intravenous bisphosphonate zoledronic acid in postmenopausal women with osteoporosis (Source: CNA Finance). What does any of that mean? Try this: Paul Miller, M.D. the medical director of the Colorado Center for Bone Research, Lakewood, Colorado and lead investigator said:

"Despite the availability of newer therapies like denosumab, bisphosphonates are commonly used first-line to treat osteoporosis [] our findings showed that denosumab (Prolia) provides significantly greater bone mineral density increases than zoledronic acid." Source: PR Newswire

Yeah, he's saying, "hey, doctors, use Amgen's treatment, it's better."

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Conclusion Amgen has a huge product line, well diversified and for the most part growing. It has a huge pipeline of drugs including truly ground breaking cancer treatmentsand so many others. The firm is essentially a biotech mutual fund and has stunning growth possibilities ahead. Wall Street simply doesn't have the knowledge or interest to share breaking technology. It just doesn't. Get free news alerts (once a day) from us and you will be the expert in the room.

#$amgn

This Biotech Just Signaled it Has Cured Cancer

##Symbol##KITE ##Date##18 Oct 2015

Kite Pharma

Written by Ophir Gottlieb, 10-18-2015 Kite Pharma (KITE) is approaching cancer not to treat it, but to cure it in a radical, revolutionary, promising and in the very sense of the word, transformational way. If successful, Kite Pharma and Juno Therapeutics would together be an end-all-cure-all for cancer. In an incredibly bold step, Kite management, though a year away from completing clinical trials, has just signaled its unambiguous belief that it has in fact found a cure for non-Hodgkin's lymphoma (NHL), a cancer which affects half a million people right now and more than 70,000 new cases every year.

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Stunning Projection by the Company Keep in mind, the clinical trials will conclude at the end of 2016, meaning even the most optimistic projections are for a yet to be FDA approved treatment to generate revenue in early 2017. But, if you're wondering how bullish management is regarding the current clinical trials check this out:

Yes, there is no other way to say this: The company is basically saying out loud that it believes it has cured non-Hodgkin's lymphoma (NHL). Period.

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What's Going On Kite is hyper focused on NHL and the 550,000 people in the United States (as of 2012) that are affected as well as the 72,000 new cases every year, according to the National Cancer Institute. Estimates read that 33% of patients die within five years of diagnosis and 45% die within ten-years of diagnosis (Source: University of Marlyand). Kite's treatment is in late stage FDA trials and involves attaching an antibody to a T-cell that enables it to recognize and attack cancer cells. The company is focused specifically on late stage patients (the most critical) and treatment would be the first T-cell modification approved for treatment of cancer (Source: Los Angeles Times). Kite is considered to be "in the lead" with respect to treating curing NHL.

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If that sounded a bit technical, let's break it down, because those words above are absolutely world changing. This approach is classified as 'Immunotherapy' and here's how it works:

"The Santa Monica company's treatment of non-Hodgkin's lymphoma reprograms a patient's T-cells — the kind that are supposed to fight disease — to seek and destroy only abnormal, cancerous lymph cells, not the healthy ones crucial for human life. But in order to do so, blood must be drawn from a patient, refrigerated and flown to Kite's headquarters, where the cells are modified, frozen and then flown back to doctors who re-inject them into patients." Source: Los Angeles Times

That's right, the firm creates personalized cells for each individual and then reinserts them into the patient so she can attack the cancer herself. That's fighting cancer person-by-person allowing their own bodies to fight and to win. New to This Site? Get News Notifications; Be The Expert in the Room. The Downside Before we get to the upside, let's turn to the difficulties thus far. There is evidence that some patients have had fairly substantial side effects:

"Last year, the company said that several patients experienced side effects that included fever, low blood pressure, neurological deficits and delirium after receiving the infusions." Source: Los Angeles Times

In a rather bold and, I must say, promising response, Arie Belldegrun, the Chairman, President and CEO of Kite, simply blamed the side effects on the extraordinary effectiveness of the treatment, which leads to an accumulation of dead cancer cells in the bloodstream (Source: Los Angeles Times). Further, Belldegrun said "It takes time — sometimes a week, sometimes two weeks, until the body gets it all out [] then the patient has no long-term side effects." Let's hope that's accurate. More downside comes from competition. In particular Juno Therapeutics is in exactly this same field and making incredible progress. While KITE is leading the charge in NHL, Juno has a pipeline deep with 10 candidates potentially in clinical trials using either CAR or TCR by early 2016 (Source: Benzinga). I authored this article on October 5th, 2015: Juno is Simply on the Brink of Changing the World

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The Upside It's just undeniable that the upside for cancer patients, immunotherapy and this company are all extraordinary. KITE has a $2.85 billion market cap with zero revenue and zero products approved for sale. That's not the stock market gone mad, that's the promise of a company that will address and hopefully cure a deadly cancer that affects 1/50 people in the country with nearly 75,000 new cases every year and over half a million cases requiring treatment right now. Even further, KITE is not flying this alone. It has a partnership with the National Cancer Institute and biotech giant Amgen. Dr. David Chang was Amgen's prior vice president of global development and he left Amgen to work as Kite's chief medical officer. Here's what he said, I warn you, it's almost so bullish it sounds impossible:

"The best way to describe where we are now is the early days of Amgen." Source: Los Angeles Times

For the record, Amgen's market cap is nearly $120 billion. Kite CEO Belldegrun has been extremely bullish on the clinical results thus far, although he has chosen to make those results public at the meeting of the American Society of Hematology in Florida in December, rather than as they come out.

More Upside Kite is not a one trick pony. Immunotherapy can address dozens of cancer types and in fact the LA Times article sited above reminds us that Kite announced positive results in early testing of a treatment for cancers caused by human papillomavirus, or HPV. The sexually transmitted virus causes cervical, neck and back cancer. Here's a snapshot from Kite's website of its pipeline.

Further, Kite has just under $400 million in cash and equivalents per the most recent balance sheet filed with the SEC and no long-term debt.

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Conclusion All told immunotherapy is hopefully (likely?) a pathway to curing cancer. The approach is transformational in that it is an individualized treatment, using cells from the patient, rather than a violently disruptive outside substance. Kite and Juno are in the lead, and all parties involved, from shareholders to the medical community and families to patients are hopeful of, if not expecting, an end to cancer as we know it. Get CMLviz News Notifications and You Will Be The Expert in the Room.

#$kite

The Stock Market May be Making an Enormous Mistake on this Biotech

##Symbol##SRPT ##Date##15 Oct 2015 Sarepta Therapeutics I originally posted an article on SRPT on July 9th, 2015. The quick and dirty is that the firm has a drug in the final phase of approval from the FDA and the stock was ripping, up from $11 to nearly $40. It has a competitor in the field, BMRN, also ready to get a drug approved. Here's where everything went sideways for SRPT, with the stock down 30% in a few weeks.

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Why SRPT Stock is Collapsing Two things have happened, neither of which are bearish. First, in an odd twist, the date expected for the FDA committee to meet was Nov. 23 and 24th and all parties believed that both BMRN and SRPT would both be reviewed on those days. It turns out BMRN will in fact meet with the FDA committee on Nov 23rd, but SRPT has been bumped to Jan. 22, 2016. That's not because the drug is less promising, it's simply because SRPT is just a little behind BMRN in its submission of data. Nothing has changed and tentative FDA schedules surprise people all of the time. In fact, by most accounts, SRPT's drug candidate is far superior to BMRN's. Second, SRPT offered 3.25 million shares in a public offering at $39 per share. Sarepta plans to use the net proceeds from the offering for product and commercial development and general corporate purposes. That's a good thing. But.. Here's the stock price chart since 10-5-2014 through today (10-15-2015).

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The Bizarre Over Reaction The market is punishing SRPT because its drug (if approved) will be two-months behind BMRN for release. Friends, this is a public company with a remarkable drug that will likely get approved and two-months means nothing to the stock price. This is not a one-time drug sale, it's a magnificent pipeline and treatment with decades of sales ahead of it. Even more bizarre, the PDUFA date, which is the date that the drug gets an actual approval or disapproval status, was always going to be two-months behind BMRN. This was a known entity for now more than three-months and was never disputed. Yes, this two-month gap has always been known. I quote myself from the prior article in September:

"BioMarin Pharmaceutical (BMRN) also has a drug under FDA review called drisapersen (from Prosensa in acquisition). Interestingly, Drisapersen's PDUFA date is Dec. 27, 2015 two months before SRPT gets its big day." Source: A Small Cap Biotech Ready to Explode

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Details about SRPT and its Drug Sarepta Therapeutics, Inc., is a biopharmaceutical company that focuses on the treatment of rare, infectious, and other diseases. The company has no products out to market and no revenue, but has a market cap of $1 billion SRPT has a drug candidate called eteplirsen that addresses Duchenne muscular dystrophy (DMD), a rare disease that affects the protective sheath surrounding muscle fibers. The FDA announced that it had in fact accepted Sarepta's new drug application filing for eteplirsen, granting it priority review status and setting its PDUFA decision date for Feb. 26, 2016. "Priority Review Status" is designated to drugs that offer benefit over existing therapies, or provide a treatment where no adequate therapy exists.

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SRPT has had its ups and down, seeing its stock price trade as low as $11 and as high as $37 in the last year, alone. It's management appears to have totally botched an advisory committee request and in a rather unusual moment, the FDA itself clarified its points on the development timeline. But after a very (very) long trial for its DMD drug, things look good. When I say "good," I mean, it has reached the final endpoint and the data looks promising. An FDA advisory committee will judge the drug and the FDA will take that into account and make a final decision. The addressable market for this drug has been estimated to be about $700 million in sales which isn't quite blockbuster status, but it's a non-trivial win if it goes through and the $1 billion market cap as of today would represent less than a 2:1 price to sales. SRPT would instantaneously become a takeover candidate for any number of mega cap biotechs. The stock drop of late apprears to be a bizarre over-reaction to essentially, no news at all. Disclosure: I am long SRPT shares.

Anthera Pharma Could Strike Gold

##Symbol##ANTH ##Date##11 Oct 2015

Anthera Pharmaceuticals

Anthera Pharmaceuticals (ANTH) is focused on developing and commercializing drugs for serious and life-threatening diseases including systemic lupus erythematosus and exocrine pancreatic insufficiency due to cystic fibrosis. The company has no revenue and no products to market but it it does have a pipeline of two late-stage candidates – Sollpura and Blisibimod (Source: ZACKS). This is a biotech to recognize right now, in its early stages. It has a market cap of under $250 million with drugs that very well could propel it to over a billion dollar valuation. Blisibimod (Lupos Treatment) Interestingly, Blisibimod was initially developed by Amgen and was subsequently acquired by Anthera Pharmaceuticals (Source: Anthera Press Release).

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As of yet the causes of Lupus are still unknown, but a growing body of evidence suggests that inhibiting B-cell activation can improve disease symptoms and that's what ANTH is after with Blisibimod . This drug is in the most advanced clinical program for ANTH, and if there's a "hold your breath and wait" candidate, this is it. Anthera expects the full data from its Blisibimod trial in Lupus to be available in the second half of 2016 (Source: The Motley Fool). There is a significant risk in any drug that is yet to receive FDA approval but at the same time, there is a substantial need for new lupus treatment options. Benzinga reported on Citi analyst Yigal Nochomovitz:

"The Phase 3 trial for Blisibimod for systemic lupus erythematosus is enrolling more severe patients who benefited in prior SLE trials. “This suggests 1) enhanced prospects for Ph3 success and 2) higher penetration of the target market vs. Benlysta" (Source: Benzinga).

Blisibimod is currently being tested in a Phase 3 study, CHABLIS-SC1, for Systemic Lupus Erythematosus, and a Phase 2 study, BRIGHT-SC, for IgA nephropathy.

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Sollpura On July 14th, 2014, ANTH acquired Sollpura (liprotamase), a novel investigational Pancreatic Enzyme Replacement Therapy ("PERT") from Eli Lilly (Source: Anthera Press Release). Here's how the company positions Sollupra:

Sollpura is potentially the first soluble, stable and non-porcine derived enzyme product intended for the treatment of patients with low digestive enzyme levels, or Exocrine Pancreatic Insufficiency (EPI), due to cystic fibrosis, and potentially other diseases. EPI is estimated to afflict more than 150,000 patients in the United States alone, with more than $600 million spent on enzyme replacement therapy annually. (Source: Anthera Press Release).

The PERT market is dominated by Creon, but the novel approach ANTH is taking with Sollpura has caught the eye of the investing world. Sollupura, in English, makes it significantly easier to digest the medication. Citibank reports that "the company should be able to witness significant adoption of Sollpura, given its differentiating features of 'pill burden reduction for adults' and 'powder formulation for paediatrics' (Source: Benzinga).

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Conclusion: Let's Talk Dollars In that same report published by Benzinga, Citibank estimated the size of the market for Sollupura to be between $240 million - $330 million depending on market share. Those revenue numbers are larger than ANTH's entire market cap. FDA approval targeted for 2018 and adoption are huge risks, but let us also not forget that the big gun here is not Sollpura, but rather Blisibimod, which is being tested for two different treatments.

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Other Facts On September 14th, 2015, Anthera was notified that its Blisibimod partner in Japan had terminated its agreement because "Progress of blisibimod in Japan, particularly for IgA nephropathy, has been disappointing. (Source: GlobeNewswire. Note, the disappointment was not based on results for Lupus but rather the Phase II trial for the alternative treatment. Anthera reacted rather positively to the news, stating that the firm was "excited" to regain worldwide control of Blisibimod development. For now, ANTH is a micro-cap biotech with two very promising treatments in various stages of FDA trials. Blisibimods Lupus results coming out from Phase III trials should be delivered sporadically until the end-all be-all results next year. Sollpura will be a multi-year undertaking, but it too shows great promise. While Anthera is hardly the type of a company one would consider a "core equity holding," it is a promising pharma, with real drugs in the pipeline each making significant progress and showing quite promising data. While the company is funding operations by selling stock and there is a risk that all fails, for now, a $240 million market cap pharma shows at least the promise of a multi-billion dollar firm in the future.

Celgene is Simply the Best Biotech in the World

##Symbol##CELG ##Date##08 Oct 2015

Fundamentals

Celgene may simply be the most compelling biotech company and stock in the world. It has the largest organic pipeline in all of biotechnology, a ten-year partnership with likely the most transformational small cap in the world, a current line-up of drugs that have generated all-time highs in revenue (TTM) every single quarter for ten straight years. For those that like to read children's books, borrowing from Roald Dahl, [Celgene is] "The Champion of the World." Pipeline Before we get into the details of what does exist, let's look at the incredible pipeline for Celgene relative to all of biotechnology in the United States. In the image below, we have plotted the number of Phase III trials on the y-axis and the number of Phase II trials on the x-axis for large cap biotechs.

That's right, Celgene has more products in Phase III and Phase II than any other biotech, period.

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Current Products In the last year, CELG has generated just over $8.4 billion in revenue. The company's revenue is driven by five key products: (1) Anemia and cancer treatment REVLIMID ($5B) (2) Breast, lung and pancreatic cancer treatment ABRAXANE ($850M) (3) Myeloma drug POMALYST/IMNOVID ($680M) (4) Bone marrow disorder myelodysplastic syndrome (MDS) drug VIDAZA ($612M) and (5) Plaque psoriasis treatment OTEZLA ($70M). Here's a chart of Celgene's revenue (TTM) over the last sixteen years.

That mountain of revenue is not only at an all-time high, it has increased consecutively to new all-time highs every quarter for the last ten years. Even given that fantastical streak, revenue is still up 20% year-over-year.

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Celgene and Juno Therapeutics Celgene and Juno (JUNO have entered into a ten-year collaboration that could generate a revenue base growth of 50%. Juno Therapeutics is a radical, promising and in the very sense of the word, transformational biotech. It has no revenue, but a market cap that tops $4 billion, and here's why: The firm is a clinical-stage company developing novel cellular immunotherapies. The company's stated goal is "to revolutionize medicine by re-engaging the body's immune system to treat cancer". And when the firm says "revolutionize," they aren't kidding. Check this out: Here's how this company works, in English, from The Motley Fool:

"Juno's CAR-T therapeutics require the removal of a cancer patient's immune cells, selection and activation of the cells, and gene transfer to train the cells to attack the patient's tumor. At that point, the cells are grown in an incubator until there are enough to put back into the patient." (Source: Fool.com).

That's right, the firm creates personalilzed cells and then reinserts them into the patient so she can attack the cancer herself. That's an attempt at curing cancer with no side effects. Here's what a recent FBR analyst wrote:

"Investors' discussions focused on the company's products in development for leukemia, lymphoma, and solid tumors but also on the science behind the treatments with questions centering on manufacturing and cell persistence. The company's pipeline is deep with 10 candidates potentially in clinical trials [] by early 2016." (Source: Benzinga).

Juno and Celgene could revolutionzie medicine, and this is yet another potential blockbuster win for Celgene.

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Acquisition of Receptos (RCPT) When Celgene purchased RCPT, the focal point was a drug called "ozanimod" that presents possible usage for multiple sclerosis and irritable bowel disorders. Upon acquisition of RCPT, Celgene made a bold case that the drug could ultimately yield $4-$6 billion in annual sales (remember, Celgene's total sales in the trailing-twelve-months is $8.4 billion). Yes, the initial forecasts from Celgene was a potential 50% growth in revenue from the acquisition. But, it gets more bullish if you believe Celgene's management. On the most recent earnings call Celgene reminded us that the $4-$6 billion projection does not include other future possible uses for ozanimod, such as Crohn's disease and lupus. With a positive ruling from the FDA, this drug could run as high as Celgene's current total revenue in several years. While we may (or may not) be in the throws of a biotech correction, CELG stock is up over the last 3-, 6- and 12-months. Celgene is "The Champion of the World," and we just explained why.

#$celg

Juno is on the Brink of Changing the World

##Symbol##JUNO ##Date##04 Oct 2015

Juno Therapeutics

Juno Therapeutics is a radical, promising and in the very sense of the word, transformational biotech. If successful, this company would be an end-all-cure-all for cancer tumors. We discuss later that the firm may have as many as ten candidates in clinical trials by early 2016. Yes, it's on the brink. The firm is a clinical-stage company developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. The company's stated goal is "to revolutionize medicine by re-engaging the body's immune system to treat cancer" (Source: Juno Therapeutics Website). We also note that Celgene and Juno have announced a ten-year collaboration. Juno was named to "MIT Technology Review's 50 Smartest Companies" for 2015 and for good reason. Here's how this company works, in English, from The Motley Fool:

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Juno's website goes on to read: "These cellular therapies have the potential to be effective regardless of the type of previous treatments patients have experienced and may avoid the long-term side effects associated with current treatments." Here's an image from Juno's website that illustrates this remarkable approach: That's right, the firm creates personalized cells and then reinserts them into the patient so she can attack the cancer herself.

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What to Know After meeting with Juno's CEO and CFO, FBR analyst Ed White stated "[investors may be] unaware of the advancements that Juno is making in lymphoma," given their focus on leukemia and solid tumors (Source: Benzinga). He further went on to say:

"The company's pipeline is deep with 10 candidates potentially in clinical trials using either CAR or TCR by early 2016." (Source: Benzinga).

#$juno

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