Unless you have gone through the experience of dealing with stage 3 or 4 leg or foot wounds, you cannot fully appreciate what Grafix is able to accomplish. Prior to passing my dad developed a stage 4 wound on his ankle that started from his slippers rubbing his ankle the wrong way. He had peripheral vascular disease and very little blood circulation in his feet, which is required for healing. As a result of the wound he had to wear pressure stockings and had his would dressed daily. The state-of-the-art care at the time (2004) was, I believe, a silver alginate wound dressing manufactured by KCI (the other big player is Smith and Nephew). It had about a 15-20% effect on his wound, but it was still a gaping hole (you could see the tendons). For Grafix to come along and close 50-70% of open wounds, included ones that were pre-treated unsuccessfully, is mind-blowing. It costs a few thousand dollars form the would treatment, and several thousand more due to the chronic nature of care for wounds. We are talking about doctors, nurses, hospital visits, dressings, wheelchairs, crutches, and more. In severe cases, there is no choice but amputation, which is tens of thousands of dollars. So if the market for Grafix is a billion in direct revenue, it will save perhaps as much as two billion more in total costs associated with chronic wounds. What this means is that Grafix will enjoy powerful pricing flexibility and very high margins. Assuming Osiris gains rapid traction in the wound care business, the stock is an easy double from here.
Sentiment: Strong Buy
Generally, I think Cramer has good instincts and makes some very good calls. And I completely agree with him that with the red-hot biotech sector, many smaller biotechs have gotten ahead of themselves - mainly the ones with no approved drug (with the exception of PCYC, with a drug that is a game changer once approved). But for him to make a blanket statement that companies under $10 billion are too pricey, he succeeded in an instant to significantly dent his credibility in the biotech sector. First, NPSP is not a wanna-be biotech. They have an approved drug with a market of 3500-5000 patients in the US and another worldwide of about 6000. At 10,000 patients @$300,000 you have a $3 billion revenue stream. Knock that in half. Make it $1.5 billion. And then Natpara, once approved, will be at least another $1.5 billion (the CEO has said several times that the market for Natpara is bigger than Gattex). So let's do a traditional 3X peak sales discounted 40% and you get 9 bill X .6 = 5.4 billion fair market valuation. That's a fair market value of $53 TODAY. AEGR's fair value is somewhere between $93 and $110, and they also have an approved drug. Celldex is riding high on some very promising drugs. The larger picture is this: the boiotech sector is red-hot because there's a paradigm shift going on in medicine that has accelerated in the past 2-3 years. That is, the technology of drug development has evolved to the point where drugs are now far more precise in their mechanisms of action, from Sangamo's DNA-binding proteins that act as genetic on-off switches to Newlink's genetically modified cancer cells to train the immune system to attack tumor cells. And with that precision comes game-changing drugs.
I believe that this decade is the decade of biotech. We are in the golden age. Keep in mind, the idea that antibodies could fight disease was discovered in 1975, nearly 40 years ago. Monoclonal antibodies were perfected at Genentech in 1990, with Herceptin, 23 yrs ago..cont
...so we now have a host of new potential blockbuster drugs that are light years ahead of where scientists were 20-40 years ago, with proteins, small molecules, genetic signaling, chaperone drugs, and so much more. We are literally watching science come of age in slowing, or stopping disease. Sangamo may have found a functional cure for HIV. Pharmacyclics has a drug that has three FDA breakthrough designations (a level of review for drugs created by the FDA to recognize the game-changing qualities of many new drugs) that can effective cure 50-70% of all blood cancers.
So, is there a biotech bubble? Somewhat, but the market is recognizing the paradigm shift, and we are at the early stages of it. And the beauty of it is that the vast majority of game-changing drugs come from biotechs UNDER 10 billion market cap. The very ones that Cramer just said to sell. We have more to go.
Seventy-eight participants with early stage Alzheimer's disease took either 50mg or 250mg doses of the drug PBT2, or a placebo, over the course of 12 weeks in a randomised, double-blind clinical trial, led by a researcher from Imperial College London working with colleagues in Australia and Sweden. Both doses of PBT2 capsules were observed to be safe and well tolerated during the course of the study.
Participants undertook a number of tests to assess their cognitive function, prior to beginning treatment and at the end of the 12-week period. In two of these tests of executive function, which involves the ability to organise information, sequence events and plan, those on a 250mg dose of PBT2 showed a significant improvement over the placebo group.
The researchers also measured how the levels of amyloid-beta in spinal fluid changed during the course of the trial. They found that levels of amyloid-beta 42 in the cerebrospinal fluid of those on the 250mg dose of PBT2 were reduced by approximately 13 percent compared to placebo at the end of the 12-week period.
Amyloid-beta needs the metals zinc and copper in order to accumulate in the brain and these two metals become abnormally distributed in the brains of people with Alzheimer's disease. PBT2 works by interrupting the interaction between the metal ions and amyloid-beta, and returns levels of zinc and copper in the brain to normal levels.
In the cognitive tests, those on a 250mg dose of PBT2 were able to complete the task in a test known as Trail Making Part B an average of 42 seconds faster than they had at the beginning of the trial. The placebo group was an average of 6 seconds slower.
In the Category Fluency Test, which looks at a person's ability to come up with as many relevant words as possible in relation to a specified category, those in the 250mg group were able to produce an average of 2.4 more words than at the beginning of the trial. This compared with a decrease of 0.3 words in the placebo group.
I want to give full credit here to Jake King of Propthink, who published these points as part of his article on Zerenex on Seeking Alpha, on March 13th 2013:
Highlights from KERX's conference call and the company's arguments that Zerenex IP is strong.
•Keryx believes that Zerenex is strongly protected in the market through 2024 based on issued API (active pharmaceutical ingredient), surface area, and intrinsic dissolution patents.
•The company refuted that OTC ferric citrate is a threat to Zerenex sales based on the concentration of iron in its formulation. According to KERX, there are 210mg of ferric iron in the 1g Zerenex tablet and 280mg ferric iron in the 1.3g tablet. The OTC version is a 25mg capsule, thus necessitating 8-11 capsules to equal 1 Zerenex tablet (Note that up to 12 grams of Zerenex are needed per patient per day).
•Keryx referenced its pending formulation patent (to protect Zerenex through 2029), which according to the company has already had an office action. KERX believes this patent will be issued.
•The company noted that standard bio-equivalency and PK assays do not apply to phosphate binders (blood levels irrelevant as the drug works in the intestinal tract). The company cited vancomycin as a key example of the difficulty in gaining generic approval for a product with these kinds of challenges.
(continued on next post)
I suspect that NPSP's decline in the past couple days was due to AEGR. While they beat, they went from $6 up to $8 down. I don't think investors like the amount of the beat. They were expecting much more. NPSP, while a better company, is similar to AEGR with it's one drug on a launch trajectory. Both drugs are priced exactly the same. Both companies have approximately the same patient numbers so far. So they are good comps for each other.
Just as I wrote weeks ago when NPSP was in the low 20's, that the analysts were only beginning to comprehend the magnitude of NPSP's revenue potential, here they are now arriving with their $40-45 price targets. After this quarter NPSP should get offers for at least $60 a share. I now own $130,000 of this stock,
my largest position after I sold REGN. Still holding aegr for one last pop!
That dip you saw from $119 to $116 and back? that was a managed short exit - Almost a million shares traded hands in that dip - that was 80% of the shorts exiting - less than a million shares are short. This thing has legs now.
Wow. that story made me tear up. If you want to read an article about another family up close and personal, go to Google search and type in "A mother's quest to save her son burlington free press". The story should be the first one in the search results, on the Burlington Free Press website. Amazing (and heartbreaking) situation.
Sentiment: Strong Buy
neo, your post is either deliberately deceiving, or you are seriously misinformed. The drug is projected to produce, by many accounts, around $7-9 billion in sales. PCYC owns half of that. At 4.5 billion PCYC is worth at least 3X that number, or 13.5 billion. I'd say with its pipeline it is worth between 160-205 per share today. The breakeven point for JNJ to buy this company at 15 billion ($203 per share), versus split the revenues, on a 100% financed deal at 6%, is around 4-4.5 billion in Ibrutinib sales (at a 40% profit margin), which is as low as 50% of projected sales, plus they are getting a great pipeline. So I believe JNJ will acquire this company for around $15 billion in the next 6 months. But even at $12 billion (which in my view would be the absolute low end), you are looking at $160+ a share. I'll take a 37-71% 6 month gain any day!
Sentiment: Strong Buy
I think sales will come in at 45 mill (30 mill royalties, 15 mill Gattex), 200+ patients on therapy full the full quarter, 450 prescriptions written, guidance raised to 35-40 mill for 2013 Gattex.
joseph, you are seeing things, as in NOT. We haven't had back to back upgrades on this strong in a long time. One at $24, the other at $20, and we are sitting at $10. That's what's moving it, because both analysts are feeling positive about the additional indications for the drug.
I think we may see a $45-50 offer from T before EOY. They can't afford to wait on this. But I would not be at all surprised to see a second bidder emerge.
Sentiment: Strong Buy
do folks here think the likelihood is that SNTS will beat eps estimates for the quarter?
you will be out of the stock when they announce positive phase 2 results from the NDD CKD study. This will jump $4.