In case it wasn't clear, pharmaceutical development is inherently risky, and thus the old mantra of diversification is especially true in the biotech industry. From the perspective of a small biotech company, this means it must develop alliances with a range of big pharma companies with different corporate strategies. The pharmaceutical industry is currently rife with mergers and swaps, and you have to just hope that the company funding your development doesn't decide to stop focusing on your disease class, or acquires a competing asset from another big pharma company.
With these considerations in mind, Array is in remarkably good shape. Its clinical stage products are variously optioned by 11 different pharmaceutical companies, significantly reducing the chances the the constantly shifting strategies will leave them in the dust.
Having your cake and eating it too
So what happens when one of your partners decides not to exercise their option to license your drug? Well that depends on your contract with them. Typically these contracts cover a portion of the development costs as well as lump sum payments when certain clinical milestones are met. But the sad fact is that these drugs often don't get optioned, and you're left scrambling to either find a new partner or cut costs.
Array has certainly had its share of tragedy and shares have been steadily declining since a deal with Amgen fell apart last summer. And there is speculation that Novartis may pull out of its contract to license melanoma drug binimetinib, perhaps because the recent asset swap with GlaxoSmithKline will include the direct competitor trametinib. Trametinib shares the same indication and method of action as binimetinib, so there is little benefit to Novartis in marketing two drugs that are effectively the same. However, binimetinib could be a very valuable asset to a competing drug company, and Novartis has committed to funding binimetinib through phase III trials, so that removes a big potential cost issue for Array.
Not likely much but Ron certainly likes attending meetings which do nothing to help the share price. There was a decent Motley Fool article key point I will post here. Arry has several shots at goal but NONE are going to the fda in 2014, SOOO this is at best a 2015 story. From Motley:
Additionally this methodology has lead to 15 products in the pipeline staggered across the clinical development cycle. Its phase 1 and 2 trials are targeting against an array of different pathways implicated predominantly in cancer, but they also have drugs in trial for asthma, cardiomyopathy, and hepatitis C. Their cancer therapeutics target a wide range of diseases, and cancer drugs have been significant money makers across the industry, with 5 out of the top 15 drugs of 2013 treating cancer. Array's two phase 3 drugs selumetinib and binimetinib are both MEK inhibitors and target lung cancer and melanoma respectively, and with potential broader applications. The market for MEK inhibitors is large as these cancers are common, and there is only one approved MEK inhibitor on the market, GlaxoSmithKlein's trametinib for melanoma approved earlier this year. The market is expected to be competitive, however, as there are several other drugs under investigation by other companies.
The initial 6.60 ended up an initial loss, shares traded down to the 5's. If they held, they could if they wished, have sold at a profit now. So a discount? Maybe but only if NWBO can get above 7.50 and stay there if they want to exercise the warrants. These shares are in NWBO hands to be issued so a dilution if sold no benefit to longs. There was no promise to buy in the future, but a right to buy if nwbo gets above the strike price.
Low 100's??? C cannot get back to 50 and hold it. I can see 53-56 by q1 2015, maybe 60 by eoy 2015, but NOTHING at C justifies 100. Unless they do another reverse split, or buy back 1/2 the float.
Think parent of 10 year old asthmatic and the added benefits helping a child to take their meds., or an elderly person who is a tad forgetful. It does not only monitor frequency but efficacy which is a good thing. Child might be taking treatment on a regular basis but doing it in an improper manner, this device can help in many ways.
Array bio has a phase 3 ready asthma drug, would love to see an opko deal, or word on the intent to start a phase 1 on our owned drug. An arry deal could get a drug to market in about 2 years, starting from phase 1 could take 4-5 if all goes fast.
How you doing Ice, if memory serves only 1/3 of all the dialysis patients are taking a script, 1/3 are on over the counter and 1/3 are taking nothing. My estimate is based on those metrics not changing, and getting market share from the firmly entrenched companies supplying that 1/3. Not going to look, others can, but think the current script market is in the 4 billion range, but total potential is 12B if ALL dialysis patients get scripts. First
year ( 2016) 10% = about 400 million, plus pharma, 150M, 200M, 4k, other diagnostics 100m-200m, so low end is in the 650-800m, with 1 billion quite likely. The upside is obviously those on over the counter, and those not taking scripts, that is an untapped 8 billion dollar market. I have no crystal ball to say, YES, they will all take Rayaldee, but I do know Drs. are currently treating 1/3 so that is the ACTUAL REAL KNOWN MARKET. All else is speculation.
FDA usually needs phase three data, um, direct is in phase 1, so phase 3 is a FEW YEARS off before approval. Brain if it works out could be approved in about 18 months. The direct data though exciting can not be handed to the fda for approval and likely min 2, 3 or so years away from fda. This is why brain is what really matters, short term, direct is down the road.
Conservative is good. I would gladly underestimate market share at 10% and then get a windfall 40% proving my targets way too low, than figure 40% market share and only get 10%. In the conservative I get share price 28-32 by end of year 2016. Hope I miss by 80 points, I deliberately figure low, I keep the high revenues and price targets in a secrete folder, lol. Can Anyone say Rayaldee potential block buster, well 10% market share minimum.
4k insurance and backing by the National Health insurer in England. Word on US insurance. 4k will roll out slow but be like a snowball rolling down a mountain. 4k global launch beginning with South America, then Spain,
( 2014 ) then Russia and the CIS 2015.
Rolapitant NDA by August. TSRO initial royalty payment could get opko profitable, before tiered payments kick in in 2015.
Opko South America launch of Rolapitant 2015?
TOP line Rayaldee data by Sept, Vitam D test, psa test by late 2014.
Word on Hep B drug and NDA progress.
No home run slam dunks here, all solid singles that given time will generate a billion in sales when combined with the growing pharma sales, about 100m in 2013.
Be a Friend to Frost, you know.
Get ready to add if he does, not looking like he will though, he is usually out with his dribble in a matter of hours not days.
Like this to pull back to 6.00, but not looking good. So come on AF you can do it unless LP filled a suit that is.
Shocked there is NO AF hit piece, he must not be feeling well, or NWBO LP sent out a gag order.
No but have been an Opko investor for 3-4 years, I guess some on that board assume I have a connection cause I refer to Dr. Frost as my step dad, and George Soros as uncle. Two men worth following, I adopted them, they did not reciprocate, well waiting on the paper work.
Direct is a platform, ie., if it pans out it supersedes prostate or the ovarian treatments. Direct could be used for those cancers if a phase 3 direct works. Frost has roughly 3.2 Billion in cash and assets, the smart thing to do is get Frost to take a stake personally, and opk to take a 15-20 million dollar position in nwbo with South American marketing royalty rights. That works for NWBO and Opko with their South American footprint. Opko also has holdings in Israel, Spain, Russia so they could be a good partner to extend global reach.
Doubt it happens, but it could work for both companies. Opko has a new product launch this year, and a New drug launch next year, so they DO HAVE enough on the table as is.
Supposedly we hit full enrollment in 3-4 months, yet we are still struggling to open test sites? With the 8th site
in Germany opening some time in July. Are they opening it in July with the intent to close enrollment in Oct-Nov? No further word about increasing patient numbers beyond 312 yet, but it was mentioned twice in back to back investor conferences. Still no word on number of patients enrolled which NWBO should be able to get with out an issue.
If these hospitals in Germany are the same hospitals that will one day administer dcvax L as part of the hospital exemption that info was not given. I thought the next word about Germany would be a negotiated price, not about Trial Sites for a trial that is NEAR FULLY enrolled?
I am now leaning toward the idea that enrollment WILL NOT be complete this year, and forging forward with the TIME and EXPENSE expended to get these 8 GERMAN hospitals is of necessity. I am also convinced NWBO will later this year announce expanding enrollment numbers and give a new time line for completion.
None of these things is an issue by itself, but if what I think will unfold does indeed happen, Linda has been less than straight forward. She does need come out and state current enrollment numbers and IF SHE intends to expand and be straight forward AND specific!!! Not we are considering this, and and might expand might not expand, oh and we are still opening test sites???
I believe the technology will prove valid in time, have less than 5% of my portfolio in NWBO, and no plans to add or sell until Linda clarifies things one way or other. Sorry, I am an investor, NOT a cheerleader, and NWBO is being less than 100% straightforward.
Instead of giving a thumbs down explain why no shares to short is not an issue for you??? The ONLY help is to wrest shares from an even stronger share holder this time. Those still here, ain't selling. All that is left are the few shares in the hands of traders, which shrinks monthly. Not good thumb guy.
the first to cover wins. Shaping up like last Sept- Oct, keep buying uncle Soros, step pop Phil.
The last time this scenario unfolded opk went from 8.35 to 12.95 in two weeks on no news, just 5m shorts exiting.
It is not the size of the purchases that matter, 5k, 10k, 20k, but the fact they are removed from the float. After the Prolar deal shorts had a TON of ammo, near 50m shares entered the float so a TON of shares to short became available. They are all gone now, either already shorted, in non margin accounts, or Frost and other insiders absorbed them. Today for example, zero-100k shares available to short. If Frost buys 10K that is 10% of the available ammo. When in a few weeks his 5k-20K purchases add up to 100k, that is 100% of the ammo. Positions change from day to day but in the bigger picture the need to cover is about at hand.
It is a matter of time before the shares available hits zero and stays there for a few days. The smart shorts know the routine at that point, over crowded position, first to cover wins.