Please spare a few minutes to look at the key facts I've assembled in the Guide for Beginners post on the INSM board.
Relatively modest demand for shares at this point imo will almost certainly generate near-term share price appreciation there - particularly fitting when one considers what you've suffered recently here from being on the receiving end of manipulation.
INSM seems almost certain to be included in the Russell 3000 in June - resulting in the automatic accumulation by the index tracker funds of millions of shares before the end of June. The higher the share price at the end of May - the greater the stock's weighting within the index, and the greater the number of shares which must be acquired in June.
As a result of initiation of coverage this week by Lazard it seems likely that the price will rise to a level by May 31 whereby the agents for the tracker funds will need to find over five million shares in June - around 50% of the number held by retail shareholders.
With the expectation of strong Phase III results mid-year it seems very unlikely that either fund managers or insiders will sell shares at anything more than a modest discount to the anticipated price if the results are indeed strong.
Lazard's initial price target is $21 - based upon a 2020 annual sales projection I suspect would be more appropriate for 2015. The shorter time frame would warrant an initial price target of $64 rather than $21. But that target of $21 is still double the current share price.
How often have you been able to benefit from knowing in advance that millions of shares of a stock with a relatively small float will be purchased by a given date - at a price likely to be considerably higher than the current price?
If you think I'm being naive you'd be doing me a real favour in pointing out any flawed assumptions on my part.
Biggatorhear - thanks for checking it out :-)
It was good news that the European Patent Office granted them the rights to the treatment of a wide variety of pulmonary infections by aminoglycosides delivered via inhaled liposomes.
But it's interesting to note what the Company originally applied for -
"In a further embodiment, the present invention relates to the aforementioned method, wherein the aerosolized pharmaceutical formulation is administered at least once per week.
In a further embodiment, the present invention relates to the aforementioned method, wherein the antiinfective is selected from the group consisting of
antiviral agents, and
In a further embodiment, the antiinfective is an antibiotic selected from the group consisting of
beta lactamase inhibitors,
In a further embodiment, the antiinfective is an aminoglycoside.
In a further embodiment, the antiinfective is
The Company does have at least one manufacturing patent - United States Patent 7491409 - which may (I don't know if it covers the current process) prevent competition until 2020 from others using the current process to deliver any other type of antibiotic.
Now that the data from the animal studies has demonstrated beyond reasonable doubt that inhaled liposome therapy is safe for at least the short periods associated with a normal course of antibiotics, I would expect a number of out-licensing deals to be announced over the next few months.
Btw - there is already one out-licensing deal.
Eleison Pharma is developing Cisplatin delivered via inhaled liposomes for inhibiting the development of secondary cancer in the lung in people being treated for bone cancer.
The principle is the same - the liposomes prevent the highly-toxic Cisplatin from going straight through the lungs into the bloodstream. And one assumes they jumped the gun because the fear that lipids might accumulate in the lungs at a rate with which the clearance mechanisms are unable to cope would have been considered the lesser of two evils.
From memory Eleison initiated a two-year Phase II/III clinical trial last year.
No.. Come on. No pumper alert necessary. As a practice, I am long everything. Long does not mean I do not sell. But I am far, far from a day trader. In the end, with a well diverse and relatively conservative portfolio, you will win by staying LONG. That does not mean to be stupid. In the case of Apple, I do believe the longs will succeed. The market is volatile. Just look at the fundamentals of a corp, seek out decent dividends, "do not be a pig", and watch for a corp that is out of touch (example RIMM....I rode that wave long 3-4 times and did well. But I saw the end.) That is not the case with Apple. It's numbers support long-term growth.
Sentiment: Strong Buy
To be fair, I've now added enough information to the original post that it may take more than a few minutes to read it.
But anybody here who adopts a "You never know" attitude and reads it just on the off-chance should end up in a good position to decide if it warrants serious consideration.
Thanks for that.
If you're a shareholder in a stock with a market cap of around $40 billion, and you're concerned about the possible effect on your market cap of fellow shareholders moving funds into a stock with a market cap of around $40 million - make sure you're one of them :-)
I've added some info to the Guide for Beginners post (INSM board) offering some colour on the economic argument for using Arikace in the treatment of pneumonia.
Most pneumonia is caused by gram-positive pathogens - which although usually susceptible to amikacin (the antibiotic delivered by the Arikace liposomes) are routinely treated with beta-lactam antibiotics such as penicillin or amoxicillin.
Gram-negative pneumonia is less common, but more serious - and amikacin injection is already approved by the FDA for the treatment of serious infections caused by those pathogens.
And given that over a million people each year in the US alone are hospitalised with pneumonia .....
I suspect these price targets in the region of $20 are motivate by fear of losing credibility.
A price target of $200 at this juncture could make the analyst look like a genius if the data due mid-year is strong. Disappointing data would make him look like an idiot.
It seems these guys are for the moment picking safe targets, and then tailoring their projections to suit.
From the Wedbush upgrade -
"We estimate that ARIKACE represents at least a $300-million worldwide opportunity for the management of chronic Pa infections in patients with CF.
We note there is additional upside to our market estimates should ARIKACE pricing come in higher than our estimated $6000/cycle estimate. We believe that the potential for once-daily dosing, effective biofilm penetration and resultant efficacy could, in our opinion, make ARIKACE the market-leading inhaled antibiotic in the CF and NTM settings."
A "cycle" comprises four weeks of therapy followed by a break of four weeks. At an annual cost of about $36,000 per patient Wedbush is projecting that just over 8,000 patients will use the therapy - and notes a potential upside if the data due mid-year evidence clear superiority to the inhaled antibiotics in current use.
The global CF population is estimated at 70,000. The defective gene is carried by individuals of European descent. 70% of adults are thought to be chronically infected with Pseudomonas (Pa).
That Wedbush projection seems overly conservative, and doesn't reflect the potential use of Arikace in treating pulmonary NTM infection.
The Company intends to apply for a label based upon the totality of the data available at the end of the year, including data from both the CF and NTM studies. It's difficult to envisage a reason for Wedbush to have ignored NTM in calculating their price target of $18, unless they have good reason to believe Arikace will fail that particular clinical trial.
50,000 are estimated to suffer from pulmonary NTM infection each year in the US alone - and unlike CF, all races are susceptible to NTM infection. And unlike CF, there are currently no approved antibiotics for NTM.
A less enthusiastic opinion than mine - published via Motley Fool just after the two analysts I mentioned increased their price targets:
"The reality here is that INSM still doesn't have a drug approved by the Food and Drug Administration, it's burning cash, and it could be at least two more years before it gets Arikace in front of the European Medicines Agency for an approval decision. A U.S. decision will be yet another year or two beyond that. With a cash burn rate that I anticipate will be right around $50 million annually, it won't be long before INSM needs cash again and reaches to potentially dilutive offerings to accomplish this. I'd strongly suggest keeping your distance."
REALITY check guys - another THREE YEARS before FDA approval ... DILUTION ...
He strongly suggests you keep your distance. I believe the only recommendation below that is "Storm the HQ and burn it to the ground".
Perhaps it was concern for your financial well-being which prompted his omission of the near-term opportunity, and his reading of a delay of three years - and dilution - into the US New Drug Application planned for around the end of this year / beginning of next year.
Or perhaps a few of his friends were suddenly ..... caught Short?
An additional incentive?
Although INSM seems likely to deliver impressive share price appreciation over the next month or two, for me the medium / long-term opportunity is far more intriguing.
Lazard's initial price target appears to be based upon approval of Arikace (amikacin delivered via inhaled liposomes) in the control of pseudomonas infection in individuals with Cystic Fibrosis. I've yet to see a single analyst or Company director acknowledge the possibility that the FDA will use the data due this year from the CF study (and a second study) as a basis for the approval of Arikace also in the treatment of pneumonia caused by amikacin-susceptible bacteria.
Amikacin kills a wide range of bacteria which cause pneumonia. Pneumonia is a major area of antibiotic use. One assumes that the relatively-inefficient delivery of antibiotics to the lungs via the bloodstream has been a major factor in the development of pathogens with resistance to antibiotics.
The FDA, NIH and CDC are co-chairs of the Interagency Task Force on Antimicrobial Resistance. It was recently reported that there are only seven new drugs in development targeted at drug-resistant pathogens. I believe inhaled liposome delivery is privately regarded as crucial for protecting the efficacy of the antibiotics which still work.
From this March -
On the heels of the director of the U.S. Centers for Disease Control declaring emerging antibiotic resistance a "nightmare," the U.K.'s Chief Medical Officer released a report today in which she calls resistance a "catastrophic threat" which poses a national security risk as serious as terrorism. In an interview published overnight, she warns that unless resistance is curbed, "We will find ourselves in a health system not dissimilar to the early 19th century" in which organ transplants, cancer chemotherapy, joint replacements and even minor surgeries become life-threatening.
Fwiw, re my -
"I believe inhaled liposome delivery is privately regarded as crucial for protecting the efficacy of the antibiotics which still work."
- in retrospect I could have been a lot clearer there.
This is nothing more than a private theory of mine.
With so few new drugs currently in development, it's a key objective of organisations such as the federal Task Force on Antimicrobial Resistance and the Transatlantic Taskforce on Antimicrobial Resistance to prolong the useful lives of the antibiotics in current use. Reducing opportunities for pathogens to develop resistant strains through non-fatal exposure to antibiotics is part of the strategy. Delivery of antibiotics to pulmonary infections via inhaled liposomes would achieve an effective concentration in the lungs far more quickly than via injection.
Given that the NIAID - part of the NIH - actually suggested a study of Arikace as a therapy for infection by a second pathogen (NTM) and is currently running said study, it seems a reasonable assumption that those task forces have been monitoring the development of Arikace.
Btw - by all means report the posts of the 'resident racist'.
But consider the possibility that he's really just a sad loser, sitting at home giggling at the reaction he provokes.
The worst thing you can do to such individuals is to act as though they're invisible.