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Been hard to hang on here for the past 1-2 weeks, but well worth the wait for those that have done their DD!
Hope the general markets can co-operate as well, but it may not matter with revenues like that.
Well, it's complicated...lol.
When I get a chance, I'll try to lay out the various scenarios and share price possibilities that I see.
The recent biotech meltdown has changed things somewhat, but risk-reward is still very good.
2day2morrow:
Sorry. I may have misread your post. If you meant manufacturing of Rexista in-house, then that makes a lot of sense, and debt financing would be the right path.
But, I still think we need a large pharma marketing partner.
I agree that debt financing is very possible at this point and the most likely way to raise capital, if IPCI decides to go this route (mfg, marketing in-house). Especially if good Focalin numbers are reported for Q1.
However, I'm not sure I agree on Rexista. Getting a large, well-placed partner seems the right path here. Zogenix seemed to be doing well alone initially, but they're now hitting a wall, as there are many big pharma names that have more clout on Capital Hill than ZGNX. Might be best to have large pharma backing when trying to navigate this arena.
Additionally, there will be competitors in this space, so it will help to have an experienced marketer (large pharma) in this space.
After listening to Dr. Odidi on the recent interview and watching his actions, my view is that a buyout is highly unlikely.
- Dr. Odidi stated he wants to grow this into a large generic developer for maximum growth.
- The Odidi's own ~30% of the company shares. A hostile takeover would not succeed, so it would have to be an extremely generous offer (unlikely to happen).
- The Odidi's haven't sold a single share, and have put up their own money to support the company when raising capital was very difficult before the Focalin approval.
Brean Capital appears to be the investment banking arm of Brean, Murray, Carrot. Could be just about anything:
1) Brean wining/dining IPCI for future business.
2) Strategic advice RE: how to grow the company, i.e., should we license out all of our generic drugs and just become a "royalty" company OR should we raise capital to do our own manufacturing and marketing OR a combination of the above. IPCI at a crossroads, as ANDAs are starting to get approved.
3) A partnership proposal is on the table (Rexista?); IPCI seeking investment banking advice as to whether partnership is reasonable.
4) A buyout offer was proposed, and again IPCI seeking advice.
If I had to lay money, it would be 1 or 2, but we also know IPCI is seeking an appropriate partner for Rexista.
Looks like there was another meeting in March with Brean (from The Fly).
Brean already has a "buy" rating on IPCI from Sep 2012, so nothing new in terms of analyst coverage.
Probably nothing imminent, but might be worth watching.
From The Fly On the Wall:
"IPCI mgt to meet with Brean Capital. Meeting to be held in NY on April 9 (hosted by Brean Capital)."
Anyone have more information on this? IPCI reviewing strategic decisions?
Doog:
GREAT find! He spells out the bull argument almost as well as you do, lol!
Massacusetts just banned the sale of Zohydro, the recently-approved high-dose opioid painkiller.
I would expect more states will follow suit to take on the abuse of painkiller meds in this country.
IPCI is right in the middle of one of the hottest issues in medicine today: rampant abuse of prescription medicines. Doctors, politicians, FDA, Congress, and Insurance companies are all clamoring for abuse-restistant/tamper-proof medicines.
Can anyone say Rexista?
If IPCI has one of the better tamper-proof technologies, I would expect a lucrative partnership to move this along.
My understanding is PAR/IPCI would be able to begin marketing after the Teva 180-day exclusive expiration. However, I don't know if there is an appeal process for Teva to delay this. Teva is a ruthless competitor, so if there is any way for them to delay, appeal and/or litigate PAR/IPCI launch in the other doses, you can be sure that they will.
Sorry I can't be much more help there.
On the flip side, the good news is that if Teva is unable to manufacture any Focalin dose adequately, it would be one less competitor for IPCI/PAR in the 15- and 30-mg ER dosage.
"Reason for the Shortage
Teva cannot provide a reason for the shortage."
One possibility, offered by CFO (Shampeze), is manufacturing difficulties. He went on to state that Focalin is not an easy drug to formulate and manufacture, because some doses provide 2 "pulses" of the chemical entity: first "pulse" is immediately when taking the pill and second "pulse" kicks in later in the day about mid-afternoon.
This is why I rate IPCI as a premium developer of generic drugs. Some drugs are easy to develop/manufacture and ANY mom & pop generic company can produce them. Other drugs require patent-protected technologies that utilize 3-4 complex chemical mechanisms to activate the drug as spec'd out by the brand manufacturers...IPCI has this skill and know-how in-house.
Why do you think PAR, an established generic manufacturer, in-licensed Focalin from IPCI?? If PAR had the capability to produce Focalin on their own, there is no way they would have come to IPCI.
And lately we are hearing other multi-billion $ companies like Teva may be having problems manufacturing Focalin...hmmm....
3 Times our current market cap of $80M would be very cheap for a multi-billion generic manufacturer to acquire this technology.
Thought I was on the OXG* board when I posted. Sorry...
OXGN DD:
15M shares outstading, 20M Fully Diluted
$25M cash, $35M (?) if all warrants/options exercised.
MC (recent price $3.80/share) = $57M, $76M F.D.
Enterprise value = $32M, $51M F.D.
Recently announced trial results in Phase 2, avastin+Zybrestat vs avastin only. Statistically significant Progression Free Survival (PFS) (32% improvement vs control) in refractory ovarian cancer, 100+ pts. Will report Overall Survival (OS) at an upcoming conference. (Note: trial was not blinded)
ECYT recently received recommendation for approval in EU based on a phase 2 combo drug trial of ~150 pts that improved PFS by 25%, but did NOT show statistically significant improvement in OS.
OXGN could apply for avastin/Zybrestat approval in EU based on similar statistically significant PFS results, even if OS is not statistically significant. EU incidence of ovarian cancer much larger than US incidence. (Avastin already approved in EU for Ovarian CA, even though it does not show statistically significant OS)
ECYT currently has a market cap of $1B, OXGN a MC of $57M.
OXGN owns all rights to Zybrestat. Potential to sign significant partnership with Roche (Avastin) or other Pharma.
If OXGN able to achieve statistically significant OS on top of phase 2 PFS results just reported, potential for 3-5X+. Avastin is NOT approved in US for ovarian cancer, so combo of Avastin/Zybrestat would be very valuable to Roche to get approval of Avastin in Ovarian in US.
Downside appears limited because of statistically significant PFS results. Precipitous drop from $6+ on report of results is most likely due to exercise and quick sale of 3M+ warrants for 100% profit.
Downside: Might take a temporary hit if OS is not statistically significant. May need a Phase III in EU. Almost certainly need another trial for US approval.
Disclosure: long from $4.15. Do your own DD.
Wrong board...
Thankfully, we have dilution going for us, or we'd be down in this awful market.
Agree with what you write...company is frugal...waiting for right price on collaborations...waiting on FDA approvals...ATM gives them flexibility.
Tekla increasing stake is a very good sign.
Daytraders caught up in the penny moves won't reap the benefits when real news hits.
Intellipharmaceuticals trading on the Toronto Exchange (I.TO in yhoo finance). Very light volume (200 shs). Up .05 lol.
Clearly Canadian shareholders are patiently waiting for the real news: report of first Focalin sales, Relista update/partnership, 2nd ANDA approval, new ANDA submittals.
No significant insider sales reported in December (insiders have to report within 10 days of a buy or sell).
Odidi (CEO) sold 8000 on 11/28
Smith (director) bought 2325 @$4.19 on 12/2
Canadian transactions can be found on SEDI online system.
Info on SEDI:
http://www.investorsfriend.com/Insidertrading.htm
Good luck longs!
Mostly a fluff article.
I'm in at 6.30.
OB:
Would appear to be the latter. This stock has strange moves...
I bought in the high 5's, and sold low 6's a few weeks back. Wish I had held back the urge to trade it, obviously.
I'd be looking to get in near 6.50, but not sure that will happen.
I believe MITI is guiding for results in Aug? Might be one of a select few summer plays I'm interested in.
mcbio/BioTechHedge:
Thanks for your comments RE: ARRY.
Seems like a buy on any dips over the next few months.
Patrick:
What is your target on ASTM, and what time-frame?
Thanks
ARRY/McBio:
I recall you were following ARRY...you still own it? Any short- to mid-term events coming up?
Seems to be have held up in this range.
I have no position, but considering.
TIA
Great news, AMRN!
I was way overweight in this stock. Sold 1/2 and will hold half for at least a month to see if they can ink a deal.
Thanks to Ronpopeil, pcrutch, Sheff, JessieLivermore, HedgefundPlays, barefootrunner and others, for bringing this stock to my attention, strong DD, and the guts to hold thru the recent share price weakness.
Good luck to all.
Interesting angle. I did note the drug company, but didn't realize they lacked clout.
Seemed like a long time (6 mos. since approval?) for formulary uptake by large ins. companies. And strange that smaller ins. companies (not sure which ins. companies) would add to formulary first.
Pradaxa: difficulty with uptake because of ins. companies?
Small sample (1 doc) that it's very difficult in Mass. to prescribe, as it requires prior auth. from large insurance companies, such as Tufts, Blue Cross and Fallon. A few smaller ins. companies have it on their formulary.
This 1 doc has tried prior auth. route (as reco'd by drug reps) and been denied by each of the above 3 insurance companies, even though some of these pts require frequent INR checks for coumadin levels.
This doc will no longer make these prior auth. attempts for pts., as it's a pain-in-the-@ss to do these, until it is on insurance company formularies.
The new medicine? Ins. companies deny until there is an outcry (lifesaving medicine), or deny until generic is available, even though doctors determine there is a health/cost benefit?
No prob!
While it is true that VLDL (very-low-density lipoprotein) is worse than LDL, a high level of either is not good.
Further, a typical cholesterol test doesn't usually break out the VLDL and LDL. That is, a physician wouldn't even see the VLDL/LDL breakdown, and would only care if the LDL total is high or increasing.
If Anchor meets or exceeds SPA requirements and is approved, the marketing potential in dyslipidemia, based on a typical cholesterol test, will be huge.
If we exceed the SPA, there is still the issue of what the FDA is looking for in an outcomes study, but we don't have enough info on that yet.
Supporting read:
www.mayoclinic.com/health/vldl-cholesterol/AN01335
Done!
One more day of insider sell pressure?
AMRN says Anchor results will be released in Q2, which starts Friday.
Insiders (Orbimed, etc) filed with SEC (in Dec?) to sell shares within an undeclared window of time. IMO, that can't coincide with the potential release of results (Q2).
Is tomorrow the last day of potential insider sales? Just a (hopeful) guess...
DVAX moving.
HGSI:
$100 would be nice for us small ihub options holders! I'll take $35, though. :)
Does it seem unusual that the FDA had a press release on the approval, but HGSI/GSK haven't? I thought the FDA held off for a few days on press releases? Or is that just on CRLs?
So far, limitations on sales don't seem too severe, although HGSI/GSK will have to run a trial in African Americans.
GSK is up $1.42 in after-hours. I briefly forgot that I typed in GSK for a quote, saw the $40 SP, and nearly dropped my keyboard...until I remembered it was GSK I was looking at. Rats!
Agree with your assessment, except I think the temporary pop could be higher than $30.
That gray area (approval with restrictions) is so difficult to handicap. FDA's 3-month decision delay added to the probability of restrictions, IMO. Too difficult to determine what FDA is thinking on those restrictions.
My wager with options is relatively small. I wouldn't feel comfortable holding the stock through FDA decision, unless I could get it for under $20, but that's not going to happen in the next few weeks without a bear raid.
Also, trying to ride a runup to FDA decision and sell before the decision may be complicated by the 3-month delay. Will the FDA use all of that 3 months, or issue an early decision?
Given the current stock price, I'm comfortable holding a few options through FDA decision, but not the stock.
ITT