No work, no market, it is DD time …
[FONT="]Putting vague ideas picked up from here and there down in writing solidifies plans and strategies going forward.[/FONT]
[FONT="]1) [/FONT][FONT="]The weight management trio[/FONT]
[FONT="]OREX is out of the picture. The only regret is that I did not buy some puts after it more than tripled and crossed 5, riding the VVUS AdComm tail wind. Leaving it alone is the only right move to make.[/FONT]
[FONT="]That leaves VVUS and ARNA to ponder. VVUS has Qnexa AdComm in the bag and waiting for PDUFA decision for Qnexa on April 17 and Avanafil on April 29. Approval for both is widely expected. IMHO, the Qnexa approval will come down with a post-approval CVOT and a highly restrictive label/REMS. As such, the pressing question is valuation. Has the present pps baked in such a conditional approval? Differences in opinions are so wide-spread that one can drive a truck through. Two polar scenarios cross mind pertaining to Qnexa --- a) the pps soars upon approval as many bull-side analysts touted (JPM tops the list); b) approval is baked in and the post-approval pps levels off or retraces mildly heading into April 29 for the Avanafil ruling. Given no firm conviction on the direction, I will sit on the fence for the Qnexa PDUFA as I did for the AdComm. Should Scenario A materialize, VVUS becomes a putting target but I will wait after the Avanafil ruling. If Scenario B follows through, I will play May calls for the Avanafil PDUFA. I plan to switch sides and putting into Qnexa launch. VVUS is a long-term putting target anyway for 5 considerations: a) the pretty much certainty of a CVOT study will cost a monstrous amount of money; b) the REMS will delay launch and labelling limit target population and hence sales; c) while the market potential is still humongous, Qnexa can’t be taken on a long-term basis given the duration limit of source drugs; d) while the CEO is a great salesman, LeLand and top executives are an extremely greedy bunch, cleaning out of positions at every top with insider information, worse than Mitch Gold of DNDN; and e) ambulance chasers will surely run wild should a few CV events/birth defects occur, which is highly expected given the wide use.[/FONT]
[FONT="]Having done all research DD that can possibly be done, my serious long position in ARNA has been taken with a conviction. It is up to fate now. Continuous trading DD dictates that I adjust position at the margin. This week, I bought back 1/2 sold April 3P to release some locked in capital and added May calls. Expected two immediate catalysts: a) VVUS Qnexa PDUFA on April 17 --- ARNA should enjoy a good run upon an approval (a rising tide lifts all boats) and will surely get a short-lived hit if VVUS is handed down a disapproval but should recover quickly as we are down to a one-horse race. This is one potential chance for a bear raid and need to be guarded against; and b) AdComm on May 10 --- trading halted, briefing documents should be publicly released on the 7th or 8th, another potential chance for a bear raid. How things proceed post May 10 is entirely conditional on the AdComm result. Assuming a positive Adcomm result, whether or not the PDUFA on June 27 is tradable depends a lot on the then valuation. Should the FDA issues another CRL, miserable suffering is the only end result awaiting ARNA shareholders post June 27. But that may not be the end of the ARNA world. EMA’s MAA ruling can be expected before the year end --- speculation alone in the fall will likely pull ARNA out of the post-CRL wreckage.[/FONT]
[FONT="]Being badly burnt twice by ARNA (2009 Blossom data release and 2010 AdComm), my conviction in the science has not wavered and hence the bet on the table now. As far as trading goes, I plan to lighten up the load pre-AdComm rather than hedging with puts that increase cost basis. Hope there will be a good selling opportunity in the near future sparked by the Qnexa approval and AdComm speculation.[/FONT]
2) The advanced colorectal cancer duo
Bad news hit the wire for KERX and AEZS Monday --- the X-pect trial failed to meet the primary end point mainly due to placebo patients living significantly longer than expected with earlier trial results/literature. When it rains, it pours down. WS was not satisfied with a single-day 67% loss caused by the failed trial, both stocks suffered multiple downgrades Tuesday, and AEZS was down another 10% intra-day. Was this killing for the exit panic overdone? Yes, way overdone, IMHO.
I have never owned KERX. With no intent to initiate a position there now, let me concentrate on AEZS. The duo are tied at the biblical cord by Perifosine --- KERX licensed its right to North America and foots all development/marketing costs. While the Phase 3 trial is ongoing for multiple myeloma, KERX CEO stated at the CC that given this failure, recruitment is expected to be more difficult than before. So, let me write off Perifosine for North America. Actually, let’s completely write it off although Phase 3 trials for advanced colorectal cancer are ongoing in Japan and South Korea by AEZS’s respective partner.
So, what is left with AEZS/AEZ.TO?
• Marketed Cetrotide. Its world-wide right was sold but manufacturing charges and royalties still produce a stream of revenues that supports pipeline developments.
• AEZS 130. A registration trial was successfully completed last year for human growth hormone difficiency test. An NDA for this indication is expected to be filed shortly. Phase 2 trials for cancer cachexia are under way.
• AEZS 108. Multiple Phase 2 trials are under way for ovarian, bladder, endometrial, and prostate cancer.
• Pre-clinical trials for a good number of pipeline candidates.
Are all of these worth a laughable quarter per share? Crazy or what! Value? Show me any better deal out there, please!
Trading wise, I owned quite a few shares before Monday (since last fall) and my paper loss is naturally rather sizable. Seeing the bad news, I bought a block at 8:01am Monday (iTrade isn't opend for PM trading until 8am), which turned out to be a very bad buy as that was the PM peak (my propensity of buying at the high is very high, sigh), about 30% higher than what could be had during regular trading. I got another block filled during the regular session, planning to buy another block either Wed. or yesterday when the dust finally settles but failed at that plan as I was more than occupied. May still get that last block comes Monday.
At the average cost basis, I am still severely under water by yesterday’s close but expect this paper loss to disappear in the not so distant future. It goes without saying that an important trial failure results in a sharp fall in pps for any baby biotech. But the degree of this panic selling and loss surprised the hell out of me --- there is simply no way Perifosine accounted for 70% of AEZS valuation despite its importance. What is unduly lost will ultimately be gained back. As much as I would kill to see, a fast bounce back may not materialize but patience will surely be rewarded handsomely in this grossly undervalued stock.
3) The Phase 3 pivotal trial final data readout duo
• ONTY (formerly BIOM). On and off with BIOM since my DNDN time. Made a killing selling Feb. puts. Heading into the final days of the second interim peek, my expectation was consistently a “continue” as the bar for passing the interim is set unusually high for most companies don’t want to significantly reduce the chance of success at the final data readout by consuming a big alpha spend. But the appeal of hitting big got the better of me and my March 15C expired worthless. Expecting a fall to around 4 and a secondary offering, I pinpoint myself to an entry after the secondary is closed. All materialized and got 1/2 position at 20 cents above what the new institutional holders paid for. Retailers can’t enjoy institutional discount anyway but I am still targeting to go for the institutional discount ($4 shares or below) to fill the remaining 1/2 position by selling near-term puts.
With the new capital raise completed, what may come down the pipe then?
Stimuvax. Final data readout for lung cancer isn’t expected until year end or early next year. The water on that front may remain still until then. However, with the numerous trials being run by Merck Germany, violent waves may still be made in that pond.
PX-866. Phase 2 trial results are expected in the near future.
ONT-10. An improved version or second-generation of Stimuvax. Phase 1 trial was initiated a while back.
Comes fall, speculation on the lung cancer trial will more likely than not heat up and carry ONTY to much higher levels.
• CLSN. Have been in since early last year. Got hit pretty badly when the interim result was a “continue”. Rebought for a possible 2nd interim peek, which was shot down by the FDA and the pps hovers around 1.8 now. The flagship candidate is ThermoDox. This is a platform of drug delivery rather than a single agent. The key indication is for primary liver cancer and everything evolves around the Heat Trial, whose final data readout is expected by year end or early next year. Other trials (e.g., chest-wall breast cancer, colorectal liver cancer metastases) won’t be worth much if Heat fails. May be dead money until the fall but will 2X holding if it ever visits the low 1.6s.
4) The lonely junior uranium miner, DNN/DML.TO
Got in after the crash post the Japanese Earthquake, only to watch the pps dipping down further and further upon Germany's declaration of planning to cease the use of nuke power by 2020 and the summer/fall market correction. Thanks to a good run earlier in the year, an exit was made and a good-percentage profit was booked. The commodity spot price and miners, by implication, may have run a little ahead of themselves. So, the correction/consolidation has been going on for a good month now. There are words out there that Japan may put reactors back online and Gernany may reverse the last-year-declared plan soon. Further, China and India are planning on more reactor buildups. Occasional accidents aside, nuke power remains the most cost effective and environmentally friendly source of power. It has been here long ago and is staying. If anything, the demand for uranium will gradually increase and a shortage of supply can be expected in the year of 2014 if not in 2013. Can DNN/DML.TO go lower, sure, anything is possible on WS. But at 1.5, the downside risk is highly limited. I am planning for a re-entry within the next couple of days.
5) The comeback alert duo
• CBLI. Enjoyed an explosion early last year on BARDA funding speculation and then, ran wild on the Japanese Earthquake for a couple of days. It has been all downhill from there, with intermittent spikes on news. After a good run to 4 not long ago, it started tanking Wed. when BARDA rejected its white paper for development funding. The flagship candidate is CBLB 502, intended for acute radiation syndrome (ARS). It addition, it has potentials in reducing side effects of cancer chemotherapy (as an adjuvant) and anti-cancer functions. The company pursues CBLB 502 on both ARS countermeasure and oncology fronts. Thus far, BARDA and DOD funded most of the development. DOD has a procurement contract of $30M in place conditional on the FDA approval based on the animal model. Phase 1 trial for head and neck cancer has been initiated. There are other activities in Russia. The company is meeting with the FDA on the animal model and human safety pathway this month or May.
• CHTP. The pps tanked all the way to multi-year low of 2.18 from low 5s in a matter of a couple of days when the company released briefing documents in advance (very rarely done), recovered somewhat heading into the AdComm and the positive AdComm result made it an instant 70% gainer, only to watch it dipping away heading into the PDUFA. I swapped shares for out-of-money calls on the decision day to reduce exposure. Upon the CRL, the pps tanked but not to the extent at which I was comfortable with an entry. Then a 10% daily haircut persisted for quite a few days and reached a multi-year low of 2.01 intraday yesterday. The drug has been used in Japan for many years and has an orphan designation. The CRL doesn’t sound a hard outright rejection. If Trial 305 provides positive results, the drug may be approved within the year. The company is meeting with the FDA in May.
Whether or not these selloffs were overdone is hard to judge at the moment. Bottom-fishing attempts can run the risk of catching falling knifes. I will just keep an eye wide open and move when dust settles. May very well miss the bottom. Should that be the case. so be it. It is better with missing than being wrong.