In the past, investor presentations featured pie-in-the-sky product release dates. The current one has DPP HIV-Syph US launch in 2015. Well, you might discount, especially given the FDA's change of direction on the Syph algo.
LS would certainly have battle the FDA for months or years about the change. Sperzel does the smart thing: change the product to comply with the new algo. He said something to the effect, "we've still got some work to do (on DPP HIV Syph)." This implies that they are well along the way toward developing the product. So, 2015 may not be the pie-in-the-sky.
Not sure when they submitted the CLIA waiver application, but the FDA clearly being very careful about it.
Couple of points: ALR makes no mention of the fact that this product doesn't yet have a waiver. Nothing on the website that I could find about it. Do ALR's customers even know that this is still moderately complex?
ALR probably had a Stat-Pak inventory of some weeks or months. It's likely that CEMI's direct sales were impacted and will be impacted in Q3.
CEMI has benefited from the fact that the Determine Combo waiver is slow in coming. Could use another few months. CEMI clearly must move at lightening speed to develop its own Ag/Ab product. I have no idea why they haven't, although I suspect technical and/or licensing issues are to blame. I'm sure we'll find out soon enough. Neither TRIB nor OSUR has made mention of work on Ag/Ab.
possibly engaged in insider trading based on early looks at PR's. I seem to recall that CEMI stock tanked before last year's secondary offering.
CEMI apparently wasn't the only victim. If this did indeed happen, I think CEMI should definitely sue.
Here's the exact quote:
"The cervix work was done at the request of federal wildlife authorities"
Federal wildlife...(me rolling on the floor with laughter). Hey, mo, don't you mean federal nightlife authorities (more rolling and more laughter).
Mo's recent most post has, and I quote, CEMI doing "cervix work." He dosen't know the difference between a cervid, which has hoofs and antlers, and a cervix, which, well, you and I both know what that is.
Mr. geology/geography has now added another classic to his repertoire.
So, while OSUR was busy with HCV and ALR was busy with Ag/Ab, CEMI was doing pioneering work with...Cervids and Elephants. Now, you could argue that CEMI is learning much about TB, perhaps enough to create a POC test for humans. If that's the argument, then perhaps I'm listening, since that would be a billion dollar test. However, I never heard LS say that. In fact, I only heard him say that a human TB test would be too difficult.
CEMI is going to live on NOL carry forwards for a couple more years. However, when it's time to pay real cash money, they're going to be at a severe disadvantage vis-a-vis the tax inverted TRIB. If the majority of CEMI's business is overseas at that point, I see no reason why CEMI wouldn't structure itself to compete with TRIB at that point.
Wrong. They spent valuable time working on DPP TB for elephants, which came out only last year. Now, I love elephants and it's a noble enterprise, but couldn't that have been done as a side project? The CDC changed it's recommended testing algo for HIV to start with an Ab/Ag product. LS was busy denigrating the effectiveness of such a product. The result is that CEMI doesn't have one. Now, if you tell me that CEMI hasn't been able to overcome technical hurdles, that's one thing. However, if they just ignored it or didn't put 100% effort into developing one, then LS is completely to blame.
Luckily, Sperzel is not so stupid or stubborn. He's refocusing R&D on the four key projects mentioned. DPP TB for squirrels is not on the list.
How is it that sailing is an expert on EXAS and I know next to nothing about it, and yet we're the same person? Is this the return of the Insane Clown Posse, or have the kids forgotten to take their meds again.
This is another situation where the company should just sell its assets and wind up operations. Time after time I watch these companies slowly run down cash to zero, at which point the shareholders get nothing. I have watched another company, PDII, go through $100 million, which was around $7 a share, with absolutely nothing to show for it. Astounding that the BOD doesn't just wind up operations.
The trend is, of course, contingent upon DPP HIV CLIA waiver. I think the odds are in favor.
I think what people initially missed last Q was that we apparently got a sustainable step up in revenues. I say sustainable because we were told that the good quarter wasn't a "lump". It's not at all clear why this has happened, but apparently it has, which qualifies this as a growth story once again. Growth stories get higher valuations.
The big questions, in my mind, are:
How big a seller is DPP HIV-Syphilis going to be internationally?
How fast can CEMI bring DPP HIV-Syphilis to market in the US?
How fast can CEMI develop an Ag/Ab product?
How much revenue can be generated via DPP licensing?
I get the feeling that, for Sperzel, this turnaround isn't particularly difficult.
I figure they'll have only between $15 and $18 million left by year-end 2015. They'll probably lose another $5 in 2016, which means they'll have maybe 75 cents a share by the time they supposedly turn profitable. With that in mind, how is it possible that the stock is trading at $3? That's at least $1.50 too much.
No, Alere hasn't yet gotten it's Determine Combo CLIA waiver. However, that seems a good bet in the next few months. Determine Combo has been on int'l markets for a few years now, and CEMI should have anticipated that ALR would bring it to the US. Yet, LS' response was to question the efficacy of this product (while attacking the FDA).
So, while CEMI was working on Elephant TB and other "niche" tests, ALR was changing the world. Now, Sperzel has got to refocus CEMI R&D. This should have been done a few years ago.
He's not running the company. We know who is. The fact is, by the end of 2015, this company will have only around $1 of cash per share left. Given the pace at which the company has run down its cash reserves in the past, I have little faith that the bleeding will stop before this company is completely bankrupt.
I had said earlier that the two conditions under which I might buy the stock would be $2.75 and Ms. Lurker gone. I must revise that. I wouldn't buy this stock at any price.
Sperzel's previous employer was Warburg Pincus. I don't know under what circumstances he left. He was slated to continue to work for them, but jumped ship for CEMI. Depending on what they think of Sperzel, it's entirely possible that they'd take a look at CEMI. If they're looking, no doubt other investment companies are as well.
No, LS and the CFO had both said on numerous occasions that Fio would buy $6 million total for 2014. Well, I seriously doubt that they bought $4.5 million in Q2, especially since we're told that it's sustainable. That implies that, either Fio is buying way more than expected (unlikely), or that there are hidden sales elsewhere. Clearly, Spurzel doesn't want to say exactly who might be buying DPP products, or how much, since this would provide information to competitors, most espeically SD Bioline.