Pharmacylics and partner Johnson & Johnson (JNJ_) are expected to seek FDA approval for their blood-cancer drug ibrutinib before the end of the third quarter. FDA has already annointed ibrutinib with multiple breakthrough therapy designations, so it makes sense for the agency to approve the drug quickly. Is an ibrutinib approval before year end a possibility? I think so, in fact, I'd say the Street expects an early approval.
Sentiment: Strong Buy
After reviewing the Company’s Form 10-K and preliminary proxy statement it is abundantly clear that the only viable path for the Company is a sale. A sale of the Company would provide the Company with access to capable management and enable the Company to enjoy economics of scale for its out of balance administrative costs.
The current management team has been completely incapable of operating the Company in a manner that created value for stockholders. In 2009, the year prior to Dr. Khatibzadeh becoming Chief Executive Officer the Company had revenues of over $56 million and a net loss of approximately $11.5 million. Last year, the Company had revenues of less than $18 million and a net loss of more than $18.2 million. Under Dr. Khatibzadeh’s leadership revenues have declined by 68% and the net loss increased by more than 58%. During Dr. Khatibzadeh’s short tenure the Company has undergone two major restructurings. The first was supposed to restore the Company to profitability. It didn’t and it is doubtful that the second restructuring will be any more successful than the first. In fact, at the end of 2012 the Company’s independent auditors expressed substantial doubt as to whether the Company could continue as a going concern.
Despite the atrocious performance of the Company over the last three years the Company has compensated its directors and officers at inappropriate levels. In 2012 the Company paid its five named executed officers more than $1.365 million of cash compensation, more than 11% of the Company’s gross revenues. In addition, the members of the Board received approximately $270,000 of cash compensation. All in all, the Company paid cash compensation to its named executive officers and directors of more than $1.637 million, or more than 14% of its gross revenues. The Company also granted stock awards that will significantly dilute stockholders.
If the Company were to be part of a larger organization there could be economies of scale for administrative costs. For example, at the end of 2009 the Company had 30 administrative employees. At the end of 2012 the Company, despite
Board of Directors
April 18, 2013
68% less revenues than in 2009, had 22 administrative employees. In fact, nearly 20% of its employees were classified as administrative.
Finally, I note that the 90% of the short-term incentive plan award for the five named executive officers is based on the Company’s revenues. I believe that these targets should be based on profit, rather than revenue. The Company’s stockholders do not benefit if revenues grow but the Company does not move towards profitability.
As the Company changes its business strategy yet again, I would hope that the Board would also explore a sale of the Company. If the Board insists on remaining independent substantial changes should be made to management and the Board.
mentioned Ibrutnib 5 times example of their breakthrough biotech, I think he even said might get approval in 2013 (not sure I got the date right)
Sentiment: Strong Buy
The same reason you do pristine financials,barriers to entry,leading engineers,management that takes 10 years to maybe get it's act together
Sure is moving in the right direction!!!!!
Guided Therapeutics, Inc. (GTHP) (GTHP) today announced that it shipped its first Edition 3 CE marked LuViva® Advanced Cervical Scan unit to its distributor in Turkey. The delivery is the first of 15 to 20 units expected to be shipped to distributors in the second quarter.
“This shipment represents a significant achievement for the company and, along with the recent units delivered to our Canadian partners, marks the beginning of commercial CE Marked sales of LuViva,” said Mark L. Faupel, Ph.D., CEO and president of Guided Therapeutics, Inc. “We plan to follow up this shipment with additional sales to Europe and Africa later this quarter.”
The LuViva Advanced Cervical Scan is now compliant with both Edition 2 and Edition 3 CE standards, has marketing approval from Health Canada and the Singapore Health Sciences Authority, and is under U.S. Food and Drug Administration Premarket review.
DLP Cinema® Technology Empowers Exhibitors With The Tools To Harness Digital Cinema's Instant Opportunities And Future Innovations
Can Mgmt turn this into revenue & profit for us the owners???
Harmonic Wows NAB Crowds with HEVC Compression Demo Showing Ultra HD to Be Realistic Upgrade to HD
The question is who knows more, the analysts who all have holds on the stock or this insider with a sterling reputation and the proven skills to grow the company. I would have to think with his knowledge of the industry and the opportunity he sees in Triquint's future should be a positive sign which could be considered as bullish as big time insider buying.
This has to be bullish, this impressive resume being attracted to become a big part of Triquint's future is a real confirmation of a reason to believe things are going to improve. I could only imagine the homework that he did before signing up.
CP: US$ 75.55
TP: US$ 90
CAP: US$ 5.5b
Third breakthrough designation for ibrutinib
C/JNJ received a breakthrough therapeutics designation for ibrutinib as a monotherapy for the treatment of CLL/SLL
patients with the 17p chromosome deletion, a high risk subset that responds well to ibrutinib. PCYC/JNJ is conducting a
patient study in
CLL patients with the 17p deletion (RESONATE). The designation provides a potential faster to market
regulatory path. This is the third indication to receive this designation; the other two were Waldenstrom's macroglobulinemia
(WM) and relapsed/refractory
mantle cell lymphoma (MCL).
Regulatory update expected at ASCO in June. We anticipate that PCYC will provide more specific guidance regarding
timing of regulatory filings and clinical trial implications of the breakthrough designation at ASCO.
ongoing: The ongoing SPARK trial is in patients that have failed Velcade. We expect this will support a broader
label including both Velcade failures and Velcade naïve patients based on the breakthrough designation.
Catalysts: WM data at 2013 ASCO, potent
ial 17p CLL data (RESONATE) and MCL data likely at 2013 ASH.
Valuation. Our $90 target assumes a launch in MCL in Q3:14, off
label use in CLL, and modest value for the Waldenstrom's
opportunity. Our valuation could go higher if the fNHL opportunity is bet
ter defined or if PCYC demonstrates efficacy in
myeloma. Longer treatment duration or substantial penetration of prevalence markets could drive higher estimates
Sentiment: Strong Buy
Sounds like very good news about another leading edge product. Any chance that management can turn this into revenue and profits????
True in this case mgmt owns almost 28% , very low float, take advantage by some now and more after we see what the actual R22 price is.
As I see it even though their is no change in the end date for production, the government seems to be encouraging venting by taking away in the short term anyway ,the only incentive that works MONEY. Not only does this go against pollution control ,but also because the price of R22 goes down short term will cause fewer A/C uses to modernize their equipment. Thus today as far as I know 85% of the equipment in the country now uses R22 and this new allocation will cause the demand to go down even slower. I do not understand what they are talking about in real terms of 2009 allocation and how it even matters if the Gov. is really concerned with the Ozone levels. Sounds to me like Gov is sending out very expensive conflicting signals and is not helping fight worldwide pollution or helping to plan an orderly transition.
I am looking for logical explanations ( if their is one) and expect to read many articles by A/C professionals as well as environmentalists.
I am confused !!!!!
We do not need to make a choice ,we need the best management in marketing . When you have the best products , pristine financials and cannot make a return for the owners for years,this is the definition of unacceptable. They have had more than enough time to learn on the job !!!