Aniustudent: Given that there are paid shills in the pharma space (See Richard Pearson articles on SeekingAlpha) and given your false statements here, you should make it clear who you are. Why are you anonymous?
You have made false statements here & elsewhere, hiding behind anonymity & dodging responsibility. Why are you anonymous? Show some courage, let everyone know who you are, be accountable.
You didn't mention the anti-pcsk9 drugs. Goldman said that AEGR faces "competition from anti-PCSK9 antibodies." Goldman also said that AEGR faces "hurdles" -- which may refer to the DOJ investigation in the USA and the anti-bribery investigation in Brazil, not to mention AEGR's recent setbacks in trying to enter international markets before the anti-PCSK9 drugs enter the field.
Sentiment: Strong Sell
EVEN IF AEGR gets the international picture sorted out, by that time PCSK9 inhibitors present their threat -- backed by big pharma.
"Wow - the Brazilian penalty is only up to 20%. Not bad at all on a drug that is 75%+ profit. Of course, that is a Matt fact."
These are not my facts. Search terms: Brazil +anti-corruption law. This NEW law was enacted January 2014. You will find articles and papers on both sides of the border outlining its scope and penalties.
"So is the German Regulator classifying Juxtapid as having "no additional benefit" when the full story is this was due to incomplete information on a needed comparison study (which is another great reason to fire CEO Marc Beer)."
The full story is that this botched attempt with the German regulators results in yet another delay in another country.
"Europe granted $AEGR approval - $ISIS was not."
What percentage of AEGR sales come from Europe? When does AEGR expect any sales? Almost all sales were coming from the USA then Brazil, and now both governments are investigating AEGR's practices. The problem seems systemic.
" Also, pharmaceuticals are an intense regulatory area. You stated "Japan had required additional study", but once you've had some pharmaceutical experience, you'll realize Japan always requires a mainland study due to its population genetic variance. "
Anti-PCSK9 drugs are showing promise and can enter the market around 2016. These international delays are not immaterial to the value of Aegerion as a company, given the limited time available before this serious threat appears.
"Your patient # speech has already been disproven."
Show me published "proof" that AEGR has not funded? And it is not my speech but facts presented by the scientists working on AEGR's drug and Nobel Prize winners working with the disease. I merely presented the facts that they use.
"Why would you use a trailing 12 month revenue? Why would look backwards in terms of sales?"
Why would you? I was speaking within the time frame that you introduced. You wrote,
"This company has a approved drug, current sales of $170 million, $116 million in cash"
Current sales are $74 million.
I am looking forward. AEGR has a market cap of $1 billion. How can current sales justify that price for the whole company when there are serious caps?
1. AntiPCSK9 drugs are progressing well and pose a threat to AEGR by 2016.
2. The scientists working on AEGR's drug have stated to the FDA and in academia that there are only 300 HoFH in the USA. AEGR has funded a study that confirmed a roughly similar prevalence rate in Germany. Nobel Prize winners also use the same number. If the scientists are correct with 300, then AEGR management's proactive attempt at 3,000 presents a risk of off-label marketing.
3. In fact, the DOJ is conducting an investigation into AEGR's sales and marketing practices.
4. AEGR's Brazil sales are not merely "delayed" … that doesn't reveal the whole picture … Brazil is holding up payments to AEGR during an anti-bribery investigation. If there is substance behind the Brazilian investigation, then I would expect a correction in marketing influence and a reduction in sales in the future. I would also expect a corresponding FCPA investigation in the USA.
AEGR has not made significant sales beyond the USA and Brazil and the PCSK9 inhibitors are progressing well and seem to be on schedule for 2016. What is the company, Aegerion, worth? Less
I am a private investor and only gain according to the success of my investments. I receive no other income/salary/financial compensation for my reports and views. Accuracy is positive. Illumination of existing facts is positive. Inaccuracy and obfuscation are negative. My articles and comments are positive. If you read the reports, you will realize that the facts I present were mostly provided by the scientists that work on AEGR's drug, AEGR's SEC filings, other scientists, rival companies, and comments by management. Get the facts from AEGR management and the scientists associated with it.
My name is matt berry. Jetmanbash is someone else. Since you are calling out for identities, why don't you identify yourself. Why are you anonymous?
If blockbuster rivals – the anti-PCSK9 drugs – arrive at end of 2015 and 2016, how can AEGR possibly close the gap between its $1 billion market cap and $75 million 12 mo trailing sales?
Brazilian regulator – ANVISA – rejected AEGR’s drug. The “named patient option” remains, but requires the patient to take legal action. Payments have been delayed due to the Brazilian Gov. investigation of AEGR via a new Anti-corruption law (enacted in Jan. 2014). The law involves bribery. If AEGR sales depended on such, then prior sales numbers will probably not return. The penalty in Brazil is up to 20% of revenue.)
Due to AEGR’s botched dossier, German Regulator -- G-BA – classified the drug as having “no additional benefit.”
Europe is making no significant contributions to revenue, and is not expected to make an impact in the near future.
Japan has required additional study.
The sales force behind rival drug, Kynamro, has been increased by Genzyme and will directly compete with Aegerion’s Juxtapid … at a much cheaper price.
Management’s version of the addressable market is at odds with the very scientists working on its drug by 1,000%. Risk of off-label promotion.
The scientists on AEGR’s drug claim that there are approx. 300 US HoFH patients in the USA; commercial management claims there can be 3,000. Even Nobel Prize winners use the number 300 when speaking of USA HoFH sufferers.
If the scientists are correct, and management incorrect, then AEGR’s proactive reach for more than 300 presents a serious risk of off-label marketing.
In fact, the Department of Justice is currently investigating Aegerion for its marketing and sales practices.
If sales depended on off-label promotion, then present scrutiny and a return to compliance could seriously reduce sales.
There has been no investor closure with the FDA Warning. If scrutiny is ongoing, sales efforts may be curtailed to insure compliance.
Sentiment: Strong Sell
Hartwick in SSTP Press Release
"'When I was approached to review the SSTP process and the utilization of the proprietary catalyst, I spent nearly five weeks reviewing the technical data before I agreed to accept the position as scientific and technical advisor. Only after I became convinced that the technology was based on sound scientific principles would I accept this position,' stated Dr. Thomas Hartwick." ~ Sustainable Power Corp. Appoints Dr. Thomas S. Hartwick as Scientific and Technical Advisor to the Company Dec 14, 2009
SSTP's John Rivera, in Federal Court
"The central fraud alleged involves claims by Rivera that USSE could produce viable commercial biofuel and fertilizer products." (Page 2.) (USSE = US Sustainable Energy Corp.)
"Rivera was also the principal shareholder of SSTP. According to the Commission, Rivera used SSTP for misconduct similar to that alleged in this case." (Page 3, Note 2)(SSTP = Sustainable Power Corp)
"The defendants also argue that two purported contracts filed with their response demonstrate that USSE (or, later, SSTP) was commercially viable." (Page 20)
~ Summary Judgment against John Rivera in July 2011, (Case 5:08-cv-00245-DCB-JMR) An exhibit in the case included the same Texas A&M study that Dr. Hartwick was tasked with. That report was submitted as an exhibit
We're talking about the original inventors of Clearsign's technology, not peripheral staff. Look up the Chief Science Officer David Goodson. Look up the lead inventor on Clearsign's first expressions of its technology: Thomas Hartwick.
Look up the numerous patents already in existence for this technology and you will see that any patents that CLIR scores will be very limited in scope.
Just go to Google patent search and look at the patent applications. Key inventors are David Goodson and Thomas Hartwick.
Also go to official web site of clearsign. David Goodson is listed as Chief Sci Officer. He is still claimed to have collaborated with nobel prize winners!
Buyer beware ... do a simple Google search on the Chief Science Officer and "original inventor" at Clearsign: David Goodson.
I only present the facts as found at the SEC, court system, US Patent office and others.
buyer beware. Do a simple Google search for the original inventors of Clearsign Combustion, esp. Chief Science Officer David Goodson and lead inventor on patents, Thomas Hartwick
Informed rational conclusions are positive ... not a downer. Uninformed rational decisions are the most dangerous decisions of all... and in all events, an inaccurate conclusion is not a positive, but a negative.
Buyer beware ... study Clearsign Combustion before you invest.
Phony patent claims
phony commercialization claims
... there is even a claim that he once collaborated with Nobel Prize winners .... before they became famous and while the two prize winners were living in separate countries.
He is also a key inventor on CLIR patents.
CLIR Chief Science Officer is David Goodson. Look him up.
Would like to know how everyone first heard of Clearsign? ... and How many are aware of the histories of the original inventors of Clearsign's technology?