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Dew - 1/5
Interesting 3/18 article on SeekingAlpha...and nice shout out to RTN
http://seekingalpha.com/article/194327-insmed-year-end-2009-update
"Insmed Year End, 2009 Update 1 comment
by: Jae Jun March 18, 2010
Insmed (INSM) released their fiscal 2009 results and the results are as I expected – not much different to Q3 results.
I first started following INSM back in November of 2009 because the company was trading below its net net value with the majority of its assets in cash. That was when the stock price was $0.78. The stock price is now $1.20, a 50% gain from November, but nothing has changed with the company since then, but there have been some major developments which I’ll get to later.
But onto the financials first. I went through the annual report filed on March 16th and it reads the same as the previous quarterly reports.
The major difference in financial data to the previous year is the cash from the sale of the FOB (follow-on-biologics) to Merck (MRK) for $130m. Due to this difference, comparing annual numbers isn’t important. It will only give you a false picture. Instead, you have to look at the company on a quarterly basis.
Balance Sheet Analysis
Above, I put the Q3 and Q4 balance sheet together to get a better view and the image below is the Q3 and Q2 comparison.
From my notes in the images above you can see how there are no red flags and INSM is doing a fine job of keeping things in check. To be frank, INSM has no operations and so expenses must continually be lowered.
Additional Quick Points from the Financials
The all important cash burn has also stopped. With no manufacturing facility, low headcount and so much cash, INSM is earning a healthy amount of interest to more than offset the expenses.
Throughout 2010 cash burn should be neutral.
But Why is INSM at $1.20 Now?
It started with the Merck CEO mentioning INSM during the JPM healthcare conference. You can view the previous post on this development if you missed it.
Feb 15 was the day INSM started seeing huge volume and there were no press releases or any major news to cause such a run up until I received some information that test results performed by ALS worldwide for IPLEX was leaked. Thanks to reader RTN for this info.
We are pleased to present the Interim Report of the Investigational New Drug trial on the use of Iplex (mecasermin rinfabate) by middle-to-late stage Amyotrophic Lateral Sclerosis patients. This trial was conducted under the direction of Principal Investigator Michael E. Schafer, MD and Medical Director of ALS WORLDWIDE, with our assistance. We are hopeful the results will be informative and will serve to facilitate the future use of Iplex for others within the ALS community. While this is a small study, it has provided relevant results for the period from April 2009 through November 2009. For more detailed information, please review the information at the following links.
Results:
During the 30-week period of Iplex usage that comprised the first half (26 week study period and follow-up four-week confirmation period) of the one year authorized investigational new drug trial, there was a remarkable parity between the apparent responsiveness of the individual patients compared to the aggregated group of patients at large. Symptoms monitored for their absence, presence, or their degree of severity included the following: Hyperreflexia; Tongue Movement; Swallow; Hand Strength; Shoulder Strength; Fatigue; Clonus; Nausea; Atrophy; Breathing; Lability; Lower Arm Strength; Fasciculations; Dizziness; Cramps/Pain; Weakness; Balance; Speech; Upper Arm Strength; Tremor/Palsy; Rigidity; Libido. In the consolidated 30 week period, individual symptoms showed a maximum decline of 9% (Balance) followed by 6% (Tremor/Palsy). The maximum improvement of an individual symptom was 39% (Fasciculations) followed by 28% (Fatigue). The critical function (Swallowing) improved by 25% and Breathing improved by 1%.
Links to the pdf reports can be found here.
After the Q4 results were announced, the stock price dropped 10% but this was good. Ever since the big increase in volume, many short term momentum players jumped on to make a buck but as the Q4 earnings announcement was flat (as expected) many of the same people sold out.
This was another good opportunity to buy when prices were falling, which is what I did.
Net Net Valuation
INSM is no longer a net net, but with the catalyst building up, it looks like the intrinsic value of $2 to 2.50 can be achieved.
Remember too that the company is still undergoing a strategic review where value could be unlocked even further. There are lots of possible “ifs” but far more on the positive side than the negative."
At the current price, looks like a 100% gain is still possible.
Disclosure: Long INSM
About the author: Jae Jun
Dear Dew - It just did your 1/10 of $500M since shares resumed trading
"Silenor won’t sell anywhere near the $500M forecast in the write-up you posted. I doubt it will sell even one-tenth of that amount."
I've been away from this game along time but i shouldn't be suprised that you still confuse your opinions w/ facts when you're asked "why" questions.
Look sport, re-read any of my posts regarding this and maybe you'll see the facts..I posted that article as general public info w/ no design on anything regarding my sentiment. You have since taken it upon yourself to form and post your assertions without any substance regarding why. So I'll invite you a second time to offer your reasons why
Agreed wrt their harshness regarding the sleep catagory but I thought FDA had pretty much handheld,spoonfed and lead SOMX all the way to this.
And DewDil called it a "crock" hmmmm
FDA Approves of Silenor for treatment of insomnia
DewDil What can you contibute to expand on your assertions? TIA
Somx details that it's a low dose formulation of doxepin in their submitals to the fda and throughout their lit on it. That's nothing new.
tx
Fm SeekingAlpha 3/17...Analyzing the Upcoming FDA Decision on Somaxon's Insomnia Drug
By March 21, 2010, the U.S. Food and Drug Administration (FDA) is expected to decide on the marketing approval of Somaxon Pharmaceuticals, Inc.'s (SOMX) drug Silenor, designed for the treatment of insomnia, which is the inability of an individual to fall asleep or remain asleep for an adequate period of time. The stock is currently trading at $4.05, with a market cap of $95.7 million.
Silenor represents one of the most promising new treatment options for insomnia. The existing approved insomnia treatments suffer from several limitations including abuse potential, limited efficacy and side effects like next-day residual effects (hangover), memory loss and addiction potential, thus driving a need for safer and more effective treatment options for the condition.
Driven by its encouraging safety and impressive efficacy profile coupled with a lack of abuse potential, Silenor could emerge as an important treatment option for insomnia. If cleared for marketing, drug is expected to generate peak revenues of approximately $500 million, or 522% of the company’s current market capitalization.
On January 31, 2008, SOMX shad ubmitted the New Drug Application (NDA) of Silenor to the U.S. FDA. The U.S. FDA had accepted the NDA of Silenor and had set a review date of December 1, 2008. But, on November 24, 2008, the U.S. FDA informed the company that it would require three more months to complete the review of Silenor, thus extending the approval timeline to February 28, 2009. Thereafter, on February 25, 2009, the U.S. FDA issued a Complete Response Letter (CRL) to Silenor, in which the agency asked SOMX to address the potential cardiovascular safety issues associated with the drug. In the CRL, the U.S. FDA also mentioned certain problems regarding the interpretation of the efficacy data of Silenor submitted by the company in the NDA filing. This drove SOMX to perform an additional analysis of Silenor’s clinical trial data and then resubmit its NDA to the U.S. FDA on June 4, 2009.
Consequently, the U.S. FDA was expected to take a decision regarding Silenor by December 4, 2009. Unfortunately, on December 7, 2009, the U.S. FDA issued ayet nother CRL to Silenor, which questioned the robustness of the submitted efficacy data of the drug. The CRL also required the submission of a revised risk management plan. Since no concerns regarding the safety of Silenor were raised, it prompted SOMX to submit its response and a revised risk management plan to the U.S. FDA on January 21, 2010.
Although this drug has been plagued by setbacks by the FDA, we believe that this time around SOMX has been able to successfully resolve all the concerns raised in the CRL. We based this on the fact that Silenor has achieved the primary endpoint in all the four of their Phase 3 clinical trials without demonstrating any serious safety problems. Its also important to note that the FDA had designated their last CRL as a Class I resubmission, which essentially implies minor application deficiencies, such as labeling issues, commitments to perform post-marketing studies, safety updates and other minor clarifying information.
Silenor belongs to the H1 antagonist class of drugs. The following is a brief explanation on how the drug works:
Both sleep and wakefulness are governed by a particular area of the brain called hypothalamus. During wakefulness, the nerve cells in specific regions of the hypothalamus (posterior hypothalamus) release a chemical called histamine, which helps the individuals to stay awake. During sleep, the histamine-releasing activity of the hypothalamus gets naturally reduced.
In healthy people, the release of histamine in the brain is balanced. However, in insomnia patients, this balance is lost and people have high levels of histamine in the brain. Excessive histamine promotes wakefulness and reduces sleep.
Histamine promotes wakefulness by binding with specific cell surface proteins in the brain called H1 receptors. The H1 antagonist class of drugs works by binding with and blocking the H1 receptors, preventing the binding of histamine with its receptors. This inhibits histamine’s activity and histamine cannot perform its wakefulness-promoting function, which in turn, promotes sleep.
Silenor offers two distinct advantages over the existing insomnia drugs in the market:
No Abuse Potential: Unlike most of the existing insomnia drugs including Ambien and Ambien CR from SNY and Lunesta from SEPR, which are classified as Schedule IV drugs by the DEA due to the abuse potential and tolerance problems associated with them, Silenor appears to be safe, without any abuse potential and is likely to be categorized as a non-scheduled drug by the DEA.
Sleep Onset and Sleep Maintenance Activity: Rozerem from TKPHF.PK, an approved insomnia drug, has been classified as a non-scheduled drug. However, this drug is only approved for patients who have difficulty in getting sleep and not for the maintenance of sleep. On the other hand, Silenor is expected to be classified as a non-scheduled insomnia drug for the maintenance of sleep.
A more detailed report on the disease, how the drug works, the market size, the competitors and their products, different mechanisms of action etc., is available here.
Disclosure: No positions in stocks mentioned
About the author: Kaushik Paul Kaushik Paul has over 10 years of experience in the Healthcare/Biotech investment sector. Currently, he is the Managing Director of New BioMedicine LLC (http://www.newbiomedicine.com), which is based out of San Francisco, CA. The company provides research and trading ideas on small to mid-cap... More
Amylin (AMLN) Falls On Reports of Inappropriate Quality Control at Ohio Plant
10:46 am ET 03/12/2010- StreetInsider
Shares of Amylin (Nasdaq: AMLN) are taking a hit on reports from Bloomberg the FDA said the company's Ohio plant had inappropriate quality control.
The company is waiting for an expected FDA decision on Byetta today.
fda quality control issues news
amln just fell out of bed...news?
Newbie here, facinated to learn more of Golden Z methods TIA
Insmed Incorporated Reports Financial Results for First Quarter Ended March 31, 2007
9:00 AM EDT May 10, 2007
Insmed Inc. (Nasdaq:INSM), a biopharmaceutical company focused on the development of drug candidates for the treatment of metabolic diseases and endocrine disorders with unmet medical needs, today announced results for the three month period ended March 31, 2007.
Total revenues for the three months ended March 31, 2007 were $1.7 million, which consisted of $0.7 million in cost recovery from our Expanded Access Program, $0.5 million in initial license income from our agreement with NAPO Pharmaceuticals, Inc., $0.4 million from commercial sales of IPLEX(TM), and $35,000 in royalties. Revenues for the corresponding period in 2006 were $54,000, all of which were royalties. The net loss for the first quarter of 2007 was $10.3 million or $0.10 per share, compared to a net loss of $13.4 million or $0.17 per share for the first quarter of 2006.
Total expenses for the first quarter of 2007 were $12.1 million, compared to $11.0 million for the corresponding quarter of 2006. The increase in expenses in the first quarter of 2007 as compared to the corresponding period in 2006 was due primarily to severance costs associated with our business restructuring, which were partially offset by reduced litigation expenses. The litigation expenses were recorded in research and development during the first quarter of 2006 and are currently recorded in selling, general and administrative expenses as we had moved from research and development to commercial operations through the first quarter of 2007.
Interest expense for the first quarter of 2007 was $0.2 million as compared to $2.8 million in the first quarter of 2006. The decrease in interest expense resulted from lower amortization of the debt discount associated with the March 2005 financing, as an acceleration of the discount took place in the first quarter of 2006 due to a conversion of notes into shares of our common stock.
As of March 31, 2007, we had total cash and cash equivalents of $12.0 million as compared to $24.1 million as of December 31, 2006.
On March 5, 2007, we reached a settlement agreement with Tercica Inc. and Genentech Inc. Pursuant to this settlement agreement, we ceased sales and marketing of IPLEX(TM) in the United States and agreed to withdraw our European Marketing Authorization Application for IPLEX(TM). Further, as a result of this settlement agreement, we restructured our business to eliminate our commercial department and downsize our manufacturing facility.
On May 4, 2007, we sold 20,255,367 shares of our common stock and warrants to purchase up to 2,025,536 shares of our common stock. The price to the investors was $0.90 per unit, which was comprised of one share of our common stock and a warrant to purchase 0.1 shares of our common stock. The units were not issued or certificated and the shares of common stock and warrants were immediately separable and issued separately. The warrants may be exercised between November 3, 2007 and May 3, 2012 and have an exercise price of $1.10 per share. The offering was made pursuant to our effective shelf registration statement on Form S-3 (Registration No. 333-131535) previously filed with the Securities and Exchange Commission. Net proceeds from the offering are expected to be approximately $16.9 million.
Conference Call
We will host a conference call on Thursday, May 10, 2007 at 11:00 a.m. Eastern Time to discuss the financial results for the first quarter of 2007, and provide a business update.
Individuals interested in listening to the live conference call may do so by dialing 866-558-6338 toll free within the United States and Canada, or 213-785-2437 for international callers.
A telephonic replay of the call will be available approximately two hours after the call for two weeks at 866-245-6755 from the United States or 416-915-1035 for international callers. The passcode is 270068.
Individuals interested in listening to the conference call via the Internet may do so by visiting our website at www.insmed.com. A replay of the call will be available on our website for 90 days.
Insmed Raises Approximately $18.2 Million in Registered Direct Offering
9:05 AM EDT May 4, 2007
Insmed Inc. (Nasdaq:INSM) today announced that it has obtained agreements from investors to purchase approximately 20 million shares of its common stock at a price of $0.90 per share. Under the terms of the offering, Insmed will also issue 5-year warrants to purchase an aggregate of approximately 2 million additional shares of Insmed's common stock at an exercise price of $1.10 per share. The closing of the offering is expected to take place today, subject to the satisfaction of customary closing conditions.
The shares and warrants are being offered under a shelf registration statement previously filed with the Securities and Exchange Commission. C.E. Unterberg, Towbin served as sole placement agent for the offering.
Insmed estimates gross proceeds from the financing will be approximately $18.2 million. The net proceeds of the financing will be used for working capital and general corporate purposes.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities described above, nor shall there be any sale of such securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state. Copies of the prospectus and the prospectus supplement can be obtained from C.E. Unterberg, Towbin, 350 Madison Avenue, New York, NY 10017, fax +1 (212) 389-8880.
About Insmed
Insmed is a biopharmaceutical company focused on the development and approval of drugs for the treatment of metabolic diseases with unmet medical needs. For more information, please visit www.insmed.com.
Insmed Announces Promising Results From IPEX Phase II Myotonic Muscular Dystrophy Clinical Study
Insmed Announces Promising Results From IPLEX Phase II Myotonic Muscular Dystrophy Clinical Study
9:15 AM EDT May 3, 2007
Insmed Inc. (Nasdaq:INSM) today announced positive results from a Phase II investigator-sponsored study of the company's drug, IPLEX(TM), in patients with myotonic muscular dystrophy (DM1).
Preliminary results of the clinical study, being conducted at the University of Rochester School of Medicine and Dentistry, showed that six months of treatment with doses of IPLEX up to 1 mg/kg/day in six patients met the primary study endpoints of being safe and well tolerated. In addition, IPLEX treatment was associated with improvements in muscle mass, cholesterol and triglycerides. During the six months of treatment, 5 out of 6 patients experienced an improvement in lean muscle mass. Patients also reported improvement in gastrointestinal function, endurance and cognitive function during treatment with IPLEX.
"We are very encouraged by the results from this preliminary study of IPLEX in myotonic dystrophy. The results not only indicate IPLEX was safe, well tolerated and had a positive effect on muscle and lipid metabolism, they also suggest IPLEX may have a positive effect on aspects of the disease that affect patients' daily living," said Dr. Geoffrey Allan, president and CEO of Insmed.
Study Description
The primary objectives of this ongoing open-label, Phase II dose escalation study are to examine the safety and tolerability of once-daily, subcutaneous injection of IPLEX in up to 15 patients with DM1 and to identify the maximum tolerated dose. The next cohort of patients will be treated for six months with a dose of IPLEX which will be titrated up to 2 mg/kg/day.
The study is funded by the National Institutes of Health and the Muscular Dystrophy Association, with supply of IPLEX drug provided by Insmed. A Phase II, placebo-controlled study to further investigate the safety and efficacy of IPLEX in a larger number of patients with DM1 is being designed based on the preliminary results of this study.
About Myotonic Muscular Dystrophy
Myotonic muscular dystrophy, also known as myotonic dystrophy, dystrophia myotonica or Steinert's disease, is the most common type of adult muscular dystrophy, affecting 1 in 8000 individuals (approximately 40,000 people in the United States). Myotonic dystrophy patients develop progressive muscle wasting and weakness in the hands, forearms, legs, neck and face, as well as cataracts and cardiac arrhythmias, and eventually can become totally disabled, dying usually from respiratory or cardiac failure. At present, there is no treatment to reverse most of these symptoms. For more information about myotonic muscular dystrophy, please visit www.mda.org.
About IPLEX(TM)
IPLEX was approved in the United States in December 2005 for the treatment of children with growth failure due to severe primary IGF-I deficiency (Primary IGFD). IPLEX (rhIGF-I/rhIGFBP-3), a complex of recombinant human insulin-like growth factor-I (rhIGF-I) and its predominant binding protein IGFBP-3 (rhIGFBP-3). The drug is also being investigated for various other indications with unmet medical needs, including HIV-associated adipose redistribution syndrome, retinopathy of prematurity and amyotrophic lateral sclerosis (otherwise known as ALS or Lou Gehrig's disease).
About Insmed
Insmed is a biopharmaceutical company focused on the development and commercialization of drugs for the treatment of metabolic diseases with unmet medical needs. For more information, please visit www.insmed.com.
About the University of Rochester School of Medicine and Dentistry
The University of Rochester School of Medicine and Dentistry is a leading medical university that consistently defines health care worldwide by conducting advanced biomedical research and providing leading life science education and complex patient care. It has been designated by the National Institutes of Health (NIH) as one of several "centers of excellence" for muscular dystrophy research and is receiving up to $1 million per year for five years in federal NIH funding and up to $500,000 per year for three years from MDA, for a total of up to $6.5 million, to identify potential muscular dystrophy therapies. For more information, please visit www.urmc.rochester.edu.
About The Muscular Dystrophy Association
The Muscular Dystrophy Association (MDA) is a voluntary health agency -- a dedicated partnership between scientists and concerned citizens aimed at conquering neuromuscular diseases that affect more than a million Americans. MDA combats neuromuscular diseases through programs of worldwide research, comprehensive medical and community services, and far-reaching professional and public health education. MDA is the world's largest non-governmental sponsor of research seeking the causes of and effective treatments for neuromuscular diseases, sponsoring some 400 research projects annually. For more information, please visit www.mda.org.
Here's Same Release - Full Version
Insmed Releases Positive Results from IPLEX Phase II HIV-Associated Adipose Redistribution Syndrome Clinical Study
9:00 AM EDT April 30, 2007
Insmed Inc., (Nasdaq:INSM) today announced positive results from a Phase II investigator-sponsored clinical study of the company's drug IPLEX(TM) in HIV-infected patients affected with HIV-associated Adipose Redistribution Syndrome (HARS).
Preliminary results from the study, being conducted at the University of California, San Francisco, showed that three months of 0.5 mg/kg/day IPLEX treatment in seven patients increased IGF-I levels 3-fold and was associated with significant improvements in fasting glucose levels, the amount of insulin secreted during an oral glucose tolerance test, and overall insulin sensitivity. Moreover, there was a significant reduction in trunk fat and a positive downward trend in waist circumference when compared to baseline. Lipid profiles also tended to improve.
Notably, normal glucose tolerance was restored in half of the six patients diagnosed with impaired glucose tolerance (IGT) at the start of the study. These IGT patients also experienced a significant decrease in visceral adipose tissue (VAT). Impaired glucose tolerance is characterized by blood glucose between 140 and 200 mg/dl at the 120-minute measurement of an oral glucose tolerance test. The next phase of the study is underway to explore an IPLEX dose of 1.0 mg/kg/day given for six months.
"Our study has demonstrated that a low dose of IPLEX increased IGF-I levels 3-fold and positively impacted abnormal glucose metabolism, dyslipdemia and abnormal fat distribution, which are present in a significant number of HIV patients treated with highly active antiretroviral therapy (HAART)," said Morris Schambelan, M.D., the study's principal investigator and professor of medicine and director of the General Clinical Research Centers at University of California, San Francisco, and chief of endocrinology at San Francisco General Hospital.
"We are very encouraged by these preliminary results with low-dose IPLEX. We believe a product that improves fat distribution while also improving insulin sensitivity would be a valuable therapy for this patient population, and the positive effects on insulin sensitivity observed in this study are consistent with what we observed in our previous studies with IPLEX in patients with diabetes. These results support the most important differentiating property of our product in this patient population, which is IPLEX's ability to improve glucose homeostasis. Competitor products such as TH9507 and growth hormone reportedly either do not alter glucose homeostasis or exacerbate it, respectively. When considering that up to 40% of this population has impaired glucose homeostasis, then this property of IPLEX becomes even more valuable," said Dr. Geoffrey Allan, president and Chief Executive Officer of Insmed.
Study Description
The ongoing, open-label, investigator-sponsored Phase II clinical study is designed to evaluate the safety and efficacy of IPLEX in two cohorts of subjects, the first of which received a 0.5 mg/kg/day dose and the second of which will receive 1.0 mg/kg/day dose. The primary endpoints of the study are to determine the safety and tolerability of IPLEX and its effects on visceral fat and insulin sensitivity.
About HARS
An estimated 80,000 HIV patients in the U.S. have HARS, according to published reports. This disorder is marked by abnormal metabolism, including central fat accumulation (visceral adiposity and buffalo hump) with or without fat loss in the limbs. These features have increased markedly with the advent of highly active antiretroviral therapy (HAART) for HIV. Recent studies performed in subjects on HAART suggest nearly 40% of individuals develop the morphologic features characteristic of this syndrome.
About IPLEX
IPLEX was approved in the United States in December 2005 for the treatment of children with growth failure due to severe primary IGF-I deficiency (Primary IGFD). IPLEX (rhIGF-I/rhIGFBP-3) is a complex of recombinant human insulin-like growth factor-I (rhIGF-I) and its predominant binding protein IGFBP-3 (rhIGFBP-3). The drug is also being investigated for various other indications with unmet medical needs, including myotonic muscular dystrophy, retinopathy of prematurity and amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig's disease).
About the University of California, San Francisco
The University of California, San Francisco (UCSF), is a leading university that consistently defines health care worldwide by conducting advanced biomedical research and providing leading life science education and complex patient care. For more information, please visit www.ucsf.com.
About Insmed
Insmed is a biopharmaceutical company focused on the development and commercialization of drugs for the treatment of metabolic diseases and endocrine disorders with unmet medical needs. For more information, please visit www.insmed.com.
I concur and will keep my seatbelt on ... this release also reads as an opening pitch to secure future funding. I like the much improved INSM website...no smoke, mirrors or curtains
Expected fallout fm settlement...
I would value buying opp sentiment fm respected posters. They would have to pull it because of the outlined mktg app for specific short stature use and would need to resubmit for further indications, correct?
TIA
S
EU Drug Watchdog: Insmed Pulls Mkt Application For IPLEX -2
7:33 AM EDT March 26, 2007
Edited Press Release
IPLEX was expected to be used for the treatment of primary growth hormone insensitivity, a rare genetic disorder, caused by the body's inability to use the growth hormone it produces, and for the treatment of patients with growth hormone deletion who have developed neutralising antibodies to growth hormone. Mecasermin rinfabate was designated as an orphan medicinal product for the treatment of these conditions on 20 June 2006.
The application for marketing authorisation for IPLEX was submitted to the EMEA on 1 June 2006. At the time of the withdrawal, it was under review by the Agency's Committee for Medicinal Products for Human Use (CHMP).
In its official letter, the company stated that the withdrawal of IPLEX was due to a business agreement that has altered Insmed's strategy for IPLEX in the European Union.
More information about IPLEX and the current state of the scientific assessment at the time of withdrawal will be made available in a question-and-answer document. This document, together with the withdrawal letter from the company, will be published on the EMEA website after the next meeting of the CHMP on 23-26 April 2007.
Company Web Site: http://www.emea.europa.eu
-Zurich Bureau, Dow Jones Newswires; +41 43 443 8040; zurichdjnews@dowjones.com
(END) Dow Jones Newswires
I'm also curious 1)why or under what circumstances he left KOS last year and 2) How TRCA can afford him? His previous salary/bonus was $578,000 + about $2.5 mill in options. His previous salary/bonus alone is more than TRCA's CEO listed salary.
http://swz.salary.com/execcomp/layouthtmls/excl_execreport_115938.html
http://finance.yahoo.com/q/pr?s=TRCA
RTN, Where's Posts 4430-4435??
Why the deletions? If anything posted regarding INSM by a stock picker can remain on the board, why isn't my post #4433 regarding Tobin's factual and pathetic performance still on the board. I presented substantiated info so that we might qualify Tobin's call. What gives?
s
Tobin Smith isn't even in the top 100 stock pickers
Heres his return results
All trades 0.9 % Target reached 48.4 %
Open positions 3.6 % Stopped out 47.4 %
Closed positions 0.7 % Average days 60
All annualized 5.6 %
Tercica Sees FDA Completing Somatuline Review By Aug 30
7:37 AM EST January 16, 2007
DOW JONES NEWSWIRES
Tercica Inc. (TRCA) said its partner Ipsen (1025915.FR) received notice from the Food and Drug Administration that the agency has accepted the company's new drug application for a 28-day sustained-release formulation of Somatuline Autogel, a treatment for acromegaly, a disease caused by an excess of human-growth hormones.
Tercica, a Brisbane, Calif., biopharmaceutical company, said Tuesday it expects the FDA to complete its review by Aug. 30.
The new drug application covers 60-, 90- and 120-milligram sustained-release Somatuline Autogel injections.
As of Dec. 31, 2005, Somatuline and Somatuline Autogel had marketing approval in more than 50 countries.
-James DeWeese; 201-938-5400; AskNewswires@dowjones.com
Relevance? Thoughts? tia
s
Thanks rtn and rod for moderating!
Re: TRCa did lie about their EU timeline...judges ruling?
I'm not sure if it's germaine to the upcoming judges decision but would/could/or should this latest revalation impact the outcome?
As much as i dislike doing so, I'm adding & averaged down below $1 avg/pps simply because the science valuation at this point...like to think I still "see the forrest throught the trees"
glta
DewD, suggest you clean the windows in your glass house before casting any stones.
RTN, thanks for trying to get this board squared away.
Rod, if your still lurking around I hope you'll eventually post again. As with all forums and boards there are always those posters whom I just don't read because they are a waste of time AND more importantly there are those that we choose to read because their insight, opinions, outlook and research (like yours) are worth the click.
I Concur and Added...
btw, RTN, did you ever set up a methhod for which we could contribute to your court docs expenses?
glta
s
Correct me if I'm wrong but i thought I just heard on the CC that the patents expire in 2010 and 2018
Are Royalties Good Only For
sales of the current production version of Iplex or do they involve/include the production Iplex w/ a new production method and new room temp formulations? TIA
s
I agree, I also see an effort to grab shares
Stops getting tested @ various dma's, obvious support levels and these folks are using your fears and restlessness to make some volatility in order to accumulate shares, imho. I've added. gl
Exactly My Thoughts ...
digging through the shallow depths of my recall file i thought an injunction was completely off the table, why are we bringing that up? tia
Good INSM Response to request for new jury instruction
http://www.xs4all.nl/~surg3on/2006-november-INSMvsTRCA_trial_motions/993%20Memorandum%20in%20Opposit...
fm Ivillage
CHM, This document is a request by TRCA and DNA to change the jury instructions so first impression is that it is they who are posturing and worried. I agree w/ north. Question I have is whether the jury was given new instruction.
regards to all
Is the judge willing...
to correct that mistake and is she aware she erred? I've been combing through all the docs and posts that appear relevent and haven't stumbled on that answer. Anyone else?
The insite, legal interpretations and generosity of everyone on this board is most appreciated and for that I am thankful.
Heading out for the holiday, Everyone have a happy and safe Thanksgiving
best regards -
S
Thanks rod...
for posting the pacer updates!
regards
s
rod, i appreciate reading any of mpet's and biowatchdog's posts as well as yours. Conjecture or not they have long established credibility for input and insite on several boards and am greatful for their time and efforts. If a post invites/provokes thought, better understanding or factual clarification they do serve useful purpose, wouldn't you agree? I too still hold and have added.
regards
s
INSM price action nbd right now, folks trying to slowly gather more shares imho
Trca up on low vol being moved around by 100 share action, part of the usual smoke and mirrors going on for those stuck in it.
Insmed Incorporated Reports Financial Results for the Third Quarter and Nine Months Ended September 30, 2006
8:15 AM EST November 3, 2006
Insmed Incorporated (Nasdaq/NMS: INSM), a biopharmaceutical company focused on the development and commercialization of drug candidates for the treatment of metabolic diseases and endocrine disorders with unmet medical needs, today announced results for the three and nine month periods ended September 30, 2006.
Nine Months Nine Months $000's (except EPS) Q3 2006 Q3 2005 2006 2005 ------------------------------------------------ Total Revenues 226 22 489 107 Net loss (12,372) (13,756) (34,711) (28,044) Earnings per share (0.12) (0.29) (0.37) (0.61)
Discussion of Revenue and Expense Items
Revenues for the three months ended September 30, 2006 were $226,000 as compared with $22,000 in the corresponding period of 2005. The revenue figure for the third quarter of 2006 includes commercial sales, sales to patients in the Company's named patient program and royalties. The revenues for the corresponding period of 2005 were comprised solely of royalties, with named patient revenues being recorded as a reduction in research and development (R&D) expense, as the Company was reporting on a R&D basis at the time.
The net loss for the third quarter ended September 30, 2006 was $12.4 million or $0.12 per share, as compared to a net loss of $13.8 million or $0.29 per share for the corresponding quarter of 2005. The $1.4 million reduction in the net loss was due to a $5.9 million decrease in interest expense, a $0.3 million increase in interest income and a $0.2 million increase in revenues, offset by a $5.0 million increase in operating expenses. The decrease in interest expense results from lower amortisation of the debt discount associated with the March 2005 financing as an acceleration of the discount took place in the third quarter of 2005 due to a conversion of notes into shares. The rise in selling, general and administrative (SG&A) expenses for the third quarter of 2006 as compared to the corresponding period of 2005 is mainly due to the hiring of the commercial team and associated marketing expenses for the Company's commercial launch of IPLEX(TM), and the recording of patent litigation expenses into the SG&A category in accordance with U.S. generally accepted accounting principles. The cost of goods sold (COGS) for the third quarter of 2006 was impacted by the planned initial commissioning of the Company's second generation manufacturing process for IPLEX(TM) at our production facility in Boulder Colorado. The time required to complete the trial run of the process reduced commercial production capacity for the quarter and consequently, the site costs, most of which are fixed, were spread over a lower output resulting in a high COGS.
Revenues reported for the nine months ended September 30, 2006 including commercial patient sales, named patient program sales and royalties were $489,000 as compared to $107,000 in royalties reported for the same period in 2005.
The net loss for the nine months ended September 30, 2006 was $34.7 million, or $0.37 per share, compared to the net loss of $28.0 million, or $0.61 per share, reported for the corresponding period in 2005. The $6.7 million increase in the net loss for the nine months of 2006 as compared to the nine months of 2005 was due mainly to a $13.0 million increase in operating expenses, partially offset by a $5.0 million decrease in interest expense, a $0.9 million increase in interest income and a $0.4 million increase in revenues. The $13.0 million rise in operating expenses is primarily due to the build-up of our commercial team and associated marketing expenses as mentioned earlier, together with increased legal costs which were higher than the corresponding period of 2005 due to elevated litigation activity. The decrease in interest expense is again associated with the March 2005 financing as the amortisation of the debt discount was accelerated in 2005 due to a partial conversion of the notes into shares.
As of September 30, 2006, the Company had total cash and cash equivalents of $35.0 million which represents an increase of $16.2 million from December 31, 2005. This net increase is due to the $52.1 million in net cash provided by financing activities, which was partially offset by the $31.4 million in net cash used in support of the Company's business operations and $4.5 million of construction in progress at the Company's Boulder manufacturing facility. The $52.1 million of cash from financing activities was generated from a combination of $42.8 million in net proceeds from the sale of common stock in March 2006, $8.8 million from the exercise of certain outstanding warrants and $0.4 million from a reduction in a restricted letter of credit and minor employee option conversions.
Conference Call
The Company will host a conference call on Friday, November 3rd; at 11:00 a.m. Eastern Time to discuss the financial results for the third quarter of 2006 and provide a business update.
Interested investors can listen to the call over the internet from Insmed's investor relations website at www.insmed.com or by dialling (800) 361-0912 (domestic) or (913) 981-5559 (international).
A telephonic replay of the call will be available for one week at 888-203-1112 (domestic) or (719) 457-0820 (international), passcode: 4663784. A web replay of the call will be available through our corporate website, in the investor relations segment, beginning at 6:00 p.m.