posted
May 7, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals (ENCY) today announced financial results for the first quarter ended March 31, 2007.
"In the quarter, we made significant progress advancing our regulatory and product commercialization plans," said Bruce D. Given, M.D., President and CEO of Encysive Pharmaceuticals. "While we continue to make sales and reimbursement inroads in the U.K. and Germany, we have just begun the process of commercializing Thelin(r)(1) in the Republic of Ireland and The Netherlands, and we expect to begin marketing Thelin in additional European countries later in the year. Also in the quarter, we achieved regulatory approval for Thelin in Australia and look to decisions concerning Thelin(tm) from both the U.S. FDA and Canada in the coming months."
First Quarter 2007 Financial Overview
-- Revenues of $5.4 million for the first quarter of 2007, compared to $3.6 million for the first quarter of 2006, reflected approximately $1.0 million in Thelin European sales and a year- over-year increase in Argatroban royalty income of approximately $0.9 million. -- For the first quarter of 2007, the Company reported a net loss of $29.9 million, or $0.49 per basic and diluted share, compared to a net loss of $30.0 million, or $0.51 per basic and diluted share, for the same period last year. -- Research and development spending for the first quarter of 2007 of $17.5 million, was slightly lower than last year's R&D spending in the first quarter of $18.4 million, due to a slowdown in clinical spending. -- Sales and marketing expenses were $10.9 million for the current quarter as compared to $9.8 million for the first quarter in 2006. General and administrative expenses were $5.6 million for the first quarter of 2007, as compared to $5.7 million during the same period in 2006. These changes reflect decreased spending in the U.S. due to internal spending controls, offset by increased spending in Europe where we are actively commercializing Thelin(r). -- Cash, cash equivalents, accrued interest and restricted cash at March 31, 2007 was $62.9 million, compared to $43.8 million at December 31, 2006. Cash utilization during the first quarter included $4.5 million in debt repayment related to the Argatroban Notes (as defined below), as well as $1.6 million in interest payments to the 2005 Convertible Note holders. The March 31 cash balance does include $10.2 million of restricted cash, related to the Argatroban Notes, held in a holdback account, pending resolution of a United Kingdom tax withholding issue. Q1 and Recent Company Highlights
-- In February 2007, Encysive's newly formed wholly-owned subsidiary, Argatroban Royalty Sub LLC (Royalty Sub), placed $60 million in aggregate principal amount of non-convertible notes (Argatroban Notes) in a private placement to institutional investors. The Argatroban Notes are secured by royalties to be paid to Royalty Sub from sales of Argatroban by GlaxoSmithKline (GSK) and by a pledge by Encysive of the stock of Royalty Sub. Going forward, Encysive will continue to report Argatroban royalty income received from GSK in our quarterly financial results. However, the Argatroban royalty income will now be used to repay the Argatroban Notes, and will no longer be available to support the operational cash requirements of the Company. -- In October 2006, Encysive entered into a common stock equity financing line with Azimuth Opportunity Ltd pursuant to which Encysive may sell to Azimuth up to $75 million of common stock or 11,866,851 shares of common stock, whichever comes first. During the 18-month term of the equity line, Encysive may sell, at its sole discretion, registered shares of its common stock to Azimuth at a predetermined discount to the market price, subject to certain limitations. During the first four months of 2007, Encysive made two draw downs, for total gross proceeds of $18 million. Since entering into the Azimuth agreement, Encysive has made a total of four draw downs, for total gross proceeds of $36 million. Of the 11,866,851 shares of common stock originally available under the Azimuth equity financing line, 2,840,755 shares remain available for future draw downs. Encysive intends to use the net proceeds of this equity line for general corporate purposes, including the development and commercialization of the Company's products. -- In March 2007, the Australian Therapeutics Goods Administration (TGA) granted marketing approval for Thelin (sitaxentan sodium) 100 mg tablets for patients with pulmonary arterial hypertension (PAH). The Company is now seeking reimbursement approval in Australia. -- Also in March, the Company re-initiated a Phase II dose ranging study of TBC3711, Encysive's next-generation, highly selective endothelin A antagonist. The 12-week, multi-center, randomized, double-blind, placebo-controlled study will evaluate four once- daily oral doses of TBC3711 in approximately 150 patients diagnosed with resistant hypertension. -- Encysive announced the commercial availability of Thelin(r) for PAH in the Republic of Ireland and in The Netherlands in April 2007. The European Commission's centralized licensing procedure permits Encysive to market Thelin in all 27 member states of the European Union. Thelin will be commercialized in other European countries as local government reimbursement approvals are obtained. Upcoming Presentations and Events
-- May 15 Rodman & Renshaw 4th Annual Global Healthcare Conference, Monte Carlo, Monaco* -- May 19-24 American Thoracic Society (ATS) International Conference, San Diego -- June 13-16 European League Against Rheumatism (EULAR), Barcelona, Spain -- June 15 U.S. FDA Prescription Drug User Fee Act (PDUFA) Date for Thelin NDA
Posts: 124 | Registered: Oct 2006
| IP: Logged |
posted
LOL...yeah ive been in this since $3.49 bought a little high...but anyways holding for the big winner here...FDA approval brings this to $10+ IMO
-------------------- Disclaimer: Not accountable for anything I say Posts: 6266 | Registered: Jun 2004
| IP: Logged |
quote:Originally posted by stocktrader22: Who wants to play a guessing game on how high it goes before approval date on anticipation?
Well, I'm hoping for high 5's on anticipation. I would like to play the "approval/rejection" period with free shares only. I felt certain it would get approved the last time around, which if I recall correctly was it's 3rd time around. The drug now has good market share in Europe so maybe this accounts for something to the FDA. Also, apparently there is this other company Gilead (Nas: GILD) has a PAH drug as well up for FDA approval 3days after ENCY's.
posted
What's up with this? Don't get me wrong I love the gains, but I can't find any news or any dates on approval. I am wondering if I should buy more now or wait for a dip, if there is one.
Posts: 124 | Registered: Oct 2006
| IP: Logged |
quote:Originally posted by scottfest: What's up with this? Don't get me wrong I love the gains, but I can't find any news or any dates on approval. I am wondering if I should buy more now or wait for a dip, if there is one.
lol buddy...
its the yearly anticipation for this one on FDA approval June 15th....with approval this thing could really take off. Thelin is a migraine drug with a multibillion market...but they have to get approved first lol
-------------------- Disclaimer: Not accountable for anything I say Posts: 6266 | Registered: Jun 2004
| IP: Logged |
posted
I have shares of ENCY that I bought at 3.38, I can only imagine how happy I could be if this gets an approval on the 15th!
Posts: 333 | From: Cullman, Al | Registered: Sep 2005
| IP: Logged |
posted
If possible try to protect all your capital before the date, if price goes up high enough in anticipation, then hold some for the huge winner. Personally, I may just risk it and leave it all hoping for approval. Worse case IMO is it drops to $1.75-$2.00 and then I gotta hold on for a while waiting for their next blockbuster drug TH3711 to be strung along.
-------------------- Disclaimer: Not accountable for anything I say Posts: 6266 | Registered: Jun 2004
| IP: Logged |
posted
I have less than 5 K invested in this...........Might as well put it into a slot machine cause I too am holding for the big winnah winnah chicken dinnah!
I thought about cashing out when it hits 4.5-5.0 but how bad would I hate myself when it hits 2.00..........Not near as bad as I would when it hits 10.00 and I am holding half as much!
With the pipeline that they have......I will hold! Posts: 333 | From: Cullman, Al | Registered: Sep 2005
| IP: Logged |
posted
No not sure, the only concerning thing in this one is no one knows for sure the effect on the stock price and sales of the competing drug by Gilead, there are analysts saying Gilead drug will get approval and its better then Thelin, others saying the opposite. Some analysts say ENCY should be at $3 even with approval, some analysts saying with approval this is a $15-$20 stock.
-------------------- Disclaimer: Not accountable for anything I say Posts: 6266 | Registered: Jun 2004
| IP: Logged |
posted
I suspect as long as Thelin gets approved, we will see a nice spike...then, after seeing if Gilead drug gets approved three days later, we may see another dramatic change up or down.
Anyone with a migraine would likely try both drugs at some point, so I don't care much about which is "better" at this point.
-------------------- Study before you buy, Sell before you think about it.... Posts: 3903 | From: Gulf Coast | Registered: Jun 2006
| IP: Logged |
posted
$4 million is very small compared to a billion. There surely is room for both drugs to be approved and both make their companies a lot of revenue even if there are already FDA approved PAH drugs in the space. Copy-n-pasted from two seperate articles:
"The overall market for these drugs is expected to expand to about $1 billion annually, with the introduction of ambrisentan and Thelin."
and
"...one plus for Encysive is that it received approval to market Thelin in Europe last year and has already captured a 40% market share in the region. While sales of the drug – at $1 million in the first quarter – were lower than expected, the capture of the market share is not insignificant".
Posts: 252 | From: WestCoast | Registered: Oct 2006
| IP: Logged |
quote:Originally posted by stocktrader22: No not sure, the only concerning thing in this one is no one knows for sure the effect on the stock price and sales of the competing drug by Gilead, there are analysts saying Gilead drug will get approval and its better then Thelin, others saying the opposite. Some analysts say ENCY should be at $3 even with approval, some analysts saying with approval this is a $15-$20 stock.
alnalysts thats what made me jump into this field funny how they're always at the complete opposite side of the spectrum ,one says red the other says blue so i say yellow that makes me an expert also lol
Posts: 657 | From: brooklyn | Registered: Jun 2006
| IP: Logged |
posted
There seems to be some resistance at 3.75 It would be nice to break through sometime soon.
Posts: 252 | From: WestCoast | Registered: Oct 2006
| IP: Logged |
posted
been holding this patiently for about 2 months! now it is finally getting some LOVE! Posts: 333 | From: Cullman, Al | Registered: Sep 2005
| IP: Logged |
posted
Canadian Health Authority Approves THELIN (Sitaxsentan Sodium) for Pulmonary Arterial Hypertension First Selective Endothelin A Receptor Antagonist, First Once-Daily Oral Treatment
Last Update: 5:46 PM ET May 30, 2007
HOUSTON, May 30, 2007 (*********wire via COMTEX) -- Encysive Pharmaceuticals (ENCY : encysive pharmaceuticals inc com Last: 4.12+0.53+14.76% 9:51am 05/31/2007 ENCY4.12, +0.53, +14.8%) today announced that Health Canada's Therapeutic Products Directorate has approved THELIN(tm) (sitaxsentan sodium) 100 mg tablets. THELIN is indicated for the treatment of primary pulmonary arterial hypertension (PAH) and pulmonary hypertension secondary to connective tissue disease, in patients with World Health Organization (WHO) functional class III who have not responded to conventional therapy. THELIN is also indicated in patients with WHO functional class II who did not respond to conventional therapy and for whom no appropriate alternative can be identified. THELIN is the first selective endothelin A receptor antagonist (ETRA) available, and the only once-daily oral treatment approved for PAH. PAH is estimated to afflict approximately 100,000 to 200,000 people in North America and Europe. The disease is characterized by high blood pressure and structural changes in the walls of the pulmonary arteries, the blood vessels that connect the right side of the heart to the lungs. As these arteries become increasingly constricted, blood flow and oxygenation may be inadequate to meet the body's demands. The heart must then pump harder to overcome the resistance, and patients become susceptible to heart failure. "The approval of THELIN represents an advance in the treatment options available for PAH patients in Canada," commented David Langleben, M.D., Professor of Medicine, McGill University and Director of the Center for Pulmonary Vascular Disease, Jewish General Hospital, Montreal. "THELIN's safety and efficacy profile and once-a-day oral formulation make it an attractive therapeutic option, and I look forward to its commercial availability." "THELIN has demonstrated a unique benefit for individuals who have developed PAH as a result of a connective tissue disease, such as scleroderma," said Janet Pope, M.D., Professor of Rheumatology, University of Western Ontario and Director, Division of Rheumatology, St. Joseph's Health Centre, London, Ontario. "As a clinician, I welcome any new treatment that may help these particular patients, as they are a more difficult group to treat." THELIN's approval is based on the largest database of patients with PAH ever assembled in an original Canadian New Drug Submission, with more than 1,000 PAH patients receiving THELIN. Encysive received European Union marketing authorization for THELIN in August 2006, marketing approval from the Australian Therapeutic Goods Administration in March 2007 and the drug is currently under evaluation by the Food and Drug Administration (FDA) in the United States. "This approval is another important step in our effort to commercialize THELIN worldwide," stated Bruce D. Given, M.D., President and Chief Executive Officer of Encysive Pharmaceuticals. "We're extremely proud to have achieved this milestone and look forward to bringing THELIN to PAH patients in Canada." THELIN(tm) (Sitaxsentan Sodium) Canadian Marketing Authorization Highlights The Canadian market authorization was based on submitted data from quality (chemistry and manufacturing) studies, as well as data from non-clinical and clinical studies. Two randomized, double-blind, multi-centre, placebo-controlled studies (n=425) were conducted to demonstrate efficacy and safety. Compared to placebo, treatment with THELIN resulted in a significant increase in exercise capacity. The placebo-corrected increases in six-minute walk distance compared to baseline were 35 meters and 31 meters for the two pivotal studies. Compared to placebo-treatment, THELIN demonstrated improvements to the cardiac index, pulmonary vascular resistance, and systemic vascular resistance after 12 weeks of treatment. Compared to placebo-treatment, THELIN improved functional class. A significant reduction in the rate of clinical worsening was also reported in patients treated with THELIN. In the STRIDE program, THELIN 100 mg was shown to significantly improve exercise capacity, as measured by improvement in six-minute walk distance, including in patients with connective tissue disease. THELIN was also shown to reduce patients' PAH symptoms (improvement in WHO/NYHA functional class) and improve PAH hemodynamic status. Survival of patients was 96% at one year in the overall patient population and 98% in patients with PAH secondary to connective tissue disease. Important Safety Information Like other ETRAs, THELIN is teratogenic, and pregnancy must be excluded before the start of treatment and prevented thereafter by the use of a reliable method. Monthly pregnancy tests during treatment with THELIN are recommended. THELIN has a potential for liver toxicity. Testing of liver enzymes is required prior to the initiation of THELIN and monthly thereafter. In placebo-controlled clinical trials, the most commonly reported adverse events with THELIN treatment were headache, peripheral edema, nasal congestion, nausea, constipation, epistaxis, insomnia, prothrombin time prolonged and international normalized ratio (INR) increase. Because THELIN inhibits the metabolism of warfarin, a dose adjustment is needed when co-administered with THELIN. THELIN is contraindicated in patients receiving cyclosporine A, patients with mild to severe hepatic impairment (Child-Pugh Class A-C), patients with elevated liver aminotransferases prior to starting treatment (elevation in liver enzymes to levels greater than 3 times the upper limit of normal), lactating patients, or patients with hypersensitivity to the active substance or any excipients. THELIN(tm) (Sitaxsentan Sodium) Overview THELIN is an endothelin A receptor antagonist, a small molecule that blocks the action of endothelin, a potent mediator of blood vessel constriction and growth of smooth muscle in vascular walls. Endothelin receptor antagonists may prove to be effective in the treatment of a variety of diseases where the regulation of vascular constriction is important. THELIN is 6,500-fold selective in the targeting of the endothelin A receptor versus the endothelin B receptor. Selective endothelin A receptor antagonism has been shown to increase blood flow and reverse vasoconstriction in human clinical pharmacology studies.
Posts: 196 | From: usa | Registered: Feb 2006
| IP: Logged |
UBBFriend: Email this page to someone!
Printer-friendly view of this topic
![[Smile]](smile.gif)
![[Big Grin]](biggrin.gif)
![[Eek!]](eek.gif)
