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Biotech / Medical : CVTX - CV Therapeutics, Inc. -- Ignore unavailable to you. Want to Upgrade?

To: mopgcw who wrote (302)	4/25/2007 10:36:53 PM
From: tom pope	Read Replies (1) \| Respond to of 411

I'll counter your GS with a Merrill (not that it adds much) Ranexa 1Q sales solid: CVTX reported 1Q:07 Ranexa sales of $12M and EPS of ($0.93), vs. our estimates of $7M and ($1.08), respectively. Total revenues were $15M vs. our $11M. In addition to revenue upside, R&D expenses were lower than expected. Please see variation analysis on page 3 for details. Raising Ranexa sales projections: We raised our Ranexa sales estimates from $45M to $66M in ‘07E, from $101M to $126M in ‘08E, and from $146M to $175M in ‘09E, mostly reflecting a pricing assumption adjustment since actual TRx growth is in-line with our projections. We lowered R&D by $5M and kept SG&A flattish as we await further company communications regarding operating expenses. We removed equity financing in ’07 from our model as management stated the company does not intend to raise money in the capital markets at the current share price. As a result, our EPS estimates are changed from ($3.20) to ($3.37) in ‘07E, from ($1.78) to ($2.00) in ‘08E, and from ($1.11) to ($1.13) in ‘09E. Please see detailed models on the following pages. But recent NRx trends not encouraging: Although TRx has been growing steadily, we are concerned that all the growth is attributable to refills while NRx has essentially remained flat since late February (please see Table 2 on page 4). In addition, management said that partnering is unlikely before they complete the analysis of MERLIN data to better define Ranexa’s product profile.

To: mopgcw who wrote (302)	7/9/2007 4:04:06 PM
From: tuck	Respond to of 411

>>CV Therapeutics Identifies Potential Anti-Diabetic Mechanism of Action for Ranexa(R) Monday July 9, 4:01 pm ET -- New preclinical information may correlate with clinical HbA1c reductions observed in Phase 3 CARISA and MERLIN TIMI-36 clinical trials -- PALO ALTO, Calif., July 9 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX - News) announced today that researchers have completed preliminary preclinical studies showing that ranolazine increased glucose stimulated insulin secretion in pancreatic beta cells. In separate experiments using preclinical models of insulin resistance, ranolazine also improved glucose homeostasis. These data could illustrate an underlying first in class mechanism of action for the statistically significant reductions in HbA1c levels observed with Ranexa in cardiovascular patients with diabetes from the phase 3 CARISA (n=189 with angina and diabetes) and MERLIN TIMI-36 (n=2,220 with acute coronary syndromes and diabetes) clinical trials. In CARISA (Combination Assessment of Ranolazine in Stable Angina), Ranexa (ranolazine extended release tablets) reduced HbA1c levels by an average of up to 0.7 percentage points in angina patients with diabetes. The reduction in HbA1c was not associated with increased hypoglycemia. "Preclinical studies have shown that Ranexa inhibits the late sodium current in cardiac cells. Potentially, the sodium channels present in pancreatic beta cells may play a role in the secretion of insulin," said Luiz Belardinelli, M.D., senior vice president of pharmacological translational and biomedical research and a distinguished fellow of cardiovascular science at CV Therapeutics. The company plans to submit data from these new preclinical experiments for publication later this year.<< snip What, these guys think they are AGIX? Cheers, Tuck

To: mopgcw who wrote (302)	8/22/2007 1:29:39 PM
From: tuck	Read Replies (1) \| Respond to of 411

>>CV Therapeutics Announces Eight Abstracts Accepted for Presentation at the European Society of Cardiology Congress 2007 Wednesday August 22, 7:00 am ET PALO ALTO, Calif., Aug. 22 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX - News) announced today that eight abstracts, including a clinical trial update session on anti-arrhythmia data from the MERLIN TIMI-36 study, have been accepted for presentation at the European Society of Cardiology (ESC) Congress 2007 taking place in Vienna, Austria from September 1-5, 2007. A clinical trial update session entitled, The Effect of Ranolazine, a Novel Anti-anginal Agent with Electrophysiologic Properties, on the Incidence of Tachyarrhythmias: Results from the MERLIN-TIMI 36 Randomized Controlled Trial, is scheduled for presentation Wednesday, September 5 at 9:45 a.m. Central European Summer Time (CEST). Other accepted abstracts include: Ranexa® (ranolazine extended-release tablets): Clinical Outcomes in Patients with Diabetes or the Metabolic Syndrome Presenting with Non- ST-elevation Acute Coronary Syndrome in the MERLIN- TIMI 36 Trial; Poster, Sunday, September 2, 8:30 a.m.-12:30 p.m. CEST Cost of Angina: Recurrent Angina Following Revascularization - Frequency, Patient Characteristics and Costs; Poster, Wednesday, September 5, 8:30 a.m. - 12:30 p.m. CEST Late Sodium Current: Reduction of Repolarization Reserve Unmasks the Role of Late Sodium Current in Rabbit Isolated Hearts; Poster, Sunday, September 2, 8:30 a.m. - 12:30 p.m. CEST Mechanism of Ranolazine Block of Cardiac Na Channels; Poster, Monday, September 3, 2:00 - 6:00 p.m. CEST Regadenoson Results from Two Randomized, Double-blind, Placebo-controlled Trials Evaluating the Safety of Regadenoson in Patients with Reactive Airways Disease; Poster, Tuesday, September 4, 2:00 - 6:00 p.m. CEST Side Effect Profile and Tolerability of Regadenoson Myocardial Perfusion Scintigraphy in Women; Poster, Tuesday, September 4, 2:00 - 6:00 p.m. CEST Superior Safety Profile of Regadenoson Versus Adenosine in Patients with Chronic Obstructive Pulmonary Disease Undergoing Radionuclide Myocardial Perfusion Imaging; Poster, Tuesday, September 4, 2:00 - 6:00 p.m. CEST In addition, on Tuesday, September 4, CV Therapeutics is sponsoring an EBAC (European Board for Accreditation in Cardiology) educational program, Targeting Myocardial Ischaemia-Future Opportunities for Improved Outcomes, chaired by Dr. Phillip Poole-Wilson of the United Kingdom and Dr. Eugene Braunwald of the United States. On Monday, September 3, CV Therapeutics is sponsoring a FOCUS Cardiology Practice Session, Chronic Stable Angina Management. Additional information regarding the ESC Congress 2007 can be accessed at escardio.org << snip >>Ranexa(R) Added to New ACC/AHA Guidelines on Unstable Angina/Non ST-Elevation Myocardial Infarction (UA/NSTEMI) Wednesday August 15, 7:00 am ET PALO ALTO, Calif., Aug. 15 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX - News) announced today that new guidelines, developed jointly by the American College of Cardiology Foundation and the American Heart Association and published in this week's issue of Circulation, state that, "ranolazine may be safely administered for symptom relief after UA/NSTEMI." Ranexa® (ranolazine extended-release tablets) is indicated for the treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs, and should be used in combination with amlodipine, beta-blockers or nitrates. The product has not been determined by regulatory authorities to be safe and effective for any other use.<< snip And they also launched the 1000mg tablet of Ranexa last week. There seems to be a lot of IV in the September options, and huge OI in the Sep and Oct calls, while the put/call ratios are teeny. The only event I know of that might be significant in that time frame is the expected sNDA for Ranexa label expansion based on safety signals observed in MERLIN. This is widely expected, though. Dicier is the FDA's reaction to said filing, but that probably won't be known until late this year, with an actual decision due next year. Meanwhile Third Point hasn't said anything public, but apparently has helped push the company towrds restructuring and seeking strategic alternatives -- though it might have done that anyhow. I'm very tempted to sell the IV, perhaps with a straddle write. Anyone know of upcoming events that could blindside me? TIA & Cheers, Tuck