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Original Source: FD (FAIR DISCLOSURE) WIRE
. Leonard Bell, Alexion Pharmaceuticals, CEO . Thomas Dubin, Alexion Pharmaceuticals, SVP . David Keiser, Alexion Pharmaceuticals, President, COO . Vikar Sinha, Alexion Pharmaceuticals, CFO . Eric Schmidt, Cowen & Company, Analyst . George Farmer, Wachovia, Analyst . Meg Malloy, Goldman Sachs, Analyst . Huanbo Lu, Piper Jaffray, Analyst
. Mike Aberman, Credit Suisse, Analyst . Rachel McMinn, Piper Jaffray, Analyst . Unidentified Participant, Morgan Stanley, Analyst
ALXN reported 2006 revenues of $1.6m and 4Q06 revenues of $0.2m. 2006 net loss of $131.5m, 4Q06 net loss 0f $39.3m. ALXN reported 2006 net loss per basic and diluted common share of $4.15 and 4Q06 net loss per basic and diluted share of $1.19.
A. Key Data From Call 1. 2006 revenue = $1.6m. 2. 4Q06 revenue = $0.2m. 3. 2006 net loss = $131.5m or $4.15 basic and diluted net loss per common share. 4. 2006 net loss (excluding share-based compensation) = $110.9m or $3.54 basic and diluted net loss per common share. 5. 4Q06 net loss = $39.3m. 6. 4Q06 non-GAAP net loss = $30m or $0.9 per common share. 7. 4Q06 net loss per basic and diluted share = $1.19. 8. 2006 total reported OpEx = $138.6m. 9. 2006 total OpEx (excluding share-based compensation expense) = $118m. 10. 4Q06 total reported OpEx = $41.1m (including $7.1m related to closure of San Diego office). 11. 4Q06 total OpEx (excluding share-based compensation expense) = $31.9m. 12. As of 12/31/06 cash, cash equivalents, and marketable securities = $250.1m.
S1. Clinical and Regulatory Activities (L.B.) 1. Soliris: 1. During 4Q06, ALXN significantly advanced the development of Soliris for PNH indication. 2. In Dec., clinical investigators presented results at American Society of Hematology meetings from three important studies evaluating Soliris and PNH.
1. Preliminary topline results from 52-week open-label controlled Phase III SHEPHERD study show that in a heterogeneous PNH population, Soliris was well tolerated and separately was shown to significantly improve hemolysis, leading to significant improvements in anemia, fatigue and health related quality of life. 2. Following on the Sept. New England Journal of Medicine publication that outlined the overall hemolysis, anemia and quality of life improvements, a further analysis from TRIUMPH, presented at ASH, demonstrated that Soliris improved hemolysis leading to significant improvement in
anemia, irrespective of baseline transfusion requirements. 3. In Phase III extension trial E05-001, assessment of a prospectively defined secondary efficacy outcome of thrombosis showed that Soliris significantly improved hemolysis, leading to a marked and significant reduction in risk of thrombosis in treated PNH patients. 3. EXPLORE Clinical Program: 1. The study will help ALXN to better understand clinical characteristics and frequency of PNH in patients with bone
marrow failure syndrome. 2. Anticipates EXPLORE will continue to enroll throughout the year and will also commence enrollment in Europe later in 2007. 3. As ALXN become more integrated into hematology and oncology clinical communities over the past few months, clinicians have increasingly suggested that implementation of an
EXPLORE [life] program in the setting of thrombosis may provide valuable information to clinical community about the frequency and clinical characteristics of PNH in patients with unexplained arterial or venous blood clots. 1. Expects to develop and implement such a clinical program later 2007. 4. PNH Patient's Access To Soliris:
1. Currently, this commitment is on a pre-approval basis with
investigational drug Eculizumab and it has active programs available for patients in US and in certain European countries. 2. In US, FDA has authorized a treatment protocol which is an early access program specifically designated for the pre-approval treatment of patients with serious and life threatening diseases. 1. It provides the most effective mechanism to prevent a diverse group of patients with PNH, to obtain pre-approval access to Soliris. 3. ALXN is diligently working with interested clinical centers, so that it may help them initiate and complete the necessary regulatory review process to allow their patients to obtain pre-approval access to Soliris under EMBRACE Early Access program. 1. It usually requires approx. three months for potential clinical site to complete its local hospital based regulatory process so that it may enroll patients in clinical studies. 4. In France, regulatory authorities have authorized a [name] patient access program for Soliris in Dec. 1. ALXN is notified that the first PNH patients have now commenced treatment with Soliris earlier at 2007. 5. Progress in Regulatory Front: 1. In US, Co. …