Bioenvision Reports Second Quarter 2007 Financial Results; Evoltra(R) Sales Double over Last Quarter.NEW YORK New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of -- Bioenvision, Inc. (NasdaqGM:BIVN) today announced financial results for the second quarter ended December 31, 2006. Results and recent events include: * Bioenvision marks record quarterly revenue of $4.5 million as Evoltra([R])(clofarabine clofarabine Warning - High-alert drug! Clolar, Evoltra (UK) Pharmacologic class: Purine nucleoside antimetabolite Therapeutic class: Antineoplastic ) sales doubled from the first quarter of 2007 * Bioenvision files with the EMeA for label extension of Evoltra([R]) in elderly AML AML - A Manufacturing Language * ASH conference spotlights pivotal filing data from study BIOV-121 * Bioenvision appoints new Chief Financial Officer * Bioenvision appoints General Manager for Bioenvision JapanCo. * Bioenvision out-licenses worldwide rights to its Oligon Oligon™ catheter Nursing A large-bore, infection-resistant, Foley-type catheter treated with Oligon, an antimicrobial which ↓ urinary catheter-related infections. See Urinary tract infection. ([R]) technology "We are very pleased with the impact our sales and marketing organization has had since the formal launch of Evoltra[R] in September," said Christopher B. Wood, M.D., Bioenvision's Chairman and Chief Executive Officer. "The revenue growth in the pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. indication, our filing for a label extension into adult Acute Myeloid Leukemia myeloid leukemia n. See myelogenous leukemia. (AML) and our progress towards bringing Evoltra into Japan are significant achievements for Bioenvision, and we remain focused on continuing to execute on our global development and commercialization strategy for Evoltra in the months ahead." Financial Review Total revenue for the quarter ended December 31, 2006 was $4.5 million, compared to $1.1 million for the same period in 2005. This increase of approximately 309% is due to an increase in net product sales of Evoltra([R]), as well as an increase in license and royalty revenue of approximately $265,000. Net product sales of Evoltra([R])for the quarter ended December 31, 2006 totaled $3.6 million compared to $1.8 million for the previous quarter ending September 30, 2006 representing an increase of 100%. Revenues for the six months ended December 31, 2006 were approximately $7.4 million and $1.8 million, respectively, representing an increase of 311%. This increase is due to the approval of Evoltra([R]) in May 2006 and commercial sales commencing in the fourth quarter of 2006. Selling, general and administrative expenses for the quarter ended December 31, 2006 were $6.3 million, compared to $2.6 million for the same period in 2005 representing an increase of 142%. The increase is primarily due to the expansion of the sales force in Europe. The Company also recognized an increase in stock-based compensation of $712,000. Selling, general and administrative expenses for the six months ended December 31, 2006 and 2005 were approximately $11.8 million and $5.5 million, respectively, representing an increase of 115%. This increase is due to the build out of the sales force in the EU after receiving marketing authorization The right or permission to use a system resource; the process of granting access. See access control. for Evoltra([R]) in May of 2006 as well as the launch of Evoltra([R]) during the first quarter of 2007, and increased overhead costs overhead costs see fixed costs. of the company. The Company also recognized an increase in stock-based compensation of $923,000. Research and development costs for the three months ended December 31, 2006 and 2005 were approximately $4.3 million and $2.0 million, respectively. This increase of 115% is due to the Company's increased development activities, including the cost of participation in the ongoing AML-16 study, BIOV-111, BIOV-121, and psoriasis psoriasis (sôrī`əsĭs), occasionally acute but usually chronic and recurrent inflammation of the skin. The exact cause is unknown, but the disease appears to be an inherited, possibly autoimmune disorder that causes the studies. Research and development costs for the six months ended December 31, 2006 and 2005 were approximately $13.6 million and $4.4 million, respectively. This increase of 209% is due to the signing of the Japanese license agreement of approximately $4.0 million during the first quarter of fiscal 2007, along with the costs associated with clinical development and regulatory activities. Net loss applicable to shareholders was approximately $7.0 million or $0.16 loss per share for the three months ended December 31, 2006 compared with net loss available to shareholders of approximately $3.9 million or $0.10 per share for the three months ended December 31, 2005. Net loss applicable to shareholders was approximately $19.2 million or $0.46 per share for the six months ended December 31, 2006 as compared to approximately $8.8 million or $0.22 per share for the six months ended December 31, 2005. Bioenvision had cash and cash equivalents and short-term Short-term Any investments with a maturity of one year or less. short-term 1. Of or relating to a gain or loss on the value of an asset that has been held less than a specified period of time. investments at December 31, 2006 of $29.1 million compared with $45.0 million at June 30, 2006. The decrease in the cash position is due to the cash burn associated with an increase in the Company's development activities and clinical studies of Evoltra([R]) in Europe, including the process of filing for approval of the first label expansion for Evoltra([R]) and the general administrative costs administrative costs, n.pl the overhead expenses incurred in the operation of a dental benefits program, excluding costs of dental services provided. associated with the marketing of Evoltra([R]). Conference Call and Webcast Information: Management will conduct a conference call today, February 8, 2007 at 10:00AM Eastern Time to review the financial and corporate results for the second quarter 2007. The dial-in number and passcode information are as follows and a replay of the call and webcast will be available for 14 days from today: Toll free (US & Canada): 866-585-6398 International: 416-849-9626 Webcast: www.bioenvision.com Replay number (US & Canada): 866-245-6755 Replay number international: 416-915-1035 Replay passcode: 752762 Webcast replay: www.bioenvision.com About Bioenvision Bioenvision's primary focus is the acquisition, development and marketing of compounds and technologies for the treatment of cancer. Bioenvision has a broad pipeline of products for the treatment of cancer, including: Evoltra([R]), Modrenal([R])(for which Bioenvision has obtained regulatory approval for marketing in the United Kingdom for the treatment of post-menopausal breast cancer following relapse to initial hormone therapy Hormone therapy Treating cancers by changing the hormone balance of the body, instead of by using cell-killing drugs. Mentioned in: Breast Cancer, Thyroid Cancer hormone therapy ), and other products. Bioenvision is also developing Suvus([R]), its anti-infective technology, which is currently in clinical development for refractory refractory Material that is not deformed or damaged by high temperatures, used to make crucibles, incinerators, insulation, and furnaces, particularly metallurgical furnaces. chronic hepatitis Chronic hepatitis Long lasting inflammation of the liver due to viruses or other causes. Mentioned in: Tube Compression of the Esophagus and Stomach chronic hepatitis C infection. For more information on Bioenvision please visit our Web site at www.bioenvision.com. Certain statements contained herein are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995). Because these statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. . Specifically, factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to: risks associated with preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. and clinical developments in the biopharmaceutical industry in general and in Bioenvision's compounds under development in particular; the potential failure of Bioenvision's compounds under development to prove safe and effective for treatment of disease; uncertainties inherent in the early stage of Bioenvision's compounds under development; failure to successfully implement or complete clinical trials; failure to receive marketing clearance from regulatory agencies regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. for our compounds under development; acquisitions, divestitures, mergers, licenses or strategic initiatives that change Bioenvision's business, structure or projections; the development of competing products; uncertainties related to Bioenvision's dependence on third parties and partners; and those risks described in Bioenvision's filings with the SEC. Bioenvision disclaims any obligation to update these forward-looking statements. Reconciliation of Non-US GAAP GAAP See: Generally Accepted Accounting Principles GAAP See generally accepted accounting principles (GAAP). Financial Measure Adjusted net loss applicable to common stockholders defined as net loss applicable to common shareholders less one-time expense for the Japanese license agreement and stock-based compensation recorded for the three and six months ended December 31, 2006 and 2005, respectively. [TABLE OMITTED] [TABLE OMITTED] [TABLE OMITTED] |
|
||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion