Exhibit 99.1
| | | | |
Contacts: | | | | |
| | |
Dov A. Goldstein, M.D. | | E. Blair Schoeb | | Aline Schimmel |
Vicuron Pharmaceuticals Inc. | | WeissComm Partners | | Burns McClellan Inc. |
610-205-2312 | | 212-923-6737 | | 212-213-0006 |
dgoldstein@vicuron.com | | Blair@weisscommpartners.com | | aschimmel@burnsmc.com |
VICURON PHARMACEUTICALS ANNOUNCES THIRD QUARTER 2004 FINANCIAL RESULTS
King of Prussia, Penn., Nov. 4, 2004— Vicuron Pharmaceuticals Inc. (NASDAQ: MICU; Nuovo Mercato) today reported financial results for the three and nine month periods ended September 30, 2004.
Total revenues for the third quarter of 2004 were $1.8 million compared with $2.8 million for the third quarter of 2003. Total operating expenses were $17.7 in the third quarter 2004 compared to $22.3 million during the third quarter of 2003.
For the third quarter of 2004, Vicuron reported a net loss of $15.4 million or a net loss per share of $0.28 on 54.9 million weighted average shares. This compares to a net loss of $18.9 million or $0.36 per share on 52.8 million weighted average shares outstanding for the third quarter of 2003. Total revenues for the first nine months were $5.7 compared to $6.8 million for the same period in 2003. Total operating expenses for the first nine months of 2004 were $70.3 compared to $160.4 million for the first nine months of 2003.
For the nine months ended September 30, 2004, Vicuron reported a net loss of $63.1 million or a net loss per share of $1.16 on 54.5 million weighted average shares outstanding. This compares to a net loss for the same period of 2003 of $152.0 million or $3.38 per share on 44.9 million weighted average shares outstanding.
At September 30, 2004, cash and cash equivalents and unrestricted marketable securities totaled approximately $96.3 million, which does not include the net proceeds of $71.4 million from the recently completed public offering.
“In the third quarter we achieved numerous corporate milestones that continue to advance Vicuron. In August, we announced positive pivotal Phase 3 data with dalbavancin for the potential treatment of skin and soft tissue infections and, in September, we completed the enrollment of our Phase 3 clinical trial of anidulafungin for the potential treatment of invasive candidiasis/candidemia,” said
George F. Horner III, President and Chief Executive Officer of Vicuron. “Following discussions with the U.S. Food and Drug Administration, we now have two defined paths towards regulatory approval for anidulafungin in the United States. With net proceeds of approximately $71.4 million from our recent public offering in September, we are well positioned to continue to advance our product candidates. This past weekend at the ICAAC annual meeting, 40 oral and poster presentations highlighted the breadth and depth of our powerful pipeline in and commitment to the area of differentiated anti-infective agents.”
About Vicuron
Vicuron Pharmaceuticals is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing vital medicine for seriously ill patients. In May 2004, Vicuron received an approvable letter from the FDA for its lead product anidulafungin for the treatment of esophageal candidiasis. The company’s other lead product, dalbavancin, a novel intravenous antibiotic for the treatment of serious Gram-positive infections, has completed Phase 3 clinical trials. The company’s versatile research engine integrates industry-leading expertise in functional genomics, natural products discovery, mechanism-based drug design and combinatorial and medicinal chemistry. These approaches are yielding promising novel and next-generation compounds, many of which are in the later stages of preclinical development. In addition, the company has research and development collaborations with leading pharmaceutical companies, such as Pfizer and Novartis.
Forward-Looking Statements
This news release contains forward-looking statements that predict or describe future events or trends. The matters described in these forward-looking statements are subject to known and unknown risks, uncertainties and other unpredictable factors, many of which are beyond Vicuron’s control. Vicuron faces many risks that could cause its actual performance to differ materially from the results predicted by its forward-looking statements, including the possibilities that clinical trials and the results thereof might be delayed, or unsuccessful, that the timing of the filing of any new drug application or any amendment to a new drug application might be delayed, that clinical trials might indicate that a product candidate is unsafe or ineffective, that the FDA might require additional information to be submitted and additional actions to be taken before it will make any decision, that any filed new drug application may not be approved by the FDA, that ongoing proprietary and collaborative research might not occur or yield useful results, that the pipeline may not yield a new clinical candidate or a commercial product, that a third party may not be willing to license our product candidates on terms acceptable to us or at all, that competitors might develop superior substitutes for Vicuron’s products or market these competitive products more effectively, that a sales force may not be developed as contemplated and that one or more of Vicuron’s product candidates may not be commercialized successfully. The reports that Vicuron files with the U.S. Securities and Exchange Commission contain a fuller description of these and many other risks to which Vicuron is subject. Because of those risks, Vicuron’s actual results, performance or achievements may differ materially from the results, performance or achievements contemplated by its forward-looking statement. The information set forth in this news release represents management’s current expectations and intentions. Vicuron assumes no responsibility to issue updates to the forward-looking matters discussed in this news release.
# # #
VICURON PHARMACEUTICALS INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share amounts)
| | | | | | | | | | | | | | | | |
| | Three Months Ended
| | | Nine Months Ended
| |
| | September 30, 2004
| | | September 30, 2003
| | | September 30, 2004
| | | September 30, 2003
| |
Revenues: | | | | | | | | | | | | | | | | |
Collaborative research and development and contract services | | $ | 1,692 | | | $ | 2,173 | | | $ | 5,262 | | | $ | 6,054 | |
License fees and milestones | | | 136 | | | | 626 | | | | 411 | | | | 784 | |
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
Total revenues | | | 1,828 | | | | 2,799 | | | | 5,673 | | | | 6,838 | |
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
Operating expenses: | | | | | | | | | | | | | | | | |
Research and development | | | 12,795 | | | | 18,113 | | | | 54,183 | | | | 55,996 | |
General and administrative | | | 4,891 | | | | 4,164 | | | | 16,154 | | | | 9,886 | |
Acquired in-process research and development | | | — | | | | — | | | | — | | | | 94,532 | |
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
Total operating expenses | | | 17,686 | | | | 22,277 | | | | 70,337 | | | | 160,414 | |
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
Loss from operations | | | (15,858 | ) | | | (19,478 | ) | | | (64,664 | ) | | | (153,576 | ) |
| | | | |
Other income (expense): | | | | | | | | | | | | | | | | |
Invesmemt income | | | 448 | | | | 607 | | | | 1,678 | | | | 1,777 | |
Interest expense | | | (16 | ) | | | (43 | ) | | | (69 | ) | | | (155 | ) |
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
Net loss | | $ | (15,426 | ) | | $ | (18,914 | ) | | $ | (63,055 | ) | | $ | (151,954 | ) |
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
Net loss per share: | | | | | | | | | | | | | | | | |
Basic and diluted | | $ | (0.28 | ) | | $ | (0.36 | ) | | $ | (1.16 | ) | | $ | (3.38 | ) |
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
Weighted average shares | | | 54,882 | | | | 52,799 | | | | 54,511 | | | | 44,903 | |
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
VICURON PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
(in thousands)
| | | | | | | | |
| | September 30, 2004
| | | December 31, 2003
| |
ASSETS | | | | | | | | |
Current assets: | | | | | | | | |
Cash and cash equivalents | | $ | 79,576 | | | $ | 113,361 | |
Marketable securities | | | 16,730 | | | | 52,796 | |
Accounts receivable, net | | | 5,013 | | | | 5,533 | |
Prepaid expenses and other current assets | | | 5,689 | | | | 6,329 | |
| |
|
|
| |
|
|
|
Total current assets | | | 107,008 | | | | 178,019 | |
Property, plant and equipment | | | 53,671 | | | | 43,757 | |
Intangible assets, net | | | 23,356 | | | | 23,373 | |
Long-term receivables | | | 11,411 | | | | 9,787 | |
Long-term marketable securities-restricted | | | 2,983 | | | | 3,232 | |
Other assets | | | 328 | | | | 330 | |
| |
|
|
| |
|
|
|
Total assets | | $ | 198,757 | | | $ | 258,498 | |
| |
|
|
| |
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY | | | | | | | | |
Current liabilities: | | | | | | | | |
Accounts payable | | $ | 8,866 | | | $ | 13,986 | |
Accrued liabilities | | | 13,020 | | | | 15,085 | |
Current portion of long-term debt | | | 609 | | | | 2,360 | |
Current portion of deferred revenue | | | 839 | | | | 1,068 | |
| |
|
|
| |
|
|
|
Total current liabilities | | | 23,334 | | | | 32,499 | |
Long-term debt, less current portion | | | 7,386 | | | | 7,493 | |
Deferred revenue, less current portion | | | 1,554 | | | | 1,750 | |
Other long-term liabilities | | | 7,786 | | | | 2,973 | |
| |
|
|
| |
|
|
|
Total liabilities | | | 40,060 | | | | 44,715 | |
| |
|
|
| |
|
|
|
Stockholders’ equity: | | | | | | | | |
Common stock | | | 55 | | | | 54 | |
Additional paid-in capital | | | 528,694 | | | | 518,275 | |
Deferred stock compensation | | | (235 | ) | | | (454 | ) |
Accumulated other comprehensive income | | | 19,962 | | | | 22,632 | |
Accumulated deficit | | | (389,779 | ) | | | (326,724 | ) |
| |
|
|
| |
|
|
|
Total stockholders’ equity | | | 158,697 | | | | 213,783 | |
| |
|
|
| |
|
|
|
Total liabilities and stockholders’ equity | | $ | 198,757 | | | $ | 258,498 | |
| |
|
|
| |
|
|
|