Full Press Release Details
Targeted Genetics Corporation
TARGETED GENETICS REPORTS THIRD QUARTER 2004
- Clinical Programs Remain on Track; Results Expected in First Half of 2005 -
Seattle, WA November 4, 2004 Targeted Genetics Corporation (NASDAQ: TGEN)
today announced its financial results for the third quarter of 2004. As
previously announced, the Company will hold a conference call with analysts
today at 10:30 AM EST. The call will be broadcast live over the Internet and
can be accessed, along with replay information, at www.targetedgenetics.com.
Revenue for the third quarter of 2004 was $2.4 million compared to $5.0 million
for the third quarter of 2003. Revenue for the nine months ended September 30,
2004 decreased to $6.5 million from $12.7 million for the same period of 2003.
Revenues in 2004 reflect amounts earned under the Company s AIDS vaccine
collaboration with the International AIDS Vaccine Initiative (IAVI) and the
Columbus Children s Research Institute, which increased in 2004 compared to
2003, and to a lesser degree contract manufacturing revenue earned in the first
quarter of 2004. Revenue for the three and nine months ending September 30,
2004 decreased compared to the same periods in 2003 as a result of revenues
received in 2003 under the Company s former collaborations with Wyeth and
Biogen that ended in 2003.
One of our primary areas of focus in 2004 has been enrolling patients in our
three core clinical programs, and we continue to make significant progress in
this regard, said H. Stewart Parker, President and Chief Executive Officer of
Targeted Genetics. During the third quarter, we completed patient enrollment
in our AIDS vaccine Phase I clinical trial. We continue to enroll patients in
our rheumatoid arthritis Phase I clinical trial, and we also remain on track to
complete enrollment of our Phase II cystic fibrosis clinical trial by the end
of the year. This puts us in a strong position to present data from these
programs in the first half of 2005, on schedule with our goals.
Ms. Parker continued, At the annual North American Cystic Fibrosis Conference,
Targeted Genetics announced results of planned safety reviews from our ongoing
Phase II cystic fibrosis clinical trial. This analysis, conducted by an
independent Data Monitoring Committee, indicated no safety concerns with the
study thus far. These results follow on the heels of a successful interim
analysis for the same study held in June of this year.
For the quarter ended September 30, 2004, the Company reported a net loss of
$2.7 million, or $0.03 per common share, compared to a net loss of $780,000, or
$0.01 per common share for the third quarter of 2003. For the nine months
ended September 30, 2004, the Company reported a net loss of $12.0 million, or
$0.15 per common share, compared to a net loss of $8.5 million, or $0.16 per
common share for the same period in 2003. Higher losses in 2004 primarily
reflect the absence of revenues from Biogen and Wyeth under collaborations that
Operating expenses were $6.1 million for the third quarter of 2004, compared to
$5.5 million for the third quarter of 2003, and were $19.4 million for the nine
months ended September 30, 2004, down from $20.3 million for the same period in
2003. Expenses in 2004 reflect increased research and development expenses,
primarily attributable to the Company s AIDS vaccine and rheumatoid arthritis
programs and higher general and administrative expenses, reflecting increases
in patent issuances and regulatory compliance costs. Total expenses for the
nine months ended September 30, 2004 decreased as a result of a $3.6 million
charge recorded during the comparable period in 2003, primarily related to the
Company s facility in Bothell, Washington.
Operating results for the quarter and nine months ended September 30, 2004 also
reflect a gain of $1.0 million from the sale of the Company s cell therapy
subsidiary, CellExSys, in July 2004. The sale of CellExSys was intended to
provide a solid infrastructure for the purpose of advancing CellExSys
technology through clinical development with the goal of product
commercialization. These technologies were outside of Targeted Genetics core
focus, and the sale of CellExSys was intended to enable the advancement of the
technologies in a manner that provides Targeted Genetics with an ability to
maintain long-term investment potential.
Recent highlights include:
| Completion of patient enrollment in Targeted Genetics AIDS vaccine Phase I clinical trial; | |||
| Presentation at the North American Cystic Fibrosis Conference in St. Louis, MO; results from an independent Data Monitoring Committee indicating no safety issues in the Company s Phase II cystic fibrosis clinical trial thus far; and | |||
| Completion of sale of CellExSys, providing product development opportunities for CellExSys and long-term investment potential for Targeted Genetics. |
About Targeted Genetics
Targeted Genetics Corporation develops gene-based products for preventing and
treating acquired and inherited diseases. The Company has three clinical
product development programs, targeting cystic fibrosis, AIDS prophylaxis and
rheumatoid arthritis. The Company also has a promising pipeline of product
candidates focused on hemophilia and cancer, and a broad platform of gene
delivery technologies for application in nucleic acid-based drug development.
For more information about Targeted Genetics, visit its website at
NOTE: This release contains forward-looking statements regarding our projected
financial resources, intellectual property, clinical trials and regulatory
filings and anticipated data from our clinical and preclinical programs. These
statements, involve current expectations, forecasts of future events and other
statements that are not historical facts. Inaccurate assumptions and known and
unknown risks and uncertainties can affect the accuracy of forward-looking
statements. Actual results could differ materially from expectations for a
number of reasons, including failure of our partners to provide funding, our
failure to make progress with our clinical trials, our failure to obtain
positive results from our preclinical programs, our failure to obtain or
maintain regulatory approvals, our failure to maintain or protect our
intellectual property and the other risks described in the section entitled
Factors Affecting Our Operating Results, Our Business and Our Stock Price in
our Quarterly Report on Form 10-Q for the quarter ended June 30, 2004. You
should not rely unduly on these forward-looking statements, which apply only as
of the date of this release. We undertake no duty to publicly announce or
report revisions to these statements as new information becomes available that
may change our expectation.
TARGETED GENETICS CORPORATION
(in thousands, except per share information)
| Three months ended | Nine months ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| Statement of Operations Information: | 2004 | 2003 | 2004 | 2003 | ||||||||||||
| Revenue: | ||||||||||||||||
| Collaborative agreements | $ | 2,388 | $ | 5,002 | $ | 6,469 | $ | 12,694 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research development | 4,268 | 3,947 | 13,333 | 12,816 | ||||||||||||
| General administrative | 1,476 | 1,133 | 5,292 | 3,907 | ||||||||||||
| Restructure charges | 381 | 374 | 797 | 3,554 | ||||||||||||
| Total operating expenses | 6,125 | 5,454 | 19,422 | 20,277 | ||||||||||||
| Loss from operations | (3,737 | ) | (452 | ) | (12,953 | ) | (7,583 | ) | ||||||||
| Gain on sale of majority-owned subsidiary | 1,006 | 1,006 | ||||||||||||||
| Investment income | 123 | 38 | 268 | 146 | ||||||||||||
| Interest expense | (116 | ) | (366 | ) | (353 | ) | (1,088 | ) | ||||||||
| Net loss | $ | (2,724 | ) | $ | (780 | ) | $ | (12,032 | ) | $ | (8,525 | ) | ||||
| Net loss per common share | $ | (0.03 | ) | $ | (0.01 | ) | $ | (0.15 | ) | $ | (0.16 | ) | ||||
| Shares used in computation of net loss per common share | 81,629 | 61,270 | 78,713 | 54,549 |
TARGETED GENETICS CORPORATION
| September 30, | December 31, | |||||||
| Balance Sheet Information: | 2004 | 2003 | ||||||
| (unaudited) | ||||||||
| Cash and cash equivalents | $ | 31,333 | $ | 21,057 | ||||
| Other current assets | 782 | 575 | ||||||
| Property and equipment, net | 2,756 | 3,423 | ||||||
| Other assets | 32,512 | 32,617 | ||||||
| Total assets | $ | 67,383 | $ | 57,672 | ||||
| Current liabilities | $ | 4,848 | $ | 6,709 | ||||
| Long-term obligations and other liabilities | 16,533 | 16,734 | ||||||
| Minority interest | 750 | |||||||
| Shareholders equity | 46,002 | 33,479 | ||||||
| Total liabilities and shareholders equity | $ | 67,383 | $ | 57,672 |