Full Press Release Details
| For More Information: | ||||
| Michael P. Gray | Jenny Viscarolasaga | |||
| Chief Financial Officer | For Curis, Inc. | |||
| Curis, Inc. | 617-503-6658 | |||
| 617-503-6632 | Jenny@tworoadscommunications.com | |||
| mgray@curis.com |
Curis Reports Third Quarter 2006 Financial Results
CAMBRIDGE, Mass., November 9, 2006 - Curis, Inc. (NASDAQ:CRIS), a therapeutic drug development company focusing on cancer, neurological and
dermatological disease indications, today reported its financial results for the third quarter ended September 30, 2006.
For the third quarter of
2006, Curis reported a net loss of $1,537,000, or ($0.03) per share, as compared to a net loss of $3,251,000 or ($0.07) per share for the same period in the prior year.
Net revenues for the third quarter of 2006 were $4,270,000 as compared to $2,065,000 for the third quarter of 2005, an increase of $2,205,000. The increase in net revenues was primarily due to the recording of
$2,284,000 of license revenue as part of a settlement agreement with Micromet, a former collaborator, and a $464,000 decrease in contra-revenues recorded under the Company s basal cell carcinoma co-development arrangement with Genentech. The
Company elected to cease its participation in co-development on August 31, 2006, and does not expect to incur any further costs related to the basal cell carcinoma program. The increase to net revenues was partially offset by a decrease in
revenues recorded under the Company s ongoing collaborative relationships. Such revenues decreased by $481,000 to $2,341,000 during the third quarter of 2006 from $2,822,000 during the same period in 2005.
Operating expenses for the third quarter of 2006 were $5,972,000 as compared to $5,543,000 for the third quarter of 2005, an increase of $429,000, or 8%. The primary
changes in research and development and general and administrative expenses are as follows:
Research and development spending decreased
slightly to $3,669,000 for the third quarter of 2006 as compared to $3,691,000 for the same period in 2005. Spending increases related to a new preclinical program focusing on multi-targeted inhibitors of validated cancer pathways were offset by
decreases in spending on Curis s other research programs.
General and administrative spending was $2,302,000 for the third quarter of
2006 as compared to $1,833,000 for the same period in 2005, an increase of $469,000, or 26%. The increase in general and administrative expenses was principally due to an increase of $639,000 in stock-based compensation expense during the third
quarter of 2006 as a result of the Company s adoption on January 1, 2006 of Statement of Financial Accounting Standards No. 123R, Share-Based Payments (SFAS 123R).
In addition, consulting and professional service fees increased $118,000 in the third quarter of 2006 as
compared to the same prior year period due to costs associated with the formation of the Company s Chinese subsidiary, Curis Shanghai. Offsetting this increase, the third quarter of 2006 includes a $256,000 decrease in patent-related legal
For the first nine months of 2006, the Company reported a net loss of $9.5 million dollars or ($0.19) per share, as compared to a net loss of
$13.5 million dollars or ($0.28) per share for the prior year period.
Net revenues for the nine months ended September 30, 2006 were $8,868,000 as
compared to $2,493,000 for the same period of 2005, an increase of $6,375,000. The increase in net revenues in the 2006 period was due to a $3,970,000 decrease in contra-revenues recorded under the Company s discontinued basal cell carcinoma
co-development arrangement with Genentech in 2006 as compared to 2005 and $2,284,000 in license revenue recognized as part of a settlement agreement with Micromet.
Operating expenses were $19,172,000 and $16,607,000 for the nine-month periods ended September 30, 2006 and 2005, respectively. The $2,565,000, or 15%, increase in the Company s research and development and general and
administrative expenses was due to the following:
Research and development expenses were $10,994,000 for the nine months ended
September 30, 2006 as compared to $10,410,000 for the same period in the prior year, an increase of $584,000, or 6%. The increase was primarily due to an increase in stock-based compensation expense of $638,000. The Company s spending in
research remained consistent from period to period.
General and administrative expenses were $8,150,000 for the nine months ended
September 30, 2006 as compared to $6,141,000 for the same period in the prior year, an increase of $2,009,000, or 33%. The increase in general and administrative expenses was principally due to an increase of $2,028,000 in stock-based
compensation expense.
As of September 30, 2006, Curis had cash, cash equivalents, marketable securities and investments of $35,187,000 and there were
49,164,945 shares of common stock outstanding. The Company currently expects that it will end 2006 with between $34,000,000 and $36,000,000 in cash. If this expectation is met, the Company s cash, cash equivalents, marketable securities and
investments will have decreased $8,000,000 to $10,000,000 from the balances at the end of 2005.
We ve accomplished many important objectives
over the past several months, said Dan Passeri, President and Chief Executive Officer of Curis. Our collaboration partner Genentech filed an IND based on our Hedgehog antagonist technologies for the systemic treatment of cancers, and we
have also made significant progress with our internal preclinical multi-target inhibitor cancer programs. We anticipate completing in vivo efficacy testing during the fourth quarter of 2006 and hope to select a lead clinical candidate during the
first half of 2007. We re also looking forward in the first half of 2007 to the potential selection of a lead clinical candidate under our topical Hedgehog agonist program in collaboration with Procter & Gamble, as well as a potential
2007 lead candidate selection under our collaboration with Wyeth.
Recent Developments and Third Quarter 2006 Highlights
The Phase I trial is designed as
an open-label study of a systemic Hedgehog antagonist in patients with locally advanced or metastatic cancers that are refractory to standard therapy or for whom no standard therapies exist. The primary objectives of the Phase I trial are to
evaluate the safety and tolerability of escalating doses of the Phase I molecule and to establish the maximum tolerable dose and dose limiting toxicities. The trial is expected to enroll approximately 50 patients spread across several
dose-escalating cohorts. The successful completion of the Phase I trial will be dependent upon, among other things, the patient enrollment rate as well as the number of patients that will ultimately need to be treated to achieve the Phase I trial
These new drug programs are currently in preclinical testing. Curis will seek to progress several classes of compounds
simultaneously through preclinical development. Assuming successful preclinical development, Curis expects to select a lead clinical candidate during the first half of 2007 and to file an IND by the end of 2007.
The Company will hold a conference call today, November 9, 2006, at 10:00 A.M. EST, to discuss its financial results, the progress of its therapeutic product
development programs, and additional corporate activities. Daniel Passeri, President and Chief Executive Officer of Curis, will host the call.
the live conference call, please call (866) 362-4820 from the United States and Canada or (617) 597-5345 from other locations, shortly before 10:00 a.m. EST. The conference ID number is 46213398. Replay will be available approximately two
hours after the completion of the call and through 5:00 P.M. EST, Monday, November 23, 2006. To access the replay, please call (888) 286-8010 from the United States and Canada or (617) 801-6888 from other locations and reference the
conference ID number 40802994.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2006 | 2005 | 2006 | 2005 | |||||||||||||
| Revenues: | ||||||||||||||||
| Gross revenues | $ | 4,625,874 | $ | 2,884,616 | $ | 10,595,479 | $ | 8,190,993 | ||||||||
| Contra-revenues from co-development with Genentech | (355,435 | ) | (819,491 | ) | (1,727,727 | ) | (5,697,993 | ) | ||||||||
| Net revenues | 4,270,439 | 2,065,125 | 8,867,752 | 2,493,000 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 3,669,368 | 3,691,261 | 10,994,327 | 10,409,583 | ||||||||||||
| General and administrative | 2,302,469 | 1,832,802 | 8,150,372 | 6,141,013 | ||||||||||||
| Amortization of intangible assets | 18,768 | 27,050 | 56,304 | |||||||||||||
| Total operating expenses | 5,971,837 | 5,542,831 | 19,171,749 | 16,606,900 | ||||||||||||
| Net loss from operations | (1,701,398 | ) | (3,477,706 | ) | (10,303,997 | ) | (14,113,900 | ) | ||||||||
| Other income, net | 164,771 | 226,365 | 794,181 | 623,308 | ||||||||||||
| Net loss | $ | (1,536,627 | ) | $ | (3,251,341 | ) | $ | (9,509,816 | ) | $ | (13,490,592 | ) | ||||
| Basic and diluted net loss per common share | $ | (0.03 | ) | $ | (0.07 | ) | $ | (0.19 | ) | $ | (0.28 | ) | ||||
| Basic and diluted weighted average common shares outstanding | 49,146,609 | 48,178,626 | 49,012,538 | 47,998,663 |
CONDENSED CONSOLIDATED BALANCE SHEETS
| September 30, 2006 | December 31, 2005 | |||||
| ASSETS | ||||||
| Cash, cash equivalents, marketable securities | $ | 35,187,362 | $ | 44,209,322 | ||
| Long-term investments restricted | 201,844 | 195,998 | ||||
| Accounts and notes receivable | 3,009,543 | 1,002,511 | ||||
| Property and equipment, net | 4,452,842 | 5,347,639 | ||||
| Intangible assets, net | 8,982,000 | 9,009,050 | ||||
| Other assets | 956,355 | 1,149,733 | ||||
| Total assets | $ | 52,789,946 | $ | 60,914,253 | ||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||
| Accounts payable, accrued expenses and other liabilities | $ | 3,962,687 | $ | 5,088,998 | ||
| Debt obligations, excluding convertible debt | 2,289,489 | 3,226,712 | ||||
| Convertible debt | 2,605,280 | |||||
| Deferred revenue | 12,418,466 | 11,993,684 | ||||
| Total liabilities | 18,670,642 | 22,914,674 | ||||
| Total stockholders equity | 34,119,304 | 37,999,579 | ||||
| Total liabilities and stockholders equity | $ | 52,789,946 | $ | 60,914,253 |
Curis, Inc. is a therapeutic drug development company focusing on cancer, neurological and dermatological disease indications, with technologies that utilize regulatory pathways that control repair and regeneration. Curis product
development involves the use of small molecules or proteins to modulate these pathways. The company has successfully used this technology and product development approach to produce several promising drug product candidates in the fields of cancer
(under collaboration with Genentech, as well as new proprietary cancer programs that target multiple validated cancer pathways), neurological disorders (under collaboration with Wyeth), hair growth (under collaboration with Procter &
Gamble), kidney and other diseases (licensed to Ortho Biotech Products and under development at Centocor, both subsidiaries of Johnson & Johnson), and cardiovascular disease. For more information, please visit www.curis.com.
Cautionary Statement: This press release
contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements concerning Curis guidance regarding year end cash balances and total year cash decline, Curis
projections regarding the completion of efficacy testing, lead candidate selection and IND filing for its lead internal programs, the expected efficacy of its new internal programs and the Company s expectations about future advances in its
programs with Wyeth and Procter & Gamble. Forward-looking statements used in this press release may contain the words believes , expects , anticipates , plans , seeks ,
estimates, should or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other factors that may cause the Company s actual
results to be materially different from those indicated by such forward-looking statements including, among other things:
In addition, any forward-looking statements represent the Company s views only as of today and
should not be relied upon as representing its views as of any subsequent date. The Company disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new
information, future events or otherwise.