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Curis Reports First Quarter 2005 Results CAMBRIDGE, MA

Key Takeaway: Curis Reports First Quarter 2005 Results CAMBRIDGE, MA, April 26, 2005 - Curis, Inc. (NASDAQ:CRIS), a therapeutic drug development company, today reported its financial results for the first quarter ended March 31, 2005. For the first quarter of 2005, we reported a net loss of

Full Press Release Details

Curis Reports First Quarter 2005 Results
CAMBRIDGE, MA, April 26, 2005 - Curis, Inc. (NASDAQ:CRIS), a therapeutic drug
development company, today reported its financial results for the first quarter ended March 31, 2005.
For the first quarter of 2005, we reported a net loss of $5,113,000 or ($0.11) per share, as compared to a net loss of $4,038,000 or ($0.10) per share for the prior year period.
Net revenues for the first quarter of 2005 were ($533,000) as compared to $856,000 for the
same period of 2004, a decrease of $1,389,000 or 162%. The decrease in net revenues was due to contra-revenues recorded under our basal cell carcinoma co-development arrangement with Genentech (NYSE: DNA), partially offset by increases in revenues
recognized under our collaborations and research grant. Revenues are summarized by type and by corporate collaborator in the following table:
For the Quarter Ended March 31,
2005 2004
Gross revenues:
Genentech $ 1,252,000 $ 463,000
Wyeth 932,000 343,000
Spinal Muscular Atrophy Foundation 588,000
Other 50,000
Subtotal 2,772,000 856,000
Contra-revenue:
Genentech co-development contra-revenue (3,305,000 )
Net revenues $ (533,000 ) $ 856,000
Gross revenues generated under our
ongoing collaborations with Genentech and Wyeth (NYSE: WYE), as well as our grant from the Spinal Muscular Atrophy Foundation, were $2,772,000 for the first quarter of 2005 as compared to $856,000 for the same period in prior year, an increase of
$1,916,000, or 224%.
As required under accounting rules outlined in Emerging
Issues Task Force No. 01-9, we recorded contra-revenue for amounts that we paid to Genentech during the first quarter of 2005 and for amounts that we owed to Genentech as of March 31, 2005 that were paid subsequent to the end of the quarter for the
reimbursement of our equal share of costs incurred by Genentech in connection with the co-development of our topical therapeutic basal cell carcinoma product
candidate. These contra-revenues offset gross revenues recorded under our collaborations and research grant. Amounts paid by us to Genentech under the
co-development arrangement will be recorded as contra-revenue up to the amount of cumulative revenue recognized by us under our collaborations with Genentech. For any co-development costs that are in excess of this cumulative revenue total, we will
first record our co-development costs against any remaining Genentech-related deferred revenue on our balance sheet and then record such costs as research and development expenses at the operating expenses section of our statement of operations.
Operating expenses for the first quarter of 2005 were $4,783,000 as compared
to $5,043,000 for the first quarter of 2004, a decrease of $260,000, or 5%. The primary changes are as follows:
Research and development: Research and development expenses were $3,116,000 for the first quarter of 2005 as compared to $2,808,000 for the same
period in the prior year, an increase of $308,000, or 11%. This increase was primarily attributable to an increase in spending related to our Spinal Muscular Atrophy, or SMA, program. This increase was partially offset by modest decreases in
spending on our other programs. Our SMA research program is funded under a grant from the SMA Foundation that we were awarded in September 2004.
General and administrative: General and administrative expenses were $1,698,000 for the first quarter of 2005 as compared to $1,915,000 for the
same period in the prior year, a decrease of $217,000, or 11%. This decrease was attributable to decreases in our administrative costs, including reductions in personnel, occupancy and depreciation, insurance, and certain other expenses.
Stock-based compensation: Stock-based compensation expense was
($50,000) for the first quarter of 2005 as compared to $302,000 for the first quarter of 2004, a decrease of $352,000, or 117%. This decrease was primarily attributable to a decrease in stock-based compensation expense recorded on options to
purchase common stock that were issued to employees with below fair market value exercise prices in August 2000. These options became fully vested in August 2004. Accordingly, no expense was recorded related to these options for the first quarter of
As of March 31, 2005, cash, cash equivalents, marketable securities and
investments, including long-term investments, were $46,944,000. As of March 31, 2005, there were 47,882,876 shares of common stock outstanding.
Regarding Curis financial outlook for the year 2005, Michael Gray, Vice President of Finance and Chief Financial Officer for Curis commented, We believe that existing cash, cash equivalents, marketable
securities and investments, together with contractually defined cash payments that we expect to receive under our collaborations with Genentech and Wyeth and our research grant with the SMA Foundation, will be sufficient to support our current
operating plans into mid-2007. We expect to end 2005 with cash, cash equivalents, marketable securities and investments of between $36,000,000 and $39,000,000, and we will seek to continue to carefully manage our cash consumption. Further, assuming
that our current collaborations continue through 2005, we expect that our gross revenues from our existing collaborators will be in a range of $11,000,000 to $13,000,000, excluding any future development milestones. We expect that 2005 costs for our
basal cell carcinoma product candidate will be in a range of
$8,500,000 to $9,000,000 and that all of these costs will be recorded as contra-revenue. Lastly, we expect that our 2005 research and development expenses
will be between $13,000,000 and $15,000,000 and our general and administrative expenses will be in a range of $7,500,000 and $9,000,000.
Second major collaboration with Genentech: On April 1, 2005, we entered into a second major collaboration with Genentech. This new collaboration, in which we will work exclusively with Genentech,
involves the discovery and development of small molecule modulators of an undisclosed signaling pathway that plays an important role in cell proliferation. This pathway is a key regulator of tissue formation and repair, and its abnormal activation
is associated with certain cancers.
Under the terms of the new agreement,
Genentech has committed to pay us an up-front license fee of $3,000,000 and up to an additional $6,000,000 over the next two years to support research at Curis dedicated to the collaboration. The agreement also provides for Genentech to make cash
payments to us contingent upon the successful achievement of certain developmental, clinical, and drug approval milestones. Genentech will also pay a royalty on net product sales if product candidates derived from the collaboration are successfully
developed. Assuming that the collaboration continues for its full term and that specified research, development and regulatory approval objectives are achieved, the total potential cash payments to us from the transaction could exceed $140,000,000
(if two products are commercialized in two indications each), excluding royalties on potential net product sales.
Extension of Funding under Hedgehog Collaboration with Genentech: On April 13, 2005, we amended our Hedgehog collaboration agreement with Genentech, which
was originally entered into in June 2003, to extend Genentech s funding of the cancer therapeutic development collaboration that is ongoing between the two companies. An additional $2,000,000 payment will be made in December 2005 to support
Curis efforts to continue to develop Hedgehog inhibition technologies for the treatment of solid tumor cancers. Genentech s research and development funding under the collaboration was due to terminate in June 2005. The amended agreement
provides for a six-month extension of support for Curis personnel with an option for an additional six-month extension.
First Quarter 2005 Highlights
Daniel Passeri, Curis President and Chief Executive Officer, stated, The progress that we have achieved to date in 2005 is, I believe, indicative of the
clinical and commercial promise of Curis approach, our scientific expertise and business strategy. The filing by Genentech of an IND for our basal cell carcinoma product candidate, the new collaboration entered into with Genentech, the
extension of our research and development funding under our existing Hedgehog antagonist collaboration with Genentech, and our achievement of a preclinical milestone under our collaboration with Wyeth, each provide evidence that we continue to
advance our product development programs.
We will hold a conference call
today, April 26, 2005, at 10:00 A.M. EDT, to discuss our financial results, our recent collaboration with Genentech, the progress of our therapeutic product development programs, and additional corporate activities. Daniel Passeri, President and
Chief Executive Officer of Curis, will host the call.
conference call, please call 800-329-9097 from the United States or Canada or 617-614-4929 from other locations, shortly before 10:00 A.M. The conference ID number is 76295624. Replay will be available approximately two hours after the completion of
the call and through 5:00 P.M. EDT, Tuesday, May 10, 2005. To access the replay, please call 888-286-8010 from the United States or Canada or 617-801-6888 from other locations and reference the conference ID number 66419694.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three-months ended March 31,
2005 2004
Gross Revenues $ 2,771,771 $ 855,805
Contra-revenues from co-development with Genentech (3,304,502 )
Net revenues (532,731 ) 855,805
Operating expenses:
Research and development 3,116,188 2,807,835
General and administrative 1,697,864 1,915,149
Stock-based compensation (49,733 ) 301,701
Amortization of intangible assets 18,768 18,768
Total operating expenses 4,783,087 5,043,453
Loss from operations (5,315,818 ) (4,187,648 )
Other income, net 202,877 149,829
Net loss $ (5,112,941 ) $ (4,037,819 )
Basic and diluted net loss per common share $ (0.11 ) $ (0.10 )
Weighted average common shares for basic and diluted net loss computation 47,846,903 41,105,756
CONDENSED CONSOLIDATED BALANCE SHEETS
March 31, 2005 December 31, 2004
ASSETS
Cash, cash equivalents, marketable securities and long-term investments $ 46,944,000 $ 52,120,643
Cash equivalents restricted 193,166 193,166
Accounts receivable 2,089,904 1,226,460
Property and equipment, net 4,165,719 3,416,620
Intangible assets, net 9,065,353 9,084,122
Other assets 1,775,083 1,593,802
Total assets $ 64,233,225 $ 67,634,813
LIABILITIES AND STOCKHOLDERS EQUITY
Accounts payable and accrued expenses $ 4,005,485 $ 2,992,964
Debt, excluding convertible debt 2,251,595 1,141,294
Convertible debt 2,460,325 5,710,007
Deferred revenue 8,407,804 8,881,253
Total liabilities 17,125,209 18,725,518
Total stockholders equity 47,108,016 48,909,295
Total liabilities and stockholders equity $ 64,233,225 $ 67,634,813
Curis, Inc. is a therapeutic drug development company. The Company s technology focus is on regulatory pathways that control repair and regeneration. Curis
product development involves the use of proteins or small molecules to modulate these pathways. Curis 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, which also includes a co-development arrangement for a basal cell carcinoma product candidate), kidney disease (licensed to Ortho Biotech Products, a subsidiary of Johnson & Johnson), neurological disorders
(under collaboration with Wyeth), hair growth, and cardiovascular disease. For more information, please visit the Curis web site at www.curis.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements concerning
Curis expectations regarding the potential outcome of its business strategies, its plans with respect to its product development programs, the potential effectiveness of its technologies under development and the Company s financial
outlook for 2005, including its expected year-end and future period cash position, revenues, contra-revenues, and operating expenses . Forward-looking statements used in this press release may contain the words believes ,
expects , anticipates , plans , seeks , estimates or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions
and other factors that may cause Curis actual results to be materially different from those indicated by such forward-looking statements. Actual results can be affected by a number of important factors including, among other things: adverse
results in Curis and its strategic collaborators and licensees product development programs; difficulties or delays in obtaining or maintaining required regulatory approvals for products being developed by Curis and its
collaborators and licensees; Curis ability to obtain or maintain the patent and other proprietary intellectual property protection necessary for the development and commercialization of products based on its technologies; changes in or
Curis inability to execute its business plan; the risk that Curis does not obtain the additional funding required to conduct research and development of its product candidates, fund its co-development obligations under its collaboration with
Genentech and execute its business plan; unplanned cash requirements and expenditures; risks relating to Curis ability to enter into and maintain important strategic collaborations, including its ability to maintain its current collaboration
agreements with Genentech, Ortho Biotech Products and Wyeth; the risk that competitors will discover and develop signaling pathway-based or other competing therapeutics faster and more successfully than Curis and its collaborators are able to; and
other risk factors identified in Curis most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent reports periodically filed with the Securities and Exchange Commission. 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. Curis 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.
Chief Financial Officer
Last updated: Apr 26, 2005