CAMBRIDGE, Mass., Feb 14, 2008 (BUSINESS WIRE) -- Curis, Inc. (NASDAQ:CRIS), a drug development company focused on
developing novel targeted medicines primarily for cancer treatment,
today reported its financial results for the fourth quarter and fiscal
year ended December 31, 2007.
"2007 has been a year of transformation for Curis, as we have made
substantial progress toward our goal of transitioning from a
discovery-stage biology company to a development-stage targeted small
molecule cancer company," commented Daniel Passeri, MSc., J.D.,
President and Chief Executive Officer of Curis. "We expect to continue
to build on this momentum in 2008, as we seek to continue to grow and
advance our portfolio of cancer drug candidates, with several key
milestones expected throughout the year."
"We were pleased with the recent announcement by our collaborator
Genentech that regression has been observed in one patient with an
established metastatic basal cell tumor in its Phase I Hedgehog
antagonist clinical trial. We believe that this early evidence of
clinical activity is important and demonstrates possible proof of
concept for this program. Additionally, we expect that Genentech will
submit the Phase I data for presentation at an upcoming scientific
conference," continued Mr. Passeri.
Financial Results
For the fourth quarter of 2007, Curis reported net income of $4.3
million or $0.07 per share, as compared to net income of $700,000 or
$0.01 per share for the same period in the prior year.
Net revenues for the fourth quarter of 2007 were $11.5 million as
compared to $6.1 million for the fourth quarter of 2006. The reasons
for the increase in net revenues are detailed below:
-- Increase in license fee revenue. During the fourth quarter of
2007, license fee revenues were $11.0 million as compared to
$1.1 million for the same period in 2006. The increase is
primarily the result of the recognition of $10.5 million in
previously deferred revenue under the June 2003 Hedgehog
antagonist collaboration with Genentech. Prior to the fourth
quarter of 2007, the Company could not estimate the
performance period related to its ongoing joint steering
committee obligation under this collaboration and therefore
deferred $7.5 million in payments that Curis had received from
Genentech in prior years. During the fourth quarter of 2007,
as a result of changed facts and circumstances relating to the
nature of the joint steering committee, including the
Company's diminished role on the steering committee as the
program advanced into clinical testing, the Company concluded
that its joint steering committee performance obligation had
become inconsequential to the agreement. Accordingly, during
the fourth quarter of 2007 Curis recorded as license fee
revenues the $7.5 million in previously deferred revenues as
well as a $3 million cash payment received in October 2007.
-- Decrease in research and development contracts revenue.
Revenue under research and development contracts was $500,000
for the fourth quarter of 2007 as compared to $2.0 million for
the same period in the prior year. This decrease was primarily
the result of the conclusion of sponsored research funding
during the fourth quarter of 2006 and first quarter of 2007
under the ongoing Hedgehog antagonist and Wnt signaling
pathway collaborations with Genentech.
-- Milestone revenue. Curis recorded $3.0 million in substantive
milestone revenue during 2006 under its Hedgehog antagonist
collaboration with Genentech. The Company did not record any
substantive milestone revenue during the fourth quarter of
2007.
Operating expenses for the fourth quarter of 2007 were $7.7
million as compared to $5.8 million for the same period in the prior
year. The primary changes in research and development and general and
administrative expenses are as follows:
-- Research and Development. Research and development spending
was $5.2 million for the fourth quarter of 2007 as compared to
$3.6 million for the same period in the prior year. Included
in the fourth quarter 2007 research and development expenses
was $900,000 in license fee payments, $750,000 of which was
made to a former collaborator as a result of the Company's
December 2007 BMP-7 transaction with Stryker Corporation.
The Company incurred expenses of $2.6 million during the fourth
quarter of 2007 related to development efforts for its lead
preclinical drug candidate, CUDC-101, $1.5 million of which
related to toxicology testing of the molecule in support of
Curis' planned IND application filing in 2008. The Company also
incurred expenses of approximately $1.1 million during the fourth
quarter of 2007 to advance earlier stage candidates under the
Company's targeted cancer platform. The Company incurred expenses
of approximately $1.0 million on these efforts during the fourth
quarter of 2006.
Offsetting the Company's increased expenses relating to its
targeted cancer drug candidates was a decline in spending on all
other programs of $1.5 million as funded research under most of
its collaborations concluded in late 2006 or early 2007. Spending
under such programs was $600,000 for the fourth quarter of 2007
as compared to $2.1 million for the prior year period.
-- General and Administrative. General and administrative
spending was $2.4 million for the fourth quarter of 2007 as
compared to $2.2 million for the same period in 2006. The
increase in general and administrative expenses was primarily
due to a $300,000 increase in legal expenses primarily related
to the Company's patent portfolio and a $100,000 increase in
personnel expenses. These increases were offset by decreases
of $100,000 in stock-based compensation as a result of a
decline in the grant date fair value of stock options issued
in 2007 as compared to 2006 as well as a decrease of $100,000
in consulting and other professional services expenses.
For the year ended December 31, 2007, the Company reported a net
loss of $7.0 million or ($0.13) per share, as compared to a net loss
of $8.8 million or ($0.18) per share for the prior year.
Net revenues for the year ended December 31, 2007 were $16.4
million as compared to $14.9 million for the prior year. The increase
in net revenues was primarily the result of the recognition of $10.5
million in license revenue related to the June 2003 Hedgehog
antagonist collaboration with Genentech, offset by decreases in
research and development contract revenues and substantive milestone
revenues.
Operating expenses were $24.8 million for the year ended December
31, 2007 as compared to $25.0 million for the prior year.
Research and development expenses were $14.8 million for the year
ended December 31, 2007 as compared to $14.6 million for the prior
year. This is the result of several offsetting variances in research
and development programs, primarily related to increased efforts on
CUDC-101 and other targeted cancer drug programs, offset by the
reduced spending on other research programs, as funded research under
most of the Company's collaborations concluded in late 2006 or early
2007. The Company spent $5.1 million during 2007 on development
efforts related to CUDC-101. The Company also spent approximately $4.9
million during 2007 to advance earlier stage candidates under its
targeted cancer platform, as compared to $2.1 million during 2006.
Spending under other programs was $3.8 million for 2007 as compared to
$11.2 million for the prior year.
General and administrative expenses were $10.0 million for the
year ended December 31, 2007 as compared to $10.4 million for the
prior year. This decrease is attributable to decreases in occupancy
costs, professional and consulting services and stock based
compensation expenses offset by increased spending related to legal
services for the Company's patent portfolio.
As of December 31, 2007, the Company's cash, cash equivalents and
marketable securities totaled $41.5 million and there were 63.2
million shares of common stock outstanding.
"In 2007, we strengthened our financial position through a $14.5
million private placement, and looking forward, we are actively
seeking collaborative opportunities for our developing pipeline,
focusing especially on our proprietary targeted cancer drug
candidates," commented Michael Gray, Chief Financial Officer and Chief
Operating Officer of Curis.
2008 Expected Milestones
-- Genentech's Phase II clinical trial initiation of a Hedgehog
systemic antagonist under the parties' 2003 collaboration
agreement in the first half of 2008.
-- File an IND application for CUDC-101, a preclinical stage
inhibitor of HDAC, EGFR and Her2, during the first quarter of
2008 and begin treating patients in a Phase I clinical trial
during the second quarter of 2008.
-- Select one to two additional preclinical development drug
candidates from the Company's proprietary targeted cancer
platform in 2008.
-- Enter into a new collaboration in 2008. The Company currently
plans to pursue an Asia territory partnering strategy for
CUDC-101 in order to retain proprietary development of
CUDC-101 in the majority of the worldwide markets into at
least early clinical testing and is also pursuing a
collaboration for one or more of the earlier stage targeted
cancer programs. The Company expects to announce a new
collaboration for one of these programs in 2008.
Financial Guidance
The Company expects to end 2008 with cash, cash equivalents and
marketable securities of $17-21 million, which excludes any potential
payments from existing or new collaborators in 2008. The Company
expects that the existing cash, cash equivalents and marketable
securities will be sufficient to support the current operating plans
into the second half of 2009.
The Company expects that 2008 research and development expenses
will be $16-19 million and that general and administrative expenses
will be $8-10 million. These expense projections include $500,000 to
$700,000 and $1.2-1.4 million of stock-based compensation expense for
research and development and general and administrative expense,
respectively. Actual 2008 stock-based compensation expense may be
higher since the Company may issue additional awards as part of its
planned compensation programs, consistent with past practices.
Fourth Quarter and Recent Highlights
-- Genentech Updates on Hedgehog Program. During the fourth
quarter of 2007 and in January 2008, Curis' collaborator
Genentech publicly provided several important updates on the
Phase I Hedgehog antagonist program. First, during the fourth
quarter of 2007, Genentech disclosed to the Company that the
initial objectives of the Phase I clinical trial had been
achieved and that Genentech had initiated an expansion cohort
in its ongoing Phase I clinical trial, which is enrolling
additional patients in a specific cancer indication for
preliminary signs of clinical response as well as the
continued accumulation of Phase I safety data. As a result of
the trial expansion, Curis received a $3 million cash
milestone payment from Genentech. Genentech also notified
Curis of its decision to progress a systemically administered
Hedgehog antagonist drug candidate into Phase II clinical
testing in 2008. The drug candidate is expected to be
evaluated in one or more solid tumor indications.
-- Sale of BMP Assets to Stryker. In December 2007, Curis entered
into a transaction with Stryker Corporation for the sale and
assignment of all of the remaining BMP assets. Under this
agreement, the Company received an initial payment of $1.75
million. As a result of the transaction, Stryker will assume
all future costs subsequent to the December 26, 2007 effective
date related to maintenance and prosecution of the patent
portfolio. The Company has deferred revenue recognition on the
initial payment until it completes its performance obligations
under the agreement. The Company estimates that such
obligations will be fulfilled, and that it will record the
up-front payment as revenue, during the first quarter of 2008.
As a result of this transaction, the Company paid $750,000 in
January 2008 to a former collaborator.
-- CUDC-101 Poster at AACR-NCI-EORTC. In October 2007, Curis
scientists presented a poster entitled "CUDC-101, a Synthetic
and Potent HDAC, EGFR and Her2 Inhibitor, Effectively Inhibits
Proliferation of Cancer Cell Lines" during a poster session at
the AACR-NCI-EORTC Conference on Molecular Targets and Cancer
Therapeutics. This presentation included discussions of a
potential mechanism of action and the anticancer properties of
CUDC-101.
Conference Call
Curis management will hold a conference call today, February 14,
2008, at 9:00 A.M. EST, to discuss the progress of CUDC-101, the other
targeted inhibitors that the Company is developing under the Targeted
Cancer Drug Development Platform, the product development programs
under collaborations, the financial results and additional corporate
activities. The Company's CEO, Daniel Passeri, will host the call.
To access the live conference call, please call (866) 356-3377
from the United States or Canada or (617) 597-5392 from other
locations, shortly before 9:00 A.M. EST. The conference ID number is
14512747. The conference call also can be accessed on the Curis
website at www.curis.com in the Investors section. A replay will be
available approximately two hours after the completion of the call and
through 5:00 P.M. EST, Thursday, February 28, 2008. 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 38258302.
CURIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
Three months ended Year ended
December 31, December 31,
2007 2006 2007 2006
----------- ----------- ------------ -------------
Revenues:
Gross revenues $11,484,842 $ 6,067,883 $16,388,554 $ 16,663,364
Contra-revenues
from co-
development with
Genentech - - - (1,727,727)
----------- ----------- ------------ -------------
Net revenues 11,484,842 6,067,883 16,388,554 14,935,637
----------- ----------- ------------ -------------
Operating expenses:
Research and
development 5,233,357 3,595,319 14,779,184 14,589,647
General and
administrative 2,441,686 2,223,515 9,983,931 10,373,883
Amortization of
intangible
assets - - - 27,050
--------------------------------------------------
Total
operating
expenses 7,675,043 5,818,834 24,763,115 24,990,580
----------- ----------- ------------ -------------
Net income/(loss)
from operations 3,809,799 249,049 (8,374,561) (10,054,943)
----------- ----------- ------------ -------------
Other income, net 482,575 431,445 1,410,318 1,225,621
----------- ----------- ------------ -------------
Net income/(loss) $ 4,292,374 $ 680,494 $(6,964,243) $ (8,829,322)
=========== =========== ============ =============
Basic and diluted
net income/(loss)
per common share $ 0.07 $ 0.01 $ (0.13) $ (0.18)
=========== =========== ============ =============
Basic weighted
average common
shares outstanding 63,180,451 49,240,712 54,914,666 49,066,680
=========== =========== ============ =============
Diluted weighted
average common
shares outstanding 63,206,837 49,422,874 54,914,666 49,066,680
=========== =========== ============ =============
CURIS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
December 31, December 31,
2007 2006
------------ ------------
ASSETS
Cash, cash equivalents and marketable
securities $41,459,176 $36,656,007
Long-term investments - restricted 210,007 201,844
Accounts receivable 230,467 1,315,412
Property and equipment, net 2,577,602 4,393,604
Goodwill 8,982,000 8,982,000
Other assets 357,433 719,386
------------ ------------
Total assets $53,816,685 $52,268,253
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable, accrued expenses and other
liabilities $ 4,715,772 $ 3,504,659
Debt obligations 403,832 1,979,622
Deferred revenue 1,852,518 10,886,833
------------ ------------
Total liabilities 6,972,122 16,371,114
Total stockholders' equity 46,844,563 35,897,139
------------ ------------
Total liabilities and stockholders' equity $53,816,685 $52,268,253
============ ============
About Curis, Inc.
Curis is a drug development company that is committed to
leveraging the innovative signaling pathway drug technologies to seek
to create new medicines, primarily for cancer. In expanding the drug
development efforts in the field of cancer through the Targeted Cancer
Drug Development Platform, the Company is building upon the previous
experiences in targeting signaling pathways in the areas of cancer,
neurological disease and cardiovascular disease. For more information,
visit the website at 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 without limitation: the Company's
expectation that it will advance additional preclinical development
candidates in 2008; the Company's expectations regarding the potential
therapeutic benefits of its clinical-stage Hedgehog antagonist and its
preclinical drug candidates, including CUDC-101; its plans to enter
into one or more collaborations in 2008, and its financial guidance
regarding working capital and operating expenses for 2008.
Forward-looking statements used in this press release may contain the
words "believes", "expects", "anticipates", "plans", "seeks",
"estimates", "will", "may" 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 actual results to be materially different from those
indicated by such forward-looking statements including, among other
things:
-- adverse results, delays and/or failures in the Company's and
the Company's strategic collaborators' product development
programs, including without limitation adverse events,
difficulties with patient enrollment and other unplanned
delays in the Hedgehog pathway antagonist currently under
Phase I clinical development with Genentech, and unplanned
delays and/or failures in the efforts to advance CUDC-101 and
the other programs under the Targeted Cancer Drug Development
Platform;
-- difficulties or delays in obtaining or maintaining required
regulatory approvals for products being developed by the
Company and by its collaborators;
-- Curis and its collaborators' ability to obtain or maintain the
patent and other proprietary intellectual property protection
necessary for the development and commercialization of
products based on the technologies;
-- changes in, or the inability to execute, the Company's
business plan;
-- the risk that the Company does not obtain the additional
funding required to conduct research and development of its
product candidates;
-- unplanned cash requirements and expenditures which, among
other things, could shorten the estimated period in which the
Company will have cash to fund the operations and which could
also adversely affect the Company's estimated operating
expenses for 2008 and beyond;
-- risks relating to the Company's ability to enter into and
maintain important strategic collaborations, and the risk that
the current and future collaborators will not perform
adequately, including such risks with respect to the current
collaboration agreements with Genentech and Wyeth;
-- competitive pressures; and
-- other risk factors identified in the Quarterly Report on Form
10-Q for the Quarter ended September 30, 2007 and other
filings that the Company periodically makes with the
Securities and Exchange Commission.
In addition, any forward-looking statements represent the views
only as of today and should not be relied upon as representing the
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.
SOURCE: Curis, Inc.
Curis, Inc.
Michael P. Gray, 617-503-6632
Chief Financial Officer and Chief Operating Officer
mgray@curis.com