12288_BC-FC 4/24/04 5:15 AM Page 1
SHAREHOLDER INFORMATION
Curis, Inc. and Subsidiaries
BOARD OF DIRECTORS
Susan B. Bayh
Distinguished Visiting Professor,
College of Business Administration,
Butler University; Director, Cubist
Pharmaceuticals, Inc., Anthem, Inc.,
and Emmis Communications, Inc.
Joseph M. Davie, Ph.D., M.D.
Director, Inflazyme Pharmaceuticals, Inc. and
Targeted Genetics, Inc.; elected to Institute of
Medicine
Martyn D. Greenacre
Chairman of Life Mist, L.L.C.; Director,
Cephalon, Inc., Acusphere, Inc. and
The Immune Response Corporation
Kenneth I. Kaitin, Ph.D.
Director of the Tufts Center for the Study of Drug
Development; Associate Professor of Medicine at
Tufts University School of Medicine; serves on
faculty of European Center for Pharmaceutical
Medicine at the University of Basel
James R. McNab, Jr.
Chairman of the Board, Curis, Inc.;
Chairman of eNOS Pharmaceuticals,
Inc. and Sontra Medical Corporation
Douglas A. Melton, Ph.D.
Chairman of the Scientific Advisory
Board, Curis, Inc.; Thomas Dudley
Cabot Professor of the Natural
Sciences, Harvard University;
Investigator, Howard Hughes Medical
Institute
Daniel R. Passeri
President and Chief Executive Officer,
Curis, Inc.
James R. Tobin
President and Chief Executive Officer,
Boston Scientific Corporation;
Director, Applera Corporation and
Boston Scientific Corporation
INDEPENDENT ACCOUNTANTS
PricewaterhouseCoopers LLP
One Post Office Square
Boston, MA 02109
P• 617.428.8400
www.pwcglobal.com
LEGAL COUNSEL
Hale and Dorr LLP
60 State Street
Boston, MA 02109
P• 617.526.6000
www.haledorr.com
MANAGEMENT
Daniel R. Passeri
President and Chief Executive Officer
Lee L. Rubin, Ph.D.
Senior Vice President, Research and Chief
Scientific Officer
Michael P. Gray
Vice President of Finance and Chief Financial
Officer and Treasurer
Marc F. Charette, Ph.D.
Vice President, Corporate
Communications
Mark W. Noel
Vice President, Technology
Management and Business
Development
Mary Elizabeth Potthoff, Esq.
Vice President, General Counsel and Secretary
Christopher U. Missling, Ph.D.
Senior Vice President of Strategic Analysis and
Planning
MARKET INFORMATION
Our common stock was first traded on the
NASDAQ National Market on August 1, 2000.
Our trading symbol is “CRIS.” There were 318
shareholders of record as of February 28, 2004.
The following table sets forth, for the fiscal
periods indicated, the high and low sales prices
per share of our common stock as reported on the
NASDAQ National Market:
FY 2003
High
Low
1st Quarter . . . . . . . . . . . . . . . . .
2nd Quarter
. . . . . . . . . . . . . . . .
3rd Quarter . . . . . . . . . . . . . . . . .
4th Quarter . . . . . . . . . . . . . . . . .
$1.25
$5.60
$5.34
$5.92
$0.65
$0.76
$2.80
$4.34
FY 2002
High
Low
1st Quarter . . . . . . . . . . . . . . . . .
2nd Quarter
. . . . . . . . . . . . . . . .
3rd Quarter . . . . . . . . . . . . . . . . .
4th Quarter . . . . . . . . . . . . . . . . .
$5.68
$2.24
$1.37
$1.28
$1.96
$1.00
$0.51
$0.50
We have never declared or paid any cash
dividends on our common stock and we do not
anticipate paying cash dividends in the
foreseeable future.
CORPORATE HEADQUARTERS
Curis, Inc.
61 Moulton Street
Cambridge, MA 02138
P• 617.503.6500
F• 617.503.6501
www.curis.com
TRANSFER AGENT
Mellon Investor Service LLC
85 Challenger Road
Ridgefield Park, NJ 07660
P• 800.288.9541
www.melloninvestor.com
ANNUAL MEETING
The annual meeting of shareholders
will be held at 10:00 a.m. on June 2,
2004, at the offices of Hale and Dorr
LLP, 60 State Street, Boston, MA 02109
SEC FORM 10-K
A copy of our 2003 annual report on Form 10-
K, without exhibits, is available without charge
upon written request to:
Investor Relations
Curis, Inc.
61 Moulton Street
Cambridge, MA 02138
info@curis.com
FORWARD-LOOKING
INFORMATION
This annual report contains forward-looking
statements within the meaning of the Private
Securities Litigation Reform Act of 1995,
including statements about Curis’ drug discovery
and development programs. Such statements 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 partners’ product development
programs; difficulties or delays in obtaining or
maintaining required regulatory approvals;
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 realigned business strategy; the risk
that Curis does not obtain the additional funding
required to conduct research and development of
its product candidates and execute on its business
plan; unplanned cash requirements and
expenditures; risks relating to Curis’ ability to
enter into and maintain important strategic
partnerships, including its ability to maintain its
current collaboration agreements with Genentech,
Ortho Biotech and Wyeth; the risk that
competitors will discover and develop signaling
pathway-based 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 10-Q and any subsequent
reports 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,
whether as a result of new information, future
events or otherwise.
Annual Report 2004 – Shareholders Letter
Dear Shareholders:
2003 has been a successful year for Curis. Our lead research programs have moved closer to reaching
human clinical trials either through collaborations with top-tier biotechnology and pharmaceutical companies or
through our internal efforts. Our financial stability is greatly improved and our stock price appreciated
substantially. These results are due to a strategic plan that was adopted by senior management and the board of
directors during 2002.
In the first quarter of 2002, we embarked on a strategy of focusing our resources on the research and
development of regulatory signaling pathway product candidates and the establishment of strategic corporate
collaborations. The principle objectives of this strategy were to concentrate on our core competencies in
regulatory signaling pathways in order to provide our most advanced programs with access to collaborators’
development and clinical trial expertise and to obtain the financial resources required to enable us to further
advance our development programs and pursue our internal research initiatives.
The implementation of this strategic plan has been successful to date. During the last eighteen months, we
have established major strategic corporate relationships with Ortho Biotech (a subsidiary of Johnson & Johnson)
in the field of kidney disease in November of 2002, Genentech in the field of cancer in June of 2003, and Wyeth
Pharmaceuticals in the field of neurological disorders in January of 2004. These three transactions resulted in a
strengthened balance sheet due to initial payments totaling $15 million. In addition, our collaborations with
Genentech and Wyeth will provide us with additional payments over the first two years of each collaboration that
we expect to use to help offset certain research costs associated with these programs. Lastly, each of these
collaborations provides significant potential future milestone and royalty revenue if product candidates under the
collaboration are successfully developed. For example, our collaboration with Wyeth includes milestone
payments of more than $170 million, assuming at least two products are successfully developed.
The establishment of these strategic corporate collaborations has enabled us to diversify our product
candidate portfolio and associated revenue opportunities, while at the same time providing us with ongoing
relationships with leaders in pharmaceutical product development and clinical trial management. Because our
collaborators are leaders in clinical development, we anticipate that these relationships may increase the
likelihood that our product candidates will ultimately be successfully developed. Additionally, we expect that our
collaborators will complement our current preclinical expertise by providing us with valuable development and
clinical experience.
During the next twelve months, we expect that at least one of our corporate collaborators will file an
investigational new drug application to initiate a human clinical trial. We believe that such a filing would provide
evidence that our licensed technology has the potential to progress towards commercialization. In addition, any
such filing would result in a meaningful cash milestone to us.
During 2003, our research team made several important scientific advances in the fields of cancer and
neurological disorders. We also were issued several key U.S. patents involving our core regulatory signaling
pathway technologies. The scientific advances of our research team and our intellectual property position were
key factors in the establishment of both the Genentech and Wyeth collaborations.
The $15 million in payments received under our collaboration agreements, coupled with $10.9 million
received through a private placement of our common stock in August of 2003, have increased our financial
strength. Our improved financial flexibility should allow us to add depth to our product development candidate
portfolio through our internal efforts and, potentially, through external technology acquisitions. For example,
while our corporate partners are advancing our programs in kidney disease, cancer, and neurological disorders,
we are continuing to develop programs in the fields of hair growth regulation and cardiovascular disease. Within
the next twelve months, we hope to announce the selection of a clinical candidate for the hair growth program.
In summary, Curis has established itself as a company with strong top-tier corporate collaborations that we
believe provide validation of our technology platform and research direction. We believe that we are in a position
to be able to advance our promising internal programs as well as explore related technology acquisitions during
2004. Our long-term goal is to create a consistently productive and, ultimately, profitable biotechnology
company. We anticipate a successful 2004, marked by the continued progression of our product candidates and
the expansion of our technology portfolio.
Lastly, I would like to thank our shareholders for their confidence, our board of directors for their support,
and our employees for their hard work, dedication, and significant achievements.
Sincerely,
Daniel R. Passeri
President and Chief Executive Officer
Curis, Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
(Mark one)
È ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
FORM 10-K
EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2003
OR
‘ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
Commission File Number 000-30347
CURIS, INC.
(Exact Name of Registrant as Specified in Its Charter)
DELAWARE
(State or other jurisdiction of
incorporation or organization)
04-3505116
(I.R.S. Employer Identification No.)
61 Moulton Street
Cambridge, Massachusetts 02138
(Address of principal executive offices) (Zip Code)
617-503-6500
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
None
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, $0.01 par value per share
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or
15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90
days. Yes È No ‘
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not
contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or
information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form
10-K. ‘
Indicate by check mark whether the registrant is an accelerated filer (as defined in Exchange Act Rule
12b-2). Yes È No ‘
As of June 30, 2003, the aggregate market value of the common stock held by non-affiliates of the registrant
was approximately $106,073,000 based on the closing sale price of the registrant’s common stock on The
NASDAQ National Market on such date.
As of February 23, 2004, there were 41,359,136 shares of the registrant’s common stock outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Specified portions of the registrant’s proxy statement for the annual meeting of stockholders scheduled to be
held on June 2, 2004, which are to be filed with the Commission not later than 120 days after the close of the
Registrant’s fiscal year ended December 31, 2003 pursuant to Regulation 14A, have been incorporated by
reference in Item 5 of Part II and Items 10-14 of Part III of this Annual Report on Form 10-K.
CURIS, INC.
TABLE OF CONTENTS
Form 10-K
PART I
BUSINESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ITEM 1.
PROPERTIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ITEM 2.
LEGAL PROCEEDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ITEM 3.
ITEM 4.
SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS . . . . . . . . . . . . . . . . .
EXECUTIVE OFFICERS OF THE REGISTRANT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY AND RELATED STOCKHOLDER
MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES . . . . . . . . . . . . . . . . . . . .
SELECTED FINANCIAL DATA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ITEM 6.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK . . . . . . . .
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA . . . . . . . . . . . . . . . . . . . . . . . .
ITEM 8.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING
ITEM 9.
AND FINANCIAL DISCLOSURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ITEM 9A CONTROLS AND PROCEDURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART III
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT . . . . . . . . . . . . . . . . . . .
ITEM 11. EXECUTIVE COMPENSATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ITEM 12.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
AND RELATED STOCKHOLDER MATTERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS . . . . . . . . . . . . . . . . . . . . . .
PRINCIPAL ACCOUNTANT FEES AND SERVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ITEM 14.
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON
FORM 8-K . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SIGNATURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART IV
1
13
13
14
14
17
18
19
45
47
93
93
94
94
94
94
94
95
96
PART I
This annual report on Form 10-K contains forward-looking statements that involve risks and uncertainties,
as well as assumptions that, if they never materialize or prove incorrect, could cause the results of Curis to differ
materially from those expressed or implied by such forward-looking statements. All statements other than
statements of historical fact are statements that could be deemed forward-looking statements, including any
projections of revenue, expenses, earnings or losses from operations, or other financial items; any statements of
the plans, strategies and objectives of management for future operations; any statements concerning product
research, development and commercialization timelines; any statements of expectation or belief; and any
statements of assumptions underlying any of the foregoing. The risks, uncertainties and assumptions referred to
above include risks that are described in “Management’s Discussion and Analysis of Financial Condition and
Results of Operations—Factors That May Affect Future Results” and elsewhere in this annual report and that
are otherwise described from time to time in our Securities and Exchange Commission reports filed after this
report.
The forward-looking statements included in this annual report represent our estimates as of the date of this
annual report. We specifically disclaim any obligation to update these forward-looking statements in the future.
These forward-looking statements should not be relied upon as representing our estimates or views as of any
date subsequent to the date of this annual report.
ITEM 1. BUSINESS
Our Company
We are a therapeutic drug development company principally focused on the discovery, development and
future commercialization of products that modulate key regulatory signaling pathways controlling the repair and
regeneration of human tissues and organs. Our product development approach involves using small molecules,
proteins or antibodies to modulate these regulatory signaling pathways, for example, to increase the pathway
signals when they are insufficient or to decrease them when they are excessive. We have successfully used this
product development approach to produce multiple compounds for several different disease indications. For
example, we have developed several promising preclinical product candidates in the fields of kidney disease,
cancer, neurological disorders, cardiovascular disease and hair growth regulation.
Regulatory signaling pathways, also referred to as signaling pathways, are prominent regulators of specific
tissue and organ formation during prenatal development and are used by the body throughout life to repair and
regulate human tissue. We are developing our product candidate programs around several major signaling
pathways including the Hedgehog and Bone Morphogenetic Protein pathways. We have substantial intellectual
property rights in these signaling pathways, which we believe will enable us to have a technological and
competitive advantage in developing therapeutic products based upon these pathways. In addition, we intend to
expand our technology offerings and associated intellectual property portfolio through in-licensing arrangements
and the acquisition of complimentary technologies, including additional signaling pathways.
Our research programs are conducted both internally and through strategic alliances and collaborations. We
currently have strategic collaborations with Ortho Biotech, Genentech and Wyeth. Our strategic alliances and
collaborations generally provide for our research, development and commercialization programs to be funded by
our collaborators and provide us with the opportunity to receive additional payments if specified milestones are
achieved, as well as royalty payments upon the successful commercialization of any products based upon the
collaboration. In some cases, we have retained development and commercialization rights in areas where we
believe we can attain the greatest potential long-term value through the application of our own internal resources.
We believe that our approach allows us to augment our development capabilities and capacities through
collaborations with leading pharmaceuticals companies and also provides us with the opportunity to discover and
develop products while reducing our internal product development costs and related risks.
1
In the future, we plan to continue to seek corporate partners for the further development and
commercialization of some of our technologies. Even though we are seeking partners to help develop some of
our technologies, we expect to select at least one program that we will develop further on our own.
Regulatory Signaling Pathways Background
Regulatory signaling pathways are the means by which tissues and organs exchange instructional messages
that regulate specific biological functions. Early in prenatal development, the instructional messages that direct
the formation of tissues and organs are controlled by master pathways, including the Hedgehog and Bone
Morphogenetic pathways, which act by initiating cascades of other pathways required for tissue formation and
regulation. Later in life, the body uses these master pathways to repair damage and regenerate tissues. For
example, in damaged nerve tissue, we have demonstrated in preclinical models that activation of the Hedgehog
pathway promotes repair and regeneration of nerve function, in part, by inducing the activation of a cascade of
secondary signaling pathways that promote the growth of new cells and blood vessels.
The ability to activate certain signaling pathways is of great interest to biotechnology and pharmaceutical
companies as many diseases and disorders are now known to be associated with insufficient or damaged
signaling pathways. For example, one of the most successful biotechnology-derived drugs is a formulation of a
signaling protein called erythropoietin. Erythropoietin is made in the kidney and controls a pathway that instructs
the bone marrow to make new red blood cells. In dialysis patients with end-stage kidney disease, in which their
kidneys have mostly or completely stopped functioning, the kidneys are unable to make erythropoietin,. These
patients therefore develop severe anemia, a critical medical condition caused by a lack of sufficient red blood
cells. Administration of erythropoietin restores normal levels of red blood cells thus alleviating the patient’s
anemia. The erythropoietin market for dialysis patients in the U.S. is estimated to be over $2 billion annually.
Our BMP-7 program, which is partnered with Ortho Biotech, is similar to erythropoietin in several respects.
BMP-7 is also a signaling protein made in the kidney that regulates several important tissue repair and
maintenance pathways. Dialysis patients develop several other serious complications in addition to severe
anemia, including bone diseases and blood vessel calcification resulting in life-threatening cardiovascular
complications. In preclinical models, administration of BMP-7 has been shown to prevent the bone and blood
vessel complications that are associated with chronic kidney disease. Preclinical studies also suggest that BMP-7
may delay progression of kidney disease, delay the need for dialysis and stabilize kidney function for dialysis
patients. If successfully developed, we estimate that the market size for BMP-7 in dialysis patients may
approximate the market size for erythropoietin in dialysis patients.
There is also significant pharmaceutical interest in the inhibition of abnormally or inappropriately activated
signaling pathways which have been implicated in certain cancers. For instance, Novartis Inc.’s Gleevec® is a
small molecule drug that inhibits a signaling pathway that is abnormally expressed in certain cancers. Gleevec®
is among the first signaling pathway inhibitors to be approved by the FDA and is Novartis’ second largest-selling
drug with estimated annual worldwide sales of more than $1 billion.
Abnormal expression of the Hedgehog signaling pathway has been shown to be associated with certain
cancers, including basal cell carcinoma, small cell lung cancer and pancreatic cancer. We have also developed
small molecule Hedgehog pathway inhibitors and Hedgehog blocking antibodies. Our Hedgehog pathway
inhibitors and antibodies, which are partnered with Genentech, have been demonstrated to slow or halt the
growth of these cancers in preclinical models of tumor growth. Because the Hedgehog signaling pathway appears
to control the expression of tissue growth factors and blood vessel growth factors, we believe that our pathway
inhibitors may be applicable to a broad array of cancers.
We believe that our focus on developing drugs based primarily on the master signaling pathways will give
us a competitive advantage over similar efforts by other biotechnology and pharmaceutical companies. Our
approach has already enabled us to develop a diverse portfolio of preclinical product candidates in several
2
important therapeutic areas including kidney disease, cancer, neurological disorders, cardiovascular disease and
hair growth regulation.
Our Strategy
Our goal is to become the leading therapeutic drug development company focusing on regulatory signaling
pathways. Our strategy to accomplish this goal includes the following:
• Focus on large markets where our regulatory signaling pathway product candidates address
significant unmet medical needs. We believe that we are one of the leading companies in the
regulatory signaling pathway field and that our skills and knowledge allow us to develop product
candidates that address attractive markets with unmet medical needs. We are principally focused on
developing proprietary regulatory signaling pathway-based drugs for large markets including kidney
disease, cancer, neurological disorders, cardiovascular disease and hair growth regulation where we
believe our product candidates can provide compelling clinical advantages over existing products. For
example, BMP-7 is a signaling protein that is synthesized in the kidney and has been implicated in the
maintenance of the normal health of the kidney, the skeleton, and the vascular system. We estimate that
the U.S. market potential for our BMP-7 product, if approved for the dialysis market, would be more
than $2 billion annually in the U.S.
•
Pursue collaborations with companies that will complement our skill sets. We have entered into and
plan to seek additional collaborations with companies that will advance selected product candidates
through the clinic. Since our regulatory signaling pathway-based product candidates have broad
applications to a variety of human diseases, some of the indications will require complex and expensive
clinical trials, which exceed our current ability and capacity to develop and fund. Since pharmaceutical
drug development companies are better qualified and experienced to develop and run clinical trials,
these collaborations will better allow our product candidates to potentially enter large markets. By
leveraging our expertise in preclinical development we believe that we will be in an attractive position
when negotiating the terms of these collaborations. Also by entering into alliances and co-development
agreements, we believe we will be able to strengthen our capabilities and capacities for developing and
managing clinical trials.
• Discover, develop and commercialize our own products. We will retain the development, sales and
marketing rights to selected proprietary product candidates in specialty markets that we can readily
address. Program selection will be based on an assessment of the time, expense and complexity of
clinical trials that we estimate will be required for approval. For instance, we believe that topically
applied or locally delivered drug candidates may be a more appropriate match with our development
capabilities. We are considering the independent development of our two Hedgehog topically-applied
small molecule product candidates, including a small molecule antagonist for inhibition of unwanted
hair growth and a small molecule agonist to promote hair growth. In addition, we have retained the right
to independently develop our Hedgehog locally-delivered agonist for selected cardiovascular
indications.
• Acquire and develop additional intellectual property around other key regulatory signaling
pathways. We currently own or have rights to approximately 164 issued and 121 pending patent
applications in the United States and have foreign counterpart patent filings. Most of our intellectual
property portfolio relates specifically to our Hedgehog and BMP technologies. We have made a
substantial investment in protecting our proprietary technologies and product candidates. We believe
that the quality and scope of our intellectual property provides us and our collaborators and licensees
with a strong patent position. In order to enhance our current intellectual property position, we intend to
invest in regulatory signaling pathway-related research and development efforts, including attracting
and retaining highly talented and experienced personnel. We also intend to expand our intellectual
property position around other key regulatory signaling pathways by investing in selected research and
development efforts and potentially acquiring complementary intellectual property.
3
Product Development Programs
We are developing product candidates in several important medical fields where there is substantial unmet
therapeutic need. These product development initiatives, described in the chart below, are being pursued using
our internal resources or through partnering and licensing arrangements with pharmaceutical or biotechnology
firms that are able to dedicate additional resources and clinical development expertise. These product
development initiatives are derived primarily from our substantial intellectual property portfolio in key
regulatory signaling pathways.
Most of our programs are in various stages of preclinical drug development. In the table below, the term
early preclinical means we are seeking to obtain initial demonstrations of therapeutic efficacy in preclinical
models of human disease, mid preclinical means we are seeking to obtain multiple demonstrations of efficacy in
preclinical models of human disease, and late preclinical means we are seeking to obtain both multiple
demonstrations of efficacy in preclinical models of human disease and relevant toxicology and safety data
required for an investigational new drug application, or IND, filing with the FDA seeking to commence a phase I
clinical trial to assess safety in humans.
Product Candidate
Primary Indication
Partner/Licensee
Status
Kidney disease
BMP-7 protein
Ortho Biotech
Hh small molecule antagonist Basal cell carcinoma
Genentech
Hh small molecule antagonist Cancer
Genentech
Cancer
Hh antibody antagonist
Genentech
Wyeth
Central nervous system disorders
Hh small molecule agonist
Peripheral nervous system disorders Wyeth
Hh small molecule agonist
Hair loss
Hh small molecule agonist
Hh agonist/protein/gene
Cardiovascular disease
Hh small molecule antagonist Hair growth inhibition
PYY peptide
Obesity
In-house development
In-house development
In-house development
Amylin Pharmaceuticals
Late preclinical
Late preclinical
Mid preclinical
Mid preclinical
Mid preclinical
Mid preclinical
Late preclinical
Mid preclinical
Early preclinical
IND filed
BMP-7 Program
BMP-7 is a signaling protein that is synthesized in the kidney and has been implicated in the maintenance of
the normal health of the kidney, the skeleton, and the vascular system. Prior to November 2002, we had been
developing BMP-7 as a therapeutic compound to halt the progression of chronic kidney failure and to prevent
skeletal and vascular complications that are associated with chronic kidney disease.
During 2003, several academic researchers published reports concluding that BMP-7 may be an effective
therapy for chronic kidney disease. These reports, from the Beth Israel Deaconess Medical Center, the Harvard
Medical School and the Washington University School of Medicine, have demonstrated the potential of using
BMP-7 as a potential treatment to both halt the progression and reverse the effects of chronic progressive kidney
disease. These reports are published in Nature Medicine 2003 July 9(7): 964-8 and The Journal of the American
Society of Nephrology 2003 June 14(6): 1559-67.
These data suggest that BMP-7 may be similar in some respects to erythropoietin, believed to be one of the
most successful biotechnology-derived drugs. Erythropoietin is a signaling protein that is made in the kidney. It
is secreted into the blood system and controls the process that instructs bone marrow to make new red blood
cells. In dialysis patients with end-stage kidney disease, in which their kidneys have mostly or completely
stopped functioning, the kidneys are unable to make erythropoietin. These patients therefore develop severe
anemia, a critical medical condition caused by a lack of sufficient red blood cells. Administration of
erythropoietin restores normal levels of red blood cells thus alleviating the patient’s severe anemia. Dialysis
patients develop several other serious complications in addition to severe anemia, including bone disease and
severe blood vessel calcification resulting in life-threatening cardiovascular complications. The preclinical
demonstration that BMP-7 prevents the bone and blood vessel complications that are associated with chronic
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kidney disease suggests that the market size for BMP-7 in dialysis patients may approximate the market size for
erythropoietin in dialysis patients, which is currently estimated to be over $2 billion in the U.S.
In November 2002, we entered into an agreement with Ortho Biotech for the continued development of this
kidney disease product candidate. Ortho Biotech is a pharmaceutical company with broad expertise in protein-
based therapeutic drug development and has an established presence in the kidney disease marketplace. Ortho
Biotech will assume all future costs and responsibility for BMP-based product development, and we will receive
clinical milestone payments and royalties on product sales if clinical evaluations of any BMP-based products are
successful. Ortho Biotech has sole responsibility for deciding if and when human clinical trials of BMP-7 will
begin.
Hedgehog Small Molecule and Antibody Antagonist Cancer Programs
The Hedgehog signaling pathway controls the development and growth of many kinds of tissues in the body
by activating other secondary pathways that control the synthesis of growth factors and angiogenic factors. The
growth factors stimulate new tissue formation, and the angiogenic factors stimulate new blood vessel growth to
nourish the newly formed tissue.
Several years ago, our scientists and scientists at independent academic and medical research laboratories
discovered that certain cancers, such as basal cell carcinoma, are expressing abnormally high concentrations of
Hedgehog protein, thereby creating local environments favorable to the rapid growth of cancerous tissue.
Furthermore, in 2003, several academic researchers published reports that also noted the link between abnormal
expression of the Hedgehog signaling pathway and the malignant growth of other tumors, including small cell
lung cancer and certain tumors of the gastrointestinal tract. These reports, from the Johns Hopkins University
School of Medicine, University of California, San Francisco, Massachusetts General Hospital, and the Harvard
Medical School were published in Nature 2003 October 23 425(6960): 846-51 and 851-6.
Our preclinical evidence indicates that inhibition of the Hedgehog pathway, in cells where it is being
abnormally activated, results in the selective and specific death of the tumor cells while conferring no harm to
adjacent normal cells. This selectivity contrasts with more traditional cancer treatments that often kill both cancer
cells and normal cells. We believe that the ability to selectively kill cancer cells while leaving healthy cells intact
represents the next generation of cancer treatments that are in development.
In June 2003, we established a collaboration with Genentech for the continued development of these anti-
cancer drug candidates. Genentech is a pharmaceutical company with broad expertise in the development of
cancer therapeutics. Except for the co-development option described below, Genentech will assume all future
responsibility for the clinical development of the Hedgehog small molecule and antibody antagonists as cancer
drugs for solid tumors. We will receive clinical milestone payments and royalties on product sales if clinical
evaluations of any Hedgehog antagonist and antibody technology-based products are successful. We have
retained a co-development option in the field of basal cell carcinoma, a type of skin cancer.
Hedgehog Small Molecule Agonist Neurological Disorders Programs
The Hedgehog signaling pathway is essential for the formation of normal nerves in the central and
peripheral nervous systems. Our scientists and academic collaborators have shown that treatment with a
Hedgehog protein accelerates the restoration of nerve function in models of nerve trauma and disease. This
finding suggests that the Hedgehog pathway may have a potential therapeutic effect in treating certain human
neurological disorders. During 2003, our scientists and several academic researchers presented reports
concluding that activation of the Hedgehog pathway promotes improved recovery from stroke, Parkinson’s
disease, and spinal cord injury. In addition to findings reported by us, reports were also made by researchers at
the Université Victor Segalen in France, the University of Manchester in the United Kingdom, the Toronto
Western Research Institute in Canada, the California Institute of Technology in Pasadena, California, and at Case
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Western Reserve University. The stroke data were presented by our scientists at the 2003 Society for
Neuroscience conference, the Parkinson’s data were published in the FASEB Journal 2003 December 17(15):
2337-8, and the spinal cord injury data were presented at the 2003 meeting of the North American Spine Society.
Our scientists have developed a series of small molecule Hedgehog agonists that, in preclinical models,
have shown to be capable of activating the Hedgehog pathway. Many of these small molecule Hedgehog agonists
are orally available and can cross the blood brain barrier, a protective barrier formed by blood vessels and brain
tissue that prevents most substances in the blood from entering brain tissue. Small molecules that cross this blood
brain barrier can reach and treat damaged brain tissue, therefore making them attractive product development
candidates.
We believe that the positive effects of the Hedgehog agonists in neuronal disease models are due to
neuroprotection that is induced by activation of the Hedgehog signaling pathway. Neuroprotection is the
prevention of the progressive death of cells in the brain caused by disease or injury. In addition, we also know
that activation of the Hedgehog pathway results in an increased proliferation of brain stem cells. We are currently
exploring the possibility that this may enable to develop drugs that can promote the replacement of brain cells
lost as a result of injury or disease.
In January 2004, we entered into a collaboration agreement with Wyeth Pharmaceuticals to continue the
development of these promising drug candidates for the treatment of neurological disorders and other potential
indications. Wyeth is one of the world’s largest research-driven pharmaceutical companies with broad expertise
in the development of drugs to treat neurological disorders and other diseases. Under the terms of the
collaboration, Wyeth paid us an up-front license fee and is obligated to provide two years of research funding. In
addition, if clinical evaluations of any Hedgehog agonist technology-based products are successful, Wyeth is
obligated to pay us clinical milestone payments and royalties on product sales.
Wyeth has agreed to assume all future responsibility for clinical development of the Hedgehog small
molecule and protein agonists as systemic treatments for neurological and other disorders. As part of the
agreement, we have retained development and licensing options for certain therapeutic applications of Hedgehog
agonist technologies, including those applications that qualify as orphan drug indications, topical applications for
hair growth, local delivery applications for treatment of cardiovascular disease, and use of the technology with
stem cells.
Hedgehog Agonist Cardiovascular Disease Program
In November 2003, researchers from the St. Elizabeth’s Medical Center in Boston, Massachusetts presented
data at the annual Scientific Sessions of the American Heart Association demonstrating that localized activation
of the Hedgehog signaling pathway, several hours after heart injury, can significantly improve heart function and
reduce overall heart damage in a model of myocardial infarction, or heart attack.
Our scientists and our academics collaborators are currently conducting additional studies to evaluate the
therapeutic potential of using locally-delivered Hedgehog agonists that activate the Hedgehog pathway to
promote recovery from cardiovascular disease. Wyeth has a first right of negotiation to license our Hedgehog
pathway technologies in the field of cardiovascular disease.
Hedgehog Small Molecule Agonist and Antagonist Hair Growth Regulation Program
Several years ago, our scientists and other researchers demonstrated that activation of the Hedgehog
pathway can stimulate rapid hair re-growth in models of hair loss, including hair loss as a result of chemotherapy
treatment. These latter results were published in the Journal of the National Cancer Institute 2001 Dec 19
93(24): 1858-64.
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More recently, our scientists have demonstrated that our small molecule Hedgehog agonists can induce hair
re-growth in animal models. We are currently evaluating the therapeutic potential of small molecule Hedgehog
agonists to promote hair re-growth in preclinical models of hair loss. We are also evaluating the potential of
Hedgehog pathway antagonists to block hair growth.
PPY Peptide Obesity License
PYY is a gut peptide that has been shown to suppress appetite and reduce food intake in animals and
humans. Several years ago, our scientists working in the field of diabetes filed patent applications on the
potential utility of using PYY as a treatment for certain metabolic disorders, including obesity.
In December 2002, we licensed our PYY patent applications to Amylin Pharmaceuticals for in-vivo
therapeutic uses in exchange for an up-front fee, milestone payments upon the achievement of specified
development objectives, and royalties on potential future product sales. Amylin has extensive development
experience with our similar gut peptides.
In December 2003, Amylin filed an investigational new drug application with the FDA on PYY for an
obesity indication and has indicated that it expects to initiate clinical testing in the first quarter of 2004. Amylin
has responsibility for all expenses related to further development of the PYY compound.
Strategic Alliances And License Agreements
Our strategy for development and commercialization of products depends upon successful strategic alliances
with third parties. We use strategic alliances as a means to provide us with the requisite capital, as well as the
necessary preclinical and clinical development and manufacturing and marketing capabilities to commercialize
product candidates produced by our discovery and preclinical programs. In evaluating possible strategic
alliances, we consider the following criteria:
•
•
•
•
•
technical and commercial resources committed to our programs;
up-front payments in the form of license fees and equity investments;
royalties and milestone payments;
technology and patent rights; and
scientific and development resources.
Since inception, substantially all of our revenue has been derived from our collaborations and other
agreements with third parties.
Our current strategic alliances are described below.
Ortho Biotech, a subsidiary of Johnson & Johnson
In November 2002, we licensed our broad BMP technology portfolio to Ortho Biotech on an exclusive,
worldwide royalty-bearing basis, for all non-orthopedic and non-dental therapeutic applications in exchange for a
$3.5 million up-front fee, a series of cash milestones if specified clinical research objectives and regulatory
approvals are achieved, including a $30 million milestone payment upon U.S. regulatory approval of a product
for the treatment of kidney disease, and a royalty on potential future product sales. If the program progresses
successfully through clinical development, we are entitled to receive additional milestone payments for the
kidney disease related product candidate and milestone payments for the first neurology product candidate. Initial
target indications include the systemic use of BMP-7 for the prevention of bone and blood vessel complications
associated with chronic kidney disease and treatments to promote recovery following stroke and brain injury.
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Genentech
In June 2003, we licensed our novel small molecule and antibody inhibitors of the Hedgehog signaling
pathway to Genentech on an exclusive worldwide royalty-bearing basis for applications in cancer therapy. Under
the terms of the agreement, Genentech paid us an upfront license fee of $5 million, purchased 1,323,835 shares
of our common stock at a price of $2.644 per share for aggregate proceeds of $3.5 million, and is also obligated
to pay us a total of $4 million in maintenance fees by July 2005. Genentech is also obligated to make cash
payments to us upon the successful achievement of clinical development and drug approval milestones. In
addition, Genentech will pay a royalty on potential future net product sales, which increases with increasing sales
volume. We have retained the right to co-develop products in the field of basal cell carcinoma, in which event we
will share in any profits related to the basal cell carcinoma program in a percentage that is equal to our co-
development cost sharing contribution.
Wyeth Pharmaceuticals, a division of Wyeth
In January 2004, we entered into an agreement to license our Hedgehog proteins and novel small molecule
Hedgehog pathway agonists to Wyeth on an exclusive worldwide, royalty-bearing basis for the development and
commercialization of pharmaceutical products for the therapeutic applications in treatment of neurological
disorders, including neurodegenerative diseases and neuropathies. Under the terms of the agreement, Wyeth
Pharmaceuticals paid us a license fee of $1.5 million and purchased 315,524 shares of our common stock at a
price of $4.754 per share for an aggregate purchase price of $1.5 million. Wyeth will provide research funding
for a minimum of two years. In addition, Wyeth is obligated to make cash payments to us upon the successful
achievement of clinical development and drug approval milestones and is obligated to pay a royalty on net
product sales, if any, that escalates with increasing sales volume. Excluding product royalties, the transaction has
a potential value to us of more than $170 million, assuming at least two products are successfully developed and
commercialized.
Amylin Pharmaceuticals
In December 2002, we granted Amylin Pharmaceuticals an exclusive worldwide, royalty-bearing license to
our PYY patent applications for use in the research, development and commercialization of products in exchange
for an up-front fee, milestone payments upon the achievement of specified development objectives, and royalties
on potential future product sales, if any. PYY is a gut peptide that has been shown in animals and humans to
suppress appetite and reduce food intake. Amylin has exclusive responsibility for expenses related to further
development of the PYY compound.
Intellectual Property
Our policy is to prosecute and enforce the patents and proprietary technology rights that are key to our
business. We intend to continue to file United States and foreign patent applications to protect technology,
inventions and improvements that are considered important to the development of our business. We will be able
to protect our proprietary technologies from unauthorized use by third parties only to the extent that our
proprietary rights are covered by valid and enforceable patents or are effectively maintained as trade secrets.
We have 164 issued patents and 121 pending patent applications in the United States expiring on various
dates between 2007 and 2021 and have foreign counterpart patent filings for most of these patents and patent
applications. These patents and patent applications are directed to compositions of matter, methods of making
and using these compositions, methods of repairing, replacing, augmenting and creating tissue for multiple
applications, methods for drug screening and discovery, developmental biological processes, and patents relating
to our proprietary technologies.
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Hedgehog Pathway. We have 38 issued U.S. patents and 5 allowed U.S. applications expiring on various
dates between 2015 and 2021, which relate to the Hedgehog pathway. These patents and patent applications
cover proteins, nucleic acids, antibodies, and certain small molecule agonists and antagonists of the Hedgehog
pathway, drug screening and discovery methods, methods of protein manufacturing, as well as methods of using
the aforementioned proteins, nucleic acids, antibodies or small molecules to activate or inhibit the Hedgehog
pathway for a variety of therapeutic indications or diagnostic uses. In addition, we have filed foreign patent
applications corresponding to many of the aforementioned U.S. filings that could provide additional patent
protection for products that activate or inhibit the Hedgehog pathway.
Bone Morphogenetic Pathway. We have 107 issued U.S. patents and 3 allowed U.S. applications expiring
on various dates between 2007 and 2021, which relate to the BMP pathway. These patents and patent
applications cover certain BMP proteins, nucleic acids, antibodies, drug screening and discovery methods,
methods of protein manufacturing, as well as methods of using these BMP proteins, nucleic acids or antibodies
for a variety of therapeutic indications or diagnostic uses. In addition, we have filed foreign patent applications
corresponding to many of the aforementioned U.S. filings that could provide additional patent protection for
BMP-related products.
Our academic and research institution collaborators have certain rights to publish data and information
regarding their discoveries to which we have rights. While we believe that the limitations on publication of data
developed by our collaborators pursuant to our collaboration agreements will be sufficient to permit us to apply
for patent protection in the areas in which we are interested in pursuing further research, there is considerable
pressure on such institutions to publish discoveries arising from their efforts. Any such publication could affect
our ability to obtain patent protection in the areas in which we may have an interest. In addition, these
collaboration agreements typically contain provisions that provide us with, at a minimum, an option to license the
institution’s rights to intellectual property arising from the collaboration.
We are party to various license agreements that give us rights to commercialize various technologies and to
use technologies in our research and development processes. The consideration payable in exchange for these
licenses includes up-front fees, issuances of shares of common stock, annual royalties, milestone payments and
running royalties on net sales by our sub-licensees and us. The licensors may terminate these agreements if we
fail to meet certain diligence requirements, fail to make payments or otherwise commit a material breach that is
not cured after notice.
In addition, we depend upon trade secrets, know-how and continuing technological advances to develop and
maintain our competitive position. To maintain the confidentiality of trade secrets and proprietary information,
we require our employees, scientific advisors, consultants and collaborators, upon commencement of a
relationship with us, to execute confidentiality agreements and, in the case of parties other than our research and
development collaborators, to agree to assign their inventions to us. These agreements are designed to protect our
proprietary information and to grant us ownership of technologies that are developed in connection with their
relationship with us.
Research Program
We have a research group that seeks to identify and develop new therapeutic applications for our existing
patent portfolio and seeks to identify new signaling pathways that may have therapeutic potential. Our research
group, working closely with our business development group, also strives to identify external technologies that
might provide in-licensing opportunities, consistent with our broad interest in regenerative signaling pathways.
As of December 31, 2003, our research group consists of 43 employees, consisting of molecular biologists, cell
biologists, pharmacologists and other scientific disciplines.
During the years ended December, 2003, 2002 and 2001, we estimate that our total company-sponsored
research and development expenses were approximately $10.8 million, $8.7 million and $26.3 million,
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respectively, and that our collaborator-sponsored research and development expenses were approximately $2.6
million, $5.3 million and $2.7 million, respectively.
Regulatory Matters
FDA Requirements for New Drug Compounds
The research, testing, manufacture and marketing of drug products are extensively regulated by numerous
governmental authorities in the United States and other countries. In the United States, drugs are subject to
rigorous regulation by the FDA. The Federal Food, Drug, and Cosmetic Act, and other federal and state statutes
and regulations, govern, among other things, the research, development, testing, manufacture, storage,
recordkeeping, labeling, promotion and marketing and distribution of pharmaceutical products. Failure to comply
with applicable regulatory requirements may subject a company to a variety of administrative or judicially-
imposed sanctions and/or the inability to obtain or maintain required approvals or to market approved drug
products.
The steps ordinarily required before a new pharmaceutical product may be marketed in the United States
include preclinical laboratory tests, animal tests and formulation studies, the submission to the FDA of a notice
of claimed investigational exemption or an investigational new drug application, which must become effective
before clinical testing may commence, and adequate and well-controlled clinical trials to establish the safety and
effectiveness of the drug for each indication for which FDA approval is sought. Satisfaction of FDA pre-market
approval requirements typically takes several years and the actual time required may vary substantially based
upon the type, complexity and novelty of the product or disease. Government regulation may delay or prevent
marketing of potential products for a considerable period of time and impose costly procedures upon a
manufacturer’s activities. Success in early stage clinical trials does not assure success in later stage clinical trials.
Data obtained from clinical activities is not always conclusive and may be susceptible to varying interpretations
that could delay, limit or prevent regulatory approval. Even if a product receives regulatory approval, later
discovery of previously unknown problems with a product may result in restrictions on the product or even
complete withdrawal of the product from the market.
Preclinical tests include laboratory evaluation of product chemistry and formulation, as well as animal trials
to assess the potential safety and efficacy of the product. The conduct of the preclinical tests and formulation of
compounds for testing must comply with federal regulations and requirements. The results of preclinical testing
are submitted to the FDA as part of an investigational new drug application.
Clinical trials involve the administration of the investigational new drug to healthy volunteers or patients
under the supervision of a qualified investigator. Clinical trials must be conducted in compliance with federal
regulations and requirements, under protocols detailing the objectives of the trial, the parameters to be used in
monitoring safety and the effectiveness criteria to be evaluated. Each protocol involving testing on U.S. subjects
must be submitted to the FDA as part of the investigational new drug application. The study protocol and
informed consent information for patients in clinical trials must be submitted to institutional review boards for
approval.
Clinical trials to support new drug applications for marketing approval are typically conducted in three
sequential phases, but the phases may overlap. In phase I, the initial introduction of the drug into healthy human
subjects or patients, the drug is tested to assess metabolism, pharmacokinetics and pharmacological actions and
safety, including side effects associated with increasing doses. Phase II usually involves trials in a limited patient
population, to determine dosage tolerance and optimum dosage, identify possible adverse effects and safety risks,
and provide preliminary support for the efficacy of the drug in the indication being studied. If a compound
demonstrates evidence of effectiveness and an acceptable safety profile in phase II evaluations, phase III trials
are undertaken to further evaluate clinical efficacy and to further test for safety within an expanded patient
population, typically at geographically dispersed clinical trial sites. Phase I, phase II or phase III testing of any
product candidates may not be completed successfully within any specified time period, if at all.
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After successful completion of the required clinical testing, generally a new drug application is prepared and
submitted to the FDA. FDA approval of the new drug application is required before marketing of the product
may begin in the United States. The new drug application must include the results of extensive clinical and other
testing and a compilation of data relating to the product’s pharmacology, chemistry, manufacture, and controls.
If FDA evaluations of the new drug application and the manufacturing facilities are favorable, the FDA may
issue an approval letter, or, in some cases, an approvable letter followed by an approval letter. An approvable
letter generally contains a statement of specific conditions that must be met in order to secure final approval of
the new drug application. If and when those conditions have been met to the FDA’s satisfaction, the FDA will
typically issue an approval letter. An approval letter authorizes commercial marketing of the drug with specific
prescribing information for specific indications. As a condition of new drug application approval, the FDA may
require post approval testing and surveillance to monitor the drug’s safety or efficacy and may impose other
conditions, including labeling restrictions which can materially impact the potential market and profitability of
the drug. Once granted, product approvals may be withdrawn if compliance with regulatory standards is not
maintained or problems are identified following initial marketing.
Once the new drug application is approved, a product will be subject to certain post-approval requirements,
including requirements for adverse event reporting and submission of periodic reports. Additionally, the FDA
also strictly regulates the promotional claims that may be made about prescription drug products. In particular,
the FDA requires substantiation of any claims of superiority of one product over another including, in many
cases, requirements that such claims be proven by adequate and well controlled head-to-head clinical trials.
If the FDA’s evaluation of the new drug application submission or manufacturing facilities is not favorable,
the FDA may refuse to approve the new drug application or issue a not approvable letter. The not approvable
letter outlines the deficiencies in the submission and often requires additional testing or information in order for
the FDA to reconsider the application. Even with submission of this additional information, the FDA ultimately
may decide that the application does not satisfy the regulatory criteria for approval. With limited exceptions,
FDA may withhold approval of a new drug application regardless of prior advice it may have provided or
commitments it may have made to the sponsor.
Foreign Regulation of New Drug Compounds
Approval of a product by comparable regulatory authorities may be necessary in foreign countries prior to
the commencement of marketing of the product in those countries, whether or not FDA approval has been
obtained. The approval procedure varies among countries and can involve requirements for additional testing.
The time required may differ from that required for FDA approval. Although there are some procedures for
unified filings for some European countries with the sponsorship of the country which first granted marketing
approval, in general each country has its own procedures and requirements, many of which are time consuming
and expensive. Thus, there can be substantial delays in obtaining required approvals from foreign regulatory
authorities after the relevant applications are filed.
In Europe, marketing authorizations may be submitted at a centralized, a decentralized or a national level.
The centralized procedure is mandatory for the approval of biotechnology products and provides for the grant of
a single marketing authorization which is valid in all European Union member states. As of January 1995, a
mutual recognition procedure is available at the request of the applicant for all medicinal products which are not
subject to the centralized procedure.
Hazardous Materials
Our research and development processes involve the controlled use of hazardous materials, chemicals and
radioactive materials and produce waste products. We are subject to federal, state and local laws and regulations
governing the use, manufacture, storage, handling and disposal of hazardous materials and waste products. We
do not expect the cost of complying with these laws and regulations to be material.
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Competition
Our product candidates will compete with existing and new products being developed by others for
treatment of the same indications. Competition in the development of human therapeutics and, in particular,
human therapeutics based upon signaling pathways, is intense. Our competitors will include many large
pharmaceutical and biopharmaceutical companies, as well as specialized biotechnology and medical device
firms.
Many of the companies competing against us have financial, marketing and human resource capacities that
are substantially greater than our own, which may provide these competitors significant competitive advantages
over us. Others have extensive experience in undertaking clinical trials, in obtaining regulatory approval to
market products and in manufacturing products on a large scale, which may enhance their competitive position
relative to ours. In addition to competing with pharmaceutical, biotechnology and medical device companies, the
products we are developing would also compete with those being developed by academic and research
institutions, government agencies and other public organizations. Any of these organizations may discover new
therapies, seek patent protection or establish collaborative arrangements for products and technologies which are
competitive with our products and technologies.
The technology underlying the development of human therapeutic products is expected to continue to
undergo rapid and significant advancement and change. Accordingly, our technological and commercial success
will be based, among other things, on our ability to develop proprietary positions in key scientific areas and
efficiently evaluate potential product opportunities.
The timing of a product’s introduction may be a major factor in determining eventual commercial success
and profitability. Early entry may have important advantages in gaining product acceptance and market share.
Accordingly, we believe the relative speed with which our collaborative partners or we can complete preclinical
and clinical testing, obtain regulatory approvals, and supply commercial quantities of a product will have an
important impact on our competitive position, both in the United States and abroad. Other companies may
succeed in developing similar products that are introduced earlier, are more effective, or are produced and
marketed more effectively. For example, our competitors may discover, characterize and develop important
inducing molecules or genes before we do, which could have a material adverse effect on any of our related
research programs. If research and development by others renders any of our products obsolete or
noncompetitive, then our potential for success and profitability may be adversely affected.
We rely on or will rely on our strategic partners for support in our disease research programs and for
preclinical evaluation and clinical development of our potential products and manufacturing and marketing of
any products. Some of our strategic partners are conducting multiple product development efforts within each
disease area that is the subject of our strategic alliance with them. Our strategic alliance agreements may not
restrict the strategic partner from pursuing competing internal development efforts. Any of our product
candidates, therefore, may be subject to competition with a product candidate under development by a strategic
partner.
Manufacturing
We have no experience or capabilities in manufacturing. We have no current plans to develop
manufacturing capability and instead plan to rely on our corporate partners or subcontractors to manufacture
products.
Sales and Marketing
We have no sales, marketing or distribution experience or infrastructure and we have no current plans to
develop a sales, marketing and distribution capability. We plan to rely on our corporate partners for product
sales, marketing and distribution.
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Scientific Advisory Board
We have established a scientific advisory board made up of leading scientists and physicians in the field of
signaling pathways. Members of our scientific advisory board consult with us on matters relating to our research
and development programs, new technologies relevant to our research and development programs and other
scientific and technical issues relevant to our business.
The current members of our scientific advisory board are as follows:
Name
Position/Institutional Affiliation
Douglas A. Melton, Ph.D. (Chairman)
Investigator, Howard Hughes Medical Institute
Professor, Department of Molecular and Cellular Biology
Harvard University
Brigid Hogan, Ph.D. . . . . . . . . . . . . . . Professor and Chair, Department of Cell Biology
Thomas Jessell, Ph.D.
. . . . . . . . . . . .
Duke University Medical School
Investigator, Howard Hughes Medical Institute
Professor, Center for Neurobiology and Behavior
Columbia University, College of Physicians and Surgeons
Andrew P. McMahon, Ph.D.
. . . . . . . Frank B. Baird, Jr. Professor of Science, Department of
Molecular and Cellular Biology
Harvard University
Roeland Nusse, Ph.D. . . . . . . . . . . . . . Professor of Developmental Biology
Investigator, Howard Hughes Medical Institute
Stanford University Medical School
Martin C. Raff, M.D.
. . . . . . . . . . . . . Professor, Department of Biology
MRC Laboratory For Molecular and Cell Biology
University College London
Matthew Scott, Ph.D. . . . . . . . . . . . . . Professor, Department of Developmental Biology & Genetics
Investigator, Howard Hughes Medical Institute
Chairman, Bio-X Scientific Leadership Council
Stanford University School of Medicine
Clifford J. Tabin, Ph.D.
. . . . . . . . . . . Professor, Department of Genetics
Harvard Medical School
Employees
As of December 31, 2003, we had 64 full-time employees, of whom 38 hold Ph.D. or other advanced
degrees. Of these employees, 43 are currently involved in research and development. None of our employees is a
party to a collective bargaining agreement, and we consider our relations with our employees to be good.
ITEM 2. PROPERTIES
We have three facilities which are located at 25, 45 and 61 Moulton Street in Cambridge, Massachusetts and
which consist of 1,526, 35,095 and 17,800 square feet, respectively. All of these facilities are leased until April
2007. Except for 17,280 square feet which we have sublet, we currently use our space to conduct our research
and development initiatives and to manage the administrative aspects of our business.
ITEM 3. LEGAL PROCEEDINGS
We are currently not party to any material legal proceedings.
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ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
We did not submit any matter to a vote of security holders during the fourth quarter of the fiscal year
covered by this annual report.
EXECUTIVE OFFICERS OF THE REGISTRANT
Our executive officers are as follows:
Name
Age
Position
Daniel R. Passeri . . . . . . . . . . . . . . .
Lee L. Rubin, Ph.D.
. . . . . . . . . . . .
43
53
President and Chief Executive Officer
Senior Vice President of Research and Chief
Scientific Officer
Michael P. Gray . . . . . . . . . . . . . . .
33 Vice President of Finance and Chief Financial
Officer
Mark W. Noel . . . . . . . . . . . . . . . . .
45 Vice President, Technology Management and
Business Development
Mary Elizabeth Potthoff, Esq.
. . . .
50 Vice President, General Counsel
Christopher U. Missling, Ph.D. . . . .
38
Senior Vice President of Strategic Analysis and
Planning
Daniel R. Passeri . . . . . . . . . . . . . . . Mr. Passeri has served as our President and Chief Executive Officer
and as a director since September 2001. From November 2000 to
September 2001, Mr. Passeri served as Senior Vice President,
Corporate Development and Strategic Planning of the Company.
From March 1997 to November 2000, Mr. Passeri was employed by
GeneLogic Inc., a biotechnology company, most recently as Senior
Vice President, Corporate Development and Strategic Planning. From
February 1995 to March 1997, Mr. Passeri was employed by
Boehringer Mannheim, a pharmaceutical, biotechnology and
diagnostic company, as Director of Technology Management. Mr.
Passeri is a graduate of the National Law Center at George
Washington University, with a J.D., of the Imperial College of
Science, Technology and Medicine at the University of London, with
a M.Sc. in biotechnology, and of Northeastern University, with a B.S.
in Biology.
Lee L. Rubin, Ph.D.
. . . . . . . . . . . . Dr. Rubin has served as our Senior Vice President of Research and
Chief Scientific Officer since September 2000 and prior to that served
as our Vice President of Research since March 2000. From October
1997 to March 2000, Dr. Rubin was employed by Ontogeny, Inc. a
predecessor life sciences company, as Vice President of Research.
Prior to joining Ontogeny, Dr. Rubin spent six years at Eisai London
Laboratories at University College London, where he served as
Director and Professor of Neurobiology. Prior to that, Dr. Rubin
worked for four years with Athena NeuroSciences, Inc., a life
sciences company, where he served as senior scientist and head of the
blood-brain barrier program. Dr. Rubin completed his Ph.D. at
Rockefeller University and his B.A. at Cornell University.
14
Michael P. Gray . . . . . . . . . . . . . . . . . . . . Mr. Gray has served as our Vice President of Finance and Chief
Financial Officer since December 2003 and served as our Senior
Director of Finance and Controller from August 2000 until December
2003. From January 1998 to July 2000, Mr. Gray was Controller at
Reprogenesis, Inc., a predecessor biotechnology company. Mr. Gray
previously served as an audit professional for the accounting and
consulting firm of Ernst & Young, LLP. Mr. Gray is a certified public
accountant, holds an M.B.A. from the F.W. Olin Graduate School of
Business at Babson College, and has a B.S. in accounting from Bryant
College.
Mark W. Noel . . . . . . . . . . . . . . . . . . . . . Mr. Noel has served as our Vice President, Technology Management
and Business Development since March 2001. From March 2000 to
February 2001, Mr. Noel was employed by GeneLogic, as Vice
President of Customer Relations. From January 1998 to February
2000, Mr. Noel was employed by GeneLogic as Senior Director of
Program Management. From December 1993 to January 1998, Mr.
Noel was employed by the National Cancer Institute’s Office of
Technology Development (now the Technology Transfer Branch of
the NCI Office of Technology and Industrial Relations), where from
July 1997 to January 1998, he served as Acting Deputy Director.
From February 1989 to November 1993, Mr. Noel worked as a patent
agent at Gist Brocades NV, a supplier of ingredients to the
pharmaceutical and food sectors. Mr. Noel completed his B.S. at the
University of Maryland.
Mary Elizabeth Potthoff . . . . . . . . . . . . . Ms. Potthoff has served as our Vice President, General Counsel and
Assistant Secretary since August 2002 and as Secretary since
December 2003. From August 1999 to April 2002, Ms. Potthoff was
Vice President, General Counsel and Corporate Secretary at
Wheelhouse Corporation, an internet marketing software and
consulting services company. From July 1994 to August 1999, Ms.
Potthoff was Vice President, General Counsel and Corporate
Secretary at Shiva Corporation, a technology company focused on
remote access network products and services. From July 1989 to July
1994, Ms. Potthoff was Senior Corporate Counsel at Bytex
Corporation, a technology company focused on network matrix
switch products and services. Ms. Potthoff received her J.D., cum
laude, from Suffolk University, an M.B.A. from Providence College,
and a B.A. from the State University of New York.
Christopher U. Missling, Ph.D. . . . . . . . . Dr. Missling has served as Senior Vice President of Strategic Analysis
and Planning since November 2003 and served as Senior Vice
President of Finance, Chief Financial Officer, Treasurer and Secretary
August 2002 until November 2003. From November 2001 until
August 2002, Dr. Missling was employed by Axaron Bioscience AG,
a genomics biotechnology company, where he served as Chief
Financial Officer. From January 2000 until October 2001,
Dr. Missling was employed by Aventis SA, a leading pharmaceutical
company, as Head of Financial Planning, with responsibility for
15
financial modeling and determining investment valuations. From July
1997 to December 1999, Dr. Missling was employed by Hoechst AG,
a pharmaceutical company, most recently as Head of Financial
Planning. Dr. Missling received his MBA from the Kellogg Graduate
School of Management at WHU and Northwestern University, and his
Ph.D., summa cum laude, and M.Sc. from Ludwig-Maximilians-
University in Munich.
16
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY AND RELATED
STOCKHOLDERS MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
(a) Market Information. Our common stock is traded on The NASDAQ National Market under the trading
symbol “CRIS”. The following table sets forth, for the fiscal periods indicated, the high and low sales prices per
share of our common stock as reported on The NASDAQ National Market:
Year ended December 31, 2002
First Quarter
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Second Quarter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Third Quarter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fourth Quarter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Year ended December 31, 2003
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
First Quarter
Second Quarter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Third Quarter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fourth Quarter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Curis
Common Stock
$5.68
$2.24
$1.37
$1.28
$1.25
$5.60
$5.34
$5.92
$1.96
$1.00
$0.51
$0.50
$0.65
$0.76
$2.80
$4.34
(b) Holders of Record. On February 23, 2004, the last reported sale price of our common stock on The
Nasdaq National Market was $4.96 and there were 329 holders of record of our common stock. The number of
record holders may not be representative of the number of beneficial owners because many of the shares of our
common stock are held by depositories, brokers or other nominees.
(c) Dividends. We have never declared or paid any cash dividends on our common stock. We currently
intend to retain earnings, if any, to support our growth strategy and do not anticipate paying cash dividends in the
foreseeable future. Payment of future dividends, if any, will be at the sole discretion of our board of directors
after taking into account various factors, including our financial condition, operating results, capital requirements
and any plans for expansion.
(d) Recent Sales of Unregistered Securities. Effective September 30, 2003, we issued an aggregate of
100,000 shares of our common stock to Johns Hopkins University, University of Washington, Philip A. Beachy
and Jeffrey Porter as partial consideration for the amendment of a license agreement. We issued and delivered
these securities in reliance upon an exemption from registration under Section 4(2) of the Securities Act of 1933.
Effective September 30, 2003, we issued an aggregate of 100,000 shares of our common stock to the
President and Fellows of Harvard College as partial consideration for the amendment of a license agreement. We
issued and delivered these securities in reliance upon an exemption from registration under Section 4(2) of the
Securities Act of 1933.
17
ITEM 6. SELECTED FINANCIAL DATA
The selected consolidated financial data set forth below have been derived from our consolidated financial
statements. These historical results are not necessarily indicative of results to be expected for any future period.
You should read the data set forth below in conjunction with “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” and the consolidated financial statements and related notes
included elsewhere in this report.
Year Ended December 31,
2003
2002
2001
2000
1999
(in thousands, except per share data)
Consolidated Statement of Operations Data:
Revenues:
Research and development contracts and government grants . . . . . . . .
License fees and royalties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
1,629
9,419
$
Total revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11,048
Costs and expenses:
Research and development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General and administrative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stock-based compensation (A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amortization of and impairment charge related to intangible assets . . .
Loss of property and equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Impairment of goodwill
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Restructuring expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
In-process research and development . . . . . . . . . . . . . . . . . . . . . . . . . . .
1999 reorganization and 1998 sale of manufacturing operations . . . . . .
Total costs and expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13,399
5,855
1,631
75
—
—
—
—
—
20,960
245
18,146
18,391
14,058
8,160
2,160
474
5,337
64,098
3,490
—
—
97,777
$
$
968
119
1,087
$
997
26
1,023
3,160
52
3,212
29,072
10,493
10,358
23,339
—
—
—
—
—
73,262
17,424
9,330
16,628
14,451
204
—
—
294,800
(38)
352,799
10,435
5,524
64
808
—
—
—
—
256
17,087
Loss from operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(9,912)
(79,386)
(72,175)
(351,776)
(13,875)
Equity in loss from joint venture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other income (expense)
Interest and other income (expense) . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interest expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total other income (expense) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accretion and repurchase costs on Series 1998/A Preferred Stock . . . . . . . .
—
(4,311)
(13,453)
—
—
(1,017)
(694)
(1,711)
(11,623)
—
2,329
(947)
1,382
4,548
(784)
3,764
(82,315)
—
(81,864)
—
1,906
(481)
1,425
(350,351)
—
—
1,926
(161)
1,765
(12,110)
(2,395)
—
Accretion on Series A Redeemable Preferred Stock . . . . . . . . . . . . . . . . . . .
(271)
(723)
(326)
Net loss applicable to common stockholders . . . . . . . . . . . . . . . . . . . . . . . . .
$ (11,894) $ (83,038) $ (82,190) $(350,351) $ (14,505)
Basic and diluted net loss per common share . . . . . . . . . . . . . . . . . . . . . . . . .
$
(0.33) $
(2.57) $
(2.58) $
(19.80) $
(1.36)
Weighted average common shares (basic and diluted)
. . . . . . . . . . . . . . . . .
36,016
32,267
31,859
17,694
10,682
(A) The following summarizes the departmental allocation of the stock-
based compensation charge:
Research and development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General and administrative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total stock-based compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
$
1,267
364
1,631
$
$
1,222
938
$
6,156
4,202
$
8,358
8,270
2,160
$ 10,358
$ 16,628
$
$
—
64
64
Consolidated Balance Sheet Data:
Cash, cash equivalents and marketable securities . . . . . . . . . . . . . . . . . . . . .
Cash and cash equivalents—restricted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Working capital
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Debt and lease obligations, net of current portion . . . . . . . . . . . . . . . . . . . . .
Convertible notes payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Series A Convertible/Exchangeable Preferred Stock . . . . . . . . . . . . . . . . . . .
Accumulated deficit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total stockholders’ equity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
18
As of December 31,
2003
2002
2001
2000
1999
(in thousands)
$ 35,148
191
34,278
55,736
—
5,334
—
(649,068)
38,865
$ 36,573
4,403
36,293
62,442
3,424
6,885
13,064
(637,174)
19,736
$ 52,107
—
42,848
144,756
4,951
2,507
12,341
(554,136)
101,020
$ 75,799
—
67,364
182,682
4,155
—
—
$ 21,371
—
17,116
28,892
1,009
—
—
(471,946)
168,814
(121,595)
23,422
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
The following discussion and analysis of financial condition and results of operations should be read
together with “Selected Financial Data,” and our financial statements and accompanying notes appearing
elsewhere in this annual report on Form 10-K. This discussion contains forward-looking statements, based on
current expectations and related to future events and our future financial performance, that involve risks and
uncertainties. Our actual results may differ materially from those anticipated in these forward-looking
statements as a result of many important factors, including those set forth below under “Factors That May Affect
Results” and elsewhere in this report.
Overview
We are a therapeutic drug development company principally focused on the discovery, development and
future commercialization of products that modulate key regulatory signaling pathways controlling the repair and
regeneration of human tissues and organs. Our product development approach involves using small molecules,
proteins or antibodies to modulate these regulatory signaling pathways. We have successfully developed several
promising preclinical product candidates in the fields of kidney disease, cancer, neurological disorders,
cardiovascular disease and hair growth regulation.
Since our inception, we have funded our operations primarily through license fees, research and
development funding from our collaborative partners, the private and public placement of our equity securities,
debt financings and the monitization of certain royalty rights. We have never been profitable and have incurred
an accumulated deficit of $649,068,000 as of December 31, 2003. We expect to incur significant operating losses
for the next several years as we devote substantially all of our resources to research and development of our
product candidates. We will need to generate significant revenues to achieve profitability and do not expect to
achieve profitability in the foreseeable future, if at all.
We currently have strategic collaborations with Ortho Biotech, Genentech and Wyeth. Our strategic
alliances and collaborations generally provide for our research, development and commercialization programs to
be funded by our collaborators and provide us with the opportunity to receive additional payments if specified
milestones are achieved, as well as royalty payments upon the successful commercialization of any products
based upon the collaboration. In some cases, we have retained development and commercialization rights in
areas where we believe we can attain the greatest potential long-term value through the application of our own
internal resources. In the future, we plan to continue to seek corporate partners for the further development and
commercialization of some of our technologies. Even though we are seeking partners to help develop some of
our technologies, we expect to select at least one program that we will develop further on our own.
Financial Operations Overview
General. Our future operating results will depend largely on the magnitude of payments from our current
and potential future corporate partners and the progress of other product candidates currently in our research and
development pipeline. The results of our operations will vary significantly from year to year and quarter to
quarter and depend on, among other factors, the timing of our entry into new collaborations, the timing of the
receipt of payments from collaborators and the cost and outcome of clinical trials. We believe that our existing
capital resources should enable us to maintain current and planned operations into the first half of 2006.
Revenue. Other than royalty revenue from Stryker Corporation’s sales of OP-1, a bone-inducing protein,
we have not generated any revenue from product sales since our inception and do not expect to generate any
revenue from the sale of products for several years, if ever. In late 2002, Stryker paid us $14,000,000 in exchange
for the termination of its future royalty obligations on OP-1. Accordingly, we will receive no future royalties on
sales by Stryker of OP-1. Other than revenues from our agreements with Stryker, substantially all of our revenue
19
to date has been derived from license fees and research and development payments that we have received from
our corporate collaborators. In the future, we will seek to generate revenue from a combination of up-front fees,
research and development funding and milestone payments in connection with strategic collaborations, and
royalties resulting from the sale of products which incorporate our intellectual property. We expect that any
revenue we generate will fluctuate from quarter to quarter as a result of the timing and amount of payments
received under our strategic collaborations, and the amount and timing of payments we receive upon the sale of
our products, to the extent that any are successfully commercialized.
Research and Development. Research and development expense consists of costs incurred to discover,
research and develop product candidates. These expenses consist primarily of salaries and related expenses for
personnel, outside service costs including medicinal chemistry, consulting and sponsored research collaborations,
occupancy and depreciation charges and the legal costs of pursuing patent protection of our intellectual property.
We expense research and development costs, including patent-related costs, as incurred.
The following table summarizes our primary research and development programs, including the current
development status of each program. In the table below, the term early preclinical means we are seeking to obtain
initial demonstrations of therapeutic efficacy in preclinical models of human disease, mid preclinical means we
are seeking to obtain multiple demonstrations of efficacy in preclinical models of human disease, and late
preclinical means we are seeking to obtain both multiple demonstrations of efficacy in preclinical models of
human disease and relevant toxicology and safety data required for an investigational new drug application, or
IND, filing with the FDA seeking to commence a phase I clinical trial to assess safety in humans. We have set
forth below under “Results of Operations” the expenses incurred with respect to each product candidate for the
fiscal years ended December 31, 2003, 2002 and 2001. We have not provided program costs since inception
because prior to 2001 we did not track and accumulate cost information by research program.
Product Candidate
Primary Indication
Partner/Licensee
Status
BMP-7 protein
Hh small molecule antagonist
Hh small molecule antagonist
Hh antibody antagonist
Hh small molecule agonist
Hh small molecule agonist
Hh small molecule agonist
Hh agonist/protein/gene
Hh small molecule antagonist
PYY peptide
Kidney disease
Basal cell carcinoma
Cancer
Cancer
Central nervous system disorders
Peripheral nervous system disorders
Hair loss
Cardiovascular disease
Hair growth inhibition
Obesity
Ortho Biotech
Genentech
Genentech
Genentech
Wyeth
Wyeth
In–house development
In–house development
In–house development
Amylin Pharmaceuticals
Late preclinical
Late preclinical
Mid preclinical
Mid preclinical
Mid preclinical
Mid preclinical
Late preclinical
Mid preclinical
Early preclinical
IND filed
There is a risk that any drug discovery and development program may not produce products or revenue.
Moreover, because of uncertainties inherent in drug discovery and development, including those factors
described below under “Risk Factors That May Affect Results,” we and our collaborative partners may not be
able to successfully develop and commercialize any of the product candidates included in the table above.
All of our product development initiatives are in various stages of preclinical testing, other than our PYY
peptide, which has been licensed to Amylin Pharmaceuticals and which is currently the subject of an
investigational new drug application seeking FDA approval to begin human clinical trials. Because all of our
product development initiatives are in early stages of development, the successful development of our product
candidates is highly uncertain. We cannot reasonably estimate or know the nature, timing and estimated costs of
the efforts necessary to complete the development of, or the period in which material net cash inflows are
expected to commence from, any of our product candidates due to the numerous risks and uncertainties
associated with developing drugs, including the uncertainty of:
•
•
the scope, rate of progress and cost of clinical trials and other research and development activities
undertaken by us or our collaborative partners;
future clinical trials results;
20
•
•
•
•
•
•
the terms and timing of any collaborative, licensing and other arrangements that we may establish;
the cost and timing of regulatory approvals;
the cost and timing of establishing sales, marketing and distribution capabilities;
the cost of establishing clinical and commercial supplies of our product candidates and any products that
we may develop;
the effect of competing technological and market developments; and
the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property
rights.
Any failure to complete the development of our product candidates in a timely manner could have a material
adverse effect on our operations, financial position and liquidity. A discussion of the risks and uncertainties
associated with completing our projects on schedule, or at all, and some consequences of failing to do so, are set
forth below in “Risk Factors That May Affect Results.”
General and Administrative. General and administrative expense consists primarily of salaries and other
related costs for personnel in executive, finance, accounting, business development, legal, information
technology, corporate communications and human resource functions. Other costs include facility costs not
otherwise included in research and development expense and professional fees for legal and accounting services.
Strategic Alliances and License Agreements. Since inception, substantially all of our revenue has been
derived from collaborations and other research and development arrangements with third parties. Our current
strategic alliances and key license agreements are as follows:
Ortho Biotech Collaboration.
In November 2002, we licensed our broad BMP technology portfolio to
Ortho Biotech on an exclusive, worldwide royalty-bearing basis, for all non-orthopedic and non-dental
therapeutic applications in exchange for a $3,500,000 up-front fee, a series of cash milestones if specified
clinical research objectives and regulatory approvals are achieved, including a $30,000,000 milestone
payment upon U.S. regulatory approval of a product for the treatment of kidney disease, and a royalty on
potential future product sales. If the program progresses successfully through clinical development, we are
entitled to receive additional milestone payments for the kidney disease related product candidate and
milestone payments for the first neurology product candidate.
Genentech, Inc. Collaboration.
In June 2003, we licensed our novel small molecule and antibody
inhibitors of the Hedgehog signaling pathway to Genentech on an exclusive worldwide royalty-bearing basis
for applications in cancer therapy. Under the terms of the agreement, Genentech paid us an upfront license
fee of $5,000,000, purchased 1,323,835 shares of our common stock at a price of $2.644 per share for
aggregate proceeds of $3,500,000, and is also obligated to pay us a total of $4,000,000 in maintenance fees
by July 2005. Genentech is also obligated to make cash payments to us upon the successful achievement of
clinical development and drug approval milestones. In addition, Genentech will pay a royalty on potential
future net product sales, which increases with increasing sales volume. We have retained the right to co-
develop products in the field of basal cell carcinoma, in which event we will share in any profits related to
the basal cell carcinoma program in a percentage that is equal to our co-development cost sharing
contribution.
Wyeth Pharmaceuticals Collaboration.
In January 2004, we entered into an agreement to license our
Hedgehog proteins and novel small molecule Hedgehog pathway agonists to Wyeth on an exclusive
worldwide, royalty-bearing basis for the development and commercialization of pharmaceutical products for
the therapeutic applications in treatment of neurological disorders, including neurodegenerative diseases and
neuropathies. Under the terms of the agreement, Wyeth Pharmaceuticals paid us a license fee of $1,500,000
and purchased 315,524 shares of our common stock at a price of $4.754 per share for an aggregate purchase
21
price of $1,500,000. Wyeth will provide research funding for a minimum of two years. In addition, Wyeth is
obligated to make cash payments to us upon the successful achievement of clinical development and drug
approval milestones and is obligated to pay a royalty on net product sales, if any, that escalates with
increasing sales volume.
Amylin Pharmaceuticals Licenses.
In December 2002, we granted Amylin Pharmaceuticals an
exclusive worldwide, royalty-bearing license to our PYY patent applications for use in the research,
development and commercialization of products in exchange for an up-front fee, milestone payments upon
the achievement of specified development objectives, and royalties on potential future product sales, if any.
PYY is a gut peptide that has been shown in animals and humans to suppress appetite and reduce food
intake. Amylin has exclusive responsibility for expenses related to further development of the PYY
compound.
Critical Accounting Policies
While our significant accounting policies are more fully described in our consolidated financial statements,
we believe the following accounting policies to be critical to understanding the judgments and estimates we use
in preparing our financial statements:
Long-Lived Assets. Long-lived assets consist of goodwill, long-term receivables, equity securities held in
Micromet, ES Cell International and Aegera Therapeutics, capitalized patent costs and long-term deposits. We
assess the impairment of identifiable intangibles and long-lived assets whenever events or changes in
circumstances indicate that the carrying value may not be recoverable. In addition, we perform a goodwill
impairment test annually. If it were determined that the carrying value of intangible or long-lived assets might
not be recoverable based upon the existence of one or more indicators of impairment, we would measure any
impairment based on a projected cash flow method.
As a result of the adoption of SFAS No. 142, effective January 1, 2002, we ceased amortization of goodwill
and performed an initial assessment of impairment of our goodwill in the first quarter of 2002. This initial
assessment involved comparing our fair value to our net assets. We determined our fair value based on quoted
market prices adjusted to provide for a control premium. Our fair value was in excess of our net assets and,
therefore, we concluded that our goodwill was not impaired. SFAS No. 142 requires us to perform an impairment
assessment annually or whenever events or changes in circumstances indicate that our goodwill may be impaired.
During the three-month period ended June 30, 2002, we concluded that the decline in our market capitalization
indicated that the carrying value of goodwill might be impaired. As a result, we conducted an impairment
assessment as required under SFAS No. 142 by comparing our fair value to our net assets, including goodwill, as
of June 30, 2002. Because the carrying value of our net assets exceeded our fair value at June 30, 2002, we
determined that our goodwill had been impaired. To determine the amount of the impairment charge as a single
reporting unit, we calculated our implied goodwill as the difference between our fair value and the fair value of
our assets and liabilities. The fair value of our intangible assets, principally consisting of completed and in-
process technology, was estimated using a discounted cash flow methodology. Based on this valuation, we
determined that our implied goodwill was $8,982,000, and we recorded a non-cash charge in the quarter ended
June 30, 2002, of $64,098,000 to write-down our existing goodwill.
The goodwill impairment analysis as of June 30, 2002 involved considerable judgment and the use of
several estimates including: control premium, discount rates, projected cash flows of OP-1 and projected cash
flows of our in-process research and development programs. The control premium used in determining our fair
value was based on an analysis of control premiums involved in other biotechnology and medical products
acquisitions. Most of our research and development programs will not be completed for several years, if ever,
and therefore estimating the costs to complete these programs and the revenue to be derived through
collaborations and commercialization of the products involves substantial judgment. The discount rates used to
determine the net present value of these cash flows were based on a consideration of the risks associated with
22
achieving these cash flow projections, including the risk of successfully completing our in-process technology.
All of these estimates involve a significant amount of judgment by our management. Although the estimates used
reflect management’s best estimates based upon all available evidence, the use of different estimates could have
yielded different results in our transitional impairment assessment conducted as of January 1, 2002, and in our
impairment assessment conducted in the second quarter of 2002. Had we used a significantly lower control
premium in determining our fair value, our transitional impairment analysis could have indicated that goodwill
was impaired at January 1, 2002. In addition, using different estimated cash flows or discount rates in
determining our implied goodwill in the second quarter of 2002 could have resulted in a higher or lower goodwill
impairment charge.
We completed our annual goodwill impairment test in December 2003, and determined that as of that date
our fair value exceeded the carrying value of our net assets. Accordingly, no goodwill impairment was
recognized in 2003.
During the year ended December 31, 2003, we recorded, in other expense, charges of $1,708,000 related to
the write-off of a euro-denominated note receivable that is due in June 2005 from Micromet, a former
collaborator, and $286,000 related to a reduction in the carrying value of Micromet equity securities held by us.
We determined that these charges were necessary due to Micromet’s recent announcement that it was terminating
one-third of its workforce as the result of a contract dispute with a co-development partner. Micromet has stated
that this dispute will result in a significant decrease of previously budgeted cash inflows in 2004, which, in our
estimate, materially and adversely affects the likelihood of collection of the note receivable.
During the fourth quarter of the year ended December 31, 2002, we recorded an impairment charge of
$271,000 to write-off the carrying value of patents associated with our OP-1 technology, which is licensed to
Stryker. The charge was recorded as a result of our transaction with Stryker under which, in exchange for
$14,000,000, we sold our rights to future royalties from Stryker on sales of OP-1. We wrote these patents off
because we will not receive any future royalties or other revenue from Stryker and because these patents cannot
be utilized for alternative uses in either current or future operations.
During the first quarter of the year ended December 31, 2002, we recorded impairment charges of property
and equipment assets related to our business realignment of $5,337,000. These charges related to impairment on
assets at our former manufacturing and development facility located at 21 Erie Street in Cambridge,
Massachusetts. Of the total impairment charge, $4,761,000 relates to the write-off of tenant improvements made
to the Erie Street facility, since such were affixed to the facility and therefore could not have been sold separately
from the facility. The remaining charge of $576,000 was to write-down equipment to its estimated salvage value.
The amount we received from the sale of these assets was not significantly different from the originally estimated
salvage value.
Revenue recognition. Revenue is a key component of our results of operations. We follow the provisions
of the Securities and Exchange Commission’s Staff Accounting Bulletin No. 104 (SAB No. 104), Revenue
Recognition, and EITF 00-21, Accounting for Revenue Arrangements with Multiple Deliverables. In accordance
with SAB No. 104, we recognize revenue related to research activities as they are performed, so long as there is
persuasive evidence of an arrangement, the fee is fixed or determinable and collection of the related receivable is
probable.
Amounts received for license fees are deferred and recognized as services are performed over the
performance period of the contract. Amounts received for milestones will be recognized upon achievement of the
milestone, as long as the milestone is deemed to be substantive and we have no other performance obligations. In
the event that we have remaining performance obligations, the portion of the milestone payment equal to the
lesser of the non-refundable cash received or the percentage of the services performed through that date
multiplied by the total milestone payment would be recognized as revenue.
23
We recognized $728,000 in revenue related to our collaboration with Genentech for the year ended
December 31, 2003. This amount primarily consists of revenue recognized under the amortization of a
$5,000,000 up-front license fee received from Genentech in July 2003 and future maintenance fees totaling
$4,000,000 that will be paid over the first two years of the collaboration. The remainder will be recognized
proportionately as the remaining services are performed. Revenues for research and development services are
recognized as such services are performed.
For the year ended December 31, 2003, we recognized $1,470,000 of revenues relating to research and
development services performed under an agreement with ES Cell International.
Royalty revenue is recognized upon the sale of the related products, provided the royalty amounts are fixed
or determinable and collection of the related receivable is reasonably assured. No royalty revenue was recognized
during the year ended December 31, 2003.
Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue
in the accompanying balance sheets. Amounts that we expect will not be recognized prior to December 31, 2004
are classified as long-term deferred revenue. As of December 31, 2003, we have recorded short- and long-term
deferred revenue of $1,241,000 and $7,089,000, respectively, both of which are solely related to the $5,000,000
up-front payment and the $4,000,000 in future maintenance fee payments under our collaboration with
Genentech.
We follow detailed guidelines in measuring revenue; however, certain judgments affect the application of
our revenue policy. For example, in connection with our collaboration agreement with Genentech, we have
recorded on our balance sheet short- and long-term deferred revenue based on our best estimate of when such
revenue will be recognized. The estimate of deferred revenue reflects management’s estimate of the period of our
involvement with the collaboration. Our period of involvement is largely determined by the time to
commercialize clinical candidates that we may co-develop with Genentech. Since the timing of clinical
development is difficult to estimate, our estimates may change in the future. Such changes to estimates would
result in a change in revenue recognition rates. As of December 31, 2003, $670,000 has been recognized as
revenue related to the amortization of the up-front license fee and future maintenance fees. The remaining
$8,330,000 is recorded as deferred revenue on our balance sheet at December 31, 2003. Under our current
operating plan, we plan to recognize this revenue on a straight-line basis through the third quarter of 2010.
The above list is not intended to be a comprehensive list of all of our accounting policies. In many cases, the
accounting treatment of a particular transaction is specifically dictated by generally accepted accounting
principles, with no need for management’s judgment in their application. There are also areas in which
management’s judgment in selecting any available alternative would not produce a materially different result.
Critical Accounting Estimates
The preparation of our consolidated financial statements in conformity with accounting principles generally
accepted in the United States requires that we make estimates and assumptions that affect the reported amounts
and disclosure of certain assets and liabilities at our balance sheet date. Such estimates include the collectibility
of receivables, the carrying value of property and equipment and intangible assets and the value of certain
liabilities. Actual results may differ from such estimates. Our more significant estimates are as follows:
Valuation of investments in privately-held companies. We have investments in Aegera, Micromet and ES
Cell International with original cost bases of $167,000, $400,000 and $150,000, respectively. These investments
are included in the “Deposits and other assets” category of our consolidated balance sheets. At each balance sheet
date, we review these investments to determine whether the fair value of these investments is less than the
carrying value and, if so, whether we should write-down the investment. These companies are not publicly-traded
and, therefore, determining the fair value of our investments in these companies involves significant judgment.
We consider available information in estimating the fair value of these investments and, as of December 31,
2003, believe that the fair value of our investments in Aegera and ES Cell are not less than their carrying value.
24
However, Micromet recently announced that it terminated one-third of its workforce as the result of a contract
dispute with a co-development partner that resulted in a significant decrease of previously budgeted cash inflows
in 2004. Accordingly, we concluded that the carrying value of our investment in Micromet common stock had
been impaired, and we recorded $286,000 in other expense to reduce the carrying value to the estimated fair
value of $400,000. If the financial condition or results of Aegera or ES Cell decline significantly or if Micromet’s
financial condition continues to decline, the fair value of these investments would likely decline and, as a result,
we may have to record an impairment charge to the extent such impairment is deemed other than temporary.
Timing of deferred revenue recognition. We have recorded short-term deferred revenue of $1,241,000 and
long-term deferred revenue of $7,089,000 as of December 31, 2003. Short-term deferred revenue consists of
amounts that are expected to be recognized as revenue by December 31, 2004. However, this estimate is based on
our current operating plan as of December 31, 2003. If this operating plan should change in the future, we may
recognize a different amount of deferred revenue over the twelve-month period from January 1, 2004, through
December 31, 2004.
Results of Operations
Years Ended December 31, 2003 and 2002
Revenues
Total revenues are summarized as follows:
For the Year Ended December 31,
2003
2002
Research and development contracts and government grants . . . . . . . . . . . . . . . . .
License fees and royalties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 1,629,000
9,419,000
$
245,000
18,146,000
Total revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$11,048,000
$18,391,000
The increase in revenue from research and development contracts and government grants for the year ended
December 31, 2003, as compared to the year ended December 31, 2002, was primarily due to our recognition of
$1,470,000 in the year ended December 31, 2003, relating to research and development services performed by us
under our licensing agreement with ES Cell International. Effective December 2003, and consistent with the
terms of this agreement, we are no longer providing research and development services and will therefore not
recognize future revenues related to this collaboration. The research and development contract and government
grant revenue for the year ended December 31, 2002, was derived entirely from revenue recognized under our
licensing agreement with ES Cell International and our former collaboration with Micromet.
Our license fee revenue for the year ended December 31, 2003, primarily consisted of $8,555,000 in
previously deferred revenue which was recognized upon the termination of our collaboration with Micromet
during the third quarter of 2003. The decrease in license fees and royalty revenue for the year ended December
31, 2003, as compared to the year ended December 31, 2002, was primarily due to the recognition of revenue
upon the completion of various transactions in 2002, including $14,000,000 in revenue we recognized upon
Stryker’s buy-out of its royalty obligation to us for OP-1 and $3,500,000 in revenue we recognized from an up-
front payment received by us in connection with the licensing of certain of our BMP technologies to Ortho
Biotech. In addition, we received $387,000 in royalty revenue from Stryker on sales of OP-1 for the year ended
December 31, 2002. As part of the Stryker transaction, we will receive no future royalties on sales by Stryker of
OP-1. The decrease in license fee and royalty revenue from transactions in 2002 was partially offset by the
Micromet revenue described above.
25
Operating Expenses
Research and development expenses are summarized as follows:
Research and Development Program
Primary Indication
Hh small molecule antagonist
Basal cell carcinoma
Hh small molecule antagonist and Hh
small molecule antibody antagonist
Cancer
For the Year Ended
December 31,
2003
2002
$
55,000
$
34,000
3,830,000
3,536,000
Hh small molecule agonist
Hh small molecule agonist
Hh small molecule agonist
Other programs
Costs allocated to Curis Newco joint
venture
Total research and development
expense
Central nervous system disorders
4,385,000
5,778,000
Peripheral nervous system disorders
2,209,000
3,511,000
Hair loss
673,000
—
2,247,000
6,462,000
—
(5,263,000)
$13,399,000
$14,058,000
In the foregoing table, “Other programs” includes expenses related to our Hh agonist/protein/gene product
candidate for cardiovascular disease, as well as research and development expenses relating to adult stem cell
and cell therapy programs. For the years ended December 31, 2003 and 2002, $1,892,000 and $5,255,000,
respectively, related to our adult stem cell and cell therapy programs. As further described below, we reduced
expenses incurred under our adult stem cell and cell therapy programs in connection with our business
realignment in 2002. To date, we have not incurred material research and development expenses for our Hh small
molecule antagonist product candidate for hair growth inhibition. All expenses relating to the development of our
BMP-7 protein product candidate for kidney disease are borne by our partner, Ortho Biotech. Costs allocated to
the Curis Newco joint venture relate to research expenses incurred by us and charged to Curis Newco, a joint
venture that, until May 16, 2003, was operated by us and affiliates of Elan Corporation. Of this aggregate
amount, $2,984,000 was related to our central nervous system disorders program and $2,279,000 was related to
our peripheral nervous system disorders program.
The decrease in research and development expenses for the year ended December 31, 2003, as compared to
the year ended December 31, 2002, was primarily due to a reduction in ongoing operating costs as a result of our
business realignment in the first quarter of 2002, including reductions in amounts spent on stem cell and cell
therapy programs. As a result of this realignment, our research and development expenses were focused
principally on regulatory signaling pathways, particulary the Hedgehog Pathway, for the year ended
December 31, 2003, and spending on our stem cell, cell therapy and other programs decreased by an aggregate of
$4,215,000, to $2,247,000 for the year ended December 31, 2003, as compared to $6,462,000 for the year ended
December 31, 2002. Reductions in spending on our stem cell, cell therapy and other programs were offset by the
termination of our collaboration with Elan, which resulted in no research and development expense being
charged to Curis Newco in 2003 verse $5,263,000 in 2002. In 2002, our research and development expenses were
presented net of these expenses charged to Curis Newco.
26
General and administrative expenses are summarized as follows:
For the Year Ended
December 31,
2003
2002
Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Occupancy and depreciation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Legal and professional services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consulting services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reserve against notes receivable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Insurance costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other general and administrative expenses . . . . . . . . . . . . . . . . . . . . . . . . . . .
$2,584,000
671,000
706,000
326,000
34,000
547,000
987,000
$3,689,000
889,000
1,221,000
327,000
686,000
512,000
836,000
Total general and administrative expenses . . . . . . . . . . . . . . . . . . . . . . .
$5,855,000
$8,160,000
The decrease in general and administrative expenses for the year ended December 31, 2003, as compared to
the year ended December 31, 2002, was primarily due to a reduction in ongoing operating costs as a result of our
business realignment in the first quarter of 2002, including reductions in personnel costs and legal and
professional services. In addition, the amount charged to reserve for the possible non-collection of notes
receivable outstanding to two former officers decreased by $652,000 to $34,000 for the year ended December 31,
2003, from $686,000 for the year ended December 31, 2002.
Stock-based compensation decreased by $529,000, or 24%, to $1,631,000 for the year ended December 31,
2003, as compared to $2,160,000 for the year ended December 31, 2002. The decrease was primarily attributable
to a decrease in the amount of stock-based compensation expense related to our issuance on August 18, 2000 of
stock options with exercise prices below fair market value. We recorded $1,100,000 and $1,893,000 in stock-
based compensation related to these options for the years ended December 31, 2003 and 2002, respectively.
Because these options were issued with exercise prices below fair market value, we recorded deferred
compensation and have been amortizing the deferred compensation over the four-year vesting period of the
options. When an option holder’s employment with us is terminated, we treat any unvested portion of their
options and related deferred compensation as charged to additional paid-in capital rather than stock-based
compensation. Accordingly, the departure of four officers and 55 additional employees as a result of the
realignment of our business and a subsequent staff reduction in December 2002 has resulted in a decrease in
stock-based compensation expense, as the remaining deferred compensation balance associated with each
terminated employees’ August 18, 2000, stock options was immediately charged to additional paid-in capital.
Amortization of intangible assets decreased by $399,000, or 84%, to $75,000 for the year ended December
31, 2003, from $474,000 for the year ended December 31, 2002. The decrease was primarily due to an
impairment charge of approximately $271,000 that we recorded during the fourth quarter of the year ended
December 31, 2002, to reduce the carrying value of patents associated with our OP-1 technology that is licensed
to Stryker. The charge was recorded as a result of our transaction with Stryker, under which Stryker bought out
its future royalty obligation to us on sales of OP-1 for $14,000,000. We wrote these patents off because we will
not receive any future royalties or other revenue from Stryker and because these patents cannot be utilized for
alternative uses in either current or future operations.
Loss on property and equipment for the year ended December 31, 2002, of $5,337,000 related to impairment
on assets at our facility at 21 Erie Street in Cambridge, Massachusetts. The total carrying value of assets at the
Erie Street facility before the impairment charge was approximately $5,652,000. The property and equipment
assets at the Erie Street facility were used to support clinical programs that were suspended or terminated as part
of the realignment and were deemed to be unlikely to be used in our future operations. Of the impairment charge,
$4,761,000 related to the write-off of tenant improvements made to the Erie Street facility since such
improvements were affixed to the facility and therefore could not have been sold separately. The remaining
27
$576,000 of impairment charge was to write down furniture and equipment assets to their estimated salvage
value. We do not expect to incur additional impairment on property and equipment related to the realignment in
future periods. The amount we received from the sale of these assets was not significantly different from the
originally estimated salvage value.
Impairment of goodwill for the year ended December 31, 2002 was $64,098,000. In accordance with SFAS
No. 142, we concluded that the decline in our market capitalization during the three-month period ended June 30,
2002 indicated that the carrying value of our goodwill might be impaired. Accordingly, we conducted an
impairment review as required under SFAS No. 142 as of June 30, 2002, and determined that goodwill
impairment had occurred as of June 30, 2002. Our value, as a single reporting unit, was calculated using quoted
market prices adjusted to provide for a control premium. In calculating the impairment charge, the fair value of
our intangible assets, principally consisting of completed and in-process technology, was estimated using a
discounted cash flow methodology.
Realignment expenses of $3,490,000 were recorded for the year ended December 31, 2002. These charges
relate to $1,139,000 associated with workforce reductions of 46 people, including 4 officers, $2,306,000
associated with the closing of clinical programs and decommissioning of a manufacturing and development
facility and other costs of $45,000. As of December 31, 2002, we expended approximately all of the $3,490,000
in realignment expenses. We do not expect to incur additional expenses related to this realignment in future
periods.
Equity in Loss from Joint Venture
We recorded no equity in loss from joint venture during the year ended December 31, 2003, as compared to
$4,311,000 during the year ended December 31, 2002. The equity in loss from joint venture relates to a joint
venture, Curis Newco, which we formed in July 2001 with affiliates of Elan Corporation. This joint venture was
terminated on May 16, 2003. As a result of the termination, we now own 100% of the outstanding shares of Curis
Newco.
Other Income (Expense)
For the year ended December 31, 2003, interest income was $428,000 as compared to $1,067,000 for the
year ended December 31, 2002, a decrease of $639,000, or 60%. The decrease in interest income resulted from a
lower available investment balance and lower average investment yields for the year ended December 31, 2003,
as compared to the year ended December 31, 2002.
For the year ended December 31, 2003, other expense was $1,445,000 as compared to other income of
$1,262,000 for the year ended December 31, 2002, a decrease of $2,707,000. This decrease was principally due
to an impairment charge of $1,994,000 for the write-off of a euro-denominated note receivable from Micromet, a
former collaborator, during the fourth quarter of the year ended December 31, 2003, as well as a decrease in the
gain recognized on currency rate fluctuations on the Micromet note receivable of $207,000. In addition, the
amount of gain recognized on sales of securities decreased by $504,000 in the year ended December 31, 2003, as
compared to the year ended December 31, 2002. We recognized gains on sales of securities of $97,000 for the
year ended December 31, 2003, as compared to $601,000 for the year ended December 31, 2002.
For the year ended December 31, 2003, interest expense was $694,000, as compared to $947,000 for the
year ended December 31, 2002, a decrease of $253,000, or 27%. The decrease in interest expense resulted from
the decrease in the amount of interest expense that we paid on capital leases in 2003 compared to 2002.
Accretion on Series A Convertible Exchangeable Preferred Stock
Accretion of preferred stock dividend for the year ended December 31, 2003 was $271,000, as compared to
$723,000 for the year ended December 31, 2002, a decrease of $452,000, or 63%. This charge relates to the
28
accretion of a mandatory 6% dividend on shares of convertible exchangeable preferred stock issued to an affiliate
of Elan as part of a joint venture with Elan. The decrease is attributed to the termination of the joint venture on
May 16, 2003, in which the convertible exchangeable preferred stock was cancelled as part of the termination.
The amounts are included in the net loss applicable to common stockholders for the years ended December 31,
2003 and 2002.
Net Loss Applicable to Common Stockholders
As a result of the foregoing, we incurred a net loss applicable to common stockholders of $11,895,000 for
the year ended December 31, 2003, as compared to $83,038,000 for the year ended December 31, 2002.
Years Ended December 31, 2002 and 2001
Revenues
Total revenues are summarized as follows:
For the Year Ended
December 31,
2002
2001
Research and development contracts and government grants . . . . . . . . . . . .
License fees and royalties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
245,000
18,146,000
$ 968,000
119,000
Total revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$18,391,000
$1,087,000
Revenue from research and development contracts and government grants for the year ended December 31,
2002, was derived entirely from revenue recognized under our licensing agreement with ES Cell International
and our former collaboration with Micromet. For the year ended December 31, 2001, this revenue was derived
solely from government grants.
The increase in license fees and royalties for the year ended December 31, 2002, as compared to the year
ended December 31, 2001, was primarily due to the recognition of revenue upon the completion of various
transactions in 2002 including $14,000,000 in revenue we recognized upon Stryker’s buy-out of its royalty
obligation to us for OP-1, $3,500,000 in revenue we recognized from an up-front payment received by us in
connection with the licensing of certain of our BMP technology to Ortho Biotech and $258,000 we recognized
under other transactions completed in 2002. In addition, royalty revenue received in 2002 from Stryker on sales
of OP-1 increased by $268,000 to $387,000 for the year ended December 31, 2002, as compared to $119,000 for
the year ended December 31, 2001. As part of the Stryker transaction, we will receive no future royalties on sales
by Stryker of OP-1.
Operating Expenses
Research and development expenses are summarized as follows:
Research and Development Program
Primary Indication
Hh small molecule antagonist
Basal cell carcinoma
Hh small molecule antagonist and Hh small
Cancer
molecule antibody antagonist
Hh small molecule agonist
Hh small molecule agonist
Hh small molecule agonist
Other programs
Costs allocated to Curis Newco joint venture
Total research and development expense
Central nervous system disorders
Peripheral nervous system disorders
Hair loss
29
Year Ended December 31,
2002
2001
$
34,000 $ 3,631,000
3,536,000
2,940,000
5,778,000
2,219,000
3,511,000
5,037,000
—
—
6,462,000
17,019,000
(5,263,000)
(1,774,000)
$14,058,000 $29,072,000
In the foregoing table, “Other programs” includes expenses related to our Hh agonist/protein/gene product
candidate for cardiovascular disease, as well as research and development expenses relating to adult stem cell
and cell therapy programs. For the years ended December 31, 2002 and 2001, $5,255,000 and $16,160,000,
respectively, related to our adult stem cell and cell therapy programs. As further described below, we reduced
expenses incurred under our adult stem cell and cell therapy programs in connection with our business
realignment in 2002. To date, we have not incurred material research and development expenses for our Hh small
molecule antagonist product candidate for hair growth inhibition. All expenses relating to the development of our
BMP-7 protein product candidate for kidney disease are borne by our partner, Ortho Biotech. Costs allocated to
the Curis Newco joint venture relate to research expenses incurred by us and charged to Curis Newco. For the
year ended December 31, 2002, $2,984,000 was related to our central nervous system disorders program and
$2,279,000 was related to our peripheral nervous system disorders program. For the year ended December 31,
2001, $764,000 was related to our central nervous system disorders program and $1,010,000 was related to our
peripheral nervous system disorders program.
The decrease in research and development expenses for the year ended December 31, 2002, as compared to
the year ended December 31, 2001, was primarily due to a reduction in ongoing operating costs as a result of our
business realignment in the first quarter of 2002, particularly for reductions in amounts spent on our cell therapy
programs since all such programs were terminated as a result of this realignment. Spending on our cell therapy
programs decreased by $12,174,000, to $742,000 for the year ended December 31, 2002, as compared to
$12,916,000 for the year ended December 31, 2001. In addition, our research expenses charged to Curis Newco
increased by $3,489,000, from $1,774,000 for year ended December 31, 2001, to $5,263,000 for the year ended
December 31, 2002. This resulted in lower research and development expenses in 2002, as compared to 2001,
since research and development expenses at our consolidated statement of operations are presented net of
expenses charged to Curis Newco.
General and administrative expenses are summarized as follows:
For the Year Ended
December 31,
2002
2001
Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Occupancy and depreciation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Legal and professional services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consulting services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Creative officer notes receivable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Insurance costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other general and administrative expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$3,689,000
889,000
1,221,000
327,000
686,000
512,000
836,000
$ 3,978,000
1,545,000
1,842,000
775,000
508,000
352,000
1,493,000
Total general and administrative expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$8,160,000
$10,493,000
The decrease in general and administrative expenses in the year ended December 31, 2002, as compared to
the year ended December 31, 2001, was primarily due to a reduction in ongoing operating costs as a result of our
business realignment in the first quarter of 2002, including reductions in consulting and legal and professional
services. We also entered into two agreements in 2002 for the sublease of 17,000 square feet of lab and office
space, resulting in decreases to our occupancy costs in 2002.
Stock-based compensation decreased by $8,198,000, or 79%, to $2,160,000 for the year ended December
31, 2002, from $10,358,000 for the year ended December 31, 2001. The decrease was primarily attributable to
the stock-based compensation expense related to deferred compensation resulting from our merger in 2000. This
stock-based compensation, which was $6,257,000 for the year ended December 31, 2001, was amortized over the
vesting period of the underlying options through August 1, 2001. Because the amortization period ended on
August 1, 2001, we recorded no stock-based compensation related to these options for the year ended December
31, 2002. In addition, there was a decrease in the amount of stock-based compensation expense related to our
issuance on August 18, 2000, of stock options with exercise prices below fair market value. We recorded
30
$1,893,000 and $3,964,000 in stock-based compensation related to these options for the years ended December
31, 2002 and 2001, respectively. Because these options were issued with exercise prices below fair market value,
we recorded deferred compensation and have been amortizing the deferred compensation over the four-year
vesting period of the options. When an option holder’s employment with us is terminated, we treat any unvested
portion of their options and related deferred compensation as charged to additional paid-in capital rather than to
stock-based compensation. Accordingly, the departure of four officers and approximately 55 other employees as
a result of the realignment of our business and a subsequent staff reduction in December 2002 has resulted in a
decrease of stock-based compensation expense, since the remaining deferred compensation balance associated
with each terminated employees’ August 18, 2000, stock options was immediately charged to additional paid-in
capital. The remaining deferred compensation related to the August 12, 2000, options will be amortized in 2004.
Amortization of intangible assets decreased by $22,864,000, or 98%, to $475,000 for the year ended
December 31, 2002, from $23,339,000 for the year ended December 31, 2001. The decrease was primarily due to
the adoption of SFAS 142, which required companies to stop amortizing goodwill and certain other intangible
assets. We currently amortize only capitalized patent and technology costs. Amortization of goodwill totaling
$23,114,000 was recorded for the year ended December 31, 2001.
Loss on property and equipment for the year ended December 31, 2002 of $5,337,000 related to impairment
on assets at our facility at 21 Erie Street in Cambridge, Massachusetts, as described above.
Impairment of goodwill for the year ended December 31, 2002 was $64,098,000, as described above.
Realignment expenses of $3,490,000 were recorded for the year ended December 31, 2002. These charges
relate to: (i) $1,139,000 associated with workforce reductions of 46 people, including 4 officers, (ii) $2,306,000
associated with the closing of clinical programs and decommissioning of a manufacturing and development
facility and other costs of $45,000. As of December 31, 2002, we expended approximately all of the $3,490,000
in realignment expenses. We do not expect to incur additional expenses in future periods.
Equity in Loss from Joint Venture
Equity in loss from joint venture decreased by $9,142,000, or 68%, to $4,311,000 for the year ended
December 31, 2002, from $13,453,000 for the year ended December 31, 2001. The equity in loss from joint
venture related to our joint venture with affiliates of Elan. The decrease was primarily caused by our 80.1%, or
$12,015,000, share of a $15,000,000 write-off of technology recorded by the joint venture in July 2001. This
decrease was partially offset by an increase in our 80.1% share of ongoing operating expenses recorded by the
joint venture for the year ended December 31, 2002, as compared to the year ended December 31, 2001. The
increase in ongoing operating expenses for the year ended December 31, 2002, as compared to the year ended
December 31, 2001, was primarily caused by the joint venture operating for twelve months in 2002 versus five
months in 2001.
Other Income (Expenses)
For the year ended December 31, 2002, interest income was $1,067,000 as compared to $2,854,000 for the
year ended December 31, 2001, a decrease of $1,787,000, or 63%. The decrease in interest income resulted from
a lower available investment balance and lower average investment yields for the year ended December 31, 2002,
as compared to the year ended December 31, 2001.
For the year ended December 31, 2002, other income was $1,262,000 as compared to $1,694,000 for the
year ended December 31, 2001, a decrease of $432,000, or 26%. This decrease was principally due to a decrease
in the amount of gain recognized on sales of Exelixis common stock. We recognized gains of $601,000 and
$1,466,000 for the years ended December 31, 2002 and 2001, respectively, related to sales of Exelixis, Inc.
common stock. The decrease in the gain recognized on sales of Exelixis common stock was partially offset by an
increase in the gain recognized on currency rate fluctuations on a euro-denominated note receivable issued to us
by Micromet in connection with a collaboration. We recognized gains on currency rate fluctuations of $660,000
and $145,000, respectively, for the years ended December 31, 2002 and 2001.
31
For the year ended December 31, 2002, interest expense was $947,000, as compared to $784,000 for the
year ended December 31, 2001, an increase of $163,000, or 21%. The increase in interest expense resulted
partially from the increase in the amount that we owed to Elan Pharma International, Ltd., an affiliate of Elan, as
part of our Curis Newco joint venture. Interest expense associated with the Curis Newco joint venture increased
to $200,000 for the year ended December 31, 2002, from $1,000 for the year ended December 31, 2001. In
addition, we incurred $193,000 for the year ended December 31, 2002 in non-cash interest expense related to a
$2,000,000 convertible subordinated note payable issued to Becton Dickinson in June 2001. This represented a
$121,000 increase over the $99,000 incurred for the year ended December 31, 2001. These increases were
partially offset by a decrease in interest expense paid on capital leases in 2002 compared to 2001.
Accretion on Series A Convertible Exchangeable Preferred Stock
Accretion on Series A Convertible Exchangeable Preferred Stock increased by $397,000, or 121%, to
$723,000 for the year ended December 31, 2002, from $326,000 for the year ended December 31, 2001. This
charge relates to the accretion of a mandatory dividend on shares of convertible exchangeable preferred stock
issued to an affiliate of Elan. The amounts are included in the net loss applicable to common stockholders for
years ended December 31, 2002 and 2001.
Net Loss Applicable to Common Stockholders
As a result of the foregoing, we incurred a net loss applicable to common stockholders of $83,038,000 for
the year ended December 31, 2002, as compared to $82,190,000 for the year ended December 31, 2001.
Liquidity and Capital Resources
Our liquidity requirements have historically consisted of research and development expenses, capital
expenditures, working capital and general corporate expenses. At December 31, 2003, our principal sources of
liquidity consisted of cash, cash equivalents, marketable securities and long-term investments of $37,538,000,
excluding restricted cash and cash equivalents of $191,000. Since inception, we have financed our operations
primarily through license fees, research and development funding from our collaborative partners, the private and
public placement of our equity securities, debt financing and the amortization of certain royalty rights.
Net cash used in operating activities was $9,761,000 for the year ended December 31, 2003, as compared to
$6,918,000 for the year ended December 31, 2002. Cash used in operating activities during the year ended
December 31, 2003 was primarily to fund our net loss of $11,623,000, partially offset by $5,588,000 in non-cash
charges including stock-based compensation expense, depreciation and amortization, non-cash interest expense
on notes payable, amortization of intangible assets and an impairment of a long-term note receivable and
investment in Micronet, a former collaborator of ours. In addition, we used $3,273,000 of operating cash as a
result of changes in certain of our operating assets and liabilities during the year ended December 31, 2003. Net
cash used in operating activities during the year ended December 31, 2002, was primarily the result of our net
loss for the period of $82,315,000, partially offset by $74,384,000 in non-cash charges including impairment
charges on our intangible and tangible assets, stock-based compensation, depreciation, amortization and non-cash
interest income and expense. Our net loss was further offset by our equity in loss of joint venture and our use of
operating cash as a result of changes in certain of our assets and liabilities.
Investing activities generated $1,645,000 of net cash for the year ended December 31, 2003, as compared to
net cash used in investing activities of $1,066,000 for the year ended December 31, 2002. Net cash generated for
the year ended December 31, 2003, was driven by a reduction in restricted cash balances of $4,213,000, resulting
from the full repayment of our loan agreement with the Boston Private Bank & Trust Company. Cash used by
investing activities in 2002 was primarily the result of the transfer of $4,403,000 to a restricted cash account
under the terms of a debt agreement with the Boston Private Bank & Trust Company, offset in part by net
proceeds from the sale of marketable securities.
32
Financing activities generated $8,930,000 of net cash for the year ended December 31, 2003, as compared to
net cash used in financing activities of $3,374,000 for the year ended December 31, 2002. The cash generated by
financing activities during 2003 was principally the result of the sale of $15,401,000 of our common stock,
including $9,805,000 from a private placement of 3,589,700 shares of common stock, and warrants to purchase
1,076,910 shares of common stock, in August 2003, $3,500,000 from the sale of 1,323,835 shares of common
stock to Genentech, and $1,057,000 in proceeds received upon stock option exercises. These amounts were
partially offset by repayments of debt totaling $6,820,000, including $4,213,000 in full repayment of our debt
with the Boston Private Bank & Trust Company, $1,500,000 as partial repayment of our convertible promissory
note payable to Elan pursuant to our May 16, 2003 termination agreement, and $1,224,000 in repayments of
notes payable and capital leases. The cash used in financing activities for the year ended December 31, 2002 was
primarily due to $2,549,000 in net repayments of obligations under capital lease and debt arrangements. In
addition, we used $869,000 in cash to repurchase shares of our common stock during 2002.
In June, 2003, we licensed our small molecule and antibody antagonists of the Hedgehog signaling pathway
to Genentech for applications in cancer therapy pursuant to the terms of a collaborative research, development
and license agreement. The collaboration agreement provides for cash payments from Genentech, including an
up-front payment of $5,000,000, maintenance fee payments totaling $4,000,000 over the first two years of the
collaboration, none of which was received in 2003, and milestone payments at various intervals during the
regulatory approval process of small molecule and antibody product candidates, assuming specified research
objectives are met. Genentech is also obligated to pay us a royalty on potential future product sales. Under the
terms of the collaboration agreement, we are required to commit eight employees to the small molecule and/or
antibody programs for a period of two years. We are recognizing revenue related to the $5,000,000 up-front
payment and the $4,000,000 maintenance fee payments receivable over our estimated period of involvement
related to the collaboration. Under our current operating plan, we expect to recognize approximately $1,200,000
in 2004 related to these payments.In addition, as partial consideration for the rights and licenses granted under
the collaboration agreement, with respect to certain types of licensed compounds, we sold 1,323,835 shares of
our common stock to Genentech at a purchase price of $2.644 per share for aggregate proceeds of $3,500,000,
pursuant to the terms of a stock purchase agreement. We also entered into a registration rights agreement with
Genentech covering the registration of the shares of common stock for resale under specified conditions.
In April 2003, we amended our loan agreement with the Boston Private Bank & Trust Company. Under the
terms of the amended loan amendment, we ceased making our quarterly principal payments. Instead, the loan
was structured as a revolving credit facility under which up to $7,000,000 could have been borrowed and
remained outstanding until the repayment date of April 1, 2005. We continued to pay interest monthly in arrears
at variable interest rates during 2003. This loan was fully collateralized with a money market account maintained
at the Boston Private Bank & Trust Company. In December 2003, we paid in full the outstanding loan balance of
$3,996,000 with funds held in our fully collateralized money market account at the Boston Private Bank & Trust
Company. We had paid $217,000 earlier in 2003.
In July 2001, we issued to Elan shares of our Series A convertible/exchangeable preferred stock valued at
$12,015,000 to fund our pro rata share of the initial capitalization of Curis Newco. We recorded a charge to
accumulated deficit of $271,000 for the year ended December 31, 2003, for the accretion of a mandatory 6%
dividend on the preferred stock. Such amounts are included in the net loss applicable to common stockholders for
the year ended December 31, 2003. The preferred stock, which had a carrying value of $13,336,000, was
cancelled on the May 16, 2003 termination date of the joint venture program with Elan. As partial consideration
for the rights and benefits described in the termination agreement, including the cancellation of the preferred
stock, we issued 2,878,782 shares of our common stock to Elan, having a fair value of $8,377,000 based on the
May 16, 2003 closing price of our common stock on The Nasdaq National Market. Upon the termination of the
Elan agreement, we recorded a credit to additional paid-in-capital of $13,736,000 to reflect the cancellation of
the Preferred Stock and the forgiveness of debt in exchange for the issuance of our common stock. Lastly, as a
result of the termination, all rights granted by both us and Elan at the formation of Curis Newco under separate
license agreements with Curis Newco terminated. In addition, intellectual property created by Curis Newco is
owned by us, both in our own right and as sole shareholder of Curis Newco. According to provisions in the
33
termination agreement, we will pay Elan future compensation, in the form of future royalty payments, in the
event of any direct sales or third party commercialization agreements related to certain compounds.
In June 2001, we received $2,000,000 from Becton Dickinson under a convertible subordinated note
payable in connection with the exercise by Becton Dickinson of an option to negotiate a collaboration agreement.
The note payable is repayable at any time up to its maturity date of June 26, 2006, by us, at our discretion, in
either cash or issuance to Becton Dickinson of shares of our common stock. The note payable bears interest at
7%. As of December 31, 2003, there was $2,352,000, including $352,000 in accrued interest, outstanding under
the note payable.
We lease equipment under various capital lease arrangements. Monthly payments on leases outstanding as
of December 31, 2003 range from $1,880 to $21,170 and maturities range from March 2004 to July 2004. The
initial terms of the leases range from 36 months to 60 months and bear interest at rates ranging from 12.5% to
16.3%. As of December 31, 2003, $323,000 was outstanding under these agreements and we were in compliance
with all material covenants under these agreements.
As of December 31, 2003, we had future payments required under contractual obligations and other
commitments as follows:
(Amounts in $ 000’s)
2004
2005
2006
2007
2008
Total
Convertible subordinated long-term debt (1) . . . . . . $ — $— $2,805 $3,812 $— $ 6,617
339
Capital lease obligations . . . . . . . . . . . . . . . . . . . . .
3,595
Operating lease obligations . . . . . . . . . . . . . . . . . . .
1,373
Outside service obligations . . . . . . . . . . . . . . . . . . .
Licensing obligations . . . . . . . . . . . . . . . . . . . . . . . .
450
$ — $12,374
Total future obligations . . . . . . . . . . . . . . . . . .
1,373 —
450 —
$ 822
— —
518 —
— —
— —
—
1,433
—
—
$ 4,238
339 —
822
$ 2,984
$ 4,330
822
(1) Convertible subordinated debt is convertible into either shares of our common stock or payable in cash at
our option.
We anticipate that existing capital resources should enable us to maintain current and planned operations
into the first half of 2006. We expect to incur substantial additional research and development and other costs,
including costs related to preclinical studies and clinical trials for the foreseeable future. Our ability to continue
funding planned operations beyond the first half of 2006 is dependent upon the success of our collaborations, our
ability to maintain or reduce our cash burn rate and our ability to raise additional funds through equity or debt
financings, or from other sources of financing. Our ability to generate sufficient cash flows depends on a number
of factors, including the ability of either us or our collaborators to obtain regulatory approval to market and
commercialize products to treat indications in major commercial markets. We are seeking additional
collaborative arrangements and also expect to raise funds through one or more financing transactions, if
conditions permit. Due to our significant long-term capital requirements, we intend to seek to raise funds through
the sale of debt or equity securities when conditions are favorable, even if we do not have an immediate need for
additional capital at such time. Additional financing may not be available or, if available, it may not be available
on favorable terms. In addition, the sale of additional debt or equity securities could result in dilution to our
stockholders. If substantial additional funding is not available, our ability to fund research and development and
other operations will be significantly affected and, accordingly, our business will be materially and adversely
affected.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements as of December 31, 2003.
Inflation
We believe that inflation has not had a significant impact on our revenue and results of operations since
inception.
34
New Accounting Pronouncements
In January 2003, the FASB issued Interpretation No. 46, Consolidation of Variable Interest Entities and, in
December 2003, issued a revision to that interpretation FIN 46R. FIN 46R replaces FIN 46 and addresses
consolidation by business enterprises of variable interest entities that possess certain characteristics. A variable
interest entity (“VIE”) is defined as (a) an ownership, contractual or monetary interest in an entity where the
ability to influence financial decisions is not proportional to the investment interest, or (b) an entity lacking the
invested capital sufficient to fund future activities without the support of a third party. FIN 46R establishes
standards for determining under what circumstances VIEs should be consolidated with their primary beneficiary,
including those to which the usual condition for consolidation does not apply. Our adoption of FIN 46R is not
expected to have any effect on our financial position or results of operations.
In April 2003, the FASB issued SFAS No. 149, Amendment of Statement 133 on Derivative Instruments and
Hedging Activities. This statement amends and clarifies financial accounting and reporting for derivative
instruments, including certain derivative instruments embedded in other contracts, collectively referred to as
derivatives, and for hedging activities under SFAS No. 133, Accounting for Derivative Instruments and Hedging
Activities. SFAS No. 149 is effective for contracts entered into or modified and for hedging relationships
designated after June 30, 2003. At December 31, 2003, we had no financial instruments falling within the scope
of SFAS No. 149.
In May 2003, the FASB issued SFAS 150, Accounting for Certain Financial Instruments with
Characteristics of both Liabilities and Equity. SFAS 150 establishes standards for how an issuer classifies and
measures certain financial instruments with characteristics of both liabilities and equity. It requires that an issuer
classify a financial instrument that is within its scope as a liability (or an asset in some circumstances). Many of
those instruments were previously classified as equity. This statement is effective for financial instruments
entered into or modified after May 31, 2003, and otherwise is effective at the beginning of the first interim period
beginning after December 15, 2003. The adoption of SFAS 150 did not have a material effect on our financial
statements.
In May 2003, the FASB also issued EITF 01-8, Determining Whether an Arrangement Contains a Lease,
which requires capital lease treatment for arrangements containing an embedded lease, thereby conveying the
right to control the use of property, plant or equipment (collectively, “property”) whether the right to control the
use of the property is explicitly or implicitly specified. The right is conveyed if the purchaser (lessee) obtains
physical or operational control of the underlying property or takes substantially all of its output. This
pronouncement applies prospectively to new or modified arrangements beginning after May 28, 2003. The
adoption of EITF 01-8 had no impact on our financial statements.
Effective July 1, 2003, we adopted EITF 00-21, Accounting For Revenue Arrangements with Multiple
Deliverables, which establishes criteria for whether revenue on a deliverable can be recognized separately from
other deliverables in a multiple deliverable arrangement. The criteria considers whether the delivered item has
stand-alone value to the customer, whether the fair value of the delivered item can be reliably determined and the
customer’s right of return for the delivered item. The adoption of EITF 00-21 did not have a material impact on
our financial statements.
On December 17, 2003, the Staff of the Securities and Exchange Commission (SEC or the Staff) issued
SAB 104, Revenue Recognition , which amends SAB 101, Revenue Recognition in Financial Statements. SAB
104’s primary purpose is to rescind accounting guidance contained in SAB 101 related to multiple element
revenue arrangements, superseded as a result of the issuance of EITF 00-21. Additionally, SAB 104 rescinds the
SEC’s Revenue Recognition in Financial Statements Frequently Asked Questions and Answers (the FAQ) issued
with SAB 101 that had been codified in SEC Topic 13, Revenue Recognition. Selected portions of the FAQ have
been incorporated into SAB 104. While the wording of SAB 104 has changed to reflect the issuance of EITF 00-
21, the revenue recognition principles of SAB 101 remain largely unchanged by the issuance of SAB 104. The
adoption of SAB 104 did not have a material impact on our financial statements.
35
Factors That May Affect Results
Risks Relating To Our Financial Results And Need For Financing
We have incurred substantial losses, we expect to continue to incur substantial losses and we may never
achieve profitability.
We expect to incur substantial operating losses for the foreseeable future, and we have no current sources of
material ongoing revenue. As of December 31, 2003, we had an accumulated deficit of approximately $649.1
million. It is uncertain when, if ever, we will develop significant sources of ongoing revenue or achieve
profitability, even if we are able to develop and commercialize products.
Even if our collaboration agreements provide funding for a portion of our research and development
expenses for some of our programs, we expect to spend significant capital to fund our internal research and
development programs for the foreseeable future. As a result, we will need to generate significant revenues in
order to achieve profitability. We cannot be certain whether or when this will occur because of the significant
uncertainties that affect our business. Our failure to become and remain profitable may depress the market price
of our common stock and could impair our ability to raise capital, expand our business, diversify our product
offerings or continue our operations.
We are likely to require additional financing, which may be difficult to obtain and may dilute your
ownership interest in us.
We will require substantial funds to continue our research and development programs. We believe that our
existing cash and working capital should be sufficient to fund our operations until the first half of 2006.
However, our future capital requirements may vary from what we expect and will depend on numerous factors,
many of which are outside our control, including the following:
•
•
•
•
•
•
•
•
continued progress in our research and development programs, as well as the magnitude of these
programs;
the cost of additional facilities requirements, if any;
our ability to establish and maintain collaborative arrangements;
the timing, receipt and amount of research funding and milestone, license, royalty and other payments, if
any, from collaborative partners;
the timing, payment and amount of research funding and milestone, license, royalty and other payments
due to licensors of patent rights and technology used to make, use and sell our product candidates;
the timing, receipt and amount of sales revenues and associated royalties to us, if any, from our product
candidates in the market;
the cost of manufacturing and commercialization activities, if any; and
the costs of preparing, filing, prosecuting, maintaining and enforcing patent claims and other patent-
related costs, including litigation costs and technology license fees.
We expect to seek additional funding through collaborative arrangements with strategic partners and may
seek additional funding through public or private financings. However, the biotechnology market in general, and
the market for our common stock, in particular, is highly volatile. Due to market conditions and the status of our
development pipeline, additional funding may not be available to us on acceptable terms, if at all. If we fail to
obtain such additional financing on a timely basis, our ability to continue all of our research, development,
commercialization, manufacturing and marketing activities will be adversely affected.
36
If we raise additional funds by issuing equity securities, dilution to our stockholders will result. In addition,
the terms of such a financing may adversely affect other rights of our stockholders. We also could elect to seek
funds through arrangements with collaborative partners or others that may require us to relinquish rights to
certain technologies, product candidates or products.
If the estimates we make and the assumptions on which we rely in preparing our financial statements
prove inaccurate, our actual results may vary significantly.
Our financial statements have been prepared in accordance with accounting principles generally accepted in
the United States. The preparation of these financial statements requires us to make estimates and judgments that
affect the reported amounts of our assets, liabilities, revenues and expenses, the amounts of charges taken by us
and related disclosure. We base our estimates on historical experience and on various other assumptions that we
believe to be reasonable under the circumstances. There can be no assurance, however, that our estimates, or the
assumptions underlying them, will be correct. Our actual financial results may vary significantly from the
estimates contained in our financial statements.
Risks Relating To Our Collaborations
We are dependent on collaborative partners for the development and commercialization of many of our
product candidates. If we lose any of these partners, of if they fail or delay in developing or
commercializing our product candidates, our anticipated product pipeline and operating results would
suffer.
The success of our strategy for development and commercialization of product candidates depends upon our
ability to form and maintain productive strategic collaborations. We currently have strategic collaborations with
Genentech, Ortho Biotech Products, and Wyeth. We expect to enter into additional collaborations in the future.
Our existing and any future alliances may not be scientifically or commercially successful.
The risks that we face in connection with these alliances include the following:
•
Each of our collaborators has significant discretion in determining the efforts and resources that they
will apply to the collaboration. The timing and amount of any future royalty and milestone revenue that
we may receive under such collaborative arrangements will depend on, among other things, such
collaborator’s efforts and allocation of resources.
• All of our strategic alliance agreements are for fixed terms and are subject to termination under various
circumstances, including in some cases, on short notice without cause. If any collaborative partner were
to terminate an agreement, we may be required to undertake product development, manufacturing and
commercialization and we may not have the funds or capability to do this, which could result in a
discontinuation of such program.
• Our collaborators may develop and commercialize, either alone or with others, products and services
that are similar to or competitive with the products and services that are the subject of the alliance with
us.
• Our collaborators may change the focus of their development and commercialization efforts.
Pharmaceutical and biotechnology companies historically have re-evaluated their priorities following
mergers and consolidations, which have been common in recent years in these industries. The ability of
certain of our product candidates to reach their potential could be limited if our collaborators decrease or
fail to increase spending related to such product candidates.
37
We may not be successful in establishing additional strategic alliances, which could adversely affect our
ability to develop and commercialize products and services.
As an integral part of our ongoing research and development efforts, we periodically review opportunities to
establish new collaborations, joint ventures and strategic alliances for the development and commercialization of
products in our development pipeline. We face significant competition in seeking appropriate collaborators and
the negotiation process is time-consuming and complex. We may not be successful in our efforts to establish
additional strategic alliances or other alternative arrangements. Even if we are successful in our efforts to
establish an alliance or agreement, the terms that we establish may not be favorable to us. Finally, such strategic
alliances or other arrangements may not result in successful products and associated revenue.
Risks Related To Our Business, Industry, Strategy And Operations
Other than OP-1, which we and Stryker commercialized under our former collaboration, we have not
commercialized any products to date, either alone or with a collaborator. If we are not able to
commercialize any products, we will not be profitable.
Most of our product opportunities are in various stages of preclinical development. Because our product
opportunities have several years of development prior to reaching commercialization, there is a substantial risk
that none of our current product opportunities will ever be commercialized. If none of our product opportunities
are commercialized, we will not be profitable.
We face substantial competition, which may result in our competitors discovering, developing or
commercializing products before or more successfully than we do.
Our product candidates face competition with existing and new products being developed by biotechnology,
medical device and pharmaceutical companies, as well as universities and other research institutions. For
example, research in the fields of regulatory signaling pathways and functional genomics, which includes our
work in cancer, with Genentech and renal disease, with Ortho Biotech, is highly competitive. A number of
entities are seeking to identify and patent randomly sequenced genes and gene fragments, typically without
specific knowledge of the function that such genes or gene fragments perform. Our competitors may discover,
characterize and develop important inducing molecules or genes in advance of us. We also face competition from
these and other entities in gaining access to DNA samples used in our research and development projects. Many
of our competitors have substantially greater capital resources, research and development staffs and facilities
than we have. Efforts by other biotechnology, medical device and pharmaceutical companies could render our
programs or products uneconomical or result in therapies superior to those that we develop alone or with a
collaboration partner. For those programs that we have selected for further internal development, we face
competition from companies that are more experienced in product development and commercialization,
obtaining regulatory approvals and product manufacturing. As a result, they may develop competing products
more rapidly and at a lower cost. For those programs that are subject to a collaboration agreement, competitors
may discover, develop and commercialize products which render our products non-competitive or obsolete. We
expect competition to intensify in genomics research and regulatory signaling pathways as technical advances in
the field are made and become more widely known.
Since our technologies have many potential applications and we have limited resources, our election to
focus on a particular application may result in our failure to capitalize on other potentially profitable
applications of our technologies.
We have limited financial and managerial resources. These limitations require us to focus on a select group
of product candidates in specific therapeutic areas and to forego the exploration of other product opportunities.
While our technologies may permit us to work in multiple areas, resource commitments may require trade-offs
resulting in delays in the development of certain programs or research areas, which may place us at a competitive
38
disadvantage. Our decisions as to resource allocation may not lead to the development of viable commercial
products and may divert resources away from other market opportunities which ultimately prove to be more
profitable.
If we or our collaborators fail to achieve market acceptance for our products under development, our
future revenue and ability to achieve profitability may be adversely affected.
If any of our product opportunities ever receive regulatory approval, the commercial success of these
products will depend upon their acceptance by patients, the medical community and third-party payors. Our
future products, if any are successfully developed, may not gain commercial acceptance among physicians,
patients and third-party payors, even if necessary marketing approvals have been obtained. We believe that
recommendations and endorsements by physicians will be essential for market acceptance of our products. If we
are not able to obtain a positive reception for our products, our expected revenues from sales of these products
would be adversely affected.
We could be exposed to significant risk from liability claims if we are unable to obtain insurance at
acceptable costs or otherwise protect ourselves against potential product liability claims.
We may be subjected to product liability claims arising from the testing, manufacturing, marketing and sale
of human health care products. Product liability claims, inherent in the process of researching and developing
human health care products, could expose us to significant liabilities and prevent or interfere with the
development or commercialization of our product candidates. Product liability claims would require us to spend
significant time, money and other resources to defend such claims and could ultimately lead to our having to pay
a significant damage award. Product liability insurance is expensive to procure for biopharmaceutical companies
such as ours. Although we maintain product liability insurance coverage for the clinical trials of our products
under development, it is possible that we will not be able to obtain additional product liability insurance on
acceptable terms, if at all, and that our product liability insurance coverage will not prove to be adequate to
protect us from all potential claims.
Our growth could be limited if we are unable to attract and retain key personnel and consultants.
Our success depends on the ability to attract, train and retain qualified scientific and technical personnel to
further our research and development efforts. The loss of services of one or more of our key employees or
consultants could have a negative impact on our business and operating results. Locating candidates with the
appropriate qualifications can be difficult. Although we expect to be able to attract and retain sufficient numbers
of highly skilled employees for the foreseeable future, we may not be able to do so.
Any growth and expansion into areas and activities that may require additional human resources or
expertise, such as regulatory affairs and compliance, would require us to either hire new key personnel or obtain
such services via an outsourcing arrangement. The pool of personnel with the skills that we require is limited. We
may not be able to hire or contract such additional personnel.
Risks Relating To Clinical And Regulatory Matters
We expect to rely heavily on third parties for the conduct of clinical trials of our product candidates. If
these clinical trials are not successful, or if we or our collaborators are not able to obtain the necessary
regulatory approvals, we will not be able to commercialize our product candidates.
In order to obtain regulatory approval for the commercial sale of our product candidates, we and our
collaborators will be required to complete extensive preclinical studies as well as clinical trials in humans to
demonstrate to the FDA and foreign regulatory authorities that our product candidates are safe and effective. We
have limited experience in conducting clinical trials and expect to rely primarily on contract research
organizations and collaborative partners for their performance and management of clinical trials of our product
candidates.
39
Clinical development, including preclinical testing, is a long, expensive and uncertain process. Accordingly,
clinical trials, if any, of our product candidates under development may not be successful. We and our
collaborators could experience delays in preclinical or clinical trials of any of our product candidates, obtain
unfavorable results in a development program, or fail to obtain regulatory approval for the commercialization of
a product. Furthermore, the timing and completion of clinical trials, if any, of our product candidates depend on,
among other factors, the numbers of patients required for approval and the rate at which those patients are
enrolled. Any increase in the required number of patients or decrease in recruitment rates may result in increased
costs, program delays or both. Also, our products under development may not be effective in treating any of our
targeted disorders or may prove to have undesirable or unintended side effects, toxicities or other characteristics
that may prevent or limit their commercial use. Any of these events would adversely affect our ability to market a
product candidate.
The development process necessary to obtain regulatory approval is lengthy, complex and expensive. If we
and our collaborative partners do not obtain necessary regulatory approvals, then our business will be
unsuccessful and the market price of our common stock will substantially decline.
To the extent that we are able to advance an internal program through the clinic, we will be required to
obtain regulatory approval for any product we develop in such program. In instances where our product
candidates are being developed by our collaborators, our partners will be required to obtain regulatory approval
for marketing and selling efforts.
The process of obtaining FDA and other required regulatory approvals is expensive. The time required for
FDA and other approvals is uncertain and typically takes a number of years, depending on the complexity and
novelty of the product. The process of obtaining FDA and other required regulatory approvals for many of our
products under development is further complicated because some of these products use non-traditional or novel
materials in non-traditional or novel ways, and the regulatory officials have little precedent to follow. To date, we
have limited experience in filing and prosecuting applications to obtain marketing approval.
Any regulatory approval to market a product may be subject to limitations on the indicated uses for which
we may market the product. These limitations may restrict the size of the market for the product and affect
reimbursement by third-party payors. In addition, regulatory agencies may not grant approvals on a timely basis
or may revoke or significantly modify previously granted approvals.
We also are subject to numerous foreign regulatory requirements governing the manufacturing and
marketing of our potential future products outside of the United States. The approval procedure varies among
countries, and the time required to obtain foreign approvals often differs from that required to obtain FDA
approvals. Moreover, approval by the FDA does not ensure approval by regulatory authorities in other countries,
and vice versa.
As a result of these factors, we or our collaborators may not successfully begin or complete clinical trials in
the time periods estimated, if at all. Moreover, if we or our collaborators incur costs and delays in development
programs or fail to successfully develop and commercialize products based upon our technologies, our stock
price could decline.
Even if marketing approval is obtained, internally developed or licensed products will be subject to
ongoing regulatory oversight which may affect the successful commercialization of our products.
Even if regulatory approval of a product candidate is obtained by us or our collaborators, the approval may
be subject to limitations on the indicated uses for which the product is marketed or require costly post-marketing
follow-up studies. After marketing approval for any product is obtained, the manufacturer and the manufacturing
facilities for that product will be subject to continual review and periodic inspections by the FDA and other
regulatory agencies. The subsequent discovery of previously unknown problems with the product, or with the
40
manufacturer or facility, may result in restrictions on the product or manufacturer, including withdrawal of the
product from the market.
If there is a failure to comply with applicable regulatory requirements, we or our collaborator may be
subject to fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating
restrictions, and criminal prosecution.
We are subject to governmental regulations other than those imposed by the FDA. We may not be able to
comply with these regulations, which could subject us to penalties and otherwise result in the limitation of
our operations.
In addition to regulations imposed by the FDA, we are subject to regulation under the Occupational Safety
and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Research Conservation
and Recovery Act, as well as regulations administered by the Nuclear Regulatory Commission, national
restrictions on technology transfer, import, export and customs regulations and certain other local, state or federal
regulations. From time to time, other federal agencies and congressional committees have indicated an interest in
implementing further regulation of biotechnology applications. We are not able to predict whether any such
regulations will be adopted or whether, if adopted, such regulations will apply to our business, or whether we
would be able to comply with any applicable regulations.
Our research and development activities involve the controlled use of hazardous materials and chemicals.
Although we believe that our safety procedures for handling and disposing of such materials comply with all
applicable laws and regulations, we cannot completely eliminate the risk of accidental contamination or injury
caused by these materials.
Risks Relating To Product Manufacturing And Sales
We will depend on our collaborators and third-party manufacturers to produce most, if not all, of our
products under development, and if these third parties do not successfully manufacture these products our
business will be harmed.
We have no manufacturing experience or manufacturing capabilities. In order to continue to develop
products, apply for regulatory approvals, and commercialize our products, we or our collaborators must be able
to manufacture products in commercial quantities, in compliance with regulatory requirements, at acceptable
costs and in a timely manner. The manufacture of our product candidates may be complex, difficult to
accomplish and difficult to scale-up when large-scale production is required. Manufacture may be subject to
delays, inefficiencies and poor or low yields of quality products. The cost of manufacturing some of our products
may make them prohibitively expensive. If supplies of any of our product candidates or related materials become
unavailable on a timely basis or at all or are contaminated or otherwise lost, clinical trials by us and our
collaborators could be seriously delayed. This is due to the fact that such materials are time-consuming to
manufacture and cannot be readily obtained from third-party sources.
To the extent that we or our collaborators seek to enter into manufacturing arrangements with third parties,
there will be a dependency upon these third parties to perform their obligations in a timely and effective manner
and in accordance with government regulations. If third-party manufacturers fail to perform their obligations, our
competitive position and ability to generate revenue may be adversely affected in a number of ways, including;
• we and our collaborators may not be able to initiate or continue clinical trials of products that are under
development;
• we and our collaborators may be delayed in submitting applications for regulatory approvals for our
product candidates; and
• we and our collaborators may not be able to meet commercial demands for any approved products.
41
We have no sales or marketing experience and, as such, will depend significantly on third parties who may
not successfully sell our products.
We have no sales, marketing or product distribution experience. If we receive required regulatory approvals,
we plan to rely primarily on sales, marketing and distribution arrangements with third parties, including our
collaborative partners. For example, as part of our agreements with Genentech, Ortho Biotech and Wyeth, we
have granted our collaborators exclusive rights to distribute certain products resulting from such collaborations,
if any are ever successfully developed. We may have to enter into additional marketing arrangements in the
future and we may not be able to enter into these additional arrangements on terms which are favorable to us, if
at all. In addition, we may have limited or no control over the sales, marketing and distribution activities of these
third parties and sales through these third parties could be less profitable to us than direct sales. These third
parties could sell competing products and may devote insufficient sales efforts to our products. Our future
revenues will be materially dependent upon the success of the efforts of these third parties.
We may seek to independently market products that are not already subject to marketing agreements with
other parties. If we determine to perform sales, marketing and distribution functions ourselves, we could face a
number of additional risks, including:
• we may not be able to attract and build a significant and skilled marketing staff or sales force;
•
•
the cost of establishing a marketing staff or sales force may not be justifiable in light of the revenues
generated by any particular product; and
our direct sales and marketing efforts may not be successful.
Risks Relating To Intellectual Property
If we breach any of the agreements under which we license or have acquired intellectual property from
others, we could lose intellectual property rights that are important to our business.
We are a party to intellectual property licenses and agreements that are important to our business and expect
to enter into similar licenses and agreements in the future. These licenses and agreements impose various
research, development, commercialization, sublicensing, royalty, indemnification, insurance and other
obligations on us. If we or our collaborators fail to perform under these agreements or otherwise breach
obligations thereunder, we could lose intellectual property rights that are important to our business.
We may not be able to obtain patent protection for our discoveries and our technologies may be found to
infringe patent rights of third parties.
The patent positions of pharmaceutical and biotechnology companies, including ours, are generally
uncertain and involve complex legal, scientific and factual questions.
The long-term success of our enterprise depends in significant part on our ability to:
•
•
•
•
obtain patents to protect our discoveries;
protect trade secrets from disclosure to third-party competitors;
operate without infringing upon the proprietary rights of others; and
prevent others from infringing on our proprietary rights.
Patents may not issue from any of the patent applications that we own or license. If patents do issue, the
allowed claims may not be sufficiently broad to protect our technology from exploitation by our competitors. In
addition, issued patents that we own or license may be challenged, invalidated or circumvented. Our patents also
may not afford us protection against competitors with similar technology. Because patent applications in the
42
United States are maintained in secrecy until 18 months after filing, it is possible that third parties have filed or
maintained patent applications for technology used by us or covered by our pending patent applications without
our knowledge.
We may not have rights under patents which may cover one or more of our product candidates. In some
cases, these patents may be owned or controlled by third party competitors and may impair our ability to exploit
our technology. As a result, we or our collaborative partners may be required to obtain licenses under third-party
patents to develop and commercialize some of our product candidates. If we are unable to secure licenses to such
patented technology on acceptable terms, we or our collaborative partners will not be able to develop and
commercialize the affected product candidate or candidates.
If we are unable to keep our trade secrets confidential, our technology and information may be used by
others to compete against us.
We also rely significantly upon proprietary technology, information, processes and know-how that is not
subject to patent protection. We seek to protect this information through confidentiality agreements with our
employees, consultants and other third-party contractors as well as through other security measures. These
confidentiality agreements may be breached, and we may not have adequate remedies for such breach. In
addition, our trade secrets may otherwise become known or be independently developed by competitors.
We may become involved in expensive patent litigation or other intellectual property proceedings which
could result in liability for damages or stop our development and commercialization efforts.
There has been substantial litigation and other proceedings regarding patent and other intellectual property
rights in the pharmaceutical and biotechnology industries. We may become a party to patent litigation or other
proceedings regarding intellectual property rights.
Situations which may give rise to patent litigation or other disputes over the use of our intellectual property
include:
•
•
•
•
•
initiation of litigation or other proceedings against third parties to enforce our patent rights;
initiation of litigation or other proceedings against third parties to seek to invalidate the patents held by
these third parties or to obtain a judgment that our product candidates or proposed services do not
infringe the third parties’ patents;
participation in interference or opposition proceedings to determine the priority of invention if our
competitors file patent applications that claim technology also claimed by us;
initiation of litigation by third parties claiming that our processes or product candidates or the intended
use of our product candidates infringe their patent or other intellectual property rights; and
initiation of litigation by us or third parties seeking to enforce contract rights relating to intellectual
property which may be important to our business.
The costs associated with any patent litigation or other proceeding, even if resolved favorably, likely would
be substantial. Some of our competitors may be able to sustain the cost of such litigation or other proceedings
more effectively than we can because of their substantially greater financial resources. If a patent litigation or
other intellectual property proceeding is resolved unfavorably, we or our collaborative partners may be enjoined
from manufacturing or selling our products and services without a license from the other party and be held liable
for significant damages. Moreover, we may not be able to obtain required licenses on commercially acceptable
terms or any terms at all. In addition, we could be held liable for lost profits if we are found to have infringed a
valid patent, or liable for treble damages if we are found to have willfully infringed a valid patent. Litigation
results are highly unpredictable and we or our collaborative partners may not prevail in any patent litigation or
other proceeding in which we may become involved.
43
Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could
damage our ability to compete in the marketplace. Patent litigation and other proceedings may also absorb
significant management time and expense.
If licensees or assignees of our intellectual property rights breach any of the agreements under which we
have licensed or assigned our intellectual property to them, we could be deprived of important intellectual
property rights and future revenue.
We are a party to intellectual property out-licenses, collaborations and agreements that are important to our
business and expect to enter into similar agreements with third parties in the future. Under these agreements, we
license or transfer intellectual property to third parties and impose various research, development,
commercialization, sublicensing, royalty, indemnification, insurance, and other obligations on them. If a third
party fails to comply with these requirements, we generally retain the right to terminate the agreement, and to
bring a legal action in court or in arbitration. In the event of breach, we may need to enforce our rights under
these agreements by resorting to arbitration or litigation. During the period of arbitration or litigation, we may be
unable to effectively use, assign or license the relevant intellectual property rights and may be deprived of current
or future revenues that are associated with such intellectual property.
Risks Related To Our Common Stock
We expect that our stock price will fluctuate significantly and the market price of our common stock could
drop below the price you paid.
The trading price of our common stock has been volatile and may continue to be volatile in the future. For
example, our stock has traded as high as $5.92 and as low as $0.65 per share in the year ended December 31,
2003. The stock market, particularly in recent years, has experienced significant volatility with respect to
biopharmaceutical- and biotechnology-based company stocks. The volatility of biopharmaceutical- and
biotechnology-based company stocks often does not relate to the operating performance of the companies
represented by the stock. Prices for our stock will be determined in the market place and may be influenced by
many factors, including:
•
announcements regarding new technologies by us or our competitors;
• market conditions in the biotechnology and pharmaceutical sectors;
•
•
•
•
•
•
•
•
•
•
•
rumors relating to us or our competitors;
litigation or public concern about the safety of our potential products;
actual or anticipated variations in our quarterly operating results;
deviations in our operating results from the estimates of securities analysts;
adverse results or delays in clinical trials;
any intellectual property lawsuits involving us;
sales of large blocks of our common stock;
sales of our common stock by our executive officers, directors or significant stockholders;
the loss of any of our key scientific or management personnel;
FDA or international regulatory actions; and
general market conditions.
While we cannot predict the individual effect that these factors may have on the price of our common stock,
these factors, either individually or in the aggregate, could result in significant variations in price during any
44
given period of time. Moreover, in the past, securities class action litigation has often been instituted against
companies following periods of volatility in their stock price. This type of litigation could result in substantial
costs and divert our management’s attention and resources.
Our common stock may be delisted from The Nasdaq National Market, which could reduce the liquidity of
our common stock and adversely affect our ability to raise additional necessary capital.
In order to continue trading on The Nasdaq National Market, we must comply with The Nasdaq National
Market’s continued listing requirements, which require that we either maintain a minimum stockholders’ equity
of $10.0 million and a minimum closing bid price of $1.00 per share or, if we fall below the minimum
stockholders’ equity requirement, maintain a minimum closing bid price of $3.00 per share.
We currently are in compliance with The Nasdaq National Market’s continued listing requirements.
However, if in the future we fail to satisfy The Nasdaq National Market’s continued listing requirements, our
common stock may be delisted from The Nasdaq National Market. The delisting of our common stock may result
in the trading of the stock on the Nasdaq SmallCap Market or the OTC Bulletin Board. Consequently, a delisting
of our common stock from The Nasdaq National Market may reduce the liquidity of our common stock and
adversely affect our ability to raise capital.
Substantially all of our total outstanding shares may be sold into the market at any time. This could cause
the market price of our common stock to drop significantly, even if our business is doing well.
Sales of a substantial number of shares of our common stock in the public market could occur at any time.
These sales, or the perception in the market that the holders of a large number of shares intend to sell shares,
could reduce the market price of our common stock. As of December 31, 2003, we had outstanding
approximately 40.6 million shares of common stock. Substantially all of these shares may also be resold in the
public market at any time. In addition, we have a significant number of shares that are subject to outstanding
options. The exercise of these options and the subsequent sale of the underlying common stock could cause a
further decline in our stock price. These sales also might make it difficult for us to sell equity securities in the
future at a time and at a price that we deem appropriate.
We have anti-takeover defenses that could delay or prevent an acquisition that our stockholders may
consider favorable and the market price of our common stock may be lower as a result.
Provisions of our certificate of incorporation, our bylaws and Delaware law may have the effect of deterring
unsolicited takeovers or delaying or preventing changes in control of our management, including transactions in
which our stockholders might otherwise receive a premium for their shares over then current market prices. In
addition, these provisions may limit the ability of stockholders to approve transactions that they may deem to be
in their best interest. For example, we have divided our board of directors into three classes that serve staggered
three-year terms, we may issue shares of our authorized “blank check” preferred stock and our stockholders are
limited in their ability to call special stockholder meetings.
In addition, we are subject to the anti-takeover provisions of Section 203 of the Delaware General
Corporation Law, which regulates corporate acquisitions. These provisions could discourage potential acquisition
proposals and could delay or prevent a change in control transaction. They could also have the effect of
discouraging others from making tender offers for our class A common stock. These provisions may also prevent
changes in our management.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We invest cash balances in excess of operating requirements in cash equivalents and short-term marketable
securities, generally money market funds, corporate debt and government securities with an average maturity of
45
less than one year. All marketable securities are considered available for sale. The primary objective of our cash
investment activities is to preserve principal while at the same time maximizing the income we receive from our
invested cash without significantly increasing risk of loss. Our marketable securities are subject to interest rate
risk and will fall in value if market interest rates increase. However, because of the short-term nature of the
marketable securities, we do not believe that interest rate fluctuations would materially impair the principal
amount of our investments. Our investments are investment grade securities and deposits are with investment
grade financial institutions. We believe that the realization of losses due to changes in credit spreads is unlikely
as we expect to hold our investments to maturity. We do not use derivative financial instruments in our
investment portfolio. We have operated primarily in the United States. Accordingly, we do not have any material
exposure to foreign currency rate fluctuations.
46
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Report of Independent Public Auditors
To the Board of Directors and Stockholders of
Curis, Inc. and Subsidiary:
In our opinion, the accompanying consolidated balance sheets and the related consolidated statements of
operations and comprehensive loss, of stockholders’ equity and of cash flows present fairly, in all material
respects, the financial position of Curis, Inc. and its subsidiaries at December 31, 2003 and 2002, and the results
of their operations and their cash flows for the years then ended, in conformity with accounting principles
generally accepted in the United States of America. These financial statements are the responsibility of the
Company’s management; our responsibility is to express an opinion on these financial statements based on our
audits. We conducted our audits of these statements in accordance with auditing standards generally accepted in
the United States of America, which require that we plan and perform the audit to obtain reasonable assurance
about whether the financial statements are free of material misstatement. An audit includes examining, on a test
basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting
principles used and significant estimates made by management, and evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable basis for our opinion.
The consolidated financial statements of Curis, Inc. and its subsidiaries as of December 31, 2001, and for
the year then ended were audited by other independent accountants who have ceased operations. Those
independent accountants expressed an unqualified opinion on those financial statements in their report dated
February 14, 2002.
As discussed in Note 3(j) to the consolidated financial statements, the Company changed its method of
accounting for goodwill in 2002.
/S/ PRICEWATERHOUSECOOPERS LLP
Boston, Massachusetts
February 4, 2004
47
Report of Independent Public Accountants
To the Board of Directors and Stockholders of
Curis, Inc. and Subsidiaries:
We have audited the accompanying consolidated balance sheets of Curis, Inc. (f.k.a. Creative BioMolecules,
Inc.) and its subsidiaries as of December 31, 2001 and 2000, and the related consolidated statements of
operations and comprehensive loss, stockholders’ equity and cash flows for the years then ended. These financial
statements are the responsibility of Curis, Inc.’s management. Our responsibility is to express an opinion on these
financial statements based on our audits.
We conducted our audits in accordance with auditing standards generally accepted in the United States.
Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the
financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material respects, the financial
position of Curis, Inc. and its subsidiaries as of December 31, 2001 and 2000 and the results of their operations
and their cash flows for the years then ended, in conformity with accounting principles generally accepted in the
United States.
ARTHUR ANDERSEN LLP
Boston, Massachusetts
February 14, 2002
NOTE: THIS IS A COPY OF THE AUDIT REPORT PREVIOUSLY ISSUED BY ARTHUR ANDERSEN LLP
IN CONNECTION WITH CURIS, INC.’S FORM 10-K FILING FOR THE FISCAL YEAR ENDED
DECEMBER 31, 2001. THE INCLUSION OF THIS PREVIOUSLY ISSUED ARTHUR ANDERSEN LLP
REPORT IS PURSUANT TO THE “TEMPORARY FINAL RULE AND FINAL RULE REQUIREMENTS
FOR ARTHUR ANDERSEN LLP AUDITING CLIENTS,” ISSUED BY THE SECURITIES AND
EXCHANGE COMMISSION IN MARCH 2002. NOTE THAT THE PREVIOUSLY ISSUED ARTHUR
ANDERSEN LLP REPORT INCLUDES REFERENCES TO CERTAIN FISCAL YEARS WHICH ARE NOT
REQUIRED TO BE PRESENTED IN THE ACCOMPANYING CONSOLIDATED FINANCIAL
STATEMENTS AS OF AND FOR THE YEAR ENDED DECEMBER 31, 2003. THIS AUDIT REPORT HAS
NOT BEEN REISSUED BY ARTHUR ANDERSEN LLP IN CONNECTION WITH THIS FILING ON FORM
10-K.
48
CURIS, INC. AND SUBSIDIARIES
Consolidated Balance Sheets
Current Assets:
ASSETS
Cash and cash equivalents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cash and cash equivalents—restricted . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Marketable securities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accounts receivable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prepaid expenses and other current assets . . . . . . . . . . . . . . . . . . . . . . . . . .
Due from joint venture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Property and Equipment, net
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Long-term investments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Goodwill, net
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other intangible assets, net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Long-term notes receivable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deposits and other assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
December 31,
2003
2002
$ 27,734,548
190,661
7,413,703
2,184,973
1,202,993
—
38,726,878
2,500,703
2,389,742
8,982,000
177,193
2,000,000
959,974
$ 55,736,490
$ 26,920,605
4,403,188
9,652,671
446,853
939,964
1,299,289
43,662,570
3,775,269
—
8,982,000
252,273
4,662,553
1,107,028
$ 62,441,693
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Debt and lease obligations, current portion . . . . . . . . . . . . . . . . . . . . . . . . .
Accounts payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred revenue, current portion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Due to joint venture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total current liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Debt and Lease Obligations, net of current portion . . . . . . . . . . . . . . . . . . . . . . .
Convertible Notes Payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred Revenue, net of current portion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
322,884
456,860
2,427,783
1,241,379
—
4,448,906
—
5,333,733
7,088,638
16,871,277
$
2,105,049
726,092
3,257,230
191,782
1,089,083
7,369,236
3,424,422
6,885,486
11,962,224
29,641,368
Preferred stock, $0.01 par value, 5,000,000 shares authorized Series A
Convertible Exchangeable Preferred Stock—1,426 shares authorized; 1,000
shares issued and outstanding at December 31, 2002 and none at
December 31, 2003 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
—
13,064,283
Commitments (Notes 10 and 11)
Stockholders’ Equity:
Common stock, $0.01 par value—125,000,000 shares authorized;
41,608,698 and 40,560,991 shares issued and outstanding, respectively,
at December 31, 2003 and 32,768,545 and 31,746,338 shares issued
and outstanding, respectively, at December 31, 2002 . . . . . . . . . . . . . . .
Additional paid-in capital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Notes receivable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Treasury stock (at cost, 1,047,707 and 1,022,207 shares at December 31,
2003 and 2002, respectively) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accumulated deficit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accumulated other comprehensive (expense) income . . . . . . . . . . . . . . . . .
Total stockholders’ equity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
416,088
689,489,382
(110,368)
327,685
659,512,957
(143,898)
(891,274)
(963,931)
(649,068,435)
(6,249)
38,865,213
$ 55,736,490
(869,384)
(2,037,230)
(637,174,017)
119,929
19,736,042
$ 62,441,693
The accompanying notes are an integral part of these consolidated financial statements.
49
CURIS, INC. AND SUBSIDIARIES
Consolidated Statements of Operations and Comprehensive Loss
Year Ended December 31,
2003
2002
2001
Revenues:
Research and development contracts and government
grants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
License fees and royalties . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 1,628,724
9,419,509
$
244,954
18,145,584
$
967,928
118,575
Total revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11,048,233
18,390,538
1,086,503
Costs and Expenses:
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Research and development
General and administrative . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stock-based compensation (a) . . . . . . . . . . . . . . . . . . . . . . . . .
Amortization and impairment charge related to intangible
assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Loss on property and equipment . . . . . . . . . . . . . . . . . . . . . . .
Impairment of goodwill . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Restructuring expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13,399,492
5,854,569
1,631,098
14,057,715
8,160,012
2,159,594
29,072,068
10,492,525
10,358,302
75,079
—
—
—
474,509
5,336,786
64,098,344
3,490,000
23,338,539
—
—
—
Total costs and expenses . . . . . . . . . . . . . . . . . . . . . . . . .
20,960,238
97,776,960
73,261,434
Loss from operations . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(9,912,005)
(79,386,422)
(72,174,931)
Equity in Loss from Joint Venture (Note 5) . . . . . . . . . . . . . . . . . .
—
(4,310,912)
(13,453,140)
Other Income (Expense):
Interest income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other income (expense)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interest expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
427,912
(1,445,055)
(694,104)
1,066,881
1,261,885
(946,867)
2,854,027
1,694,193
(783,799)
Total other income (expense) . . . . . . . . . . . . . . . . . . . . .
(1,711,247)
1,381,899
3,764,421
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accretion on Series A Redeemable Preferred Stock . . . . . . . . . . . .
(11,623,252)
(271,306)
(82,315,435)
(722,903)
(81,863,650)
(326,381)
Net loss applicable to common stockholders . . . . . . . . .
$(11,894,558) $(83,038,338) $(82,190,031)
Net Loss per Common Share (Basic and Diluted) . . . . . . . . . . . . .
$
(0.33) $
(2.57) $
(2.58)
Weighted Average Common Shares (Basic and Diluted) . . . . . . . .
36,015,610
32,267,106
31,858,923
Net Loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Unrealized (Loss) Gain on Marketable Securities . . . . . . . . . . . . .
$(11,623,252) $(82,315,435) $(81,863,650)
116,398
(126,178)
119,929
Comprehensive loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$(11,749,430) $(82,195,506) $(81,747,252)
(a) The following summarizes the departmental allocation of the
stock-based compensation charge:
Research and development
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General and administrative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 1,266,902
364,196
$ 1,221,563
938,031
$ 6,156,323
4,201,979
Total stock-based compensation . . . . . . . . . . . . . . . . . . .
$ 1,631,098
$ 2,159,594
$ 10,358,302
The accompanying notes are an integral part of these consolidated financial statements.
50
CURIS, INC. AND SUBSIDIARIES
Consolidated Statements of Stockholders’ Equity
Balance, January 1, 2001 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31,383,585 $313,836 $662,339,492 $(1,204,596) $
— $(22,893,619) $(471,945,648)
$2,204,301
$168,813,766
Common Stock
Shares
Amount
Additional
Paid-in
Capital
Notes
Receivable
Treasury
Stock
Deferred
Compensation
Accumulated
Deficit
Accumulated
Other
Comprehensive
Income (Loss)
Total
Stockholders’
Equity
Issuance of common stock, net of issuance costs of
approximately $147,000 . . . . . . . . . . . . . . . . . . . . . . . . . .
Other issuances of common stock . . . . . . . . . . . . . . . . . . . . .
Issuance of common stock for license fee . . . . . . . . . . . . . . .
Issuance of common stock as repayment of note payable . . .
Interest on notes receivable . . . . . . . . . . . . . . . . . . . . . . . . . .
Stock-based compensation from modification of option
agreement and options granted at below market value . . .
Amortization of deferred compensation . . . . . . . . . . . . . . . .
Reversal of deferred compensation related to forfeited
options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reversal of deferred compensation related to options
granted to non-employees . . . . . . . . . . . . . . . . . . . . . . . . .
Realized gain on sale of Exelixis common stock . . . . . . . . .
Unrealized gain on marketable securities . . . . . . . . . . . . . . .
Discount on subordinated debt
. . . . . . . . . . . . . . . . . . . . . . .
Accretion of Series A redeemable preferred stock dividend . . .
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
546,448
328,528
10,667
60,000
—
5,464
3,285
107
600
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
3,847,268
947,474
97,896
309,600
—
138,050
—
(2,260,433)
(796,139)
—
—
266,370
—
—
—
—
—
—
(87,336)
—
—
—
—
—
—
—
—
—
Balance, December 31, 2001 . . . . . . . . . . . . . . . . . . . . . . . . . . . 32,329,228
396,231
43,086
Issuance of restricted common stock for services . . . . . . . . .
Other issuances of common stock . . . . . . . . . . . . . . . . . . . . .
Issuance of stock options with exercise prices below fair
323,292
3,962
431
664,889,578
272,550
39,824
(1,291,932)
—
—
5
1
market value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interest on notes receivable . . . . . . . . . . . . . . . . . . . . . . . . . .
Amortization of deferred compensation . . . . . . . . . . . . . . . .
Reversal of deferred compensation related to forfeited
options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reclassification of reserve on officer note receivable . . . . . .
Purchase of treasury stock . . . . . . . . . . . . . . . . . . . . . . . . . . .
Realized gain on sale of Exelixis common stock . . . . . . . . .
Unrealized loss on marketable securities . . . . . . . . . . . . . . . .
Accretion of Series A Convertible Exchangeable preferred
stock dividend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
131,500
—
(26,590)
—
(45,629)
—
(5,793,905)
—
— 1,193,663
—
—
—
— (869,384)
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
10,220,252
2,260,433
796,139
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
(326,381)
(81,863,650)
(9,616,795)
(554,135,679)
—
—
(131,500)
—
1,917,160
5,793,905
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
(1,469,517)
116,398
—
—
—
851,182
—
—
—
—
—
—
—
—
(601,292)
(129,961)
3,852,732
950,759
98,003
310,200
(87,336)
138,050
10,220,252
—
—
(1,469,517)
116,398
266,370
(326,381)
(81,863,650)
101,019,646
276,512
40,255
—
(45,629)
1,890,570
—
1,193,663
(869,384)
(601,292)
(129,961)
Balance, December 31, 2002 . . . . . . . . . . . . . . . . . . . . . . . . . . . 32,768,545 $327,685 $659,512,957 $ (143,898) $(869,384) $ (2,037,230) $(637,174,017)
$ 119,929
$ 19,736,042
—
—
—
—
—
—
—
—
(722,903)
(82,315,435)
—
—
(722,903)
(82,315,435)
CURIS, INC. AND SUBSIDIARIES
Consolidated Statements of Stockholders’ Equity—(Continued)
Common Stock
Shares
Amount
Additional
Paid-in
Capital
Notes
Receivable
Treasury
Stock
Deferred
Compensation
Accumulated
Deficit
Accumulated
Other
Comprehensive
Income (Loss)
Total
Stockholders’
Equity
Balance, December 31, 2002 . . . . . . . . . . . . . . . . . . . . . . . . . . . 32,768,545 $327,685 $659,512,957 $(143,898) $(869,384) $(2,037,230) $(637,174,017)
$119,929
$19,736,042
Issuance of common stock in connection with the
cancellation of Series A preferred stock and forgiveness
of debt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Issuance of common stock and warrants, net of issuance
2,878,782
28,788
13,706,801
costs of $1,107,000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3,589,700
35,897
9,769,491
Issuance of common stock under technology license
agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Issuance of common stock to collaborator . . . . . . . . . . . . . . .
Issuance of stock options to non-employees for services . . . .
Other issuances of common stock . . . . . . . . . . . . . . . . . . . . .
Mark-to-market on stock options to non-employees . . . . . . .
Amortization of deferred compensation . . . . . . . . . . . . . . . . .
Reversal of deferred compensation related to forfeited
options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reserve on officer note receivable . . . . . . . . . . . . . . . . . . . . .
Purchase of treasury stock . . . . . . . . . . . . . . . . . . . . . . . . . . .
Realized gain on sale of investment . . . . . . . . . . . . . . . . . . . .
Unrealized loss on marketable securities . . . . . . . . . . . . . . . .
Accretion of Series A Convertible Exchangeable preferred
stock dividend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
200,000
1,323,835
—
847,836
—
—
2,000
13,239
—
8,479
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
1,005,000
3,486,981
99,108
1,450,354
610,818
—
(152,128)
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
33,530
—
—
—
—
—
—
—
(21,890)
—
—
—
—
—
—
—
—
—
—
(269,693)
1,190,864
152,128
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
(96,597)
(29,581)
13,735,589
9,805,388
1,007,000
3,500,220
99,108
1,458,833
341,125
1,190,864
—
33,530
(21,890)
(96,597)
(29,581)
—
—
(271,166)
(11,623,252)
—
—
(271,166)
(11,623,252)
Balance, December 31, 2003 . . . . . . . . . . . . . . . . . . . . . . . . . . . 41,608,698 $416,088 $689,489,382 $(110,368) $(891,274) $ (963,931) $(649,068,435)
$ (6,249)
$38,865,213
5
2
The accompanying notes are an integral part of these consolidated financial statements.
CURIS, INC. AND SUBSIDIARIES
Consolidated Statements of Cash Flows
Cash Flows from Operating Activities:
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Adjustments to reconcile net loss to net cash used in operating activities—
Year Ended December 31,
2003
2002
2001
$(11,623,252) $(82,315,435) $(81,863,650)
Depreciation and amortization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stock-based compensation expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amortization of intangible assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Equity in loss of joint venture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Issuance of common stock in lieu of cash for license fee . . . . . . . . . . . . .
Noncash interest expense on notes payable . . . . . . . . . . . . . . . . . . . . . . . .
Noncash interest income on notes receivable . . . . . . . . . . . . . . . . . . . . . .
Loss on impairment of property and equipment
. . . . . . . . . . . . . . . . . . . .
Impairment of goodwill . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Impairment of long-term receivable and investment . . . . . . . . . . . . . . . . .
Foreign currency exchange gain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Increase (decrease) in operating assets and liabilities—
Accounts receivable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prepaid expenses and other current assets . . . . . . . . . . . . . . . . . . . . .
Accounts payable and accrued liabilities . . . . . . . . . . . . . . . . . . . . . .
Due from joint venture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred contract revenue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1,425,842
1,631,096
75,079
—
—
461,377
—
281
—
1,994,782
(452,857)
(1,738,120)
(263,029)
(1,065,149)
210,207
(417,013)
1,954,856
2,159,594
474,509
4,310,912
—
405,467
(45,629)
5,336,786
64,098,344
—
—
(72,253)
(158,945)
(2,732,786)
(341,491)
8,473
3,288,575
10,358,302
23,338,539
13,453,140
98,003
83,487
(215,189)
—
—
—
(16,212)
147,352
(591,183)
(957,798)
8,000,000
Total adjustments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1,862,496
75,397,837
56,987,016
Net cash used in operating activities . . . . . . . . . . . . . . . . . . . . .
(9,760,756)
(6,917,598)
(24,876,634)
Cash Flows from Investing Activities:
Purchase of marketable securities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sale of marketable securities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Decrease (increase) in restricted cash . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Purchase of long-term investments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Expenditures for property and equipment
. . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from sale of assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Notes receivable from related parties . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Increase in other long-term assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(21,063,891)
23,176,683
4,212,527
(2,389,742)
(152,057)
—
—
(2,138,794)
(16,237,437)
19,022,779
(4,403,188)
—
(411,691)
405,491
700,000
(141,692)
(24,387,748)
33,249,661
—
—
(1,745,949)
—
(500,000)
(187,366)
Net cash provided by (used in) investing activities . . . . . . . . . .
1,644,726
(1,065,738)
6,428,598
Cash Flows from Financing Activities:
Proceeds from issuance of common stock, net of issuance costs . . . . . . . .
Proceeds from other issuances of common stock . . . . . . . . . . . . . . . . . . . .
Issuance of notes payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Repayment of note payable to Genetics Institute . . . . . . . . . . . . . . . . . . . .
Repayment of convertible notes payable . . . . . . . . . . . . . . . . . . . . . . . . . .
Purchases of treasury stock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Repayments of notes payable and capital leases . . . . . . . . . . . . . . . . . . . .
9,805,388
5,966,052
—
—
(1,601,563)
(21,890)
(5,218,014)
—
44,217
4,696,804
—
—
(869,384)
(7,245,505)
3,852,732
950,759
2,000,000
(83,800)
—
—
(1,603,273)
Net cash provided by (used in) financing activities . . . . . . . . . . . . . .
8,929,973
(3,373,868)
5,116,418
Effect of Exchange Rates on Cash and Cash Equivalents . . . . . . . . . . . . . . . . .
Net Increase (Decrease) in Cash and Cash Equivalents . . . . . . . . . . . . . . . . . . .
Cash and Cash Equivalents, beginning of period . . . . . . . . . . . . . . . . . . . . . . . .
—
813,943
26,920,605
(660,253)
(12,017,457)
38,938,062
(144,632)
(13,476,250)
52,414,312
Cash and Cash Equivalents, end of period . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 27,734,548
$ 26,920,605
$ 38,938,062
The accompanying notes are an integral part of these consolidated financial statements.
53
CURIS, INC. AND SUBSIDIARIES
Consolidated Statements of Cash Flows
Year Ended December 31,
2003
2002
2001
Supplemental Disclosure of Noncash Investing and Financing
Activities:
Property and equipment purchased under financing or capital
lease obligations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
— $
— $ 3,905,542
Repayment of notes payable by issuance of 60,000 shares of
common stock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
— $
— $
310,200
Issuance of common stock in connection with cancellation of
Series A preferred stock and forgiveness by Elan Pharma
International, Limited of a portion of convertible note
payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Issuance of notes receivable and receipt of common stock in
$13,735,589
$
— $
—
Micromet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
— $
— $ 4,145,533
Issuance of convertible note payable to Elan Pharma
International, Limited to fund the Company’s 80.1% interest
in joint venture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
Issuance of Series A redeemable preferred stock to purchase
— $3,986,442
$
673,929
initial 80.1% interest in joint venture . . . . . . . . . . . . . . . . . . . .
$
— $
— $12,015,000
The accompanying notes are an integral part of these consolidated financial statements.
54
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
(1) OPERATIONS
The Company is a therapeutic drug development company principally focused on the discovery,
development and future commercialization of products that modulate key regulatory signaling
pathways controlling the repair and regeneration of human tissues and organs. The Company’s product
development approach involves using small molecules, proteins or antibodies to modulate these
regulatory signaling pathways. The Company has successfully developed several preclinical product
candidates in the fields of kidney disease, cancer, neurological disorders, cardiovascular disease and
hair growth regulation.
The Company is subject to risks common to companies in the biotechnology industry including, but not
limited to, development by its competitors of new technological innovations, dependence on key
personnel, its ability to protect proprietary technology, reliance on corporate partners to successfully
research, develop and commercialize products based on the Company’s technologies, its ability to
comply with FDA government regulations and approval requirements as well as its ability to grow its
business and obtain adequate financing to fund this growth.
(2) FINANCIAL STATEMENT RECLASSIFICATIONS
The Company has reclassified $1,194,000 reserve on notes receivable to former officers of Creative
BioMolecules (see Note 12) from “Accrued liabilities” to “Notes receivable” in the Company’s
Stockholders’ Equity section of its Consolidated Balance Sheets. The underlying notes total $1,338,000
and are presented net of the underlying reserve. As of December 31, 2003 and 2002, the Company
recorded reserves on these notes of $1,228,000 and $1,194,000, respectively. Accordingly, as of
December 31, 2003 and 2002, the Notes receivable balances, presented net of the underlying reserve at
the Company’s Stockholders’ Equity section of its Consolidated Balance Sheets, were $110,000 and
$144,000, respectively.
(3) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The following are the Company’s significant accounting policies:
(a) USE OF ESTIMATES
The preparation of the Company’s consolidated financial statements in conformity with accounting
principles generally accepted in the United States requires management to make estimates and
assumptions that affect the reported amounts and disclosure of certain assets and liabilities at the
balance sheet date. Such estimates include the collectibility of receivables, the carrying value of
property and equipment and intangible assets and the value of certain investments and liabilities.
Actual results may differ from such estimates.
(b) CONSOLIDATION
The accompanying consolidated financial statements include the Company and its wholly owned
subsidiaries, Curis Securities Corporation, Inc., and beginning May 16, 2003, Curis Newco, Ltd.
Intercompany balances have been eliminated in consolidation.
(c) REVENUE RECOGNITION
The Company’s research and development contract revenue is primarily derived from contracts with
biotechnology and pharmaceutical companies. These contracts may include payments for research-
55
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
related activities, license fees, research and development milestones and royalties. The Company
follows the provisions of the Securities and Exchange Commission’s Staff Accounting Bulletin (SAB)
No. 104 (SAB No. 104), Revenue Recognition and EITF 00-21, Accounting for Revenue Arrangements
with Multiple Deliverables. In accordance with SAB No. 104 and EITF 00-21, the Company recognizes
revenue related to research activities as they are performed, so long as there is persuasive evidence of
an arrangement, the fee is fixed or determinable and collection of the related receivable is probable.
Amounts received for license fees are deferred and recognized as services are performed over the
performance period of the contract. Amounts received for milestones will be recognized upon
achievement of the milestone as long as the milestone is deemed to be substantive and the Company
has no other performance obligations. In the event the Company has remaining performance
obligations, the portion of the milestone payment equal to the lesser of the non-refundable cash
received or the percentage of the services performed through that date multiplied by the total milestone
payment would be recognized as revenue. The percentage of services performed is based on the ratio of
the number of labor hours performed to-date to total labor hours the Company is obligated to perform
under the related contract, as determined on a full-time equivalent basis. The remainder, if any, will be
recognized proportionately as the remaining services are performed. Royalty revenue is recognized
upon the sale of the related products, provided the royalty amounts are fixed or determinable and
collection of the related receivable is reasonably assured.
Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred
revenue in the accompanying balance sheets. Amounts not expected to be recognized during the year
ended December 31, 2004, are classified as long-term deferred revenue. As of December 31, 2003, the
Company has short- and long-term deferred revenue of $1,241,000 and $7,089,000, respectively,
related to its collaboration with Genentech, Inc. (see Note 4(a)).
Government grant revenues consist of grant awards from the Department of Health and Human
Services and the National Institute of Standards and Technology (NIST). Revenue is recognized under
government grants as the services are provided and when payment is reasonably assured under the
terms of the grant. The Company will not receive additional revenue under these government grants.
During the years ended December 31, 2003, 2002 and 2001, total revenues from major customers as a
percent of total revenues of the Company were as follows:
Year Ended
December 31,
2003
2002
2001
77% 1% — %
Micromet AG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13% — % — %
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ES Cell International
Genentech, Inc.
7% — % — %
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stryker Corporation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . — % 78% 9%
Ortho Biotech Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . — % 19% — %
NIST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . — % — % 88%
(d) RESEARCH AND DEVELOPMENT
Research and development costs, including internal and external costs, are charged to operations as
incurred. Certain research and development projects are, or have been, partially funded by research and
development contracts and government grants, and the expenses related to these activities are included
56
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
in research and development costs. Research and development costs include personnel costs, lab and
animal supplies, outside services including sponsored research agreements, an allocation of facility
costs and fringe benefits, and legal costs associated with the Company’s patent portfolio.
For the years ended December 31, 2002 and 2001, research and development costs are presented net of
costs incurred by the Company on behalf of Curis Newco, Ltd. (Curis Newco), a joint venture
established by the Company and affiliates of Elan Corporation, or Elan. Curis Newco was originally
formed in July 2001 and became a wholly-owned subsidiary of the Company as part of a termination
agreement between the Company and Elan entered into on May 16, 2003. Curis Newco did not incur
any research expenses for the year ended December 31, 2003. Research expenses of $5,263,000 were
recognized for the year ended December 31, 2002. However, 80.1% of these costs, the Company’s
share of the joint venture’s costs, are included as part of Equity in loss from joint venture in the 2002
Consolidated Statement of Operations and Comprehensive Loss.
(e) CASH EQUIVALENTS, MARKETABLE SECURITIES AND LONG-TERM INVESTMENTS
Cash equivalents consist of short-term, highly liquid investments purchased with maturities of three
months or less. All other liquid investments are classified as marketable securities. In accordance with
Statement of Financial Accounting Standards (SFAS) No. 115, Accounting for Certain Investments in
Debt and Equity Securities, all of the Company’s marketable securities have been designated as
available-for-sale and are stated at market value with any unrealized holding gains or losses included as
a component of stockholders’ equity and any realized gains and losses recorded in the statement of
operations in the period the securities are sold.
The amortized cost, unrealized gains (losses) and fair value of marketable securities available-for-sale
as of December 31, 2003, with maturity dates ranging between one and 12 months and with a weighted
average maturity of 3.4 months are as follows:
U.S. government obligations . . . . . . . . . . . . . . . . . . . .
Corporate bonds and notes . . . . . . . . . . . . . . . . . . . . . .
$ 250,000
7,168,000
$ — $ 250,000
7,164,000
(4,000)
Total marketable securities . . . . . . . . . . . . . . . . . . . . . .
$7,418,000
$(4,000) $7,414,000
Amortized
Cost
Unrealized
Loss
Fair Value
The amortized cost, unrealized gains and fair value of marketable securities available-for-sale as of
December 31, 2002, with maturity dates ranging between one and 11 months and with a weighted
average maturity of 2.5 months are as follows:
Insurance annuity contracts . . . . . . . . . . . . . . . . . . . . .
$9,533,000
$120,000
$9,653,000
Amortized
Cost
Unrealized
Gain
Fair Value
As of December 31, 2003, the Company recorded long-term investments of $2,390,000 on its
Consolidated Balance Sheet. This amount is comprised of corporate debt securities with maturities in
excess of 12 months and with amortized cost totaling $2,392,000, less unrealized losses of $2,000.
57
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
(f) FAIR VALUE OF FINANCIAL INSTRUMENTS
The Company’s financial instruments consist mainly of cash and cash equivalents, marketable
securities, short- and long-term accounts receivable, long-term investments, common stock in
privately-held companies, accounts payable, convertible notes payable and lease obligations. The
estimated fair values of the Company’s financial instruments have been determined by the Company
using available market information and appropriate valuation methodologies.
Cash and cash equivalents, short-term accounts receivable and accounts payable are reflected in the
accompanying consolidated financial statements at cost, which approximates fair value due to the
short-term nature of these instruments. Notes receivable are recorded at the lesser of cost or net
realizable value, which approximates the fair value of these instruments.
The fair values of marketable securities and short- and long-term investments are based on current
quoted market values. Equity investments in privately-held companies are reflected in the
accompanying consolidated financial statements at a value based on the Company’s best estimate of
the fair value of such equity investments. When determining the fair values of such investments, the
Company generally considers such factors as the fair value paid by outside investors for similar equity
in such companies, the liquidity of the investment and both company-specific and macroeconomic
factors that may have effected values since the last such investment by other outside investors. The
Company periodically reevaluates the book valuation of its investments in privately-held companies to
determine if its carrying value should be changed. As of December 31, 2003 and 2002, the value of the
Company’s investments in privately-held companies was $717,000 and $853,000, respectively, and
these amounts are included in “Deposits and other assets” in the Consolidated Balance Sheets.
The convertible notes payable and lease obligations have fixed rates of interest and will be subject to
fluctuations in fair value during their terms. As of December 31, 2003, the Company estimates that the
fair values of these instruments approximate their carrying amounts.
(g) PLANT AND EQUIPMENT
Purchased equipment is recorded at cost. Leased equipment is recorded at the lesser of cost or the
present value of the minimum lease payments. Depreciation and amortization are provided on the
straight-line method over the estimated useful lives of the related assets or the remaining terms of the
leases, as follows:
Asset Classification
Estimated
Useful Life
Laboratory equipment and computers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Leasehold improvements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Life of the lease
Office furniture and equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Equipment under lease obligations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Life of the lease
3-5 years
5 years
As a result of a realignment of the Company’s operations during the first quarter of 2002, the Company
recorded an impairment charge of property and equipment assets of $5,337,000. This charge related to
impairment on assets at the Company’s Erie Street facility (see Note 6).
58
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
(h) OTHER INTANGIBLE ASSETS
The Company has filed applications for United States and foreign patents covering aspects of its
technology. Certain costs related to patent applications for which patents have issued and certain costs
related to pending patent applications from which the Company is currently deriving economic benefit,
were capitalized and are being amortized over the estimated useful life of the patent, generally 16 to 20
years, using the straight-line method. The Company evaluates all patent costs annually and, to the
extent there is uncertainty as to the realizability of such costs, they are expensed.
(i) LONG-LIVED ASSETS OTHER THAN GOODWILL
Long-lived assets other than goodwill consist of long-term investments in corporate debt securities,
investments in certain of the Company’s former and current strategic alliance partners, capitalized
patent costs and long-term deposits. The aggregate balances for these long-lived assets were
$5,527,000 and $6,022,000 as of December 31, 2003 and 2002, respectively. The Company adopted
SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets, which superceded
SFAS No. 121, Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to Be
Disposed Of, effective January 1, 2002. SFAS No. 144 further refines the requirements of SFAS No.
121, requiring that companies (1) recognize an impairment loss only if the carrying amount of a long-
lived asset is not recoverable based on its undiscounted future cash flows and (2) measure an
impairment loss as the difference between the carrying amount and fair value of the asset. In addition,
SFAS No. 144 provides guidance on accounting and disclosure issues surrounding long-lived assets to
be disposed of by sale. The Company adopted SFAS No. 144 on January 1, 2002.
During the fourth quarter of the year ended December 31, 2003, the Company recorded an impairment
charge of $1,708,000 for the write-off of a euro-denominated note receivable from Micromet AG, a former
collaborator of the Company (see Note 5(b)). During the fourth quarter of the year ended December 31,
2002, the Company recorded an impairment charge of $271,000 to reduce the carrying value of patents
associated with the Company’s OP-1 technology which is licensed to Stryker (see Note 7).
(j) GOODWILL
Effective January 1, 2002, the Company applied the provisions of SFAS No. 142, Goodwill and Other
Intangible Assets. In accordance with SFAS No. 142, on January 1, 2002, the Company reclassified
assembled workforce as goodwill and ceased amortization of goodwill. During 2003, the Company
completed its goodwill impairment test in December 2003, and determined that as of that date the fair
value of the Company exceeded the carrying value of its net assets. Accordingly, no goodwill
impairment was recognized.
In 2002, goodwill was subject to both a transitional goodwill impairment test as of January 1, 2002 and
an annual assessment for impairment based on fair value. The Company determined that it consists of a
single reporting unit. In conjunction with the adoption of SFAS No. 142, the Company completed the
transitional goodwill impairment test in the first quarter of 2002 by comparing the Company’s fair
value to its net assets, including goodwill. If the carrying value of the Company’s net assets exceeded
the Company’s fair value, then goodwill would have been impaired. In performing its analysis, the
Company determined its fair value based on quoted market prices adjusted to provide for a control
premium. The transitional goodwill impairment test indicated that no impairment of goodwill had
occurred as of January 1, 2002.
59
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
In addition to requiring transitional and annual assessments of goodwill impairment, SFAS No. 142
requires that a goodwill impairment review be performed whenever events or changes in circumstances
indicate that the carrying value may not be recoverable. Because key employees were terminated and
certain development programs were suspended or terminated as part of a realignment of our operations
in the first quarter of 2002, the Company determined that an impairment indicator had arisen during the
three-month period ending March 31, 2002 that required the Company to reevaluate the carrying value
of goodwill. The Company performed this reevaluation and concluded that no goodwill impairment
had occurred as of March 31, 2002.
After the March 31, 2002, goodwill impairment test was completed, the Company experienced a decrease
in its market value during the three-month period ended June 30, 2002. The Company concluded that the
decline in market value served as an indication that the carrying value of its goodwill asset may be
impaired. Accordingly, the Company conducted an impairment review as required under SFAS No. 142
as of June 30, 2002, and concluded that goodwill impairment had occurred as of June 30, 2002. To
determine the amount of the impairment charge, the Company calculated its implied goodwill as the
difference between the fair value of the Company as a whole and the fair value of the Company’s assets
and liabilities. In calculating the impairment charge, the fair value of the Company’s intangible assets,
principally consisting of completed and in-process technology, was estimated using a discounted cash
flow methodology. The Company determined that its implied goodwill was $8,982,000 and recorded a
non-cash charge of $64,098,000 to write-down its existing goodwill. This charge is included in operating
costs and expenses within the Company’s Consolidated Statements of Operations and Comprehensive
Loss for the year ended December 31, 2002.
The Company recorded expense related to the amortization of goodwill of $23,114,000 during the year
ended December 31, 2001. The Company recorded expense related to the amortization of assembled
workforce of $100,000 during the year ended December 31, 2001. Due to the adoption of SFAS No.
142, the Company recorded no amortization of either goodwill or assembled workforce during the
years ended December 31, 2003 or 2002. As of December 31, 2002, the Company determined that all
of its intangible assets, other than goodwill and assembled workforce, have finite lives and, therefore,
the Company will continue to amortize these intangible assets in future periods. This assessment is
only made upon adoption of SFAS 142.
The following table presents the impact SFAS 142 would have had on the Company’s net loss and net
loss per share had the standard been in effect for the year ended December 31, 2001:
The Year Ended December 31, 2001
As
Reported
Goodwill
Amortization
Adjustment
As
Adjusted
Net Loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$(81,863,000) $(23,114,000) $(58,749,000)
Net Loss per Common Share . . . . . . . . . . . . . . . . . . . . .
$
(2.58) $
(0.73) $
(1.85)
(k) TREASURY STOCK
On May 31, 2002, the Company announced that its Board of Directors had approved the repurchase of
up to $3,000,000 of the Company’s common stock. Such purchases can be made from time to time, at
the discretion of certain members of the Company’s management. The Company accounts for its
common stock repurchases as treasury stock under the cost method. The repurchased stock provides the
60
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
Company with treasury shares for general corporate purposes, such as stock to be issued under
employee stock option and stock purchase plans. Under this repurchase program, the Company
repurchased 25,500 shares during the year ended December 31, 2003, at a cost of $22,000. Since May
31, 2002, the Company has repurchased 1,047,707 shares of its common stock at a cost of $891,000
pursuant to this repurchase program.
(l) BASIC AND DILUTED LOSS PER COMMON SHARE
The Company applies SFAS No. 128, Earnings per Share, which establishes standards for computing
and presenting earnings per share. Basic and diluted net loss per share were determined by dividing net
loss, after giving effect to the accretion on Series A Convertible Exchangeable Preferred Stock, by the
weighted average common shares outstanding during the period. As of May 16, 2003, the Series A
Convertible Exchangeable Preferred Stock was cancelled as part of the termination of the collaboration
with affiliates of Elan Corporation (see Note 5(a)). Diluted net loss per common share is the same as
basic net loss per common share for all periods presented, as the effect of the potential common stock
equivalents is antidilutive due to the Company’s net loss position for all periods presented. Antidilutive
securities consist of stock options, warrants, convertible debt and Series A Convertible Exchangeable
Preferred Stock, that were not included in diluted net loss per common share were 11,070,422,
12,812,883 and 9,608,562 as of December 31, 2003, 2002 and 2001, respectively.
(m) STOCK-BASED COMPENSATION
Stock options issued to employees under the Company’s stock option and employee stock purchase
plans are accounted for under APB Opinion No. 25, Accounting for Stock Issued to Employees and
related interpretations, including FASB Interpretation No. 44 (see Note 15). All stock-based awards to
non-employees are accounted for at their fair value in accordance with SFAS No. 123, Accounting for
Stock-Based Compensation, and Emerging Issues Task Force (EITF) Issue No. 96-18, Accounting for
Equity Instruments that are Issued to Other than Employees.
SFAS 123 requires that companies either recognize compensation expense for grants of stock options and
other equity instruments based on fair value, or provide pro forma disclosure of net loss and net loss per
share in the notes to the financial statements. At December 31, 2003, the Company has two stock-based
compensation plans, which are described more fully in Note 15. The Company accounts for these plans
under the recognition and measurement principles of APB Opinion No. 25 and related interpretations.
Accordingly, no compensation cost has been recognized under SFAS 123 for the Company’s employee
stock option plans.
Under SFAS No. 123, the fair value of stock-based awards to employees is calculated through the use
of option pricing models, even though such models were developed to estimate the fair value of freely
tradable, fully transferable options without vesting restrictions, which significantly differ from the
Company’s stock option awards. These models also require subjective assumptions, including future
stock price volatility and expected time to exercise, which greatly affect the calculated values. The
Company’s calculations were made using the Black-Scholes option-pricing model with the following
assumptions and weighted average values:
Year Ended
December 31,
2003
2002
2001
Risk-free interest rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
—
Expected dividend yield . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . —
7.0
Expected lives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.0
121% 116% 111%
Expected volatility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Weighted average grant date fair value . . . . . . . . . . . . . . . . . . . . . . . .
3.1% 2.1% 5.0%
—
7.0
$3.20
$2.44
$1.22
61
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
Forfeitures for grants to executives are recognized as they occur. If the computed fair values of the 2003,
2002 and 2001 awards had been amortized to expense over the vesting period of the awards consistent
with SFAS No. 123, pro forma net loss and net loss per common share would have been as follows:
Year Ended December 31,
2003
2002
2001
Net loss applicable to common stockholders
as reported . . . . . . . . . . . . . . . . . . . . . . . . . .
$(11,895,000) $(83,038,000) $(82,190,000)
Add back: Stock-based compensation,
included in net loss, as reported . . . . . . . . .
1,124,000
2,160,000
10,358,000
Deduct: Stock-based compensation expense
determined under fair value based method
for all award . . . . . . . . . . . . . . . . . . . . . . . .
(7,838,000)
(7,406,000)
(23,131,000)
Total
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$(18,609,000) $(88,284,000) $(94,963,000)
Net loss per common share (basic and
diluted)—
As reported . . . . . . . . . . . . . . . . . . . . . . .
Pro forma . . . . . . . . . . . . . . . . . . . . . . . . .
$
(0.33) $
(0.52)
(2.57) $
(2.80)
(2.57)
(2.98)
(n) DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITIES
SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities, as amended by SFAS
No. 137 and SFAS No. 138, establishes accounting and reporting standards for derivative instruments,
including certain derivative instruments embedded in other contracts, and for hedging activities. As of
December 31, 2003, 2002 and 2001, the Company did not have any derivative instruments.
(o) NEW ACCOUNTING PRONOUNCEMENTS
In January 2003, the FASB issued Interpretation (“FIN”) No. 46, Consolidation of Variable Interest
Entities (“FIN 46”) and, in December 2003, issued a revision to that interpretation (“FIN 46R”). FIN
46R replaces FIN 46 and addresses consolidation by business enterprises of variable interest entities
that possess certain characteristics. A variable interest entity (“VIE”) is defined as (a) an ownership,
contractual or monetary interest in an entity where the ability to influence financial decisions is not
proportional to the investment interest, or (b) an entity lacking the invested capital sufficient to fund
future activities without the support of a third party. FIN 46R establishes standards for determining
under what circumstances VIEs should be consolidated with their primary beneficiary, including those
to which the usual condition for consolidation does not apply. The Company’s adoption of FIN 46R did
not have a material effect on its financial position or results of operations.
In April 2003, the FASB issued SFAS No. 149, Amendment of Statement 133 on Derivative
Instruments and Hedging Activities. This Statement amends and clarifies financial accounting and
reporting for derivative instruments, including certain derivative instruments embedded in other
contracts (collectively referred to as derivatives) and for hedging activities under SFAS No. 133,
Accounting for Derivative Instruments and Hedging Activities. SFAS No. 149 is effective for contracts
entered into or modified and for hedging relationships designated after June 30, 2003. At December 31,
2003, the Company had no financial instruments falling within the scope of SFAS No. 149.
62
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
In May 2003, the FASB issued SFAS 150, Accounting for Certain Financial Instruments with
Characteristics of both Liabilities and Equity. SFAS 150 establishes standards for how an issuer
classifies and measures certain financial instruments with characteristics of both liabilities and equity.
It requires that an issuer classify a financial instrument that is within its scope as a liability (or an asset
in some circumstances). Many of those instruments were previously classified as equity. This
Statement is effective for financial instruments entered into or modified after May 31, 2003, and
otherwise is effective at the beginning of the first interim period beginning after June 15, 2003. The
adoption of SFAS 150 did not have a material effect on the Company’s financial statements.
In May 2003, the FASB also issued EITF 01-8, Determining Whether an Arrangement Contains a
Lease, which requires capital lease treatment for arrangements containing an embedded lease, thereby
conveying the right to control the use of property, plant or equipment (collectively, “property”)
whether the right to control the use of the property is explicitly or implicitly specified. The right is
conveyed if the purchaser (lessee) obtains physical or operational control of the underlying property or
takes substantially all of its output. This pronouncement applies prospectively to new or modified
arrangements beginning after May 28, 2003. The adoption of EITF 01-8 had no impact on the
Company’s financial statements.
Effective July 1, 2003, the Company adopted EITF 00-21, Accounting For Revenue Arrangements with
Multiple Deliverables, which establishes criteria for whether revenue on a deliverable can be
recognized separately from other deliverables in a multiple deliverable arrangement. The criteria
considers whether the delivered item has stand-alone value to the customer, whether the fair value of
the delivered item can be reliably determined and the customer’s right of return for the delivered item.
The adoption of EITF 00-21 did not have a material impact on the Company’s financial statements.
On December 17, 2003, the Staff of the Securities and Exchange Commission (SEC or the Staff) issued
SAB 104, Revenue Recognition , which amends SAB 101, Revenue Recognition in Financial
Statements. SAB 104’s primary purpose is to rescind accounting guidance contained in SAB 101
related to multiple element revenue arrangements, superseded as a result of the issuance of EITF 00-21.
Additionally, SAB 104 rescinds the SEC’s Revenue Recognition in Financial Statements Frequently
Asked Questions and Answers (the FAQ) issued with SAB 101 that had been codified in SEC Topic 13,
Revenue Recognition. Selected portions of the FAQ have been incorporated into SAB 104. While the
wording of SAB 104 has changed to reflect the issuance of EITF 00-21, the revenue recognition
principles of SAB 101 remain largely unchanged by the issuance of SAB 104. The adoption of SAB
104 did not have a material impact on the Company’s financial statements.
(4) RESEARCH AND DEVELOPMENT AND SIGNIFICANT COLLABORATIONS
(a) GENENTECH, INC.
On June 11, 2003, the Company licensed its small molecule and antibody antagonists of the Hedgehog
signaling pathway to Genentech for applications in cancer therapy pursuant to the terms of a
Collaborative Research, Development and License Agreement. The Collaboration Agreement provides
for cash payments from Genentech, including an up-front payment of $5,000,000, maintenance fee
payments totaling $4,000,000 over the first two years of the collaboration, and milestone payments at
various intervals during the regulatory approval process of small molecule and antibody product
candidates, assuming specified development objectives are met. Genentech is also obligated to pay the
Company a royalty on any future product sales.
63
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
Under the terms of the Collaboration Agreement, the Company is required to commit eight employees
to the small molecule and/or antibody programs for a period of two years. In addition, the Company
will participate on a joint steering committee to oversee the preclinical development of product
candidates. Per the Collaboration Agreement, product candidates identified by the joint steering
committee for further (i.e., clinical) development are classified as either “Lead Products” or “Co-
Development Products.”
•
Lead Products: Lead Products include all small molecule and antibody antagonists of the
Hedgehog signaling pathway, except for those in either the basal cell carcinoma, a form of skin
cancer, or the hair growth prevention fields. Genentech bears sole decision making authority and
development costs for all Lead Products, including clinical trial development and management,
regulatory, clinical and commercial manufacturing, product formulation, and, if FDA approval is
received, sales and marketing.
• Co-Development Products: Co-Development Products include only those product candidates
identified by the joint steering committee for further development in either the basal cell
carcinoma or the hair growth prevention fields. For product candidates in the basal cell carcinoma
field, Genentech will create a co-development plan and budget and the Company will have the
option to share in the development costs. For product candidates in the hair growth prevention
field, the Company will create a co-development plan and budget and Genentech will have the
option to share in the development costs. In both co-development scenarios, a co-development
committee will be formed, consisting of an equal number of members from Genentech and the
Company, to oversee the co-development efforts.
The Company has recorded the $5,000,000 up-front payment and the $4,000,000 in maintenance fee
payments due from Genentech as deferred revenue and has been recognizing these amounts as revenue
on a straight-line basis over the development period. For the year ended December 31, 2003, the
Company recorded license revenue related to this collaboration of $670,000. This revenue is included
in “License fees and royalties” in the Consolidated Statement of Operations and Comprehensive Loss.
In addition, the Company has performed certain services or incurred costs that were requested by
Genentech but which are outside of the scope of the original contract. The Company has been
reimbursed for such costs. For the year ended December 31, 2003, the Company has recorded $58,000
in revenue related to such cost reimbursement. This revenue is included in “Research and development
contracts and government grants” in the Consolidated Statement of Operations and Comprehensive
Loss.
In addition, as partial consideration for the rights and licenses granted to Genentech under the
Collaboration Agreement, the Company sold to Genentech 1,323,835 shares of its common stock at a
purchase price of $2.644 per share for aggregate proceeds of $3,500,000, pursuant to the terms of a
stock purchase agreement. The Company also entered into a registration rights agreement with
Genentech pursuant to which the Company shall use its reasonable best efforts to register the shares of
common stock for resale in the future under specified conditions.
(b) ORTHO BIOTECH PRODUCTS, L.P.
In November of 2002, the Company licensed its broad bone morphogenetic protein, or BMP,
technology portfolio to Ortho Biotech Products, L.P., a member of the Johnson & Johnson family of
companies. Two of Ortho Biotech’s research affiliates, Johnson & Johnson Pharmaceutical Research &
Development, L.L.C. and Centocor Research & Development, also members of the Johnson & Johnson
64
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
family of companies, will have joint responsibility for further research and development of the
Company’s licensed BMP technology portfolio.
The transaction covers all of the Company’s proprietary BMP compounds including BMP-7, which has
been studied in animal models as a treatment for chronic kidney disease and systemic complications
(renal osteodystrophy and vascular calcification) associated with chronic kidney disease. Use of the
Company’s BMPs for the repair or regeneration of local musculoskeletal tissue defects and dental
defects is the subject of an exclusive agreement with Stryker and is not included as part of this
transaction.
The agreement provides for cash payments from Ortho Biotech to the Company, including an up-front
payment of $3,500,000, which was paid in December 2002, and milestone payments at various
intervals during the U.S. and European regulatory approval process for the first two therapeutic
indications developed. These milestones include a $30,000,000 payment for U.S. regulatory approval
of a product for the treatment of kidney disease or associated complications. The agreement further
specifies that the Company will receive a royalty on net sales of products that incorporate the
Company’s BMP technologies. The Company recognized the upfront payment of $3,500,000 as
revenue in the fourth quarter of 2002 because the Company has no continuing performance obligations
under the contract.
(c) AMYLIN PHARMACEUTICALS, INC.
In December 2002, the Company licensed its PYY patent applications to Amylin Pharmaceuticals, Inc.
in exchange for an up-front fee, milestone payments and a royalty on product sales, if any are ever
realized. Amylin has sole responsibility for all further development of the PYY compound. Since the
Company has no continuing obligation under the terms of this transaction, 100% of the up-front
payment was recognized as revenue during 2002.
(d) ES CELL INTERNATIONAL, PTE, LTD.
On December 17, 2002, the Company assigned and licensed its patent rights related to the development
of cellular therapeutics for the treatment of diabetes to ES Cell International pte, Ltd. in exchange for
an up-front fee and an equity position in ES Cell International. As of December 17, 2002, ES Cell
International has assumed all responsibility for future development of the Company’s diabetes stem-
cell technologies, including the funding of six of the Company’s scientists through December 17, 2003
at a rate of $250,000 per scientist per year. For the years ended December 31, 2003 and 2002, the
Company recognized $1,470,000 and $62,000, respectively, in revenue related to its contract research
performed by these six scientists. Because the funding portion of this program ended on December 17,
2003, the Company will not recognize future revenues under this collaboration.
Since the Company had a performance obligation to employ six scientists through December 17, 2003,
as part of this transaction, the Company recognized as revenue the up-front cash payment and the value
of the equity received over the one-year term of its obligation. As of December 31, 2002, the Company
had recorded $192,000 in deferred revenue relating to this transaction. Since the Company’s obligation
was completed during 2003, this amount was recognized as revenue during the year ended December
31, 2003, and the Company will not recognize additional revenue related to this collaboration.
65
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
The Company maintains an equity position in ES Cell International. As of December 31, 2003 and
2002, the Company has recorded this investment at a carrying value of $150,000, included within the
“Deposits and other assets” section of its Consolidated Balance Sheets.
(5) FORMER COLLABORATIONS AND GOVERNMENT GRANTS
(a) ELAN INTERNATIONAL SERVICES
On May 16, 2003, the Company and affiliates of Elan Corporation, plc entered into a termination
agreement to conclude the joint venture that the Company and Elan had originally formed in July 2001.
The purpose of the joint venture, called Curis Newco, was to research and develop molecules that
stimulate the Hedgehog signaling pathway in the field of neurology, including disease targets such as
Parkinson’s Disease and diabetic neuropathy. Prior to the termination, the Company and Elan owned
80.1% and 19.9%, respectively, of the outstanding shares of Curis Newco. As a result of the
termination, Elan transferred its 19.9% share of Curis Newco to the Company, such that Curis Newco
has become a wholly-owned subsidiary of the Company and Curis Newco is consolidated into the
Company’s consolidated financial statements.
Curis Newco did not incur any research expenses during the twelve-month period ended December 31,
2003. In accordance with the development agreement between the Company and Elan that governed
Curis Newco’s operations prior to the termination agreement, the Company and Elan were required to
agree upon a Curis Newco development plan in order for any expenses to be incurred by Curis Newco.
The Company and Elan did not reach agreement on a development plan prior to termination of the joint
venture on May 16, 2003, and, therefore, no research expenses were recorded at Curis Newco in 2003.
As of the termination date, the Company had recorded a payable to Curis Newco of $1,089,000, which
represented the Company’s 80.1% share of Curis Newco’s loss for the three-month period ended
December 31, 2002. In addition, the Company had recorded a receivable from Curis Newco of
$1,299,000 which represented charges for services performed by the Company on behalf of Curis
Newco for the three-month period ended December 31, 2002. Both of these amounts were paid as part
of the termination and there are no remaining balances related to these amounts as of December 31,
2003.
In July 2001, the Company entered into a convertible note payable with Elan Pharma International
Limited, or EPIL, of which $4,900,000 was outstanding at the termination date. As part of the
termination, of the $4,900,000 outstanding, the Company repaid $1,500,000 in cash and EPIL forgave
$400,000. The Company then entered into an amended and restated convertible note payable with EPIL
for the remaining principal amount of $3,000,000. The terms of the amended and restated convertible
note payable were substantially the same as those under the original note payable except that the
interest rate was reduced from 8% to 6% and the conversion rate was increased to $10.00 from $8.63.
As of December 31, 2003, there was $3,115,000, including $115,000 in accrued interest, outstanding
under the amended and restated convertible note payable.
In July 2001, the Company issued to Elan shares of its Series A convertible/exchangeable preferred
stock valued at $12,015,000 to fund the Company’s pro rata share of the initial capitalization of Curis
Newco. The Company recorded a charge to accumulated deficit of $271,000 for the year ended
December 31, 2003, for the accretion of a mandatory 6% dividend on the preferred stock. Such
amounts are included in the net loss applicable to common stockholders for the year ended December
31, 2003. The preferred stock, which had a carrying value of $13,336,000, was cancelled on the May
66
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
16, 2003 termination date. As partial consideration for the rights and benefits described in the
termination agreement, including the cancellation of the preferred stock, the Company issued
2,878,782 shares of its common stock to Elan, having a fair value of $8,377,000 based on the May 16,
2003 closing price of the Company’s common stock on the Nasdaq National Market. Upon the
termination of the Elan agreement, the Company recorded a credit to additional paid-in-capital of
$13,736,000 to reflect the cancellation of the Preferred Stock and the forgiveness of debt in exchange
for the issuance of the Company’s common stock.
Lastly, as a result of the termination, all rights granted by both the Company and Elan at the formation
of Curis Newco under separate license agreements with Curis Newco terminated. In addition,
intellectual property created by Curis Newco is owned by the Company, both in its own right and as
sole shareholder of Curis Newco. According to provisions in the termination agreement the Company
will pay Elan future compensation, in the form of future royalty payments, in the event of any direct
sales or third party commercialization agreements related to certain compounds.
(b) MICROMET AG
In July 2001, the Company entered into three agreements with Micromet including: (i) a purchase and
sale agreement pursuant to which the Company assigned its single-chain-polypeptide technology to
Micromet in exchange for up-front consideration of $12,146,000, consisting of $8,000,000 in cash,
$3,460,000 in a euro-denominated note receivable, and equity valued by the Company at $686,000, (ii)
a product development agreement and (iii) a target research and license agreement. The note receivable
received under the purchase and sale agreement bears interest at 7% and is due and payable in full on
the earlier of (i) the closing date of an initial public offering of Micromet’s shares or (ii) June 30, 2005.
At maturity, the Company has the option to receive either cash or shares of Micromet common stock.
Further, under these agreements, the Company was entitled to receive royalties on Micromet’s
revenues, if any, arising out of the assigned technology, rights to jointly develop and commercialize
future product discoveries, if any, arising out of the product development agreement and access to other
technologies. The product development agreement provided the Company with the right, but not the
obligation, to jointly fund research to develop antibodies on up to four potential targets through the
proof of principle stage. The Company had the right, but not the obligation, to jointly fund the
development of two such antibody targets from the proof of principle stage through the completion of
Phase I clinical trials.
The Company was recognizing revenue under these contracts as services were performed to satisfy the
Company’s performance obligation under the product development agreement. The Company
recognized approximately $183,000 in revenue over the course of its relationship with Micromet
through July 31, 2003. Amounts that had not been recognized as revenue were recorded on the
Company’s Consolidated Balance Sheet as short- and long-term deferred revenue based on the
Company’s best estimate of when such revenue would be recognized. As of December 31, 2002, the
Micromet note receivable was recorded at $4,663,000.
Effective July 31, 2003, the Company and Micromet entered into agreements to terminate the target
research and license agreement and the product development agreement. As a result of the termination
of these agreements, the Company no longer has any performance or contractual obligations with
Micromet. Accordingly, the Company immediately recognized as revenue $8,555,000 of previously
deferred revenue related to its agreements with Micromet.
67
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
As of the July 31, 2003 termination date, the Company had continued to defer $3,407,000 in revenues
related to the long-term note receivable from Micromet and had intended to recognize this as revenue
upon payment of the note receivable. During the fourth quarter of the year ended December 31, 2003,
however, the Company determined that the note receivable was impaired and recorded an impairment
charge of $1,708,000 to write-off of this note receivable. Prior to the impairment charge, the Company
had reported this note as a long-term note receivable asset of $5,115,000, reflecting the note’s then-
current carrying value after giving effect to interest income and foreign currency gains. The
impairment charge reflects the net effect of the write-off of the $5,115,000 note receivable and the
elimination of $3,407,000 in related deferred revenue. The Company determined that this charge was
necessary due to Micromet’s announcement that it was terminating one-third of its workforce as the
result of a contract dispute with a co-development partner. Micromet has stated that this dispute will
result in a significant decrease in previously budgeted cash inflows in 2004.
(c) STRYKER CORPORATION
Creative BioMolecules, Inc., one of the companies that merged to form Curis in 2000, had an
agreement with Stryker to identify and develop OP-1, a bone-inducing protein, as orthopaedic
reconstruction and dental therapy products. In exchange for research funding, future royalties and
revenue from commercial manufacturing, Creative developed OP-1 as a therapy for orthopedic
reconstruction and cartilage regeneration and supplied Stryker material for use in clinical trials.
Creative restructured its agreements with Stryker in November 1998 to provide Stryker with the
exclusive rights to manufacture OP-1 products in these fields. At that time, Stryker acquired Creative’s
commercial manufacturing operations. As a result, Stryker had the exclusive right to develop, market,
manufacture and sell products based on OP-1 proteins for use in orthopedic reconstruction and dental
therapies and was required to pay the Company royalties on such commercial sales. Stryker paid the
Company royalties of $387,000 and $97,000 for the years ended December 31, 2002 and 2001,
respectively.
On October 1, 2002, the Company completed a transaction with Stryker, under the terms of which
Stryker paid the Company $14,000,000 in cash in exchange for the termination of any future BMP-7
(OP-1) royalty obligations. This transaction also allows the Company to reduce future BMP-7 royalties
that it would owe to Stryker for products sold in therapeutic indications other than orthopedics and
dental, if any such sales are ever achieved. The Company recorded the $14,000,000 received as
revenue during the fourth quarter of 2002 because the Company has no continuing performance
obligations under the contract. As a result of this transaction, the Company will receive no future
royalties or payments of any other kind from Stryker.
(d) AEGERA THERAPEUTICS
The Company entered into a license and collaboration agreement, effective January 5, 2001, with
Aegera Therapeutics, Inc. granting the Company an exclusive worldwide license of Aegera’s skin-
derived, adult stem cell technologies. In consideration for the technology license, the Company paid
$100,000 up-front license fee, paid $250,000 for equity securities in privately-held Aegera, and issued
to Aegera 10,667 shares of the Company’s common stock with an approximate value of $100,000 . In
addition, under the terms of the agreement, the Company made one additional license payment of
$100,000 which was expensed in 2002.
The agreement also provided for a three-year research collaboration under which the Company was
obligated to fund six full-time equivalent researchers per year at Aegera dedicated to the agreement at
68
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
an aggregate cost to the Company of $600,000. Effective October 24, 2002, the Company terminated
the research collaboration component of its relationship. Effective April 30, 2003, the Company
terminated the remaining components of this license and collaboration agreement.
(e) GOVERNMENT GRANTS
Effective September 20, 1998, Reprogenesis received a grant award for its vesicoureteral reflux
product under the Orphan Drug Program of the Department of Health and Human Services. This grant
award provides for cost reimbursement funding over a three-year period of approximately $323,000 for
certain patient costs associated with a vesicoureteral reflux Phase III clinical trial to the extent the
Company complies with all of the requirements governing the grant. The Company recognized
$101,000 under this grant for the year ended December 31, 2003. The Company has received all
reimbursement that it is entitled to under this grant and, as such, will not recognize future revenue
related to this grant.
Effective November 1, 1999, Reprogenesis, one of the companies that merged to form Curis in 2000,
received a grant award for its cardiovascular project from the advanced technology program of the
National Institute of Standards and Technology (NIST) to support the development of the Company’s
cardiovascular products, Vascugel and Vascuject. The Company has assumed this award in conjunction
with the Merger. Under the terms of the grant award, the Company will receive $2,000,000 in cost
reimbursement funding to be paid at a rate of approximately $666,000 annually over a three-year
period. Funding under the NIST grant is contingent on the Company meeting minimum cost-sharing
and other requirements, as defined in the financial assistance award and annual government
appropriations for the award. The Company terminated its work on its cardiovascular products as part
of the Realignment. As a result, on April 15, 2002, this award was terminated.
On October 5, 2000, the Company announced the receipt of a second $2,000,000 grant from NIST to
support the development of a new class of biomaterials designed to enable surgical procedures that
augment, repair or regenerate lost structural tissue or physiological function. The grant period is from
January 1, 2001 to December 31, 2003. Under the terms of the grant award, the Company will receive
$2,000,000 in cost reimbursement funding to be paid at a rate of approximately $666,000 annually over
a three-year period. Funding under the NIST grant is contingent on the Company meeting minimum
cost-sharing and other requirements, as defined in the financial assistance award and annual
government appropriations for the award. The Company terminated its work on biomaterials research
as part of the Realignment. As a result, on April 15, 2002, this award was terminated.
The Company recognized $101,000 of government grant revenue for the year ended December 31,
2003. No government grant revenue was recorded for the year ended December 31, 2002 and
approximately $968,000 of government grant revenue under was recognized for the year ended
December 31, 2001.
(6) REALIGNMENT
The Company announced a realignment of its research and development programs in the first quarter of
2002. Realignment expenses of $3,490,000 were recorded in the three-month period ended March 31,
2002. These charges related to: (i) $1,139,000 associated with workforce reductions of 46 people,
including 4 officers, (ii) $2,306,000 associated with the closing of clinical programs and
decommissioning of a manufacturing and development facility and (iii) other costs of $45,000. As of
69
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
December 31, 2002, the Company had paid all of these costs and does not expect to incur additional
costs related to this realignment in the future.
In connection with this realignment, the Company recorded impairment charges of property and
equipment assets of $5,337,000. This charge related to impairment of assets at the Company’s
manufacturing and development facility located at its facility located at 21 Erie Street, Cambridge,
MA. $4,761,000 of the total impairment charge related to the write-off of tenant improvements made to
the Erie Street facility since such improvements were affixed to the facility and therefore could not
have been sold separately from the facility. The remaining $576,000 of impairment charge represented
the write-down of the furniture and equipment assets held at the Erie Street facility to their estimated
salvage value. The amount the Company received from the sale of these assets was not significantly
different from the originally estimated fair value.
(7) GOODWILL AND INTANGIBLE ASSETS
As of December 31, 2003 and 2002, the Company had recorded goodwill of $8,982,000. During 2003,
the Company completed its goodwill impairment test in December 2003, and determined that as of that
date, the fair value of the Company exceeded the carrying value of its net assets. Accordingly, no
goodwill impairment was recognized.
Intangible assets consist of the following:
December 31,
2003
2002
Patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Less—Accumulated amortization . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 612,000
(435,000)
$ 612,000
(360,000)
$ 177,000
$ 252,000
The changes in the carrying amounts of goodwill for the year ended December 31, 2002, are as
follows:
Balance as of January 1, 2002 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Impairment loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 73,080,000
(64,098,000)
Balance as of December 31, 2002 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 8,982,000
During the fourth quarter of the year ended December 31, 2002, the Company recorded an impairment
charge of $271,000 to reduce the carrying value of patents associated with the Company’s OP-1
technology which is licensed to Stryker. The charge was recorded as a result of the Company’s
transaction with Stryker, under which the Company sold its rights to future royalties from Stryker on
sales of OP-1 in exchange for $14,000,000. The Company wrote these patents off because the
Company will not receive any future royalties or other revenue from Stryker and because these patents
cannot be utilized for alternative uses in either current or future operations and have no alternative
future use to the Company.
70
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
(8) PROPERTY AND EQUIPMENT
Property and equipment consist of the following:
December 31,
2003
2002
Laboratory equipment and computers . . . . . . . . . . . . . . . . . . . . .
Equipment and furniture under capital leases . . . . . . . . . . . . . . .
Leasehold improvements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Leasehold improvements under capital leases . . . . . . . . . . . . . .
Office furniture and equipment . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 5,701,000
1,610,000
3,857,000
703,000
553,000
$ 4,515,000
2,701,000
4,316,000
703,000
523,000
Less—Accumulated depreciation and amortization . . . . . . . . . .
12,424,000
(9,923,000)
12,758,000
(8,983,000)
Total
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 2,501,000
$ 3,775,000
The Company recorded depreciation and amortization expense of $1,426,000, $1,955,000 and
$3,289,000 for the years ended December 31, 2003, 2002 and 2001, respectively.
During the year ended December 31, 2002, the Company recorded property and equipment impairment
charges of $5,337,000 related to a realignment of its research and development programs. This charge
relates to an impairment of assets at the Company’s manufacturing and development facility located at
21 Erie Street in Cambridge, Massachusetts. $4,761,000 of the total impairment charge related to the
write-off of tenant improvements made to the Erie Street facility since such improvements were affixed
to the facility and, therefore, could not be sold separately from the facility. The remaining $576,000 of
impairment charge represented the loss on disposition of the furniture and equipment assets held at the
Erie Street facility.
(9) ACCRUED LIABILITIES
Accrued liabilities consist of the following:
Collaboration and clinical costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Professional fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 481,000
740,000
320,000
887,000
$ 856,000
936,000
702,000
763,000
Total
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$2,428,000
$3,257,000
December 31,
2003
2002
71
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
(10) LONG-TERM DEBT AND CAPITAL LEASE OBLIGATIONS
Long-term debt and capital lease obligations consist of the following at December 31, 2003 and 2002:
Notes payable to financing agencies for capital purchases . . . . . . . . . . . . . . . . . . . . . .
Obligations under capital leases, net of approximately $12,000 and $31,000 discount
at December 31, 2003 and 2002, respectively . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Convertible promissory note agreement with Elan Pharma International, Limited
including approximately $115,000 and $200,000 of accrued interest at December
31, 2003 and 2002, respectively . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Convertible subordinated note payable to Becton Dickinson, net of $133,000 and
$187,000 discount and including $352,000 and $212,000 of accrued interest at
December 31, 2003 and 2002, respectively . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Less—current portion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
December 31,
2003
2002
$
— $ 4,239,000
323,000
1,291,000
3,115,000
4,860,000
2,219,000
2,025,000
5,657,000
(323,000)
12,415,000
(2,105,000)
Total long-term debt and capital lease obligations . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$5,334,000
$10,310,000
On June 14, 2002, the Company entered into a loan agreement with the Boston Private Bank & Trust
Company under which the Company borrowed $4,695,000. The Company used the proceeds of the
loan agreement to pay off its existing credit facility with Fleet National Bank. Under the terms of the
loan agreement, the Company was required to (i) pay interest monthly in arrears at a variable interest
rate and (ii) repay principal in equal quarterly installments of $235,000 over a five-year term,
beginning September 1, 2002. The outstanding balance on the loan agreement was fully collateralized
with a money market account maintained by the Company at the Boston Private Bank & Trust
Company. Effective April 2, 2003, the Company amended this loan agreement with the Boston Private
Bank & Trust Company. Under the terms of the amended loan amendment, the Company ceased its
quarterly principal payments. The loan was structured as a revolving credit facility under which up to
$7,000,000 could have been borrowed and remained outstanding until the repayment date of April 1,
2005. Curis continued to pay interest monthly in arrears at a variable interest rate during 2003. This
loan was fully collateralized with a money market account of Curis maintained at the Boston Private
Bank & Trust Company. On December 1, 2003, the Company paid in full to the Boston Private Bank &
Trust Company its outstanding loan balance of $3,996,000, comprised of $3,991,000 in principal and
$5,000 in accrued interest. The Company had paid $217,000 earlier in 2003. The Company paid this
loan with funds held in its fully collateralized money market account at the Boston Private Bank &
Trust Company.
On July 18, 2001, the Company entered into a convertible promissory note agreement with Elan
Pharma International Limited, or EPIL, an affiliate of Elan Corporation in the amount of $8,010,000.
This note agreement was amended as part of the termination of the Company’s collaboration with Elan
Corporation on May 16, 2003 as described in Note 5. At the May 16, 2003 termination date, there was
$4,900,000 outstanding under the note agreement. As part of the termination, the Company repaid
$1,500,000 in cash and EPIL forgave $400,000. The Company then entered into an amended and
restated convertible note payable with EPIL for the remaining principal amount of $3,000,000. Under
the terms of the amended and restated note agreement the default maturity is July 18, 2007. However,
EPIL has the option to convert all or any portion of the outstanding principal amount into the
72
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
Company’s common stock at any time until July 18, 2007. In addition, the interest rate was reduced
from 8% at the original note agreement to 6% at the amended and restated note agreement and the
conversion rate was increased to $10.00 from $8.63. As of December 31, 2003, there was $3,115,000,
including $115,000 in accrued interest, outstanding under the amended and restated convertible note.
The Company leases equipment under various capital lease arrangements. Monthly payments on leases
outstanding as of December 31, 2003 range from $1,880 to $21,170 and maturities range from March
2004 to July 2004. The initial terms of the leases range from 36 months to 60 months and bear interest
at rates ranging from 12.5% to 16.3%. As of December 31, 2003, $323,000 was outstanding under
these agreements and the Company was in compliance with all covenants under these agreements.
On June 26, 2001, the Company received $2,000,000 from Becton Dickinson under a convertible
subordinated note payable in connection with the exercise of an option to negotiate a collaboration
agreement. The note payable is repayable, at the option of the Company, in either cash or issuance of
the Company’s common stock at any time up to its maturity date of June 26, 2006. The Note bears
interest at 7%, which was below the fair market interest rate on date of issue. The Company estimated
the fair market interest rate to be 11%. The difference between the fair market interest rate of 11% and
the coupon interest rate of 7% is being amortized as interest expense over the term of the note payable.
As of December 31, 2003, $2,352,000, including $352,000 of accrued interest, was outstanding under
the note payable.
Maturities of long-term debt and future capital lease obligations are as follows:
Year Ending December 31,
2004 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2005 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2006 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Thereafter
Total minimum payments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Less—Amount representing interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Principal obligation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Less—Current portion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 339,000
—
2,219,000
3,115,000
—
5,673,000
(16,000)
5,657,000
(323,000)
$5,334,000
73
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
(11) COMMITMENTS
(a) OPERATING LEASES
The Company has noncancellable operating lease agreements for office and laboratory space. The
Company’s remaining operating lease commitments for all leased facilities with an initial or remaining
term of at least one year are as follows:
Year Ending December 31,
2004 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2005 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2006 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Thereafter
$ 822,000
822,000
1,433,000
518,000
—
Total minimum payments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$3,595,000
Rent expense for all operating leases was $339,000, $1,227,000 and $2,017,000 for the years ended
December 31, 2003, 2002 and 2001, respectively, net of facility sublease income of $583,000,
$607,000 and $405,000 in 2003, 2002 and 2001, respectively. The Company’s lease obligations expire
on April 30, 2007. The Company has an option to extend its lease to April 2012.
Effective August 15, 2002, the Company sublet approximately 12,000 square feet, or 67%, of the
rentable square footage of its facility at 61 Moulton Street, Cambridge, MA, at a rate of $29.48 per
square foot. The Company’s cost of the sublet space is $26.50 per square foot. The initial term of the
sublease is two years with an option, at the subtenant’s discretion, to extend the sublease for an
additional term of two years and eight months. During the twelve months ending December 31, 2003
and 2002, the Company received sublease payments of $370,000 and $132,000, respectively. In
addition to the sublease payments, the subtenant is required to pay its pro rata share (approximately
67%) of all building operating costs. The Company’s lease obligation ends on April 30, 2007.
As a result of a realignment of its research and development programs, effective June 30, 2002, the
Company terminated its lease for a 50,000 square foot facility at 21 Erie Street, Cambridge, MA.
Under the terms of the agreement, the Company made no payments upon lease termination and has no
further financial or other obligations after June 30, 2002.
Effective March 1, 2002, the Company subleased approximately 5,000, or 15%, of the rentable square
footage of its facility at 45 Moulton Street, Cambridge, MA, at a rate of $37.00 per square foot. The
Company’s cost of the sublet space is $8.85 per square foot. The term of the sublease is two years and
six months. During the twelve months ending December 31, 2003 and 2002, the Company received
sublease payments of $213,000 and $163,000, respectively. In addition to the sublease payments, the
subtenant is required to pay its pro rata share (approximately 15%) of all building operating costs. The
Company’s lease obligation ends on April 30, 2007.
During 2000, the Company entered into a sublease for its Boston, Massachusetts, facility previously
occupied by Creative BioMolecules commencing on July 1, 2000. The sublease terminated on July 31,
2002, also the termination date of the Company’s original lease on this facility. For the years ended
December 31, 2002 and 2001, the Company received sublease payments of $312,000 and $332,000,
respectively.
74
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
(b) LICENSE AGREEMENTS
The Company licenses a significant portion of its technology from several universities and foundations.
In exchange for the right to use licensed technology in its research and development efforts, the
Company has entered into various license agreements. These agreements generally stipulate that the
Company pays an annual license fee and is obligated to pay royalties on future product sales, if any,
resulting from the underlying licensed technology. In addition, some of the agreements commit the
Company to make contractually defined payments upon the attainment of scientific or clinical
milestones. The Company expenses license fee payments over their respective service periods and
expenses royalty payments as related product sales are recorded. The Company accrues expenses for
scientific and clinical milestones over the period that the work required to meet the milestone is
completed, provided that the Company believes that the achievement of the milestone is probable. The
Company incurred license fee expenses of $1,264,000, $364,000 and $691,000 for the years ended
December 31, 2003, 2002 and 2001, respectively. During the twelve months ending December 31,
2003, the Company incurred $74,000 in expenses associated with development milestone payments or
royalties on licensed technology. The Company did not incur any such expenses for the years ended
December 31, 2002 and 2001.
During the year ended December 31, 2003, the Company amended its license agreements with Harvard
University and Johns Hopkins University. These contracts were amended to reduce future royalties and
milestones payments payable on future revenues generated by the Company on the licensed
technology, including revenues derived from the Company’s corporate collaborators. During the year
ended December 31, 2003, the Company recorded $1,007,000 in non-cash expense associated with the
issuance of an aggregate of 200,000 shares of common stock pursuant to the terms of these amended
license agreements. The fair value of the common stock issued was charged to research and
development expense because the technology covered under the amended license agreement is
currently in preclinical development and is not currently commercializable. The terms of the amended
license agreements also state that the Company is obligated to issue up to an aggregate of 200,000
additional shares of common stock if there is a change of control in the Company (i.e., acquisition) or
if any product candidate covered under these amended license agreements should advance into Phase
III clinical trials. The Company has not recorded any expense associated with the potential future
issuance of its common stock since such issuance is contingent upon future events.
In connection with the termination of a collaboration, for which the Company retained its rights to the
underlying technology, the Company is required to make milestone payments of $3,500,000 contingent
upon regulatory approval and commercialization of the reflux and incontinence products. The
Company terminated its reflux and incontinence programs as part of the realignment. No milestone
payments have been made on this agreement through December 31, 2003.
(12) NOTES RECEIVABLE—FORMER OFFICERS
On February 8, 2000, Creative BioMolecules loaned to two executive officers an aggregate of
$1,131,000, which was equal to the aggregate exercise price of incentive stock options exercised by
them on the same date. The officers immediately used these funds to pay Creative the exercise price of
such incentive stock options. Neither of these executive officers became officers or employees of the
Company after the merger of Creative into Curis on July 31, 2000. The underlying notes are full
recourse loans that each bear interest at an annual rate of 7.0%. All principal and interest was due and
payable on the earlier of May 8, 2002, or 30 days following the sale of the stock purchased with these
75
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
funds. As of December 31, 2003, the notes have not been repaid. The book value of the notes is
$1,338,000 as of December 31, 2003 and 2002, respectively, and is included as “Notes receivable” in
the Company’s Stockholders’ Equity section of its Consolidated Balance Sheets. The book value of the
notes is presented net of a reserve for the estimated uncollectible portion of the notes. During 2002 and
the first quarter of 2003, this reserve was equal to the total amount outstanding under the Creative
Notes less the underlying value of the Curis common stock that collateralize the notes. Beginning in the
second quarter of 2003, the value of the underlying Curis common stock began appreciating. The
Company elected not to decrease the reserve based on increases in Curis’ common stock value and will
not reverse the reserve until the Company believes collection of an amount in excess of the carrying
value is reasonably assured. The Company has recorded charges of $34,000 during 2003 and $686,000
for the year ended December 31, 2002, to write-down the carrying value of the notes. The reserve on
the notes was $1,229,000 and $1,194,000 as of December 31, 2003 and 2002, respectively, and is
included in “Notes receivable” at the Company’s Stockholders’ Equity section of its Consolidated
Balance Sheets .
(13) SERIES A PREFERRED STOCK
On July 18, 2001, the Company issued to Elan shares of its Series A convertible/exchangeable
preferred stock valued at $12,015,000 to fund the Company’s pro rata share of the initial capitalization
of Curis Newco. The fair value of the Series A preferred shares was determined based on an arm’s
length negotiation between the Company and Elan. The Company recorded charges to accumulated
deficit for the accretion of a mandatory 6% dividend on the preferred stock of $271,000, $723,000 and
$326,000 for the years ended December 31, 2003, 2002 and 2001, respectively. Such amounts are
included in the net loss applicable to common stockholders for the year ended December 31, 2003.
As part of a termination agreement entered into between the Company and Elan (see Note 5(a)), the
preferred stock, which had a carrying value of $13,336,000, was cancelled on May 16, 2003.
(14) WARRANTS
The Company has a total of 1,135,884 warrants to purchase its common stock outstanding as of
December 31, 2003. These warrants are summarized as follows:
(a)
In connection with the private placement of 3,589,700 shares of its common stock on August 14,
2003, the Company issued warrants to purchase 1,076,910 shares of its common stock at an
exercise price of $4.45 per share. The warrants expire on August 14, 2008. As of December 31,
2003, none of these warrant have been exercised.
(b) On July 18, 2001, and in connection with its common stock issuance to an affiliate of Elan
Corporation, the Company issued a warrant to purchase up to 50,000 shares of the Company’s
common stock at $10.46 per share. The warrant expires on July 18, 2006. As of December 31,
2003, the warrant has not been exercised.
(c) At December 31, 2003, other warrants to purchase 8,974 shares of common stock with prices
ranging from $9.76 to $19.51 per share are outstanding. These warrants expire at various dates,
ranging from November 2004 until December 2009.
76
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
(15) STOCK PLANS
(a) OPTION PLANS
In March 2000, the Board of Directors adopted and, in June 2000, the stockholders approved, the 2000
Stock Incentive Plan (the 2000 Plan), which permits the grant of incentive and non-qualified stock
options as well as the issuance of restricted shares. As of December 31, 2003, the number of shares of
common stock subject to issuance under the 2000 Plan is 13,000,000. At December 31, 2003,
2,893,549 shares are available for grant under the 2000 Plan.
The 2000 Plan permits the granting of incentive and nonqualified stock options to employees, officers,
directors, and consultants of the Company and its subsidiaries at prices determined by the
Compensation Committee of the Company’s Board of Directors. Awards of stock may be made to
consultants, directors, employees or officers of the Company and its subsidiaries, and direct purchases
of stock may be made by such individuals also at prices determined by the Compensation Committee.
Options become exercisable as determined by the Compensation Committee and expire up to 10 years
from the date of grant.
In March 2000, the 2000 Director Stock Option Plan (the 2000 Director Plan) was adopted by the
Board of Directors and in June 2000, was approved by the stockholders. The 2000 Director Plan
provides for the granting of options to non-employee directors. As of December 31, 2003, the number
of shares of common stock subject to issuance under the 2000 Director Plan is 500,000. As of
December 31, 2003, 210,000 shares are available for grant under the 2000 Director Plan.
Activity under both the 2000 Plan and 2000 Director Plan is summarized as follows:
Weighted
Average
Exercise
Price per
Share
Number of
Shares
Outstanding, January 1, 2001 (2,384,703 exercisable at weighted average price of $10.16
per share) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Granted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Exercised . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Canceled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6,883,684
3,512,399
(274,640)
(1,914,044)
12.00
3.43
2.67
13.19
Outstanding, December 31, 2001 (2,484,998 exercisable at weighted average price of
$9.40 per share) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Granted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Exercised . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Canceled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8,207,399
4,761,800
(1,822)
(4,262,485)
Outstanding, December 31, 2002 (4,220,759 exercisable at weighted average price of
$5.38 per share) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8,704,892
Granted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Exercised . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Canceled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3,351,445
(797,119)
(2,141,969)
8.37
1.44
1.18
8.92
8.30
2.65
1.73
4.06
Outstanding, December 31, 2003 (4,186,437 exercisable at weighted average price of
$5.37 per share) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9,117,249
$ 4.01
77
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
The table below summarizes options outstanding and exercisable at December 31, 2003:
Exercise Price Range
$ 0.56 - $ 1.32 . . . . . . . . . . . . . . . . . . . . . . . .
1.95 . . . . . . . . . . . . . . . . . . . . . . . .
1.50 -
3.90 . . . . . . . . . . . . . . . . . . . . . . . .
2.32 -
5.89 . . . . . . . . . . . . . . . . . . . . . . . .
4.38 -
6.30 -
8.75 . . . . . . . . . . . . . . . . . . . . . . . .
10.00 - 17.94 . . . . . . . . . . . . . . . . . . . . . . . .
20.00 - 31.15 . . . . . . . . . . . . . . . . . . . . . . . .
Options Outstanding
Options Exercisable
Weighted
Average
Remaining
Contractual
Life (in years)
Weighted
Average
Exercise Price
per Share
8.64
8.03
8.50
6.83
6.19
6.57
3.49
8.02
$ 0.92
1.52
2.91
5.01
7.00
13.69
28.53
$ 4.01
Number of
Shares
508,841
1,225,802
1,103,022
379,058
25,425
860,999
83,290
4,186,437
Weighted
Average
Exercise Price
per Share
$ 0.90
1.53
3.49
5.06
7.11
13.71
28.72
$ 5.37
Number of
Shares
1,255,823
1,866,742
4,169,023
646,871
32,800
1,059,927
86,063
9,117,249
(b) EMPLOYEE STOCK PURCHASE PLAN
In March 2000, the Board of Directors adopted and, in June 2000, the stockholders approved, the 2000
Employee Stock Purchase Plan (the ESPP Plan). The Company has reserved 1,000,000 of its shares of
common stock for issuance under the ESPP Plan. Eligible employees may purchase shares at 85% of
the lower closing market price at the beginning or ending date of the ESPP Plan period, as defined.
During the years ended December 31, 2003, 2002 and 2001, 50,717, 41,264, and 53,888 shares,
respectively, were issued under the ESPP Plan. As of December 31, 2003, 837,000 shares are available
for future purchase under the ESPP Plan.
(c) STOCK-BASED COMPENSATION
The Company accounts for its stock-based awards using the intrinsic value method in accordance with
APB Opinion No. 25 and its related interpretations. Accordingly, no compensation expense has been
recognized in the consolidated financial statements at the date of grant for employee stock option
arrangements for which the exercise price is equal to the fair market value of the underlying shares at
that date.
In June 2002, the Company issued from the 2000 Plan 352,752 shares of restricted common stock to its
Board of Directors. These shares were awarded in lieu of cash compensation for director and
committee services for the period beginning October 2001 through June 12, 2003. In addition, the
Company issued 43,478 shares of restricted common stock to an executive officer in exchange for a
$50,000 reduction in cash compensation for the period of June 13, 2002 through June 12, 2003. All of
the restricted shares were fully vested on October 21, 2002. Each Director and the executive officer
paid consideration equal to the par value for each share awarded ($0.01). The total value of the
restricted stock, less the cash consideration paid, was $431,000.
In connection with stock options granted to employees and non-employees during the year ended
December 31, 2000, the Company recorded deferred compensation of approximately $17,330,000,
which represents the aggregate difference between the option exercise price and the fair market value
of the common stock on the grant date. The deferred compensation is being recognized as an expense
on a straight-line basis over the vesting period, generally four years, of the underlying stock options for
78
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
options granted to employees and as earned for non-employees in accordance with EITF 96-18. The
options granted to non-employees were valued based upon the fair value of the options granted. The
Company recorded compensation expense related to these options for the years ended December 31,
2003, 2002 and 2001, per the following table:
Employees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Non-employees . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total
For the Year ended December 31,
2003
$1,076,000
24,000
$1,100,000
2002
$1,914,000
(21,000)
$1,893,000
2001
$3,934,000
30,000
$3,964,000
During the years ended December 31, 2003 and 2002, the Company reversed $152,000 and $5,794,000,
respectively, of unamortized deferred compensation related to options which were forfeited by
terminated employees. The deferred compensation balance at December 31, 2003, relating to stock
options held by existing employees was $651,000.
As a result of the merger in July 2000, the Company recorded $19,146,000 of deferred compensation as
a component of stockholders’ equity related to the value of unvested stock options held by employees
and consultants primarily of Ontogeny, which were exchanged for options to acquire the Company’s
common stock. The Company amortized this amount over the one-year vesting period of the stock
options ending on August 1, 2001. During the year ended December 31, 2001, compensation expense
related to these options totaled $6,257,000. During the year ended December 31, 2001, the Company
also reversed approximately $421,000 of unamortized deferred compensation related to options which
were forfeited by terminated employees.
(16)
INCOME TAXES
Deferred tax assets and deferred tax liabilities are recognized based on temporary differences between
the financial reporting and tax basis of assets and liabilities using future expected enacted rates. A
valuation allowance is recorded against deferred tax assets if it is more likely than not that some or all
of the deferred tax assets will not be realized.
The provision for income taxes for continuing operations was at rates different from the U.S. federal
statutory income tax rate for the following reasons:
Statutory federal income tax rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
State income taxes, net of federal benefit . . . . . . . . . . . . . . . . . . . . . . . . .
Equity in loss from foreign joint venture . . . . . . . . . . . . . . . . . . . . . . . . .
Impairment of non-deductible goodwill . . . . . . . . . . . . . . . . . . . . . . . . . .
Research and development tax credits . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Valuation allowance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Effective income tax rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
For the Year Ended December 31,
2003
34.0%
8.2%
—%
—%
4.3%
(4.5%)
(1.2%)
(40.8%)
—%
2002
34.0%
1.2%
(1.8%)
(26.5%)
0.8%
(—%)
(1.1%)
(6.6%)
—%
79
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
The principle components of the Company’s deferred tax assets and liabilities at December 31, 2003
and 2002, respectively are as follows:
December 31, 2003 December 31, 2002
Deferred Tax Assets:
Net operating loss carryforwards . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Research and development tax credit carryforwards . . . . . . . . . . . . . .
Depreciation and amortization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Capitalized research and development expenditures . . . . . . . . . . . . . .
Deferred revenue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Impairment of investments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued expenses and other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 63,720,000
7,574,000
1,335,000
19,893,000
3,354,000
473,000
1,826,000
$ 61,094,000
7,109,000
815,000
17,952,000
4,894,000
—
1,111,000
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total Gross Deferred Tax Asset
Valuation Allowance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
98,175,000
(98,175,000)
92,975,000
(92,975,000)
Net Deferred Tax Asset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
—
$
—
As of December 31, 2003, the Company had federal net operating loss and research and
experimentation credit carryforwards of approximately $182,143,000 and $6,474,000, respectively,
which may be available to offset future federal income tax liabilities which expire at various dates
starting in 2004 and going through 2023. The Company has recorded a deferred tax asset of
approximately $98,175,000. The future realization, if any amount, of deferred tax asset attributable to
disqualifying dispositions of incentive stock options and the exercise of nonqualified stock options will
not be recognized as a tax benefit in the statement of operations, but rather as a component of
stockholder’s equity. As required by Statement of Financial Accounting Standards No. 109,
management of the Company has evaluated the positive and negative evidence bearing upon the
realizability of its deferred tax assets, which are comprised principally of net operating loss and
research and experimentation credit carryforwards. Management has determined that it is more likely
than not that the Company will not recognize the benefits of federal and state deferred tax assets and, as
a result, a valuation allowance of approximately $98,175,000 has been established at December 31,
2003.
Ownership changes, as defined in the Internal Revenue Code, may have limited the amount of net
operating loss carryforwards that can be utilized annually to offset future taxable income. Subsequent
ownership changes could further affect the limitation in future years.
(17) RETIREMENT SAVINGS PLAN
The Company has a 401(k) retirement savings plan covering substantially all of the Company’s
employees. Matching Company contributions are at the discretion of the Compensation Committee of
the Board of Directors. For the year ended December 31, 2003, the Compensation Committee
authorized matching contributions up to 6% of participants’ salaries for a total of $184,000. The
Compensation Committee authorized matching contributions of $213,000 for the year ended December
31, 2001. The Compensation Committee did not authorize matching contributions for 2002.
80
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
(18) SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED)
The following are selected quarterly financial data for the years ended December 31, 2003 and 2002:
Revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income (loss) from operations . . . . . . . . . . . . . . . . .
Net income (loss) applicable to common
stockholders . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Basic net income (loss) per share . . . . . . . . . . . . . . .
Diluted net income (loss) per share . . . . . . . . . . . . .
Shares used in computing basic net loss per
Quarter Ended
March 31,
2003
June 30,
2003
September 30,
2003
December 31,
2003
$
435,358
(4,295,352)
$
548,942
(5,210,056)
$ 9,308,838
4,525,326
$
755,095
(4,931,923)
(4,470,029)
(5,038,873)
$
$
(0.14) $
(0.14) $
(0.15) $
(0.15) $
4,549,916
0.12
0.11
(6,935,572)
(0.17)
(0.17)
$
$
share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
31,731,009
33,501,511
38,282,799
40,426,650
Shares used in computing diluted net loss per
share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
31,731,009
33,501,511
42,031,957
40,426,650
Revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income (loss) from operations . . . . . . . . . . . . . . . . .
Net income (loss) applicable to common
stockholders . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Basic net income (loss) per share . . . . . . . . . . . . . . .
Diluted net income (loss) per share . . . . . . . . . . . . .
Shares used in computing basic net loss per
Quarter Ended
March 31,
2002
June 30,
2002
September 30,
2002
December 31,
2002
$
158,632
(17,315,950)
$
189,603
(70,443,999)
$
222,351
(4,737,026)
$17,819,952
13,110,553
(18,002,269)
(71,173,411)
(5,932,911)
$
$
(0.56) $
(0.56) $
(2.20) $
(2.20) $
12,070,253
0.38
0.35
(0.18) $
(0.18) $
share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
32,329,228
32,334,965
32,578,225
31,843,548
Shares used in computing diluted net loss per
share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
32,329,228
32,334,965
32,578,225
35,528,208
The net loss amounts presented above for the quarter ending December 31, 2003 included the
following expenses:
•
Issuance of common stock under amendment to technology license agreement: The Company
recorded $1,007,000 in non-cash expense associated with the issuance of an aggregate of 200,000
shares of common stock pursuant to the terms of these amended license agreements. The fair
value of the common stock issued was charged to research and development expense because the
technology covered under the amended license agreements is currently in preclinical development
and is not currently commercializable.
• Write-off of Note Receivable from former collaboration partner: During the fourth quarter of the
year ended December 31, 2003, the Company recorded an impairment charge of $1,708,000 for
the write-off of a euro-denominated note receivable from Micromet AG, a former collaborator of
the Company. The Company determined that this charge was necessary due to Micromet’s
announcement that it was terminating one-third of its workforce as the result of a contract dispute
with a co-development partner. Micromet stated that this dispute would result in a significant
decrease in previously budgeted cash inflows in 2004.
81
CURIS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements—Continued
(19) SUBSEQUENT EVENTS
(a) COLLABORATION WITH WYETH PHARMACEUTICALS
On January 12, 2004, the Company licensed its Hedgehog proteins and novel small molecule
Hedgehog pathway agonists to Wyeth for therapeutic applications in the treatment of neurological and
other disorders. Under the terms of the agreement, Wyeth paid the Company $3,000,000, of which of
$1,500,000 was applied to the purchase of 315,524 shares of the Company’s common stock. Wyeth is
also obligated to provide financial support of the Company’s research under the collaboration for a
minimum of two years as well as to make additional cash payments if the licensed programs
successfully achieve clinical development and drug approval milestones. Wyeth is also obligated to pay
the Company a royalty on net product sales, if any, that escalates with increasing sales volume. As part
of the agreement, the Company has retained development and licensing options for certain therapeutic
applications of the Hedgehog agonist technologies, including those applications that qualify as orphan
drug indications, topical applications for hair growth, local delivery applications for treatment of
cardiovascular disease and use of the technology with stem cells. Wyeth has a right of first negotiation
to obtain an exclusive license to the orphan drug indications and the cardiovascular applications.
(b) BOSTON PRIVATE BANK & TRUST COMPANY DEBT FINANCING
Effective January 20, 2004, the Company entered into a loan agreement with the Boston Private Bank
& Trust Company to finance up to $1,250,000 in purchases of equipment and facility leasehold
improvements from December 1, 2003, until January 20, 2005. Under the terms of the loan agreement,
the Company will request periodic financings for qualifying purchases of equipment and leaseholds
through January 20, 2005. Until January 20, 2005, the Company will pay interest on any borrowings on
a monthly basis in arrears. On January 20, 2005, the Company will convert the then outstanding
balance into a 36-month term note that bears interest at either a variable rate (currently 5.00%) or a
fixed rate (currently 6.04%) for the repayment period. The note will be secured by any equipment and
leaseholds financed. The Company has not drawn any amounts under the loan agreement.
82
REPORT OF INDEPENDENT PUBLIC AUDITORS
To the Board of Directors and Stockholders of
Curis Newco, Ltd.:
In our opinion, the accompanying balance sheet as of December 31, 2002 and the related statements of
operations and comprehensive loss, of stockholders’ equity and of cash flows present fairly, in all material
respects, the financial position of Curis Newco, Ltd. (a development stage enterprise) at December 31, 2002, and
the results of operations and cash flows for the year then ended, in conformity with accounting principles
generally accepted in the United States of America. We did not audit the cumulative totals of the Company for
the period from July 16, 2001 (date of inception) to December 31, 2001, which totals reflect a deficit of
$16,795,490 accumulated during the development stage. These cumulative totals were audited by other
independent accountants who have ceased operations and whose report dated January 25, 2002 expressed an
unqualified opinion on the cumulative amounts. These financial statements are the responsibility of the
Company’s management; our responsibility is to express an opinion on these financial statements based on our
audit. We conducted our audit of these statements in accordance with auditing standards generally accepted in
the United States of America which require that we plan and perform the audit to obtain reasonable assurance
about whether the financial statements are free of material misstatement. An audit includes examining, on a test
basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting
principles used and significant estimates made by management, and evaluating the overall financial statement
presentation. We believe that our audit provides a reasonable basis for our opinion. The financial statements of
Curis Newco, Ltd. for the year ended December 31, 2001 were audited by other independent accountants who
have ceased operations. Those independent accountants expressed an unqualified opinion on those financial
statements in their report dated January 25, 2002.
/s/ PRICEWATERHOUSECOOPERS LLP
Boston, Massachusetts
February 4, 2003
83
REPORT OF INDEPENDENT PUBLIC ACCOUNTANTS
To the Stockholders and Board of Directors of
Curis Newco, Ltd.:
We have audited the accompanying balance sheet of Curis Newco, Ltd. (a Bermuda corporation in the
development stage) as of December 31, 2001, and the related statements of operations, stockholders’ deficit and
cash flows for the period from inception (July 16, 2001) to December 31, 2001. These financial statements are
the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial
statements based on our audit.
We conducted our audit in accordance with auditing standards generally accepted in the United States.
Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the
financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audit provides a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material respects, the financial
position of Curis Newco, Ltd. as of December 31, 2001 and the results of its operations and its cash flows for the
period from inception (July 16, 2001) to December 31, 2001, in conformity with accounting principles generally
accepted in the United States.
ARTHUR ANDERSEN LLP
Hamilton, Bermuda
January 25, 2002
NOTE: THIS IS A COPY OF THE AUDIT REPORT PREVIOUSLY ISSUED BY ARTHUR ANDERSEN LLP
IN CONNECTION WITH CURIS, INC.’S FORM 10-K FILING FOR THE FISCAL YEAR ENDED
DECEMBER 31, 2001. THE INCLUSION OF THIS PREVIOUSLY ISSUED ARTHUR ANDERSEN LLP
REPORT IS PURSUANT TO THE “TEMPORARY FINAL RULE AND FINAL RULE REQUIREMENTS
FOR ARTHUR ANDERSEN LLP AUDITING CLIENTS,” ISSUED BY THE SECURITIES AND
EXCHANGE COMMISSION IN MARCH 2002. THIS AUDIT REPORT HAS NOT BEEN REISSUED BY
ARTHUR ANDERSEN LLP IN CONNECTION WITH THIS FILING ON FORM 10-K.
84
CURIS NEWCO, LTD.
(A DEVELOPMENT STAGE COMPANY)
BALANCE SHEET
December 31,
2003
December 31,
2002
(Unaudited)
(Audited)
Current Assets:
ASSETS
Cash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
$
140
140
$
$
1,143
1,143
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Due to Curis (Note 5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Due to Elan (Note 5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total current liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
—
—
—
1,299,289
61,067
1,360,356
Stockholders’ Deficit:
Non-redeemable convertible preferred stock, $1.00 par value—
Authorized, issued and outstanding—6,000 shares as of December 31, 2003
and 2002 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6,000
6,000
Common stock, $1.00 par value—
Authorized, issued and outstanding—6,000 shares as of December 31, 2003
and 2002 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6,000
6,000
Additional paid-in capital
Capital in excess of par value of stock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Additional capital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Due from stockholders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deficit accumulated during the development stage . . . . . . . . . . . . . . . . . . . . . . . . .
—
22,178,006
—
(22,189,866)
Total stockholders’ equity (deficit)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
140
140
$
14,988,000
7,177,843
(1,359,653)
(22,177,403)
(1,359,213)
$
1,143
The accompanying notes are an integral part of these financial statements.
85
CURIS NEWCO, LTD.
(A DEVELOPMENT STAGE COMPANY)
STATEMENT OF OPERATIONS
For the Year
Ended
December 31,
2003
For the Year
Ended
December 31,
2002
For the Period
from Inception
(July 16, 2001)
through
December 31,
2001
For the Period
Beginning
July 16, 2001
through
December 31,
2003
(Unaudited)
(Audited)
(Audited)
(Unaudited)
Costs and Expenses:
Research and development
. . . . . . . . . . . . . . . . . .
General and administrative . . . . . . . . . . . . . . . . . .
$ — $ 5,360,748 $ 16,782,156 $ 22,142,904
46,962
21,165
12,463
13,334
Net loss applicable to common stockholders . .
$(12,463)
$(5,381,913) $(16,795,490) $(22,189,866)
Basic and Diluted Net Loss per Common Share . . . . . .
$
(2.08)
$
(896.99) $
(2,799.25) $
(3,698.31)
Basic and Diluted Weighted Average Shares
Outstanding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6,000
6,000
6,000
6,000
The accompanying notes are an integral part of these financial statements.
86
CURIS NEWCO, LTD.
(A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF STOCKHOLDERS’ DEFICIT
Non-redeemable
convertible
preferred stock Common Stock
Number
of
Shares
$1.00
Par
Value
Number
of
Shares
$1.00
Par
Value
Additional
Paid-in
Capital
Due from
Stockholders
Deficit
Accumulated
During the
Development
Stage
Total
Stockholder’s
Equity
Incorporation of the Company:
Issuance of non-redeemable convertible
preferred stock . . . . . . . . . . . . . . . . . . . .
Issuance of common stock . . . . . . . . . . . . .
Capital contribution . . . . . . . . . . . . . . . . . .
Due from stockholders . . . . . . . . . . . . . . . .
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . .
6,000
—
—
—
—
$6,000
— $ — $ 7,494,000 $
— 6,000
—
—
—
—
—
—
$6,000
—
—
—
7,494,000
1,805,275
—
—
— $
—
—
(963,916)
—
— $ 7,500,000
7,500,000
—
1,805,275
—
(963,916)
—
(16,795,490)
(16,795,490)
Balance, December 31, 2001 . . . . . . . . . . .
6,000
$6,000
6,000
$6,000 $16,793,275 $ (963,916) $(16,795,490) $ (954,131)
Capital contribution . . . . . . . . . . . . . . . . . .
Capital contributions received in cash . . . .
Total capital contributions . . . . . . . . . . . . .
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . .
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
5,372,568
—
4,976,831
— (5,372,568)
—
—
—
—
—
(5,381,913)
5,372,568
4,976,831
(5,372,568)
(5,381,913)
Balance, December 31, 2002 . . . . . . . . . . .
6,000
$6,000
6,000
$6,000 $22,165,843 $(1,359,653) $(22,177,403) $(1,359,213)
Capital contribution (unaudited) . . . . . . . .
Payments from stockholders
(unaudited) . . . . . . . . . . . . . . . . . . . . . . .
Net loss (unaudited) . . . . . . . . . . . . . . . . . .
—
—
—
—
—
—
—
—
—
—
—
—
12,163
—
—
12,163
—
—
1,359,653
—
—
(12,463)
1,359,653
(12,463)
Balance, December 31, 2003
(unaudited) . . . . . . . . . . . . . . . . . . . . . . .
6,000
$6,000
6,000
$6,000 $22,178,006 $
— $(22,189,866) $
140
The accompanying notes are an integral part of these financial statements.
87
CURIS NEWCO, LTD.
(A DEVELOPMENT STAGE COMPANY)
STATEMENT OF CASH FLOWS
For the Year
Ended
December 31,
2003
For the Year
Ended
December 31,
2002
For the Period
from Inception
(July 16, 2001)
through
December 31,
2001
For the Period
Beginning July 16,
2001 through
December 31,
2003
(Unaudited)
(Audited)
(Audited)
(Unaudited)
$
(12,463) $(5,381,913) $(16,795,490)
$(22,189,866)
—
—
15,000,000
15,000,000
Cash Flows from Operating Activities:
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Adjustments to reconcile net loss to net cash
used in operating activities—
Write-off of acquired technology . . . . .
Non-cash increase in capital
contributions . . . . . . . . . . . . . . . . . . .
(1,360,356)
400,595
963,916
4,155
Changes in operating assets and liabilities—
Due from stockholders . . . . . . . . . . . . . .
Due to Curis . . . . . . . . . . . . . . . . . . . . . .
Due to Elan . . . . . . . . . . . . . . . . . . . . . .
1,359,653
—
—
(400,595)
341,491
54,949
(963,916)
957,798
6,118
(4,858)
1,299,289
61,067
Net cash used in operating
activities . . . . . . . . . . . . . . . . . . .
(13,166)
(4,985,473)
(831,574)
(5,830,213)
Cash Flows from Financing Activities:
Capital contributions received . . . . . . . .
12,163
4,976,831
841,359
5,830,353
Net cash provided by financing
activities . . . . . . . . . . . . . . . . . . .
12,163
4,976,831
841,359
5,830,353
Net change in cash . . . . . . . . . . . . . . . . . . . . . . . . .
Cash, beginning of period . . . . . . . . . . . . . . . . . . .
(1,003)
1,143
(8,642)
9,785
9785
—
Cash, end of period . . . . . . . . . . . . . . . . . . . . . . . .
$
140
$
1,143
$
9,785
$
140
—
140
Supplemental Disclosure of Noncash Financing
Activities:
Issuance of non-redeemable preferred stock
and common stock for technology license . .
$
— $
— $ 15,000,000
$ 15,000,000
The accompanying notes are an integral part of these financial statements.
88
CURIS NEWCO, LTD.
(A DEVELOPMENT STAGE COMPANY)
NOTE TO FINANCIAL STATEMENTS
All information as of and for the year ended December 31, 2003 is unaudited.
(1) OPERATIONS
Curis Newco, Ltd. (Curis Newco) was incorporated on July 16, 2001, as a Bermuda company. Curis Newco
is a wholly-owned subsidiary of Curis, Inc. (Curis). From July 16, 2001 until May 16, 2003, Curis Newco
was owned by Curis and Elan International Services Ltd. (EIS), holding 80.1% and 19.9% (non-voting
shares) interests, respectively. Curis Newco was committed to the research and development of molecules
that stimulate the hedgehog (Hh) signaling pathway as defined in the Subscription, Joint Development and
Operating Agreement dated July 18, 2001, between EIS and Curis. This pathway has been previously shown
to play a role in the development of the central and peripheral nervous systems.
On May 16, 2003, Curis and affiliates of Elan Corporation, plc entered into a termination agreement
(Termination Agreement) to conclude the joint venture. As a result of the termination, Elan transferred
its 19.9% share of Curis Newco to Curis, such that Curis Newco has become a wholly-owned
subsidiary of Curis and Curis Newco is consolidated into Curis’ consolidated financial statements.
On July 18, 2001, EIS was issued 1,000 shares of Curis’ Series A convertible exchangeable preferred
stock (Series A Preferred Stock) valued at $12,015,000. The Series A Preferred Stock was convertible,
at EIS’s option, into newly issued, fully paid, non-assessable shares of Curis’ common stock or into the
preferred stock originally issued to Curis representing 30.1% of the aggregate outstanding shares of
Curis Newco on a fully diluted basis. Such exchange would have increased EIS’s ownership in Curis
Newco to 50% on a fully diluted basis. Curis used the value of the Series A Preferred Stock to acquire
its 80.1% interest in Curis Newco on a fully diluted basis. Curis Newco used this investment along with
the 19.9% investment from EIS to acquire a license from Neuralab, Ltd., an affiliate of EIS, valued at
$15,000,000, giving Curis Newco rights to use specific Elan drug technologies. Immediately upon
completing this transaction, the cost of the license was expensed as a research and development cost as
the technology acquired had not yet reached technological feasibility and there was no future
alternative use for the technology. The Series A Preferred Stock was cancelled as part of the
Termination Agreement. As partial consideration for the rights and benefits set forth in the Termination
Agreement, including the cancellation of the Series A Preferred Stock, Curis issued 2,878,782 shares of
its common stock to Elan, having a fair value of $8,377,000 based on the May 16, 2003 closing price of
the common stock on the Nasdaq National Market.
Within the period commencing on July 18, 2001 and ending upon termination on May 16, 2003, Curis
and EIS had agreed to provide Curis Newco up to an aggregate amount of $10,000,000 (Development
Funding). Such Development Funding was to be provided by Curis and EIS on a pro rata basis based
on their respective ownership interests (see Note 4). In order to ensure Curis had funds available for its
share of the Development Funding, Curis entered into an $8,010,000 convertible promissory note
agreement (the Note Agreement) with Elan Pharma International Ltd. (EPIL). The borrowings under
the Note Agreement were subject to Elan’s consent and were restricted for Curis’ funding of its pro rata
share of Curis Newco expenses. As of December 31, 2002, borrowings of $4,860,000, including
capitalized interest of $200,000 were outstanding under the Note Agreement. As part of the
termination, of the $4,900,000 outstanding under the Note Agreement, Curis repaid $1,500,000 in cash
and EPIL forgave $400,000. Curis then entered into an amended and restated convertible note payable
with EPIL for the remaining principal amount of $3,000,000. The terms of the amended and restated
convertible note payable were substantially the same as those under the original note payable except
that the interest rate was reduced from 8% to 6% and the conversion rate was increased to $10.00 from
$8.63. As of December 31, 2003, there was $3,115,000, including $115,000 in accrued interest,
outstanding under the amended and restated convertible note payable.
89
CURIS NEWCO, LTD.
(A DEVELOPMENT STAGE COMPANY)
NOTE TO FINANCIAL STATEMENTS—CONTINUED
Curis Newco incurred minimal expenses during the twelve-month period ended December 31, 2003. In
accordance with the development agreement between Curis and Elan that governed Curis Newco’s
operations prior to the effectiveness of the Termination Agreement, Curis and Elan were required to
agree upon a Curis Newco development plan in order for any research expenses to be incurred by Curis
Newco. Curis and Elan did not reach agreement on a development plan prior to the termination of the
joint venture on May 16, 2003, and, therefore, no research expenses were recorded at Curis Newco in
2003. Curis Newco, however, incurred minimal administrative expenses, including an annual fee to
Bermuda to maintain its legal status. As of the termination date, Curis had recorded a payable to Curis
Newco of $1,089,000, which represented the Company’s 80.1% share of Curis Newco’s loss for the
three-month period ended December 31, 2002 (see Note 5). In addition, the Company had recorded a
receivable from Curis Newco of $1,299,000 that represented charges for services performed by Curis
on behalf of Curis Newco for the three-month period ended December 31, 2002. Both of these amounts
were paid as part of the termination and there are no remaining balances related to these amounts as of
December 31, 2003.
(2) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The accompanying financial statements reflect the application of certain accounting policies described
below and elsewhere in the notes to the financial statements.
(a) FAIR VALUE OF FINANCIAL INSTRUMENTS
The carrying amounts of Curis Newco’s financial instruments, which include cash, amounts due from
stockholders and the amounts due to Curis and EIS approximate their fair value.
(b) CONCENTRATIONS OF SUPPLIERS
Certain materials used in Curis Newco’s development process are procured from a single source. The
failure of a supplier, including a subcontractor, to deliver on schedule could delay or interrupt the
development process and thereby adversely affect Curis Newco’s operating results.
(c) USE OF ESTIMATES
The preparation of financial statements in conformity with generally accepted accounting principles
requires management to make estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and
the reported amounts of expenses during the reporting period. Actual results could differ from those
estimates.
(d) RESEARCH AND DEVELOPMENT EXPENSES
Curis Newco charges research and development expenses to operations as incurred.
(e) NET LOSS PER SHARE
Basic and diluted net loss per common share is calculated by dividing the net loss applicable to
common stockholders by the weighted average number of common shares outstanding during the
period. Diluted net loss per common share is the same as basic net loss per common share, since the
effects of potentially dilutive securities are antidilutive for all periods presented. Antidilutive securities,
which consist of non-redeemable convertible preferred stock, aggregated to 6,000 shares as of
December 31, 2003, 2002 and 2001.
90
CURIS NEWCO, LTD.
(A DEVELOPMENT STAGE COMPANY)
NOTE TO FINANCIAL STATEMENTS—CONTINUED
(f) COMPREHENSIVE LOSS
Comprehensive loss is defined as the change in stockholders’ deficit during a period from transactions
and other events and circumstances from non-owner sources. Curis Newco’s net loss is equal to its
comprehensive loss for the period presented.
(g) ORGANIZATION COSTS
All organization costs have been expensed as incurred.
(h) DISCLOSURES ABOUT SEGMENTS OF AN ENTERPRISE
Operating segments are identified as components of an enterprise about which separate discrete
financial information is available for evaluation by the chief operating decision maker, or decision
making group, in making decisions regarding resource allocation and assessing performance. To date,
Curis Newco has viewed its operations and manages its business as principally one operating segment.
(3)
INCOME TAXES
Under current Bermuda law, Curis Newco is not required to pay any taxes in Bermuda on either
income or capital gains. Curis Newco has received an undertaking from the Minister of Finance in
Bermuda that, in the event of such taxes being imposed, Curis Newco will be exempted from taxation
until the year 2016.
(4) STOCKHOLDERS’ EQUITY (DEFICIT)
(a) AUTHORIZED STOCK
Curis Newco has authorized capital stock of 12,000 shares, of which 6,000 are $1.00 par value
common stock and 6,000 are $1.00 par value non-voting non-redeemable convertible preferred stock.
(b) COMMON STOCK
In July 2001, Curis Newco issued 6,000 shares of common stock at $1,250 per share at a value of
$7,500,000.
(c) NON-REDEEMABLE CONVERTIBLE PREFERRED STOCK
In July 2001, Curis Newco issued 6,000 shares of non-redeemable convertible preferred stock
(Preferred Stock) at $1,250 per share at a value of $7,500,000. As part of the Termination Agreement
entered into between Curis and Elan, the preferred stock, which had a carrying value of $13,336,000,
was cancelled on May 16, 2003. The rights, preferences and privileges of the Preferred Stock were as
follows:
Voting Rights
Preferred stockholders do not have voting rights.
Dividends
Preferred stockholders are entitled to dividends as and when declared by the board of directors.
Preferred stockholders are entitled to participate equally on a pro rata basis in any dividend declared for
the holders of common stock.
91
CURIS NEWCO, LTD.
(A DEVELOPMENT STAGE COMPANY)
NOTE TO FINANCIAL STATEMENTS—CONTINUED
Liquidation Preference
In the event of liquidation, dissolution or winding-up of Curis Newco and before any distribution to
common stockholders and any prior series of preferred stock, the holders of Preferred Stock are entitled
to receive $1,250 per share, respectively, plus all declared but unpaid dividends.
Conversion
Each share of Preferred Stock was convertible, at the option of the holder, into one share of common
stock, subject to adjustments for dilutive issuances of stock at any time after July 18, 2003.
(5) RELATED PARTY TRANSACTIONS
Curis Newco’s research and development and general and administrative costs were paid for directly
by the Curis Newco stockholders. These transactions are incurred in the normal course of operations
and amounts payable to these stockholders are summarized as follows:
The following table summarizes Curis Newco’s related party transactions:
Due to Curis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Due to Elan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(Unaudited)
$—
—
Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$—
(Audited)
$1,299,289
61,067
$1,360,356
December 31,
2003
December 31,
2002
These balances were unsecured and interest free with no set terms of repayment. They are classified as
current liabilities as Curis Newco will reimburse Curis and Elan upon its funding by its stockholders.
Due from stockholders represents the amounts required to be funded into Curis Newco as contributed
capital by its stockholders. As of December 31, 2003 and 2002, Curis and ESI are obligated to
contribute the following to Curis Newco:
Due from Curis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Due from Elan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(Unaudited)
$—
—
Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$—
(Audited)
$1,089,082
270,571
$1,359,653
December 31,
2003
December 31,
2002
As of May 16, 2003, the date of termination of Curis Newco joint venture, Curis had recorded a payable to Curis
Newco of $1,089,000, which represented the Company’s 80.1% share of the Curis Newco’s loss for the three-
month period ended December 31, 2002. In addition, the Company had recorded a receivable from Curis Newco
of $1,299,000 which represented charges for services performed by Curis on behalf of Curis Newco for the three-
month period ended December 31, 2002. Both of these amounts were paid as part of the termination and there are
no remaining balances related to these amounts as of December 31, 2003.
92
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
On April 26, 2002, we dismissed Arthur Andersen LLP as its independent public accountants. The decision
to dismiss Arthur Andersen LLP was approved by our Audit Committee. None of the reports of Arthur Andersen
LLP on our financial statements for either of the two fiscal years prior to Arthur Andersen LLP’s dismissal
contained an adverse opinion or a disclaimer of opinion, or was qualified or modified as to uncertainty, audit
scope or accounting principles. During our two most recently completed fiscal years and any subsequent interim
period preceding the date of the dismissal of Arthur Andersen LLP, we had no disagreements with Arthur
Andersen LLP on any matter of accounting principles or practices, financial statement disclosure or auditing scope
or procedure, which disagreement(s), if not resolved to the satisfaction of Arthur Andersen LLP, would have
caused Arthur Andersen LLP to make reference to the subject matter of the disagreement in connection with its
reports on our financial statements. None of the reportable events listed in Item 304(a)(1)(v) of Regulation S-K
under the Securities Exchange Act of 1934 occurred with respect to either of our two most recently completed
fiscal years or any subsequent interim period preceding the date of the dismissal of Arthur Andersen LLP.
During our two most recent fiscal years and the subsequent interim period prior to engaging
PricewaterhouseCoopers LLP on April 26, 2002, except as indicated below, neither we nor anyone acting on our
behalf consulted with PricewaterhouseCoopers LLP regarding either (i) the application of accounting principles
to a specified transaction, either completed or proposed, or the type of audit opinion that might be rendered on
our financial statements, and neither a written report nor oral advice was provided to us by
PricewaterhouseCoopers LLP that was an important factor considered by us in reaching a decision as to any
accounting, auditing or financial reporting issue; or (ii) any matter that was either the subject of a disagreement,
as that term is defined in Item 304(a)(1)(iv) of Regulation S-K and the related instructions to Item 304 of
Regulation S-K, or a reportable event, as that term is defined in Item 304(a)(1)(v) of Regulation S-K.
PricewaterhouseCoopers LLP served as independent public accountants of Ontogeny, Inc. until July 31, 2000,
the date it was merged, together with Creative Biomolecules, Inc., with and into Curis.
ITEM 9A. DISCLOSURE CONTROLS AND PROCEDURES
(a) Evaluation of disclosure controls and procedures. Our management, with the participation of our
chief executive officer and chief financial officer, evaluated the effectiveness of our disclosure controls
and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of December
31, 2003. Based on this evaluation, our chief executive officer and chief financial officer concluded
that, as of December 31, 2003, our disclosure controls and procedures were (1) designed to ensure that
material information relating to us, including our consolidated subsidiaries, is made known to our chief
executive officer and chief financial officer by others within those entities, particularly during the
period in which this report was being prepared and (2) effective, in that they provide reasonable
assurance that information required to be disclosed by us in the reports that we file or submit under the
Exchange Act is recorded, processed, summarized and reported within the time periods specified in the
SEC’s rules and forms.
(b) Changes in internal controls. No change in our internal control over financial reporting (as defined in
the Securities Exchange Act of 1934, Rules 13a-15(f) and 15d-15(f)) occurred during the fiscal quarter
ended December 31, 2003 that has materially affected, or is reasonably likely to materially affect, our
internal control over financial reporting.
93
PART III
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
Information concerning directors that is required by this Item 10 is set forth in our proxy statement for our
2004 annual meeting of stockholders under the headings “Directors and Nominees for Director,” “Board
Committees” and “Section 16(a) Beneficial Ownership Reporting Compliance,” which information is
incorporated herein by reference. The name, age, and position of each of our executive officers is set forth under
the heading “Executive Officers of the Registrant” in Part I of this Annual Report on Form 10-K, which
information is incorporated herein by reference.
ITEM 11. EXECUTIVE COMPENSATION
Information required by this Item 11 is set forth in our proxy statement for our 2004 annual meeting of
stockholders under the headings “Compensation of Executive Officers,” “Director Compensation,” “Report of
the Compensation Committee on Executive Compensation” and “Comparative Stock Performance” which
information is incorporated herein by reference.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
AND RELATED STOCKHOLDER MATTERS
Information required by this Item 12 is set forth in our proxy statement for our 2004 annual meeting of
stockholders under the headings “Compensation of Executive Officers” and “Security Ownership of Certain
Beneficial Owners and Management,” which information is incorporated herein by reference.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Information required by this Item 13 is set forth in our proxy statement for our 2004 annual meeting of
stockholders under the headings “Director Compensation” and “Compensation of Executive Officers,” which
information is incorporated herein by reference.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
Information required by this Item 14 is set forth in our proxy statement for our 2004 annual meeting of
stockholders under the heading “Independent Auditor’s Fees,” which information is incorporated herein by
reference.
94
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K
PART IV
(a)(1) Financial Statements.
Curis, Inc. and Subsidiaries
Report of Independent Public Auditors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Report of Independent Public Accountants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Balance Sheets as of December 31, 2003 and 2002 . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Statements of Operations and Comprehensive Loss for the Years Ended
December 31, 2003, 2002 and 2001 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2003,
2002 and 2001 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Statements of Cash Flows for the Years Ended December 31, 2003, 2002 and
2001 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Notes to Consolidated Financial Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Curis Newco, Ltd.
Report of Independent Public Auditors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Report of Independent Public Accountants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Balance Sheet as of December 31, 2003 and 2002 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Statement of Operations for the Years Ended December 31, 2003, 2002, for the period from
inception (July 16, 2001) through December 31, 2001 and for the period beginning July 16,
2001 through December 31, 2003 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Statement of Stockholders’ Deficit for the Years Ended December 31, 2003, 2002 and
2001 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Statement of Cash Flows for the Years Ended December 31, 2003, 2002, for the period from
inception (July 16, 2001) through December 31, 2001 and for the period beginning July 16,
2001 through December 31, 2003 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Notes to Financial Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Page
number
in this
report
47
48
49
50
51
53
55
83
84
85
86
87
88
89
(a)(2) Financial Statement Schedules.
All schedules are omitted because they are not applicable or the required information shown in the Financial
Statement or Notes thereto.
(a)(3) List of Exhibits. The list of Exhibits filed as a part of this annual report on Form 10-K is set forth on
the Exhibit Index immediately preceding such Exhibits, and is incorporated herein by this reference.
(b) Reports on Form 8-K.
(b)(1) On December 30, 2003, we filed a Current Report on Form 8-K to report under Item 5 (Other Events)
that we had filed a universal shelf registration statement with the Securities Exchange Commission to sell up to
$40,000,000 of various securities in one or more future offerings.
(b)(2) On November 6, 2003, we furnished a Current Report on Form 8-K to report under Item 12 (Results
of Operations and Financial Condition) that we had issued a press release announcing our financial results for the
third quarter ended September 30, 2003.
95
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
SIGNATURES
CURIS, INC.
By:
/s/ DANIEL R. PASSERI
Daniel R. Passeri
President and Chief Executive Officer
Date: February 27, 2004
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by
the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/ DANIEL R. PASSERI
President, Chief Executive Officer and
February 27, 2004
Daniel R. Passeri
Director (Principal Executive
Officer)
/s/ MICHAEL P. GRAY
Vice President of Finance and Chief
February 27, 2004
Michael P. Gray
Financial Officer (Principal
Financial and Accounting Officer)
/s/
JAMES R. MCNAB, JR.
James R. McNab, Jr.
/s/ SUSAN B. BAYH
Susan B. Bayh
/s/
JOSEPH M. DAVIE
Joseph M. Davie
Chairman of the Board of Directors
February 27, 2004
Director
Director
February 27, 2004
February 27, 2004
/s/ MARTYN D. GREENACRE
Director
February 27, 2004
Martyn D. Greenacre
/s/ KENNETH I. KAITIN
Director
February 27, 2004
Kenneth I. Kaitin
/s/ DOUGLAS A. MELTON
Director
February 27, 2004
Douglas A. Melton
/s/
JAMES R. TOBIN
James R. Tobin
Director
February 27, 2004
96
Exhibit
No.
Description
Articles of Incorporation and By-laws
EXHIBIT INDEX
Incorporated by Reference
Form
SEC Filing
Date
Exhibit
Number
Filed with
this 10-K
3.1 Restated Certificate of Incorporation of Curis, Inc.
S-4/A (333-32446) 06/19/00
3.2 Certificate of Designations of Curis, Inc.
3.3 Amended and Restated By-laws of Curis, Inc.
S-3 (333-50906)
08/10/01
S-1 (333-50906)
11/29/00
3.3
3.2
3.2
Instruments defining the rights of security holders, including indentures
4.1 Form of Curis Common Stock Certificate
Material contracts—Management Contracts and Compensatory Plans
#10.1 Employment Agreement, effective as of September 20, 2001,
10-Q
11/14/01
10.3
between Curis and Daniel R. Passeri
#10.2 Employment Agreement, effective as of August 1, 2002,
10-Q
11/12/02
10.4
between Curis and Christopher U. Missling
#10.3 Amendment to the Employment Agreement, effective as of
January 1, 2004, between Curis and Christopher U. Missling
#10.4 Employment Agreement, effective as of November 27, 2003,
between Curis and Michael P. Gray
#10.5 Employment Agreement, effective as of September 1, 2002,
between Curis and Mary Elizabeth Potthoff
#10.6 Board of Director and Scientific Advisory Board Services
Agreement, effective as of August 11, 2000, between Curis and
Douglas A. Melton
#10.7 Curis 2000 Stock Incentive Plan
#10.8 Curis 2000 Director Stock Option Plan
S-4/A (333-32446) 05/31/00
10.71
S-4/A (333-32446) 05/31/00
10.72
#10.9 Curis 2000 Employee Stock Purchase Plan
S-4/A (333-32446) 05/31/00
10.73
Material contracts—Leases
10.10 Lease, dated November 16, 1995, as amended, between
S-4 (333-32446)
03/14/00
10.42
Ontogeny, Inc., Moulton Realty Corporation and the trustees of
Moulton Realty Trust relating to the premises at 33 and 45
Moulton Street, Cambridge, Massachusetts
10.11 Lease, dated March 15, 2001, between Curis and Moulton
10-K
03/30/01
10.3
Realty Company relating to the premises at 61 Moulton Street,
Cambridge, Massachusetts
10.12 Amendment to Lease, dated August 9, 2002, between Curis and
10-Q
11/12/02
10.1
FPRP Moulton LLC relating to the premises at 25, 27, 33, 45
and 61 Moulton Street, Cambridge, Massachusetts
Material contracts—Financing Agreements
10.13 Line of Credit Agreement for the Acquisition of Equipment and
Leasehold Improvements, dated January 20, 2004, between
Curis and Boston Private Bank & Trust Company
10.14 Security Agreement (Specific Equipment), dated January 20,
2004, between Curis and Boston Private Bank & Trust Company
10.15 Secured Non-Revolving Time Note, dated January 20, 2004,
made by Curis in favor of Boston Private Bank & Trust
Company
1
X
X
X
X
X
X
X
X
Exhibit
No.
Description
Incorporated by Reference
Form
SEC Filing
Date
Exhibit
Number
Filed with
this 10-K
Material contracts—License and Collaboration Agreements
††10.16 Master Restructuring Agreement, dated as of October 15, 1998,
10-K
03/30/99
10.10
between Creative and Stryker Corporation
10.17 Second Amendment to Master Restructuring Agreement, dated
October 1, 2002, between Curis and Stryker Corporation
10-Q
11/12/02
10.5
10.18 Irrevocable License Agreement, dated November 20, 1998,
10-K
03/13/00
10.7
between Creative and Stryker Corporation
10.19 Stryker Irrevocable License Agreement, dated November 20,
10-K
03/13/00
10.8
1998, between Creative and Stryker Corporation
††10.20 Cross-License Agreement, dated as of July 15, 1996, by and
among Creative, Genetics Institute, Inc. and Stryker
Corporation
10-Q
11/06/96
10.1
††10.21 License Agreement, dated as of February 12, 1996, between
S-4/A (333-32446) 06/02/00
10.43
S-4/A (333-32446) 04/03/00
10.45
Curis and Leland Stanford Junior University
††10.22 License Agreement, dated as of January 1, 1995 as amended on
July 19, 1995 and August 30, 1996, between Ontogeny and The
Trustees of Columbia University in the City of New York
†10.23 Amended and Restated License Agreement, dated June 1, 2003,
between Curis, The Johns Hopkins University and University of
Washington School of Medicine
†10.24 Amended and Restated License Agreement (2000), dated
June 10, 2003, between Curis and the President and Fellows of
Harvard University
†10.25 Amended and Restated License Agreement (1995), dated
June 10, 2003, between Curis and the President and Fellows of
Harvard University
†10.26 Agreement, dated as of November 27, 2002, by and between
8-K
12/09/02
10.1
Curis and Ortho Biotech Products, L.P.
†10.27 License Agreement, dated December 4, 2002, between Curis
and Amylin Pharmaceuticals
†10.28 Collaborative Research, Development and License Agreement,
dated June 11, 2003, between Curis and Genentech, Inc.
†10.29 Collaboration, Research and License Agreement, dated January
12, 2004, between Curis and Wyeth
Material contracts—Miscellaneous
8-K
07/10/03
10.1
†10.30 Termination Agreement and Amendments to Finance
8-K
06/03/03
10.1
Documents, dated May 16, 2003, between Elan Corporation,
PLC, Neuralab Limited, Elan International Services, LTD, Elan
Pharma International Limited, Curis, Inc. and Curis Newco,
LTD
10.31 Registration Rights Agreement, dated as of July 18, 2001,
10-Q
08/14/01
4.1
among Elan International Services, LTD, Elan Pharma
International Limited and Curis, Inc.
10.32 Registration Rights Agreement, dated June 13, 2003, between
8-K
07/10/03
10.3
the Curis and Genentech, Inc.
2
X
X
X
X
X
Exhibit
No.
Description
Incorporated by Reference
Form
SEC Filing
Date
Exhibit
Number
Filed with
this 10-K
10.33 Common Stock Purchase Agreement, dated June 11, 2003, between the Curis
8-K 07/10/03
10.2
and Genentech
10.34 Common Stock Purchase and Registration Rights Agreement, dated January
9, 2004, between Curis and Wyeth
10.35 Form of Common Stock and Warrant Purchase Agreement, dated August 11,
2003, entered into by Curis and certain investors, together with a schedule of
such investors and the material details of each such agreement
10.36 Convertible Note, dated September 11, 2001, made by Micromet AG in favor
10-Q 11/12/03
10.1
of Curis
Code of Conduct
14 Code of Business Conduct and Ethics
Additional Exhibits
21 Subsidiaries of Curis
23.1 Consent of PricewaterhouseCoopers LLP
23.2 Notice Regarding Consent of Arthur Andersen LLP
31.1 Certification of the Chief Executive Officer pursuant to Rule 13a-14(a) of the
Exchange Act
31.2 Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) of the
Exchange Act
32.1 Certification of the Chief Executive Officer pursuant to Rule 13a-14(b) of the
Exchange Act and 18 U.S.C. Section 1350
32.2 Certification of the Chief Financial Officer pursuant to Rule 13a-14(b) of the
Exchange Act and 18 U.S.C. Section 1350
Indicates management contract or compensatory plan or arrangement.
Confidential treatment has been requested as to certain portions of this exhibit.
#
†
†† Confidential treatment has been granted as to certain portions of this exhibit.
X
X
X
X
X
X
X
X
Furnished
Furnished
3
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