Exhibit 99.1
ARIAD Reports Third Quarter 2007
Results
Key Milestones Achieved Year-to-Date
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 7, 2007--ARIAD
Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced financial results
for the quarter and nine months ended September 30, 2007 and provided
an update on corporate developments.
"The past few months have been marked by major milestones in
ARIAD's evolution, led by the announcement of our collaboration with
Merck & Co., Inc. on our most advanced oncology product, deforolimus,
and the launch of our Phase 3 pivotal trial under a Special Protocol
Assessment for oral deforolimus in metastatic sarcomas," said Harvey
J. Berger, M.D., chairman and chief executive officer of ARIAD. "The
highly favorable financial terms and innovative structure of the Merck
collaboration provide the foundation for becoming a fully integrated
oncology company. To this end, we are also advancing our second
development candidate, AP24534, to clinical trials. This
multi-targeted kinase inhibitor has a unique profile and has
demonstrated compelling preclinical results in models of chronic
myeloid leukemia. We expect to file an Investigational New Drug
application for AP24534 and to present new data at the American
Society of Hematology meeting, both by year end 2007."
Financial Highlights
For the quarter ended September 30, 2007, the Company reported a
net loss of $10.9 million, or $0.16 per share, as compared to a net
loss of $15.2 million, or $0.25 per share, for the quarter ended
September 30, 2006. For the nine months ended September 30, 2007, the
Company reported a net loss of $42.8 million, or $0.63 per share, as
compared to a net loss of $47.6 million, or $0.77 per share, for the
nine months ended September 30, 2006. These results reflect the
initial positive impact of the Company's collaboration with Merck &
Co., Inc., announced in July 2007, for the development and
commercialization of deforolimus, resulting in higher license and
collaboration revenue based on upfront and milestone payments and
lower research and development expenses due to the cost sharing
provisions of the collaboration agreement.
For the nine months ended September 30, 2007, cash provided by
operations was $33.9 million, as compared to cash used in operations
of $42.2 million for the nine months ended September 30, 2006. Cash
provided by operations for the nine months ended September 30, 2007
includes the $75 million up-front payment received from Merck pursuant
to the terms of the collaboration agreement. The Company ended the
third quarter of 2007 with $86.1 million in cash, cash equivalents and
marketable securities, compared with $39.8 million at the end of 2006.
In connection with the recently announced initiation of the Phase
3 clinical trial of deforolimus in patients with metastatic sarcomas,
the Company will receive a $13.5 million payment from Merck in the
fourth quarter of 2007. Based on the Company's current operating
projections and the favorable impact of the Merck collaboration, the
Company has raised its guidance for cash, cash equivalents and
marketable securities at December 31, 2007 from a range of $72 million
to $76 million to approximately $80 million.
Corporate and Development Highlights
Recent developments at ARIAD highlight the progress being made in
the Company's lead programs:
Novel mTOR Inhibitor - Deforolimus in Oncology
-- Initiation of Phase 3 SUCCEED Trial: ARIAD initiated the
SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the
Efficacy of Deforolimus) trial under a Special Protocol
Assessment with the Food and Drug Administration. The SUCCEED
trial is a randomized, double-blind, placebo-controlled Phase
3 study of oral deforolimus in approximately 650 patients with
metastatic sarcomas who have achieved a favorable response to
chemotherapy. This pivotal trial will assess progression-free
survival as the primary endpoint and overall survival as a
secondary endpoint.
-- Global Collaboration with Merck & Co. to Jointly Develop and
Commercialize Deforolimus: The companies are planning a
broad-based global development program in which clinical
trials and biomarker studies will be conducted concurrently in
multiple cancer indications. The companies share overall
responsibility for global commercialization and development -
key components of ARIAD's strategy to build a sustainable
oncology business. The agreement calls for up to $727 million
in upfront and milestone payments to ARIAD and at least $200
million in estimated contributions by Merck to global
development. Of note, ARIAD will distribute and sell
deforolimus for all cancer indications and book all sales in
the U.S. ARIAD's potential commercial return will be based on
50/50 profit sharing in the U.S. and royalties paid by Merck
on sales of deforolimus outside the U.S.
Novel mTOR Inhibitor - Deforolimus in Drug-Eluting Stents
-- New Deforolimus-Eluting Stent Study from Medinol Ltd.
Collaboration Presented at TCT 2007 Annual Meeting: A team of
scientists from Medinol, Exogenesis Corp. and ARIAD have
collaborated to develop a carrier-free (non-polymer based)
deforolimus-eluting stent, and initial in-vitro data on this
stent system were presented, for the first time, at the
Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting
in Washington, D.C., October 20 - 25, 2007. These studies
demonstrated the feasibility of delivering deforolimus with
controlled kinetics from a Medinol stent using the Exogenesis
"gas cluster ion beam" technology for surface modification of
implantable medical devices. Eliminating the drug carrier
entirely may lead to a decreased incidence of late adverse
events after implantation of drug-eluting stents.
-- Collaboration with ICON Medical Corp. to Develop
Deforolimus-Eluting Stents: ARIAD entered into a non-exclusive
license agreement with ICON Medical Corp., under which ICON
may develop and commercialize drug-eluting stents that deliver
deforolimus to prevent restenosis of injured vessels following
interventions in which stents are used in conjunction with
balloon angioplasty. As part of the agreement, ARIAD received
an equity stake in ICON and is eligible to receive up to $27
million in payments based on achievement of certain clinical,
regulatory and commercial milestones for two products and
royalties on worldwide sales of all ICON medical devices
delivering deforolimus. This agreement highlights how ARIAD
has leveraged its core assets by exploiting commercial
opportunities outside of oncology.
Novel Bcr-Abl Inhibitor for Drug-Resistant CML - AP24534
-- Design of Small-Molecule Drugs to Treat Drug Resistant
Leukemia Published: The September issue of Chemical Biology
and Drug Design highlighted the high-resolution structure of
the protein responsible for one of the major clinically
relevant genetic variants of drug-resistant chronic myeloid
leukemia (CML). These findings by a team of ARIAD scientists
were used to guide the design of ARIAD's oral multi-targeted
kinase inhibitor, AP24534, for use in CML and other cancers.
This study showed in detail how inhibitors of the Bcr-Abl
protein, such as AP24534, are able to overcome the structural
changes induced by the T315I mutation - which currently
accounts for 15 to 20 percent of all drug resistance in CML -
and bind to the mutated form of the protein.
Upcoming Scientific and Medical Meetings
ARIAD has presentations at the following scientific and medical
meeting:
-- American Society Hematology 49th Annual Meeting, Atlanta,
Georgia, December 8 to 11, 2007.
Upcoming Investor Meetings
ARIAD management will make corporate presentations at the upcoming
investor conferences:
-- Lazard Capital Markets 4th Annual Healthcare Conference, New
York, New York, November 27 to 28, 2007.
-- JPMorgan 26th Annual Healthcare Conference, San Francisco,
California, January 7 to 10, 2008.
Today's Conference Call Reminder
ARIAD will hold a live webcast of its quarterly conference call
today at 8:30 a.m. (EDT). The live webcast can be accessed by visiting
the investor relations section of the Company's website at
http://www.ariad.com/investor. The call can be accessed by dialing
1-800-591-6923 (domestic) or 617-614-4907 (international) five minutes
prior to the start time and providing the passcode 30619185. A replay
of the call will be available on the ARIAD website approximately two
hours after completion of the call and will be archived for two weeks.
About ARIAD
ARIAD is engaged in the discovery and development of breakthrough
medicines to treat cancer by regulating cell signaling with small
molecules. ARIAD is developing a comprehensive approach to patients
with cancer that addresses the greatest medical need - aggressive and
advanced-stage cancers for which current treatments are inadequate.
ARIAD has a global partnership with Merck & Co., Inc. to develop and
commercialize deforolimus, ARIAD's lead cancer product candidate.
Medinol Ltd. and ICON Medical Corp. are also developing
deforolimus-eluting stents to prevent restenosis of injured vessels
following interventions in which stents are used in conjunction with
balloon angioplasty. ARIAD has an exclusive license to pioneering
technology and patents related to certain NF-(kappa)B treatment
methods, and the discovery and development of drugs to regulate
NF-(kappa)B cell-signaling activity, which may be useful in treating
certain diseases. Additional information about ARIAD can be found on
the web at http://www.ariad.com.
This press release contains "forward-looking statements,"
including statements related to future development plans and
regulatory filings for our product candidates, commercialization plans
for deforolimus, and the amount and timing of milestone payments from
partners. Forward-looking statements are based on management's
expectations and are subject to certain factors, risks and
uncertainties that may cause actual results, outcome of events, timing
and performance to differ materially from those expressed or implied
by such statements. These risks and uncertainties include, but are not
limited to, the costs associated with our research, development,
manufacturing and other activities, the conduct and results of
pre-clinical and clinical studies of our product candidates,
difficulties or delays in obtaining regulatory approvals to market
products resulting from our development efforts, our reliance on our
strategic partners and licensees and other key parties for the
successful development, manufacturing and commercialization of
products, the adequacy of our capital resources and the availability
of additional funding, patent protection and third-party intellectual
property claims relating to our and any partner's product candidates,
the timing, scope, cost and outcome of legal and patent office
proceedings concerning our NF-(kappa)B patent portfolio, the potential
acquisition of or other strategic transaction regarding the minority
stockholders' interests in our 80%-owned subsidiary, ARIAD Gene
Therapeutics, Inc., future capital needs, key employees, markets,
economic conditions, prices, reimbursement rates, competition and
other factors detailed in the Company's public filings with the U.S.
Securities and Exchange Commission. The information contained in this
press release is believed to be current as of the date of original
issue. The Company does not intend to update any of the
forward-looking statements after the date of this document to conform
these statements to actual results or to changes in the Company's
expectations, except as required by law.
ARIAD PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
In thousands,
except share and Three Months Ended Nine Months Ended
per share data September 30, September 30,
----------------------- -------------------------
2007 2006 2007 2006
---------- ---------- ---------- ----------
(Unaudited) (Unaudited)
Total license
revenue $ 1,602 $ 229 $ 1,981 $ 688
---------- ---------- ---------- ----------
Operating
expenses:
Research and
development 8,242 10,564 29,805 32,382
General and
administrative 5,006 5,244 16,307 17,231
---------- ---------- ---------- ----------
Total
operating
expenses 13,248 15,808 46,112 49,613
---------- ---------- ---------- ----------
Other income, net 796 359 1,325 1,351
---------- ---------- ---------- ----------
Net loss $ (10,850) $ (15,220) $ (42,806) $ (47,574)
========== ========== ========== ==========
Net loss per
common share
(basic and
diluted) $ (.16) $ (.25) $ (.63) $ (.77)
========== ========== ========== ==========
Weighted average
number of shares
of common stock
outstanding
(basic and
diluted) 69,160,289 62,120,381 67,870,622 62,013,462
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
In thousands September 30, December 31,
2007 2006
------------- ------------
(Unaudited)
Cash, cash equivalents and marketable
securities $ 86,110 $ 39,804
Total assets $ 100,704 $ 51,043
Total liabilities $ 94,453 $ 20,781
Stockholders' equity $ 6,251 $ 30,262
CONTACT: ARIAD Pharmaceuticals, Inc.
Edward M. Fitzgerald, 617-621-2345
or
Pure Communications
Sondra Newman, 617-877-5687