EXHIBIT 99.1
ARIAD Reports Second Quarter 2007 Results
Significant Milestones Achieved Year-to-Date
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 6, 2007--ARIAD Pharmaceuticals,
Inc. (NASDAQ: ARIA) today announced financial results for the quarter and six
months ended June 30, 2007 and provided an update on corporate developments.
"With our recently announced strategic collaboration with Merck & Co., we
have embarked on a markedly expanded global development program for deforolimus
in which substantial clinical trials and biomarker studies will be conducted
concurrently in multiple cancers. Importantly, we anticipate that the
combination of the up-front payment received from Merck plus the significant
future milestone payments triggered by the start of pre-specified Phase 2 and
Phase 3 clinical trials will fund our portion of the remaining development costs
of deforolimus," said Harvey J. Berger, M.D., chairman and chief executive
officer of ARIAD. "As a result, our financial position has been greatly
strengthened, enabling us to invest more fully in building our oncology product
pipeline, including our next clinical candidate, AP24534."
Financial Highlights
For the quarter ended June 30, 2007, the Company reported a net loss of
$17.0 million, or $0.25 per share, as compared to a net loss of $17.0 million,
or $0.27 per share, for the quarter ended June 30, 2006. For the six months
ended June 30, 2007, the Company reported a net loss of $32.0 million, or $0.48
per share, as compared to a net loss of $32.4 million, or $0.52 per share, for
the six months ended June 30, 2006. These results reflect the continued
development of the Company's lead product candidate, deforolimus, and its next
clinical candidate, AP24534.
For the six months ended June 30, 2007, cash used in operations was $26.4
million, as compared to $27.4 million for the six months ended June 30, 2006.
The Company ended the second quarter 2007 with $25.7 million in cash, cash
equivalents and marketable securities, compared with $39.8 million at the end of
2006.
In July 2007, the Company received an up-front payment of $75 million from
Merck in connection with the execution of the deforolimus collaboration
agreement. In addition, the Company expects to receive a milestone payment of
$13.5 million for the commencement of the Phase 3 clinical trial of oral
deforolimus in patients with metastatic sarcomas in third quarter 2007.
After taking into account the estimated impact of the collaboration
agreement with Merck, the Company expects positive cash flow from operations for
the year ending December 31, 2007 in the range of $30 to $35 million. Based on
these estimates, the Company expects that its cash, cash equivalents and
marketable securities at December 31, 2007 will be in the range of $72 to $76
million.
Corporate and Development Highlights
The Company has made substantial progress this year on multiple fronts,
including:
Novel mTOR Inhibitor -- Deforolimus
-- Global Collaboration with Merck & Co. to Jointly Develop and
Commercialize Deforolimus. The Company believes this partnership
should maximize the commercial and clinical potential of deforolimus
and enable ARIAD to realize its vision of becoming a fully integrated
oncology company. The all-cash agreement provides for an initial
payment of $75 million to ARIAD, up to $452 million more in milestone
payments to ARIAD based on the successful development of deforolimus
in multiple cancer indications (including up to $128 million for the
initiation of Phase 2 and Phase 3 clinical trials), up to $200 million
more based on achievement of significant sales thresholds, and at
least $200 million in estimated contributions by Merck to global
development. If the global development program is expanded further and
ARIAD pays over $150 million in global development costs, ARIAD can
access up to $200 million in interest-bearing repayable
development-cost advances from Merck to cover ARIAD's share of these
global-development costs. ARIAD's potential commercial returns 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.
-- Additional Positive Efficacy Data in Sarcomas. In June, at the annual
meeting of the American Society of Clinical Oncology (ASCO), ARIAD
reported positive efficacy data on single-agent deforolimus from
further analysis of its ongoing Phase 2 trial in patients with
advanced soft-tissue and bone sarcomas. The expanded analysis focused
on the 60 patients with a deforolimus clinical-benefit response (CBR)
- the primary endpoint of the 212-patient trial - and its relationship
to overall survival. The new results demonstrated that documented
disease stabilization and/or tumor regression with deforolimus is a
strong predictor of improved overall survival. Patients with a
deforolimus CBR had a median overall survival of approximately 17
months, nearly double that of the overall trial population (vs.
approximately 9 months).
-- Positive Efficacy Results in Endometrial Cancer. Also at ASCO, ARIAD
reported that deforolimus demonstrated efficacy and was well tolerated
as a single agent in a multi-center Phase 2 trial in metastatic
endometrial cancer involving 45 patients, all of whom had progressive
disease. The primary end-point of the trial - evidenced by significant
clinical-benefit response (CBR) rates - was achieved. Twenty-nine
percent (29%) of patients had a CBR - tumor regression or disease
stabilization - including 10% with partial responses.
-- Positive Safety and Tolerability Data in Combination with Paclitaxel.
ARIAD also presented results from a Phase 1b dose-escalation trial
evaluating the safety and tolerability, pharmacokinetics and
anti-cancer activity of deforolimus in combination with paclitaxel in
patients with progressive solid tumors. Anti-tumor activity was seen
in patients with advanced pharyngeal, pancreatic, ovarian, thyroid and
breast cancers when treated with the combination. Deforolimus combined
with paclitaxel was well-tolerated, with predictable and manageable
side-effects, which provides the basis for additional trials of this
important combination regimen in several tumor types.
Novel Bcr-Abl Inhibitor for Drug-Resistant CML - AP24534
-- Progress with Pipeline. The Company has completed extensive
preclinical studies on the efficacy of AP24534 in chronic myeloid
leukemia and its potential utility in other cancers. The
investigational new drug (IND) application for this multi-targeted
kinase inhibitor is on track for filing in the fourth quarter 2007.
Corporate Activities
-- Strengthened Senior Leadership Team. Pierre F. Dodion, M.D. joined the
Company as senior vice president, oncology, which includes leadership
of medical research, medical affairs, clinical operations, drug safety
and pharmacovigilence and biostatistics and outcomes research. Dr.
Dodion has over twenty-five years of experience in the global
pharmaceutical industry and academia, most recently as executive
director, oncology at Pfizer, Inc.
Scientific and Medical Meetings
ARIAD expects to have presentations at the following scientific and medical
meetings:
-- AACR-NCI-EORTC International Conference on Molecular Targets & Cancer
Therapeutics, San Francisco, California, October 22 to 26, 2007.
-- 13th Annual Connective Tissue Oncology Society Meeting, Seattle,
Washington, November 1 to 3, 2007.
-- American Society Hematology 49th Annual Meeting, Atlanta, Georgia,
December 8 to 11, 2007.
Upcoming Investor Meetings
ARIAD management will present updated overviews of the Company's progress
and business plans at several investor conferences:
-- Credit Suisse Boston Biotech Forum, Boston, Massachusetts, September
5, 2007.
-- Bear Stearns 20th Annual Healthcare Conference, New York, New York,
September 10 to 11, 2007.
-- ThinkEquity Partners 5th Annual Growth Conference, San Francisco,
California, September 17 to 20, 2007.
-- UBS 2007 Global Life Sciences Conference, New York, New York,
September 24 to 27, 2007.
-- Lazard Capital Markets Annual Life Sciences Conference, New York, New
York, November 27 to 28, 2007.
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 1-866-831-6270 (domestic) or 617-213-8858
(international) five minutes prior to the start time and providing the passcode
54320658. 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 to develop
and commercialize deforolimus, ARIAD's lead cancer product candidate. Medinol
Ltd. also is developing stents and other medical devices that deliver
deforolimus to prevent reblockage at sites of vascular injury following
stent-assisted 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 the expected timing of the Phase 3 clinical trial of
deforolimus in metastatic sarcoma, expanded development plans for deforolimus in
collaboration with Merck, financial terms of our collaboration with Merck, plans
for and the expected timing of the filing of an IND for AP24534 and our
financial projections. 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 partners, including
Merck and Medinol, 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
per share data
Three Months Ended Six Months Ended
June 30, June 30,
----------------------- -----------------------
2007 2006 2007 2006
---------- ---------- ---------- ----------
(Unaudited) (Unaudited)
Total license
revenue $ 189 $ 229 $ 379 $ 458
---------- ---------- ---------- ----------
Operating expenses:
Research and
development 10,540 10,144 21,563 21,818
General and
administrative 6,898 7,531 11,301 11,987
---------- ---------- ---------- ----------
Total
operating
expenses 17,438 17,675 32,864 33,805
---------- ---------- ---------- ----------
Other income, net 244 450 529 993
---------- ---------- ---------- ----------
Net loss $ (17,005) $ (16,996) $ (31,956) $ (32,354)
---------- ---------- ---------- ----------
---------- ---------- ---------- ----------
Net loss per common
share
(basic and diluted)$ (.25) $ (.27) $ (.48) $ (.52)
---------- ---------- ---------- ----------
---------- ---------- ---------- ----------
Weighted average
number of
shares of common
stock
outstanding (basic
and diluted) 68,786,835 62,093,353 67,215,100 61,827,494
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
In thousands
June 30, December 31,
2007 2006
--------- ------------
(Unaudited)
Cash, cash equivalents and marketable
securities $ 25,696 $ 39,804
Total assets $ 37,432 $ 51,043
Total liabilities $ 22,501 $ 20,781
Stockholders' equity $ 14,931 $ 30,262
CONTACT: ARIAD Pharmaceuticals, Inc.
Edward M. Fitzgerald, 617-621-2345
or
Pure Communications
Andrea L. Johnston, 910-616-5858