ARIAD
Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial
results for the third quarter and nine months ended September 30, 2010
and provided an update on corporate developments.
?Patient enrollment is off to a very good start in the PACE trial of ponatinib,
our investigational pan-BCR-ABL inhibitor, in patients with resistant or
intolerant chronic myeloid leukemia, and we are advancing our
investigational anaplastic lymphoma kinase inhibitor through
IND-enabling studies,? stated Harvey J. Berger, M.D., chairman and chief
executive officer of ARIAD. ?With our recently completed equity offering
of $57.4 million in net proceeds, we now have the funds sufficient to
advance the development of these promising product candidates into the
second half of 2012, and to prepare regulatory approval applications for
ponatinib around that same time.?
Financial Highlights
For the quarter ended September 30, 2010, the Company reported a net
loss of $20.4 million, or $0.18 per share compared to a net loss of
$20.8 million, or $0.21 per share, for the same period in 2009. For the
nine-month period ended September 30, 2010, the Company reported net
income of $115.6 million, or $1.05 per share compared to a net loss of
$62.0 million, or $0.70 per share for the same period in 2009. Net
income for the nine-month period ended September 30, 2010 primarily
reflects the positive impact of the Company's restructured agreement
with Merck, entered into in May 2010, for the development, manufacture
and commercialization of ridaforolimus
in oncology, which resulted in the recognition of $175 million in
revenue in the second quarter of 2010.
The Company reported operating expenses of $16.8 million for the quarter
ended September 30, 2010, as compared to $17.9 million for the same
period in 2009, and operating expenses of $54.1 million for the
nine-month period ended September 30, 2010, as compared to $60.4 million
for the same period in 2009. The decreases in operating expenses for
these periods primarily reflect the assumption by Merck as of January 1,
2010 of all of the costs related to the development, manufacture and
commercialization of ridaforolimus per the restructured agreement,
offset largely by increases in costs related to the development of
ponatinib, for which the Company initiated a pivotal Phase 2 trial in
the third quarter of 2010.
For the nine-month period ended September 30, 2010, cash provided by
operating activities was $18.8 million, as compared to cash used in
operating activities of $36.0 million for the same period in 2009. The
increase in cash provided by operating activities is primarily due to
the receipt from Merck in 2010 of the $50 million up-front payment and
$12.8 million in reimbursement of the Company's share of ridaforolimus
costs upon execution of the restructured agreement, offset in part by
the receipt in 2009 of $22.5 million in milestone payments from Merck
related to the start of two Phase 2 clinical trials pursuant to the 2007
ridaforolimus collaboration agreement.
The Company ended the third quarter of 2010 with cash and cash
equivalents of $59.3 million, compared to $40.4 million at December 31,
2009. On October 29, 2010, the Company completed a public offering of 16
million shares of its common stock for net proceeds of approximately
$57.4 million. In connection with this offering, the Company granted the
underwriters a 30-day option to purchase up to 2.4 million shares of its
common stock to cover over-allotments, if any.
Revised Financial Guidance for 2010
The Company expects to end 2010 with cash provided by operations of
approximately $5 million, reflecting the impact of payments received in
connection with executing the restructured agreement with Merck in May
2010. With the net proceeds from the October offering of common stock,
the Company expects that its cash and cash equivalents at December 31,
2010 will be approximately $102 million.
?Our balance sheet is substantially strengthened, and our cash position
is expected to take us into the second half of 2012,? said Edward M.
Fitzgerald, executive vice president and chief financial officer of
ARIAD. ?This revised guidance does not take into account the positive
impact of any regulatory or sales milestone payments the Company may
receive from Merck related to ridaforolimus or any payments relating to
a potential collaboration agreement on ponatinib.?
SUCCEED Trial Data Expected in Early 2011
ARIAD expects final results from the Phase 3 SUCCEED trial of oral
ridaforolimus in patients with metastatic soft-tissue and bone sarcomas
to be announced in the first quarter of 2011. The final analysis will be
performed by Merck. If the data from the SUCCEED trial are positive,
Merck is expected to file applications for regulatory approval of
ridaforolimus in 2011. ARIAD is eligible to receive $65 million in
potential near-term milestone payments related to ridaforolimus in
metastatic sarcomas.
Advancements in Research and Development
ARIAD made excellent progress in its research and development programs
during the third quarter of 2010, including:
-
The initiation of a pivotal Phase 2 clinical trial of its
investigational pan-BCR-ABL inhibitor, ponatinib,
in patients with resistant or intolerant chronic myeloid leukemia
(CML) and Philadelphia positive acute lymphoblastic leukemia (Ph+
ALL). The PACE (Ponatinib Ph+ ALL and CML Evaluation)
trial is designed to provide definitive clinical data for regulatory
approval of ponatinib. Patient enrollment is underway and expected to
be completed in the fourth quarter of 2011.
-
Presentation of positive interim results in October from a randomized,
open?label, active-control, Phase 2 study of oral ridaforolimus,
ARIAD's investigational mTOR inhibitor, in patients with metastatic or
recurrent endometrial cancer. Based on this interim analysis, the
study demonstrated a statistically significant improvement in the
primary endpoint of median progression-free survival in patients
receiving single-agent ridaforolimus compared to patients receiving
standard-of-care treatment (ridaforolimus, 3.6 months; standard of
care, 1.9 months, p=0.007). Merck stopped further enrollment in the
trial due to the positive interim data and is continuing to follow
surviving patients.
-
Advancement of AP26113,
ARIAD's investigational, next-generation anaplastic lymphoma kinase
(ALK) inhibitor, in IND (investigational new drug)-enabling studies.
ARIAD expects to file an IND application in mid-2011 for AP26113 and
begin a biomarker-based targeted clinical trial in tumors including
non small-cell lung cancer shortly thereafter. In preclinical studies,
AP26113 has been shown to have significantly higher potency than the
investigational ALK inhibitor being developed by Pfizer, crizotinib,
and to inhibit mutated forms of ALK that are now being observed in
patients becoming resistant to crizotinib.
-
The award this month of three federal grants totaling approximately
$733,000 for each of ARIAD's development programs – ridaforolimus,
ponatinib and AP26113 – as part of the Qualifying Therapeutic
Discovery Project (QTDP) program created by Congress through the
federal health reform law approved last spring. The QTDP program
provides support for innovative projects that are determined by the
U.S. Department of Health and Human Services to have reasonable
potential to result in new therapies or reduce health care costs, or
represent significant advances in finding a cure for cancer.
Upcoming Medical Meeting
Additional safety and efficacy data from the ongoing Phase 1 clinical
trial of ponatinib in patients with resistant and refractory chronic
myeloid leukemia will be presented in an oral session of the American
Society of Hematology annual meeting in Orlando, Florida on December 6,
2010. These data will include an update on cytogenetic and molecular
responses to ponatinib, as well as median duration of response for
patients treated with ponatinib.
Upcoming Investor Meetings
ARIAD management will be making corporate presentations at the following
investor conferences:
-
Lazard Capital Markets Healthcare Conference 2010, New York, NY,
November 16, 2010.
-
Barclays Capital 2010 Healthcare Small & Mid-Cap One-on-One Day,
Minneapolis, MN, November 18, 2010.
Today's Conference Call at 8:30 a.m.
ARIAD will hold a live webcast of its quarterly conference call today,
November 9, 2010, at 8:30 a.m. (ET). The live webcast can be accessed by
visiting the investor relations section of the Company's website at http://investor.ariad.com.
The call can be accessed by dialing (866) 362-4831(domestic) or (617)
597-5347(international) five minutes prior to the start time and
providing the pass code 60708669. 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 three weeks.
About ARIAD
ARIAD's vision is to transform the lives of cancer patients with
breakthrough medicines. The Company's mission is to discover, develop
and commercialize small-molecule drugs to treat cancer in patients with
the greatest and most urgent unmet medical need - aggressive cancers
where current therapies are inadequate. ARIAD's lead product candidate,
ridaforolimus, is an investigational mTOR inhibitor being developed by
Merck and is in Phase 3 clinical development in patients with advanced
sarcomas. ARIAD's second internally discovered product candidate,
ponatinib, is an investigational pan-BCR-ABL inhibitor in a pivotal
Phase 2 clinical trial in patients with chronic myeloid leukemia and Ph+
acute lymphoblastic leukemia. For additional information about the
Company, please visit http://www.ariad.com.
This press release contains "forward-looking statements" including, but
not limited to statements relating to enrollment of patients in the
pivotal Phase 2 PACE trial of ponatinib, projected 2010 cash from
operations, cash and cash equivalents at year-end 2010 and sufficiency
of funds to last into the second half of 2012, final results from the
Phase 3 SUCCEED trial and near-term milestones from Merck, and filing of
an IND application for AP26113. 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, preclinical data and early-stage clinical data that may not
be replicated in later-stage clinical studies, the costs associated with
our research, development, manufacturing and other activities, the
conduct, timing and results of pre-clinical and clinical studies of our
product candidates, the adequacy of our capital resources and the
availability of additional funding, 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 per share data
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
|
2010
|
|
|
|
2009
|
|
|
|
2010
|
|
|
|
2009
|
|
|
|
(Unaudited)
|
|
|
|
(Unaudited)
|
|
|
Total revenue
|
$
|
1,242
|
|
|
$
|
2,155
|
|
|
$
|
178,444
|
|
|
$
|
6,148
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
13,168
|
|
|
|
14,384
|
|
|
|
41,817
|
|
|
|
47,939
|
|
|
General and administrative
|
|
3,670
|
|
|
|
3,472
|
|
|
|
12,245
|
|
|
|
12,412
|
|
|
Total operating expenses
|
|
16,838
|
|
|
|
17,856
|
|
|
|
54,062
|
|
|
|
60,351
|
|
|
Other income (expense), net
|
|
(4,804
|
)
|
|
|
(5,108
|
)
|
|
|
(8,832
|
)
|
|
|
(7,797
|
)
|
|
Net income (loss)
|
$
|
(20,400
|
)
|
|
$
|
(20,809
|
)
|
|
$
|
115,550
|
|
|
$
|
(62,000
|
)
|
|
Net income (loss) per common share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
– basic
|
$
|
(0.18
|
)
|
|
$
|
(0.21
|
)
|
|
$
|
1.05
|
|
|
$
|
(0.70
|
)
|
|
– diluted
|
$
|
(0.18
|
)
|
|
$
|
(0.21
|
)
|
|
$
|
1.04
|
|
|
$
|
(0.70
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares of common stock
outstanding – basic
|
|
110,810
|
|
100,275
|
|
|
|
110,045
|
|
|
|
88,120
|
|
|
– diluted
|
|
110,810
|
|
|
|
100,275
|
|
|
|
111,556
|
|
|
|
88,120
|
|
|
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
|
|
|
|
|
|
|
|
|
|
In thousands
|
|
|
September 30,
2010
|
|
|
December 31,
2009
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
Cash, cash equivalents and marketable securities
|
|
$
|
59,305
|
|
$
|
40,362
|
|
|
Total assets
|
|
$
|
79,723
|
|
$
|
65,010
|
|
|
Working capital
|
|
$
|
46,656
|
|
$
|
8,212
|
|
|
Deferred revenue, total
|
|
$
|
12
|
|
$
|
111,611
|
|
|
Total liabilities
|
|
$
|
44,179
|
|
$
|
154,026
|
|
|
Stockholders' equity (deficit)
|
|
$
|
35,544
|
|
$
|
(89,016
|
)
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION
|
|
|
|
|
|
|
In thousands
|
|
|
Nine Months Ended
September 30,
|
|
|
|
|
2010
|
|
|
2009
|
|
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
|
Net cash provided by (used in) operating activities
|
|
$
|
18,779
|
|
$
|
(36,018
|
)
|
|
Net cash provided by (used in) investing activities
|
|
|
(1,497
|
)
|
|
11,588
|
|
|
Net cash provided by financing activities
|
|
|
1,661
|
|
|
57,660
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents
|
|
$
|
18,943
|
|
$
|
33,230
|
|
ARIAD Pharmaceuticals, Inc.
Maria E. Cantor, 617-621-2208
United Kingdom
France
Deutschland
Schweiz (DE)
