Conference Call Scheduled Today at 8:30 a.m.
ET
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported
financial results for the second quarter of 2014, including revenue
from sales of Iclusig® (ponatinib). The Company also provided an
update on corporate developments.
“We made steady progress in the second quarter on Iclusig sales
in both the U.S. and Europe, and expect this momentum to build in
the second half of the year,” said Harvey J. Berger, M.D., chairman
and chief executive officer of ARIAD. “We are also focused on
initiating a new randomized dose-ranging trial for Iclusig aimed at
further improving the benefit/risk profile of this approved
medicine and accelerating patient enrollment in the ALTA clinical
trial of AP26113 in patients with ALK-positive non-small cell lung
cancer.”
2014 Second Quarter Financial Results
Revenues
Total revenue for the quarter ended June 30, 2014 was $12.1
million, which includes product revenue from sales of Iclusig and
license revenue.
Net product revenues from sales of Iclusig were $11.9 million
for the quarter ended June 30, 2014. Net product revenues for the
quarter include Iclusig revenues of $7.9 million in the U.S. and
$4.0 million in Europe. Net revenues reported exclude $3.6 million
related to the following items:
- Deferred revenue of $1.3 million in the
U.S., representing Iclusig inventory on hand at our specialty
pharmacy as of June 30, 2014 but not yet shipped to patients as of
the end of the quarter.
- Shipments of $2.3 million of Iclusig to
patients in France during the second quarter ($16.8 million
cumulatively through June 30, 2014). We will record revenue related
to cumulative shipments to patients in France upon completion of
pricing and reimbursement negotiations, net of any amounts that
will be refunded to the French health authorities based on the
results of such negotiations. We now anticipate that such
negotiations will be completed in the first half of 2015.
Net Income/Loss
Net loss for the quarter ended June 30, 2014 was $56.9 million,
or $0.30 per share, compared to net loss of $69.0 million, or $0.37
per share, for the same period in 2013.
Research and development expenses decreased by $8.9 million, or
22%, from the second quarter of 2013 to the second quarter of 2014,
predominantly reflecting a decrease in clinical trial costs, as
well as decreased manufacturing and other supporting costs related
to Iclusig clinical trials, and decreased personnel and related
costs reflecting the impact of the Company’s reduction in workforce
effected in the fourth quarter of 2013. These decreases were
offset, in part, by increases in clinical-trial and related costs
for AP26113 due to the initiation of the pivotal Phase 2 ALTA
trial.
Selling, general and administrative expenses decreased by $7.9
million, or 19%, from the second quarter of 2013 to the second
quarter of 2014, reflecting a decrease in personnel expenses in the
U.S. as a result of the reduction in workforce in the fourth
quarter of 2013 and a decrease in expenses related to sales and
marketing initiatives and other consulting services in support of
the initial commercial launch of Iclusig in the U.S. in 2013. These
decreases were offset, in part, by an increase in personnel and
other expenses in Europe due to the launch of Iclusig in various
European countries in the second half of 2013.
Cash Position
In June, the Company completed a private placement of
convertible senior notes due 2019, resulting in $177.3 million in
net proceeds to ARIAD, after expenses and the cost of related bond
hedge and warrant transactions. Also in June, the Company paid off
the remaining $8.0 million balance of its outstanding bank term
loan.
As of June 30, 2014, cash and cash equivalents totaled $310.0
million, compared to $183.0 million at March 31, 2014.
Financial Guidance for 2014
We anticipate cash used in operations in 2014 to range from $165
million to $175 million, unchanged from prior guidance.
We now expect that our cash, cash equivalents and marketable
securities at December 31, 2014 will range from $230 million to
$235 million, sufficient to fund operations into the second half of
2016. This does not take into account any commercial agreements for
Iclusig that may be entered into during this period.
Recent Progress on Key Objectives
Commercialization of Iclusig
- Through June 30, 2014, more than 500
patients in the U.S. received Iclusig obtained commercially based
on physicians’ prescriptions.
- By the end of the second quarter, there
were over 400 unique prescribers of Iclusig in the U.S., an
increase in the prescriber base of approximately one-third from the
first quarter.
- Approximately 60 percent of prescribers
are community-based physicians, with the remainder being physicians
practicing in academic medical centers. We expect that adoption of
Iclusig among community oncologists and hematologists will continue
to increase as utilization progresses further.
- In Europe, we continue selling Iclusig
in Germany, the United Kingdom, France, Austria, the Netherlands,
Norway, and Sweden.
- The review of Iclusig under the Article
20 procedure by the Pharmacovigilance Risk Assessment Committee
(PRAC) is ongoing in Europe. This procedure is aimed at obtaining a
better understanding of the adverse events observed with Iclusig
and proposing potential ways to further improve its benefit/risk
profile. Responses have been submitted to the PRAC’s questions
regarding proposed dose modifications after achievement of a
response and patient monitoring and details concerning a risk
management plan. Following input from the agency’s Scientific
Advisory Group in September, we expect that the PRAC will complete
its review and make final recommendations to the Committee for
Medicinal Products for Human Use (CHMP) at its meeting in October
2014.
Iclusig Clinical Development
- We continue to work with the U.S. Food
and Drug Administration and the European Medicines Agency to
finalize the randomized trial to evaluate a variety of doses of
Iclusig. We expect to complete these discussions and have an
agreed-upon protocol this year.
- Six investigator-sponsored trials are
now open to patient enrollment: a U.S. trial in patients with
non-small cell lung cancer (NSCLC) with RET translocation, a U.S.
trial in patients with RET translocation and/or FGFR1
amplification, a U.S. trial in patients with medullary thyroid
cancer with or without RET mutations, a U.S. trial in endometrial
cancer patients with FGFR2 mutations, a French trial in patients
with FLT3-positive acute myeloid leukemia (AML), and a UK trial in
patients with Philadelphia chromosome-positive (Ph+) acute
lymphoblastic leukemia (ALL).
- Nine additional investigator-sponsored
trials are pending regulatory or institutional review board (IRB)
approval; these include investigations in chronic-phase and
blast-phase CML, Ph+ALL, AML, and bile duct carcinoma with FGFR
fusions.
Advancing AP26113
- A pivotal global Phase 2 trial of
AP26113 in patients with locally advanced or metastatic non-small
cell lung cancer (NSCLC) who were previously treated with
crizotinib continues to enroll patients. The ALTA trial is designed
to determine the safety and efficacy of AP26113 in refractory NSCLC
patients who have tested positive for the anaplastic lymphoma
kinase (ALK+) oncogene. The trial will enroll approximately 220
patients in the United States and Europe, including those with
brain metastasis.
- We will present an update from the
ongoing Phase 1/2 clinical trial of AP26113 at the 2014 ESMO annual
meeting.
Upcoming Medical Meeting
- European Society of Medical Oncology
(ESMO) 2014 Annual Meeting, Madrid, Spain, September 26 to 30,
2014
Upcoming Investor Meetings
ARIAD management will be making corporate presentations at the
following investor conferences:
- Citi Biotech Conference, Boston,
September 3-4, 2014
- Stifel Healthcare Conference, New York,
November 18, 2014
Today’s Conference Call at 8:30 a.m. ET
We will hold a live webcast and conference call of our first
quarter financial results this morning 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 888-771-4371 (domestic) or 847-585-4405
(international) five minutes prior to the start time and providing
the pass code 37600188. 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 Iclusig® (ponatinib) tablets
Iclusig is a kinase inhibitor. The primary target for Iclusig is
BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic
myeloid leukemia (CML) and Philadelphia-chromosome positive acute
lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using
ARIAD’s computational and structure-based drug-design platform
specifically to inhibit the activity of BCR-ABL. Iclusig targets
not only native BCR-ABL but also its isoforms that carry mutations
that confer resistance to treatment, including the T315I mutation,
which has been associated with resistance to other approved
TKIs.
Important U.S. Safety Information for Iclusig®
(ponatinib)
WARNING: VASCULAR OCCLUSION, HEART FAILURE, and
HEPATOTOXICITY
See full U.S. prescribing information for complete boxed
warning
- Vascular Occlusion: Arterial and
venous thrombosis and occlusions have occurred in at least 27% of
Iclusig treated patients, including fatal myocardial infarction,
stroke, stenosis of large arterial vessels of the brain, severe
peripheral vascular disease, and the need for urgent
revascularization procedures. Patients with and without
cardiovascular risk factors, including patients less than 50 years
old, experienced these events. Monitor for evidence of
thromboembolism and vascular occlusion. Interrupt or stop Iclusig
immediately for vascular occlusion. A benefit risk consideration
should guide a decision to restart Iclusig therapy.
- Heart Failure, including fatalities,
occurred in 8% of Iclusig-treated patients. Monitor cardiac
function. Interrupt or stop Iclusig for new or worsening heart
failure.
- Hepatotoxicity, liver failure and
death have occurred in Iclusig-treated patients. Monitor hepatic
function. Interrupt Iclusig if hepatotoxicity is
suspected.
Please see the full U.S. Prescribing Information
for Iclusig, including the Boxed Warning, for additional
important safety information.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts and Lausanne, Switzerland, is an integrated global
oncology company focused on transforming the lives of cancer
patients with breakthrough medicines. ARIAD is working on new
medicines to advance the treatment of various forms of chronic and
acute leukemia, lung cancer and other difficult-to-treat cancers.
ARIAD utilizes computational and structural approaches to design
small-molecule drugs that overcome resistance to existing cancer
medicines. For additional information, visit
http://www.ariad.com or follow ARIAD on Twitter
(@ARIADPharm).
Iclusig® is a registered trademark of ARIAD
Pharmaceuticals, Inc.
This press release contains “forward-looking statements”
including, but not limited to, updates on clinical and regulatory
developments and commercialization plans for our products and
product candidates and financial guidance for 2014. 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,
difficulties or delays in obtaining regulatory and pricing and
reimbursement approvals to market our products; our ability to
successfully commercialize and generate profits from sales of
Iclusig; competition from alternative therapies, our reliance on
the performance of third-party manufacturers and specialty
pharmacies for the distribution of Iclusig; the occurrence of
adverse safety events with our products and product candidates; our
ability to meet anticipated clinical trial commencement and
completion dates; delays in or failure of obtaining regulatory
clearance for resumption of clinical trials; 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 and
results of preclinical and clinical studies of our product
candidates; the adequacy of our capital resources and the
availability of additional funding; patent protection and
third-party intellectual property claims; risks related to key
employees, markets, economic conditions, health care reform, prices
and reimbursement rates; and other risk 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
(Unaudited)
In thousands, except per share data Three Months
Ended
June 30,
Six Months Ended
June 30,
2014 2013 2014
2013 Total revenue $ 12,114 $ 14,011 $
23,895 $ 20,476 Operating expenses: Cost of product revenue
2,395 228 3,683 497 Research and development 31,794 40,668 60,348
81,931 Selling, general and administrative 34,199 42,101 65,790
71,583 Total operating expenses 68,388 82,997 129,821
154,011 Other income (expense), net (541 ) 87 (592 ) 25 Provision
for income taxes 106 86 225 145 Net loss $ (56,921 )
$ (68,985 ) $ (106,743 ) $ (133,655 ) Net loss per common
share: -- basic and diluted $ (0.30 ) $ (0.37 ) $ (0.57 ) $
(0.74 ) Weighted-average number of shares of common stock
outstanding: -- basic and diluted 186,815 184,726 186,535 181,651
CONDENSED CONSOLIDATED BALANCE SHEET
INFORMATION
(Unaudited)
In thousands June 30,
2014
December 31,
2013
Cash and cash equivalents $ 310,039 $ 237,179 Total assets $
492,810 $ 370,894 Total liabilities $ 370,046 $ 185,377
Stockholders’ equity $ 122,764 $ 185,517
CONDENSED CONSOLIDATED STATEMENT OF
CASH FLOWS INFORMATION
(Unaudited)
In thousands Six Months Ended
June 30,
2014 2013 Net cash
used in operating activities $ (95,016
)
$ (114,144
)
Net cash provided by (used in) investing activities (2,010 ) 17,118
Net cash provided by (used in) financing activities 169,885 309,563
Effect of exchange rates on cash 1 (25 ) Net increase
in cash and cash equivalents $ 72,860 $ 212,512
For InvestorsKendra Adams,
617-503-7028Kendra.adams@ariad.comorFor MediaLiza Heapes,
617-621-2315Liza.heapes@ariad.com
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