Conference Call Scheduled Today at 8:30 a.m.
ET
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported
financial results for the third quarter of 2014, including revenue
from sales of Iclusig® (ponatinib). The Company also provided an
update on corporate developments.
“Our third quarter results show solid growth in U.S. sales of
Iclusig and continued commercial progress in Europe,” said Harvey
J. Berger, M.D., chairman and chief executive officer of ARIAD.
“The EMA has adopted its final opinion on Iclusig following the
Article 20 review in Europe, leaving the Iclusig indications
unchanged, and we are now focused on obtaining pricing and
reimbursement in all key European markets. As we head into the end
of the year, we are also finalizing the details of the new
randomized dose-ranging trial for Iclusig aimed at further
improving the benefit-risk profile of Iclusig and accelerating
patient enrollment in the ALTA trial of AP26113 in patients with
ALK+ non-small cell lung cancer, which we expect will be the basis
for our initial registration of AP26113.”
2014 Third Quarter Financial Results
Revenues
Total revenue for the quarter ended September 30, 2014 increased
21% to $14.7 million, versus the second quarter of 2014. Total
revenue includes product revenue from sales of Iclusig and license
revenue.
Net product revenues from sales of Iclusig were $14.5 million
for the quarter ended September 30, 2014, an increase of 22% from
the second quarter of 2014. Net product revenues for the quarter
include Iclusig revenues of $10.5 million in the U.S. and $4.0
million in Europe. Net revenues reported do not include $2.9
million related to deferred revenue of $1.2 million in the U.S.,
representing Iclusig inventory on hand at our specialty pharmacy as
of September 30, 2014 and shipment of $1.7 million of Iclusig to
patients in France during the quarter ($17.3 million cumulatively
through September 30, 2014).
We will record revenue related to cumulative shipments in France
upon completion of pricing and reimbursement negotiations, net of
any amounts that will be refunded to the French health authorities
as a result of such negotiations, which we anticipate will be
completed in mid-2015.
Net Income/Loss
Net loss for the quarter ended September 30, 2014 was $50.1
million, or $0.27 per share, compared to net loss of $66.3 million,
or $0.36 per share, for the same period in 2013.
Research and development expenses decreased by $17.5 million, or
39%, from the third quarter of 2013 to the third 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 our investigational anaplastic lymphoma kinase positive (ALK+)
inhibitor, AP26113, due to the initiation of the pivotal Phase 2
ALTA trial.
Selling, general and administrative expenses decreased by $3.8
million, or 10%, from the third quarter of 2013 to the third
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
As of September 30, 2014, cash and cash equivalents totaled
$273.5 million, compared to $310.0 million at June 30, 2014.
Financial Guidance for 2014
We now expect research and development expenses of $125 million
to $130 million, compared to our previous guidance of $140 million
to $150 million for 2014. The decrease in research and development
spend is driven by the cost of clinical trials, manufacturing and
other activities.
We anticipate cash used in operations in 2014 will now range
from $150 million to $155 million, compared to our previous
guidance of $165 million to $175 million. As a result, we expect
that our cash, cash equivalents and marketable securities at
December 31, 2014 will range from $250 million to $255 million,
sufficient to fund operations into the second half of 2016. This
does not take into account any distributorship or partnership
agreements that may be entered into during this period.
Recent Progress on Key Objectives
Commercialization of Iclusig
- Through September 30, 2014,
approximately 650 patients in the U.S. received Iclusig
commercially.
- By the end of the third quarter, there
were nearly 550 unique prescribers of Iclusig in the U.S., an
increase in the prescriber base of approximately 38% from the
second quarter.
- Approximately 60% of prescribers are
community-based physicians, with the remainder being physicians
practicing in academic medical centers.
- In Europe, we are selling Iclusig in
select countries and are working to reach full pricing and
reimbursement in additional European countries by mid-2015.
- In October, the European Medicines
Agency (EMA) endorsed the recommendation by the Pharmacovigilance
Risk Assessment Committee (PRAC) that Iclusig continue to be used
in Europe in accordance with its already approved indications in
Philadelphia-chromosome positive leukemias. The authorized
indications and the favorable benefit-risk balance of Iclusig give
healthcare providers the ability to optimize the use of Iclusig in
patients with resistant or intolerant chronic myeloid leukemia
(CML) and Philadelphia-chromosome positive acute lymphoblastic
leukemia (Ph+ ALL).
Iclusig Clinical Development
- We are working with the U.S. Food and
Drug Administration (FDA) and the European Medicines Agency to
finalize the design of the randomized trial to evaluate a range of
starting doses of Iclusig. We expect to complete these discussions
and have a final trial protocol by year-end.
- Seven investigator-sponsored trials
(ISTs) are open to patient enrollment, and nine additional ISTs are
pending regulatory or institutional review board approval. This
includes three trials in RET driven non-small cell lung cancer
(NSCLC), six trials in CML or Ph+ALL, two trials in acute myeloid
leukemia (AML) and various other cancers.
Advancing AP26113
- AP26113 received Breakthrough Therapy
designation from the FDA for the treatment of patients with ALK+
metastatic NSCLC whose tumors are resistant to crizotinib. Results
from the ongoing Phase 1/2 trial show sustained anti-tumor activity
of AP26113 in patients with ALK+ NSCLC, including patients with
active brain metastases. As follow-up to the Breakthrough Therapy
designation, we will meet with FDA to discuss our plans and timing
regarding AP26113 regulatory submission.
- A pivotal global Phase 2 trial of
AP26113 in patients with locally advanced or metastatic 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 are positive
for the ALK oncogene. The trial will enroll approximately 220
patients in the United States, Europe and Asia, including those
with brain metastases.
Upcoming Medical Meeting
- 56th Annual Meeting of the American
Society of Hematology (ASH), San Francisco, December 6 to 9,
2014.
Upcoming Investor Meeting
ARIAD management will be making corporate presentations at the
following investor conference:
- 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 38094306. 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 EndedSeptember
30,
Nine Months EndedSeptember
30,
2014 2013 2014
2013 Total revenue $ 14,682 $ 16,732 $ 38,577 $
37,208 Operating expenses: Cost of product revenue 594 415 4,277
913 Research and development 27,600 45,145 87,948 127,076 Selling,
general and administrative 33,622 37,395 99,411 108,977 Total
operating expenses 61,816 82,955 191,636 236,966 Other income
(expense), net (2,820 ) (6) (3,413) 18 Provision for income taxes
154 110 379 255 Net loss $ (50,108 ) $ (66,339 ) $ (156,851
) $ (199,995 ) Net loss per common share: -- basic and diluted $
(0.27 ) $ (0.36 ) $ (0.84 ) $ (1.09 )
Weighted-average number of shares ofcommon
stock outstanding:
-- basic and diluted 187,034 185,238 186,703 182,859
CONDENSED CONSOLIDATED BALANCE SHEET
INFORMATION
(Unaudited)
In thousands
September 30,2014
December 31,2013
Cash and cash equivalents $ 273,451 $ 237,179 Total assets $
483,692 $ 370,894 Total liabilities $ 402,600 $ 185,377
Stockholders’ equity $ 81,092 $ 185,517
CONDENSED CONSOLIDATED STATEMENT OF
CASH FLOWS INFORMATION
(Unaudited)
In thousands
Nine Months EndedSeptember
30,
2014 2013
Net cash used in operating activities $ (131,930 ) $ (170,313 ) Net
cash provided by (used in) investing activities (2,475) 23,243 Net
cash provided by (used in) financing activities 170,524 312,157
Effect of exchange rates on cash 153 (30) Net increase in
cash and cash equivalents $ 36,272 $ 165,057
ARIAD Pharmaceuticals, Inc.For InvestorsKendra Adams,
(617) 503-7028Kendra.adams@ariad.comorFor MediaLiza Heapes,
(617) 621-2315Liza.heapes@ariad.com
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