Conference Call Scheduled Today at 8:30 a.m.
ET
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported
financial results for the first quarter of 2015, including revenue
from sales of Iclusig® (ponatinib). The Company also provided an
update on corporate developments.
“Iclusig demonstrated strong performance in both the U.S. and
European markets during the first quarter driven by steady
underlying demand,” said Harvey J. Berger, M.D., chairman and chief
executive officer of ARIAD. “We continue to expand the global
commercial opportunity for Iclusig, most recently through
additional marketing approvals in Israel and Canada. Additionally,
we are on track to initiate three new randomized Iclusig clinical
trials during 2015 and to achieve full patient enrollment in the
brigatinib pivotal trial in the third quarter.”
2015 First Quarter Financial
Results
Revenues
- Net product revenues from sales of
Iclusig were $23.9 million for the quarter ended March 31, 2015, an
increase of 12% versus the fourth quarter of 2014. Net product
revenues for the first quarter include Iclusig revenues of $18.7
million in the U.S. and $5.2 million in Europe. U.S. sales of
Iclusig increased 10% from the fourth quarter of 2014 to the first
quarter of 2015, and European sales increased 18%, net of the
impact of changes in foreign exchange rates for the first
quarter.
- In the quarter ended March 31, 2015, we
transitioned to the sell-in method for recognition of product
revenues in the U.S., resulting in a one-time addition to revenue
of approximately $1.2 million for the first quarter.
- Shipments of Iclusig to patients in
France were $1.9 million for the first quarter of 2015. Cumulative
total shipments in France, taking into account the effects of
foreign exchange, totaled $18.3 million through March 31, 2015. We
will record revenue related to cumulative shipments in France upon
completion of pricing and reimbursement negotiations in France, 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 Loss
- Net loss for the quarter ended March
31, 2015 was $52.7 million, or $0.28 per share, compared to a net
loss of $49.8 million, or $0.27 per share, for the same period in
2014.
- R&D expenses were $39.4 million for
the first quarter of 2015, an increase of 38% compared to the first
quarter of 2014, reflecting an increase in costs for our
investigational ALK+ inhibitor, brigatinib, related to the ongoing
Phase 2 ALTA trial and NDA-enabling pre-clinical studies, as well
as increase in personnel and other costs in support of our R&D
activities.
- Selling, general and administrative
expenses were $33.6 million for the first quarter of 2015, an
increase of 6% compared to the first quarter of 2014, reflecting an
increase in professional fees and other expenses related to the
commercialization of Iclusig, as well as legal and proxy-related
matters.
Cash Position
- As of March 31, 2015, cash and cash
equivalents totaled $304.0 million, compared to $352.7 million at
December 31, 2014.
Recent Progress and Key
Objectives
Commercialization of Iclusig®
- Approximately 120 new patients were
treated with Iclusig in the U.S. during the first quarter of
2015.
- By the end of the first quarter, there
were nearly 750 unique prescribers of Iclusig in the U.S., an
increase in the prescriber base of approximately 14% from the
fourth quarter of 2014.
- In Europe, we are now selling Iclusig
in Germany, the United Kingdom, Austria, the Netherlands, Norway,
Sweden, and Italy. In addition, we are distributing Iclusig to
patients in France and Spain prior to pricing and reimbursement
approval as permitted under local regulations.
- As of the end of March, Iclusig is
approved for reimbursement in Sweden in accordance with the full EU
label. This reimbursement decision followed an extensive Health
Technology Assessment completed by the Swedish Dental and
Pharmaceutical Benefits Agency (TLV).
- In April, Iclusig received a positive
decision for reimbursement by the Scottish Medicine Consortium.
Iclusig is now reimbursed in Scotland for the treatment of
resistant forms of chronic myeloid leukaemia (CML) and Philadelphia
chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL).
- Iclusig is now approved in Israel and
Canada for adult patients with resistant forms of CML and Ph+ ALL.
We expect our distributor Medison Pharma Ltd. will begin to
commercialize Iclusig in Israel during the second quarter.
- Earlier this week, we announced an
agreement with Gen Ilac, a Turkish pharmaceutical company, to
distribute Iclusig in Turkey for patients with
Philadelphia-positive leukemias.
Iclusig Clinical Development
- Three randomized Iclusig clinical
trials are on track to begin in 2015, two of which will evaluate
Iclusig in earlier lines of treatment, as follows:
- A Phase 3 trial in approximately 500
patients with chronic-phase chronic myeloid leukemia (CP-CML) who
have experienced treatment failure after imatinib therapy.
- A dose-ranging trial of Iclusig in
approximately 450 patients with CP-CML who have become resistant to
at least two prior TKIs.
- An early-switch trial of Iclusig in
approximately 1,000 patients with CP-CML in the United Kingdom
(known as the SPIRIT3 trial).
- Additionally, 10 ISTs in the ponatinib
program are open to patient enrollment, and three additional ISTs
are pending regulatory or institutional review board approval.
Advancing Brigatinib
- Our first U.S. patent for brigatinib
was issued last month and provides composition-of-matter protection
through at least December 30, 2030. Additional patent applications
covering brigatinib in the U.S. and in other countries are
pending.
- Brigatinib is currently being evaluated
in the global, Phase 2 pivotal ALTA trial that is anticipated to
form the basis for its initial regulatory approval. We are on track
to achieve full patient enrollment of approximately 220 patients in
the ALTA trial in the third quarter of 2015 and to file for
approval of brigatinib in the U.S. next year.
- We anticipate presenting an update from
the ongoing Phase 1/2 clinical trial of brigatinib at the 2015
American Society of Clinical Oncology meeting. Additionally, we
expect to present preliminary data from the brigatinib ALTA trial
in the second half of 2015.
Upcoming Medical Meetings
- American Society of Clinical Oncology
(ASCO) 2015 Annual Meeting, Chicago, May 29 to June 2, 2015
- European Hematology Association (EHA)
20th Congress, Austria, Vienna June 11 to 14, 2015
Today’s Conference Call at 8:30 a.m. ET
We will hold a live webcast and conference call of our first
quarter 2015 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 39467029. 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.
Iclusig is approved in the U.S., EU, Australia, Switzerland,
Israel and Canada.
In the U.S., Iclusig is a kinase inhibitor indicated for
the:
- Treatment of adult patients with
T315I-positive chronic myeloid leukemia (chronic phase, accelerated
phase, or blast phase) or T315I-positive Philadelphia chromosome
positive acute lymphoblastic leukemia (Ph+ ALL).
- Treatment of adult patients with
chronic phase, accelerated phase, or blast phase chronic myeloid
leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor
(TKI) therapy is indicated.
IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED
WARNING
WARNING: VASCULAR OCCLUSION, HEART FAILURE, and
HEPATOTOXICITY
See full 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).
Forward-Looking Statements
This press release contains forward-looking statements, each of
which are qualified in their entirety by this cautionary statement.
Any statements contained herein which do not describe historical
facts, including, but not limited to, statements regarding: our
unaudited expected first quarter 2015 financial results; our
progress against our 2015 financial and business objectives; the
expected timing for recording revenue for cumulative shipments of
Iclusig to patients in France; the therapeutic and commercial
potential of Iclusig and our other product candidates; the expected
timing for commencing and completing clinical trials and for
clinical trial data presentations and regulatory filings for our
products and product candidates; the expected timing for Iclusig’s
commercial launch in Israel; and the duration of our U.S.
composition-of-matter patent for brigatinib and the status of
additional patent applications covering brigatinib, are
forward-looking statements that 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 factors, risks and uncertainties
include, but are not limited to, our ability to meet anticipated
clinical trial commencement, enrollment and completion dates for
our products and product candidates and to move new development
candidates into the clinic; our ability to secure a partnership for
AP26113; 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 or our other product candidates, if approved; 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; 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 our
public filings with the U.S. Securities and Exchange Commission,
including our most recent Annual Report on Form 10-K and subsequent
Quarterly Reports on Form 10-Q. Except as otherwise noted, these
forward-looking statements speak only as of the date of this press
release and we undertake no obligation to update or revise any of
these statements to reflect events or circumstances occurring after
this press release. We caution investors not to place considerable
reliance on the forward-looking statements contained in this press
release.
ARIAD PHARMACEUTICALS, INC. AND
SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(Unaudited)
In thousands, except per share data Three Months
Ended
March 31,
2015 2014 Revenue:
Product revenue, net $ 23,901 $ 7,992 License and other revenue 90
3,790 Total revenue 23,991 11,782
Operating expenses: Cost of product revenue 695 1,288 Research and
development 39,444 28,554 Selling, general and administrative
33,550 31,591 Total operating expenses 73,689
61,433 Other income (expense), net (2,764 ) (52 ) Provision
for income taxes 214 119 Net loss $ (52,676 )
$ (49,822
)
Net loss per common share: -- basic and diluted $ (0.28 ) $ (0.27
)
Weighted-average number of shares
of common stock outstanding:
-- basic and diluted 187,837 186,252
CONDENSED CONSOLIDATED BALANCE SHEET
INFORMATION
In thousands March 31,
2015
December 31,
2014
Cash and cash equivalents $ 304,016 $ 352,688 Total assets $
580,451 $ 603,870 Total liabilities $ 542,388 $ 523,069
Stockholders’ equity $ 38,063 $ 80,801
CONDENSED CONSOLIDATED STATEMENT OF
CASH FLOWS INFORMATION
In thousands Three Months Ended
March 31,
2015 2014 Net cash used
in operating activities $ (50,194) $ (52,409 ) Net cash used in
investing activities (754) (1,706) Net cash provided by (used in)
financing activities 2,051 (90) Effect of exchange rates on cash
225 (1) Net decrease in cash and cash equivalents $ (48,672)
$ (54,206)
ARIAD Pharmaceuticals, Inc.For InvestorsKendra Adams,
617-503-7028Kendra.adams@ariad.comorFor MediaLiza Heapes,
617-621-2315Liza.heapes@ariad.com
Ariad (NASDAQ:ARIA)
Historical Stock Chart
From Aug 2024 to Sep 2024
Ariad (NASDAQ:ARIA)
Historical Stock Chart
From Sep 2023 to Sep 2024