[August 05, 2015] |
|
ARIAD Reports Second Quarter 2015 Financial Results and Progress on Strategic Objectives
ARIAD
Pharmaceuticals, Inc. (NASDAQ:ARIA) today reported financial results
for the second quarter of 2015, including revenue from sales of Iclusig®
(ponatinib). The Company also provided an update on key corporate
initiatives and clinical-trial plans.
"During the second quarter, the Company continued strong commercial
execution of Iclusig with double-digit percentage, quarter-over-quarter
growth in both the U.S. and European markets. We expect additional
commercial launches and positive pricing and reimbursement decisions in
several European countries during the remainder of the year," said Harvey
J. Berger, M.D., chairman and chief
executive officer of ARIAD.
"With our recently announced non-dilutive synthetic-royalty financing,
we are able to maximize the value of brigatinib by accelerating to early
next year the start of a randomized front-line trial of brigatnib vs.
crizotinib," he continued. "This trial is one of four randomized
clinical trials that we expect to begin within the next two to three
quarters. In addition, we are on track to achieve full patient
enrollment in the ALTA pivotal trial of brigatinib in refractory
non-small cell lung cancer (NSCLC), which will form the basis for an NDA
filing in third quarter of next year."
2015 Second Quarter Financial Results
Revenues
-
Net product revenues from sales of Iclusig were $27.8 million for the
quarter ended June 30, 2015, an increase of 134% vs. the second
quarter of 2014 and 16% vs. the first quarter of 2015. These
Iclusig product revenues are comprised of revenues of $21.6 million in
the U.S. and $6.2 million in Europe. U.S. sales of Iclusig increased
16% from the first quarter to the second quarter of 2015, and European
sales increased 19%.
-
Shipments of Iclusig to patients in France were $2.5 million for the
second quarter of 2015. Cumulative total shipments in France, taking
into account the impact of foreign exchange, totaled $20.8 million
through June 30, 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 the fourth quarter of 2015.
Net Loss
-
Net loss for the quarter ended June 30, 2015 was $63.2 million, or
$0.33 per share, compared to a net loss of $56.9 million, or $0.30 per
share, for the same period in 2014.
-
Research and development (R&D) expenses were $38.7 million for the
second quarter of 2015, an increase of 22% compared to the second
quarter of 2014. This reflects an increase in costs for our ongoing
Phase 2 ALTA trial of brigatinib and NDA-enabling pharmacology and
manufacturing activities, as well as an increase in personnel and
other costs in support of our continuing Iclusig R&D activities.
-
Selling, general and administrative (SG&A) expenses were $48.6 million
for the second quarter of 2015, an increase of 42% compared to the
second quarter of 2014. This reflects an increase in personnel costs,
including the impact of severance and related costs associated with
the retirement of our chief executive later this year ($2.6 million
for the quarter) and an increase in legal and consulting costs,
including costs associated with the preparation of this year's proxy
and related initiatives ($4.9 million for the quarter).
Cash Position
-
As of June 30, 2015, cash and cash equivalents totaled $273.9 million,
compared to $352.7 million at December 31, 2014.
Financial Guidance for 2015
-
Our guidance for revenues from sales of Iclusig remains unchanged. We
expect Iclusig revenues for 2015 to be in the range of $130 million to
$140 million.
-
We now expect total R&D expenses for 2015 to be in the range of $177
million to $183 million, compared to our previous guidance of $185
million to $195 million. The decrease in R&D expenses is primarily
attributable to a reclassification in our forecast of certain expenses
from R&D to SG&A to be consistent with our financial-statement
classification of such expenses.
-
Additionally, we expect total SG&A expenses for 2015 to be in the
range of $166 million to $172 million, compared to our previous
guidance of $135 million to $145 million for 2015. The increase in
SG&A expenses is primarily attributable to the above-noted
reclassification of certain expenses, as well as legal and consulting
costs associated with this year's proxy and related initiatives ($6.7
million), and severance and related costs associated with the
retirement of our chief executive by year-end ($7.5 million), all of
which are non-recurring expenses.
-
As a result of the revised R&D and SG&A guidance and the $50 million
in funding received from PDL BioPharma, Inc. in July 2015 pursuant to
a synthetic-royalty financing, we expect our cash and cash equivalents
at December 31, 2015 to be at least $240 million.
Recent Progress and Key Objectives
Commercialization of Iclusig®
-
Approximately 145 new patients were treated with Iclusig in the U.S.
during the second quarter of 2015, an increase of 22% compared to the
first quarter of 2015.
-
At the end of the second quarter, there were approximately 870 unique
prescribers of Iclusig in the U.S., an increase in the prescriber base
of approximately 16% from the first quarter of 2015.
-
In Europe, we are now promoting Iclusig in the United Kingdom, France,
Germany, Italy, Austria, Switzerland, The Netherlands, Luxembourg,
Denmark, Norway, and Sweden. In addition, Iclusig is available for
purchase and is being supplied through named-patient programs and
prior authorizations in Spain, Portugal, Finland, Ireland, Turkey, and
in several markets in Eastern Europe. Prior to the end of the year, we
expect additional pricing and reimbursement decisions and commercial
launches in additional markets across the European region.
-
In June, we announced a commercialization agreement with Paladin Labs
Inc., a Canadian specialty pharmaceutical company, to distribute
Iclusig in Canada for patients with Philadelphia chromosome-positive
leukemias. We expect commercial launch of Iclusig in Canada during the
third quarter of this year.
Iclusig Clinical Development
-
Three randomized Iclusig clinical trials are set to begin in 2015, two
of which will evaluate Iclusig in earlier lines of treatment, as
follows:
-
A Phase 3 trial of Iclusig 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).
Brigatinib Clinical Development
-
Brigatinib is currently being evaluated in the global, Phase 2 pivotal
ALTA trial that we anticipate will form the basis for its initial
regulatory approval. We are on track to achieve full patient
enrollment of approximately 220 patients in the third quarter of 2015
and to file for approval of brigatinib in the U.S. in the third
quarter of 2016.
-
We recently announced a non-dilutive synthetic-royalty financing with
PDL BioPharma, Inc., which provides the Company with increased
financial flexibility to accelerate clinical development of
brigatinib, as well as to support brigatinib commercial readiness. A
randomized front-line clinical trial of brigatinib is now set to begin
in early 2016. This Phase 3 trial will compare brigatinib and
crizotinib in approximately 300 patients with ALK+ NSCLC, who have not
received prior ALK inhibitors.
Advancing the Pipeline
-
At the end of 2014, we nominated our next internally discovered
development candidate, AP32788. This orally active TKI has a unique
profile against a validated class of mutated targets in NSCLC and
certain other solid tumors and may address an important unmet medical
need.
-
We are on track to file an investigational new drug (IND) application
for AP32788 by year-end 2015 and to begin a Phase 1/2 proof-of-concept
clinical trial in 2016.
Today's Conference Call at 8:30 a.m. ET
We will hold a live webcast and conference call of our second 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 888-311-8173 (domestic) or
330-863-3376 (international) five minutes prior to the start time and
providing the pass code 76034435. 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.
These indications are based upon response rate. There are no trials
verifying an improvement in disease-related symptoms or increased
survival with Iclusig.
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 (News - Alert) (@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 second quarter 2015 financial results; our revised 2015
financial guidance; 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,
including brigatinib and AP32788; the expected timing for commencing and
completing clinical trials and for clinical trial data presentations,
regulatory filings, and commercial launches of our products and product
candidates; our plans for using the proceeds from our synthetic-royalty
financing and the expected benefits resulting therefrom; and our
expectation that our brigatinib Phase 2 ALTA trial will form the basis
for its initial regulatory approval, 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
and regulatory filing dates for our products and product candidates and
to move new development candidates into the clinic; our ability to
execute on our key corporate initiatives; regulatory developments and
safety issues, including 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, including brigatinib, 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; the costs associated with our
research, development, manufacturing and other activities; the conduct
and results of preclinical and clinical studies of our products and
product candidates, including that preclinical data and early-stage
clinical data may not be replicated in later-stage clinical studies; 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.
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ARIAD PHARMACEUTICALS, INC. AND SUBSIDIARIES
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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(Unaudited)
|
|
In thousands, except per share data
|
|
|
Three Months Ended June 30,
|
|
|
|
|
Six Months Ended June 30,
|
|
|
|
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2015
|
|
|
|
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2014
|
|
|
|
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2015
|
|
|
|
|
2014
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net
|
|
$
|
27,818
|
|
|
|
$
|
11,881
|
|
|
|
$
|
51,719
|
|
|
|
$
|
19,872
|
|
|
License and other revenue
|
|
|
1,420
|
|
|
|
|
233
|
|
|
|
|
1,510
|
|
|
|
|
4,023
|
|
|
Total revenue
|
|
|
29,238
|
|
|
|
|
12,114
|
|
|
|
|
53,229
|
|
|
|
|
23,895
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenue
|
|
|
488
|
|
|
|
|
2,395
|
|
|
|
|
1,183
|
|
|
|
|
3,683
|
|
|
Research and development
|
|
|
38,739
|
|
|
|
|
31,794
|
|
|
|
|
78,183
|
|
|
|
|
60,348
|
|
|
Selling, general and administrative
|
|
|
48,622
|
|
|
|
|
34,199
|
|
|
|
|
82,172
|
|
|
|
|
65,790
|
|
|
Total operating expenses
|
|
|
87,849
|
|
|
|
|
68,388
|
|
|
|
|
161,538
|
|
|
|
|
129,821
|
|
|
Other income (expense), net
|
|
|
(4,249
|
)
|
|
|
|
(541
|
)
|
|
|
|
(7,012
|
)
|
|
|
|
(592
|
)
|
|
Provision for income taxes
|
|
|
300
|
|
|
|
|
106
|
|
|
|
|
514
|
|
|
|
|
225
|
|
|
Net loss
|
|
$
|
(63,160
|
)
|
|
|
$
|
(56,921
|
)
|
|
|
$
|
(115,835
|
)
|
|
|
$
|
(106,743
|
)
|
|
Net loss per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-- basic and diluted
|
|
$
|
(0.33
|
)
|
|
|
$
|
(0.30
|
)
|
|
|
$
|
(0.62
|
)
|
|
|
$
|
(0.57
|
)
|
|
Weighted-average number of shares of common stock
outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-- basic and diluted
|
|
|
188,598
|
|
|
|
|
186,815
|
|
|
|
|
188,220
|
|
|
|
|
186,535
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
In thousands
|
|
|
|
June 30, 2015
|
|
|
|
|
December 31, 2014
|
|
Cash and cash equivalents
|
|
|
$
|
273,966
|
|
|
|
$
|
352,688
|
|
Total assets
|
|
|
$
|
542,977
|
|
|
|
$
|
603,870
|
|
Total liabilities
|
|
|
$
|
556,744
|
|
|
|
$
|
523,069
|
|
Stockholders' equity (deficit)
|
|
|
$
|
(13,767
|
)
|
|
|
$
|
80,801
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
In thousands
|
|
|
|
Six Months Ended June 30,
|
|
|
|
|
|
2015
|
|
|
|
|
2014
|
|
Net cash used in operating activities
|
|
|
$
|
(78,617
|
)
|
|
|
$
|
(96,095
|
)
|
Net cash provided by (used in) investing activities
|
|
|
|
(2,700
|
)
|
|
|
|
(2,010
|
)
|
Net cash provided by financing activities
|
|
|
|
2,461
|
|
|
|
|
170,964
|
|
Effect of exchange rates on cash
|
|
|
|
134
|
|
|
|
|
1
|
|
Net increase in cash and cash equivalents
|
|
|
$
|
(78,722
|
)
|
|
|
$
|
72,860
|
|
|
|
|
|
|
|
|
|
|
|
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20150805005674/en/
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