Conference Call Scheduled Today at 8:30 a.m.
ET
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
(@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.
ARIAD PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited) In thousands, except per share
data
Three Months EndedJune
30,
Six Months EndedJune 30,
2015
2014
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 EndedJune 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/
ARIAD Pharmaceuticals, Inc.InvestorsKendra Adams,
617-503-7028Kendra.adams@ariad.comorMediaLiza Heapes,
617-621-2315Liza.heapes@ariad.com
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