Conference Call Scheduled Today at 8:30 a.m.
ET
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported
financial results for the third quarter of 2015, including revenue
from sales of Iclusig® (ponatinib). The Company also provided an
update on key corporate initiatives and clinical-trial plans.
“We are on track to achieve our product revenue guidance of $130
to $140 million for 2015, with important contributions coming from
European and U.S. sales and anticipated successful resolution of
pricing negotiations for Iclusig in France,” stated Harvey J.
Berger, M.D., chairman and chief executive officer of ARIAD. “Each
of the major clinical initiatives – outlined at the beginning of
2015 as part of our three-year strategic operating plan – is
progressing as projected. These include full patient enrollment in
the ALTA pivotal trial of brigatinib, ongoing enrollment of
patients in the dose-ranging OPTIC trial of Iclusig and anticipated
initiation before year-end of the second-line trial of Iclusig. We
expect that results from these randomized trials, if positive, will
form the basis for expanded utilization of Iclusig and initial
approval of brigatinib. We are also moving ahead with another
randomized trial – a comparison of brigatinib and crizotinib in
front-line non-small cell lung cancer – which we anticipate
beginning in the first half of next year.”
2015 Third Quarter Financial
Results
Revenues
- Net product revenues from sales of
Iclusig were $27.5 million for the third quarter, compared to $14.5
million in the third quarter of 2014 and $27.8 million in the
second quarter of 2015.
- U.S. sales of Iclusig were $20.3
million for the third quarter, compared to $21.6 million in the
second quarter of 2015, the difference primarily due to flat
quarter-over-quarter demand and an increase in gross-to-net
adjustments.
- European sales of Iclusig were $7.2
million for the third quarter, compared to $6.2 million in the
second quarter of 2015, the difference primarily due to increased
quarter-over-quarter demand.
- Shipments of Iclusig to patients in
France were $2.2 million for the third quarter of 2015. Cumulative
total shipments in France totaled $23.3 million through September
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 these negotiations, which we
anticipate will be completed by year-end 2015.
Operating Expenses
- Research and development (R&D)
expenses were $48.2 million for the third quarter of 2015, an
increase of 75% compared to the third 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, costs related to the initiation of the Iclusig Phase 2
dose-ranging OPTIC trial, as well as an increase in personnel and
other costs in support of our continuing R&D activities.
- Selling, general and administrative
(SG&A) expenses were $36.7 million for the third quarter of
2015, an increase of 9% compared to the third quarter of 2014. This
reflects an increase in personnel costs, including the impact of
severance costs associated with the pending retirement of our chief
executive officer and an increase in costs in support of expanding
distribution and sales of Iclusig.
Net Loss
- Net loss for the quarter ended
September 30, 2015 was $55.5 million, or $0.29 per share, compared
to a net loss of $50.1 million, or $0.27 per share, for the same
period in 2014.
- During the quarter ended September 30,
2015, we recorded in marketable securities on our balance sheet the
value of shares of common stock we own in REGENXBIO, Inc., which
completed an initial public offering during the quarter; these
shares are not saleable until the first quarter of 2016. The value
of the shares at September 30, 2015 was $15.1 million. The value
net of tax, $9.1 million, is recorded in other comprehensive
income. An intra-period tax benefit of $6.0 million related to the
tax consequences of this item included in other comprehensive
income is recorded as a tax benefit in our statement of
operations.
Cash Position
- As of September 30, 2015, cash and cash
equivalents totaled $282.2 million, compared to $352.7 million at
December 31, 2014.
- During the quarter ended September 30,
2015, we entered into a royalty financing agreement with PDL
BioPharma, Inc. (PDL) under which we received $50 million from PDL
in exchange for payments to PDL based on a percentage of global
sales of Iclusig over time until PDL receives a 10% internal rate
of return. In July 2016, we will receive an additional $50 million
from PDL. Under the agreement, we also have an option, in our sole
discretion, to receive up to an additional $100 million through
July 2016.
Recent Progress and Key
Objectives
Commercialization of Iclusig®
- Approximately 125 new patients were
treated with Iclusig in the U.S. during the third quarter of 2015.
Importantly, approximately 55% of these new patients receiving
Iclusig are patients with chronic-phase chronic myeloid leukemia
(CP-CML).
- Through the third quarter, there have
been approximately 980 unique prescribers of Iclusig in the U.S.,
an increase in the cumulative prescriber base of approximately 13%
from the second quarter of 2015.
- In Europe, we are now promoting Iclusig
in 12 countries: the United Kingdom, France, Germany, Italy,
Austria, Switzerland, The Netherlands, Luxembourg, Denmark, Norway,
Sweden, and Finland. In addition, Iclusig is available for purchase
and is being supplied through named-patient programs and prior
authorizations in Spain, Portugal, Ireland, Turkey and in several
markets in Eastern Europe.
- Iclusig is now reimbursed in Canada and
Australia, and commercial launches continue in both countries
through our regional distribution partners.
Iclusig Clinical Development
- In August, we initiated patient
enrollment in the OPTIC
(Optimizing Ponatinib Treatment In CML) trial
of Iclusig. This randomized, dose-ranging trial is designed to
evaluate three different starting doses of ponatinib in patients
with refractory CP-CML and is expected to inform the optimal use of
Iclusig in these patients. Approximately 450 patients will be
enrolled at clinical sites around the world.
- Later this quarter, we expect to begin
a Phase 3 trial of Iclusig in patients with CP-CML, who have
experienced treatment failure after imatinib therapy. This
second-line study of Iclusig is expected to enroll approximately
600 patients and is aimed at expanding the indication for Iclusig
in patients with resistant and intolerant CML.
Brigatinib Clinical Development
- In September, we achieved full patient
enrollment in the pivotal Phase 2 ALTA trial of brigatinib. This
registration study enrolled approximately 220 patients at 71 sites
in North America, Europe and Asia. We are on
track to file in the third quarter of 2016 for approval of
brigatinib in the U.S.
- The randomized front-line clinical
trial of brigatinib is expected to begin in the first half of 2016.
This Phase 3 trial will compare brigatinib and crizotinib in
approximately 300 patients with ALK+ non-small cell lung cancer
(NSCLC), who have not received prior ALK inhibitors.
Advancing the Pipeline
- 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. AP32788 is an orally active tyrosine-kinase inhibitor (TKI),
which 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.
Today’s Conference Call at 8:30 a.m. ET
We will hold a live webcast and conference call of our third
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 55634805. 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 third quarter 2015 financial results; progress
against our 2015 financial and business objectives, including our
2015 revenue guidance; 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; and
PDL’s obligation to pay us $50 million in July 2016, 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
SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(Unaudited)
In thousands, except per share data
Three Months EndedSeptember
30,
Nine Months EndedSeptember
30,
2015 2014 2015
2014 Revenue: Product revenue, net $ 27,543 $ 14,499 $
79,262 $ 34,371 License and other revenue 1,527 183
3,038 4,206 Total revenue 29,070 14,682 82,300 38,577
Operating expenses: Cost of product revenue 483 594 1,666 4,277
Research and development 48,219 27,600 126,401 87,948 Selling,
general and administrative 36,744 33,622 118,916 99,411 Total
operating expenses 85,446 61,816 246,983 191,636 Other income
(expense), net (4,917) (2,820 ) (11,930) (3,413) Benefit from
(provision for) income taxes 5,842 (154 ) 5,328 (379
)
Net loss $ (55,451) $ (50,108 ) $ (171,285) $ (156,851 ) Net loss
per common share: -- basic and diluted $ (0.29) $ (0.27 ) $ (0.91)
$ (0.84 ) Weighted-average number of shares of common stock
outstanding: -- basic and diluted 188,921 187,034 188,456 186,703
CONDENSED CONSOLIDATED BALANCE SHEET
INFORMATION(Unaudited)
In thousands
September 30,2015
December 31,2014
Cash and cash equivalents $ 282,187 $ 352,688 Total assets $
576,139 $ 603,116 Total liabilities $ 625,789 $ 522,315
Stockholders’ equity (deficit) $ (49,650) $ 80,801
CONDENSED CONSOLIDATED STATEMENT OF
CASH FLOWS INFORMATION(Unaudited)
In thousands
Nine Months EndedSeptember
30,
2015 2014 Net cash used in operating
activities $ (119,523) $ (131,930 ) Net cash provided by (used in)
investing activities (4,446) (2,475) Net cash provided by financing
activities 53,643 170,524 Effect of exchange rates on cash (175)
153 Net increase in cash and cash equivalents $ (70,501) $ 36,272
View source
version on businesswire.com: http://www.businesswire.com/news/home/20151103005174/en/
ARIAD Pharmaceuticals, Inc.For InvestorsKendra Adams,
617-503-7028Kendra.adams@ariad.comorFor MediaLiza Heapes,
617-621-2315Liza.heapes@ariad.com
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