UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): February
19, 2015
ARIAD
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
Delaware
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001-36172
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22-3106987
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(State
or other jurisdiction
of
incorporation)
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(Commission
File
Number)
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(I.R.S.
Employer
Identification
No.)
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26 Landsdowne Street, Cambridge,
Massachusetts
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02139
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant's telephone number, including
area code: (617) 494-0400
Not
Applicable
(Former
name or former address, if changed since last report)
Check the
appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions (see General Instruction A.2.
below):
⃞
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
⃞
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
⃞
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
⃞
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
ITEM 2.02 Results of Operations and Financial Condition.
In a press release dated February 19, 2015, ARIAD Pharmaceuticals, Inc.
(the “Company”) announced financial results for the fourth quarter and
full year ended December 31, 2014 and issued 2015 financial guidance.
Additionally, the Company provided an update on corporate developments
and key objectives for 2015. A copy of the press release is attached
hereto as Exhibit 99.1. The information under the headings “2014 Fourth
Quarter and Full-Year Financial Results,” “Today’s Conference Call at
8:30 a.m. ET” and the condensed consolidated financial information
included in the press release are incorporated by reference into this
Item 2.02 of this Current Report on Form 8-K.
ITEM 7.01 Regulation FD Disclosure.
In the press release dated February 19, 2015, the Company also provided
financial guidance for 2015, as well as upcoming investor meetings. The
information set forth under the headings “2015 Financial Guidance” and
“Upcoming Investor Meetings” in the press release are incorporated by
reference into this Item 7.01 of this Current Report on Form 8-K.
ITEM 8.01 Other Events.
In the press release dated February 19, 2015, the Company also provided
an update on its Iclusig®, Brigatinib (AP26113) and
pipeline programs. The second paragraph of the press release and the
information set forth under the heading “Recent Progress and Key
Objectives,” together with the forward-looking statement disclaimer at
the end of the press release, are incorporated by reference into this
Item 8.01 of this Current Report on Form 8-K.
ITEM 9.01 Financial Statements and Exhibits.
(d)
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Exhibits.
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Exhibit
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Description
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99.1
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Press release dated February 19, 2015.
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The press release contains hypertext links to information on our
websites. The information on our websites is not incorporated by
reference into this Current Report on Form 8-K and does not constitute a
part of this Form 8-K.
The portions of the press release incorporated by reference into Item
8.01 of this Current Report on Form 8-K are being filed pursuant to such
item. The remaining portions of the press release dated February 19,
2015 are being furnished pursuant to Items 2.02 and 7.01 of this Current
Report on Form 8-K and shall not be deemed “filed” for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended (the
“Exchange Act”) or otherwise subject to the liabilities of that Section,
nor shall they be deemed incorporated by reference in any filing under
the Securities Act of 1933, as amended, or the Exchange Act except as
shall be expressly set forth by specific reference in such filing.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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ARIAD Pharmaceuticals, Inc.
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By:
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/s/ Edward M. Fitzgerald
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Edward M. Fitzgerald
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Executive Vice President, Chief Financial Officer
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Date:
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February 19, 2015
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Exhibit 99.1
ARIAD
Reports 2014 Financial Results, Provides 2015 Financial Guidance and
Outlines Strategic Objectives
Iclusig
Net Product Revenue Guidance for 2015 in the Range of $130 Million to
$140 Million
Three
New Iclusig Clinical Trials Planned to Begin This Year
CAMBRIDGE, Mass.--(BUSINESS WIRE)--February 19, 2015--ARIAD
Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results
for the fourth quarter and full year ended December 31, 2014 and issued
2015 financial guidance. Additionally, the Company provided an update on
corporate developments and key objectives for 2015.
“We made solid progress throughout our business during 2014 --
commercializing Iclusig® (ponatinib) and advancing our
pipeline, moving brigatinib into a pivotal trial in patients with
refractory anaplastic lymphoma kinase positive non-small cell lung
cancer and nominating our next drug candidate, AP32788,” said Harvey J.
Berger, M.D., chairman and chief executive officer of ARIAD.
“Additionally, we strengthened our balance sheet last year with
non-dilutive funding from the agreements with Otsuka Pharmaceutical Co.,
Ltd. and Bellicum Pharmaceuticals, Inc. In 2015, our focus is on
expanding the global commercial opportunity for Iclusig and
strategically investing in value-driving clinical initiatives to
position the Company for sustained growth and anticipated profitability
in 2018.”
2014 Fourth Quarter and Full-Year Financial Results
Revenues
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Net product revenues from sales of Iclusig were $21.4 million for the
quarter ended December 31, 2014 and $55.7 million for the year ended
December 31, 2014. Net product revenues for the fourth quarter include
Iclusig revenues of $17.0 million in the U.S. and $4.4 million in
Europe. Net product revenues in the fourth quarter represented a 47%
increase from the prior quarter.
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Cumulative shipments of Iclusig to patients in France totaled $18.3
million through December 31, 2014. We will record revenue related to
cumulative shipments in France upon completion of pricing and
reimbursement negotiations in France, net of 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.
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License revenues for the fourth quarter of 2014 were $45.5 million,
which includes the impact of payments from Bellicum Pharmaceuticals,
Inc. (Bellicum) under the amended license agreement signed in October
2014. Of the $50 million in payments received from Bellicum, $45.2
million is included in license revenue, while the remaining $4.8
million is included in other income related to the value of Bellicum
common stock returned to Bellicum.
Net Loss
Quarter Ended December 31, 2014
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Net loss for the fourth quarter ended December 31, 2014 was $5.7
million, or $0.03 per share, compared to a net loss of $74.2 million,
or $0.40 per share, for the same period in 2013. The decrease in net
loss is primarily due to the $50 million received from Bellicum in the
fourth quarter of 2014, an increase of $13.2 million in Iclusig
product revenue and a decrease in operating expenses of $8.0 million,
reflecting lower research and development (R&D) expenses, offset in
part by an increase in interest expense of $3.8 million due to our
convertible debt issuance in June 2014.
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R&D expenses were $32.6 million for the fourth quarter of 2014, a
decrease of 9% from the fourth quarter of 2013, reflecting a decrease
in Iclusig clinical-trial costs, as well as decreased manufacturing
and other supporting costs related to Iclusig. These decreases were
offset, in part, by increases in clinical-trial and related costs for
our investigational ALK+ inhibitor, brigatinib, related to the ongoing
Phase 2 ALTA trial.
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Selling, general and administrative expenses were $40.4 million for
the fourth quarter of 2014, an increase of 7% from the fourth quarter
of 2013, reflecting an increase in personnel and other expenses in
Europe due to the commercial launch of Iclusig in various European
countries in the second half of 2014.
Year Ended December 31, 2014
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Net loss for the full year 2014 was $162.6 million, or $0.87 per
share, compared to a net loss of $274.2 million, or $1.49 per share,
for the full year 2013.
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These results include an increase in Iclusig product revenue of $10.5
million and the $50 million received from Bellicum, as well as a
decrease in operating expenses of $53.4 million in 2014 as compared to
2013, reflecting a reduction in R&D expenses related to a decrease in
clinical-trial costs, as well as manufacturing and other support costs
related to Iclusig clinical trials, and a decrease in personnel and
related costs reflecting a lower number of R&D employees in 2014
compared to 2013.
Cash Position
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As of December 31, 2014, cash and cash equivalents totaled $352.7
million, compared to $237.2 million at December 31, 2013.
Recent Progress and Key Objectives
Commercialization of Iclusig®
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In 2014, nearly 800 patients received Iclusig commercially in the U.S.
Approximately 150 new patients were treated with Iclusig during the
fourth quarter of 2014, an increase of approximately 10% from the
third quarter.
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By the end of the fourth quarter, there were nearly 660 unique
prescribers of Iclusig in the U.S., an increase in the prescriber base
of approximately 25% from the third quarter of 2014.
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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 prior to pricing and
reimbursement approval as permitted under French regulations.
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Full pricing and reimbursement in France and other European countries
is expected by mid-2015. In total, we anticipate that Iclusig will be
available for sale in 16 European countries by the third quarter of
this year.
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In December of 2014, we entered into an agreement with Otsuka
Pharmaceutical Co., Ltd. (Otsuka) for them to commercialize Iclusig in
Japan and nine other Asian countries and to fund agreed-upon future
clinical development in those countries. We anticipate filing of the
Japanese New Drug Application for Iclusig in the second half of 2015.
Iclusig Clinical Development
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Three new Iclusig clinical trials are planned to begin in 2015, two of
which will evaluate Iclusig in earlier lines of treatment, as follows:
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A randomized, Phase 3 trial in approximately 500 patients with
chronic-phase chronic myeloid leukemia (CP-CML) who have
experienced treatment failure after imatinib therapy.
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A dose-ranging trial of Iclusig in approximately 450 patients with
CP-CML who have become resistant to at least two prior TKIs.
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An early-switch trial of Iclusig in approximately 1,000 patients
with CP-CML in the United Kingdom (known as the SPIRIT3 trial) –
an investigator-sponsored trial (IST).
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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
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Brigatinib received Breakthrough Therapy designation from the U.S.
Food and Drug Administration in 2014, which may accelerate its
regulatory approval timeline. 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 in the ALTA trial in the third quarter
of 2015 and to file for approval of brigatinib in the U.S. next year.
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We recently announced plans to secure a broad partnership in 2015 to
co-develop and co-commercialize brigatinib. We expect that such a
partnership will leverage our existing infrastructure and
capabilities, as well as support a randomized, first-line trial of
brigatinib vs. crizotinib in anaplastic lymphoma kinase
positive (ALK+) non-small cell lung cancer (NSCLC). A partnership may
also support the exploration of new combination therapies in lung
cancer that include brigatinib with other approved and unapproved
medicines.
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We anticipate presenting updates from the ongoing Phase 1/2 clinical
trial of brigatinib at the 2015 European Lung Cancer Conference and
the American Society of Clinical Oncology meetings later this year.
Additionally, we expect to present preliminary data from the
brigatinib ALTA trial in the second half of 2015.
Expanding the Pipeline
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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.
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We expect to file an investigational new drug (IND) application for
AP32788 this year and to begin a Phase 1/2 proof-of-concept trial in
2016. This will be our third IND filing of an internally discovered
oncology development candidate in the past eight years.
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This complements our earlier discovery of ridaforolimus, which is
being developed by Medinol Ltd. for use in drug-eluting stents
(BioNIR) and is in global pivotal trials, and rimiducid (AP1903),
which is being developed by Bellicum for use in novel cellular
immunotherapies and is in Phase 1/2 clinical trials.
2015 Financial Guidance
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Net product revenues from sales of Iclusig are expected to be in the
range of $130 million to $140 million. This guidance includes sales of
Iclusig in the U.S., Europe, and other select countries where ARIAD
has distributorships in place.
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R&D expenses are expected to be in the range of $185 million to $195
million, reflecting increased development activities for Iclusig,
brigatinib, and AP32788, as well as ongoing discovery research
efforts. Expenses related to Iclusig represent approximately 50% of
total R&D expenses and include the three new planned trials to begin
this year, as well as all ongoing trials. Expenses related to
brigatinib represent approximately 35% of total R&D expenses and
include the two ongoing trials and NDA-enabling pre-clinical studies.
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Selling, general and administrative expenses are expected to be in the
range of $135 million to $145 million, of which approximately 55%
represents U.S. and EU commercial operations and supporting activities
for Iclusig.
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Non-cash expenses are expected to be in the range of $45 million to
$50 million, consisting primarily of stock-based compensation and
depreciation and amortization expenses.
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Cash and cash equivalents at December 31, 2015 is expected to be at
least $200 million.
Upcoming Investor Meetings
ARIAD management will be making corporate presentations at the following
investor conferences:
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RBC Capital Markets’ Healthcare Conference, New York City, February
25, 2015
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Cowen and Company Healthcare Conference, Boston, March 2, 2015
Today’s Conference Call at 8:30 a.m. ET
We will hold a live webcast and conference call of our fourth
quarter/year-end 2014 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 38869071. 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 and Switzerland.
In the U.S., Iclusig is a kinase inhibitor indicated for the:
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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).
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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
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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.
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Heart Failure, including fatalities, occurred in 8% of
Iclusig-treated patients. Monitor cardiac function. Interrupt or stop
Iclusig for new or worsening heart failure.
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Hepatotoxicity, liver failure and death have occurred in
Iclusig-treated patients. Monitor hepatic function. Interrupt Iclusig
if hepatotoxicity is suspected.
Vascular Occlusion: Arterial and venous thrombosis and
occlusions, including fatal myocardial infarction, stroke, stenosis of
large arterial vessels of the brain, severe peripheral vascular disease,
and the need for urgent revascularization procedures have occurred in at
least 27% of Iclusig-treated patients from the phase 1 and phase 2
trials. Iclusig can also cause recurrent or multi-site vascular
occlusion. Overall, 20% of Iclusig-treated patients experienced an
arterial occlusion and thrombosis event of any grade. Fatal and
life-threatening vascular occlusion has occurred within 2 weeks of
starting Iclusig treatment and in patients treated with average daily
dose intensities as low as 15 mg per day. The median time to onset of
the first vascular occlusion event was 5 months. Patients with and
without cardiovascular risk factors have experienced vascular occlusion
although these events were more frequent with increasing age and in
patients with prior history of ischemia, hypertension, diabetes, or
hyperlipidemia. Interrupt or stop Iclusig immediately in patients who
develop vascular occlusion events.
Heart Failure: Fatal and serious heart failure or left
ventricular dysfunction occurred in 5% of Iclusig-treated patients
(22/449). Eight percent of patients (35/449) experienced any grade of
heart failure or left ventricular dysfunction. Monitor patients for
signs or symptoms consistent with heart failure and treat as clinically
indicated, including interruption of Iclusig. Consider discontinuation
of Iclusig in patients who develop serious heart failure.
Hepatotoxicity: Iclusig can cause hepatotoxicity, including liver
failure and death. Fulminant hepatic failure leading to death occurred
in an Iclusig-treated patient within one week of starting Iclusig. Two
additional fatal cases of acute liver failure also occurred. The fatal
cases occurred in patients with blast phase CML (BP-CML) or Philadelphia
chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Severe
hepatotoxicity occurred in all disease cohorts. Iclusig treatment may
result in elevation in ALT, AST, or both. Monitor liver function tests
at baseline, then at least monthly or as clinically indicated.
Interrupt, reduce or discontinue Iclusig as clinically indicated.
Hypertension: Treatment-emergent hypertension (defined as
systolic BP≥140 mm Hg or diastolic BP≥90 mm Hg on at least one occasion)
occurred in 67% of patients (300/449). Eight patients treated with
Iclusig (2%) experienced treatment-emergent symptomatic hypertension as
a serious adverse reaction, including one patient (<1%) with
hypertensive crisis. Patients may require urgent clinical intervention
for hypertension associated with confusion, headache, chest pain, or
shortness of breath. In 131 patients with Stage 1 hypertension at
baseline, 61% (80/131) developed Stage 2 hypertension. Monitor and
manage blood pressure elevations during Iclusig use and treat
hypertension to normalize blood pressure. Interrupt, dose reduce, or
stop Iclusig if hypertension is not medically controlled.
Pancreatitis: Clinical pancreatitis occurred in 6% (28/449) of
patients (5% Grade 3) treated with Iclusig. Pancreatitis resulted in
discontinuation or treatment interruption in 6% of patients (25/449).
The incidence of treatment-emergent lipase elevation was 41%. Check
serum lipase every 2 weeks for the first 2 months and then monthly
thereafter or as clinically indicated. Consider additional serum lipase
monitoring in patients with a history of pancreatitis or alcohol abuse.
Dose interruption or reduction may be required. In cases where lipase
elevations are accompanied by abdominal symptoms, interrupt treatment
with Iclusig and evaluate patients for pancreatitis. Do not consider
restarting Iclusig until patients have complete resolution of symptoms
and lipase levels are less than 1.5 x ULN.
Neuropathy: Peripheral and cranial neuropathy have occurred in
Iclusig-treated patients. Overall, 13% (59/449) of Iclusig-treated
patients experienced a peripheral neuropathy event of any grade (2%,
grade 3/4). In clinical trials, the most common peripheral neuropathies
reported were peripheral neuropathy (4%, 18/449), paresthesia (4%,
17/449), hypoesthesia (2%, 11/449), and hyperesthesia (1%, 5/449).
Cranial neuropathy developed in 1% (6/449) of Iclusig-treated patients
(<1% grade 3/4). Of the patients who developed neuropathy, 31% (20/65)
developed neuropathy during the first month of treatment. Monitor
patients for symptoms of neuropathy, such as hypoesthesia,
hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic
pain or weakness. Consider interrupting Iclusig and evaluate if
neuropathy is suspected.
Ocular Toxicity: Serious ocular toxicities leading to blindness
or blurred vision have occurred in Iclusig-treated patients. Retinal
toxicities including macular edema, retinal vein occlusion, and retinal
hemorrhage occurred in 3% of Iclusig-treated patients. Conjunctival or
corneal irritation, dry eye, or eye pain occurred in 13% of patients.
Visual blurring occurred in 6% of the patients. Other ocular toxicities
include cataracts, glaucoma, iritis, iridocyclitis, and ulcerative
keratitis. Conduct comprehensive eye exams at baseline and periodically
during treatment.
Hemorrhage: Serious bleeding events, including fatalities,
occurred in 5% (22/449) of patients treated with Iclusig. Hemorrhagic
events occurred in 24% of patients. The incidence of serious bleeding
events was higher in patients with accelerated phase CML (AP-CML),
BP-CML, and Ph+ ALL. Most hemorrhagic events, but not all occurred in
patients with grade 4 thrombocytopenia. Interrupt Iclusig for serious or
severe hemorrhage and evaluate.
Fluid Retention: Serious fluid retention events occurred in 3%
(13/449) of patients treated with Iclusig. One instance of brain edema
was fatal. In total, fluid retention occurred in 23% of the patients.
The most common fluid retention events were peripheral edema (16%),
pleural effusion (7%), and pericardial effusion (3%). Monitor patients
for fluid retention and manage patients as clinically indicated.
Interrupt, reduce, or discontinue Iclusig as clinically indicated.
Cardiac Arrhythmias: Symptomatic bradyarrhythmias that led to a
requirement for pacemaker implantation occurred in 1% (3/449) of
Iclusig-treated patients. Advise patients to report signs and symptoms
suggestive of slow heart rate (fainting, dizziness, or chest pain).
Supraventricular tachyarrhythmias occurred in 5% (25/449) of
Iclusig-treated patients. Atrial fibrillation was the most common
supraventricular tachyarrhythmia and occurred in 20 patients. For 13
patients, the event led to hospitalization. Advise patients to report
signs and symptoms of rapid heart rate (palpitations, dizziness).
Interrupt Iclusig and evaluate.
Myelosuppression: Severe (grade 3 or 4) myelosuppression occurred
in 48% (215/449) of patients treated with Iclusig. The incidence of
these events was greater in patients with AP-CML, BP-CML and Ph+ ALL
than in patients with CP-CML. Obtain complete blood counts every 2 weeks
for the first 3 months and then monthly or as clinically indicated, and
adjust the dose as recommended.
Tumor Lysis Syndrome: Two patients (<1%) with advanced disease
(AP-CML, BP-CML, or Ph+ ALL) treated with Iclusig developed serious
tumor lysis syndrome. Hyperuricemia occurred in 7% (30/449) of patients
overall; the majority had CP-CML (19 patients). Due to the potential for
tumor lysis syndrome in patients with advanced disease, ensure adequate
hydration and treat high uric acid levels prior to initiating therapy
with Iclusig.
Compromised Wound Healing and Gastrointestinal Perforation: Since
Iclusig may compromise wound healing, interrupt Iclusig for at least 1
week prior to major surgery. Serious gastrointestinal perforation
(fistula) occurred in one patient 38 days post-cholecystectomy.
Embryo-Fetal Toxicity: Iclusig can cause fetal harm. If Iclusig
is used during pregnancy, or if the patient becomes pregnant while
taking Iclusig, the patient should be apprised of the potential hazard
to the fetus. Advise women to avoid pregnancy while taking Iclusig.
Most common non-hematologic adverse reactions: (≥20%) were
hypertension, rash, abdominal pain, fatigue, headache, dry skin,
constipation, arthralgia, nausea, and pyrexia. Hematologic adverse
reactions included thrombocytopenia, anemia, neutropenia, lymphopenia,
and leukopenia.
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).
This press release contains “forward-looking statements” including, but
not limited to, updates on clinical, preclinical and regulatory
developments and commercialization plans for our products and product
candidates and financial guidance for 2015. Forward-looking statements
are based on management's good faith 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;
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 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. After the date of this
document, the Company does not intend to update any of the
forward-looking statements 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
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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(Unaudited)
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In thousands, except per share data
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Three Months Ended
December 31,
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Year Ended
December 31,
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2014
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2013
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2014
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2013
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Revenue:
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Product revenue, net
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$
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21,349
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$
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8,281
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$
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55,720
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$
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45,238
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License and other revenue
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|
|
45,486
|
|
|
|
|
|
72
|
|
|
|
|
|
49,692
|
|
|
|
|
|
323
|
|
Total revenue
|
|
|
|
|
66,835
|
|
|
|
|
|
8,353
|
|
|
|
|
|
105,412
|
|
|
|
|
|
45,561
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenue
|
|
|
|
|
947
|
|
|
|
|
|
8,699
|
|
|
|
|
|
5,224
|
|
|
|
|
|
9,612
|
|
Research and development
|
|
|
|
|
32,645
|
|
|
|
|
|
35,824
|
|
|
|
|
|
120,593
|
|
|
|
|
|
162,900
|
|
Selling, general and administrative
|
|
|
|
|
40,379
|
|
|
|
|
|
37,637
|
|
|
|
|
|
139,790
|
|
|
|
|
|
146,615
|
|
Total operating expenses
|
|
|
|
|
73,791
|
|
|
|
|
|
82,160
|
|
|
|
|
|
265,607
|
|
|
|
|
|
319,127
|
|
Other income (expense), net
|
|
|
|
|
1,636
|
|
|
|
|
|
(172
|
)
|
|
|
|
|
(1,777
|
)
|
|
|
|
|
(153
|
)
|
Provision for income taxes
|
|
|
|
|
251
|
|
|
|
|
|
184
|
|
|
|
|
|
630
|
|
|
|
|
|
439
|
|
Net loss
|
|
|
|
$
|
(5,751
|
)
|
|
|
|
$
|
(74,163
|
)
|
|
|
|
$
|
(162,602
|
)
|
|
|
|
$
|
(274,158
|
)
|
Net loss per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-- basic and diluted
|
|
|
|
$
|
(0.03
|
)
|
|
|
|
$
|
(0.40
|
)
|
|
|
|
$
|
(0.87
|
)
|
|
|
|
$
|
(1.49
|
)
|
Weighted-average number of shares of common stock outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-- basic and diluted
|
|
|
|
|
187,226
|
|
|
|
|
|
185,699
|
|
|
|
|
|
186,835
|
|
|
|
|
|
183,575
|
|
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
|
|
|
|
|
|
|
|
|
|
|
|
In thousands
|
|
|
|
|
December 31,
2014
|
|
|
|
|
December 31,
2013
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
$
|
352,688
|
|
|
|
$
|
237,179
|
Total assets
|
|
|
|
$
|
603,870
|
|
|
|
$
|
370,894
|
Total liabilities
|
|
|
|
$
|
523,069
|
|
|
|
$
|
185,377
|
Stockholders’ equity
|
|
|
|
$
|
80,801
|
|
|
|
$
|
185,517
|
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION
|
|
|
|
|
|
|
|
In thousands
|
|
|
|
|
Year Ended
December 31,
|
|
|
|
|
|
|
2014
|
|
|
|
|
2013
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
|
$
|
(57,794)
|
|
|
|
$
|
(221,882
|
)
|
Net cash provided by (used in) investing activities
|
|
|
|
|
1,981
|
|
|
|
|
26,138
|
|
Net cash provided by financing activities
|
|
|
|
|
171,060
|
|
|
|
|
313,584
|
|
Effect of exchange rates on cash
|
|
|
|
|
262
|
|
|
|
|
(40)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents
|
|
|
|
$
|
115,509
|
|
|
|
$
|
117,800
|
|
CONTACT:
ARIAD Pharmaceuticals, Inc.
For Investors
Kendra
Adams, 617-503-7028
Kendra.adams@ariad.com
or
For
Media
Liza Heapes, 617-621-2315
Liza.heapes@ariad.com
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