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): August
6, 2014
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
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Results of Operations and Financial Condition.
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In a press release dated August 6, 2014, ARIAD Pharmaceuticals, Inc.
(the “Company”) announced financial results for the second quarter ended
June 30, 2014 and provided an update on corporate developments. A copy
of the press release is attached hereto as Exhibit 99.1. The information
under the headings “2014 Second Quarter Financial Results” and “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
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Regulation FD Disclosure.
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In the press release dated August 6, 2014, the Company also provided
updated financial guidance and information regarding upcoming medical
and investor meetings. The information set forth under the headings
“Financial Guidance for 2014,” “Upcoming Medical Meeting” 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.
In the press release dated August 6, 2014, the Company also provided an
update on its Iclusig® and AP26113 programs. The second
paragraph of the press release and the information set forth under the
heading “Recent Progress on 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
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Financial Statements and Exhibits.
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(d) Exhibits.
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Exhibit
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Description
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99.1
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Press release dated August 6, 2014.
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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 August 6, 2014
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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August 6, 2014
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Exhibit 99.1
ARIAD
Reports Second Quarter 2014 Financial Results and Development Progress
Conference
Call Scheduled Today at 8:30 a.m. ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--August 6, 2014--ARIAD
Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results
for the second quarter of 2014, including revenue from sales of Iclusig®
(ponatinib). The Company also provided an update on corporate
developments.
“We made steady progress in the second quarter on Iclusig sales in both
the U.S. and Europe, and expect this momentum to build in the second
half of the year,” said Harvey J. Berger, M.D., chairman and chief
executive officer of ARIAD. “We are also focused on initiating a new
randomized dose-ranging trial for Iclusig aimed at further improving the
benefit/risk profile of this approved medicine and accelerating patient
enrollment in the ALTA clinical trial of AP26113 in patients with
ALK-positive non-small cell lung cancer.”
2014 Second Quarter Financial Results
Revenues
Total revenue for the quarter ended June 30, 2014 was $12.1 million,
which includes product revenue from sales of Iclusig and license revenue.
Net product revenues from sales of Iclusig were $11.9 million for the
quarter ended June 30, 2014. Net product revenues for the quarter
include Iclusig revenues of $7.9 million in the U.S. and $4.0 million in
Europe. Net revenues reported exclude $3.6 million related to the
following items:
-
Deferred revenue of $1.3 million in the U.S., representing Iclusig
inventory on hand at our specialty pharmacy as of June 30, 2014 but
not yet shipped to patients as of the end of the quarter.
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Shipments of $2.3 million of Iclusig to patients in France during the
second quarter ($16.8 million cumulatively through June 30, 2014). We
will record revenue related to cumulative shipments to patients in
France upon completion of pricing and reimbursement negotiations, net
of any amounts that will be refunded to the French health authorities
based on the results of such negotiations. We now anticipate that such
negotiations will be completed in the first half of 2015.
Net Income/Loss
Net loss for the quarter ended June 30, 2014 was $56.9 million, or $0.30
per share, compared to net loss of $69.0 million, or $0.37 per share,
for the same period in 2013.
Research and development expenses decreased by $8.9 million, or 22%,
from the second quarter of 2013 to the second quarter of 2014,
predominantly reflecting a decrease in clinical trial costs, as well as
decreased manufacturing and other supporting costs related to Iclusig
clinical trials, and decreased personnel and related costs reflecting
the impact of the Company’s reduction in workforce effected in the
fourth quarter of 2013. These decreases were offset, in part, by
increases in clinical-trial and related costs for AP26113 due to the
initiation of the pivotal Phase 2 ALTA trial.
Selling, general and administrative expenses decreased by $7.9 million,
or 19%, from the second quarter of 2013 to the second quarter of 2014,
reflecting a decrease in personnel expenses in the U.S. as a result of
the reduction in workforce in the fourth quarter of 2013 and a decrease
in expenses related to sales and marketing initiatives and other
consulting services in support of the initial commercial launch of
Iclusig in the U.S. in 2013. These decreases were offset, in part, by an
increase in personnel and other expenses in Europe due to the launch of
Iclusig in various European countries in the second half of 2013.
Cash Position
In June, the Company completed a private placement of convertible senior
notes due 2019, resulting in $177.3 million in net proceeds to ARIAD,
after expenses and the cost of related bond hedge and warrant
transactions. Also in June, the Company paid off the remaining $8.0
million balance of its outstanding bank term loan.
As of June 30, 2014, cash and cash equivalents totaled $310.0 million,
compared to $183.0 million at March 31, 2014.
Financial Guidance for 2014
We anticipate cash used in operations in 2014 to range from $165 million
to $175 million, unchanged from prior guidance.
We now expect that our cash, cash equivalents and marketable securities
at December 31, 2014 will range from $230 million to $235 million,
sufficient to fund operations into the second half of 2016. This does
not take into account any commercial agreements for Iclusig that may be
entered into during this period.
Recent Progress on Key Objectives
Commercialization of Iclusig
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Through June 30, 2014, more than 500 patients in the U.S. received
Iclusig obtained commercially based on physicians’ prescriptions.
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By the end of the second quarter, there were over 400 unique
prescribers of Iclusig in the U.S., an increase in the prescriber base
of approximately one-third from the first quarter.
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Approximately 60 percent of prescribers are community-based
physicians, with the remainder being physicians practicing in academic
medical centers. We expect that adoption of Iclusig among community
oncologists and hematologists will continue to increase as utilization
progresses further.
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In Europe, we continue selling Iclusig in Germany, the United Kingdom,
France, Austria, the Netherlands, Norway, and Sweden.
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The review of Iclusig under the Article 20 procedure by the
Pharmacovigilance Risk Assessment Committee (PRAC) is ongoing in
Europe. This procedure is aimed at obtaining a better understanding of
the adverse events observed with Iclusig and proposing potential ways
to further improve its benefit/risk profile. Responses have been
submitted to the PRAC’s questions regarding proposed dose
modifications after achievement of a response and patient monitoring
and details concerning a risk management plan. Following input from
the agency’s Scientific Advisory Group in September, we expect that
the PRAC will complete its review and make final recommendations to
the Committee for Medicinal Products for Human Use (CHMP) at its
meeting in October 2014.
Iclusig Clinical Development
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We continue to work with the U.S. Food and Drug Administration and the
European Medicines Agency to finalize the randomized trial to evaluate
a variety of doses of Iclusig. We expect to complete these discussions
and have an agreed-upon protocol this year.
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Six investigator-sponsored trials are now open to patient enrollment:
a U.S. trial in patients with non-small cell lung cancer (NSCLC) with
RET translocation, a U.S. trial in patients with RET translocation
and/or FGFR1 amplification, a U.S. trial in patients with medullary
thyroid cancer with or without RET mutations, a U.S. trial in
endometrial cancer patients with FGFR2 mutations, a French trial in
patients with FLT3-positive acute myeloid leukemia (AML), and a UK
trial in patients with Philadelphia chromosome-positive (Ph+) acute
lymphoblastic leukemia (ALL).
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Nine additional investigator-sponsored trials are pending regulatory
or institutional review board (IRB) approval; these include
investigations in chronic-phase and blast-phase CML, Ph+ALL, AML, and
bile duct carcinoma with FGFR fusions.
Advancing AP26113
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A pivotal global Phase 2 trial of AP26113 in patients with locally
advanced or metastatic non-small cell lung cancer (NSCLC) who were
previously treated with crizotinib continues to enroll patients. The
ALTA trial is designed to determine the safety and efficacy of AP26113
in refractory NSCLC patients who have tested positive for the
anaplastic lymphoma kinase (ALK+) oncogene. The trial will enroll
approximately 220 patients in the United States and Europe, including
those with brain metastasis.
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We will present an update from the ongoing Phase 1/2 clinical trial of
AP26113 at the 2014 ESMO annual meeting.
Upcoming Medical Meeting
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European Society of Medical Oncology (ESMO) 2014 Annual Meeting,
Madrid, Spain, September 26 to 30, 2014
Upcoming Investor Meetings
ARIAD management will be making corporate presentations at the following
investor conferences:
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Citi Biotech Conference, Boston, September 3-4, 2014
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Stifel Healthcare Conference, New York, November 18, 2014
Today’s Conference Call at 8:30 a.m. ET
We will hold a live webcast and conference call of our first quarter
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 37600188. 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.
Important U.S. Safety Information for Iclusig®
(ponatinib)
WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY
See full U.S. 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.
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).
Iclusig® is a registered trademark of ARIAD
Pharmaceuticals, Inc.
This press release contains “forward-looking statements” including, but
not limited to, updates on clinical and regulatory developments and
commercialization plans for our products and product candidates and
financial guidance for 2014. Forward-looking statements 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 risks and uncertainties include, but are not
limited to, 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; our ability to meet anticipated
clinical trial commencement and completion dates; delays in or failure
of obtaining regulatory clearance for resumption of clinical trials;
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. The Company does not intend to update any of the forward-looking
statements after the date of this document to conform these statements
to actual results or to changes in the Company's expectations, except as
required by law.
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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
June 30,
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Six Months Ended
June 30,
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2014
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2013
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2014
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2013
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Total revenue
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$
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12,114
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$
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14,011
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$
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23,895
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$
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20,476
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Operating expenses:
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Cost of product revenue
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2,395
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228
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3,683
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497
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Research and development
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31,794
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40,668
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60,348
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81,931
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Selling, general and administrative
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34,199
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42,101
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65,790
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71,583
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Total operating expenses
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68,388
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82,997
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129,821
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154,011
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Other income (expense), net
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(541
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)
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87
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(592
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)
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25
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Provision for income taxes
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106
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86
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225
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145
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Net loss
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$
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(56,921
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)
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$
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(68,985
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$
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(106,743
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)
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$
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(133,655
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)
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Net loss per common share:
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-- basic and diluted
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$
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(0.30
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)
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$
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(0.37
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)
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$
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(0.57
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)
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$
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(0.74
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)
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Weighted-average number of shares of common stock outstanding:
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-- basic and diluted
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186,815
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184,726
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186,535
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181,651
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CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
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(Unaudited)
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In thousands
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June 30,
2014
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December 31,
2013
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Cash and cash equivalents
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$
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310,039
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$
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237,179
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Total assets
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$
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492,810
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$
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370,894
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Total liabilities
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$
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370,046
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$
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185,377
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Stockholders’ equity
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$
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122,764
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$
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185,517
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CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION
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(Unaudited)
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In thousands
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Six Months Ended
June 30,
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2014
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2013
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Net cash used in operating activities
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$
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(95,016
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)
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$
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(114,144
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)
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Net cash provided by (used in) investing activities
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(2,010
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)
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17,118
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Net cash provided by (used in) financing activities
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169,885
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309,563
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Effect of exchange rates on cash
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1
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(25
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)
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Net increase in cash and cash equivalents
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$
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72,860
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$
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212,512
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CONTACT:
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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