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): November
5, 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 November 5, 2014, ARIAD Pharmaceuticals, Inc.
(the “Company”) announced financial results for the third quarter ended
September 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 Third 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 November 5, 2014, the Company also provided
information regarding updated financial guidance for 2014 as well as
upcoming medical and investor meetings. The information set forth under
the headings “Financial Guidance for 2014,” “Upcoming Medical Meeting”
and “Upcoming Investor Meeting” 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 November 5, 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.
Exhibit
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Description
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99.1
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Press release dated November 5, 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
items. The remaining portions of the press release dated November 5,
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 it 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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November 5, 2014
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Exhibit 99.1
ARIAD
Reports Third Quarter 2014 Financial Results and Development Progress
Conference
Call Scheduled Today at 8:30 a.m. ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--November 5, 2014--ARIAD
Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results
for the third quarter of 2014, including revenue from sales of Iclusig®
(ponatinib). The Company also provided an update on corporate
developments.
“Our third quarter results show solid growth in U.S. sales of Iclusig
and continued commercial progress in Europe,” said Harvey J. Berger,
M.D., chairman and chief executive officer of ARIAD. “The EMA has
adopted its final opinion on Iclusig following the Article 20 review in
Europe, leaving the Iclusig indications unchanged, and we are now
focused on obtaining pricing and reimbursement in all key European
markets. As we head into the end of the year, we are also finalizing the
details of the new randomized dose-ranging trial for Iclusig aimed at
further improving the benefit-risk profile of Iclusig and accelerating
patient enrollment in the ALTA trial of AP26113 in patients with ALK+
non-small cell lung cancer, which we expect will be the basis for our
initial registration of AP26113.”
2014 Third Quarter Financial Results
Revenues
Total revenue for the quarter ended September 30, 2014 increased 21% to
$14.7 million, versus the second quarter of 2014. Total revenue includes
product revenue from sales of Iclusig and license revenue.
Net product revenues from sales of Iclusig were $14.5 million for the
quarter ended September 30, 2014, an increase of 22% from the second
quarter of 2014. Net product revenues for the quarter include Iclusig
revenues of $10.5 million in the U.S. and $4.0 million in Europe. Net
revenues reported do not include $2.9 million related to deferred
revenue of $1.2 million in the U.S., representing Iclusig inventory on
hand at our specialty pharmacy as of September 30, 2014 and shipment of
$1.7 million of Iclusig to patients in France during the quarter ($17.3
million cumulatively through September 30, 2014).
We will record revenue related to cumulative shipments in France upon
completion of pricing and reimbursement negotiations, 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 mid-2015.
Net Income/Loss
Net loss for the quarter ended September 30, 2014 was $50.1 million, or
$0.27 per share, compared to net loss of $66.3 million, or $0.36 per
share, for the same period in 2013.
Research and development expenses decreased by $17.5 million, or 39%,
from the third quarter of 2013 to the third 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 our investigational
anaplastic lymphoma kinase positive (ALK+) inhibitor, AP26113, due to
the initiation of the pivotal Phase 2 ALTA trial.
Selling, general and administrative expenses decreased by $3.8 million,
or 10%, from the third quarter of 2013 to the third 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
As of September 30, 2014, cash and cash equivalents totaled $273.5
million, compared to $310.0 million at June 30, 2014.
Financial Guidance for 2014
We now expect research and development expenses of $125 million to $130
million, compared to our previous guidance of $140 million to $150
million for 2014. The decrease in research and development spend is
driven by the cost of clinical trials, manufacturing and other
activities.
We anticipate cash used in operations in 2014 will now range from $150
million to $155 million, compared to our previous guidance of $165
million to $175 million. As a result, we expect that our cash, cash
equivalents and marketable securities at December 31, 2014 will range
from $250 million to $255 million, sufficient to fund operations into
the second half of 2016. This does not take into account any
distributorship or partnership agreements that may be entered into
during this period.
Recent Progress on Key Objectives
Commercialization of Iclusig
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Through September 30, 2014, approximately 650 patients in the U.S.
received Iclusig commercially.
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By the end of the third quarter, there were nearly 550 unique
prescribers of Iclusig in the U.S., an increase in the prescriber base
of approximately 38% from the second quarter.
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Approximately 60% of prescribers are community-based physicians, with
the remainder being physicians practicing in academic medical centers.
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In Europe, we are selling Iclusig in select countries and are working
to reach full pricing and reimbursement in additional European
countries by mid-2015.
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In October, the European Medicines Agency (EMA) endorsed the
recommendation by the Pharmacovigilance Risk Assessment Committee
(PRAC) that Iclusig continue to be used in Europe in accordance with
its already approved indications in Philadelphia-chromosome positive
leukemias. The authorized indications and the favorable benefit-risk
balance of Iclusig give healthcare providers the ability to optimize
the use of Iclusig in patients with resistant or intolerant chronic
myeloid leukemia (CML) and Philadelphia-chromosome positive acute
lymphoblastic leukemia (Ph+ ALL).
Iclusig Clinical Development
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We are working with the U.S. Food and Drug Administration (FDA) and
the European Medicines Agency to finalize the design of the randomized
trial to evaluate a range of starting doses of Iclusig. We expect to
complete these discussions and have a final trial protocol by year-end.
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Seven investigator-sponsored trials (ISTs) are open to patient
enrollment, and nine additional ISTs are pending regulatory or
institutional review board approval. This includes three trials in RET
driven non-small cell lung cancer (NSCLC), six trials in CML or
Ph+ALL, two trials in acute myeloid leukemia (AML) and various other
cancers.
Advancing AP26113
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AP26113 received Breakthrough Therapy designation from the FDA for the
treatment of patients with ALK+ metastatic NSCLC whose tumors are
resistant to crizotinib. Results from the ongoing Phase 1/2 trial show
sustained anti-tumor activity of AP26113 in patients with ALK+ NSCLC,
including patients with active brain metastases. As follow-up to the
Breakthrough Therapy designation, we will meet with FDA to discuss our
plans and timing regarding AP26113 regulatory submission.
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A pivotal global Phase 2 trial of AP26113 in patients with locally
advanced or metastatic 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 are positive for the ALK oncogene. The trial will enroll
approximately 220 patients in the United States, Europe and Asia,
including those with brain metastases.
Upcoming Medical Meeting
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56th Annual Meeting of the American Society of Hematology (ASH), San
Francisco, December 6 to 9, 2014.
Upcoming Investor Meeting
ARIAD management will be making corporate presentations at the following
investor conference:
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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 38094306. 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 September 30,
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Nine Months Ended September 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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14,682
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$
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16,732
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$
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38,577
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$
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37,208
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Operating expenses:
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Cost of product revenue
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594
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415
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4,277
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913
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Research and development
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27,600
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45,145
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87,948
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127,076
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Selling, general and administrative
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33,622
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37,395
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99,411
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108,977
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Total operating expenses
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61,816
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82,955
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191,636
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236,966
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Other income (expense), net
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(2,820
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)
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(6)
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(3,413)
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18
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Provision for income taxes
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154
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110
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379
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255
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Net loss
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$
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(50,108
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)
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$
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(66,339
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)
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$
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(156,851
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)
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$
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(199,995
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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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(0.27
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)
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$
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(0.36
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)
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$
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(0.84
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)
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$
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(1.09
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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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187,034
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185,238
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186,703
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182,859
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CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
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(Unaudited)
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In thousands
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September 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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273,451
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$
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237,179
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Total assets
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$
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483,692
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$
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370,894
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Total liabilities
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$
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402,600
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$
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185,377
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Stockholders’ equity
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$
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81,092
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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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Nine Months Ended September 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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(131,930
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)
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$
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(170,313
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)
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Net cash provided by (used in) investing activities
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(2,475)
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23,243
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Net cash provided by (used in) financing activities
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170,524
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312,157
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Effect of exchange rates on cash
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153
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(30)
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Net increase in cash and cash equivalents
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$
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36,272
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$
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165,057
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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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