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
23, 2016
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 February 23, 2016, ARIAD Pharmaceuticals, Inc.
(the “Company”) announced financial results for the fourth quarter and
full year ended December 31, 2015 and issued 2016 product revenue
guidance. Additionally, the Company provided an update on corporate
developments and key objectives for 2016. A copy of the press release is
attached hereto as Exhibit 99.1. The information under the headings
“2015 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
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Regulation FD Disclosure.
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In the press release dated February 23, 2016, the Company also provided
product revenue guidance for 2016, as well as upcoming investor
meetings. The information set forth under the headings “2016 Product
Revenue 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.
In the press release dated February 23, 2016, the Company also provided
an update on its Iclusig®, brigatinib and pipeline
programs. The second paragraph of the press release and the information
set forth under the heading “Research and Development 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
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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 February 23, 2016.
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The press release may contain 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 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 23, 2016
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Exhibit List.
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Exhibit
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Description
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99.1
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Press release dated February 23, 2016.
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Exhibit 99.1
ARIAD
Reports 2015 Financial Results, Provides 2016 Product Revenue Guidance
and Outlines Company Progress
Iclusig
Net Product Revenue Guidance for 2016 in the Range of $190 Million to
$200 Million
Filing
for U.S. Marketing Approval of Brigatinib Expected This Year
Conference
Call Scheduled Today at 8:30 a.m. ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--February 23, 2016--ARIAD
Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results
for the fourth quarter and full year ended December 31, 2015 and issued
2016 product revenue guidance. Additionally, the Company provided an
update on corporate developments and key objectives for 2016.
”We had a strong fourth quarter of sales for Iclusig and 102 percent
growth year over year,” stated Paris Panayiotopoulos, president and
chief executive officer of ARIAD. “This is a very important year for
ARIAD as we work to complete our ongoing review of strategic initiatives
to deliver patient and shareholder value. In addition to maximizing
top-line growth of Iclusig, a key event this year will be the
presentation of pivotal, registration data on brigatinib at ASCO, along
with our planned filing for marketing approval of brigatinib in the U.S.”
2015 Fourth Quarter and Full-Year Financial Results
Revenues
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Net product revenues from sales of Iclusig were $33.3 million for the
fourth quarter of 2015, an increase of 56% from the fourth quarter of
2014.
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U.S. sales of Iclusig were $25.1 million for the fourth quarter,
an increase of 48% from the fourth quarter of 2014.
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European sales of Iclusig were $8.2 million for the fourth
quarter, an increase of 86% from the fourth quarter of 2014.
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Net product revenues from sales of Iclusig for the year ended December
31, 2015 were $112.5 million, an increase of 102% from 2014. In the
U.S., net product revenue totaled $85.7 million in 2015, an increase
of 114% from 2014, while in the EU, net product revenue totaled $26.8
million in 2015, an increase of 71% from 2014.
Net Loss
Quarter Ended December 31, 2015
-
Net loss for the fourth quarter ended December 31, 2015 was $59.9
million, or $0.32 per share, compared to a net loss of $5.8 million,
or $0.03 per share, for the same period in 2014. The net loss for 2014
included $50 million in non-recurring income resulting from an
amendment to our license agreement with Bellicum Pharmaceuticals, Inc.
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R&D expenses were $44.8 million for the fourth quarter of 2015, an
increase of 37% from the fourth quarter of 2014, reflecting an
increase in Iclusig clinical-trial costs, as well as increased
manufacturing and other supporting costs related to Iclusig.
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Selling, general and administrative expenses were $43.8 million for
the fourth quarter of 2015, an increase of 9% from the fourth quarter
of 2014, reflecting an increase in personnel and commercial-related
expenses.
Year Ended December 31, 2015
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Net loss for the full year 2015 was $231.2 million, or $1.23 per
share, compared to a net loss of $162.6 million, or $0.87 per share,
for the full year 2014. The net loss for 2014 included $50 million in
non-recurring income resulting from an amendment to our license
agreement with Bellicum, noted above. The net loss for 2015 includes
approximately $14.5 million in non-recurring expenses related to the
retirement of our chief executive officer and costs associated with
our 2015 proxy and legal matters.
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The 2015 results include an increase in Iclusig product revenue of
$56.8 million as well as an increase in operating expenses of $70.5
million in 2015 compared to 2014, reflecting an increase in R&D
expenses related to an increase in clinical-trial costs, as well as
manufacturing and other support costs related to Iclusig and
brigatinib clinical trials, and an increase in personnel and related
costs reflecting a larger number of R&D employees in 2015 compared to
2014.
Cash Position
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As of December 31, 2015, cash, cash equivalents and marketable
securities totaled $242.3 million, compared to $352.7 million in cash
and cash equivalents at December 31, 2014.
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Cash, cash equivalents and marketable securities include $50 million
we received in the third quarter of 2015 from PDL BioPharma, Inc.
(PDL) pursuant to a royalty financing agreement. In July 2016, we will
receive an additional $50 million from PDL. Under the agreement, we
also have an option, in our sole discretion, to receive up to an
additional $100 million through July 2016.
2016 Product Revenue Guidance
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Net product revenues from sales of Iclusig are expected to be in the
range of $190 million to $200 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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ARIAD will provide guidance on 2016 operating expenses at the time of
completing its ongoing strategic review expected in the second quarter
of 2016.
Research and Development Progress and Key Objectives
Iclusig Clinical Development
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Late last year we initiated the OPTIC-2L trial, a Phase 3 trial of
Iclusig in patients with chronic-phase chronic myeloid leukemia
(CP-CML) who have experienced treatment failure after imatinib
therapy. This second-line study of Iclusig is aimed at expanding the
indication for Iclusig in patients with resistant and intolerant CML.
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Patient enrollment is ongoing in the OPTIC (Optimizing Ponatinib
Treatment In CML) trial of Iclusig. This randomized, dose-ranging
trial is designed to evaluate three different starting doses of
ponatinib in patients with refractory CP-CML and is expected to inform
the optimal use of Iclusig in these patients.
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Otsuka Pharmaceutical Co., Ltd. (Otsuka), our commercial partner for
Iclusig in Japan and several other Asian countries, submitted a new
drug application (NDA) to the Japanese Pharmaceuticals and Medical
Devices Agency (PMDA) seeking approval for Iclusig for the treatment
of resistant or intolerant CML and Philadelphia-chromosome positive
acute lymphoblastic leukemia (Ph+ALL). This marketing application was
submitted in early 2016 and is expected to lead to an initial approval
of Iclusig in Japan by the end of this year.
Brigatinib Clinical Development
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We submitted clinical data from the Phase 2 ALTA trial of brigatinib
to this year’s annual meeting of the American Society of Clinical
Oncology (ASCO) in June, 2016. The ALTA trial enrolled approximately
220 patients at 71 sites in North America, Europe and Asia. In
addition to an anticipated data presentation at ASCO, we are on track
to file for approval of brigatinib in the U.S. in the third quarter of
this year. Brigatinib has received breakthrough-therapy designation
from the U.S. Food and Drug Administration.
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The randomized front-line clinical trial of brigatinib is expected to
begin in the second quarter of 2016. This Phase 3 trial is designed to
compare brigatinib and crizotinib in patients with ALK+ non-small cell
lung cancer (NSCLC), who have not received prior ALK inhibitors, and
is expected to serve as a confirmatory trial for accelerated approval
of brigatinib.
Advancing the Pipeline
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We submitted an investigational new drug (IND) application for AP32788
in late 2015 and received clearance from the U.S. Food and Drug
Administration at the end of January to begin a Phase 1/2
proof-of-concept clinical trial which we expect to begin in 2016.
AP32788 is an orally active tyrosine-kinase inhibitor (TKI), designed
to address the unmet medical need in NSCLC patients with specific EGFR
and HER2 kinase mutations. ARIAD estimates that there are
approximately 6,000 patients in the United States living with EGFR
exon 20 or HER2 point mutations.
Upcoming Investor Meetings
ARIAD management will be participating at the following investor
conferences:
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RBC Capital Markets’ Healthcare Conference, New York City, February
24, 2016
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Cowen and Company Healthcare Conference, Boston, March 9, 2016
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Barclays Global Healthcare Conference, Miami, March 17, 2016
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 2015 financial results this morning at 8:30 a.m. ET.
The live webcast can be accessed by visiting the investor relations
section of the Company’s website at http://investor.ariad.com.
The call can be accessed by dialing 888-311-8173 (domestic) or
330-863-3376 (international) five minutes prior to the start time and
providing the pass code 38796876. A replay of the call will be available
on the ARIAD website approximately two hours after completion of the
call and will be archived for three weeks.
About Iclusig® (ponatinib) tablets
Iclusig is a kinase inhibitor. The primary target for Iclusig is
BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic
myeloid leukemia (CML) and Philadelphia-chromosome positive acute
lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s
computational and structure-based drug-design platform specifically to
inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL
but also its isoforms that carry mutations that confer resistance to
treatment, including the T315I mutation, which has been associated with
resistance to other approved TKIs.
Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel and
Canada.
In the U.S., Iclusig is a kinase inhibitor indicated for the:
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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.
These indications are based upon response rate. There are no trials
verifying an improvement in disease-related symptoms or increased
survival with Iclusig.
IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED WARNING
WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY
See full prescribing information for complete boxed warning
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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).
Forward-Looking Statements
This press release contains forward-looking statements, each of which
are qualified in their entirety by this cautionary statement. Any
statements contained herein which do not describe historical facts,
including, but not limited to, statements regarding: our plans to
complete our ongoing review of strategic initiatives to deliver patient
and shareholder value; our efforts to maximize top-line growth of
Iclusig; our plans to present pivotal, registration data on brigatinib
at ASCO and file for marketing approval of brigatinib in the U.S.; the
receipt of additional funding from PDL; our 2016 product revenue
guidance and the assumptions used in developing that guidance; our plans
for the OPTIC and OPTIC-2L clinical trials of Iclusig and expected
regulatory approval in Japan; our plans to commence a front-line trial
of brigatinib; and our plans to commence a Phase 1/2 clinical trial of
AP32788, are forward-looking statements that are based on management's
expectations and are subject to certain factors, risks and uncertainties
that may cause actual results, outcome of events, timing and performance
to differ materially from those expressed or implied by such statements.
These factors, risks and uncertainties include, but are not limited to,
our ongoing strategic review, our ability to successfully commercialize
and generate profits from sales of Iclusig and our product candidates,
if approved; competition from alternative therapies; our ability to meet
anticipated clinical trial commencement, enrollment and completion dates
and regulatory filing dates for our products and product candidates and
to move new development candidates into the clinic; our ability to
execute on our key corporate initiatives; regulatory developments and
safety issues, including difficulties or delays in obtaining regulatory
and pricing and reimbursement approvals to market our products; our
reliance on the performance of third-party manufacturers and specialty
pharmacies for the supply and distribution of our products and product
candidates; the occurrence of adverse safety events with our products
and product candidates; the costs associated with our research,
development, manufacturing, commercialization and other activities; the
conduct, timing and results of preclinical and clinical studies of our
products and product candidates, including that preclinical data and
early-stage clinical data may not be replicated in later-stage clinical
studies; the adequacy of our capital resources and the availability of
additional funding; the ability to satisfy our contractual obligations,
including under our leases, convertible debt and royalty financing
agreements; patent protection and third-party intellectual property
claims; litigation; our operations in foreign countries; risks related
to key employees, markets, economic conditions, health care reform,
prices and reimbursement rates; and other risk factors detailed in our
public filings with the U.S. Securities and Exchange Commission,
including our most recent Annual Report on Form 10-K and subsequent
Quarterly Reports on Form 10-Q. Except as otherwise noted, these
forward-looking statements speak only as of the date of this press
release and we undertake no obligation to update or revise any of these
statements to reflect events or circumstances occurring after this press
release. We caution investors not to place considerable reliance on the
forward-looking statements contained in this press release.
ARIAD PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
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In thousands, except per share data
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Three Months Ended
December 31,
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Twelve Months Ended
December 31,
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2015
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2014
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2015
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2014
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Revenue:
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Product revenue, net
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$
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33,266
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$
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21,349
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$
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112,527
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$
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55,720
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License and other revenue
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3,239
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45,486
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6,277
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49,692
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Total revenue
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36,505
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66,835
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118,804
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105,412
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Operating expenses:
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Cost of product revenue
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449
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947
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2,114
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5,224
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Research and development
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44,814
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32,645
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171,216
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120,593
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Selling, general and administrative
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43,834
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40,379
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162,750
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139,790
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Total operating expenses
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89,097
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73,971
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336,080
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265,607
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Other income (expense), net
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(5,344)
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1,636
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(17,274)
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(1,777)
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Benefit from (provision for) income taxes
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(1,935)
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(251
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)
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3,394
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(630
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)
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Net loss
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$
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(59,871)
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$
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(5,751
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)
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$
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(231,156)
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$
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(162,602
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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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(0.32)
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$
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(0.03
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)
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$
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(1.23)
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$
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(0.87
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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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189,299
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187,226
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188,669
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186,835
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CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
(Unaudited)
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In thousands
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December 31, 2015
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December 31, 2014
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Cash, cash equivalents and marketable securities
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$
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242,295
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$
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352,688
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Total assets
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$
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546,692
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$
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603,116
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Total liabilities
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$
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649,833
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$
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522,315
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Stockholders’ equity (deficit)
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$
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(103,141)
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$
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80,801
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CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION
(Unaudited)
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In thousands
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Twelve Months Ended December 31,
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2015
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2014
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Net cash used in operating activities
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$
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(159,245)
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$
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(57,794)
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Net cash provided by (used in) investing activities
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(17,205)
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1,981
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Net cash provided by financing activities
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54,257
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171,060
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Effect of exchange rates on cash
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393
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262
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Net increase (decrease) in cash and cash equivalents
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$
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(121,800)
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$
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115,509
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CONTACT:
For Investors
Maria Cantor, 617-621-2208
Maria.Cantor@ariad.com
or
For
Media
Liza Heapes, 617- 621-2315
Liza.heapes@ariad.com
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