~Recorded Net Product Revenue of $33.6
million for the first quarter of 2016; growth of 41% from prior
year
~Provides guidance for 2016, including
strengthened year-end cash position, following announced Incyte
transaction:
- Global product and royalty revenue of
$170 million to $180 million
- R&D expense of $175 million to $180
million
- SG&A expense of $120 million to
$125 million
- Year-end cash of $280 million to $290
million
~Conference Call Scheduled Today at 8:30
a.m. ET
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported
financial results for the first quarter of 2016, including revenue
from sales of Iclusig® (ponatinib). The Company also provided an
update on corporate developments and its ongoing strategic review
and provided financial guidance following its announced transaction
with Incyte Corporation.
“Iclusig demonstrated strong performance in both the U.S. and
European markets during the first quarter of 2016 compared to the
prior year period, primarily driven by increasing demand and new
patient growth,” said Paris Panayiotopoulos, president and chief
executive officer of ARIAD. “Following our major announcement
yesterday with Incyte regarding our agreement to divest our
European operations and license the commercial rights to Iclusig in
Europe, we are on track to complete our strategic review this
quarter aimed at delivering patient and shareholder value. We also
look forward to the presentation of pivotal, registration data on
brigatinib at ASCO, along with our planned filing for marketing
approval of brigatinib in the U.S. in the third quarter of this
year.”
2016 First Quarter Financial
Results
Revenues
- Net product revenues from sales of
Iclusig were $33.6 million for the first quarter of 2016, compared
to $23.9 million in the first quarter of 2015, representing growth
of 41%. Excluding the impact of one-time revenue of $1.2 million
recognized in Q1 2015 in connection with our transition to the
sell-in method in the U.S., worldwide growth would have been 48%.
- U.S. sales of Iclusig were $24.9
million for the first quarter of 2016, compared to $18.7 million in
the first quarter of 2015, representing growth of 33%. Excluding
the impact of one-time revenue of $1.2 million recognized in Q1
2015 in connection with our transition to the sell-in method, U.S.
growth would have been 42%.
- European sales of Iclusig were $8.7
million for the first quarter of 2016, compared to $5.2 million in
the first quarter of 2015, representing growth of 67%. This
difference is primarily due to increased demand and the launch of
Iclusig in new countries.
GAAP and Non-GAAP Net Loss
GAAP net loss for the quarter ended March 31, 2016 was $53.8
million, or $0.28 loss per share, compared to GAAP net loss of
$52.7 million, or $0.28 loss per share, for the quarter ended March
31, 2015.
Non-GAAP net loss for the quarter ended March 31, 2016 was $44.1
million, or $0.23 loss per share, compared to non-GAAP net loss of
$44.2 million, or $0.24 per share for the quarter ended March 31,
2015.
Non-GAAP net loss excludes stock-based compensation and
restructuring charges. See “Use of Non-GAAP Financial Measures”
below for a description of non-GAAP financial measures and the
reconciliation between GAAP and non-GAAP measures at the end of
this press release.
Operating Expenses
- GAAP R&D expenses were $44.1
million for the first quarter of 2016, an increase of 12% compared
to the first quarter of 2015, reflecting an increase in costs for
our investigational ALK+ inhibitor, brigatinib, related to the
ongoing Phase 2 ALTA trial and NDA-enabling pre-clinical studies,
as well as increase in personnel and other costs in support of our
R&D activities.
- GAAP selling, general and
administrative expenses were $36.0 million for the first quarter of
2016, an increase of 7% compared to the first quarter of 2015,
reflecting an increase in professional fees and other expenses
related to the commercialization of Iclusig.
- Restructuring charge expenses were $2.9
million for the first quarter of 2016, associated with employee
workforce reductions of approximately 90 positions.
Cash Position
- As of March 31, 2016, cash, cash
equivalents and marketable securities totaled $168.3 million,
compared to $242.3 million at December 31, 2015.
2016 Financial Guidance
- Following the anticipated closing of
the transaction announced yesterday in which ARIAD has agreed to
sell its European operations and license commercial rights to
Iclusig in Europe to Incyte, we are revising our product revenue
guidance for 2016 and providing expense and year-end cash guidance
for 2016, as follows:
- Cash position at December 31, 2016 is
expected to be in the range of $280 million to $290 million,
including the $140 million upfront payment from Incyte and $50
million to be received under our royalty financing agreement with
PDL.
- The foregoing 2016 financial guidance
reflects the anticipated completion of the transaction with Incyte,
which is expected to close on or about June 1, 2016, subject to
customary closing conditions. In addition, the revenue guidance
assumes that pricing and reimbursement approval in France (and the
corresponding recognition of revenue) will occur prior to the
closing of the Incyte transaction.
Recent Progress and Key
Objectives
Iclusig Clinical Development
- Patient enrollment is ongoing in the
OPTIC and OPTIC-2L clinical trials in patients with resistant
chronic-phase chronic myeloid leukemia (CP-CML)
- Otsuka Pharmaceutical Co., Ltd.
(Otsuka) 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
- The ALTA 1L randomized, front-line
clinical trial of brigatinib opened to patient enrollment in early
April and is now underway. This global, 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.
- Clinical data from the Phase 2 ALTA
trial of brigatinib has been accepted for oral presentation at this
year’s annual meeting of the American Society of Clinical Oncology
(ASCO) in June, 2016. We are on track to file for approval of
brigatinib in the U.S. in the third quarter of this year.
Advancing the Pipeline
- Preclinical data on AP32788 were
presented at last month’s American Association of Clinical Research
meeting and a Phase 1/2 proof-of-concept clinical trial is now open
to patient enrollment.
AP32788 targets tumors driven by EGFR or HER2
kinases and was designed to achieve selective inhibition of exon 20
mutations in these kinases. ARIAD estimates that there are
approximately 6,000 patients in the United States living with EGFR
exon 20 or HER2 point mutations.
Upcoming Meetings
- American Society of Clinical Oncology
(ASCO) 2016 Annual Meeting, Chicago, June 3 to June 7, 2016
- Jefferies Healthcare Conference, New
York City, June 7-10, 2016
- European Hematology Association (EHA)
20th Congress, Austria, Vienna June 9 to 12, 2016
- ARIAD Analyst and Investor Day, New
York City, June 17, 2016
Today’s Conference Call at 8:30 a.m. ET
We will hold a live webcast and conference call of our first
quarter 2016 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 84030796. A replay of the call will be
available on the ARIAD website approximately two hours after
completion of the call and will be archived for three weeks.
About Iclusig® (ponatinib) tablets
Iclusig is a kinase inhibitor. The primary target for Iclusig is
BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic
myeloid leukemia (CML) and Philadelphia-chromosome positive acute
lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using
ARIAD’s computational and structure-based drug-design platform
specifically to inhibit the activity of BCR-ABL. Iclusig targets
not only native BCR-ABL but also its isoforms that carry mutations
that confer resistance to treatment, including the T315I mutation,
which has been associated with resistance to other approved
TKIs.
Iclusig is approved in the U.S., EU, Australia, Switzerland,
Israel and Canada.
In the U.S., Iclusig is a kinase inhibitor indicated for
the:
- Treatment of adult patients with
T315I-positive chronic myeloid leukemia (chronic phase, accelerated
phase, or blast phase) or T315I-positive Philadelphia chromosome
positive acute lymphoblastic leukemia (Ph+ ALL).
- Treatment of adult patients with
chronic phase, accelerated phase, or blast phase chronic myeloid
leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor
(TKI) therapy is indicated.
IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED
WARNINGWARNING: VASCULAR OCCLUSION, HEART FAILURE, and
HEPATOTOXICITYSee full prescribing information for complete
boxed warning
- Vascular Occlusion: Arterial and
venous thrombosis and occlusions have occurred in at least 27% of
Iclusig treated patients, including fatal myocardial infarction,
stroke, stenosis of large arterial vessels of the brain, severe
peripheral vascular disease, and the need for urgent
revascularization procedures. Patients with and without
cardiovascular risk factors, including patients less than 50 years
old, experienced these events. Monitor for evidence of
thromboembolism and vascular occlusion. Interrupt or stop Iclusig
immediately for vascular occlusion. A benefit risk consideration
should guide a decision to restart Iclusig therapy.
- Heart Failure, including fatalities,
occurred in 8% of Iclusig-treated patients. Monitor cardiac
function. Interrupt or stop Iclusig for new or worsening heart
failure.
- Hepatotoxicity, liver failure and
death have occurred in Iclusig-treated patients. Monitor hepatic
function. Interrupt Iclusig if hepatotoxicity is
suspected.
Please see the full U.S. Prescribing Information
for Iclusig, including the Boxed Warning, for additional
important safety information.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts and Lausanne, Switzerland, is an orphan 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 orphan 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).
Use of Non-GAAP Financial Measures
This press release contains non-GAAP financial measures,
including costs and expenses and other expenses adjusted to exclude
certain cash and non-cash expenses. These measures are not in
accordance with, or an alternative to, generally accepted
accounting principles, or GAAP, and may be different from non-GAAP
financial measures used by other companies. The items included in
GAAP presentations but excluded for purposes of determining
non-GAAP financial measures for the periods presented in this press
release are: (i) employee-related non-cash expenses, including
stock-based compensation expense, which may fluctuate from period
to period based on factors including the timing and accounting of
grants for stock options, restricted stock units and performance-
based stock units and changes in the Company’s stock price which
impacts the fair value of these awards, and (ii) restructuring
charge expenses associated with employee workforce reductions. The
Company believes the presentation of non-GAAP financial measures
provides useful information to management and investors regarding
various financial and business trends relating to our financial
condition and results of operations. When GAAP financial measures
are viewed in conjunction with non-GAAP financial measures,
investors are provided with a more meaningful understanding of our
ongoing operating performance. In addition, these non-GAAP
financial measures are among those indicators the Company uses as a
basis for evaluating operational performance, allocating resources
and planning and forecasting future periods. Non-GAAP financial
measures are not intended to be considered in isolation or as a
substitute for GAAP financial measures. To the extent this release
contains historical or future non-GAAP financial measures, the
Company has also provided corresponding GAAP financial measures for
comparative purposes. Reconciliation between certain GAAP and
non-GAAP measures is provided at the end of this press release.
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 the statements related to our
financial and operational guidance, the closing of our transaction
with Incyte, including the anticipated benefits of the transaction
and impact on our results of operations and financial position, our
proposed presentation of clinical data from the Phase 2 ALTA trial
of brigatinib at ASCO in June 2016, the expected timing for filing
of approval for brigatinib in the U.S., and the clinical
development plans for our product candidates, along with the
statements made by our Chief Executive Officer, 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)
In thousands, except per share data
Three Months EndedMarch
31,
2016 2015
Revenue:
Product revenue, net $ 33,633 $ 23,901 License and other revenue
1,964 90 Total revenue 35,597 23,991 Operating expenses: Cost of
product revenue 486 695 Research and development 44,079 39,444
Selling, general and administrative 35,977 33,550 Restructuring
charges 2,918 --- Total operating expenses 83,460 73,689
Other expense, net (5,672) (2,764) Provision for income taxes 252
214 Net loss $ (53,787 ) $ (52,676 ) Net loss per common share: --
basic and diluted $ (0.28) $ (0.28 ) Weighted-average number of
shares of common stock outstanding: -- basic and diluted 190,304
187,837
CONDENSED CONSOLIDATED BALANCE SHEET
INFORMATION
(Unaudited)
In thousands
March 31,2016
December 31,2015
Cash, cash equivalents and marketable securities $ 168,348 $
242,295 Total assets $ 502,549 $ 546,692 Total liabilities $
656,561 $ 649,833 Stockholders’ deficit $ (154,012) $ (103,141)
CONDENSED CONSOLIDATED STATEMENT OF
CASH FLOWS INFORMATION
(Unaudited)
In thousands
Three Months EndedMarch
31,
2016 2015 Net cash used in
operating activities $ (65,095) $ (50,194 ) Net cash used in
investing activities (15,300) (754) Net cash provided by financing
activities 10,478 2,051 Effect of exchange rates on cash (44) 225
Net decrease in cash and cash equivalents $ (69,961) $
(48,672)
Reconciliation of Selected GAAP
Measures to Non-GAAP Measures (1)
(Unaudited)
In thousands, except per share data
Three Months EndedMarch
31,
2016 2015 Reconciliation of GAAP to
non-GAAP Net loss: GAAP Net loss $ (53,787) $ (52,676) Add:
Stock-based compensation (2) 6,719 8,434 Add: Restructuring charges
(3) 2,918 - Non-GAAP Net loss $ (44,150) $ (44,242)
Three Months EndedMarch
31,
2016 2015 Reconciliation of GAAP to non-GAAP
Net loss per share: GAAP Net loss per share $ (0.28) $ (0.28) Add:
Stock-based compensation (2) 0.03 0.04 Add: Restructuring charges
(3) 0.02 - Non-GAAP Net loss per share $ (0.23) $ (0.24)
(1) This presentation includes non-GAAP measures. The Company’s
non-GAAP measures are not meant to be considered in isolation or as
a substitute for comparable GAAP measures and should be read only
in conjunction with its financial statements prepared in accordance
with GAAP.
(2) All stock-based compensation expenses were excluded for the
non-GAAP analysis.
(3) Restructuring charges associated with employee workforce
reductions were excluded for the non-GAAP analysis.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160510005888/en/
For InvestorsMaria Cantor,
617-621-2208Maria.cantor@ariad.comorFor MediaLiza Heapes,
617-621-2315Liza.heapes@ariad.com
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