~Product revenue of $65.3 million for Q2 2016,
including one-time $25.5 million from France
~U.S. product revenue of $32.6 million for Q2
2016, representing 50% growth from prior year
~Conference call scheduled today at 8:30 a.m.
ET
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported
financial results for the second quarter and first half of 2016,
including revenue from sales of Iclusig® (ponatinib). The Company
also provided an update on corporate developments.
“We had a strong second quarter, during which we initiated a
rolling NDA submission for brigatinib based on our data from the
ALTA pivotal trial, presented four-year data from the PACE clinical
trial for Iclusig, and advanced AP32788 for EGFR/HER2 exon 20
non-small cell lung cancer patients into a Phase 1/2 trial,” said
Paris Panayiotopoulos, president and chief executive officer of
ARIAD. “We also strengthened our financial position through our
agreement with Incyte and the strong sales performance of Iclusig.
Our teams are focused on Iclusig growth, preparations for the
potential launch of brigatinib in the U.S. and driving forward our
promising pipeline.”
Financial Results for the Quarter and
Six Months Ended June 30, 2016
Revenue
- Net product revenue from sales of
Iclusig were $65.3 million for the second quarter of 2016, compared
to $27.8 million in the second quarter of 2015; and $99.0 million
for the first half of 2016, compared to $51.7 million for the first
half of 2015. Net product revenue in the quarter and six months
ended June 30, 2016 includes one-time revenue of approximately
$25.5 million related to cumulative shipments of Iclusig in France
that were recorded upon obtaining pricing and reimbursement
approval in May 2016.
- U.S. sales of Iclusig were $32.6
million for the second quarter of 2016, compared to $21.7 million
in the second quarter of 2015, representing growth of 50 percent;
and $57.6 million for the first half of 2016, compared to $40.4
million for the first half of 2015, representing growth of 43
percent.
- European sales of Iclusig were $32.7
million for the second quarter of 2016, compared to $6.1 million in
the second quarter of 2015, representing growth of 436 percent; and
$41.4 million for the first half of 2016, compared to $11.3 million
for the first half of 2015, representing growth of 266 percent.
European sales for the second quarter of 2016 included the one-time
French revenue of $25.5 million noted above and approximately $7.2
million of product revenue in the first two months of the second
quarter of 2016. On June 1, 2016, ARIAD out-licensed the rights to
Iclusig in Europe to Incyte Corporation (Incyte). From June 1,
2016, ARIAD records royalty revenue based on tiered royalty rates
from Iclusig sales in Europe recognized by Incyte.
GAAP and Non-GAAP Net Income (Loss)
GAAP net income for the quarter ended June 30, 2016 was $109.8
million, or $0.57 and $0.56 per basic and diluted share,
respectively, compared to GAAP net loss of $63.2 million, or $0.33
loss per basic and diluted share, for the quarter ended June 30,
2015. GAAP net income for the six months ended June 30, 2016 was
$56.1 million, or $0.29 per basic and diluted share, compared to
GAAP net loss of $115.8 million, or $0.62 loss per basic and
diluted share, for the six months ended June 30, 2015. During the
2016 periods, the Company recorded $128.7 million of gain related
to the Incyte transaction under other income (expense) related to
closing the sale of the Company’s European operations and
out-license of Iclusig rights in Europe.
Non-GAAP net income for the quarter ended June 30, 2016 was
$114.1 million, or $0.59 per diluted share, compared to non-GAAP
net loss of $52.5 million, or $0.28 per diluted share for the
quarter ended June 30, 2015. Non-GAAP net income for the six months
ended June 30, 2016 was $69.9 million, or $0.36 per diluted share,
compared to non-GAAP net loss of $96.8 million, or $0.51 per
diluted share, for the six months ended June 30, 2015.
Non-GAAP net loss excludes stock-based compensation,
restructuring charges for a reduction in force in March 2016 and
transaction costs for the Incyte transaction. 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
- R&D expenses were $42.9 million for
the second quarter of 2016, an increase of $4.2 million or 10.6
percent, compared to $38.7 million for the second quarter of 2015.
R&D expenses were $86.9 million for the first half of 2016, an
increase of $8.7 million or 11.2 percent compared to $78.2 million
for the first half of 2015.
- Selling, general and administrative
expenses were $34.2 million for the second quarter of 2016, a
decrease of $14.4 million or 29.6 percent, compared to $48.6
million for the second quarter of 2015. Selling, general and
administrative expenses were $70.2 million for the first half of
2016, a decrease of $12.0 million or 14.5 percent, compared to
$82.2 million for the first half of 2015.
Other income (expense), net
- For the second quarter and half year
ended 2016, other income (expense), net includes a recorded gain on
the Incyte transaction of $128.7 million.
Cash Position
- As of June 30, 2016, cash, cash
equivalents and marketable securities totaled $278.5 million,
compared to $168.3 million at March 31, 2016 and $242.3 million at
December 31, 2015.
Recent Progress and Key
Objectives
Business Development
- On June 1, 2016, ARIAD completed the
sale of its European operations to Incyte Corporation, as well as
an exclusive license under which Incyte will commercialize Iclusig
in Europe and other select countries. ARIAD received approximately
$140 million at the closing and will receive 32-50 percent of
European net sales going forward.
- ARIAD also completed two distribution
agreements for Iclusig outside of the U.S. In Latin America, our
agreement with Pint Pharma International S.A. covers Argentina,
Brazil, Chile, Colombia and Mexico. In the Middle East and North
Africa (MENA), our agreement with Biologix FZCo. covers Saudi
Arabia, the Gulf Coast countries, Lebanon, and selected other
countries in the region. Under these agreements ARIAD will receive
more than 50 percent of Iclusig net sales moving forward.
Iclusig
- Long-term safety and efficacy data from
the PACE clinical trial were presented in June at the European
Hematology Association (EHA) meeting. The study shows that Iclusig
continued to demonstrate anti-leukemic activity in chronic phase
chronic myeloid leukemia (CP-CML) patients treated with Iclusig,
with a median follow-up of 4.0 years. Additionally, 96 percent of
CP-CML patients who underwent Iclusig dose reductions while in
response maintained their responses (major cytogenetic response
[MCyR]) at the four-year time point.
- ARIAD has submitted the four-year PACE
data to the FDA and other health authorities as a label supplement,
with an FDA action date in the fourth quarter of this year.
- Patient enrollment is ongoing in the
OPTIC and OPTIC-2L clinical trials in patients with resistant
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 chronic
myeloid leukemia (CML) and Philadelphia-chromosome positive acute
lymphoblastic leukemia (Ph+ALL). This marketing application was
submitted in early 2016, with an anticipated action date in third
quarter 2016, and reimbursement and launch expected in late 2016 or
early 2017.
Brigatinib
- ARIAD initiated the New Drug
Application (NDA) submission for brigatinib to the FDA for patients
with ALK+ non-small cell lung cancer (NSCLC) who are resistant to
crizotinib. The Company will be seeking accelerated approval for
brigatinib from the FDA and plans to request a priority review of
the application. We anticipate completion of the rolling submission
in the third quarter of this year.
- Clinical data from the Phase 2 ALTA
trial of brigatinib were the subject of an oral presentation at the
annual meeting of the American Society of Clinical Oncology (ASCO).
The data show that, of patients on the 180 mg regimen (Arm B) with
a median follow-up of 8.3 months, 54 percent achieved a confirmed
objective response, the trial’s primary endpoint. In this arm, the
median progression free survival (PFS) exceeded one year (12.9
months) in this post-crizotinib setting. Additionally, a 67 percent
confirmed intracranial objective response rate (ORR) was achieved
in patients with measurable brain metastases.
- Other brigatinib data presented at ASCO
included more mature efficacy and safety data from the long-term
Phase 1/2 trial follow-up, with median time on treatment now at 17
months in ALK+ NSCLC patients and the longest time on treatment now
more than 3.5 years. Also, clinical data were presented from
molecular analysis of ALK+ NSCLC patients in both the ALTA and
Phase 1/2 trials, showing confirmed responses in patients with
different secondary ALK mutations, including one G1202R case. There
are no currently approved ALK treatments that have demonstrated
activity against the G1202R mutation.
- The ALTA 1L randomized, front-line
clinical trial of brigatinib opened to patient enrollment in early
April and patient enrollment is underway. This global, Phase 3
trial is designed to compare brigatinib and crizotinib in patients
with ALK+ NSCLC who have not received prior ALK inhibitors. Full
enrollment is expected in 2018.
- In the U.S. an Expanded Access Program
is now open to provide brigatinib access to eligible patients with
ALK+ NSCLC who are resistant or intolerant to at least one prior
ALK TKI. In Europe, an Early Access Program is being
established.
Advancing the Pipeline
- At ARIAD’s Analyst and Investor Day in
June, the Company detailed its decision to invest in potential new
opportunities in immuno-oncology, which leverages its core
competency in kinase inhibitors for precision therapies to explore
the potential for small molecules in immuno-oncology. ARIAD has
achieved genetic and pharmacologic validation on an initial target
kinase, with the program anticipated to enter lead optimization by
the end of 2016.
- The Phase 1/2 trial of ARIAD’s
investigational kinase inhibitor AP32788 is now enrolling patients
at multiple sites in the U.S. 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 U.S. living with EGFR exon 20
or HER2 point mutations.
Upcoming Medical Meetings
- European School of Haematology (ESH)/
International Chronic Myeloid Leukemia Foundation (iCMLf), Houston,
September 15 to September 18, 2016
- European Society for Medical Oncology
(ESMO), Copenhagen, Denmark, October 7 to October 11, 2016
- Japanese Society of Hematology (JSH),
Yokohama City, Japan, October 13 to October 15, 2016
Today’s Conference Call at 8:30 a.m. ET
We will hold a live webcast and conference call of our second
quarter and first half 2016 financial results this morning at 8:30
a.m. ET, at which we will also provide an update on corporate
developments. 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
844-249-9386 (domestic) or 270-823-1534 (international) five
minutes prior to the start time and providing the pass code
39871230. 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.
These indications are based upon response rate. There are no
trials verifying an improvement in disease-related symptoms or
increased survival with Iclusig.
Limitations of use:
Iclusig is not indicated and is not recommended for the
treatment of patients with newly diagnosed chronic phase CML.
IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED
WARNING
WARNING: VASCULAR OCCLUSION, HEART FAILURE, and
HEPATOTOXICITY
See 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, is focused on discovering, developing and
commercializing precision therapies for patients with rare cancers.
ARIAD is working on new medicines to advance the treatment of rare
forms of chronic and acute leukemia, lung cancer and other rare
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:
- Stock-based
compensation expense: The Company has excluded the impact of
stock-based compensation, 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.
- Restructuring
charge expense: The Company has excluded restructuring
charge expenses associated with employee workforce reductions
because apart from ongoing expense savings as a result of such
items, these expenses have no direct correlation to the operation
of our business in the future.
- Transaction
related cost: The Company has excluded transaction costs
related to the Incyte transaction because they relate to a specific
transaction and are not reflective of our ongoing financial
performance.
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 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 the anticipated timing of potential
regulatory actions and research and clinical development plans and
milestones 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 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, specialty pharmacies, distributors and other
collaborators for the supply, distribution, development and/or
commercialization 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 with or through third parties;
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)
Three Months Ended Six Months Ended In thousands,
except per share data June 30, June 30,
2016 2015 2016
2015 Revenue: Product revenue, net $
65,326 $ 27,818 $ 98,960 $ 51,719 License and other revenue
2,799 1,420 4,763 1,510
Total revenue 68,125 29,238
103,723 53,229 Operating
expenses: Cost of product revenue 1,108 488 1,594 1,183 Research
and development 42,864 38,739 86,943 78,183 Selling, general and
administrative 34,242 48,622 70,219 82,172 Transaction related cost
1,482 - 1,482 - Restructuring charge 92 -
3,010 - Total operating expenses
79,788 87,849 163,248 161,538
Other income (expense), net (5,399 ) (4,249 ) (11,072 ) (7,012 )
Gain related to the Incyte transaction 128,664
- 128,664 - Total other income
(expense), net 123,265 (4,249 ) 117,592 (7,012 )
Provision for income taxes 1,754
300 2,006 514 Net income
(loss) $ 109,848 $ (63,160 ) $ 56,061 $ (115,835 )
Net income (loss) per common share: -- basic $ 0.57 $ (0.33
) $ 0.29 $ (0.62 ) -- diluted $ 0.56 $ (0.33 ) $ 0.29
$ (0.62 ) Weighted-average number of shares of common stock
outstanding: -- basic 191,485 188,598 190,894 188,220 -- diluted
194,569 188,598 193,504 188,220
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
(Unaudited) June 30, December 31, In
thousands 2016 2015
Cash, cash equivalents and marketable securities $ 278,544 $
242,295 Total assets $ 624,367 $ 546,692 Total liabilities $
662,256 $ 649,833 Stockholders’ deficit $ (37,889 ) $ (103,141 )
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
INFORMATION (Unaudited)
Six Months Ended In thousands June 30,
2016 2015 Net cash used
in operating activities $ (97,747 ) $ (78,617 ) Net cash provided
by (used in) investing activities 113,343 (2,700 ) Net cash
provided by financing activities 26,607 2,461 Effect of exchange
rates on cash (44 ) 134 Net increase
(decrease) in cash and cash equivalents $ 42,159 $ (78,722 )
Reconciliation of Selected GAAP Measures to Non-GAAP Measures
(1) (Unaudited) Three Months Ended Six
Months Ended In thousands, except per share data June
30, June 30, 2016 2015 2016
2015 Reconciliation of GAAP to non-GAAP Net
income (loss): GAAP Net income (loss) $ 109,848 $ (63,160 ) $
56,061 $ (115,835 ) Add: Stock-based Compensation (2) 2,658 10,644
9,378 19,078 Add: Restructuring Charges (3) 92 - 3,010 - Add:
Transaction related cost (4) 1,482 -
1,482 - Non-GAAP Net income (loss) $ 114,080 $
(52,516 ) $ 69,931 $ (96,757 )
Three Months
Ended Six Months Ended June 30, June 30,
2016 2015 2016 2015
Reconciliation of GAAP to non-GAAP Net income (loss) per
diluted share: GAAP Net income (loss) $ 0.56 $ (0.33 ) $ 0.29 $
(0.62 ) Add: Stock-based Compensation (2) 0.02 0.05 0.05 0.11 Add:
Restructuring Charges (3) 0.00 - 0.01 - Add: Transaction related
cost (4) 0.01 - 0.01 -
Non-GAAP Net income (loss) per diluted share $ 0.59 $ (0.28
) $ 0.36 $ (0.51 )
(1) This presentation includes non-GAAP measures. The Company's
non-GAAP measures are not meant to beconsidered in isolation or as
a substitute for comparable GAAP measures and should be read only
in conjunctionwith 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.
(4) Transaction related cost associated with the Incyte
transaction were excluded for the non-GAAP analysis.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160728005409/en/
ARIAD Pharmaceuticals, Inc.For InvestorsManmeet Soni,
617-503-7298Manmeet.soni@ariad.comorFor MediaLiza Heapes,
617-621-2315Liza.heapes@ariad.com
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