~Brigatinib granted Priority Review with a
PDUFA date of April 29, 2017
~ Regulatory approval of Iclusig® in Japan
~ Enrollment continues in OPTIC, OPTIC-2L,
ALTA-1L, AP32788 trials highlighting ARIAD's continued R&D
investment for patients with rare cancers
~ U.S. product revenue of $33.6 million for the
quarter (~66% growth from prior year)
~ Net loss for the quarter of $27.8 million
~Conference call scheduled today at 8:30 a.m.
ET
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported
financial results for the third quarter and first nine months of
2016. The Company also provided an update on corporate developments
and reaffirmed 2016 financial guidance.
“During the third quarter, ARIAD achieved several important
milestones that further our commitment as a small, research-based
biotechnology company to patients with rare cancers,
including those with no other targeted treatment
options available,” said Paris
Panayiotopoulos, president
and chief executive officer of
ARIAD. “Iclusig was approved in Japan and
we received priority review from the FDA
for brigatinib in crizotinib-treated ALK+ non-small
cell lung cancer. We are continuing to invest heavily in
R&D and to progress in enrolling in the OPTIC,
OPTIC-2L and ALTA-1L trials
for Iclusig and brigatinib, as well as our
clinical trial for AP32788, a novel kinase
inhibitor for a rare form of lung cancer involving
mutations in the EGFR and HER2 genes, and for which there
are currently no approved targeted treatments.”
Financial Results for the Quarter and
Nine Months Ended September 30, 2016
Revenue
- Worldwide net product revenue from
sales of Iclusig were $34.3 million for the third quarter of 2016,
compared to $27.5 million in the third quarter of 2015, an increase
of 25%; and $133.3 million for the first nine months of 2016,
compared to $79.3 million for the first nine months of 2015, an
increase of 68%. Net product revenue for the nine months ended
September 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. net product revenue from sales of
Iclusig were $33.6 million for the third quarter of 2016, compared
to $20.3 million in the third quarter of 2015, an increase of 66
percent; and $91.2 million for the first nine months of 2016,
compared to $60.6 million for the first nine months of 2015, an
increase of 50 percent.
- European royalties on sales of Iclusig
were $4.0 million of which $3.5 million was recorded as other
revenue during the third quarter of 2016. European royalties on
sales of Iclusig were $5.3 million of which $4.6 million was
recorded as other revenue during the first nine months 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. European sales of Iclusig were $7.2
million for the third quarter of 2015 and $18.7 million for the
first nine months of 2015.
- For the three and nine months ended
September 30, 2016, license and other revenue includes $3.5 million
from research and development cost sharing amounts from Incyte and
achievement of a $2.0 million milestone from Medinol Ltd. earned
during the third quarter of 2016.
GAAP and Non-GAAP Net Income (Loss)
GAAP net loss for the quarter ended September 30, 2016 was $27.8
million, or $0.14 per basic and diluted share, respectively,
compared to GAAP net loss of $55.5 million, or $0.29 loss per basic
and diluted share, for the quarter ended September 30, 2015. GAAP
net income for the nine months ended September 30, 2016 was $28.2
million, or $0.15 per basic share and $0.14 per diluted share,
compared to GAAP net loss of $171.3 million, or $0.91 loss per
basic and diluted share, for the nine months ended September 30,
2015. During the nine months ended September 30, 2016, the Company
recorded a $129.0 million gain related to the Incyte
transaction under other income (expense), net related to closing
the sale of the Company’s European operations and out-license of
Iclusig rights in Europe.
Non-GAAP net loss for the quarter ended September 30, 2016 was
$22.5 million, or $0.12 per diluted share, compared to non-GAAP net
loss of $45.5 million, or $0.24 per diluted share for the quarter
ended September 30, 2015. Non-GAAP net income for the nine months
ended September 30, 2016 was $47.4 million, or $0.24 per diluted
share, compared to non-GAAP net loss of $142.3 million, or $0.75
per diluted share, for the nine months ended September 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 $43.6 million for
the third quarter of 2016, a decrease of $4.6 million or 10
percent, compared to $48.2 million for the third quarter of 2015.
R&D expenses were $130.6 million for the first nine months of
2016, an increase of $4.2 million or 3 percent, compared to $126.4
million for the first nine months of 2015.
- Selling, general and administrative
expenses were $26.2 million for the third quarter of 2016, a
decrease of $10.5 million or 29 percent, compared to $36.7 million
for the third quarter of 2015. Selling, general and administrative
expenses were $96.5 million for the first nine months of 2016, a
decrease of $22.4 million or 19 percent, compared to $118.9 million
for the first nine months of 2015.
Other income (expense), net
- For the nine months ended September 30,
2016, other income (expense), net includes a recorded gain on the
Incyte transaction of $129.0 million.
Cash Position
- As of September 30, 2016, cash, cash
equivalents and marketable securities totaled $314.7 million,
compared to $278.5 million at June 30, 2016 and $242.3 million at
December 31, 2015.
PDL Royalty Financing and Convertible Notes 2019
- In July 2016, the Company received
$50.0 million from PDL BioPharma, Inc. (PDL), representing the
second tranche of funding under the terms of the original royalty
financing agreement. As of September 30, 2016, the amount due under
the PDL royalty financing totaled $96.8 million.
- In addition, as of September 30, 2016,
the Company has $200 million of aggregate principal amount of
convertible notes which are due to mature on June 15, 2019.
2016 Financial Guidance
- We are reaffirming our prior guidance
for global Iclusig net product and royalty revenue of $170 million
to $180 million.
- We are reaffirming our prior guidance
for research and development expense of $175 million to $180
million, and sales, general and administration expense of $120
million to $125 million.
- We are reaffirming our prior guidance
for cash, cash equivalents and marketable securities
at December 31, 2016, of $280 million to $290
million.
Recent Progress and Key
Objectives
Iclusig
- Our partner for Iclusig in Asia, Otsuka
Pharmaceutical Co., Ltd. (Otsuka), received approval from
the Japanese Pharmaceuticals and Medical Devices
Agency (PMDA) for Iclusig for the treatment of chronic
myeloid leukemia (CML) resistant or intolerant to preceding drug
treatment and relapsed or treatment
resistant Philadelphia chromosome-positive acute
lymphoblastic leukemia (Ph+ ALL). Additional regulatory
applications are pending for Taiwan and South Korea.
- ARIAD has submitted the four-year
efficacy and safety data from the pivotal Phase 2 PACE clinical
trial to the FDA and other health authorities as a label
supplement, with an FDA action date of December 12, 2016.
- Patient enrollment is ongoing in the
OPTIC and OPTIC-2L clinical trials in patients with resistant or
intolerant chronic phase (CP) CML. Initial results from OPTIC are
expected to be presented at the American Society of Hematology
(ASH) conference in December 2017.
- Investigator-sponsored trials are
ongoing in a focused set of additional clinical settings where
Iclusig has potential activity, including frontline
Philadelphia-positive acute lymphoblastic leukemia (Ph+ALL), acute
myeloid leukemia (AML), and molecularly subtypes of solid tumors,
including FGFR+ and RET+ non-small cell lung cancer.
- At ASH in December 2016, clinical trial
data will be presented for both CP-CML and Ph+ ALL, in addition to
new translational and real world data on Iclusig.
Brigatinib
- ARIAD completed the New Drug
Application (NDA) submission for brigatinib to the FDA for patients
with ALK+ non-small cell lung cancer (NSCLC) who are resistant or
intolerant to crizotinib in August 2016, and the application was
accepted by the FDA in October 2016. The FDA granted
ARIAD’s request for Priority Review and has set an action date
of April 29, 2017 under the Prescription Drug User Fee
Act (PDUFA). ARIAD is also working on the European Marketing
Authorization Application, which should be ready for submission
early next year.
- On October 9th, updated safety and
efficacy data were presented at the 41st Annual Congress of the
European Society for Medical Oncology (ESMO) held in Copenhagen,
Denmark, from the Phase 1/2 study of brigatinib in ALK+ NSCLC,
showing greater than 12 months progression free survival in both
the post-crizotinib and crizotinib naive settings, as well as
continued ongoing responses in patients with CNS metastases.
- For the World Conference on Lung
Cancer, to be held December 4-7 in Vienna, ARIAD and its academic
collaborators will be presenting four abstracts on brigatinib.
Updated results will be presented from the ALTA trial, based on a
data cut later than the one underlying the ASCO presentation
earlier this year. There will also be an update on CNS metastases
data from the Phase 1/2 and ALTA studies.
- Patient enrollment continues for the
ALTA 1L randomized, front-line clinical trial of brigatinib, a
global, Phase 3 study designed to compare brigatinib and crizotinib
in patients with ALK+ NSCLC who have not received prior ALK
inhibitors. Full enrollment is expected in 2018.
- Investigators are moving forward with
several investigator-sponsored studies, including a trial in ROS1+
NSCLC, a trial in patients who experience failure of a
second-generation TKI, and a basket study to evaluate brigatinib in
patients with ALK/ROS1-mutant metastatic solid tumors.
- In the United States, 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 has
been established.
Advancing the Pipeline
- We continued to advance the Phase 1/2
clinical trial of AP32788, our investigational precision therapy
for patients with NSCLC having exon 20 mutations in EGFR or HER2.
There are currently no approved targeted treatment options
available for the approximately 6,000 U.S. patients with this
disease. We continue to expect first trial data to be released in
2017.
- Finally, during the third quarter, we
also continued to advance our emerging small molecule program
focused on kinase targets within the space of immuno-oncology. The
program remains on track with earlier guidance to enter lead
optimization by the end of this year.
Upcoming Meetings
- Jefferies London Healthcare Conference,
London, United Kingdom, November 16-17, 2016
- IASLC World Conference on Lung Cancer
(WCLC), Vienna, Austria, December 4-7, 2016
- American Society of Hematology (ASH),
San Diego, CA, December 4-8, 2016
Recent Event
- On October 20, 2016, ARIAD received a
Congressional letter requesting information from the Company
related to Iclusig. The Company provided a response on November 4,
2016.
Today’s Conference Call at 8:30 a.m. ET
We will hold a live webcast and conference call of our third
quarter and first nine months 2016 financial results this evening
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
99997465. 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, Canada and Japan.
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.
Iclusig is a registered trademark of ARIAD Pharmaceuticals,
Inc.
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 our
financial and operational guidance, the anticipated timing of
potential regulatory actions and research and clinical development
plans and milestones for Iclusig and our product candidates, along
with the statements made by our Chief Executive Officer and under
the caption “Recent Progress and Key Objectives,” 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 our products; 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; competition from
alternative therapies; 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
and government investigations; 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
Nine Months Ended In thousands, except per share data
September 30, September 30, 2016 2015
2016 2015 Revenue: Product revenue, net $ 34,300 $
27,543 $ 133,260 $ 79,262 License and other revenue 11,716
1,527 16,479 3,038
Total revenue 46,016 29,070 $ 149,739
82,300 Operating expenses: Cost of
product revenue 1,131 483 2,725 1,666 Research and development
43,626 48,219 130,569 126,401 Selling, general and administrative
26,249 36,744 96,468 118,916 Transaction related cost - - 1,482 -
Restructuring charge - - 3,010
- Total operating expenses 71,006
85,446 234,254 246,983
Loss from operations (24,990 ) (56,376 )
(84,515 ) (164,683 ) Other income (expense),
net (5,171 ) (4,917 ) 112,421
(11,930 ) (Loss) income before benefit from income taxes
(30,161 ) (61,293 ) 27,906 (176,613 )
Benefit from income taxes (2,334 ) (5,842 )
(328 ) (5,328 ) Net (loss) income $ (27,827 ) $
(55,451 ) $ 28,234 $ (171,285 ) Net (loss) income per common
share: -- basic $ (0.14 ) $ (0.29 ) $ 0.15 $ (0.91 ) --
diluted $ (0.14 ) $ (0.29 ) $ 0.14 $ (0.91 )
Weighted-average number of shares of common stock outstanding: --
basic 193,225 188,921 191,677 188,456 -- diluted 193,225 188,921
195,079 188,456
CONDENSED CONSOLIDATED BALANCE SHEET
INFORMATION (Unaudited)
September 30, December 31, In thousands
2016 2015 Cash, cash equivalents and
marketable securities $ 314,665 $ 242,295 Total
assets $ 676,591 $ 546,692 Total liabilities $ 722,940 $ 649,833
Stockholders’ deficit $ (46,349 ) $ (103,141 )
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION
(Unaudited) Nine
Months Ended In thousands September 30,
2016 2015 Net cash used in operating
activities $ (121,436 ) $ (120,658 ) Net cash provided by (used in)
investing activities 103,577 (4,446 ) Net cash provided by
financing activities 92,053 54,778 Effect of exchange rates on cash
(44 ) (175 ) Net increase (decrease) in cash
and cash equivalents $ 74,150 $ (70,501 )
Reconciliation of Selected GAAP Measures to Non-GAAP Measures
(1) (Unaudited)
Three Months Ended Nine Months Ended In
thousands, except per share data September 30,
September 30, 2016 2015 2016
2015 Reconciliation of GAAP to non-GAAP Net (loss)
income: GAAP Net (loss) income $ (27,827 ) $ (55,451 ) $ 28,234 $
(171,285 ) Add: Stock-based Compensation (2) 5,282 9,931 14,659
29,009 Add: Restructuring Charges (3) - - 3,010 - Add: Transaction
related cost (4) - - 1,482
- Non-GAAP Net (loss) income $ (22,545 ) $
(45,520 ) $ 47,385 $ (142,276 )
Three Months
Ended Nine Months Ended September 30,
September 30, 2016 2015 2016
2015 Reconciliation of GAAP to non-GAAP Net (loss)
income per diluted share: GAAP Net (loss) income $ (0.14 ) $ (0.29
) $ 0.14 $ (0.91 ) Add: Stock-based Compensation (2) 0.02 0.05 0.08
0.16 Add: Restructuring Charges (3) - - 0.01 - Add: Transaction
related cost (4) - - 0.01
- Non-GAAP Net (loss) income per diluted share $
(0.12 ) $ (0.24 ) $ 0.24 $ (0.75 ) (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.
(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/20161107005374/en/
ARIAD Pharmaceuticals, Inc.For InvestorsJennifer
Robinson, 617-621-2286Jennifer.Robinson@ariad.comorFor
MediaLiza Heapes, 617-621-2315Liza.Heapes@ariad.com
Ariad (NASDAQ:ARIA)
Historical Stock Chart
From Apr 2024 to May 2024
Ariad (NASDAQ:ARIA)
Historical Stock Chart
From May 2023 to May 2024