Conference Call Scheduled Today at 8:30 a.m.
ET
ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today reported
financial results for the fourth quarter and full year ended
December 31, 2013 and provided an update on corporate
developments.
“I am extremely pleased with the commercial and R&D progress
we made in 2013, especially ending the year with Iclusig
commercially available to refractory Philadelphia-positive leukemia
patients in the United States. We are off to a strong start with
our re-launch in the U.S. and are building momentum in Europe,”
said Harvey J. Berger, M.D., chairman
and chief executive officer of ARIAD. “As we advance into 2014, we
are focused on building shareholder value and executing a fiscally
responsible operating plan.”
Recent Progress and Key Objectives
Commercialization of Iclusig®
- Iclusig was re-launched in the U.S. in
mid-January with all members of the commercial team in place.
Through the first five weeks of commercialization, approximately
180 out of 305 patients from the single-patient IND program have
transitioned to commercial supply. We anticipate that approximately
50 additional patients will transition by the end of this
quarter.
- Additionally, we expect that 7% to 10%
of patients from the IND program will remain on Iclusig but will
qualify for free drug through our patient assistance program. As
expected, the remaining 18% to 20% of patients, predominantly those
with advanced phase disease, will discontinue Iclusig from the IND
program.
- In Europe, we are selling Iclusig in
Germany, the United Kingdom, France, Austria and the Netherlands.
This year, we will expand commercialization of Iclusig to all of
the major markets in Europe – 16 individual countries – based on
staged achievement of pricing and reimbursement approvals in each
country. We anticipate the majority of the remaining EU pricing
approvals will occur in the second half of 2014.
- Earlier this month, Iclusig was
approved in Switzerland for use in adult patients with all phases
of chronic myeloid leukemia (CML) or Philadelphia
chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) for
whom treatment with other tyrosine-kinase inhibitors is not
appropriate or for patients with the T315I mutation of BCR-ABL.
Commercial launch in Switzerland is expected by mid-2014, upon
pricing and reimbursement approval.
- In January, we announced a distribution
agreement with Specialised Therapeutics Australia Pty Ltd (STA) for
exclusive rights to commercialize Iclusig in Australia. Under the
terms of the agreement, STA will book sales of Iclusig to
pharmacies and other distributors, while ARIAD will supply packaged
drug to STA. Australian marketing approval and commercial launch of
Iclusig are expected in the fourth quarter of this year.
Iclusig Clinical Development
- A new clinical trial for Iclusig will
begin in the second half of 2014 as part of our FDA post-marketing
requirements. This will be a randomized multi-arm trial to
characterize several Iclusig doses and to inform its safe use in
patients with refractory forms of chronic-phase CML. Importantly,
data from this trial will allow physicians to better understand the
benefit/risk profile of Iclusig when treatment is started at doses
less than 45 mg per day, the currently approved dose in the U.S.
and EU.
- The Phase 2 trial of Iclusig in
patients with gastrointestinal stromal tumors (GIST) is almost
fully enrolled, and patient follow up is continuing. We anticipate
that the trial will re-open to further patient enrollment upon
lifting of the partial clinical hold in the second quarter of this
year.
- Follow up of patients with resistant or
intolerant CML and Ph+ ALL in the Phase 1/2 clinical trial of
Iclusig in Japan is ongoing. We plan to file for marketing approval
of Iclusig with the Pharmaceuticals and Medical Devices Agency,
Japan next year.
- Numerous Investigator Sponsored Trials
(ISTs) are underway or planned that explore the potential clinical
utility of Iclusig in various hematologic malignancies, as well as
solid tumors driven by FGFR, RET, and other genetic markers of
malignancy.
- Clinical data on Iclusig, including
data from the front-line EPIC trial and initial Phase 2 data in
patients with GIST, have been submitted for presentation to the
2014 annual meeting of the American Society of Clinical
Oncology.
Advancing AP26113
- Patient enrollment and follow up in the
Phase 2 portion of the Phase 1/2 clinical trial of AP26113 are
ongoing, and we plan to begin a pivotal Phase 2 trial of AP26113 in
ALK+ non-small cell lung cancer (NSCLC) patients resistant to
crizotinib later in the first quarter of this year. We expect this
trial to be the basis for our initial registration of AP26113.
- The planned pivotal trial for AP26113
will be global in design and is expected to enroll approximately
220 patients. All patients in the trial will begin at a dose of 90
mg per day and after one week, will be randomized one-to-one,
increasing half of the patients to 180 mg per day, while the other
half remain at 90 mg per day. Patients will be evaluated for
objective response rate as the primary end-point.
- We anticipate presenting clinical
updates on AP26113 at the 2014 annual meetings of the American
Society of Clinical Oncology and the European Society of Medical
Oncology.
Next Oncology Drug Candidate
- We expect to nominate a potential
best-in-class development candidate in the second half of 2014.
This compound is a product of our internal discovery program driven
by structure-based drug design. The candidate will be an orally
active small-molecule drug, targeted against an oncogenic kinase in
a class that is well understood and clinically validated, but with
a unique target product profile.
Ridaforolimus
- Last week, Merck informed us that it is
terminating its license agreement for the global development and
commercialization of ridaforolimus, our mTOR inhibitor, in
oncology. By the terms of the agreement, this becomes effective in
November 2014 at which time all rights related to ridaforolimus in
oncology will be returned to ARIAD, creating a new clinical and
business opportunity for ARIAD.
- Medinol, Ltd. expects patient
enrollment to begin imminently in the first of its two registration
trials of NIRsupremeTM, its drug-eluting stent system that
incorporates ridaforolimus. The commencement of patient enrollment,
along with the submission of an investigational device exemption
with the U.S. Food and Drug Administration, triggers milestone
payments to ARIAD of $3.75 million, with the potential for
additional regulatory, clinical and sales milestones, as well as
royalties on product sales.
2013 Fourth Quarter and Full-Year Financial Results
Product Revenues
- Net sales of Iclusig were $8.3 million
for the quarter ended December 31, 2013 and $45.2 million for the
year ended December 31, 2013. For the full-year 2013, this includes
sales in the U.S. from January through October and in the EU
from July through December.
- Iclusig revenue recognition for France
continues to be deferred until the time we have an established list
price, which is expected to occur in the second half of 2014. As of
December 31, 2013, we had total sales of Iclusig in France of $12.9
million, representing shipments of $4.1 million for the period from
October 1, 2013 to December 31, 2013 and $8.8 million in shipments
under the Autorisation Temporaire d'Utilisation (ATU), or Temporary
Authorization for Use, which concluded on September 30, 2013.
Net Loss
Quarter Ended December 31, 2013
- Net loss for the fourth quarter ended
December 31, 2013 was $74.2 million, or $0.40 per share, compared
to a net loss of $60.5 million, or $0.36 per share, for the same
period in 2012. The increase in net loss is primarily due to an
increase in operating expenses of $21.6 million, reflecting
commercialization of Iclusig, as well as continued development of
our marketed product and our product candidates, offset in part by
Iclusig product revenues noted above.
Year Ended December 31, 2013
- Net loss for the full year 2013 was
$274.2 million, or $1.49 per share, compared to a net loss of
$220.9 million, or $1.34 per share, for the full year 2012.
- These results include Iclusig product
revenue, as well as an increase in operating expenses of $113.5
million in 2013 as compared to 2012, reflecting further development
of our marketed product and our product candidates, as well as
commercial launch of Iclusig in the U.S. and EU.
Cash Position
- As of December 31, 2013, cash, cash
equivalents and marketable securities totaled $237.2 million,
compared to $164.4 million at December 31, 2012.
Financial Guidance for 2014
We anticipate cash used in operations in 2014 to range from $165
million to $175 million. Our guidance includes:
- Research and development expenses of
$140 million to $150 million, reflecting development activities for
Iclusig and AP26113, and ongoing discovery research efforts.
Expenses related to Iclusig represent approximately 75 percent of
total research and development expenses and include: follow-up of
patients in the Phase 1 and PACE trials, clinical pharmacology
studies to meet post-approval commitments, the Japanese Phase 1/2
trial, the Phase 2 trial in GIST, multiple ongoing and planned
ISTs, and initiation of a new Phase 2 randomized dosing trial.
Expenses related to AP26113 include the pivotal Phase 2 trial and
NDA-enabling clinical pharmacology studies.
- Selling, general and administrative
expenses of $135 million to $145 million, which includes U.S. and
EU commercial operations and supporting activities for
Iclusig.
- Non-cash expenses of $35 million to $45
million, consisting primarily of stock-based compensation and
depreciation and amortization expenses.
- We expect that our cash, cash
equivalents and marketable securities at December 31, 2014 will
range from $60 million to $70 million, sufficient to fund
operations until mid-2015.
Upcoming Investor Meetings
ARIAD management will be making corporate presentations at the
following investor conferences:
- RBC Capital Markets’ Healthcare
Conference, New York City, February 26, 2014
- Cowen and Company Healthcare
Conference, Boston, March 4, 2014
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 2013 financial results this morning at 8:30 a.m.
ET. The live webcast can be accessed by visiting the investor
relations section of the Company’s website at
http://investor.ariad.com. The call can be accessed by dialing
888-771-4371 (domestic) or 847-585-4405 (international) five
minutes prior to the start time and providing the pass code
36613162. A replay of the call will be available on the ARIAD
website approximately two hours after completion of the call and
will be archived for three weeks.
About Iclusig® (ponatinib) tablets
Iclusig is a kinase inhibitor. The primary target for Iclusig is
BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic
myeloid leukemia (CML) and Philadelphia-chromosome positive acute
lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using
ARIAD’s computational and structure-based drug-design platform
specifically to inhibit the activity of BCR-ABL. Iclusig targets
not only native BCR-ABL but also its isoforms that carry mutations
that confer resistance to treatment, including the T315I mutation,
which has been associated with resistance to other approved
TKIs.
Important U.S. Safety Information for Iclusig®
(ponatinib)
WARNING: VASCULAR OCCLUSION, HEART FAILURE, and
HEPATOTOXICITY
See full U.S. prescribing information for complete boxed
warning
- 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 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).
This press release contains “forward-looking statements”
including, but not limited to, updates on clinical, preclinical and
regulatory developments and commercialization plans for our
products and product candidates and financial guidance for 2014.
Forward-looking statements are based on management's expectations
and are subject to certain factors, risks and uncertainties that
may cause actual results, outcome of events, timing and performance
to differ materially from those expressed or implied by such
statements. These risks and uncertainties include, but are not
limited to, difficulties or delays in obtaining regulatory and
pricing and reimbursement approvals to market our products; our
ability to successfully commercialize and generate profits from
sales of Iclusig; competition from alternative therapies, our
reliance on the performance of third-party manufacturers and
specialty pharmacies for the distribution of Iclusig; the
occurrence of adverse safety events with our products and product
candidates; our ability to meet anticipated clinical trial
commencement and completion dates; delays in or failure of
obtaining regulatory clearance for resumption of clinical trials;
preclinical data and early-stage clinical data that may not be
replicated in later-stage clinical studies; the costs associated
with our research, development, manufacturing and other activities;
the conduct and results of preclinical and clinical studies of our
product candidates; the adequacy of our capital resources and the
availability of additional funding; patent protection and
third-party intellectual property claims; risks related to key
employees, markets, economic conditions, health care reform, prices
and reimbursement rates; and other risk factors detailed in the
Company's public filings with the U.S. Securities and Exchange
Commission. The information contained in this press release is
believed to be current as of the date of original issue. The
Company does not intend to update any of the forward-looking
statements after the date of this document to conform these
statements to actual results or to changes in the Company's
expectations, except as required by law.
ARIAD PHARMACEUTICALS, INC. AND
SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(Unaudited)
In thousands, except per share data Three Months
Ended
December 31,
Year Ended
December 31,
2013
2012 2013
2012 Revenue: Product revenue, net $
8,281 $ --- $ 45,238 $ --- Other revenue 72 74 323 558 Total
revenue 8,353 74 45,561 558 Operating expenses: Cost of product
revenue 8,699 --- 9,612 --- Research and development 35,824 37,689
162,900 144,709 Selling, general and administrative 37,637 22,915
146,615 60,909 Total operating expenses 82,160 60,604 319,127
205,618 Other income (expense), net (172
)
77 (153
)
(15,812 ) Provision for income taxes 184 --- 439 -- Net loss $
(74,163
)
$ (60,453 ) $ (274,158
)
$ (220,872 ) Net loss per common share: -- basic and diluted $
(0.40
)
$ (0.36 ) $ (1.49
)
$ (1.34 ) Weighted-average number of shares of common stock
outstanding: -- basic and diluted 185,699 166,707 183,575 164,964
CONDENSED CONSOLIDATED BALANCE SHEET
INFORMATION
In thousands December 31,
2013
December 31,
2012
Cash, cash equivalents and marketable securities $ 237,179 $
164,414 Total assets $ 370,894 $ 180,193 Total liabilities $
185,377 $ 67,342 Stockholders’ equity $ 185,517 $ 112,851
CONDENSED CONSOLIDATED STATEMENT OF
CASH FLOWS INFORMATION
In thousands Year Ended
December 31,
2013 2012 Net cash
used in operating activities
$
(221,882 )
$
(153,681 ) Net cash provided by (used in) investing activities
26,138 (50,400 ) Net cash provided by financing activities 313,584
17,204 Effect of exchange rates on cash
(40
)
--- Net increase (decrease) in cash and cash equivalents
$
117,800
$
(186,877 )
For InvestorsKendra Adams,
617-503-7028Kendra.adams@ariad.comorFor MediaLiza Heapes,
617-621-2315Liza.heapes@ariad.com
Ariad (NASDAQ:ARIA)
Historical Stock Chart
From Jun 2024 to Jul 2024
Ariad (NASDAQ:ARIA)
Historical Stock Chart
From Jul 2023 to Jul 2024