ARIAD Reports 2012 Financial Results and Outlines Key Objectives for 2013
Commercial Oncology Company Established Following U.S. Approval of Iclusig^TM
Conference Call Scheduled Today at 8:30 a.m. ET
CAMBRIDGE, Mass. -- February 25, 2013
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results
for the fourth quarter and full year ended December 31, 2012 and provided an
update on corporate developments.
“Last year was clearly a landmark period for ARIAD as we transformed into a
commercial oncology company,” said Harvey J. Berger, M.D., chairman and chief
executive officer of ARIAD. “We received U.S. approval of Iclusig™
(ponatinib), established a commercial organization in the U.S. and hired our
European leadership team. We advanced the development of AP26113 and presented
positive clinical proof-of-concept data showing the great promise of AP26113
as our next internally discovered tyrosine kinase inhibitor that overcomes
drug resistance. We are now a sustainable, fully integrated global oncology
company with the highly differentiated capability to discover, develop and
deliver innovative cancer medicines.”
Key Highlights from 2012
*In December, we received accelerated approval in the U.S. of Iclusig for
the treatment of adult patients with chronic, accelerated or blast phase
chronic myeloid leukemia (CML) that is resistant or intolerant to prior
tyrosine kinase inhibitor (TKI) therapy or Philadelphia
chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) that is
resistant or intolerant to prior TKI therapy.
*We submitted a Marketing Authorization Application (MAA) for Iclusig to
the European Medicines Agency seeking marketing approval in the EU of
Iclusig in adult patients with resistant or intolerant CML or Ph+ ALL. The
Committee for Medicinal Products for Human Use granted ARIAD’s request for
accelerated assessment of the MAA.
*In Europe, we established early-access programs for Iclusig, established
the supply chain in key markets and implemented initial pricing and
reimbursement activities. We began building our leadership team in our
European headquarters in Lausanne, Switzerland.
*We advanced the Phase 1/2 clinical trial of AP26113, our investigational
inhibitor of anaplastic lymphoma kinase (ALK), epidermal growth factor
receptor (EGFR), and c-ros oncogene 1 (ROS1). Compelling anti-tumor
activity of AP26113 in patients with ALK-positive non-small cell lung
cancer (NSCLC) and initial anti-tumor activity in patients with
EGFR-mutant NSCLC were presented at the European Society of Medical
Oncology meeting. Importantly, AP26113 showed clinical activity in
ALK-positive NSCLC patients with brain metastases.
*The New England Journal of Medicine published results from the Phase 1
studyof Iclusig in heavily pretreated patients with resistant and
refractory CML and Ph+ ALL.
*We initiated the global, Phase 3 EPIC trial of Iclusig in patients with
newly diagnosed CML. This trial compares Iclusig to imatinib and has a
primary endpoint of major molecular response at 12 months of treatment.
*We initiated a Phase 1/2 clinical trial of Iclusig in resistant or
intolerant CML and Ph+ ALL patients in Japan in the second half of 2012.
The trial is designed to establish the recommended dose of Iclusig in
Japanese patients, confirm its anti-leukemic activity in this patient
population, and provide the necessary data required for regulatory
approval of Iclusig in Japan.
Recent Progress and Key Objectives
Global Commercialization of Iclusig
*All of the key functions in our U.S. commercial organization, including
account specialists, market access, and marketing, are in place and
implementing the commercial plans for Iclusig.
*Our European business is also fully operational. We hired the General
Manager of our European operations, along with other key members of our
leadership team. Medical science liaisons and sales representatives in
each of other major markets in Europe are now being recruited, and we
expect to be launch-ready in Europe by July 1, 2013.
*We anticipate approval of Iclusig in the EU in the third quarter of 2013
and regulatory submissions in Canada, Switzerland, and Australia in the
second half of 2013.
Broadening Iclusig Clinical Development
*Patient enrollment is ongoing in the global, Phase 3 EPIC trial of Iclusig
in patients with newly diagnosed CML. We anticipate full patient
enrollment in the trial by the end of 2013. The study includes an interim
analysis of the primary endpoint one year after one-half of the
approximately 500 patients in the trial have been enrolled. We anticipate
the interim analysis to occur in mid-2014.
*We plan to submit for regulatory approval of Iclusig in Japan in mid-2014.
*ARIAD and the U.K. National Cancer Research Institute (NCRI) began
collaboration on a randomized Phase 3 trial, named SPIRIT 3, to assess the
impact of switching patients with CML being treated with a first-line
tyrosine kinase inhibitor, upon suboptimal response or treatment failure,
to Iclusig. The NCRI expects to begin enrollment in the trial of 1,000
patients at approximately 172 clinical research sites in the U.K. in the
second quarter of 2013.
*We plan to begin company-sponsored and investigator-sponsored Phase 2
trials of Iclusig in patients with gastrointestinal stromal tumors (GIST),
acute myeloid leukemia, certain molecularly defined types of lung cancer
and other solid tumors during 2013. Depending on the clinical findings
from these trials and discussions with regulatory agencies, we may begin
additional pivotal trials of Iclusig, including, for example, in patients
with GIST who have failed prior therapy.
Advancing AP26113 Through Clinical Development
*The Phase 1 portion of our Phase 1/2 clinical trial of AP26113 is ongoing,
and we expect to transition into the four Phase 2 expansion cohorts during
the first half of 2013.
*In parallel to the Phase 1/2 trial, we are actively planning the pivotal
trial of AP26113 in ALK-positive NSCLC patients resistant to crizotinib.
Depending on the clinical findings from the Phase 2 portion of the
currently ongoing Phase 1/2 trial and discussions with regulatory
agencies, we may begin additional pivotal trials of AP26113, including,
for example, in patients with EGFR-mutant NSCLC who have failed prior EGFR
*We anticipate presenting clinical updates on AP26113 at the 2013 annual
meetings of the American Society of Clinical Oncology and the European
Society of Medical Oncology.
2012 Fourth Quarter and Full-Year Financial Results
Quarter Ended December 31, 2012
Net loss for the fourth quarter ended December 31, 2012 was $60.5 million, or
$0.36 per share, compared to a net loss of $51.8 million, or $0.38 per share,
for the same period in 2011. The increase in net loss is primarily due to an
increase in operating expenses of $28.8 million, reflecting our preparations
for commercial launch of Iclusig, including the hiring of sales personnel and
other professional staff, as well as continued development of our product
candidates, and a decrease of $20.1 million in the non-cash charge related to
the revaluation of our warrant liability.
Year Ended December 31, 2012
Net loss for the full year 2012 was $220.9 million, or $1.34 per share,
compared to a net loss of $123.6 million, or $0.93 per share, for the full
These results show an increase in operating expenses of $103.5 million in 2012
as compared to 2011 reflecting ongoing development of our product candidates
and planning and preparations for commercial launch of Iclusig. Our results
also include a decrease of $30.8 million in the non-cash charge related to the
revaluation of our warrant liability in 2012 as compared to 2011.
As of December 31, 2012, cash, cash equivalents and marketable securities
totaled $164.4 million, compared to $306.3 million at December 31, 2011.
Subsequently, in January 2013, we raised net proceeds of $310 million in an
underwritten public offering and sale of approximately 16.5 million shares of
our common stock.
Financial Guidance for 2013
We anticipate cash used in operations in 2013 to range from $255 million to
$265 million. Our guidance includes:
*Research and development expenses of $238 million to $248 million,
reflecting further expansion of development activities for Iclusig and
AP26113, as well as expanded discovery research activities. This includes,
for Iclusig, the ongoing Phase 1, PACE and EPIC trials, ongoing clinical
pharmacology studies to meet post-approval commitments, the ongoing
Japanese Phase 1/2 trial, a Phase 2 trial in GIST to initiate shortly,
multiple ongoing and contemplated investigator-sponsored trials including
SPIRIT 3, and planning for additional potential trials in new indications
including a pivotal trial in GIST; and for AP26113, the pivotal-trial
program, including multiple NDA-enabling clinical pharmacology studies.
*Selling, general and administrative expenses of $108 million to $116
million, including growth in global commercial operations and supporting
activities for the commercial launch of Iclusig in the U.S. and
anticipated commercial launch of Iclusig in Europe and in selected
countries in other regions.
*Non-cash expenses of $35 million to $41 million, consisting primarily of
stock-based compensation and depreciation and amortization expenses. The
increase is due to the impact of an increase in number of employees and
our stock price on stock-based compensation and an increase in
depreciation and amortization resulting from capital expenditures.
We expect that our cash, cash equivalents and marketable securities at
December 31, 2013 will range from $195 million to $205 million, sufficient to
advance the Company’s programs into the fourth quarter of 2014.
Upcoming Investor Meetings
ARIAD management will be making corporate presentations at the following
*RBC Capital Markets’ Healthcare Conference, New York, NY, February 26,
*Cowen and CompanyHealthcare Conference, Boston, MA, March 6, 2013
*Barclays Global Healthcare Conference, Miami, FL, March 13, 2013
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
2012 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 866-831-6272
(domestic) or 617-213-8859 (international) five minutes prior to the start
time and providing the pass code 59632303. 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^TM (ponatinib) tablets
Iclusig is a kinase inhibitor indicated for the treatment of adult patients
with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia
(CML) that is resistant or intolerant to prior tyrosine kinase inhibitor
therapy or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+
ALL) that is resistant or intolerant to prior tyrosine kinase inhibitor
therapy. This indication is based upon response rate. There are no trials
verifying an improvement in disease-related symptoms or increased survival
Important Safety Information for Iclusig^TM (ponatinib)
WARNING: ARTERIAL THROMBOSIS and HEPATOTOXICITY
Arterial Thrombosis: Cardiovascular, cerebrovascular, and peripheral vascular
thrombosis, including fatal myocardial infarction and stroke have occurred in
Iclusig-treated patients. In clinical trials, serious arterial thrombosis
occurred in eight percent of Iclusig-treated patients. Interrupt and consider
discontinuation of Iclusig in patients who develop arterial thrombotic events.
Hepatotoxicity: Hepatotoxicity, liver failure and death have occurred in
Iclusig-treated patients. Monitor hepatic function prior to and during
treatment. Interrupt and then reduce or discontinue Iclusig for
Please visit www.iclusig.com for full prescribing information, including boxed
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.comor follow ARIAD on
This press release contains “forward-looking statements” including, but not
limited to, updates on clinical, preclinical and regulatory developments and
commercialization plans for our product candidates and financial guidance for
2013. 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, our ability to successfully launch,
commercialize and generate profits from sales of Iclusig; competition from
alternative therapies, our ability to obtain approval for Iclusig outside of
the United States and in additional indications; our reliance on third-party
manufacturers, and on specialty pharmacies for the distribution of Iclusig;
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; difficulties or
delays in obtaining regulatory approvals to market products; the adequacy of
our capital resources and the availability of additional funding; patent
protection and third-party intellectual property claims; our failure to comply
with extensive regulatory requirements; the occurrence of serious adverse
events in patients being treated with Iclusig or our product candidates; 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
Three Months Ended Year Ended
except per December 31, December 31,
2012 2011 2012 2011
Total revenue $ 74 $ 78 $ 558 $ 25,300
Research and 37,689 24,723 144,709 77,743
General and 22,915 7,046 60,909 24,380
operating 60,604 31,769 205,618 102,123
warrant --- (20,086 ) (15,924 ) (46,715 )
Other 77 (25 ) 112 (65 )
Other income 77 (20,111 ) (15,812 ) (46,780 )
Net income $ (60,453 ) $ (51,802 ) $ (220,872 ) $ (123,603 )
- basic $ (0.36 ) $ (0.38 ) $ (1.34 ) $ (0.93 )
- diluted $ (0.36 ) $ (0.38 ) $ (1.34 ) $ (0.93 )
of shares of
- basic 166,707 135,816 164,964 132,375
- diluted 166,707 135,816 164,964 132,375
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
In thousands December 31, December 31,
Cash, cash equivalents and marketable $ 164,414 $ 306,256
Total assets $ 180,193 $ 320,712
Working capital $ 119,484 $ 282,195
Deferred revenue, total $ 769 $ 999
Total liabilities $ 67,342 $ 100,571
Stockholders’ equity $ 112,851 $ 220,141
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION
In thousands Year Ended
Net cash used in operating activities $ (153,681 ) $ (53,262 )
Net cash used in investing activities (50,400 ) (2,123 )
Net cash provided by financing activities 17,204 258,001
Net increase (decrease) in cash and cash $ (186,877 ) $ 202,626
ARIAD Pharmaceuticals, Inc.
Kendra Adams, (617) 503-7028
Liza Heapes, (617) 621-2315
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