"Our second-quarter results demonstrate strong growth of Iclusig sales in the U.S.," said
2013 Second Quarter Financial Results
Net sales of Iclusig were
We currently use the sell-through method of accounting for recognition of product revenues. As of
In addition, in the quarter ended
Net loss for the quarter ended
Research and development expenses increased by
Selling, general and administrative expenses increased by
Revised Financial Guidance for 2013
We now anticipate cash used in operations in 2013 of
Global Commercialization of Iclusig
By the end of the second quarter of commercialization of Iclusig in the U.S., there were more than 450 unique prescribers of Iclusig, more than doubling the prescriber base from the first quarter. As of
June 30, 2013, more than 610 patients in the U.S. have been treated with Iclusig supplied commercially.
Importantly, approximately 40 percent of U.S. patients who started Iclusig therapy during the second quarter had failed only one prior tyrosine kinase inhibitor (TKI). In addition, the number of chronic-phase patients receiving Iclusig grew to approximately 70 percent by the end of
- Approximately 70 percent of Iclusig prescribers are community-based physicians, with the remainder based in the academic setting. We expect that adoption of Iclusig among community oncologists and hematologists will continue to increase as utilization progresses further.
July 2013, the European Commissiongranted a Marketing Authorization for Iclusig as an orphan medicinal product for use in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ALL).
As of today, we have begun selling Iclusig in
Germany, the United Kingdomand Austriaand expect the Netherlandsto follow later this quarter. Additionally, we expect to receive Marketing Authorization in Switzerlandin the fourth quarter of 2013.
We have filed for Iclusig regulatory approval in
Broadening Iclusig Clinical Development
- The global, Phase 3 EPIC trial of Iclusig, which compares Iclusig to imatinib in patients with newly diagnosed CML, is advancing towards full patient enrollment by the end of 2013. Approximately 150 clinical sites in 20 countries are now participating in the trial, and data from an interim analysis of safety and efficacy are anticipated, as planned, in the third quarter of 2014.
Japan, the Phase 2 portion of the Phase 1/2 clinical trial of Iclusig in resistant or intolerant CML and Ph+ ALL patients has completed enrollment. We are on schedule to file for regulatory approval of Iclusig in Japannext year.
We expect patient enrollment in the randomized Phase 3 SPIRIT 3 trial to begin this quarter. We are collaborating with the
U.K. National Cancer Research Institute(NCRI) on this trial 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 enroll 1,000 patients at approximately 172 clinical research sites in the U.K.
- A Phase 2 trial of Iclusig in patients with gastrointestinal stromal tumors (GIST) is underway. The trial will enroll approximately 45 patients and is designed to provide initial clinical data evaluating the efficacy and safety of Iclusig in patients with GIST following failure of prior TKI therapy.
Advancing AP26113 Through Clinical Development
The Phase 2 portion of the ongoing Phase 1/2 clinical trial of AP26113 in patients with advanced non-small cell lung cancer (NSCLC) is enrolling patients at eight sites in
the United Statesand Europe. The Phase 2 portion of the trial consists of five expansion cohorts at a daily dose of 180 mg:
- ALK-positive (ALK+) NSCLC treatment naïve patients,
- ALK+ NSCLC patients, resistant to crizotinib,
- EGFRm NSCLC patients, resistant to one prior EGFR TKI with documented T790M mutation,
- ROS1-positive NSCLC patients and patients with other targets of AP26113,
- ALK+ NSCLC patients, either naïve or resistant to crizotinib, with active brain metastases. This fifth expansion cohort will begin enrolling patients this quarter.
- In parallel to enrollment of patients in the Phase 2 expansion cohorts, this quarter, we will begin a pivotal trial of AP26113 in ALK-positive NSCLC patients who are resistant to crizotinib.
- Additionally, further Phase 1 evaluation of the 240 mg dose is continuing in NSCLC patients with documented EGFRm and the secondary mutation, T790M, following disease progression on prior EGFR TKI therapy.
We will present a clinical update on AP26113 at the 2013 annual meeting of the
European Society of Medical Oncologyin September that will include data in both ALK+ and EGFR T790M patients.
Upcoming Medical Meetings
European Society of Medical Oncology(ESMO) 2013 Annual Meeting, Amsterdam, Netherlands, September 27 to October 1, 2013.
World Conference on Lung Cancer(WCLC), Sydney, Australia, October 27 to 30, 2013.
Upcoming Investor Meetings
ARIAD management will be making corporate presentations at the following investor conferences:
Citi Biotech Day,
Boston, September 4, 2013
Morgan Stanley Global Healthcare Conference, New York City, September 11, 2013
Stifel Nicolaus Healthcare Conference, Boston, September 11, 2013
Today's Conference Call at
We will hold a live webcast and conference call of our second quarter financial results this morning at
About Iclusig® (ponatinib) tablets
Iclusig is a kinase inhibitor indicated in
Important U.S. Safety Information for Iclusig® (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 hepatotoxicity.
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
ARIAD PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|In thousands, except per share data||
Three Months Ended
Six Months Ended
|Product revenue, net||$||13,934||$||---||$||20,298||$||---|
|Cost of product revenue||228||---||497||---|
|Research and development||40,668||39,425||81,931||68,198|
|Selling, general and administrative||42,101||12,224||71,583||23,512|
|Total operating expenses||82,997||51,649||154,011||91,710|
|Other income (expense), net||87||19||25||(15,895||)|
|Provision for income taxes||86||---||145||--|
|Net loss per common share:|
|-- basic and diluted||$||(0.37||)||$||(0.31||)||$||(0.74||)||$||(0.66||)|
|Weighted-average number of shares of common stock outstanding:|
|-- basic and diluted||184,726||165,848||181,651||163,409|
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
|Cash, cash equivalents and marketable securities||$||351,907||$||164,414|
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION
Six Months Ended
|Net cash used in operating activities||$||(114,144||)||$||(68,157||)|
|Net cash provided by (used in) investing activities||17,118||(92,185||)|
|Net cash provided by financing activities||309,563||14,819|
|Effect of exchange rates on cash||(25)||---|
|Net increase (decrease) in cash and cash equivalents||$||212,512||$||(145,523||)|