ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) reported financial results for the first quarter of 2015, including revenue from sales of Iclusig® (ponatinib). The Company also provided an update on corporate developments.
“Iclusig demonstrated strong performance in both the U.S. and European markets during the first quarter driven by steady underlying demand,” said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “We continue to expand the global commercial opportunity for Iclusig, most recently through additional marketing approvals in Israel and Canada. Additionally, we are on track to initiate three new randomized Iclusig clinical trials during 2015 and to achieve full patient enrollment in the brigatinib pivotal trial in the third quarter.”
2015 First Quarter Financial Results
- Net product revenues from sales of Iclusig were $23.9 million for the quarter ended March 31, 2015, an increase of 12% versus the fourth quarter of 2014. Net product revenues for the first quarter include Iclusig revenues of $18.7 million in the U.S. and $5.2 million in Europe. U.S. sales of Iclusig increased 10% from the fourth quarter of 2014 to the first quarter of 2015, and European sales increased 18%, net of the impact of changes in foreign exchange rates for the first quarter.
- In the quarter ended March 31, 2015, we transitioned to the sell-in method for recognition of product revenues in the U.S., resulting in a one-time addition to revenue of approximately $1.2 million for the first quarter.
- Shipments of Iclusig to patients in France were $1.9 million for the first quarter of 2015. Cumulative total shipments in France, taking into account the effects of foreign exchange, totaled $18.3 millionthrough March 31, 2015. We will record revenue related to cumulative shipments in France upon completion of pricing and reimbursement negotiations in France, net of any amounts that will be refunded to the French health authorities as a result of such negotiations, which we anticipate will be completed in mid-2015.
- Net loss for the quarter ended March 31, 2015 was $52.7 million, or $0.28 per share, compared to a net loss of $49.8 million, or $0.27 per share, for the same period in 2014.
- R&D expenses were $39.4 million for the first quarter of 2015, an increase of 38% compared to the first quarter of 2014, reflecting an increase in costs for our investigational ALK+ inhibitor, brigatinib, related to the ongoing Phase 2 ALTA trial and NDA-enabling pre-clinical studies, as well as increase in personnel and other costs in support of our R&D activities.
- Selling, general and administrative expenses were $33.6 million for the first quarter of 2015, an increase of 6% compared to the first quarter of 2014, reflecting an increase in professional fees and other expenses related to the commercialization of Iclusig, as well as legal and proxy-related matters.
- As of March 31, 2015, cash and cash equivalents totaled $304.0 million, compared to $352.7 millionat December 31, 2014.
Recent Progress and Key Objectives
Commercialization of Iclusig®
- Approximately 120 new patients were treated with Iclusig in the U.S. during the first quarter of 2015.
- By the end of the first quarter, there were nearly 750 unique prescribers of Iclusig in the U.S., an increase in the prescriber base of approximately 14% from the fourth quarter of 2014.
- In Europe, we are now selling Iclusig in Germany, the United Kingdom, Austria, the Netherlands,Norway, Sweden, and Italy. In addition, we are distributing Iclusig to patients in France and Spainprior to pricing and reimbursement approval as permitted under local regulations.
- As of the end of March, Iclusig is approved for reimbursement in Sweden in accordance with the full EU label. This reimbursement decision followed an extensive Health Technology Assessment completed by the Swedish Dental and Pharmaceutical Benefits Agency (TLV).
- In April, Iclusig received a positive decision for reimbursement by the Scottish Medicine Consortium. Iclusig is now reimbursed in Scotland for the treatment of resistant forms of chronic myeloid leukaemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL).
- Iclusig is now approved in Israel and Canada for adult patients with resistant forms of CML and Ph+ ALL. We expect our distributor Medison Pharma Ltd. will begin to commercialize Iclusig in Israelduring the second quarter.
- Earlier this week, we announced an agreement with Gen Ilac, a Turkish pharmaceutical company, to distribute Iclusig in Turkey for patients with Philadelphia-positive leukemias.
Iclusig Clinical Development
- Three randomized Iclusig clinical trials are on track to begin in 2015, two of which will evaluate Iclusig in earlier lines of treatment, as follows:
- A Phase 3 trial in approximately 500 patients with chronic-phase chronic myeloid leukemia (CP-CML) who have experienced treatment failure after imatinib therapy.
- A dose-ranging trial of Iclusig in approximately 450 patients with CP-CML who have become resistant to at least two prior TKIs.
- An early-switch trial of Iclusig in approximately 1,000 patients with CP-CML in the United Kingdom(known as the SPIRIT3 trial).
- Additionally, 10 ISTs in the ponatinib program are open to patient enrollment, and three additional ISTs are pending regulatory or institutional review board approval.
- Our first U.S. patent for brigatinib was issued last month and provides composition-of-matter protection through at least December 30, 2030. Additional patent applications covering brigatinib in the U.S. and in other countries are pending.
- Brigatinib is currently being evaluated in the global, Phase 2 pivotal ALTA trial that is anticipated to form the basis for its initial regulatory approval. We are on track to achieve full patient enrollment of approximately 220 patients in the ALTA trial in the third quarter of 2015 and to file for approval of brigatinib in the U.S. next year.
- We anticipate presenting an update from the ongoing Phase 1/2 clinical trial of brigatinib at the 2015 American Society of Clinical Oncology meeting. Additionally, we expect to present preliminary data from the brigatinib ALTA trial in the second half of 2015.
Upcoming Medical Meetings
- American Society of Clinical Oncology (ASCO) 2015 Annual Meeting, Chicago, May 29 to June 2, 2015
- European Hematology Association (EHA) 20th Congress, Austria, Vienna June 11 to 14, 2015 (Original Source)
Shares of Ariad closed yesterday at $8.77 . ARIA has a 1-year high of $9.89 and a 1-year low of $4.90. The stock’s 50-day moving average is $8.73 and its 200-day moving average is $7.32.
On the ratings front, Ariad has been the subject of a number of recent research reports. In a report issued on April 20, BMO analyst Jim Birchenough reiterated a Buy rating on ARIA, with a price target of $14, which represents a potential upside of 59.6% from where the stock is currently trading. Separately, on February 23, H.C. Wainwright’s Reni Benjamin reiterated a Buy rating on the stock and has a price target of $10.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jim Birchenough and Reni Benjamin have a total average return of 43.2% and -4.2% respectively. Birchenough has a success rate of 62.2% and is ranked #9 out of 3594 analysts, while Benjamin has a success rate of 33.3% and is ranked #3413.
In total, 2 research analysts have assigned a Hold rating and 2 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $8.77 which is 4.1% above where the stock closed yesterday.
ARIAD Pharmaceuticals Inc is an oncology company. The Company is engaged in transforming the lives of cancer patients with breakthrough medicines. It commercializes & develops products and product candidates including Iclusig, Brigatinib, and AP32788.