Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) reported financial results for the fourth quarter and full year ended December 31, 2015and issued 2016 product revenue guidance. Additionally, the Company provided an update on corporate developments and key objectives for 2016.

”We had a strong fourth quarter of sales for Iclusig and 102 percent growth year over year,” statedParis Panayiotopoulos, president and chief executive officer of ARIAD. “This is a very important year for ARIAD as we work to complete our ongoing review of strategic initiatives to deliver patient and shareholder value. In addition to maximizing top-line growth of Iclusig, a key event this year will be the presentation of pivotal, registration data on brigatinib at ASCO, along with our planned filing for marketing approval of brigatinib in the U.S.”

2015 Fourth Quarter and Full-Year Financial Results

Revenues

  • Net product revenues from sales of Iclusig were $33.3 million for the fourth quarter of 2015, an increase of 56% from the fourth quarter of 2014.
    • U.S. sales of Iclusig were $25.1 million for the fourth quarter, an increase of 48% from the fourth quarter of 2014.
    • European sales of Iclusig were $8.2 million for the fourth quarter, an increase of 86% from the fourth quarter of 2014.
  • Net product revenues from sales of Iclusig for the year ended December 31, 2015 were $112.5 million, an increase of 102% from 2014. In the U.S., net product revenue totaled $85.7 million in 2015, an increase of 114% from 2014, while in the EU, net product revenue totaled $26.8 millionin 2015, an increase of 71% from 2014.

Net Loss

Quarter Ended December 31, 2015

  • Net loss for the fourth quarter ended December 31, 2015 was $59.9 million, or $0.32 per share, compared to a net loss of $5.8 million, or $0.03 per share, for the same period in 2014. The net loss for 2014 included $50 million in non-recurring income resulting from an amendment to our license agreement with Bellicum Pharmaceuticals, Inc.
  • R&D expenses were $44.8 million for the fourth quarter of 2015, an increase of 37% from the fourth quarter of 2014, reflecting an increase in Iclusig clinical-trial costs, as well as increased manufacturing and other supporting costs related to Iclusig.
  • Selling, general and administrative expenses were $43.8 million for the fourth quarter of 2015, an increase of 9% from the fourth quarter of 2014, reflecting an increase in personnel and commercial-related expenses.

Year Ended December 31, 2015

  • Net loss for the full year 2015 was $231.2 million, or $1.23 per share, compared to a net loss of$162.6 million, or $0.87 per share, for the full year 2014. The net loss for 2014 included $50 million in non-recurring income resulting from an amendment to our license agreement with Bellicum, noted above. The net loss for 2015 includes approximately $14.5 million in non-recurring expenses related to the retirement of our chief executive officer and costs associated with our 2015 proxy and legal matters.
  • The 2015 results include an increase in Iclusig product revenue of $56.8 million as well as an increase in operating expenses of $70.5 million in 2015 compared to 2014, reflecting an increase in R&D expenses related to an increase in clinical-trial costs, as well as manufacturing and other support costs related to Iclusig and brigatinib clinical trials, and an increase in personnel and related costs reflecting a larger number of R&D employees in 2015 compared to 2014.

Cash Position

  • As of December 31, 2015, cash, cash equivalents and marketable securities totaled $242.3 million, compared to $352.7 million in cash and cash equivalents at December 31, 2014.
  • Cash, cash equivalents and marketable securities include $50 million we received in the third quarter of 2015 from PDL BioPharma, Inc. (PDL) pursuant to a royalty financing agreement. InJuly 2016, we will receive an additional $50 million from PDL. Under the agreement, we also have an option, in our sole discretion, to receive up to an additional $100 million through July 2016.

2016 Product Revenue Guidance

  • Net product revenues from sales of Iclusig are expected to be in the range of $190 million to $200 million. This guidance includes sales of Iclusig in the U.S., Europe, and other select countries where ARIAD has distributorships in place.
  • ARIAD will provide guidance on 2016 operating expenses at the time of completing its ongoing strategic review expected in the second quarter of 2016.

Research and Development Progress and Key Objectives

Iclusig Clinical Development

  • Late last year we initiated the OPTIC-2L trial, a Phase 3 trial of Iclusig in patients with chronic-phase chronic myeloid leukemia (CP-CML) who have experienced treatment failure after imatinib therapy. This second-line study of Iclusig is aimed at expanding the indication for Iclusig in patients with resistant and intolerant CML.
  • Patient enrollment is ongoing in the OPTIC (Optimizing Ponatinib Treatment In CML) trial of Iclusig. This randomized, dose-ranging trial is designed to evaluate three different starting doses of ponatinib in patients with refractory CP-CML and is expected to inform the optimal use of Iclusig in these patients.
  • Otsuka Pharmaceutical Co., Ltd. (Otsuka), our commercial partner for Iclusig in Japan and several other Asian countries, submitted a new drug application (NDA) to the Japanese Pharmaceuticalsand Medical Devices Agency (PMDA) seeking approval for Iclusig for the treatment of resistant or intolerant CML and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ALL). This marketing application was submitted in early 2016 and is expected to lead to an initial approval of Iclusig in Japan by the end of this year.

Brigatinib Clinical Development

  • We submitted clinical data from the Phase 2 ALTA trial of brigatinib to this year’s annual meeting of the American Society of Clinical Oncology (ASCO) in June, 2016. The ALTA trial enrolled approximately 220 patients at 71 sites in North America, Europe and Asia. In addition to an anticipated data presentation at ASCO, we are on track to file for approval of brigatinib in the U.S. in the third quarter of this year. Brigatinib has received breakthrough-therapy designation from the U.S. Food and Drug Administration.
  • The randomized front-line clinical trial of brigatinib is expected to begin in the second quarter of 2016. This Phase 3 trial is designed to compare brigatinib and crizotinib in patients with ALK+ non-small cell lung cancer (NSCLC), who have not received prior ALK inhibitors, and is expected to serve as a confirmatory trial for accelerated approval of brigatinib.

Advancing the Pipeline

  • We submitted an investigational new drug (IND) application for AP32788 in late 2015 and received clearance from the U.S. Food and Drug Administration at the end of January to begin a Phase 1/2 proof-of-concept clinical trial which we expect to begin in 2016. AP32788 is an orally active tyrosine-kinase inhibitor (TKI), designed to address the unmet medical need in NSCLC patients with specific EGFR and HER2 kinase mutations. ARIAD estimates that there are approximately 6,000 patients in the United States living with EGFR exon 20 or HER2 point mutations.

Upcoming Investor Meetings

ARIAD management will be participating at the following investor conferences:

  • RBC Capital Markets’ Healthcare Conference, New York City, February 24, 2016
  • Cowen and Company Healthcare Conference, Boston, March 9, 2016
  • Barclays Global Healthcare Conference, Miami, March 17, 2016 (Original Source)

Shares of Ariad closed yesterday at $5.08. ARIA has a 1-year high of $10.07 and a 1-year low of $4.37. The stock’s 50-day moving average is $5.21 and its 200-day moving average is $6.48.

On the ratings front, Barclays analyst Jonathan Eckard initiated coverage with a Sell rating on ARIA and a price target of $6, in a report issued on January 19. The current price target implies an upside of 18.1% from current levels. According to TipRanks.com, Eckard has a total average return of -3.7%, a 31.3% success rate, and is ranked #2718 out of 3638 analysts.

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.