Earnings Release • Feb 26, 2016
Earnings Release
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Paris (France), Copenhagen (Denmark), February 26, 2016 – Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), an innovative company specializing in the development of orphan oncology therapeutics, today announced its 2015 consolidated accounts and provided a review of its 2015 achievements and anticipated milestones for 2016.
Judith Greciet, CEO of Onxeo, commented: "2015 has been a year of consolidation and progress for our company and our innovative therapeutics, advancing our position as a leading player in orphan oncology and paving the way for greater achievements in the coming months. 2016 will be a key year for Onxeo as we prepare for a first read-out of the Phase III results of Livatag® in hepatocellular carcinoma in 2017, and will report the initial results of our high-potential preclinical research on Beleodaq® and Livatag® in combination with various compounds including immuno-oncology agents. In financial terms, 2015 saw a significant increase in sales revenues from our three commercialized products, which generated €2.7 million in recurring revenues. The increase in R&D expenses over the period reflects the advancement of our clinical programs, and with our commitment to carefully control expenses, we concluded the year with €33.6 million in cash, allowing us to confirm financial visibility until mid-2017."
The consolidated accounts for 2015 reflect the progressive commercialization of Beleodaq® and Sitavig®, generating increased recurring revenues, as well as the roll-out of our clinical programs resulting in an increased R&D spend. General and administrative expenses have been contained as a result of the smooth integration of the Topotarget teams after the merger and an overall optimized monitoring. The discrepancy in revenues and net loss between 2015 and 2014 is mainly linked to nonrecurring revenues received in 2014, i.e. milestone payments from partners, as well as one-time costs due to the merger.
| Consolidated accounts (IFRS-compliant) | 31/12/2015 | 31/12/2014 |
|---|---|---|
| In thousands Euros | ||
| Revenues, out of which | 3,481 | 22,081 |
| Recurring revenues | 2,733 | 1,625 |
| Non-recurring revenues | 0,749 | 20,455 |
| Operating expenses, out of which | (25,657) | (22,697) |
| R&D expenses | 16,350 | 12,978 |
| G&A and other expenses | 9,307 | 9,719 |
| Operating profit/loss | (22,365) | (5,554) |
| Non-current operating profit/loss | (189) | (4,938) |
| Financial income | 602 | 5 |
| Income tax | 2,353 | (2,150) |
| Net profit/loss | (19,409) | (7,699) |
According to IFRS, the above 2014 figures do not take into account the activity of Topotarget over the first semester as the merger of this entity into Onxeo was effective on June 30, 2014.
In 2015, recurring revenues increased 68% over 2014 to €2.7 million as a result of the U.S. commercialization of both Beleodaq® by partner Spectrum Pharmaceuticals and Sitavig® by Innocutis/Cipher.
In the absence of any contractual milestone during the period, non-recurring revenues were limited to the revenue recognition of upfront payments received in previous years as per IAS 18. As a reminder, milestone and upfront payments received in 2014 and related to Beleodaq® and Sitavig® were booked as revenues in the consolidated accounts for an amount of \$25 million (€20 million). On a proforma basis, these milestones totaled \$43 million over 2014.
Operating expenses totaled €25.6 million, of which 64% was related to R&D, mostly reflecting the roll-out and ramp-up of the international ReLive study with Livatag, which is in line with the planned use of our resources. Research tax credits totaled €3.7 million, in France and in Denmark, and have been netted with operating expenses according to IFRS.
The consolidated cash position at the end of December 2015 stood at €33. 8 million, confirming the good situation of the company and the visibility until mid-2017.
The 2015 financial results were subject to a review by the Company's Statutory Auditors and was approved by the Board of Directors on February 26, 2016.
Onxeo will comment on major company updates and its financial statements during its SFAF meeting which will be held on March 7, 2016 at 11:00 AM CET at the Intercontinental Paris Avenue Marceau (64, avenue Marceau – 75015 Paris).
Onxeo is a leading developer of orphan oncology drugs. The Company is focused on developing innovative therapeutics for rare cancers, one of the fastest growing markets in the healthcare industry with high, unmet medical needs. Onxeo's comprehensive portfolio features a deep orphan oncology pipeline, with three independent programs in advanced clinical development, including Onxeo's first approved orphan oncology drug, Beleodaq®. In addition, Onxeo has successfully developed and registered two non-cancer products currently being commercialized in the U.S. and Europe. Onxeo's vision is to become a global leader and pioneer in oncology, with a focus on orphan or rare cancers, by developing advanced, effective and safe therapeutics designed to improve the lives of patients. The Company is headquartered in Paris, France and has about 50 employees. Onxeo is listed on Euronext in Paris, France (Ticker: ONXEO, ISIN Code: FR0010095596) and Nasdaq Copenhagen, Denmark (Ticker: ONXEO).
belinostat in combination with CHOP (BelCHOP) is also currently in development as first-line treatment for patients with PTCL.
Onxeo is also evaluating its lead product candidates in combination with other cancer agents to expand their value.
Learn more by visiting www.onxeo.com.
This communication expressly or implicitly contains certain forward-looking statements concerning Onxeo and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Onxeo to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Onxeo is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of Onxeo to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the 2014 Reference Document filed with the AMF on April 14, 2015, which is available on the AMF website (http://www.amf-france.org) or on the company's website (www.onxeo.com).
Contacts: Nathalie Delair-Trepo Investor Relations, Onxeo [email protected] + 33 1 45 58 76 00
Caroline Carmagnol and Florence Portejoie – Alize RP (France) [email protected] +33 6 64 18 99 59 / +33 6 47 38 90 04
Kirsten Thomas / Lee Roth – The Ruth Group (U.S.) [email protected] / [email protected] +1 508 280 6592 / +1 646 536 7012
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