Earnings Release • May 11, 2016
Earnings Release
Open in ViewerOpens in native device viewer
Breda, the Netherlands / Ghent, Belgium, 11 May 2016 - argenx N.V. (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, today announced financial results for the first quarter ended 31 March 2016.
"On the strategic side we were very pleased to announce our collaboration with AbbVie last month for the exclusive opt-in right to ARGX-115 which targets the novel immune checkpoint GARP. The collaboration not only provides an upfront payment of \$40 million further strengthening our financial position but also provides validation from a global oncology player of our first immuno-oncology asset from our Innovative Access program (IAP), which has quickly generated novel and valuable compounds," said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
"We remain very focused on advancing our pipeline programs and on driving forward our ongoing studies in cancer and autoimmune diseases including several upcoming milestones. We have defined the doses for our multiple ascending dose escalation study for ARGX-113; we expect data from this study by the end of July of this year and to announce our Phase 2 plan in the second half of 2016. We will also have data from our two lead oncology programs this year with top-line Phase 1 data of ARGX-110 in T-cell lymphoma in the third quarter of 2016 and top-line data from the Phase 1 safety expansion cohort of ARGX-111 by mid-2016."
In the first quarter of 2016, the Company
More recently, the Company
Initiated a collaboration with AbbVie to develop and commercialize ARGX-115. ARGX-115, a preclinical-stage human antibody program targeting the novel immuno-oncology target GARP, is a protein that is believed to contribute to immunosuppressive effects of T-cells. argenx will receive an upfront payment of \$40 million and near-term preclinical milestones of \$20 million from AbbVie in return for the exclusive option to license ARGX-115. argenx is also eligible to receive additional development, regulatory and commercial payments up to \$625 million upon achievement of pre-determined milestones as well as tiered, up to double-digit royalties on net sales upon commercialization.
Cash position of EUR 53.8 million (cash, cash-equivalents and financial assets) (31 March 2015: EUR 52.2 million) allowing Company to pursue development of its product portfolio in line with its communicated business plan.
Interim data of Phase 1b safety expansion cohort by mid- 2016
| Financial overview | |||
|---|---|---|---|
| in thousands of euros | Period ended Period ended | ||
| March 31, | March 31, | ||
| 2016 | 2015Variance | ||
| Revenue | 2,216 | 1,210 | 1,006 |
| Other operating income | 619 | 614 | 5 |
| Total operating income | 2,835 | 1,825 | 1,011 |
| Research and development expenses | (4,408) | (3,950) | (458) |
| General and administrative expenses | (1,401) | (1,105) | (296) |
| Operating profit/(loss) | (2,974) | (3,230) | 257 |
| Financial income | 42 | 91 | (50) |
| Exchange gains/(losses) | (38) | 160 | (198) |
| Profit/loss for the period | (2,970) | (2,979) | 9 |
| Net increase (decrease) in cash, cash-equivalents and | |||
| financial assets | 11,520 | (3,809) | 15,329 |
| Cash, cash-equivalents and financial assets at the end of the | |||
| period | 53,847 | 52,164 | 1,683 |
For the three-month period ended 31 March 2016, operating income reached EUR 2.8 million compared to EUR 1.8 million during the same period in 2015. The higher operating income in the first quarter of 2016 is mainly explained by the partial recognition of the upfront payment received following the signature of a partnership with LEO Pharma in May 2015.
Research and development expenses were EUR 4.4 million and EUR 4 million for the three-month period ended 31 March 2016 and 2015, respectively. The EUR 0.4 million increase in R&D expenses in the first three months of 2016 corresponds principally to increased clinical trial activities and to the recruitment of additional R&D personnel.
General and administrative expenses amounted to EUR 1.4 million in the first three months of 2016 compared to EUR 1.1 million on 31 March 2015. The EUR 0.3 million increase in the first quarter of 2016 is principally explained by expenses related to the move of the company to its new premises, the implementation of a new IT infrastructure and the recruitment of additional G&A personnel for supporting the operational activities of the company.
The Company generated a net loss of EUR 3 million in the three-month periods ended 31 March 2016 and 31 March 2015.
The Company's cash, cash equivalents and financial assets amounted to EUR 53.8 million on 31 March 2016 compared to EUR 42.3 million on 31 December 2015 and EUR 52.2 million on 31 March 2015.
argenx combines the diversity of the llama immune system with antibody engineering to advance a clinical pipeline to treat patients with cancer and autoimmune diseases. Our platforms allow us to unlock novel and complex targets and develop antibody-based drugs designed for greater efficacy and longer duration of effect. The strength of our team, our deep understanding of the biology and our committed collaborations with industry leaders contribute to the success of our journey.
argenx is listed on the Euronext Brussels exchange under the symbol ARGX.
www.argenx.com
Joke Comijn, Corporate Communications Manager +32 (0)477 77 29 44 +32 (0)9 243 40 70 [email protected]
Beth DelGiacco (US IR) Stern Investor Relations +1 212 362 1200 [email protected]
The contents of this announcement include statements that are, or may be deemed to be, "forwardlooking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes", "estimates", "anticipates", "expects", "intends", "may", "will", or "should", and include statements argenx makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx' actual results may differ materially from those predicted by the forward-looking statements. argenx undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.