Q4 and Full Year 2015 Interim Financial Report
Bionor Pharma ASA
Interim Financial Report
1 January - 31 December 2015
Oslo, 12 February 2016
HIGHLIGHTS Q4 2015
In the fourth quarter of 2015, Bionor accelerated the company's revitalization by executing the updated business strategy and development plans presented at the company's Capital Markets Day in October 2015. The first clinical trial application for BIOSKILL was submitted, and most importantly, the REDUC trial successfully provided proof of the 'Shock & Kill' principle.
- 21 December, Bionor announced successful completion of the HIV 'Shock & Kill' trial REDUC with Vacc-4x and romidepsin, which met its endpoints by demonstrating control of viral load and a reduction of the latent HIV reservoir
- 17 November, Bionor announced the submission of a clinical trial application (CTA) to the Danish Medicines Agency requesting approval to initiate BIOSKILL in Denmark
- 30 October, Bionor announced a strategic augmentation of its Clinical Advisory Board to emphasize the company's focus on functional HIV cure
- 7 October, Bionor hosted a Capital Markets Day in Oslo, Norway to present its revised company strategy and development plans for advancing toward a functional cure for HIV
- Net cash flow in Q4 2015 was NOK -25.2 million (Q4 2014: NOK -10.6 million)
- Cash and cash equivalents at 31 December 2015 was NOK 10.6 million (30 December 2014: NOK 93.1 million)
Events after the balance sheet date
- 11 February 2016, the company's shareholders approved the completion of a private placement raising NOK 45 million in gross proceeds, which is expected to fund the company through the first half of 2016, and a subsequent repair offering for existing shareholders
- 1 February 2016, Bionor was granted up to NOK 9.2 million from the Research Council of Norway to further advance Vacc-4x in a combination treatment regimen.
Financial guidance for 2015 and 2016
For the full year 2015, Bionor met its financial guidance for 2015 of a Core cost base in the range of NOK 55-63 million. The Core cost base amounted to NOK 63.1 million. The Core cost base is defined as Employee Benefit Expenses plus Other operating expenses less External R&D expenses.For the full year 2016, Bionor expects the Core cost base to be in the range of NOK 58-66 million.
David Horn Solomon, President and CEO commented:
"The fourth quarter of 2015 was a period with significant advances in Bionor. The findings in the REDUC trial announced in December 2015 fostered worldwide and substantial interest in Bionor from patients, caregivers and the media. We also succeeded in attract-ing additional functional HIV cure experts to our Clinical Advisory Board, and we submitted the first clinical trial applications for BIOSKILL. Finally, I am grateful for the strong support from new and existing shareholders in the recently completed private placement. We can now diligently complete the preparation of the BIOSKILL trial and other clinical studies. With all these major events, we are highly encouraged to continue our pioneering work to develop a functional cure for HIV."
Teleconference 12 February 2016 at 13:00 CET
Bionor will host a conference call for analysts and investors 12 February 2016 at 13:00 CET at which David H. Solomon, President and CEO, and Jens Krøis, CFO, will provide an update of the business. To attend the conference, please use theparticipant code 1059479.
Norway: +47 2316 2771
Denmark: +45 32 71 16 58
United Kingdom: +44 20 3427 1905
USA: +1 646 254 3365
Sweden: +46 8 5033 6538
A presentation will be available on the company's website prior to the call. A webcast of the conference call will be available during and after the event. Link to webcast: http://edge.media-server.com/m/p/wrriyzu2.
This information is subject of the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.
David Horn Solomon, President and CEO, +45 22 20 63 00, email@example.com
Jens Krøis, CFO, +45 20 80 16 68, firstname.lastname@example.org
Jørgen Fischer Ravn, VP Investor Relations & Communications, +45 20 30 39 03, email@example.com
Bionor Pharma is a Norwegian biopharmaceutical company focused on advancing its proprietary therapeutic vaccine Vacc-4x in combination with other medicines toward a functional HIV cure. The company believes it has first mover potential based on clinical results to date and early adoption of now recognized clinical strategy. In December 2015, Bionor announced that the HIV 'Shock & Kill' trial REDUC with Vacc-4x and romidepsin successfully met its primary endpoint by significantly reducing latent HIV reservoir and further demonstrated control of viral load. Bionor is currently planning BIOSKILL, a proof-of-concept Phase II trial, which may lead to a major value inflection point and partnering opportunities. Bionor currently retains full ownership rights to Vacc-4x, i.e., the upside potential from partnering or licensing remains with the company. Bionor is based in Oslo, Norway, and also has offices in Copenhagen, Denmark and New York, USA. Bionor is listed on Oslo Børs (OSE:BIONOR). More information about Bionor is available at www.bionorpharma.com.
A PDF of the full Q4 and Full Year 2015 Interim Financial Report is available here.
A PDF of the corresponding Q4 2015 presentation is available here.