On February 17, 2016, BioInvent reported its Financial Statement for January 1 to December 31 2015 (Press release, BioInvent, FEB 17, 2016, http://www.bioinvent.com/media-centre/press-releases/release/?ReleaseID=A87CE808F590960A [SID:1234509076]).
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Fourth quarter 2015, October – December
Net sales for October-December 2015 amounted to SEK 10 (1.7) million.
Earnings after tax for October-December 2015: SEK -21 (-28) million.
Earnings after tax per share for October-December 2015 before and after dilution: -0.13 (-0.25) SEK.
Cash flow from current operations and investment activities for October-December 2015: SEK -11 (-25) million.
Full year report 2015, January – December
Net sales for January-December 2015 amounted to SEK 16 (47) million.
Earnings after tax for January-December 2015: SEK -91 (-54) million.
Earnings after tax for January- December 2015 before and after dilution: SEK -0.64 (-0.53).
Liquid funds as of 31 December 2015: SEK 40 (46) million. Cash flow from current operations and investment activities for January- December 2015: SEK -73 (-76) million.
Important events in the fourth quarter and after the reporting period
The Board of Directors of BioInvent resolved on 16th of February on a private placement of SEK 43 million to the US-based healthcare investor Omega Funds and a rights issue of SEK 191 million subject to approval by an Extraordinary General Meeting on 18 March 2016. Notice to the General Meeting is published in a separate press release.
BioInvent announced in December 2015 that the company had been selected by a major global pharmaceutical company to provide manufacturing services for one of the products in the pharmaceutical company’s development portfolio. Revenues are expected to amount to approximately SEK 25 million.
In December 2015 BioInvent announced the increased commitment to the BI-505 programme and the submission of a clinical trial application to the US Food and Drug Administration (FDA).
BioInvent announced in December 2015 that it had gained access to novel technology for making highly efficacious immune stimulatory antibodies to combat cancer. This initiative continues BioInvent’s long standing research collaborations with the University of Southampton.
In January BioInvent announced that the FDA had completed the safety review of its Investigational New Drug application for TB-403 and have concluded that the proposed pediatric clinical investigation can proceed.
Comments from the CEO
"In 2015, through collaboration with leading international research groups, charities and patient organizations, BioInvent secured most of the financial and operational resources needed to implement our three clinical programs in Phase I and II with a total of approximately 200 patients. As a result, we have ensured funding for these trials while retaining our ownership and interest in them.
I am now pleased to announce a further significant step forward in the development of BioInvent.
Based on recent progress in our project portfolio, including important scientific publications and the projected initiation of clinical trials in three of our immuno-oncology programs during 2016, BioInvent has attracted considerable interest from international and local health care-investors. From this position of strength, we now intend to create the financial leverage to fully exploit the commercial potential of our key programs.
The MSEK 234 financing round announced yesterday is anchored by a private placement of MSEK 43 to Omega Funds – a US-based healthcare investor, reputable for actively supporting its portfolio companies in creating long-term shareholder value. In parallel, we are offering our current shareholders to participate in a fully guaranteed MSEK 191 rights issue at equal terms. The investors guaranteeing the rights issue are renowned private investors, foundations and institution like investors such, such as LMK, Bengt Sjöberg, Kamprad foundation, Crafoord foundation, Peter Edwall and Laurent Leksell.
Omega Funds will be a welcome addition as shareholders, partly because they make their own team of experts available, but also as BioInvent gains the opportunity to leverage on Omega’s longstanding and strong relationships with major pharmaceutical companies, financial institutions and investors.
The capital from the equity issues is mainly intended to finance BioInvent’s costs related to clinical trials, supporting pre-clinical work aiming to optimize the value of the clinical projects and continued development of the Company’s prioritized pre-clinical projects. In addition, a strengthened financial position enables increased strategic flexibility and improved ability to negotiate with potential partners.
BioInvent has an attractive clinical portfolio in the orphan oncology area; niche categories with significant unmet medical needs. This focus combines a shorter and more cost-effective way to market, while providing an opportunity for reimbursement and rapid uptake of our products. The company’s pre-clinical research in immuno-oncology is of high quality and has gained significant interest from the pharmaceutical industry for collaboration.
All three studies planned to start in 2016, are designed as open, which offers the possibility to monitor results continuously. This increases the opportunities for transparency with the stock market and flexibility in negotiations with future partners in order to maximize shareholder value. BioInvent’s antibody BI-1206 will undergo a Phase I/II trial in patients with non-Hodgkin’s lymphoma and chronic lymphatic leukaemia. Further development will be focused on subgroups with high, unmet medical needs and short time to market. Two of BioInvent’s programs, BI-505 for multiple myeloma and TB-403 in childhood cancer are both orphan drug projects. The trials for these programs are designed to potentially form the basis for registration files, provided that the clinical endpoints are met.
The share issues provide BioInvent with a new large international shareholder, and will enable the company to reach important value inflection points in our key programs over a period of at least two years. I am confident that this major milestone in BioInvent’s development will further increase our ability to deliver significant value to our shareholders in the short and long term," says Michael Oredsson, President and CEO of BioInvent.