FDA-process and commercialization on track. New study results confirm the potential. Year-End Report (May-January 2018/2019)

SEK thousands                         Q4 18/19    Q4 17/18 May-April 18/19 May-April 17/18

Net sales                                               1,715           1,433                 3,005                    2,723

Operating profit (loss)                        -8,569          -4,132              -21,718                -17,956

Loss for the period                              -8,631          -4,176              -21,556                -18,010

Earnings per share, after dilution        -0.47            -0.24                  -1.18                     -1.01

Significant events during the fourth quarter

  •  New data from study presented at AACR in April
  •  Shares now traded on Nasdaq First North Premier
  •  Lars Holmqvist elected as new Chairman
  •  Two new customers, a pharmaceutical company and a CRO, and sales of SEK 1.5 million.
  •  Biovica and IBL America initiate a sales collaboration in USA

Significant events after the end of the period

  •  Targeted new share issue for SEK 60 million to European and Swedish institutional investors and family offices
  •  Positive study results with DiviTum® published in the prestigious European Journal of Cancer

CEO’s comments

Commercialization of DiviTum® for breast cancer

During the fourth quarter, we achieved several important milestones for launching DiviTum® in the US and European markets.  

  • In April, we submitted Supplement II to the FDA, detailing our plan for clinical validation
  • We presented new, positive results from studies involving 289 patients that confirm the results from prior studies
  • We increased sales to the research market and added two major pharmaceutical companies as new customers
  • We started off the new financial year with a targeted new share issue, thereby widening the scope of ownership in the company and securing financing for the upcoming commercialization

FDA-process on track

Supplement II, which is in the third stage of the process, was submitted to the FDA in April. It contains a report on Biovica’s plan for clinical validation of the product. It is expected that the FDA will provide us with feedback after the summer. As soon as our plan is approved, we can proceed with implementing the actual studies.

Publication of a compilation of all the results from studies

In order to commercialize DiviTum®, our clinical development program must substantiate and document the benefits that DiviTum® can offer to patients and society. Results from studies are required for the regulatory process and for gaining access to the systems that regulate reimbursement to healthcare providers. They are also very important for spreading knowledge of DiviTum®, generating demand and establishing commercial partnerships for sales.

In April, positive results from a study involving 45 patients were presented showing that DiviTum®, as the first blood-based biomarker, can be used to evaluate the effects on patients with metastatic breast cancer who have been treated with palbociclib (CDK4/6 inhibitor). 

At the end of May, we published a compilation of all the results from studies where DiviTum® was used in conjunction with breast cancer treatment. It shows the positive results from studies involving more than 1,000 patients where DiviTum® was used in treating breast cancer. The report has been published on Biovica’s website and it is important documentation that will be used in discussions with government authorities and commercial partners.

Increased sales to the research market

Sales to the research market increased and amounted to SEK 1.5 million. Customers are major pharmaceutical companies that are using DiviTum® to develop new applications and drugs. The additional revenue boosts the company and confirms the value of DiviTum®. These sales also pave the way for more widespread use of DiviTum®, along with future commercial collaborations.

Broader ownership and equity injection of SEK 60 million

Biovica boosted its equity by SEK 60 million during the fourth quarter via a targeted new share issue. The new share issue was targeted at professional investors like European funds, institutional investors and family offices. In total, 29 professional investors subscribed for shares. The financing provides Biovica with the resources for pursuing its business plan and taking DiviTum® the rest of the way through FDA approval.

Moving closer to the launch of DiviTum®

We’re pursuing our commercialization plan, reporting positive results from studies and are involved in a constructive dialog with the FDA on clinical validation of DiviTum®. Biovica has a unique product. It fulfills a great need in a market that is both large and attractive.

I can proudly conclude that we are getting very close to the day when we will launch DiviTum® for clinical use and thereby offer patients with metastatic breast cancer a diagnostic tool ensuring that they get the best possible treatment from day one. In doing so, we will also generate value to our shareholders.

Anders Rylander

CEO

Release

More information:

Anders Rylander, CEO Biovica.
Phone: +46 (0)18 444 48 35,
E-mail: anders.rylander@biovica.com

Cecilia Driving, CFO
Phone +46 (0)73 125 92 47
Email: cecilia.driving@biovica.com

This information is information that Biovica is obliged to make public pursuant to the Nasdaq First North Rule Book. The information was submitted for publication, through the agency of the contact person set out above, at 8:00 pm CET on June 14, 2019.

In the event of contradictions or differences between the Swedish press release and this English version the Swedish text will prevail.

About Biovica

Biovica develops and commercializes blood-based biomarker assays that improve monitoring of modern cancer therapies and predict patient outcome. The company’s DiviTum® assay, a test for accurately measuring cell proliferation, has successfully demonstrated its capabilities to early evaluate therapy effectiveness in several clinical trials. Biovica aims to make best-possible-treatment from day one a reality.

Biovica collaborates with world-leading cancer institutes as well as pharmaceutical companies launching next-generation therapies. The company is ISO 13485 certified for Quality Management Systems. DiviTum® is CE-labeled and MPA-registered. Appointed Certified Adviser to the company is FNCA Sweden AB, info@fnca.se, +46 8 528 00 399.

Read more: www.biovica.com

2019-10-20T08:13:49+00:00 June 14th, 2019 08:00|Press Release|