The English text is an unofficial translation of the Swedish report.

Commercialization underway

Fourth quarter 2020

• Revenue amounted to SEK 3.382 (5.948) m, of which capitalized costs amounted to SEK  2.963 (5.574) m.
• Loss after tax amounted to SEK -11.524 (-6.823)) m.
• Loss per share amounted to SEK -0.19 (-0.45).

Full year 2020

• Revenue amounted to SEK 18.557 (22.277) m, of which capitalized costs amounted to SEK 17.104 (21.787) m.
• Loss after tax amounted to SEK -31.006 (-19.415) m.
• Loss per share amounted to SEK -0.51 (-1.74).
• The equity ratio was 97 (60) percent at the end of the year.

Significant events during the quarter

• A share issue was directed at a limited group of investors, including Cardeon AB and its management team as well as Nyenburgh Holding BV, which raised a total of SEK 90 m.
• CFO Jörgen Vrenning left the company to retire. He will continue in an advisory role until the end of May 2021 to ensure a smooth transition.
• The company joined a scientific partnership to evaluate the NeoNavia pulse biopsy system for knee and bone tissue sampling in a new potential indication, osteoarthritis.
• The company received its first order for the NeoNavia pulse biopsy system from the British Buckinghamshire Healthcare NHS Trust.

Significant events after the period

• The European Patent Office (EPO) issued a so-called Notice of Allowance intending to grant a European patent for NeoDynamics’ pulse biopsy instrument that includes a multifunctional handset that can be used for several different types of biopsy needles.

 

CEO Comment

The commercialization of the pulse biopsy system NeoNavia has begun. Centers in Germany, UK and Sweden evaluate the system in their own envir-onment, on their own patients and experience the difference to the systems they have used to date. The feedback is positive from both radio-logists and pathologists evaluating the tissue samples.

First order for NeoNavia

During the fourth quarter, we received our first order for NeoNavia, thereby reaching an impor-tant milestone in the company’s history. The order came from Buckinghamshire Healthcare NHS Trust, a reputable hospital in the UK. We expect to complete additional sales in the near future as a number of quotes are out for decisions and evaluation programs are ongoing.

Launch

The launch strategy in Europe involves a gradual introduction of NeoNavia to centers in the UK, Sweden and Germany with nearby German-speaking countries. We ensure that centers are confident in using the product, how the different needles work and suit different situations, and also in passing on this knowledge to all doctors at the clinic. This way, we build trust in the product and pave the way for broad use. With reference clinics in place that can convince others to follow their lead, we expect to get a boost in sales later in the year.

Pandemic slowdown

Unfortunately, the launch is being slowed down by the pandemic making it difficult to visit clinics and assist doctors in getting to know the new technology. Conferences are digital, a format that does not promote hands-on testing of NeoNavia. However, the team skillfully finds ways around challenges and centers participating in our clinical program will be our early users. Feedback from demonstrations, digital and physical outside of hospitals is positive.

Ready for 2021

During the fourth quarter, we completed a directed issue of SEK 90 million. This is also an important milestone giving us peace of mind to fully focus on what we are to achieve during the year.

Of course, the agenda includes a continued introduction of the system in our markets in Europe. We will show our medical results and we will pursue our plan for the US. Compiling the FDA documentation has also been affected by the pandemic as we have not been able to carry out user studies as planned. We expect to be able to complete these in order for the application to be submitted during the first half of this year. We will do is a 510(k) registration, which is a less complex procedure than a drug approval.

The United States is key

A US registration is a milestone for NeoDynamics and the product. It opens up a very large market and positions NeoDynamics completely differ-ently towards potential partners. Moreover, a US registration also paves the way for an approval in China, the next country in line for NeoNavia.  Preparations for transferring the production of disposables to a manufacturer in Thailand are proceeding according to plan. Production is exp-ected to start in mid-2021, and will enable us to achieve our long-term goals for manufacturing costs.I look forward to an eventful 2021.

CEO Anna Eriksrud

This is information that NeoDynamics AB (publ) is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 08.30 CET on February 17, 2021.

For further information about NeoDynamics, please contact:                         

Anna Eriksrud, CEO NeoDynamics AB (publ), telephone: +46 8 522 79 667, e-mail: anna.eriksrud@neodynamics.com.

 

About NeoDynamics

NeoDynamics AB (publ) is a Swedish Medical Technology Company dedicated to advancing diagnosis and care of breast cancer. The company has an innovative biopsy system, NeoNavia®. The precision biopsy system is built on a patented pulse technology, based on research at the Karolinska Institutet in Sweden. The system is designed to offer clinicians and patients accurate lesion targeting and high tissue yield for correct diagnosis and individualized treatment. NeoNavia® is evaluated at leading clinics in UK, Germany and Sweden.

About NeoNavia

NeoNavia is the brand name for the entire biopsy system intended to be used under ultrasound guidance.  NeoNavia consists of a base unit, a handheld driver and three different types of biopsy needles. Each needle type is driven by the pulses enabling high precision and control when inserting and positioning the biopsy needle in a suspicious lesion. Read more at neodynamics.com