2021-08-19 Regulatory

Interim report Jan-June 2021

Clinics build experience

Second Quarter 2021

  • Revenue amounted to SEK 411 (6,263) thousand, of which SEK 383 (5,787) thousand were capitalized costs.
  • Loss after tax amounted to SEK-18,263 (-5,516) thousand.
  • Loss per share SEK -0.30 (-0.18).
  • Cash and cash equivalents amounted to SEK 48,339 (7,177) thousand.

First half of 2021

  • Revenues amounted to SEK 816 (12,531) thousand, of which SEK 762 (12,090) thousand capitalized costs.
  • Cash flow from operating activities amounted to SEK -23,999 (-13,107) thousand.
  • Profit after tax amounted to SEK -35,519 (-12,751) thousand.
  • Earnings per share amounted to SEK -0.59 (-0.53).
  • The equity ratio was 95 (94) percent.

Significant events during the quarter

  • NeoDynamics presented a scientific abstract at the annual surgery conference ABS, Association of Breast Surgeons, in Birmingham, which describes how the company’s FlexiPulse needle surpasses standard biopsy in preclinical models by almost 300 percent in terms of volume.
  • The Annual General Meeting re-elected the Board members Carina Bolin, Claes Pettersson, Ingrid Salén, Jie Bao and Xiao-Jun Xu, and appointed Matthey E. Colpoys Jr. as a new Board member.
  • At mid-year, about 30 clinics with radiology teams in Sweden, the United Kingdom, Germany and other German-speaking countries in Europe had had workshops with the biopsy system NeoNavia.

Significant events after period-end

  • Hermann-Josef-Hospital in Erkelenz, a university hospital within the University of Aachen, became the first German hospital to order NeoNavia.

CEO comment

Clinics build experience

We continue to introduce the biopsy system NeoNavia in clinics in our markets in Europe. The pandemic has made traditional and effective launch methods impossible, which means introducing the product to doctors at congresses and trade fairs, in parallel with building experience through workshops and thereby reaching out more quickly. Instead, NeoDynamics has been forced to rely on individual hospital meetings with workshops where doctors are given the opportunity to test the product and train in how it is used.

The challenge with this procedure during the spring has been to get permission to be at the clinic. On a few occasions, smaller workshops have been held outside the hospitals. Once these workshops are completed, a majority of clinics want to use the product in regular operation for 2-3 months to see how it fits in and let the whole team of the hospital’s radiologists, or as in Germany gynecologists, get used to handling NeoNavia in clinical everyday life. In dialogue with the clinic, the hospital’s purchasing department is involved in designing a quote and qualifying NeoDynamics as a supplier. Only then can NeoDynamics expect an order for the product. The process takes time and  varies between clinics. By mid-year, the team had conducted about 30 workshops.

First in Germany to place an order was the reputable breast center at Hermann-Josef-Hospital in Erkelenz, Germany, which belongs to the University Hospital of Aachen, which participated in the PULSE study and which also serves as a reference center. We expect to recruit more reference centers in different countries to pave the way for the majority of the clinics that have tried the product to also adopt the technology and submit orders during the latter part of 2021.

The team continues to arrange workshops with specialists and in the autumn, several conferences once again welcome participants to participate physically. The first conference we plan to attend on site is the Schweizerische Gesellschaft fur Senology, which will be held in Basel on September 8-9 to be followed by two further congresses in September and October for the German-speaking part of the country. A very positive sign which means that we in Europe are gradually beginning to return to a more normal market situation.

Publications create interest

 Another important way to present NeoNavia to physicians is to present peer reviewed abstracts from our clinical program through various types of scientific conferences. Getting an abstract selected for presentation is a measure of the scientific level we hold in our study program - and of course a way to make NeoNavia known.

During the second quarter, NeoNavia was exposed in this way at the prestigious annual British Breast Surgery Congress, ABS. NeoDynamics continues the work of documenting the product through its clinical program and more scientific abstracts are expected this year. The work of course facilitates the dialogue with doctors, at the same time as it is also a part of creating interest in NeoNavia among potential partners. 

United States the next major milestone

In the United States, work continues on compiling the registration application to be able to submit it to the US Food and Drug Administration FDA in the fall. We have a dialogue with the authority, which also communicates that their response times are longer than normal as a result of a large part of the authority’s resources being redirected to matters related to Covid-19. With a well-prepared application, however, the need for interaction with the authority after the file has been submitted decreases. The team’s ambition is to achieve an application of high quality through underhand dialogue with the FDA. A registration of the product in the USA is an important milestone for both NeoDynamics and NeoNavia as it is an important stamp of quality that also opens up a significant new market. It is also expected to lead to a significantly more concrete interest from potential partners.

During the quarter, NeoDynamics strengthened its expertise in the important US market through the election of Matt Colpoys to the Board. Matt adds valuable knowledge about both the market and potential partners. The pieces are thus beginning to come into place for NeoDynamics to be able to add the USA as a market.

I look forward to a continued eventful 2021.

CEO Anna Eriksrud