NeoDynamics Half-year report 2019

Second quarter 2019

• No sales have taken place during the quarter. Revenue amounted to SEK 6.328 m (7.848 m). Capitalized costs of SEK 6.328 m (7.847 m) are incluced in the revenue.
• Loss after tax amounted to SEK-3.981 m (-3.101 m).
• Earnings per share amounted to SEK -0,26 (-0,45).

Half-year 2019

• Revenue amounted to SEK 11.748 m (12.125 m). No sales have taken place during the period.Capitalized costs of SEK 11.745 m (12.124 m) are included in the revenue.
• Loss after tax amounted to SEK -8.115 m (-5 634 m).
• Earnings per share amounted to  SEK-0.53 (-0.82).
• Equity per share was  SEK 4.34 (4.87).
• Equity ratio was 91 (90) per cent.

Significant events during the second quarter

• Market research conducted showing substantial potential in China.
• New partly owned company started with dermatologist for development of innovative skin biopsy instruments.

Significant events after the period

• Anna Forsberg appointed as Country Manager in the USA.
• Petra Lindholm appointed as Chief Compliance & Regulatory Affairs
• An EGM in to be held 16 September was called to make decision on a convertibles issue.

Invitation to Audiocast

The half year report will be presented in an audiocast today at 10.15 (CET) by CEO Anna Eriksrud and CFO Jörgen Vrenning.To participate in the Audiocast, please select:

https://financialhearings.com/event/11969

CEO´s comments

Approaching the market – registrations in focus  

Our product development journey with NeoNavia is in the final phase and work on verification, validation and documentation for registration in the EU and the US are underway. We are approaching the market at rapid pace.

In Europe, the MDD (Medical Device Directive) has been replaced by the MDR (Medical Device Regulation) bringing registration requirements more in line with US FDA legislation. Consequently, all Notified Bodies must undergo a new authorization by authorities. We are well prepared to be among the first to have a product approved according to MDR requirements. Exactly when this will happen is not only dependent on us but also on when our Notified Body, Intertek, will be authorized by the Medical Products Agency. Our goal is to submit our CE-application to Intertek by the end of 2019.

In parallel work is underway to document our 510 (k) application with the US FDA (Food & Drug Administration).

In China, we are also getting closer to registration. We are ready to begin registration work during the first quarter of 2020. Since 2016, we have Boai NKY Medical as a shareholder. We have now deepened the relationship with Boai who has the right expertise and staff that match market requirements including departments for clinical programs, registration, marketing and sales.

Data from the recent market survey give an idea of the size of the Chinese market. In Beijing alone, about 100 large hospitals, of which many carry out as many biopsies per month as major European hospitals perform in a year. We have interviewed both radiologists and distributors and conclude that the market in China for tissue sampling by needle biopsy is large and growing. We note that the Chinese biopsy market is becoming more similar to the European market and that prices of imported biopsy needles are in line with prices in Europe, which is very positive for us.

During the summer we appointed a Country Manager for the US market, Anna Forsberg. She is highly qualified with many years of US experience where she has worked throughout her career. She will focus on our clinical work, the application for the FDA-registration and initiate our work in the US market. An important task for her will be to develop our network at the major cancer clinics to prepare the launch of NeoNavia in 2020.

In Germany, studies are underway at seven prominent cancer centres and recruitment is proceeding according to plan. NeoNavia was presented with two scientific posters at the Senology Congress in Berlin, the largest annual national breast radiology meeting of the year.

It is worth highlighting that we have added strong regulatory expertise through the recruitment of Petra Lindholm, PhD with experience from regulatory processes in different med tech companies. She has previously been responsible for managing both EU registration authorities as well as US FDA. She will be instrumental during the upcoming intensive registration work.

To further leverage our expertise in product development and clinical areas, we founded as minority owners however with potential to grow, a company together with a Swedish dermatologist at Karolinska Hospital to develop a new skin biopsy instrument for skin cancer. This is a promising project that has already been granted financial support by the Swedish Innovation Agency,

Through the capital injection announced in a separate press release today, the company is adequately financed until the beginning of 2020 after the planned submission of regulatory applications.

CEO Anna Eriksrud

Lidingö 2019-08-28