2022-05-12 Regulatory

NeoDynamics AB (publ) first quarter 2022

European order activities growing, and ramping up for the US commercialization

First Quarter 2022

  • Revenues amounted to SEK 147 (405) thousand, of which SEK 0 (378) thousand capitalized costs and SEK 92 (22) thousand net sales, i.e., sales of finished products.
  • Loss after tax amounted to SEK -17,192 (-17,261) thousand.
  • Loss per share amounted to SEK -0.29 (-0.29).
  • Cash and cash equivalents amounted to SEK 8,301 (62,278) thousand.

Significant events during the quarter

  • NeoDynamics filed a registration application of type 510(K) for its innovative pulse biopsy system NeoNavia® with the US Food and Drug Administration, FDA.
  • On March 31, 2022 NeoDynamics announced the outcome of its fully guaranteed rights issue of approximately SEK 69.3 million before transaction costs, which is expected to increase the number of shares by 60,250,592 to 120,501,184, resulting in an increase in the share capital of SEK 6,025,059.20 to SEK 12,050,118.40. At the time of publication of the Q1 report a partial registration of the rights issue has been completed and a second partial registration is being processed. A payment of SEK 2 335 415,40 is outstanding from one guarantor, with whom the company is in dialogue with. It is the company's current assessment that the outstanding payment will be received shortly.
  • Aaron Wong assumed the position as CFO on February 1, 2022. Aaron Wong most recently came from a similar position at the medical technology company ADDvise Group AB.
  • As part of the preparations for launching NeoNavia in the US market, a subsidiary in the USA, NeoDynamics USA Inc., was started. The subsidiary facilitates the recruitment of employees and for the company to enter into various types of agreements which will directly support the launch.
  • Data from the PULSE study showing the benefits of the NeoNavia biopsy system in particularly challenging axillary lymph nodes were accepted for presentation at the SBI / ACR Breast Imaging Symposium in Savannah, Georgia, to be held May 16-19, 2022. The symposium is considered the most important annual meeting for breast radiologists in the U.S.

Significant events after period-end

  • NeoDynamics was approved for trading on Nasdaq First North Growth Market in Stockholm, where the share began trading on May 2, 2022.

CEO Comment

European order activities growing, and ramping up for the US commercialization

During the quarter, we took several important initiatives towards the introduction of NeoNavia in the US. After careful preparatory work, the registration application for NeoNavia was submitted to the FDA, and we are now awaiting approval. Once approved, marketing of the product can start within a relatively short period of time, in comparison with the pharmaceutical industry which takes much longer. We count on the possibility to commercialise the Neonavia system in the US before the end of this year.

In Germany and the UK, we are proceeding with the evaluation phase which is based on products delivered and invoiced during December 2021. It is a delicate and timeconsuming process when each hospital transitions through the “new product evaluation” and final decision making process. The first time is always unique. On an averge it takes approximately 3 months, however, we are patiently waiting for the final go-ahead for each of the hospitals to include NeoNavia in their clinical practice.

We also started our US subsidiary, NeoDynamics Inc., which will house our highly specialised sales organization. Initially, we will employ a smaller number of specialist sales representatives to liaise with key university centers who are ready to get started with the system in their clinical practice. Adding to that, the change of our listing to the Nasdaq First North Growth Market signals our commitment toward the US and to our current and future shareholders.

Furthermore, we are looking forward to our presentation at the SBI / ACR (Society of Breast Imaging / American College of Radiologists) Breast Imaging Symposium in Savannah, Georgia, on the 16th of May. This is a great opportunity for us because this is the most important US meeting in our space and our study has been selected for oral presentation, offered to only a few companies with these study results. Here, we will present data from a subgroup in the PULSE study with particularly challenging biopsy conditions.

Setting out on a journey

Notwithstanding these recently intensified activities, our efforts to enter the US market began some time ago, as we started to forge bonds with key clinics in Europe and designed a study program that would allow us to showcase our products’ value within a clinical setting. These activities have paved the way to where we stand today, presenting at important congresses and seeing the benefits of independent advocates with clinical experience using our product. This is an important point of reference when you enter a new market such as the USA.

Product transfer underway

From our base in Sweden, we have also overseen the transfer of our needle production to Asia, to more effectively manage our cost base. Production and assembly in Asia, instead of Sweden, starts now with the first of three needles. Meanwhile we still maintain the NeoNavia base unit and driver production here in Sweden.

Good progress in Europe

In total, there are currently over 35 clinics that are using NeoNavia in their clinical practice, of which six are our customers, and 30 are running pilots. The feedback we are receiving from these clinics is very encouraging and I feel confident that we will have great support in our continued launch efforts.

Positioned for success

The pandemic is no longer hindering us to gain access to the hospitals or participate in “live” congresses. Last, but certainly not least, I am also very pleased that we managed to strengthen our finances through our most recent rights issue. This will mean that  we can continue our efforts to bring NeoNavia to the market, both in Europe and in the US. We are well positioned for success.

CEO Anna Eriksrud

The interim report is attached to this press release and can also be found on the company’s website https://www.neodynamics.com/en-gb/reports

For further information, please contact

CEO Anna Eriksrud, phone +46 (0)708 444 966, e-mail anna.eriksrud@neodynamics.com

CFO Aaron Wong, phone +46 (0)79 010 1714, e-mail aaron.wong@neodynamics.com

The company’s Certified Adviser is Redeye AB, e-mail address: certifiedadviser@redeye.se and telephone number +46 8 121 576 90.

This disclosure contains information that NeoDynamics AB is obliged to make public pursuant to the EU Market AbuseRegulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 12-05-2022 10:00 CET.