NeoDynamics AB (publ) full-year report 2023

 
Fourth Quarter 2023

• Revenues amounted to SEK 621 (130) thousand, of which SEK 204 (0) thousand were net sales.
• Net loss amounted to SEK -17,863 (-26,857) thousand.
• Loss per share amounted to SEK -0.03 (-0.22).
• Cash and cash equivalents amounted to SEK 2,301 (20,067 prior year) thousand.

 
Full Year 2023

• Revenues amounted to SEK 1,851 (902) thousand, of which SEK 321 (135) thousand were net sales.
• Net loss amounted to SEK -91,938 (-74,516) thousand.
• Loss per share amounted to SEK -0.30 (-0.73).
• Cash and cash equivalents amounted to SEK 2,301 (20,067 prior year) thousand.

 
Significant events during the quarter

• NeoDynamics received a new order from large hospital in Germany, Western Rhineland-Palatinate Hospital.
• NeoDynamics presented NeoNavia® at the British Society of Breast Radiology meeting in Belfast on 5-7 November 2023.
• The Board of Directors of NeoDynamics had assessed the current financial situation of the company as critical and were in discussions to secure short and long-term financing. A result of this has been that the Board of Directors and Managemnet Team have decided to streamline the companies operations, through a cost reduction plan.
• NeoDynamics received approximately SEK 0.5 million through the exercise of warrants of series T02.
• NeoDynamics secured short-term financing by means of a SEK 10 million loan.
• NeoDynamics launched a device registry in Germany, a cost-effective collection of real-world data.
• It was announced that as a consequence of the cost reduction plan announced in November, Aaron Wong, CFO will be leaving NeoDynamics by end of May 2024.

 
Significant events after the end of the quarter

• In January 2024, NeoDynamics announced that subject to the EGM, it intended to carry out a Rights Issue of shares in an amount of up to approximately SEK 25 million to finance commercialization and marketing activities and also intends to carry out a reverse split.
• NeoDynamics AB (publ) held an Extraordinary General Meeting on 2 February 2024, and resolved on the Rights Issue and a reverse share split.
• NeoDynamics secured short-term financing by means of a second loan for SEK 15 million.

CEO Comment

Cost reduction plan implemented, short-term financing secured
As announced in November, we have implemented a cost reduction plan which means that we are now operating with a reduced headcount and cost structure. We have matched staffing levels to our current situation, while maintaining an appropriate presence in our target markets.

We firmly believe we are close to a commercial breakthrough and final proof of concept in the US based on positive customer feedback and ongoing dialogue with leading hospitals and cancer centres. However, the process has been more time consuming than anticipated in the procurement area, and we have therefore had to balance our cash, costs, and commercial activities in the short term.

The cost savings will be visible from March 2024 onwards, and will have full effect in the second half of 2024.

All needles available for sale and delivery in target markets
Our full suite of needles; VacuPulse, CorePulse and FlexiPulse are now available for sale and delivery in all our targeted markets in Europe, while the FlexiPulse and VacuPulse needles are available in the US. We have built small interim stocks in the UK and the US by the end of December to be able to deliver to end-customers outside the EU without further delays.

The CorePulse needles are high in demand in Europe and are working well. However, the CorePulse needle is also the most price sensitive product in our portfolio, i.e. the price pressure is high. The VacuPulse and FlexiPulse needles have another competitive environment, and we can offer these needles at a different price structure.

The VacuPulse needle is anticipated to be the most used in the US, and it comes with both advanced features, and we can offer these needles with a different price structure. Due to implemented product improvements, the delivery of the VacuPulse needle was delayed until the end December 2023, and sales in 2023 has therefore been limited.

We are currently working with 18 medical centres in UK and 23 medical centres in the DACH region. So far, they have been testing our biopsy system and needles in pilot studies and are now in the process of making decisions to buy base units for future use. During the trial period, the centres have paid for needles but have rented the base unit and driver. We count on closing our pilots during this Q1 2024, as they have had time to also evaluate the VacuPulse needle.

In the US, we are in negotiations with “Tier One Hospitals”, and we are confident that this will result in a commercial break-through soon. However, getting through procurement and compliance at these hospitals is extremely time consuming for a first order.

The most important imminent milestone for us is to get a commercial breakthrough in the US, which means that we will have demonstrated a commercial proof of concept.

The next milestone is to develop and adapt our product offering to other indications such as prostate, liver head and neck precision biopsy.

Financing
To secure funding for operations in Europe and the commercial launch of NeoNavia in the US, we have raised capital in several steps during 2023. In total, we have raised approximately SEK 88 million through a combination of loans and rights issues. The Board and Management are pursuing a long-term solution that will secure sufficient capital to continue the commercialisation of NeoNavia® in Europe and the US.

In the short-term, we have approval from the EGM to press ahead with the Rights Issue, which is fully guaranteed to 100%. With this raise of approximately SEK 25 million, we will be able to continue to focus on the milestones we need to achieve our proof of concept in all key markets.

CEO Anna Eriksrud

All reports are available at the company ́s website: https://www.neodynamics.com/en-gb/reports