On February 16, 2023 Group consolidated reported it have been prepared for the fourth quarter, and full year, which includes the consolidation of NeoDynamics AB, NeoDynamics GmbH and NeoDynamics Inc (Press release, NeoDynamics, FEB 16, 2023, View Source [SID1234627347]). These are represented in the financial statements as adjusted numbers, and are the comparative figures used for last year.
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Fourth Quarter 2022
Revenues amounted to SEK 130 (931) thousand, of which SEK 0 (1,039) thousand were net sales
Net loss amounted to SEK -26,857 (-19,957) thousand.
Loss per share amounted to SEK -0.22 (-0.33).
Cash and cash equivalents amounted to SEK 20,067 (24,960 at year-end) thousand.
Full Year 2022
Revenues amounted to SEK 903 (2,086) thousand, of which SEK 135 (1,162) thousand were net sales
Net loss amounted to SEK -74,514 (-68,553) thousand.
Loss per share amounted to SEK -0.73 (-1.14).
Cash and cash equivalents amounted to SEK 20,067 (24,960 at year-end) thousand.
Significant events during the quarter
In early November, NeoDynamics hired National Sales Director in the USA, Brendan Carney, for the launch of its NeoNavia Biopsy System. Brendan has more than 20 years of experience including Genentech and Pharmacia, leading teams and product launches in oncology, infectious diseases, endocrinology, and medical devices
In late November, NeoDynamics geared up for the US launch by partnering with Diligent Health Solutions. Diligent will assist NeoDynamics in communicating with patients, caregivers, and health care professionals, from initial consultation to strategic implementation and daily operations. Their specialists will support the company’s efforts to manage medical information, reimbursement and coding services.
In December, NeoDynamics appointed Matthew Colpoys, to lead US operations. Matt will remain on the board and reports to CEO Anna Eriksrud.
Significant events after the end of the quarter
In January, NeoDynamics Partnered with Uniphar for US Distribution and Logistics support. Uniphar is a global distribution and logistics giant and will help to ensure a successful US launch of NeoNavia
In February NeoDynamics’ largest owner secures the launch of NeoNavia in the US. Gryningskust Holding AB, offered the company a loan of SEK 14 million. The loan is intended to be converted into shares if the company issues new shares in the future, subject to shareholder approval.
NeoDynamics announed that Jie Bao and Xiaojun Xu will step down from the Board of Directors as of 2023-02-14 based on a mutual agreement. They will instead focus on supporting the company and its plans for the Chinese market.
CEO Comment
Ready for commercialisation in the US
In September 2022, we reached an essential milestone with the FDA clearance of NeoNavia. The US approval is a cornerstone in our strategic way forward and path to profitability.
The covid pandemic delayed all FDA applications and made the timing of approvals unpredictable. Thus, it was prudent for a small company such as NeoDynamics to wait for the go-ahead from the FDA before starting to build the US organization.
The recently deployed management team is preparing for fullscale commercialization of Neonavia in 2023. This includes identifying and hiring personnel, locking in attendance at key scientific congresses and building the infrastructure to support sales activities in the field. The first product to market is FlexiPulse. The FlexiPulse needle is unique in its design and allows insertion into challenging locations. Checking lymph nodes in the axilla (armpit) is critical to assessing whether cancer has spread. The introduction of FlexiPulse will allow physicians to safely and effectively simplify biopsy of the lymph nodes in the axilla in a minimally invasive fashion. Shortcomings of existing biopsy systems result in most axillary nodes being removed surgically. A common side effect of surgical removal of axilla lymph nodes is persistent swelling (edema) of the arm, and a FlexiPulse biopsy minimizes this risk. Further, the design of the FlexiPulse makes it ideal for tissue sampling in suspected lesions in the proximity of breast implants, which is an increasingly common problem, especially in the United States.
An ever more critical stakeholder in breast cancer treatment is the patient themselves and related patient advocacy groups. Patient empowerment is an increasingly important aspect of delivering breast cancer care. For this reason, NeoDynamics’ hired a US management team with significant backgrounds working with specialty products and associated patient associations. Another advantage of the organization’s special markets background is working with key-opinion-leading physicians at the most prestigious treatment centers in the United States.
To ensure cost-effectiveness, NeoDynamics Inc. outsources customer care and logistics functions to its partners Diligent Health Solutions and Uniphar Logistics, both divisions of Uniphar Group of Ireland.
Of course, the deep experience gained in Europe is vital for success in the USA. In more than 30 cancer research centres in Germany, the UK and Sweden, we continue our work and collaboration with key opinion leaders. From this ongoing experience we can conclude that clinics in Europe remain very engaged. We have fine-tuned two needles during 2022, which has resulted in better products, but also in postponed deliveries. It is our firm commitment to make no compromise on product quality.
Also, we continue to run our clinical study program to document the pulse technology and our different needles in clinical practice. The clinical program has resulted in several presentations at congresses during 2022 including the prestigious SBI congress in Savannah in May.
Organisational development
In 2022, we added several senior and experienced members to our team. On December 1, 2022, Matthew E. Colpoys, Jr. (member of the Board of Directors) assumed the position of US CEO for NeoDynamics Inc. We also welcomed Brendan Carney, our national sales director in the US. In February 2022, we also onboarded Aaron Wong as our Group CFO of NeoDynamics AB. We now have an organization that is capable of executing the strategy in both the short and long term.
Our performance in 2022
Our revenue is still modest while we continue to deploy resources in a controlled fashion to develop our products in Europe and the US. We are pleased to have secured short-term funding for the launch in the US.