NeoDynamics AB (publ) full-year report 2022
Pre-Launch Activities in the US underway
Group consolidated accounts have been prepared for the fourth quarter, and full year, which includes the consolidation of NeoDynamics AB, NeoDynamics GmbH and NeoDynamics Inc. These are represented in the financial statements as adjusted numbers, and are the comparative figures used for last year.
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.
CEO Anna Eriksrud
All reports are available at the company ́s website: https://www.neodynamics.com/en-gb/reports
This disclosure contains information that NeoDynamics is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 17-02-2023 08:30 CET.
For further information, please contact:
Anna Eriksrud, CEO NeoDynamics AB, phone +46708 444 966 or e-mail anna.eriksrud@neodynamics.com
Aaron Wong, CFO NeoDynamics AB, phone +46735 972 011 or e-mail aaron.wong@neodynamics.com
About NeoDynamics
NeoDynamics AB is a Swedish Medical Technology Company dedicated to advancing diagnosis and care of cancer. The company’s first product NeoNavia®, a new innovative pulse biopsy system for ultrasound-guided tissue sampling, is currently being introduced to the market. The biopsy system is built on a patented pulse technology, based on research at the Karolinska Institutet in Sweden. NeoNavia is evaluated for breast cancer diagnosis at leading clinics in Europe and will soon launch in the USA. NeoDynamic’s shares are listed on Nasdaq First North Growth Market Stockholm (ticker: NEOD). The company’s Certified Adviser is Redeye AB.
About NeoNavia
NeoNavia is a modern biopsy system with a completely new patented pulse technology intended for ultrasound-guided tissue sampling. Each needle type is driven by the pulse technology providing a more controlled needle insertion and precise placement of the needle in the tumor whilst enabling high-quality tissue samples from both breasts and lymph nodes. The pulse biopsy system NeoNavia is designed to offer clinicians and patients accurate lesion targeting and high tissue yield for correct diagnosis and individualized treatment.
About Karolinska Institute
The Karolinska Institute is consistently ranked amongst the world's best medical schools, ranking 6th worldwide for medicine in 2021. The Nobel Assembly at the Karolinska Institute awards the Nobel Prize in Physiology or Medicine.
