Summing up a productive 2019
Fourth quarter 2019
Significant events during the fourth quarter
Significant events after the end of the period
Summing up a productive 2019
NeoDynamics has now closed the fiscal year 2019, a very productive year is summed up, which ended with the presentation of a fully guaranteed rights issue that will raise approximately SEK 46 million. Thereby, NeoDynamics is very well prepared for the launch of the Neonavia biopsy system in 2020.
At the end of October, an important piece of the puzzle came into place with the approval for marketing of NeoNavia with three micropulse-driven needle types in the EU. NeoDynamics can thus offer radiologists a complete range of precision needles for all types of ultrasound-guided biopsy.
It also stands clear that a so-called 510 (k) application is sufficient for the sale of NeoNavia in the US, which is a less complex procedure than an application for a completely new product. This reduces the risk of delays in the schedule. Compiling the file for a US approval with a submission in the middle of the year is proceeding as planned.
At the end of November, an agreement was signed for the production of the system’s disposable biopsy needles. The agreement was signed with an FDA approved Asian manufacturer and means that the needles will be manufactured at competitive costs. This is of course also an important puzzle piece before the launch of NeoNavia in the middle of the year.
In December, NeoNavia was exhibited for the first time to American radiologists at the annual meeting of the Radiologic Society of North America (RSNA), which gathers over 50,000 participants from around the world. The meeting showed that there is a great interest in innovations that help doctors and patients to better diagnosis and treatment. It was also clear that there are many technologically interested radiologists, which may prove an advantage when NeoNavia becomes commercially available.
NeoDynamics established good contacts with several important US centres at the meeting and looks forward to continuing to develop these relationships during the year. The next important event in the United States is the Society of Breast Imaging (SBI) meeting in Denver in April which brings together thousands of breast radiologists, ie our target audience. NeoDynamics will participate in the congress, including an abstract by Associate professor Edward Azavedo about the clinical experience of NeoNavia in breast cancer patients at Karolinska Hospital. The company also plans to participate in the most important congresses for the target group in 2020 in priority markets in Europe, i.e. in Sweden, Germany and the UK. Already today an active dialogue with many clinics are ongoing to prepare the launch.
In addition to the studies the company conducts in Germany and the United Kingdom, it is important to also develop good relationships with reference clinics, the centres in Europe that are pioneers in the use of the product. The centres help build knowledge, recommendations and experience around how Neonavia can be used in clinical practice. This way of approaching the market gives a cautious start where sales increase gradually as the clinical experience grows and spreads to other centres through peer to peer recommendations. The strategy reduces the risk of setbacks and paves the way for a successful introduction on a broad front.
The SEK 45.9 million rights issue with subscription period February 7-21, will provide NeoDynamics the financial strength to continue the work of bringing Neonavia to hospitals and thus help many women with breast cancer to better diagnosis and treatment. Almost half of the issue is covered by subscription undertakings from major shareholders while the remainder is guaranteed. The fact that financing is thus secured further reduces the risk in the company, which – everything else alike – should make it more attractive for shareholders to exercise their rights to subscribe for new shares at SEK 3 each.
At the same time, the company welcomes new shareholders to participate in the share issue and thereby become involved in an important period in the company's history.
Anna Eriksrud, CEO, Lidingö, 5 February 2020
Fourth Quarter 2019
During the fourth quarter 2019, the company developed according to plan, with the main costs being associated with product development, clinical studies, marketing and personnel. NeoDynamics applies a policy of capitalizing development costs to intangible assets, however not personnel costs.
Capitalized costs accounted for SEK 6.007 (9.019) m of the reported revenue of SEK 6.381 (9.104 m). The Company had no sales in the period.
The loss after depreciation amounted to SEK -5.944 (-7.372) m in the fourth quarter. External costs decreased to SEK -9.421 (-12.580) m, mainly comprising costs related to clinical studies, product development and marketing. Personnel costs decreased to SEK -2.715 (-3.598) m. The loss for the quarter before and after tax amounted to SEK -6.930 (-8.598) m during the quarter.
At the end of 2019, the equity ratio was 60 percent, compared with 90 percent at previous year-end. Shareholders’ equity amounted to SEK 55.581 m, compared with SEK 74.563 m one year ago. Cash and cash equivalents at the end of December amounted to SEK 6,195 (25.654 m at year-end 2018). In December 2019, the company signed a loan facility of a maximum of SEK 14 million. Total assets amounted to SEK 92.286 m (82.455 m at year-end).
The working capital requirement for the the next 12 months has been met by a rights issue of SEK 45.9 million with preferential rights for shareholders. The Board continuously reviews the company’s financial position to ensure that the company has sufficient funding based on the established strategic plan.
No dividend is proposed.
The complete annual report will be available at least three weeks before the Annual meeting.
During the fourth quarter, the company received regulatory approval for NeoNavia (EC), entered the final phase of verification and validation and begun planning for the production of CE marked products for delivery during the first half of 2020. Development costs are expected to decrease sharply in 2020 and onwards.
For further information about NeoDynamics, please contact:
Anna Eriksrud, CEO NeoDynamics AB (publ), telephone: +46 8 522 79 667, e-mail: firstname.lastname@example.org or
Jörgen Vrenning, CFO/IR NeoDynamics AB (publ), Telephone: +46 708 519 648, email: email@example.com
This information is information that NeoDynamics AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation.
The information was submitted for publication by the contact person above on February 5, 2020.
NeoDynamics AB (publ) is a Swedish Medical Technology Company dedicated to advancing diagnosis and care of breast cancer. The company has an innovative biopsy system, NeoNavia®. The precision biopsy system is built on a patented micropulse technology, based on research at the Karolinska Institutet in Sweden. The system is designed to offer clinicians and patients accurate lesion targeting and high tissue yield for correct diagnosis and individualized treatment. NeoNavia® is evaluated at leading clinics in UK, Germany and Sweden. A commercial launch is expected in 2020.
NeoNavia is the brand name for the entire biopsy system intended to be used under ultrasound guidance. NeoNavia consists of a base unit, a handheld driver and three different types of biopsy needles. Each needle type is driven by the micro-pulses enabling high precision and control when inserting and positioning the biopsy needle in a suspicious lesion. The system is designed to offer accurate lesion targeting and high tissue yield for correct diagnosis and individualized treatment.
About the micro-pulse technology
The patented micropulse technology is based on a pneumatically driven mechanism that enables high precision and control when inserting and positioning the biopsy needle, independent of tissue type. The pneumatic driver that generates micropulses is placed in a handheld instrument. With power from the base-unit, the driver accelerates the needle with great control even over a short distance, enabling its distinct stepwise insertion without the risk of destroying surrounding tissue. This facilitates ease of access and flexibility in sampling, even in very small lesions in delicate and difficult locations.