13.03.2024 07:00:54 - dpa-AFX: EQS-Adhoc: Kuros reports 163% growth in direct MagnetOs sales and 153% increase in total medical device sales for the full year 2023 (english)

Kuros reports 163% growth in direct MagnetOs sales and 153% increase in
total medical device sales for the full year 2023


   Kuros Biosciences AG / Key word(s): Annual Results
   Kuros reports 163% growth in direct MagnetOs sales and 153%
   increase in total medical device sales for the full year 2023
   13-March-2024 / 07:00 CET/CEST
   Release of an ad hoc announcement pursuant to Art. 53 LR
   The issuer is solely responsible for the content of this
   announcement.
     ____________________________________________________________


   
   Financial highlights
     * Direct MagnetOs sales grew by 163% to CHF 31.7 million in
       2023, climbing from CHF 12.1 million in 2022. Total medical
       device sales accelerated by 153% from CHF 13.3 million in
       2022 to CHF 33.6 million in 2023
     * The Medical Devices segment achieved a positive EBITDA of CHF
       6.8 million driven by MagnetOs
     * Cash and cash equivalents amounted to CHF 14.2 million and
       funds available (including trade and other receivables)
       totaled at CHF 21.8 million as of December 31, 2023


   Operational highlights
     * MagnetOs surpassed the important milestone of 25,000 patients
       treated
     * MAXA clinical trial comparing MagnetOs standalone to the gold
       standard autograft for the challenging posterior lateral
       spinal fusion showed a fusion rate of 79% versus 47% in the
       full study population and 80% versus 32% in a
       difficult-to-heal smoker population
     * FDA market clearance received for interbody use of MagnetOs
       Flex Matrix, MagnetOs Easypack Putty and MagnetOs Granules as
       well as MagnetOs Putty for standalone us
     * Fibrin-PTH discontinued based on the MAXA results


   Outlook
   Kuros expects a similar sales growth trend going forward. The
   Company is adequately financed on its planned organic growth path
   and - adjusted for the Fibrin-PTH costs - will generate positive
   single-digit EBITDA for the first time in 2024.


   Schlieren (Zurich), Switzerland, March 13, 2024 - Kuros
   Biosciences ("Kuros" or the "Company"), a leader in
   next-generation bone graft technologies, today announced
   financial results for full year 2023 along with continued
   significant growth.



   Direct sales of MagnetOs rose 163% to CHF 31.7 million in 2023
   from CHF 12.1 million in 2022. Total medical device sales
   accelerated from CHF 13.3 million in 2022 to CHF 33.6 million in
   2023, which is a 153% increase. MagnetOs exceeded its commercial
   plan in 2023 by reaching the important milestone of 25,000
   patients treated worldwide, resulting in a positive EBITDA of CHF
   6.8 million in the Medical Devices product segment in 2023.


   Chris Fair, Chief Executive Officer, stated: "Kuros Biosciences
   experienced a tremendous year in 2023 as we built a newly
   focused, scientifically led and clinically proven, pure play
   MedTech business. Last year's record sales revenue, coupled with
   our global expansion efforts and a dedicated strategy, marked a
   successful period as we transitioned to becoming a global leader
   in bone grafting technologies. Our significant, 153% revenue
   growth of MagnetOs sales in 2023 compared to last year
   corresponds to the treatment of over 25,000 patients with
   MagnetOs.



   Mr. Fair continued, "The marked growth in revenue for 2023 is a
   result of a well-executed plan of geographic and sales channel
   expansion led by our expert sales, marketing, and customer
   service teams. In addition, our continued investment in
   innovation, and operational excellence in manufacturing, quality,
   and logistics has ensured that we can meet and exceed our
   customers' demands, ensuring that no patient will miss treatment.
   With our recent decision to focus our financial resources on the
   MagnetOs technology and associated portfolio of products, and not
   to proceed into Phase 3 with Fibrin-PTH, we have made significant
   progress toward reaching a cash flow break-even point more
   quickly. These strong financial results underline our commitment
   to increasing shareholder value by balancing high sales growth
   with targeted profitability."




Key developments in 2023 and so far in 2024


February 16, 2023

Kuros Biosciences announces changes to Executive Management Team


February 21, 2023

   Kuros Biosciences announces publication of supportive
   osteoimmunology data for MagnetOs bone graft


March 15, 2023

Kuros Biosciences reports results for the full year 2022

April 27, 2023

   Kuros Biosciences reports 168% increase in direct MagnetOs sales
   in the first quarter of 2023


May 8, 2023

   Annual General Meeting of Kuros Biosciences approves all
   resolutions


July 13, 2023

   Kuros Biosciences announces completion of enrollment in the
   Fibrin-PTH Phase 2 trial


August 9, 2023

Kuros Biosciences reports results for first half 2023

October 12, 2023

   Kuros Biosciences reports a 150% increase in direct MagnetOs
   sales in the first nine months of 2023 and announces changes
   within Executive Management Team


November 28, 2023

   Kuros Biosciences receives US FDA 510(k) clearance for use of
   MagnetOs in interbody spinal cages


December 20, 2023

   Kuros Biosciences receives US FDA 510(k) clearance for use of
   MagnetOs Putty standalone


December 27, 2023

   Kuros Biosciences announces results from two prospective
   randomized clinical trials: STRUCTURE and MAXA


January 4, 2024

   Kuros Biosciences announces three advancements related to its
   MagnetOs portfolio including impressive fusion data from MAXA
   prospective randomized clinical trial and two 510(k) clearances
   from FDA


January 31, 2024

   Kuros Biosciences receives US FDA 510(k) clearance for MagnetOs
   Granules for interbody use and regulatory clearance of MagnetOs
   Granules and MagnetOs Putty in New Zealand


February 1, 2024

   Kuros Biosciences presents at the CG 2024 Musculoskeletal
   Conference



Group financial results


Revenue and cost of goods sold

   In 2023, direct sales of MagnetOs rose by 163% from CHF 12.1
   million to CHF 31.7 million in 2023.  Total revenue from medical
   devices arrived at CHF 33.6 million (2022: CHF 13.3 million),
   showing an increase of 153% or 166% on a constant currency basis
   versus 2022. Cost of goods sold amounted to CHF 9.6 million
   (2022: CHF 7.2 million) of which CHF 1.8 million (2022: CHF 2.2
   million) related to the amortization of capitalized R&D; and CHF
   4.4 million and CHF 0.1 million related to impairment of goodwill
   and intangible assets respectively. (2022: impairment of goodwill
   of CHF 3.6 million).



Net operating costs

   Operating costs amounted to CHF 37.1 million, compared to CHF
   24.2 million in the previous year. The increase is primarily
   driven by sales and marketing costs resulting from growing
   commercial activities. Therefore, sales and marketing costs
   increased from CHF 12.8 million in 2022 to CHF 23.3 million in
   2023, mainly due to the increase in sales force headcount and
   general sales and distribution costs. Research and development
   costs increased from CHF 5.2 million in 2022 to CHF 5.6 million
   in 2023. General and administrative costs increased from CHF 6.6
   million in 2022 to CHF 8.4 million in 2023. Other income amounted
   to CHF 0.2 million (2022: CHF 0.4 million).



Net finance expense

   Net finance expense amounted to CHF 0.2 million (2022: CHF 2.5
   million), mainly comprised of a gain resulting from a revaluation
   on financial liability to XOMA because of the re-assessment of
   the probability assumption of future milestone payments, net of
   the result of foreign exchange.



Financial position and other assets

   Cash and cash equivalents amounted to CHF 14.2 million and funds
   available (including trade and other receivables) totaled CHF
   21.8 million as of December 31, 2023.  This is a decrease of CHF
   5.9 million from CHF 27.7 million as of December 31, 2022. The
   decrease is mainly driven by net operating cash outflows.



   As of December 31, 2023, total intangible assets amounted to CHF
   16.5 million (2022: CHF 19.4 million) and goodwill amounted to
   CHF 24.5 million (2022: CHF 29.3 million). The impairment of
   goodwill of CHF 4.4 million resulted from a reassessment of the
   assumptions underlying the expected milestones from Checkmate
   licensing.



Key figures


2023

2022

In TCHF, IFRS




- Revenue from product sales


33,564

13,265

- Revenue from collaborations


-

4,721

Total Revenue


33,564

17,986

Cost of Goods sold


(9,628)

(7,217)

Gross profit


23,936

10,769

- Sales and marketing costs


(23,328)

(12,785)

- Research and development costs


(5,599)

(5,194)

- General and administrative costs


(8,449)

(6,598)

- Other income


248

362

Net operating costs


(37,128)

(24,215)

Operating loss


(13,192)

(13,446)

Net finance expense


(155)

(2,545)

Income tax


(380)

1,396

Net loss


(13,727)

(14,595)

Net loss per share (in CHF)


(0.38)

(0.43)

Cash and cash equivalents


14,208

24,065

Trade and other receivables


7,617

3,618


Events after the reporting period

   The group has no significant events after the reporting period up
   to the date of this announcement.



Outlook

   Kuros' products are advancing according to plan with MagnetOs
   continuing to generate strong sales growth in the U.S., Europe,
   and the rest of the world. The company is adequately funded along
   the planned organic growth path and - adjusted for the Fibrin-PTH
   costs - will generate positive single-digit EBITDA for the first
   time in 2024.



   The annual report 2023 is available on our corporate website
   under the following link:



Kuros Biosciences 2023 Annual Report


   We will discuss the 2023 results in a virtual call on March 13,
   2024, at 3pm CET. If you wish to participate, please register in
   advance for this webinar:



Kuros Biosciences FY-2023 Financial Report Investor Webcast


   After registering, you will receive a confirmation email
   containing instructions to join the webinar.


   For further information, please contact:
   Kuros Biosciences AG
   Daniel Geiger
   Chief Financial Officer
   Tel +41 79 673 43 69
   daniel.geiger@kurosbio.com LifeSci Advisors
   Sandya von der Weid
   Investors Relations
   +41 78 680 0538
   svonderweid@lifesciadvisors.com


About MagnetOs

   MagnetOs is a bone graft like no other: thanks to its
   NeedleGripTM surface technology, it grows bone even in soft
   tissues. This surface technology provides traction for our body's
   vitally important 'pro-healing' immune cells (M2 macrophages).
   This in turn, unlocks previously untapped potential to stimulate
   stem cells - and form new bone throughout the graft. The growing
   body of science behind NeedleGrip is called osteoimmunology. But
   for surgeons and their patients it means one thing: a more
   predictable fusion. 1-5*



Indications statement

   Please refer to the instructions for use for your local region
   for a full list of indications, contraindications, warnings, and
   precautions.



About Kuros Biosciences

   Kuros Biosciences is on a mission to discover, develop and
   deliver innovative biologic fusion technologies. With locations
   in the United States, Switzerland and the Netherlands, the
   company is listed on the SIX Swiss Exchange. The company's first
   commercial product, MagnetOsTM, is a unique synthetic bone graft
   that has already been used across three continents in 25,000
   fusion surgeries. For more information on the company, its
   products and pipeline, visit kurosbio.com.



Forward Looking Statements

   This media release contains certain forward-looking statements
   that involve risks and uncertainties that could cause actual
   results to be materially different from historical results or
   from any future results expressed or implied by such
   forward-looking statements. You are urged to consider statements
   that include the words "will" or "expect" or the negative of
   those words or other similar words to be uncertain and
   forward-looking. Factors that may cause actual results to differ
   materially from any future results expressed or implied by any
   forward-looking statements include scientific, business, economic
   and financial factors. Against the background of these
   uncertainties, readers should not rely on forward-looking
   statements. The Company assumes no responsibility for updating
   forward-looking statements or adapting them to future events or
   developments.



   1. Van Dijk, et al. eCM. 2021; 41:756-73.
   2. Duan, et al. eCM. 2019; 37:60-73.
   3. Van Dijk, et al. Clin Spine Surg. 2020;33(6): E276-E287.


4. Van Dijk, et al. JOR Spine. 2018 ; e1039

5. Van Dijk, et al. J Biomed Mater Res. Part B: Appl Biomater.

   *Results from in vivo laboratory testing may not be predictive of
   clinical experience in humans. For important safety and intended
   use information please visit kurosbio.com.
   MagnetOs is not cleared by the FDA or TGA as an osteoinductive
   bone graft.
   MagnetOs has been proven to generate more predictable fusions
   than two commercially available alternatives in an ovine model of
   posterolateral fusion.


____________________________________________________________

   End of Inside Information
     ____________________________________________________________


   Language:    English
   Company:     Kuros Biosciences AG
                Wagistrasse 25
                8952 Schlieren
                Switzerland
   Phone:       +41 44 733 4747
   Fax:         +41 44 733 4740
   E-mail:      info@kurosbio.com
   Internet:    www.kurosbio.com
   ISIN:        CH0325814116
   Valor:       32581411
   Listed:      SIX Swiss Exchange
   EQS News ID: 1857015



   End of Announcement EQS News Service
     ____________________________________________________________


1857015 13-March-2024 CET/CEST

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