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.
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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.
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End of Inside Information
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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
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1857015 13-March-2024 CET/CEST