Schlieren (Zurich), Switzerland, March 15, 2023 – Kuros Biosciences today announces continued robust progress with its results for full year 2022, increasing MagnetOs direct sales by 75% and completing enrollment of the randomized stage of the Phase 2 spine study for Fibrin-PTH, confirming its successful transition into a fully-fledged orthobiologics company with scientific, clinical, and commercial excellence in bone regeneration. Total revenue from medical devices came in at CHF 13.3 million (vs FY 2021: CHF 8.3 million), increased by 59% and 56% on a constant currency basis.
MagnetOs achieved strong sales growth in the U.S. and passed the important milestone of 10,000 patients treated worldwide, demonstrating its utility in real-world practice as well as in controlled trial environments.
Joost de Bruijn, Chief Executive Officer, said: “Kuros Biosciences has achieved a year of impressive continued upward sales momentum, outstanding progress with clinical development and strong business performance, underlining our growing success as a leading orthobiolgics company. Our MagnetOs bone graft technology reached several notable goals including new commercial launches, which extended the product line and strengthened the MagnetOs family brand, as well as passing the major milestone of 10,000 patients treated worldwide and completing enrollment of patients in the PARTNER clinical trial. We made more encouraging progress during 2022 with our Fibrin-PTH clinical program, which represents a substantial commercial opportunity for the company. We continued to receive milestone payments from our agreement with Regeneron, which has acquired Checkmate Pharmaceuticals, and we successfully conducted a CHF 6 million private placement, maintaining a strong cash position as we move forward into 2023.”
|
| Key developments in 2022 and so far in 2023 |
| January 20, 2022 |
Publication of first-in-human clinical data for Fibrin-PTH (KUR-113) in treatment of open tibial shaft fractures |
| February 3, 2022 |
MagnetOs Granules cleared by FDA for expanded spinal indications |
| April 21, 2022 |
MagnetOs Flex Matrix cleared by FDA for spinal indications |
| May 18, 2022 |
Announces commercial launch of MagnetOs Easypack Putty in the U.S. |
| May 31, 2022 |
Announces favorable preliminary results of MagnetOs as standalone alternative to autograft in first randomized controlled trial |
| June 2, 2022 |
Completion of acquisition of Checkmate Pharmaceuticals by Regeneron Pharmaceuticals triggers a USD 5.0 million milestone payment |
| August 23, 2022 |
MagnetOs Bone Graft successfully achieves three key milestones |
| September 15, 2022 |
Announces successful CHF 6.0 million private placement |
| October 3, 2022 |
Appoints Chris Fair as Chief Operating Officer |
| October 19, 2022 |
warded 2022 Spine Technology Award for MagnetOs Flex Matrix by Orthopedics This Week |
| November 2, 2022 |
Completes enrollment in Level 1 clinical study of MagnetOs Granules |
| November 23, 2022 |
Completes enrollment of randomized stage of Phase 2 trial for Fibrin-PTH |
| February 16, 2023 |
Appoints Daniel Geiger as Chief Financial Officer ad interim |
| February 21, 2023 |
Announces publication of supportive osteoimmunology data for MagnetOs Bone Graft |
|
Financial position
General remark – Direct sales of MagnetOs increased by 75%
In 2022, direct sales of MagnetOs rose 75% from 6.9 million to CHF 12.1 million in 2022. Total revenue from medical devices came in at CHF 13.3 million (vs FY 2021: CHF 8.3 million), increased by 59% and 56% on a constant currency basis. Revenues from collaborations amounted to CHF 4.7 million (vs FY 2021: CHF 5.5 million). Cost of goods sold amounted to CHF 7.2 million (vs FY 2021: CHF 3.7 million) of which CHF 2.2 million (vs FY 2021: CHF 2.2 million) is the amortization from currently marketed products and CHF 3.6 million (vs FY 2021: CHF nil) is due to an impairment of goodwill.
Financial position and other assets
Funds available for financing the operations of Kuros amounted to CHF 27.7 million as of December 31, 2022, which included cash and cash equivalents, trade and other receivables. This is a decrease of CHF 3.0 million from CHF 30.7 million as of December 31, 2021. The decrease is mainly driven by a net operating cash outflow partially compensated by a CHF 6.0 million capital increase through a private placement of 3,750,000 new shares.
As of December 31, 2022, total intangible assets amounted to CHF 19.4 million (vs FY 2021: CHF 22.6 million) and goodwill amounts to CHF 29.3 million (vs FY 2021: CHF 33.4 million). The decrease in the goodwill amount is driven by an impairment after re-assessing the expected timeline for clinical development of the licensing agreement with Checkmate (now: acquired by Regeneron Pharmaceuticals).
Operating loss
Operating costs amounted to CHF 24.2 million, compared to CHF 18.8 million in the previous year. The increase is primarily driven by sales and marketing costs because of the growing commercial activities. Research and development costs increased from CHF 5.0 million in 2021 to CHF 5.2 million in 2022. General and administrative costs increased from CHF 6.3 million in 2021 to CHF 6.6 million in 2022. Sales and marketing costs increased from CHF 7.7 million in 2021 to CHF 12.8 million in 2022, mainly due to increased sales force headcount and general sales costs. Other income amounted to CHF 0.4 million (2021: CHF 0.2 million).
Net finance expense
Finance costs amounted to CHF 2.5 million (2021: CHF 0.8 million) which is mainly the result of foreign exchange and revaluation of financial liability to XOMA upon receipt of the Change of Control milestone payment.
|
| Key figures |
|
2022 |
2021 |
| In TCHF, IFRS |
|
|
|
| – Revenue from product sales |
|
13,265 |
8,341 |
| – Revenue from collaborations |
|
4,721 |
5,474 |
| Total Revenue |
|
17,986 |
13,815 |
| Cost of Goods sold |
|
(7,217) |
(3,749) |
| – Research and development costs |
|
(5,194) |
(4,989) |
| – General and administrative costs |
|
(6,598) |
(6,329) |
| – Sales and marketing costs |
|
(12,785) |
(7,723) |
| – Other income |
|
362 |
208 |
| Net operating costs |
|
(24,215) |
(18,833) |
| Operating loss |
|
(13,446) |
(8,767) |
| Net finance expense |
|
(2,545) |
(787) |
| Income taxes |
|
1,396 |
2,013 |
| Net loss |
|
(14,595) |
(7,541) |
| Net loss per share (in CHF) |
|
(0.43) |
(0.23) |
| Cash and cash equivalents, trade and other receivables |
|
27,683 |
30,670 |
|
Events after the reporting period
In February 2023, the Group terminated the supply agreement with Seaspine.
The Group noted on Friday, March 10, 2023, that funds equal to a low single-digit percentage of total cash were at stake as U.S. financial regulators have decided to take Silicon Valley Bank off the market. On March 12, 2023, the U.S. government announced that all Silicon Valley Bank deposits will be guaranteed. The Group will take the appropriate steps to further mitigate the associated financial risks by installing remedies and further reducing the respective counterparty risk.
Outlook
Kuros’ products are advancing according to plan, with MagnetOs continue to generate sales growth in the U.S. and in Europe, it is expected that this product segment becomes cashflow positive in the second half of 2023. Kuros is financed to accelerate the commercial roll-out of MagnetOs in the U.S. and to complete the Phase 2 clinical study of Fibrin-PTH in spine, with the first data expected to be available by end of 2023.
The annual report 2022 is available on our corporate website under the following link:
https://kurosbio.com/resources/kuros-annual-report-2022/
We will discuss the results of 2022 in a virtual call on March 21, 2023, at 2pm CET. If you wish to participate, please register in advance for this webinar:
https://octavian-ch.my.webex.com/octavian-ch.my-en/j.php?MTID=mc689956bed61446357a4fe9415b53d7e
After registering, you will receive a confirmation email containing information about joining the webinar.
Upcoming Events
May 8, 2023 Annual General Meeting
Aug 9, 2023 Half-Year Report H1 2023
|
|
|
