Kuros Biosciences AG / Key word(s): Miscellaneous Financial highlights
Operational highlights
Schlieren (Zurich), Switzerland, March 16, 2022 - Kuros Biosciences closed the year with outstanding results for 2021, increasing product sales by 107% and continuing to enroll the Phase II spine study for Fibrin-PTH, confirming its successful transition into a fully-fledged orthobiologics company with scientific, clinical, and commercial excellence in bone regeneration.
MagnetOs achieved strong sales growth in the U.S. and was successfully launched in additional European countries, despite the worldwide pandemic, and its very significant impact on the elective surgeries MagnetOs is primarily used in.
Joost de Bruijn, Chief Executive Officer, said: 'The Kuros team has delivered an outstanding performance in a complex environment, making significant progress on all fronts in 2021. The impressive sales growth of MagnetOs confirms our successful transformation into a commercial company. Combined with our Fibrin-PTH clinical program which has tremendous commercial potential, we are well-postioned to become a leader in orthobiologics. Beyond this we have received USD 6 million in milestone payments from the agreement with Checkmate Pharmaceuticals and successfully monitized the agreement with Checkmate for an upfront payment of USD 7.0 million while retaining potential additional income of USD 166.5 million.'
Key developments in 2021 and so far in 2022
Financial position Cash and cash equivalents (including trade and other receivables) as of December 31, 2021, amounted to CHF 30.7 million, compared to CHF 29.8 million as of December 31, 2020.
Net operating costs increased to CHF 18.8 million (2020: CHF 13.4 million) primarily due to increased marketing and sales costs of CHF 7.7 million (2020: CHF 4.3 million), including personnel and administration and maintenance costs. Research and development costs increased to CHF 5.0 million (2020: CHF 4.0 million), primarily through the ongoing clinical phase 2 trial of Fibrin-PTH. Other income amounted to CHF 0.2 million (2020: CHF 0.3 million) and mainly consisted of patent recharges to Checkmate.
The group's revenues amounted to CHF 13.8 million (2020: CHF 4.0 million), originating from product sales and collaborations.
The net loss for 2021 amounted to CHF 7.5 million, compared to CHF 11.5 million in 2020.
Events after the reporting period The Group has no significant events after the reporting period and up to the date of this report.
Outlook Kuros' products are advancing according to plan, with MagnetOs generating sales in the U.S. and in Europe and expected to become cashflow positive by the end of 2022. Kuros is financed to accelerate the commercial roll-out of MagnetOs in the U.S. and to complete the Phase II clinical study of Fibrin-PTH in spine, with the first data expected to be available by mid 2023.
The annual report 2021 is available on our corporate website under the following link: https://kurosbio.com/resources/kuros-annual-report-2021/
We will discuss the results of 2021 in a zoom call on March 23, 2022, at 2pm CET. If you wish to participate, please register in advance for this webinar: https://us02web.zoom.us/webinar/register/WN_kp0K1XHnSz24Wp2wOm8rJg
After registering, you will receive a confirmation email containing information about joining the webinar.
For further information, please contact:
About MagnetOs
About Fibrin-PTH (KUR-113) The latest candidate in our pipeline is based on proprietary controlled-release technology that combines the well-established mechanism of the bone growth factor parathyroid hormone (PTH) with the natural healing matrix, fibrin. Once implanted, the released PTH promotes spinal fusion by increasing the number and lifespan of bone-forming (osteogenic) cells in the fusion space. Fibrin-PTH is the first ever investigational drug-biologic candidate to be evaluated for spinal fusion; and the first to be compatible with narrow gauge cannulas for truly non-invasive surgical procedures. Fibrin-PTH is undergoing a Phase 2 clinical trial in the U.S. as part of a de-risked pre-market clinical program.§
Investigational Product Candidates Fibrin-PTH (KUR-113) is an investigational drug/biologic combination product candidate and is not approved by FDA for the indications mentioned in this release. The safety & efficacy of Fibrin-PTH (KUR-113) has not yet been evaluated for spinal fusion in humans.
About Kuros Biosciences Kuros Biosciences is a fast-growing leader in the development of spinal fusion biologics that ease the burden of back pain. 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, MagnetOs, is a unique synthetic bone graft that has already been used successfully across three continents and in over 5,000 spinal fusion surgeries. The next candidate in the Kuros pipeline is Fibrin-PTH - the first drug-biologic combination for interbody spinal fusions, currently undergoing a Phase 2 clinical trial in the US. 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.
References: 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. *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. §Fibrin-PTH (KUR-113) is an investigational drug-biologic combination product candidate. Fibrin-PTH (KUR-113) has been evaluated in animals for use in lumbar interbody fusion. The safety & efficacy of Fibrin-PTH (KUR-113) has not yet been evaluated for spinal fusion in humans. End of ad hoc announcement |
| 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: | 1303541 |
| End of Announcement | EQS News Service |
1303541 16-March-2022 CET/CEST
