Halle (Saale) / Munich, Germany, April 28, 2022 – Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon) ), a clinical stage company focused on discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, today announced financial results for the twelve month period ending December 31, 2021 and provided an update on its corporate progress. The report is available on the Company’s website https://www.vivoryon.com/investors-news/financial-information/.
“2021 was a truly outstanding year for Vivoryon, marked by a number of hugely important achievements in the clinical development of our lead candidate varoglutamstat for the treatment of Alzheimer’s disease. Despite the pandemic-related challenges, we have met the recruitment objectives for our European Phase 2b VIVIAD study and initiated our Phase 2a/b study VIVA-MIND in the U.S. as planned. Clinical development in the U.S. is further supported by the Fast Track designation the FDA has granted for varoglutamstat last December. In addition, the regulatory achievements of our Chinese partner Simcere, enabling near-term clinical development in China, broadens the tremendous opportunity we have to make varoglutamstat available to as many patients as possible. All of these highlights are a testimony to our team’s unwavering dedication to making a difference for those affected by Alzheimer’s disease worldwide,” said Dr. Ulrich Dauer, CEO of Vivoryon. “As an oral small molecule designed to target all hallmarks of AD, varoglutamstat is truly differentiated from all other approaches and we are convinced that its unique mode of action positions it as an urgently needed alternative to solely Abeta-focused, antibody-based treatments. For the remainder of the year, we are looking at a number of key milestones and inflection points that we believe will further substantiate the potential of varoglutamstat in AD. The successful placement of new shares amounting to EUR 21 million at the beginning of April this year, with participation of a number of high-quality institutional investors from Europe and the U.S., will enable us to reach these milestones, and we are extremely grateful to all our shareholders for their continued support.”
Clinical Portfolio Highlights
Corporate Development Highlights
Post-period Events
Financial Results for the Full Year 2021
The Company generated license revenues of EUR 10.8 million in 2021 from a regional licensing partnership with Simcere Pharmaceutical Group Ltd for Greater China (Mainland China, Hong Kong, Macao and Taiwan) signed on June 29, 2021. No revenues were generated in 2020, respectively.
Research and development expenses increased in 2021 by EUR 4.2 million compared to the year ended December 31, 2020. This increase is primarily attributable to a EUR 3.7 million higher expenses for our clinical trial, VIVIAD, and the related production of PQ912, as well as EUR 0.8 million higher expenses for share-based payments
General and administrative expenses increased by EUR 1.7 million largely attributable to EUR 0.8 million higher expenses for share based payments as well as EUR 0.6 higher expesenses for legal and consulting services in connection with preparation of a US listing.
Net loss for the twelve months ended December 31, 2021 was EUR 12.7 million, compared to EUR 16.5 million for the twelve months ended December 31, 2020. The Company held EUR 14.7 million in cash and cash equivalents as of December 31, 2021, compared to EUR 26.3 million as of December 31, 2020.
Financial Guidance Following the capital raise completed in April 2022, according to current planning and estimates, Vivoryon expects that its existing cash and cash equivalents will be sufficient to fund its research and development expenses as well the general and administrative expenses and cash flows from investing and financing activities at least through end of May 2023. This guidance does not include potential milestone payments from development partnerships, potential payments from licensing agreements and/or additional financing measures, as far as such payments have not yet been recognized in revenues. The financial guidance takes into account all costs to ensure sustainable study drug supply with varoglutamstat for the VIVA-MIND U.S. study.
Vivoryon Therapeutics N.V. Financial Statements
Statement of Profit or Loss and Other Comprehensive Income for the Years Ended December 31, 2021 and 2020
in kEUR, except for share data | 2021 | 2020 |
Revenue | 10,764 | — |
Cost of Sales | (1,569) | — |
Gross profit | 9,196 | — |
Research and development expenses | (17,452) | (13,210) |
General and administrative expenses | (4,549) | (2,807) |
Other operating income | 7 | 6 |
Operating loss | (12,798) | (16,011) |
Finance income | 967 | 105 |
Finance expense | (392) | (604) |
Finance result | 575 | (499) |
Result before income taxes | (12,223) | (16,510) |
Income taxes | (432) | — |
Net loss for the period | (12,655) | (16,510) |
Items not to be reclassified subsequently to profit or loss | ||
Remeasurement of the net defined benefit pension liability | 83 | (93) |
Total other comprehensive income / (loss) | 83 | (93) |
Comprehensive loss | (12,572) | (16,603) |
Loss per share in EUR (basic and diluted) | (0.63) | (0.83) |
Vivoryon Therapeutics N.V.
Statements of Financial Position as December 31, 2021 and 2020
in kEUR | 2021 | 2020 |
ASSETS | ||
Non-current assets | ||
Intangible assets | 533 | 565 |
Property, plant and equipment | 66 | 80 |
Right-of-use assets | 219 | 310 |
Financial assets | 3,473 | 3 |
Total non-current assets | 4,291 | 958 |
Current assets | ||
Financial assets | 3,074 | 21 |
Other current assets and prepayments | 2,494 | 2,487 |
Cash and cash equivalents | 14,661 | 26,306 |
Total current assets | 20,229 | 28,793 |
TOTAL ASSETS | 24,520 | 29,751 |
Equity | ||
Share capital | 20,050 | 19,975 |
Share premium | 83,211 | 82,143 |
Other capital reserves | 6,168 | 4,404 |
Accumulated other comprehensive loss | (572) | (655) |
Accumulated deficit | (92,300) | (79,646) |
Total equity | 16,557 | 26,221 |
Non-current liabilities | ||
Pension liability | 1,823 | 1,981 |
Provisions long-term | 12 | — |
Lease liabilities | 132 | 224 |
Other liabilities | 513 | — |
Deferred tax liabilities | 432 | — |
Total non-current liabilities | 2,912 | 2,205 |
Current liabilities | ||
Provisions | 35 | 47 |
Trade payables | 4,360 | 911 |
Lease liabilities | 92 | 90 |
Other liabilities | 564 | 276 |
Total current liabilities | 5,051 | 1,325 |
Total Liabilities | 7,963 | 3,530 |
TOTAL EQUITY AND LIABILITIES | 24,520 | 29,751 |
Vivoryon Therapeutics N.V.
Statements of Changes in Shareholders’ Equity for the Years Ended December 31, 2021 and 2020
in kEUR | Share capital | Share premium | Other capital reserves | Accumulated other compre-hensive loss | Accumulated deficit | Total equity |
January 1, 2020 | 19,975 | 82,143 | 4,245 | (562) | (63,136) | 42,665 |
Net loss for the period | — | — | — | — | (16,510) | (16,510) |
Remeasurement of the net defined benefit pension liability | — | — | — | (93) | — | (93) |
Comprehensive income / (loss) | — | — | — | (93) | (16,510) | (16,603) |
Share-based payments | — | — | 159 | — | — | 159 |
December 31, 2020 | 19,975 | 82,143 | 4,404 | (655) | (79,646) | 26,221 |
Net loss for the period | — | — | — | — | (12,655) | (12,655) |
Remeasurement of the net defined benefit pension liability | — | — | — | 83 | — | 83 |
Comprehensive income / (loss) | — | — | — | 83 | (12,655) | (12,572) |
Share-based payments | — | — | 1,763 | — | — | 1,763 |
Proceeds from exercise of share options | 75 | 1,069 | — | — | — | 1,144 |
December 31, 2021 | 20,050 | 83,211 | 6,168 | (572) | (92,300) | 16,557 |
Vivoryon Therapeutics N.V.
Statements of Cash Flows for the Years ended December 31, 2021 and 2020
in kEUR | 2021 | 2020 |
Operating activities | ||
Result before income taxes | (12,223) | (16,510) |
Adjustments for: | ||
Finance result | (575) | 499 |
Depreciation and amortization | 165 | 146 |
Share based payments | 1,763 | 159 |
Other non-cash adjustments | 178 | (5) |
Changing in | ||
Financial assets | (6,522) | 310 |
Other current assets and prepayments | 1,852 | 1,056 |
Pension liabilities | (158) | (80) |
Provisions | — | 35 |
Trade payables | 3,449 | 372 |
Other liabilities | 800 | (12) |
Interest received | 21 | 26 |
Interest paid | (7) | (7) |
Taxes paid | — | — |
Cash flows used in operating activities | (11,257) | (14,012) |
Investing activities | ||
Purchase of plant and equipment | (20) | (64) |
Purchase of intangible assets | (8) | (576) |
Cash flows used in investing activities | (28) | (640) |
Financing activities | ||
Capital raising costs | (1,881) | — |
Payment of lease liabilities | (90) | (90) |
Proceeds from exercise of share options | 1,144 | — |
Cash flows provided by /(used in) financing activities | (827) | (90) |
Net decrease in cash and cash equivalents | (12,112) | (14,742) |
Cash and cash equivalents at the beginning of period | 26,306 | 41,524 |
Effect of exchange rate fluctuation on cash held | 467 | (476) |
Cash and cash equivalents at the end of period | 14,661 | 26,306 |
Annual Financial Report 2021
The financial statements of Vivoryon have been prepared in accordance with International Financial Reporting Standards (IFRS) of the International Accounting Standards Board, as adopted by the European Union (EU-IFRS) and with Section 2:362(9) of the Netherlands Civil Code. The auditor KPMG has issued an unqualified auditor’s report for both statements. The reports are available on the Company’s website (https://www.vivoryon.com/investors-news/financial-information/).
Conference Call and Webcast
Vivoryon will host a conference call and webcast today, April 28, 2022, at 3:00 pm CEST (09:00 am EDT). A Q&A session will follow the presentation of the full year results.
Please dial one of the following access numbers:
From Germany: +49 69 201 744 220
From The Netherlands: +31 207 168 020
From Switzerland:+41445806522
From UK: +44 20 30 092 470
From the U.S.: +1 877 423 08 30
PIN Code: 84537239#
Please dial in ten minutes prior to commencement.
A live webcast and slides will be made available at: www.vivoryon.com/investors-news/news-and-events/presentations-webcasts/
Approximately one day after the call, a slide-synchronized audio replay of the conference will be available on: www.vivoryon.com/investors-news/news-and-events/presentations-webcasts/
###
About Vivoryon Therapeutics N.V.
Vivoryon is a clinical-stage biotechnology company focused on developing innovative small molecule-based medicines. Driven by our passion for ground-breaking science and innovation, we strive to change the lives of patients in need suffering from severe diseases. We leverage our in-depth expertise in understanding post-translational modifications to develop medicines that modulate the activity and stability of proteins which are altered in disease settings. Beyond our lead program, varoglutamstat, which is in Phase 2 clinical development to treat Alzheimer‘s disease, we have established a solid pipeline of orally available small molecule inhibitors for various indications including cancer, inflammatory diseases and fibrosis. www.vivoryon.com
Vivoryon Forward Looking Statements
This press release includes forward-looking statements, including, without limitation, those regarding the business strategy, management plans and objectives for future operations of the Vivoryon Therapeutics N.V. (the “Company”), estimates and projections with respect to the market for the Company’s products and forecasts and statements as to when the Company’s products may be available. Words such as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “project,” “predict,” “should” and “will” and similar expressions as they relate to the Company are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance; rather they are based on the Management’s current expectations and assumptions about future events and trends, the economy and other future conditions. The forward-looking statements involve a number of known and unknown risks and uncertainties. These risks and uncertainties and other factors could materially adversely affect the outcome and financial effects of the plans and events described herein. Actual results, performance or events may differ materially from those expressed or implied in such forward-looking statements and from expectations. As a result, no undue reliance should be placed on such forward-looking statements. This press release does not contain risk factors. Certain risk factors that may affect the Company’s future financial results are discussed in the published annual financial statements of the Company. This press release, including any forward-looking statements, speaks only as of the date of this press release. The Company does not assume any obligation to update any information or forward-looking statements contained herein, save for any information required to be disclosed by law.
For more information, please contact:
Investor Contact
Vivoryon Therapeutics N.V.
Dr. Manuela Bader, Director IR & Communication
Tel: +49 (0)345 555 99 30
Email: IR@vivoryon.com
Media Contact
Trophic Communications
Valeria Fisher
Tel: +49 175 8041816
Email: vivoryon@trophic.eu