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Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
---|---|---|---|---|---|
Oxurion Nv | LSE:0G99 | London | Ordinary Share | BE0003846632 | OXURION NV ORD SHS |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 4.88 | 0.00 | 01:00:00 |
Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
---|---|---|---|---|---|
Pharmaceutical Preparations | 442k | -31.69M | -0.0771 | 0.00 | 0 |
Leuven, BE, Boston, MA, US – February 22, 2022 – 08.00 AM CET – Oxurion NV (Euronext Brussels: OXUR) (the “Company” or “Oxurion”), a biopharmaceutical company developing next generation standard of care ophthalmic therapies, with a clinical stage portfolio in vascular retinal disorders today announces its unaudited full year results for the twelve-month period ending December 31, 2021, and provides an operational update and an outlook for the remainder of 2022.
The Company has two novel therapeutics in clinical development. THR-149 is a potent plasma kallikrein inhibitor being developed as a potential new standard of care for the 40-50% of DME patients showing suboptimal response to anti-VEGF therapy. THR-687 is a highly selective pan-RGD integrin antagonist that is being developed as a potential first line therapy for DME patients as well as potentially wet age-related macular degeneration (wet AMD) and macular edema following retinal vein occlusion (ME-RVO).
Tom Graney, CFA, CEO of Oxurion, commented:
“During 2021, Oxurion made excellent progress by focusing our resources on the clinical development of THR-149 and THR-687, which if successfully developed together would serve a market exceeding USD 12 billion. In addition, we secured sources of capital to enable us to further invest behind both of our exciting programs.
Earlier this month we were pleased to report positive results from Part A of our Phase 2 trial of THR-149 in patients with DME. The Part A results included post-hoc analysis by a masked reading center revealing that by excluding two patients with certain abnormalities at baseline, a >9 letter gain in mean BCVA was achieved during Part A. This >9 letter gain was maintained for the remaining four months of the trial after the last THR-149 injection with no rescue treatment required. As a result, patients with these abnormalities will be excluded from Part B of the trial, which compares THR-149 to current standard of care aflibercept for the 40-50% of patients that suboptimally respond to anti-VEGF therapy and currently have limited treatment options. Part B of the KALAHARI trial is recruiting with these protocol amendments in place with topline data expected mid-2023.
We are also delighted that Part A of our Phase 2 DME trial of THR-687 is fully enrolled with results expected in the second quarter of this year. THR-687 has the potential to become a first line treatment for DME, and we are also planning to develop THR-687 for wet AMD and potentially ME-RVO assuming Part A of the DME trial is successful.
We look forward to reporting on our progress as we continue to deliver further value inflection points for both THR-149 and THR-687, including very important THR-687 Part A data in the near future.”
2021 Highlights
Operational
Financial
Post-closing events
2022 outlook
Details 2021 Full Year Financial Results (unaudited)
Total income amounted to EUR 1.1 million in 2021, compared to EUR 2.1 million in 2020.
Gross profit of EUR 0.5 million in 2021, compared to EUR 1.5 million in 2020.
R&D expenses in 2021 were EUR 20.7 million compared to EUR 22.1 million in 2020. R&D expenses were mainly related to clinical activities in THR-687 and THR-149. The 2020 figure included a milestone payment of EUR 2.0 million related to the development of THR-149. Government grants and income from recharge of costs are deducted from the research and development expenses.
Selling and marketing expenses of EUR 1.3 million in 2021, compared to EUR 3.3 million in 2020.
General and administrative expenses of EUR 7.2 million in 2021, compared to EUR 5.5 million in 2020.
In 2021, Oxurion made a loss for the year of EUR 29.6 million, compared to a loss for the year in 2020 of EUR 28.6 million resulting in negative diluted earnings per share of EUR 0.77 in 2021 versus EUR 0.75 in 2020.
The financial results included in this press release were prepared on the basis of continuation. On December 31, 2021, the Company had cash and cash equivalents of EUR 10 million (including investments), compared with EUR 24.8 million (including investments) at December 31, 2020. In addition to available cash, the Company expects to meet its working capital requirements through a combination of debt and equity, including drawing future tranches from the Negma funding program described above, accessing the debt markets through Kreos/Pontifax and/or other debt providers, raising additional equity capital, and/or attracting potential non-dilutive funding, all of which is uncertain. Under the funding program with Negma described above, the Company will have access to up to EUR 27.5 million in the twelve-month period starting from this press release provided the Company can and does draw the maximum tranche on a monthly basis, which is subject to certain conditions that may not be met.
Considering the current available cash position, the budgets for 2022 and 2023, the funding possibilities potentially available to the Company from Negma and others, and the possibility the Company has to reduce its working capital requirements if necessary, the board of directors considers that it is appropriate for the Company to continue to account on the basis of continuation based on the information available on the date of this press release.
When approving the Company’s 2020 annual report and its 2021 HY report, the board of directors considered that there was a material uncertainty with respect to the Company’s ability to continue as a going concern. In the opinion of the board of directors, there continues to be a material uncertainty with respect to the Company’s ability to continue as a going concern on the date of this press release. A more complete description of the Company’s risks can be found in the latest PDF-version of the Company’s presentation, which can be found here.
The financial results contained in this press release are unaudited. Audited financial results and the 2021 annual report for the period ending December 31, 2021, will be published on the Company’s website by March 25, 2022.
Unaudited consolidated statement of profit and loss
In '000 euro (for the year ended 31 December) | 2021 | 2020 |
Income | 1.128 | 2.078 |
Sales | 967 | 2.000 |
Income from royalties | 161 | 78 |
Cost of sales | -612 | -550 |
Gross profit | 516 | 1.528 |
Research and development expenses | -20.696 | -22.053 |
General and administrative expenses | -7.150 | -5.489 |
Selling expenses | -1.274 | -3.252 |
Other operating income | 1.245 | 777 |
Other operating expense | -9 | -6 |
Impairment losses | -1.127 | -125 |
Operating result | -28.495 | -28.620 |
Finance income | 171 | 468 |
Finance expense | -1.268 | -408 |
Result before income tax | -29.592 | -28.560 |
Taxes | -3 | 0 |
Result of the year | -29.595 | -28.560 |
Attributable to: | ||
Equity holders of the company | -29.158 | -28.012 |
Non-controlling interest | -437 | -548 |
Result per share | ||
Basic earnings / loss (-) per share (euro) | -0,77 | -0,75 |
Diluted earnings / loss (-) per share (euro) | -0,77 | -0,75 |
In '000 euro (as at 31 December) | 2021 | 2020 |
Result of the year | -29.595 | -28.560 |
Other comprehensive income: | ||
Remeasurement of defined benefit pension schemes | 566 | -297 |
Fair value gain/(loss) on investments designated as at FVTOCI | -5 | 0 |
Other comprehensive income that will not be reclassified to profit or loss | 561 | -297 |
Exchange differences arising on translation of foreign operations | 122 | -127 |
Other comprehensive income that will or may be reclassified to profit or loss | 122 | -127 |
Other comprehensive income, net of income tax | 683 | -424 |
Total comprehensive loss (-) / income for the year | -28.912 | -28.984 |
Attributable to: | ||
Equity holders of the company | -28.475 | -28.436 |
Non-controlling interest | -437 | -548 |
Unaudited consolidated statement of financial position
In '000 euro (as at 31 December) | 2021 | 2020 |
ASSETS | ||
Property, plant and equipment | 120 | 230 |
Right-of-use assets | 252 | 1.069 |
Intangible assets | 1.000 | 2.127 |
Other non-current assets | 95 | 96 |
Non-current tax credit | 4.000 | 3.708 |
Non-current assets | 5.467 | 7.230 |
Inventories | 60 | 85 |
Trade and other receivables | 2.517 | 1.451 |
Current tax receivables | 845 | 719 |
Investments | 247 | 288 |
Cash and cash equivalents | 9.740 | 24.511 |
Current assets | 13.409 | 27.054 |
Total assets | 18.876 | 34.284 |
EQUITY AND LIABILITIES | ||
Share capital | 46.029 | 44.913 |
Share premium | 234 | 0 |
Other comprehensive income | -356 | -1.039 |
Other reserves | -5.266 | -6.133 |
Retained earnings | -41.719 | -12.561 |
Equity attributable to equity holders of the company | -1.078 | 25.180 |
Non-controlling interest | -30 | -132 |
Total equity | -1.108 | 25.048 |
Lease liabilities | 44 | 447 |
Employee benefit liabilities | 594 | 1.096 |
Convertible loans | 8.433 | 0 |
Non-current liabilities | 9.071 | 1.543 |
Trade payables | 4.979 | 4.377 |
Lease liabilities | 221 | 649 |
Convertible loans | 3.401 | 0 |
Other short-term liabilities | 2.312 | 2.667 |
Current liabilities | 10.913 | 7.693 |
Total equity and liabilities | 18.876 | 34.284 |
Unaudited consolidated statement of cash flows
In '000 euro (for the year ended 31 December) | 2021 | 2020 |
Cash flows from operating activities | ||
Loss for the period | -29.595 | -28.560 |
Finance expense | 896 | 408 |
Finance income | -171 | -468 |
Depreciation of property, plant and equipment | 77 | 194 |
Amortization and impairment of intangible assets | 1.127 | 125 |
Amortization of right-of-use assets | 600 | 916 |
Gain on sale of property, plant and equipment | -344 | -7 |
Fair value adjustments of financial instruments | 372 | 0 |
(Reversal of) impairment losses on current assets | 629 | 801 |
Increase / Decrease (-) in provisions | 64 | 0 |
Equity settled share-based payment transactions | 1.107 | 458 |
Increase (-) / Decrease in trade and other receivables and inventories | -2.037 | 700 |
Increase / Decrease (-) in short-term liabilities | 297 | -1.646 |
Net cash flows generated / used (-) in operating activities | -26.978 | -27.079 |
Cash flows from investing activities | ||
Disposal of property, plant and equipment (following a sale) | 394 | 35 |
Decrease / Increase (-) in investments | 36 | 10.154 |
Interest received and similar income | 9 | -6 |
Purchase of property, plant and equipment | -32 | -119 |
Net cash flows generated / used (-) in investing activities | 407 | 10.064 |
Cash flows from financing activities | ||
Principal paid on lease liabilities | -599 | -903 |
Proceeds from loans and borrowings | 11.150 | 0 |
Other financial income / expense (-) | -20 | 0 |
Interest paid on lease liabilities | -3 | -16 |
Proceeds from capital increases in subsidiaries from non-controlling interest | 86 | 0 |
Proceeds from capital and share premium increases, gross amount | 1.350 | 0 |
Paid interests and other bank charges | -186 | -12 |
Net cash flows used (-) / generated in financing activities | 11.778 | -931 |
Net change in cash and cash equivalents | -14.793 | -17.946 |
Net cash and cash equivalents at the beginning of the period | 24.511 | 42.492 |
Effect of exchange rate fluctuations | 22 | -35 |
Net cash and cash equivalents at the end of the period | 9.740 | 24.511 |
Unaudited consolidated statement of changes in equity
Share capital | Share premium | Other comprehensive income reserve | Other reserves | Retained earnings | Attributable to equity holders of the company | Non-controlling interest | Total | |
Balance as at 1 January 2020 | 100.644 | 0 | -615 | -12.122 | -34.747 | 53.160 | 146 | 53.306 |
Total comprehensive income of the year | ||||||||
Result of the year | 0 | 0 | 0 | 0 | -28.012 | -28.012 | -548 | -28.560 |
Change to foreign currency translation difference | 0 | 0 | -127 | 0 | 0 | -127 | 0 | -127 |
Remeasurement of DBO | 0 | 0 | -297 | 0 | 0 | -297 | 0 | -297 |
Net change in fair value of investments | 0 | 0 | 0 | -2 | 0 | -2 | 0 | -2 |
Contributions by and distributions to owners | ||||||||
Issue of ordinary shares | 0 | 0 | 0 | 0 | 0 | 0 | 270 | 270 |
Capital decrease | -55.731 | 0 | 0 | 5.533 | 50.198 | 0 | 0 | 0 |
Share-based payment transactions | 0 | 0 | 0 | 458 | 0 | 458 | 0 | 458 |
Balance as at 31 December 2020 | 44.913 | 0 | -1.039 | -6.133 | -12.561 | 25.180 | -132 | 25.048 |
Share capital | Share premium | Other comprehensive income reserve | Other reserves | Retained earnings | Attributable to equity holders of the company | Non-controlling interest | Total | |
Balance as at 1 January 2021 | 44.913 | 0 | -1.039 | -6.133 | -12.561 | 25.180 | -132 | 25.048 |
Total comprehensive income of the year | ||||||||
Result of the year | 0 | 0 | 0 | 0 | -29.158 | -29.158 | -437 | -29.595 |
Change to foreign currency translation difference | 0 | 0 | 122 | 0 | 0 | 122 | 0 | 122 |
Remeasurement of DBO | 0 | 0 | 566 | 0 | 0 | 566 | 0 | 566 |
Net change in fair value of investments | 0 | 0 | -5 | 0 | 0 | -5 | 0 | -5 |
Total comprehensive income for the year | 0 | 0 | 683 | 0 | -29.158 | -28.475 | -437 | -28.912 |
Contributions by and distributions to owners | ||||||||
Issue of ordinary shares | 1.116 | 234 | 0 | 213 | 0 | 1.563 | 0 | 1.563 |
Share-based payment transactions | 0 | 0 | 0 | 1.107 | 0 | 1.107 | 0 | 1.107 |
Total contributions by and distributions to owners | 1.116 | 234 | 0 | 1.320 | 0 | 2.670 | 0 | 2.670 |
Transactions with non-controlling interests | 0 | 0 | 0 | -453 | 0 | -453 | 539 | 86 |
Balance as at 31 December 2021 | 46.029 | 234 | -356 | -5.266 | -41.719 | -1.078 | -30 | -1.108 |
About Oxurion
Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing next generation standard of care ophthalmic therapies, which are designed to better preserve vision in patients with retinal vascular disorders including diabetic macular edema (DME), the leading cause of vision loss in diabetic patients worldwide as well as other conditions, including wet age-related macular degeneration (wet AMD) and macular edema following retinal vein occlusion (ME-RVO).
Oxurion is aiming to build a leading global franchise in the treatment of retinal vascular disorders based on the successful development of its two novel therapeutics. THR-149 is a potent plasma kallikrein inhibitor being developed as a potential new standard of care for the 40-50% of DME patients showing suboptimal response to anti-VEGF therapy. THR-687 is a highly selective pan-RGD integrin antagonist that is being developed as a potential first line therapy for DME patients as well as wet AMD and potentially ME-RVO. Oxurion is headquartered in Leuven, Belgium, with corporate operations in Boston, MA. More information is available at www.oxurion.com.
Important information about forward-looking statements
Certain statements in this press release may be considered “forward-looking”. Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company’s Annual Report and in the latest PDF-version of the Company’s presentation; which can be found here. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of Oxurion in any jurisdiction. No securities of Oxurion may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.
For further information please contact:
Oxurion NV Tom GraneyChief Executive OfficerTel: +32 16 75 13 10tom.graney@oxurion.com Michaël DillenChief Business OfficerTel: +32 479 783 583michael.dillen@oxurion.com | EU MEDiSTRAVA ConsultingDavid Dible/Sylvie Berrebi/Frazer HallTel: +44 203 928 6900oxurion@medistrava.com USWestwicke, an ICR companyChristopher BrinzeyTel: +1 617 835 9304chris.brinzey@westwicke.com |
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