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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Mithra Pharmaceuticals SA | TG:1TM | Tradegate | Ordinary Share |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.216 | 0.216 | 0.216 | 0.00 | 01:00:00 |
Mithra Financial Results for First-Half 2023
Liege, Belgium, 26 September 2023 – 7:00 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces its financial results for the six-month period ending on 30 June 2023, prepared in accordance with IFRS. The full interim report is available on the Investors section of the website.
David Solomon, CEO Mithra Women’s Health, commented: “Mithra has made significant progress in the first half of 2023 advancing our business strategy, with the aim of becoming a global leader in women’s health. Dispensed cycles of Estelle®, the first contraceptive based on Estetrol (E4) natural estrogen, have surged 80% in the U.S. compared to the previous 6 months period and it has now been launched in Chile, Ecuador and Malta as well as Australia. We reported positive topline efficacy results of the Phase 3 Donesta® program and are now completing the filing of U.S. marketing authorization application, expected in H2 2023.
“We have significantly reinforced our financial position through several measures, including raising EUR 20 million in a successful private placement equity financing, with potential for up to an additional EUR 45 million in equity; we accessed EUR 12.5 million in loan financing and received EUR 2.5 million in proceeds from an equity investment by Highbridge and Whitebox after amending our loan facility agreement with them. We also signed a binding term sheet for a new Canadian licensing deal for Donesta® with Searchlight Pharma, worth up to EUR 17.05 million plus royalties.
“Mithra’s businesses will continue to provide access to capital and afford us opportunities to pursue our ambitious goals. We are now completing the U.S. marketing authorization application for Donesta®. We also are taking steps to continue to invest strongly in Donesta®, along with our commercialization partners, by generating more clinical trial data to support new claims on the Estetrol® risk/benefit profile to further differentiate and expand on its already significant market potential. These examples showcase our efforts, in line with our newly laid out plan to drive for growth.”
Financial Highlights (including post-period end)
Operational Highlights (including post-period events)
Estetrol (E4) Platform
Novalon complex therapeutics
Tyrosine kinases inhibitors
Mithra CDMO
Governance
Strategic priorities and outlook
FINANCIAL RESULTS
1. Interim consolidated statement of income statement
(in € thousand) | 30 June 2023 | 30 June 2022 |
Revenue | 7.035 | 11.357 |
Cost of sales | (8.430) | (7.083) |
Gross profit | (1.396) | 4.275 |
Research and development expenses | (32.386) | (27.518) |
General and administrative expenses | (7.198) | (7.042) |
Selling expenses | (1.194) | (1.185) |
Other operating income | 1.955 | 3.933 |
Loss from operations | (40.219) | (27.537) |
Change in the fair value of contingent consideration payable | (944) | 4.332 |
Financial income | 741 | 1.889 |
Financial expenses | (11.013) | (7.638) |
Loss before taxes | (51.435) | (28.952) |
Income taxes | 966 | (2.295) |
NET LOSS FOR THE PERIOD | (50.469) | (31.247) |
2. Interim consolidated statement of financial position
(in € thousand) | 30 June 2023 | 31 December 2022 |
ASSETS | ||
Property, plant and equipment | 39.051 | 40.717 |
Right-of-use assets | 63.259 | 65.534 |
Goodwill | 5.233 | 5.233 |
Other intangible assets | 136.537 | 134.905 |
Deferred income tax assets | 16.009 | 16.354 |
Contracts assets | 203 | 2.828 |
Derivatives financial assets | 67 | - |
Investments in equity securities | 11.315 | 21.437 |
Other non-current assets | 10.144 | 9.544 |
Non-current assets | 281.817 | 296.552 |
Inventories | 49.447 | 50.312 |
Contract assets | 5.630 | 44.988 |
Derivatives financial assets | 200 | - |
Trade and other receivables | 13.934 | 22.277 |
Cash and cash equivalents | 23.714 | 28.285 |
Current assets | 92.926 | 145.863 |
TOTAL ASSETS | 374.744 | 442.414 |
(in € thousand) | 30 June 2023 | 31 December 2022 |
EQUITY AND LIABILITIES | ||
Share capital | 42.891 | 41.228 |
Additional paid-in-capital | 413.163 | 408.647 |
Other reserves | (20) | (19.934) |
Accumulated deficit | (464.763) | (396.254) |
Equity attributable to equity holders | (8.730) | 33.687 |
Subordinated loans | 10.124 | 10.710 |
Other loans | 136.291 | 127.052 |
Lease liabilities | 34.350 | 38.253 |
Refundable government advances | 8.592 | 8.127 |
Other financial liabilities | 75.304 | 74.210 |
Derivative financial liabilities | 15.601 | 15.261 |
Contract liabilities | 10.300 | - |
Provisions | 266 | 266 |
Deferred tax liabilities | 3.574 | 4.420 |
Non-current liabilities | 294.402 | 278.298 |
Current portion of subordinated loans | 919 | 1.252 |
Current portion of other loans | 19.848 | 45.980 |
Current portion of lease liabilities | 6.230 | 5.179 |
Current portion of refundable government advances | 1.499 | 1.417 |
Current portion of other financial liabilities | 13.558 | 15.959 |
Derivative financial liabilities | 2.306 | 2.561 |
Trade and other payables | 44.711 | 58.082 |
Current liabilities | 89.071 | 130.430 |
TOTAL EQUITY AND LIABILITIES | 374.744 | 442.414 |
3. Interim consolidated statement of cash flow
(in € thousand) | 30 June 2023 | 30 June 2022 |
Cash and cash equivalents at beginning of year | 28.285 | 32.872 |
Net cash (used in)/ provided by operating activities | 14.234 | (33.204) |
Net cash (used in)/ provided by investing activities | 2.361 | (12.124) |
Net cash (used in)/provided by financing activities | (21.129) | 41.765 |
Net increase/(decrease) in cash and cash equivalents | (4.535) | (3.563) |
Effects of exchange rate changes on cash and cash equivalents | (37) | (10) |
Cash and cash equivalents at end of period | 23.714 | 29.299 |
Profit and Loss
The Group reported a net loss of EUR 50.5 million for the first half 2023, compared to a net loss of EUR 31.2 million for the first half 2022.
Revenues stand at EUR 7.0 million mainly driven by Myring® for EUR 2.4 million and Estelle® product sales of EUR 2.6 million.
Research and development expenses (including depreciation) increased by 17.7% to EUR 32.3 million, compared to EUR 27.5 million in the first half of 2022. This increase is mainly attributable to Donesta® clinical studies and the end of Phase 3 in the US.
General and administrative expenses and selling expenses are relatively stable versus the same period in 2022.
Other operating income (EUR 1.9 million compared to EUR 3.9 million in the first half 2022) are composed of: R&D tax credit for EUR 0.5 million; wage tax reductions for researchers of EUR 0.5 million, and of costs reinvoicing for EUR 0.4 million.
The negative impact of approximately EUR -0.9 million for change in fair value related to contingent consideration payable Estelle® is mainly the consequence of the updated of both discount rate and timing effect.
The decrease in financial income is explained by the impact of the remeasurement of refundable government advances measured at amortized cost, due to the review of revenue forecasts.
Increase of financial expenses is mostly driven by interest charges linked to the higher financial liabilities during the period, which are higher than first half 2022. The financial expenses contain interests and commitment fees paid in kind to Highbridge and Whitebox lenders for a total amount of EUR 2.8 million
The group recorded a tax income of EUR 1 million for the six months mainly resulting from the review of tax impact on temporary differences, partially offset by the recognition of tax losses carried forward. The latter are limited compared to previous periods in the view of the tax forecasts and the accumulated losses already recorded on the balance sheet (to be set off against future taxable income).
Alternative performance measures
Mithra has applied some alternative performance measures (APMs) that are not defined by IFRS but that provide helpful additional information to better assess how the business has performed over the period. Mithra uses REBITDA and EBITDA in order to provide information on recurring items, but those measures should not be viewed in isolation or as an alternative to the measures presented in accordance with IFRS.
REBITDA is an alternative performance measure calculated by excluding the non-recurring items and the depreciation & amortization from EBIT (loss from operations) from the consolidated statement of profit or loss prepared in accordance with IFRS. The Group considers share-based payments as non-recurring items above EBITDA.
EBITDA is an alternative performance measure calculated by excluding the depreciation and amortization from EBIT (loss from operations) from the consolidated statement of profit or loss prepared in accordance with IFRS.
Financial Highlights (management figures) are presented as follows in the first part of this report (with a condensed view):
(in € thousand) | 30 June 2023 | 30 June 2022 |
Revenue | 7.035 | 11.357 |
Cost of sales | (8.156) | (6.842) |
Gross profit | (1.121) | 4.516 |
Research and development expenses | (27.009) | (22.714) |
General and administrative expenses | (6.365) | (5.818) |
Selling expenses | (1.160) | (1.143) |
Other operating income | 1.955 | 3.933 |
REBITDA | (33.701) | (21.226) |
Share-based payments expenses | (365) | (485) |
EBITDA | (34.066) | (21.711) |
Depreciations | (6.153) | (5.826) |
Loss from operations | (40.219) | (27.537) |
Change in the fair value of contingent consideration payable | (944) | 4.332 |
Financial income | 741 | 1.889 |
Financial expenses | (11.013) | (7.638) |
Loss before taxes | (51.435) | (28.952) |
Income taxes | 966 | (2.295) |
NET LOSS FOR THE PERIOD | (50.469) | (31.247) |
Please refer to the table below for the reconciliation to loss from operations as presented within consolidated statement of profit or loss:
(in € thousand) | 30 June 2023 | 30 June 2022 |
Loss from operations | (40.219) | (27.537) |
Depreciations | 6.153 | 5.826 |
Share-based payments | 365 | 485 |
REBITDA | (33.701) | (21.226) |
Share-based payments | (365) | (485) |
EBITDA | (34.066) | (21.711) |
2023 Half Year Financial Results Webcast
Mithra will host a live webcast on Tuesday, 26 September 2023 at 14:00 CEST to announce its 2023 Half Year financial and operating results. The live webcast can be accessed on the Mithra website or by clicking here. A replay of the webcast will be available on the Mithra investor’s website shortly after the close of the call.
For more information, please contact:
Mithra Pharmaceuticals SADavid Horn SolomonChief Executive Officerinvestorrelations@mithra.com | Investor & media relationsChris MaggosCohesion Bureauchris.maggos@cohesionbureau.com +41 79 367 6254 |
About Mithra
Mithra (Euronext: MITRA) is a Belgian biotech company dedicated to transforming Women’s Health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span. Mithra explores the potential of the unique native estrogen estetrol in a wide range of applications in women health and beyond. After having successfully launched the first estetrol-based product in 2021, the contraceptive pill Estelle®, Mithra is now focusing on its second product Donesta®, the next-generation hormone therapy. Mithra also develops and manufactures complex therapeutics in the areas of contraception, menopause and hormone-dependent cancers. It offers partners a complete spectrum of research, development and specialist manufacturing at its technological platform Mithra CDMO. Active in more than 100 countries around the world, Mithra has an approximate headcount of 300 staff members and is headquartered in Liège, Belgium. www.mithra.com
Estelle®, Donesta®, Haloette®, Myring®, Zoreline® are registered trademarks of Mithra Pharmaceuticals or one of its affiliates. Drovelis® is a registered trademark of Gedeon Richter Nyrt. Nextstellis® is a registered trademark of Mayne Pharma.
Important information
The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The Company's actual results may differ materially from those predicted by the forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.
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