Mithra Pharmaceuticals S.A.

Annual / Quarterly Financial Statement • Mar 7, 2023

Mithra reports full year 2022 financial results

• Revenues increased steadily to reach EUR 67 million, mainly driven by the signature of the first license agreement for Donesta® with Gedeon Richter
• Acceleration in the number of NEXTSTELLIS® cycles dispensed in the United States; launch in Australia by Mayne Pharma. Commercial roll out of DROVELIS® in all major European countries. In 2022, product sales on Estelle® stand at EUR 9.2 million
• Cash position at EUR 28.3 million end 2022, strengthened by post-closing events linked to the collection of an out-licensing upfront payment on Donesta® of EUR 50 million, the collection of the Mayne Pharma dividend for EUR 3 million and the milestone payment of EUR 1.6 million following Myring® commercialization in the U.S., which led to a cash position of EUR 67.5 million at end February 2023
• R&D expenses decreased by 25% to reach EUR 64.0 million compared to EUR 85.2 million in 2021
• Positive efficacy topline results from Donesta® Phase III Program
• Positive safety topline results from Donesta® Phase III Study in North America supporting the filing with U.S. regulatory agency anticipated by end of H1 2023 for a market authorization in H1 2024 whereas primary safety data are anticipated for H1 2024 in Europe with a market authorization expected for H1 2025
• FDA approval of Myring® commercialized under the trademark HALOETTE® in the U.S., leading to a milestone payment of EUR 6 million collected in H2 2022
• Convertible loan signed with Highbridge Capital Management and Whitebox Advisors for an amount up to EUR 100 million, including repurchase of EUR 34.1 million tranche of the convertible bonds due in 2025 at a 15% discount to par

Liege, Belgium, 07 March 2023 – 07:30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women's Health, today announces its financial results for the year ended 31 December 2022, prepared in accordance with IFRS.

Leon Van Rompay, CEO Mithra Women's Health, commented: "2022 marks a historical turning point for Mithra with the reception of the positive top-line efficacy results on our core asset Donesta® and the signature of a landmark license agreement with our long-standing partner Gedeon Richter. The positive topline safety results announced early March 2023 are supporting the filing with U.S. regulatory agency anticipated by end of H1 2023 for a market authorization in H1 2024. Recent media attention on menopausal discomfort menopause around the globe demonstrates a clear shift towards Hormone Therapy. Building further upon our product lifecycle development plan, we remain confident to sign a future partnership for Donesta® in the US by the end of H1 2023. I am very pleased with our operational achievements in 2022 leading to revenues which increased steadily to reach EUR 67 million, the second highest level of revenues in Mithra's history. We remain committed to deliver on our promises and deliver value for our shareholders despite a share price evolution that do not meet Mithra's potential."

Financial highlights

• Revenues stand at EUR 67 million compared to EUR 22.7 million in 2021, mainly driven by an out-licensing upfront payment of EUR 44.7 million for Donesta® (being a portion of the EUR 55 million to be recognized as revenue according to our IFRS 15 accounting policy). Under the terms of the licence agreement for the commercialisation of Donesta®, Mithra received EUR 55 million in upfront payment – EUR 5 million paid upon signature of the binding term sheet in December 2022 and EUR 50 million paid upon signature of this license agreement in February 2023.
• On top, there are EUR 9.2 million of product sales of Estelle® reported in 2022, EUR 6.5 million of product sales of generic portfolio and EUR 2.3 million of R&D contracting revenue from CDMO.
• Cash collection of the major out-licensing milestones on Myring® with Mayne (EUR 6 million) in H2 2022, one Estelle® out-licensing milestone relating to Latin America with Gedeon Richter (EUR 1 million) as well as several others amounts relating to Estelle® (for a total of EUR 1 million), without impact on revenue as already recognized previously as per IFRS. A milestone payment of EUR 1.6 million following Myring® commercialization in the U.S. has been collected in February 2023, a post-closing event.
• R&D expenses stand at EUR 64.0 million in 2022 compared to EUR 85.2 million in 2021 (- 25%). The decrease is the result of a strategy based on focusing on core R&D projects (Donesta® and Estelle®) leading to non-core R&D costs being delayed in 2023.
• EBITDA stands at EUR -14.3 million compared to EUR -77.5 million in 2021. EBITDA improves thanks to the upfront payment collected on the Donesta® license agreement combined with the decrease in operating expenses (lower R&D expenses) compared to last year.
• Loss before taxes improves thanks to the positive impact of EUR 28.3 million booked in the change in fair value of the contingent consideration payable related to Estelle®.
• Reversal of significant amount of deferred tax assets explained by two events that occurred in H2 2022. The first one is the reception of a positive ruling from Belgian tax authorities, enabling Mithra to benefit from Innovation income deduction (IID) for Estelle® and Donesta® that considers 100% of their revenue as eligible to IID mechanism. This event is changing our previous assumptions about future taxation of the related entities. The second one is arising from a tax audit on fiscal deductibility of the Uteron future payments. This tax audit had no cash consequences but has modified the assumptions to be taken into account for the deferred taxes computation. Both events result in a reversal of EUR 47.4 million impacting the deferred tax assets position on the balance sheet at closing date.
• Net Cash position stands at EUR 28.3 million end 2022 and is strengthened as mentioned above by post-closing events linked to the collection of an out-licensing upfront payment on Donesta® of EUR 50 million, the collection of the Mayne Pharma dividend for c. EUR 3 million and the milestone payment of EUR 1.6 million following Myring® commercialization in the U.S., which led to a cash position of EUR 67.5 million end February 2023. On top of this, Mithra has access to several facilities of which:
  • o EUR 52.8 million under the LDA Capital commitment agreement entered in April 2020 with a maturity in April 2025;
  • o EUR 25 million from the senior secured convertible facilities agreement signed on 8 August 2022 with funds managed by Highbridge Capital and funds managed by Whitebox Advisors for an amount of EUR 100 million, with a maturity in August 2025.

The first tranche of EUR 50 million was received upon signing of the agreement, with around 29 million used to repurchase outstanding convertible bonds of the Company held by the Lenders. The second tranche of EUR 25 million was drawn on 31st October 2022.

• Equity stands at EUR 33.7 million, flat compared to December 2021 (EUR 33.8 million). The total comprehensive loss for the period (EUR 77.9 million) was compensated by several capital increases for a total amount of EUR 77.0 million (net of transaction costs):
  • o EUR 13.0 million from LDA Capital;
  • o EUR 13.7 million in the framework of flexible equity financing agreement with Goldman Sachs International;
  • o EUR 23.3 million from the private placement completed in June 2022;
  • o EUR 26.9 million from the senior secured convertible facilities agreement with funds managed by Highbridge Capital and funds managed by Whitebox Advisors.

Operational highlights (including post-period events)

Estetrol (E4) platform

• Commercial launch of Estelle® in Australia by Mayne Pharma (July 2022) under the trademark NEXTSTELLIS®.
• Commercial launch of Estelle® in 19 additional countries by Gedeon Richter under the trademark DROVELIS®: the Netherlands, Czech Republic, Lithuania, Portugal, Finland, Croatia, Latvia, Sweden, Spain, Bulgaria, Norway, Romania, Denmark, Switzerland, Slovenia, United Kingdom, Ireland, Moldavia and Russia, under the brand name ESTERETTA®. In 2022, sales revenues for our partner Gedeon Richter reached EUR 16 million, slightly higher than the forecast of EUR 15 million.
• Launch of NEXTSTELLIS® contraceptive direct-to-consumer (DTC) campaign across targeted digital and social media channels in the U.S. (July 2022). Collaboration with the leading digital healthcare platform GoodRx, one of the most downloaded medical apps reaching millions of patients a month. In February 2023, the DTC campaign was launched on television.
• Increase of NEXTSTELLIS® sales in the U.S. with 164,000 cycles dispensed in 2022 and a month-over-month growth rate of 12%. Mayne Pharma committed to a forecast of more than 350,000 cycles for its FY 2023 (period going from July 2022 until June 2023).
• License agreement with Gedeon Richter for the commercialization of Donesta® in about 90 territories through an exclusive license in Europe, Russia, Central Asia, Latin America and through a semi-exclusive license in Brazil, Australia and New Zealand (February 2023). Mithra received EUR 5 million at the signature of the head of terms end December 2022 and EUR 50 million at the closing of the licence agreement in February 2023. Mithra is still eligible to receive EUR 15 million in additional milestone payments depending on specific regulatory achievements as well as tiered double-digit royalties depending on net sales' evolution throughout time.
• Positive top-line results in Phase III clinical studies of FSN-013. These studies aim at evaluating the estetrol/drospirenone combination product for treatment of Japanese patients with dysmenorrhea or endometriosis. Mithra's partner, Fuji Pharma, announced in February 2023 that the Phase III study in patients with dysmenorrhea (FSN-013P-03) met its primary endpoint by demonstrating a statistically significant difference for the change in the total dysmenorrhea score when compared to placebo. The other Phase III study in patients with

endometriosis (FSN-013P-04) also met its primary endpoint by demonstrating a statistically significant difference for the change in the Visual Analog Scale¹ for the most severe pelvic pain (lower abdominal pain/back pain) when compared to placebo.

• Positive top-line efficacy results from Donesta® Phase III clinical trials for the treatment of vasomotor symptoms in post-menopausal women (January 2022). Donesta® demonstrated a meaningful reduction in vasomotor symptoms from baseline and compared to placebo. All coprimary efficacy endpoints were statistically (all p<0.01) met in C301 (Europe, Latam and Russia) and in C302 (North America) studies. Both studies also showed that the number and severity of hot flushes continued to decrease week after week until the end of the study, i.e. 3 months of treatment. Secondary endpoints evaluated at 3 months in the C301 study suggest a very positive impact of Donesta® on the quality of life.
• Positive safety top-line results from Donesta® Phase III Study in North America support overall good safety profile of Mithra's next generation Estetrol (E4)-based product candidate for menopause, as consistently demonstrated in previous E4 studies (March 2023). These results will support the filing with U.S. regulatory agency anticipated by end of H1 2023 whereas primary safety data are anticipated for H1 2024 in Europe with a market authorization expected for H1 2025. The European study C301 is still ongoing with primary safety data anticipated for H1 2024. Barring any unforeseen event, Mithra confirms its ambition to achieve marketing authorization for Donesta® in H1 2024 for the United States and in H1 2025 for Europe.
• Completion of the screening of the Donesta® European Study extension (C301) on menopausal non-hysterectomized women in December 2022. The primary safety results from the C301 study are anticipated for H1 2024 and the last patient last visit is anticipated in Q1 2024.
• Launch of the clinical program on Neonatal Hypoxic-Ischemic Encephalopathy (NHIE), a lifethreatening form of neonatal asphyxia, in Q2 2022. The first clinical trial (Phase I) aims to characterise, in healthy adult volunteers, the safety, tolerability and pharmacokinetics of a novel formulation of estetrol for intravenous administration. The current study is a prerequisite for the initiation of a clinical trial in the neonatal population. A first cohort has been completed. Depending on the results, the clinical trial in the neonatal population will be launched in H2 2024.
• Positive preclinical data demonstrating efficacy of estetrol to promote wound healing and support its use in clinic. Estetrol improves wound closure and dampens local inflammation, supported by a unique gene signature, compared to other estrogens. The finalization of the formulation development to produce a first clinical batch is ongoing. The target indication has been defined and Mithra will first focus on chronic wound (ulcers) indication. The clinical development plan should be initiated with a pilot Phase II trial to explore the safety and efficacy of E4 in venous leg ulcer population. A proof of concept should be demonstrated in 2025.
• Mithra's CMC team continues to invest in the continuous improvement of the patented Estetrol synthesis process in order to lower the cost of goods. Mithra is evaluating ideas to optimize the processes and the yield and to replace expensive raw materials. All relevant optimizations will be implemented at commercial scale in due time.

¹ Visual Analog Scale using 100mm line by which patients can evaluate their pain

Complex therapeutics

• FDA approval of Myring® under the trademark HALOETTE® (August 2022), followed by the commercial launch in the U.S. by Mayne Pharma in January 2023. Mithra has received two additional milestone payments: EUR 6 million upon FDA approval in H2 2022 and EUR 1.6 million at the commercial launch early 2023. On February 27, 2023, our partner in charge of the commercialization of Myring®, Mayne Pharma, announced that it entered into an agreement with Dr. Reddy's Laboratories SA to sell its US retail generics portfolio (i.e. Myring®).
• Commercial launch of Myring® in Canada by Searchlight Pharma under the trademark HALOETTE® (February 2022). Myring® is the first available alternative in the Canadian contraceptive ring market.
• Development of new formulations for Zoreline® with a pharmacokinetic profile closer to Zoladex®. The R&D team has been working on the clinical trial preparation for a trial launch in 2023. Marketing authorization expected in early 2026.

Tyrosine kinases inhibitors

• Positive progression in the research collaboration with BCI Pharma, with the identification of 4 distinct chemical series of selective CSF1R inhibitors, showing very promising profiles in a range of in vitro and in vivo tests. Through those tests, promising compounds have demonstrated proof of concept in cancer and endometriosis indications, which were the initial focus. Additional studies are currently ongoing at BCI Pharma's end to further characterize the potential in relevant disease models.

Mithra CDMO

• Agreement with MedinCell for the development of two long-acting injectable products: a 3 month long acting injectable designed as an additional tool to fight Malaria as well as a longacting injectable of tacrolimus for transplant patients aiming at improving efficacity, tolerance and patient observance.
• Collaboration with VaRi Bioscience for the development of an innovative long-acting vaginal ring indicated for the treatment of vulvovaginal atrophy for menopausal women.
• Production of around 1 million Myring® vaginal rings in line with the forecasted volume for Europe and other geographies worldwide, including the first U.S. batch.

Expected milestones for 2023

• Estelle® further commercial launch in Europe, Latin America and Asia, as well as additional marketing authorizations in Brazil, Israel, Peru & Serbia.
• Launch of post approval safety study (PASS) early Q2 2023 for Europe (EMA). Protocol for the U.S. sent early 2023.
• License and supply agreement for Donesta® in the U.S. and Canada expected in H1 2023. Other countries are also being addressed/under negotiations.
• Filing Donesta® by the FDA in the U.S. expected to be submitted by the end of H1 2023.
• Launch of 3 Phase II studies in Donesta® Clinical Program carried out on skin health, hair quality and female sexual arousal disorder (FSAD), which Clinical Safety Results (CSR) are expected in Q4 2024 for skin health and hair quality study. The skin health study aims at

defining the effect of the treatment on the skin hydration and the skin elasticity. The hair quality study will measure the effect of the treatment on hair density.

• The full data set to make decision on acquisition of the IP from BCI Pharma will be available in Q2 2023. As a reminder, Mithra has an option to acquire patents covering CSF1R inhibitor series with upfront payment of EUR 2.25 million on execution of option, following the first results conducted by BCI Pharma. Mithra will fund the preclinical and clinical development with a focus on female cancers and endometriosis, with a focus on orphan indications, such as TNBC.

FINANCIAL RESULTS

1. Consolidated statement of profit or loss

	As at 31 December
Thousands of Euro (€)	2022	2021
Revenue	66,997	22,668
Cost of sales	(19,623)	(15,724)
Gross profit	47,374	6,945
Research and development expenses	(64,041)	(85,243)
General and administrative expenses	(14,675)	(12,515)
Selling expenses	(2,100)	(1,871)
Other operating income	7,196	4,809
Loss from operations	(26,245)	(87,875)
Change in fair value of contingent consideration payable	28,335	(19,265)
Net fair value gains/(losses) on financial assets at fair value through profit or loss	-	(6,351)
Financial income	9,852	2,838
Financial expenses	(23,422)	(13,116)
Loss before taxes	(11,480)	(123,769)
Income taxes	(48,139)	6,895
NET LOSS FOR THE PERIOD	(59,620)	(116,875)

2. Consolidated statement of financial position

	As at 31 December
Thousands of Euro (€)	2022	2021
ASSETS
Property, plant and equipment	40,717	38,354
Right-of-use assets	65,534	69,322
Goodwill	5,233	5,233
Other intangible assets	134,905	104,954
Deferred income tax assets	16,354	63,456
Contract assets	2,828	49
Investment in equity securities	21,437	31,898
Other non-current assets	9,544	9,263
Non-current assets	296,552	322,528
Inventories	50,312	43,852
Contract assets	44,988	12,522
Derivatives financial assets	-	100
Trade and other receivables	22,277	10,044
Cash and cash equivalents	28,285	32,872
Current assets	145,863	99,389
TOTAL ASSETS	442,414	421,918

	As at 31 December
Thousands of Euro (€)	2022	2021
EQUITY AND LIABILITIES
Share capital	41,228	32,250
Additional paid-in-capital	408,647	340,769
Other reserves	(19,934)	(2,545)
Accumulated deficit	(396,254)	(336,633)
Equity attributable to equity holders	33,687	33,840
Subordinated loans	10,710	11,629
Other loans	127,052	113,608
Lease liabilities	38,253	42,353
Refundable government advances	8,127	12,769
Other financial liabilities	74,210	102,675
Derivatives financial liabilities	15,261	2,897
Provisions	266	266
Deferred tax liabilities	4,420	6,089
Non-current liabilities	278,298	292,285
Current portion of subordinated loans	1,252	1,314
Current portion of other loans	45,980	45,253
Current portion of lease liabilities	5,179	6,561
Current portion of refundable government advances	1,417	1,617
Current portion of other financial liabilities	15,959	15,829
Derivatives financial liabilities	2,561	1,886
Trade and other payables	58,082	23,331
Current liabilities	130,431	95,793
TOTAL EQUITY AND LIABILITIES	442,414	421,918

3. Consolidated statement of cash flows

	As at 31 December
Thousands of Euro (€)	2022	2021
Cash and cash equivalents at beginning of year	32,872	138,675
Net cash (used in)/ provided by operating activities	(56,819)	(76,788)
Net cash (used in)/ provided by investing activities	(25,490)	(54,682)
Net cash (used in)/provided by financing activities	77,869	25,646
Net increase/(decrease) in cash and cash equivalents	(4,440)	(105,824)
Effects of exchange rate changes on cash and cash equivalents	(147)	21
Cash and cash equivalents at end of period	28,285	32,872

Statement of profit and loss

The Group reported a net loss of EUR 59.6 million in 2022, compared to a net loss of EUR 116.9 million in 2021.

Revenues stood at EUR 67.0 million compared to EUR 22.7 million in 2021. The revenues breakdown as follows:

• 1. Product sales were largely driven by Estelle® (EUR 9.2 million) from owned product portfolio, which are lower than in 2021 (EUR 13.3 million) because of a slower ramp-up, and Myring® (EUR 4.5 million) that improves the revenue on our generic portfolio to EUR 6.5 million compared to EUR 3.8 million in 2021.
• 1. Out-licensing revenue, at EUR 49 million in 2022, are essentially Estelle® and Donesta® milestones (respectively EUR 4.1 million and EUR 44.7 million). On the one hand, EUR 4.1 million relates to an out-licensing revenue of the license and supply agreement with Gedeon Richter for the commercialization of Estelle® in Latin America. On the other hand, EUR 44.7 million (being a portion of the EUR 55 million to be recognized as revenue according to our IFRS 15 accounting policy) relates to the terms of the licence agreement for the commercialisation of Donesta®, where Mithra received EUR 55 million in upfront payment – EUR 5 million paid upon signature of the binding term sheet in December 2022 and EUR 50 million paid upon signature of this license agreement in February 2023.
• 1. The revenues contain also the revenue recognized from the R&D contracting activities from CDMO for EUR 2.3 million.

R&D expenses (including depreciations) decreased by 25% in 2022 to EUR 64million (2021: EUR 85.2 million). The decrease is the result of a strategy based on focusing on our core R&D projects, like Donesta® Phase III clinical studies and Estelle® post approval safety study (PASS). As a consequence, some costs have been delayed to 2023.

G&A and selling expenses increased by 17%, due to a higher impact of share-based payments accounting entries (charge of EUR 2.0 million compared to charge of EUR 1.1 million in 2021) but also due to an increase in insurance costs, salaries indexation and, in general, several external fees.

Other operating income of EUR 7.2 million (compared to EUR 4.8 million in 2021) are composed of a R&D tax credit for EUR 2.1 million which is directly related to R&D expenses level, of EUR 1.5 million exemption from the withholding tax on professional income for R&D staff and of EUR 2.2 million of cost reinvoicing.

The positive impact about EUR 28.3 million of change in fair value gain related to contingent consideration payable Estelle® is mainly the consequence of conservative review of management estimate and the underlying updated business plans, as well as discount rate (2022 WACC is 2.44% higher than in 2021 to reach 13.78%).

Financial income increase is explained by the positive impact of the remeasurement of refundable government advances measured at amortized cost (EUR 3.6 million) following the update of forecasts. This update of the forecasts is explained by a slower ramp-up compared to company's initial estimates on Estelle® product sales and by the global contractual landscape agreed with Gedeon Richter concerning the supply of Estetrol for Estelle®. Following this agreement, Mithra is no longer entitled to receive supply revenues for Estelle as Gedeon Richter is in charge of the supply and the production of the product for all its territories (Europe & Latin America). Mithra is still eligible to collect the royalties negotiated in the agreement² signed in September 2018.

It also includes EUR 3million of dividend from Mayne Pharma as well as a realized gain of EUR 2.5 million following the early repurchase of EUR 34.1 million tranche of our convertible bonds due in 2025 at a discount to par, via the convertible loan signed with Highbridge and Whitebox.

Increase of financial expenses is mostly driven by the interest charges for a total of EUR 16.8 million, higher than in 2021, linked to the higher financial liabilities in 2022 and to the use of straight's lines and financing solutions, and a realized foreign exchange loss for EUR 5.9 million following the early settlement of one of the derivative financial instruments.

The group recorded a tax loss of EUR 48.1 million for 2022 that mainly results of two events which both result in a reversal of EUR 47.4 million of deferred tax assets (DTA). The first one is a reversal of DTA on temporary differences on contingent consideration payable Estelle® as a consequence of a tax audit performed on deductibility of the Uteron futures payments during the second half of 2022. There are no cash consequences but assumptions regarding the computation of deferred taxes have been modified. In addition, Mithra received a positive ruling from Belgian tax authorities, enabling to benefit from Innovation income deduction (IID) for Estelle® and Donesta®. This ruling considers 100% of their revenue as eligible to IID mechanism. This event is changing our previous assumptions about future taxation of the relevant entities. Indeed, the update of business plans and IID are limiting the amount of losses carried forward to be set off of against future taxable income as from July 2021 onwards, because this IID will allow a company to deduct 85% of the net income derived from intellectual property rights.

Statement of financial position

• Assets

As of 31 December 2022, the Statement of financial position shows a total of EUR 296.6 million in Non-current assets, the majority of which are Other intangible assets (EUR 134.9 million), Property, plant and equipment (EUR 40.7 million), Right-of-use assets (EUR 65.5 million), Deferred tax assets (EUR 16.4 million) and Investments in equity securities (EUR 21.4 million).

In 2022, a total of EUR 33.3 million has been added to the Other intangible assets among which the Tech Transfer to allow Mithra to control the E4 synthesis industrial process in large scale of production (EUR 28.3 million), capitalization of internal development costs incurred for the development of the API E4 (EUR 0.5 million) and capitalization of R&D costs regarding the post approval safety study for Estelle® (EUR 4.3 million). This amount is offset by EUR 3.1 million of depreciation that increased regarding 2021 since the beginning of depreciation of Myring® PPA since August 2022 (triggered by the FDA approval) and a full year of depreciation for Estelle® PPA (ready for use since Estelle®'s commercialisation from May 2021).

Tangible fixed assets (Property, plant and equipment and the Right-of-use assets) decreased about EUR 1.4 million, mainly explained by the increase of depreciations in 2022 (EUR 8.8 million). This impact is partially offset by acquisitions done in 2022 (EUR 7.8 million), which are mainly the result of the capitalization of internal development costs incurred for equipment set ups and process improvement in the production zones (polymer, injectable, …) for EUR 5.5 million and all the related equipment for EUR 1.2 million.

² Mithra's press release, 12/09/2018

Deferred tax assets decreased about EUR 47.1 million mainly due to reversal primarily because of the reception of the ruling from Belgian Tax Authorities regarding the innovation income deduction which allows to consider 100% of revenues from Estelle® and Donesta® for as eligible deduction and secondly because of the conclusion of a tax audit on fiscal deductibility of Uteron futures payments. Both events have modified our assumptions and tax forecasts which impact this accounting estimate computation.

Investment in equity securities are decreasing due to the change in fair value explained by the decrease in Mayne's share price at reporting date as well as the decrease in AUD/EUR conversion rate.

Contract assets amount to EUR 47.8 million (non-current and current) versus EUR 12.8 million in 2021. The variance relates to out-licensing revenue, mainly from Gedeon Richter (EUR 43.2 million of contract assets), offset by unbilled revenues recognized in prior years and billed in 2022 (among which EUR 1million to Gedeon Richter and EUR 8.1 million to Mayne Pharma).

Current assets at the end of 2022 are about EUR 145.9 million and include Cash and cash equivalents of EUR 28.3 million, Trade & other receivables of EUR 22.3 million, and Inventories of EUR 50.3 million.

Inventories increased to EUR 50.3 million from EUR 43.9 million in 2021, mainly due to the increase of E4 inventory ( EUR 7million) in 2022, which has been built up in order to be able to meet the demand from partners for Estelle®.

• Equity and liabilities

Total equity at year-end remained flat at EUR 33.7 million. The total comprehensive loss for the period (EUR 77.9 million) was compensated by several capital increases for a total amount of EUR 77million (net of transaction costs).

Non-current liabilities decreased to EUR 278.3 million at the end of 2022, compared to EUR 292.3 million end of 2021, primarily due to a decrease of the fair value of contingent considerations payables (EUR -28.5 million), which are reported under Other financial liabilities, and to the amortized cost treatment of refundable government advances (EUR 3.6 million). The other loans increase (EUR 13.4 million) is mainly the result of the convertible bond early repurchase (EUR 31.3 million) offset by the debt part of the new facility contracted with Highbridge and Whitebox (EUR 42.1 million). The derivatives financial liabilities increase is explained by the derivative instrument part of the facility Highbridge and Whitebox (EUR 7.6 million).

Current liabilities increased to EUR 130.4 million at the end of 2022, compared to EUR 95.8 million in 2021. The increase of the Current liabilities is mainly explained by the increase of Trade payables (EUR 34.6 million). This increase is namely due to the open amount of Trade payables as per year end 2022 against E4 manufacturer with whom Mithra is in current dispute. Based on an assessment of its available stocks, Mithra confirms that it has a sufficient volume of estetrol to meet the current needs of its partners.

To mitigate its risks, Mithra has initiated in the past the process of selecting new suppliers of Estetrol in a diversification perspective. In such a way, Mithra is taking all necessary measures to secure the continuity of Estetrol's deliveries in the medium and long term.

Alternative performance measures

Mithra decided to use some alternative performance measures (APMs) that are not defined in IFRS but that provide helpful additional information to better assess how the business has performed over the period. Mithra decided to use 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 nonrecurring item 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 are presented as follows in the first section of this press release (management figures) :

		As at 31 December
Thousands of Euro (€)	2022	2021
Revenue	66,997	22,668
Cost of sales	(19,112)	(15,724)
Gross profit	47,886	6,945
Research and development expenses	(53,668)	(76,577)
General and administrative expenses	(11,707)	(10,021)
Selling expenses	(2,029)	(1,541)
Other operating income	7,196	4,809
REBITDA	(12,323)	(76,385)
Share-based payments expenses	(1,983)	(1,065)
EBITDA	(14,305)	(77,450)
Depreciation	(11,940)	(10,426)
Non-recurring items	-	-
Loss from operations	(26,245)	(87,875)
Change in fair value of contingent consideration payable	28,335	(19,265)
Net fair value gains/(losses) on financial assets at fair value through profit or loss	-	(6,351)
Financial income	9,852	2,838
Financial expenses	(23,422)	(13,116)
Loss before taxes	(11,480)	(123,769)
Income taxes	(48,139)	6,895
NET LOSS FOR THE PERIOD	(59,620)	(116,875)

Please refer to the table below for the reconciliation to loss from operations as presented within consolidated statement of profit or loss :

		As at 31 December
Thousands of Euro (€)	2022	2021
Loss from operations	(26.245)	(87.875)
Depreciation	11.940	10.426
Share-based payments	1.983	1.065
REBITDA	(12.323)	(76.385)
Share-based payments	(1.983)	(1.065)
EBITDA	(14.305)	(77.450)

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For more information, please contact:

Benoît Mathieu (IRO) : +32 473 35 80 18 - investorrelations@mithra.com

Annual report 2022

The auditor, BDO Réviseurs d'Entreprises SRL, has confirmed that he substantially completed the audit of the accounting data included in this press release and that he will finalize in the coming weeks his audit of the notes to the consolidated financial statements.

Webcast

Mithra will host a conference call and live webcast today (March 7, 2023) at 09.00 CET. 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.

Financial Calendar

• 18 April 2023 : 2022 Annual Report
• 25 May 2023 : Annual General Shareholders Meeting
• 26 September 2023 : Half Year Report 2023

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 hormonedependent 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 around 230 staff members and is headquartered in Liège, Belgium. www.mithra.com

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ESTELLE® DONESTA® , MYRING® , NEXTSTELLIS® and HALOETTE® are registered trademarks of Mithra Pharmaceuticals or one of its affiliates.

DROVELIS® and ESTERETTA® are registered trademarks of Gedeon Richter Nyrt. NUVARING® is a registered trademark of Organon NV. ZOLADEX® is a registered trademark of AstraZeneca UK Limited.

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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