New Risk • Sep 04
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -€2.2m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€2.2m free cash flow). Negative equity (-€103m). Minor Risk Market cap is less than US$100m (€14.9m market cap, or US$16.5m). Breakeven Date Change • Mar 28
Forecast to breakeven in 2026 The 2 analysts covering Mithra Pharmaceuticals expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 58% per year to 2025. The company is expected to make a profit of €44.1m in 2026. Average annual earnings growth of 89% is required to achieve expected profit on schedule. Reported Earnings • Mar 10
Full year 2023 earnings released Full year 2023 results: Revenue: €40.2m (down 40% from FY 2022). Net loss: €173.5m (loss widened 191% from FY 2022). Revenue is forecast to grow 19% p.a. on average during the next 2 years, compared to a 7.6% growth forecast for the Pharmaceuticals industry in Europe. New Risk • Mar 08
New major risk - Revenue and earnings growth Earnings have declined by 19% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Negative equity (-€8.7m). Earnings have declined by 19% per year over the past 5 years. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€31m net loss in 2 years). Shareholders have been diluted in the past year (22% increase in shares outstanding). Market cap is less than US$100m (€16.3m market cap, or US$17.8m). Aankondiging • Mar 06
Mithra Pharmaceuticals SA Announces CEO Changes Mithra Pharmaceuticals SA announced the termination of the management agreement with David Horn Solomon as CEO and his replacement by Christophe Maréchal and Xavier Paoli as co-CEOs. As announced, Mithra will commence a monetization process involving the sale of various selected assets of Mithra and/or the business as a whole (the "Monetization Process"). Concurrent therewith, the board of directors decided that a change in Mithra's management was needed. Therefore, Mr. Solomon’s1management agreement was terminated with immediate effect. To lead Mithra from now on, the board of directors has decided to appoint Christophe Maréchal and Xavier Paoli as co-CEOs pending the implementation of the Monetization Process. Christophe Maréchal has been Chief Financial Officer (CFO) at Mithra since the beginning of 2017. With more than 20 years of experience in international finance in the industrial, telecommunications, manufacturing, and banking industries, he has strong skills in operational, financial, and commercial strategy. Xavier Paoli has been Chief Operating Officer (COO) at Mithra since September 2023. Xavier Paoli has a 20-year international career in the biotech and biopharmaceutical industry, with deep experience and knowledge of the full biotech value chain from fundraising to commercialization. Already involved in the day-to-day management of Mithra and in all its strategic and operational decisions, with the support of the board of directors and the entire management team, Christophe Maréchal2 and Xavier Paoli have all the expertise required to take over as co-CEOs of Mithra. Aankondiging • Feb 06
Mithra Pharmaceuticals SA to Report Fiscal Year 2023 Results on Mar 08, 2024 Mithra Pharmaceuticals SA announced that they will report fiscal year 2023 results on Mar 08, 2024 Major Estimate Revision • Dec 01
Consensus EPS estimates upgraded to €0.66 loss The consensus outlook for fiscal year 2023 has been updated. 2023 losses forecast to reduce from -€0.805 to -€0.66 per share. Revenue forecast unchanged from €69.3m at last update. Pharmaceuticals industry in Belgium expected to see average net income growth of 26% next year. Consensus price target down from €2.10 to €1.90. Share price fell 3.2% to €1.14 over the past week. Breakeven Date Change • Nov 30
No longer forecast to breakeven The 3 analysts covering Mithra Pharmaceuticals no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of €8.01m in 2025. New consensus forecast suggests the company will make a loss of €11.0m in 2025. Major Estimate Revision • Nov 08
Consensus revenue estimates increase by 31% The consensus outlook for revenues in fiscal year 2023 has improved. 2023 revenue forecast increased from €71.0m to €93.0m. Now expected to report a profit of €0.09 instead of losses of -€0.635 per share. Pharmaceuticals industry in Belgium expected to see average net income growth of 24% next year. Consensus price target down from €2.17 to €2.10. Share price rose 6.2% to €1.33 over the past week. Breakeven Date Change • Nov 07
No longer forecast to breakeven The 3 analysts covering Mithra Pharmaceuticals no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of €10.6m in 2025. New consensus forecast suggests the company will make a loss of €11.0m in 2025. Major Estimate Revision • Oct 03
Consensus revenue estimates decrease by 46% The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from €82.0m to €44.4m. EPS estimate unchanged from -€1.19 per share at last update. Pharmaceuticals industry in Belgium expected to see average net income growth of 25% next year. Consensus price target down from €2.65 to €2.15. Share price fell 30% to €1.23 over the past week. Reported Earnings • Sep 28
First half 2023 earnings released First half 2023 results: Revenue: €7.04m (down 38% from 1H 2022). Net loss: €50.5m (loss widened 62% from 1H 2022). Revenue is forecast to grow 20% p.a. on average during the next 3 years, compared to a 7.2% growth forecast for the Pharmaceuticals industry in Europe. New Risk • Sep 27
New major risk - Negative shareholders equity The company has negative equity. Total equity: -€8.7m This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (16% average weekly change). Negative equity (-€8.7m). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€4.8m net loss in 2 years). Shareholders have been diluted in the past year (26% increase in shares outstanding). Aankondiging • Sep 27
Mithra Announces Presentation of Positive Data on Estetrol (E4) Native Estrogen at NAMS 2023 Mithra announced there will be four presentations on Estetrol (E4) native estrogen at the North American Menopause Society (NAMS) 2023 Annual Meeting, being held September 27-30 in Philadelphia, USA. E4 is a key active pharmaceutical ingredient in both Mithra’s marketed contraceptive Estelle® and its next generation hormone therapy product candidate for postmenopausal symptoms, Donesta®. Amanda Black MD, MPH, FRCSC, Professor of Obstetrics and Gynecology at The University of Ottawa, will hold an independent oral presentation on the use of E4 for contraception and menopause. Dr. Black will be discussing the science and safety behind the use of E4 in the menopause at the opening symposium and will present some of the data on the effects of E4 on breast tissue. Dr. Wulf Utian, MD, PhD, DSc, Executive Director Emeritus and Honorary Founding President of NAMS, who is considered to be one of the world’s authorities on menopause and women’s health, will hold an oral presentation on the Phase 3 results of E4 in postmenopausal symptoms. The data, from two multi-center, double-blind, placebo-controlled trials with 2,550 postmenopausal women aged 40-65, show beneficial effects from 12-week treatment with E4. These include a significant increase in high-density lipoprotein (HDL) – or “good” – cholesterol and a significant decrease in the ratio total of HDL cholesterol to low-density lipoprotein (LDL) “bad” cholesterol and lipoprotein. There was also a significant decrease in fasting plasma glucose and HbA1c average blood glucose (glycemia) level. Also observed were trends for decreases in insulin and Homeostatic Model Assessment for Insulin Resistance (HOMA-IR). Dr. Black and Dr. Utian will each also hold poster presentations on E4 at NAMS 2023. Mithra has previously reported positive results from Phase 3 trials, showing strong efficacy and a favorable safety profile for contraception, for Estelle®, and separately, a statistically significant reduction in vasomotor symptoms, or hot flushes and night sweats, in postmenopausal women, with Donesta®. Aankondiging • Aug 30
Mithra Pharmaceuticals SA has completed a Follow-on Equity Offering in the amount of €20 million. Mithra Pharmaceuticals SA has completed a Follow-on Equity Offering in the amount of €20 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 10,000,000
Price\Range: €2
Transaction Features: Subsequent Direct Listing Aankondiging • Aug 28
Mithra Pharmaceuticals SA announced that it has received €20 million in funding from Armistice Capital, LLC On August 28, 2023, Mithra Pharmaceuticals SA closed the transaction. Breakeven Date Change • Jul 30
Forecast breakeven date pushed back to 2025 The 4 analysts covering Mithra Pharmaceuticals previously expected the company to break even in 2023. New consensus forecast suggests losses will reduce by 49% per year to 2024. The company is expected to make a profit of €16.4m in 2025. Average annual earnings growth of 88% is required to achieve expected profit on schedule. New Risk • Jul 28
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: €79.9m (US$88.2m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (10% average weekly change). Minor Risks Less than 1 year of cash runway based on current free cash flow (-€82m). Shareholders have been diluted in the past year (16% increase in shares outstanding). Market cap is less than US$100m (€79.9m market cap, or US$88.2m). Aankondiging • Jun 15
Mithra Announces New Positive Preclinical Data from Csf-1R Inhibitor Program Mithra announced new positive data from preclinical studies on inhibitors of CSF-1R in development, in collaboration with BCI Pharma, for treatment of endometriosis, oncology and inflammatory disorders. Colony-stimulating factor 1 receptor (CSF-1R) is a cell-surface tyrosine kinase receptor and a key regulator of macrophage biology and homeostasis. Tumor-associated macrophages are key components of the tumor microenvironment and have emerged as a promising avenue for discovery of novel cancer immunotherapies. CSF-1R kinase inhibition is therefore a promising therapeutic strategy for cancer treatment. A first study, conducted in a widely used preclinical immune-oncology model, demonstrated that the lead compound, as well as several backups, showed anti-tumor activity as a single agent. The well tolerated compounds demonstrated pronounced and consistent modulation of the tumor microenvironment, including an increase of T cells, which mediate anti-tumor immune responses, and infiltration of natural killer (NK) cells, containing enzymes that can kill tumor cells, into the tumors. Data showed a decrease in tumor-infiltrating macrophages, a type of white blood cell that plays an important role in the human immune system, and repolarization of the tumor-supportive M2 macrophage to the tumor-suppressive M1 macrophage. These results are consistent with anti-tumor activity, and tumor growth inhibition of up to 59%. The efficacy of the lead compound was further assessed as a single agent or in combination with anti PD1 therapeutic antibody in additional preclinical studies using three different cancer models: MC38 (colorectal), 4T1 (orthotopic triple negative breast) and EMT6 (triple negative breast). The significant anti-tumor activity of the lead compound used as a single agent was confirmed and was further enhanced with twice daily administration, compared to once daily. Additivity or synergy on tumor growth inhibition was observed when the lead compound was used in combination with anti-PD1 therapy; the triple negative breast cancer model showed that 50% of the animals achieved a complete tumor regression after the combination treatment. Further data will be presented in a peer-reviewed setting. The research was conducted under a partnership with BCI Pharma, first announced in November 2021. Mithra’s primary focus is on endometriosis and cancers affecting women, including orphan indications such as triple negative breast cancer (TNBC). Under the terms of the agreement, Mithra has an option to acquire from BCI all rights, title and interest in the series of CSF-1R inhibitors, and part of the BCI rights, title and interest in and to the results of the research and related intellectual property. Price Target Changed • May 29
Price target decreased by 29% to €14.70 Down from €20.67, the current price target is an average from 3 analysts. New target price is 530% above last closing price of €2.34. Stock is down 70% over the past year. The company is forecast to post earnings per share of €2.91 next year compared to a net loss per share of €1.22 last year. Aankondiging • May 29
Mithra Appoints Christian Homsy as Chairman Mithra announced the appointment of leading life sciences executive Dr. Christian Homsy as Chairman of the Board of Directors. The Board of Directors also appointed Inge Beernaert as President of the Compensation and Nomination Committee and Gaudeto, represented by Jacques Galloy as President of the Audit Committee. Christian Homsy, who recently joined the Board as an Independent Director of Mithra, has more than 30 years’ experience in the life sciences industry, most recently as founder and interim Chief Executive Officer and Board Member of Capstan Therapeutics. He was also founder, Chief Executive Officer and Board Member of Celyad SA and spent the first part of his career in senior roles at Guidant Corporation, now part of Boston Scientific and Abbott. Christian gained his Medical Doctorate at the University of Louvain, Belgium and his MBA at IMD Business School, Lausanne, Switzerland. Aankondiging • May 26
Mithra Approves Board Appointments Mithra at its Annual General Meeting, held on May 25, 2023, approved the appointment of new directors for a two-year mandate as follows: Ribono SRL, Mr. Sidney Bens (Independent Director) Sidney is a seasoned financial executive, with over 35 years’ experience. He spent most of his career at Atenor, where he served as Chief Financial Officer. Prior to this he worked in banking, as Senior Corporate Banker at Paribas Bank Belgium (now Belfius) and in Retail and SMC banking at BBL (now ING). Sidney holds a Masters degree in Finance, Accounting and Trade from Lucien Cooremans Institute, Belgium and a Postgraduate in Finance from KU Leuven, Belgium. Mrs. Igne Beernaert (Independent Director) Igne is an experienced financial services professional, specializing in audit, corporate finance, internal controls, tax, management and M&A. She is the founder of Bedrijfsrevisor Beernaert, where she served as company auditor for the last 27 years. Prior to this, she founded bb3 Revisoren, another financial advisory firm. Igne holds a Masters degree in Applied Economics from KU Leuven, Belgium and a postgraduate degree in liability and insurance law from the University of Antwerp. Life Science Strategy Consulting SRL, Mr. Christian Homsy (Independent Director) Christian is a leading life sciences executive with over 30 years’ industry experience. Most recently he founded and served as interim Chief Executive Officer and Board Member of biotechnology company Capstan Therapeutics. He was also founder, Chief Executive Officer and Board Member of Celyad SA for 15 years. He spent a large part of his career at Guidant Corporation (part of Boston Scientific and Abbott Labs) in a number of senior roles. Christian gained his Medical Doctorate at the University of Louvain, Belgium and his MBA at IMD Business School, Lausanne, Switzerland. Gaudeto SRL, Mr. Jacques Galloy (Independent Director) Jacques has over 25 years of business leadership experience including private and public equity capital markets, focusing on digital imaging, medical technology, digital media and digital transition. He is currently the founder and managing partner of Guadeto SPRL. He is a current investor in 7 companies, entrepreneur in 5 businesses and charities, and has over 10 board mandates. He also has 12 years’ experience as Board member and CFO of EVS Broadcast Equipment SA. Jacques holds a Masters in Commercial Engineering from Ulg-HEC Liège, Belgium. Aankondiging • May 11
Mithra Announces Completion of Recruitment in Pediatric Study of Estelle in Adolescent Patients Mithra announced that a pediatric study of Estelle®? in adolescent patients has completed recruitment. Data from the study is expected to be available in first half of 2024. Developed by Mithra, Estelle is the first and only contraceptive pill containing estetrol (E4), the onlyrogen native to human pregnancy. The objective of the pediatric study (MIT-Es001-C303, ClinicalTrials.gov: NCT04792385, EudraCT: 2019-003002-27) is to evaluate the safety, compliance, and pharmacokinetics profile of Estelle (estetrol monohydrate 15 mg and drospirenone 3 mg) in 100 participants aged 12 to 17 years old, as agreed with regulatory authorities. The study is being conducted in a number of European countries (Estonia, Finland, Georgia, Latvia, Poland, Sweden). Combined Oral Contrace contraceptive such as Estelle are the most popular hormonal contraceptives1 in the adolescent population, and adolescents are more likely than adult women to use these products for health purposes other than birth control such as cycle and bleeding control2. Despite widespread use in adolescents, clinical data from this population is limited. Studies such as this one are needed in order to bring safe and effective contraceptive to those that need it most. Developed by MithRA, Estelle®? is a novel patent protected combined oral contraceptive pill containing 3 mg drospirenone (DRSP) and 15 mg estetrol (E4). E4 is a naturally produced estrogen during pregnancy, which can now be made from a plant source. In two phase 3 clinical studies conducted in 3,725 women, Estelle®? was shown to be both safe and effective and met its primary efficacy endpoint of pregnancy prevention. It also delivered excellent results on a variety of secondary endpoints that demonstrated outstanding cycle control, bleeding control, safety, and tolerability. Mithra has signed 15 licensing deals for Estelle®? with a number of leading women's health companies covering more than 100 countries in the world. Breakeven Date Change • Mar 28
Forecast breakeven date pushed back to 2024 The 3 analysts covering Mithra Pharmaceuticals previously expected the company to break even in 2023. New consensus forecast suggests losses will reduce by 92% to 2023. The company is expected to make a profit of €4.87m in 2024. Average annual earnings growth of 139% is required to achieve expected profit on schedule. Reported Earnings • Mar 09
Full year 2022 earnings released Full year 2022 results: Revenue: €67.0m (up 196% from FY 2021). Net loss: €59.6m (loss narrowed 49% from FY 2021). Revenue is forecast to grow 15% p.a. on average during the next 2 years, compared to a 5.5% growth forecast for the Pharmaceuticals industry in Europe. Aankondiging • Jan 14
Mayne Pharma Group Limited and Mithra Pharmaceuticals, SA Announces US Launch of Haloette, a Generic Version of Nuvaring Mayne Pharma Group Limited and Mithra Pharmaceuticals, SA announced the launch of HALOETTE (etonogestrel and ethinyl estradiol) a vaginal hormonal contraceptive ring into the US market. HALOETTE contraceptive is a generic version of NUVARING, a combined hormonal contraceptive flexible ring indicated for the prevention of pregnancy. Under the terms of the long-term license and supply agreement, Mayne Pharma will pay Mithra a milestone of EUR 1.6 million. Aankondiging • Jan 12
Mithra Pharmaceuticals SA to Report Fiscal Year 2022 Final Results on Apr 18, 2023 Mithra Pharmaceuticals SA announced that they will report fiscal year 2022 final results on Apr 18, 2023 Price Target Changed • Jan 05
Price target decreased to €20.67 Down from €24.00, the current price target is an average from 3 analysts. New target price is 481% above last closing price of €3.56. Stock is down 83% over the past year. The company is forecast to post earnings per share of €0.01 next year compared to a net loss per share of €2.69 last year. Breakeven Date Change • Jan 01
Forecast breakeven date pushed back to 2024 The 4 analysts covering Mithra Pharmaceuticals previously expected the company to break even in 2022. New consensus forecast suggests losses will reduce by 67% per year to 2023. The company is expected to make a profit of €53.8m in 2024. Average annual earnings growth of 46% is required to achieve expected profit on schedule. Board Change • Nov 16
Less than half of directors are independent There are 7 new directors who have joined the board in the last 3 years. Of these new board members, 4 were independent directors. The company's board is composed of: 7 new directors. 2 experienced directors. No highly experienced directors. 4 independent directors (5 non-independent directors). President of the Scientific Advisory Board & Executive Director Jean-Michel Foidart is the most experienced director on the board, commencing their role in 2016. Independent Vice Chairman Erik Van Eynden was the last independent director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Lack of experienced directors. Price Target Changed • Oct 13
Price target decreased to €22.50 Down from €25.23, the current price target is an average from 4 analysts. New target price is 247% above last closing price of €6.48. Stock is down 65% over the past year. The company is forecast to post earnings per share of €1.71 next year compared to a net loss per share of €2.69 last year. Reported Earnings • Sep 26
First half 2022 earnings released: €0.69 loss per share (vs €1.28 loss in 1H 2021) First half 2022 results: €0.69 loss per share (improved from €1.28 loss in 1H 2021). Revenue: €11.4m (down 6.5% from 1H 2021). Net loss: €31.2m (loss narrowed 43% from 1H 2021). Revenue is forecast to grow 30% p.a. on average during the next 3 years, compared to a 6.0% growth forecast for the Pharmaceuticals industry in Europe. Over the last 3 years on average, earnings per share has fallen by 36% per year whereas the company’s share price has fallen by 39% per year. Aankondiging • Aug 08
FDA Grants Approval to Mayne Pharma Group Limited and Mithra Pharmaceuticals, SA of the Abbreviated New Drug Application (Anda) for Haloette Mayne Pharma Group Limited and Mithra Pharmaceuticals, SA announced that the US Food and Drug Administration (FDA) has granted approval of the Abbreviated New Drug Application (ANDA) for HALOETTE® (etonogestrel and ethinyl estradiol) vaginal hormonal contraceptive ring. Mayne Pharma anticipates the commercial launch of HALOETTE® ring by early calendar year 2023. HALOETTE® contraceptive is a generic version of NUVARING®, a combined hormonal contraceptive flexible ring that combines etonogestrel and ethinyl estradiol and is indicated for the prevention of pregnancy. According to IQVIA, NUVARING® US brand and generic sales were approximately USD 580 million for the 12 months ended June 20221. Under the terms of the long-term license and supply agreement, Mayne Pharma will pay Mithra EUR 6 million as a result of receiving FDA approval and EUR 1.6 million upon commercial launch in the US. Mithra will manufacture HALOETTE® at its contract development and manufacturing organisation (CDMO) facility in Belgium. Aankondiging • Jul 26
Mayne Pharma Group Limited and Mithra Pharmaceuticals, Sa Announces NEXTSTELLIS Oral Contraceptive Now Available in Australia Mayne Pharma Group Limited and Mithra Pharmaceuticals, SA announced NEXTSTELLIS (14.2 mg of estetrol and 3 mg drospirenone tablets), a first- of-its kind oral contraceptive with a novel estrogen is now available in Australia. NEXTSTELLIS was approved by the Therapeutic Goods Administration (TGA) in November 2021 and is the first and only contraceptive pill containing a new low impact estrogen, estetrol (E4), and a progestin, drospirenone. E4 is a natural estrogen produced by the human body during pregnancy and in NEXTSTELLIS, E4 is derived from a plant source. NEXTSTELLIS will compete in the Australian combined (estrogen plus progestin) oral contraceptive market which is valued at AUD 60 million. Combined oral contraceptives continue to be the most common method of contraception with nearly 1 million Australian women using them. Aankondiging • Jun 22
Mithra Pharmaceuticals SA announced that it expects to receive €23.500005 million in funding Mithra Pharmaceuticals SA announced that it will receive 3,871,500 shares at a price of €6.07 per share for gross proceeds of €23.5 million on June 21, 2022. Issue price of €6.07 per share, representing a 5% discount to closing share price. The company will issue equity in the transaction. The transaction is expected to be completed on or about June 24, 2022. Price Target Changed • Jun 10
Price target decreased to €28.55 Down from €32.30, the current price target is an average from 3 analysts. New target price is 317% above last closing price of €6.85. Stock is down 71% over the past year. The company is forecast to post earnings per share of €3.53 next year compared to a net loss per share of €2.69 last year. Board Change • Apr 27
High number of new directors There are 6 new directors who have joined the board in the last 3 years. Independent Chairman Ajit Shetty was the last director to join the board, commencing their role in 2021. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Mar 10
Full year 2021 earnings: Revenues miss analyst expectations Full year 2021 results: Revenue: €22.7m (up 151% from FY 2020). Net loss: €116.9m (loss widened 27% from FY 2020). Revenue missed analyst estimates by 53%. Over the next year, revenue is forecast to grow 1,122%, compared to a 7.1% growth forecast for the pharmaceuticals industry in Belgium. Aankondiging • Nov 29
Mayne Pharma Group Limited and Mithra Pharmaceuticals, SA Announces Therapeutic Goods Administration Approval of NEXTSTELLIS® Oral Contraceptive Mayne Pharma Group Limited and Mithra Pharmaceuticals, SA announced the Therapeutic Goods Administration (TGA) has approved the novel combined oral contraceptive NEXTSTELLIS® (14.2 mg of estetrol and 3 mg drospirenone tablets). Mayne Pharma anticipates the commercial launch of NEXTSTELLIS by mid-2022 supported by healthcare professional market education from January 2022. Developed by Mithra Pharmaceuticals, NEXTSTELLIS is a first-of-its-kind contraceptive pill containing a new low impact estrogen - estetrol (E4) and the proven progestin - drospirenone (DRSP). E4 is a natural estrogen produced by the human body during pregnancy, now derived from a plant source. Containing a new chemical entity (NCE), NEXTSTELLIS will receive 5 years of market exclusivity. The Australian contraceptive market is valued at AUD 125 million with the short-acting combined (estrogen and progestin) oral contraceptive market worth over AUD 65 million1. Aankondiging • May 27
Mayne Pharma Group Limited and Mithra Pharmaceuticals, SA Announces Nextstellis Receives FDA Marketing Exclusivity and Phase Iii Data Published Mayne Pharma Group Limited and Mithra Pharmaceuticals, SA announced that the novel oral contraceptive NEXTSTELLIS ® (3 mg drospirenone and 14.2 mg estetrol (E4) tablets) has been granted marketing exclusivity as a new chemical entity (NCE) from the US Food and Drug Administration (FDA). The exclusivity runs for five years from FDA approval of the New Drug Application for NEXTSTELLIS. NEXTSTELLIS was approved by the FDA in April 2021 and is the first and only pill containing E4, a natural estrogen produced during pregnancy that is now made from a plant source. E4 is the first new estrogen introduced in the US in more than 50 years. A new article has been published in Contraception - an international, peer-reviewed reproductive health journal - with the results of the NEXTSTELLIS North American Phase III clinical study involving nearly 2,000 women. The publication concluded that NEXTSTELLIS is an effective oral contraceptive with a predictable bleeding pattern for most women and a low rate of adverse events. In addition to efficacy and safety, a predictable bleeding pattern is another key consideration for women and their healthcare providers. Bothersome breakthrough bleeding is a common side effect of hormonal contraception and can often lead to discontinuation of contraceptives. Unscheduled bleeding occurred in less than 2% of patients after cycle 2 (bleeding only) with less than 1 day of unscheduled bleeding or spotting on average per cycle after cycle 1. Price Target Changed • May 24
Price target increased to €35.36 Up from €32.78, the current price target is an average from 4 analysts. New target price is 51% above last closing price of €23.35. Stock is up 9.1% over the past year. Price Target Changed • May 06
Price target increased to €35.36 Up from €32.78, the current price target is an average from 4 analysts. New target price is 55% above last closing price of €22.80. Stock is up 1.1% over the past year. Reported Earnings • Apr 26
Full year 2020 earnings released: €2.25 loss per share (vs €0.70 loss in FY 2019) The company reported a poor full year result with increased losses, weaker revenues and weaker control over costs. Full year 2020 results: Revenue: €9.03m (down 91% from FY 2019). Net loss: €92.1m (loss widened 247% from FY 2019). Products in clinical trials Phase II: 2 Phase III: 2 Post-clinical trial products Pre-registration: 1 Over the last 3 years on average, earnings per share has increased by 17% per year but the company’s share price has only increased by 3% per year, which means it is significantly lagging earnings growth. Price Target Changed • Mar 30
Price target increased to €32.78 Up from €25.28, the current price target is an average from 3 analysts. New target price is 17% above last closing price of €28.00. Stock is up 26% over the past year. Reported Earnings • Mar 11
Full year 2020 earnings released The company reported a poor full year result with increased losses, weaker revenues and weaker control over costs. Full year 2020 results: Revenue: €9.03m (down 91% from FY 2019). Net loss: €92.1m (loss widened 238% from FY 2019). Products in clinical trials Phase III: 1 Aankondiging • Mar 10
Mithra and Searchlight Pharma Announces Nextstellis Approval in Canada Mithra and Searchlight Pharma announced that Health Canada has approved Nextstellis, the first and only combined oral contraceptive (COC) product based on the unique native estrogen estetrol (E4). Once launched, E4 will be the first new estrogen in a COC in the Canadian market in over half a century, and will be the only COC alternative to ethinyl estradiol-based COC pills in Canada. Developed by Mithra, Nextstellis is composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP) in a 24/4 dosing regimen. E4 is a naturally occurring native estrogen produced in the human body, with a unique mechanism of action that displays tissue selective activity. E4 shows agonist activity on the vagina, the uterus and the endometrium, the bones and the brain, and antagonistic activities in breast tissue. Neutral impact on lipids and a distinct metabolic and hemostatic profile provide further differentiation based on its unique mechanism of action. E4 is synthesized from plant-based sources and represents the first native estrogen available in any contraceptive product in Canada. Health Canada's approval of Nextstellis is based on two multinational, multicentre Phase 3 clinical studies of 3,725 women who were 16 to 50 years of age, and who had a Body Mass Index (BMI) up to 35kg/m2. Nextstellis demonstrated contraceptive efficacy across all evaluated age and BMI ranges. The studies also demonstrated good bleeding profiles, cycle control, and tolerability, and with low rates of adverse reactions. The approval in Canada is the first marketing authorization for Nextstellis in any jurisdiction, anywhere in the world. Regulatory reviews remain ongoing in the United States and European Union, with expected marketing authorizations in H1 2021. Currently, the Canadian hormonal contraceptive market is worth approximately CAD 348 million a year, with combined oral contraceptives accounting for about 66% of the market. Nextstellis will complement and deepen Searchlight Pharma's industry-leading women's health product portfolio which includes Addyi (flibanserin), a first-in-class medication in Canada for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in both pre and post-menopausal women up to age 60, as well as market-leading brands such as Mona Lisa IUDs for contraception, and menopausal treatments such as Divigel and Estragyn Vaginal Cream. Is New 90 Day High Low • Mar 09
New 90-day high: €23.40 The company is up 5.0% from its price of €22.35 on 09 December 2020. The Belgian market is flat over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is down 9.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €148 per share. Valuation Update With 7 Day Price Move • Mar 09
Investor sentiment improved over the past week After last week's 15% share price gain to €23.40, the stock is trading at a trailing P/E ratio of 31.7x, up from the previous P/E ratio of 27.5x. This compares to an average P/E of 24x in the Pharmaceuticals industry in Europe. Total returns to shareholders over the past three years are 5.4%. Aankondiging • Feb 06
Mithra Announces Executive Changes The Board of Directors of Mithra accepted that Francois Fornieri take a step back as CEO, until further notice, for a maximum of 12 months. In doing so, Francois Fornieri is laying down any executive function at Mithra. As a result hereof, the Board of Directors has decided to appoint Leon Van Rompay as CEO ad interim until further notice. Francois Fornieri remains at the disposal of the CEO ad interim. Leon Van Rompay has more than 40 years of experience in the international pharmaceutical industry. After holding various management positions in several big pharma companies (Bayer, Glaxosmithkline, Zambon), Leon Van Rompay created Docpharma in 1999, a company specializing in marketing generic drugs. Docpharma got listed on the stock exchange (Euronext), and was successfully sold to the Matrix Group in 2005. Aankondiging • Jan 13
Mithra Pharmaceuticals SA, Annual General Meeting, May 20, 2021 Mithra Pharmaceuticals SA, Annual General Meeting, May 20, 2021. Price Target Changed • Dec 11
Price target lowered to €24.57 Down from €27.18, the current price target is an average from 3 analysts. The new target price is 26% above the current share price of €19.52. As of last close, the stock is down 26% over the past year. Major Estimate Revision • Nov 28
Analysts lower revenue estimates to €29.6m The 2020 consensus revenue estimate decreased from €51.0m. Earnings per share (EPS) also decreased, with analysts lowering their estimates from -€0.35 to -€0.69 for the same period. The Pharmaceuticals industry in Belgium is expected to see an average net income growth of 13% next year. The consensus price target was lowered from €26.17 to €25.50. Share price is up 20% to €22.50 over the past week. Price Target Changed • Nov 27
Price target lowered to €25.50 Down from €27.98, the current price target is an average from 3 analysts. The new target price is 13% above the current share price of €22.50. As of last close, the stock is down 19% over the past year. Is New 90 Day High Low • Oct 29
New 90-day low: €16.42 The company is down 4.0% from its price of €17.16 on 30 July 2020. The Belgian market is down 6.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is down 21% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €14.85 per share. Is New 90 Day High Low • Sep 26
New 90-day low: €16.54 The company is down 14% from its price of €19.20 on 26 June 2020. The Belgian market is flat over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €14.90 per share. Aankondiging • Jun 22
Mithra Pharmaceuticals SA has completed a Follow-on Equity Offering in the amount of €64.999988 million. Mithra Pharmaceuticals SA has completed a Follow-on Equity Offering in the amount of €64.999988 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 3,421,052
Price\Range: €19
Transaction Features: Subsequent Direct Listing