New Risk • Oct 26
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: €2.32m (US$2.44m) This is considered a major 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 Risks Less than 1 year of cash runway based on free cash flow trend (-€13m free cash flow). Share price has been highly volatile over the past 3 months (27% average weekly change). Negative equity (-€3.1m). Market cap is less than US$10m (€2.32m market cap, or US$2.44m). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (€1.2m net loss in 3 years). New Risk • Oct 02
New major risk - Negative shareholders equity The company has negative equity. Total equity: -€3.1m 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 Less than 1 year of cash runway based on free cash flow trend (-€13m free cash flow). Share price has been highly volatile over the past 3 months (10% average weekly change). Negative equity (-€3.1m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€1.4m net loss in 3 years). Market cap is less than US$100m (€31.1m market cap, or US$32.7m). Reported Earnings • Sep 04
Second quarter 2023 earnings released: €0.69 loss per share (vs €0.70 loss in 2Q 2022) Second quarter 2023 results: €0.69 loss per share. Revenue: €4.52m (up 21% from 2Q 2022). Net loss: €4.93m (loss widened 28% from 2Q 2022). Revenue is forecast to grow 38% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Germany. Announcement • Jul 13
Paion AG Announces Supervisory Board Changes Paion AG at its Annual General Meeting held on July 12, 2023, elected Dr. Mirko Jean Sickinger, lawyer and partner at the law firm Heuking Kühn Lüer Wojtek, as a new member of the company’s Supervisory Board. The background to this is that due to his activity on the Management Board, Mr. Gregor Siebert’s membership of the Supervisory Board was suspended and his term of office as a member of the Supervisory Board ended at the end of the Annual General Meeting. With Mr. Siebert’s departure from the Supervisory Board, a position on the Supervisory Board therefore became vacant. New Risk • Jun 17
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 6.6% per year for the foreseeable future. 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 expected to decline, then in most cases the share price will decline over time as well. 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 (12% average weekly change). Earnings are forecast to decline by an average of 6.6% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€3.4m net loss in 3 years). Market cap is less than US$100m (€59.1m market cap, or US$64.5m). Reported Earnings • Nov 18
Third quarter 2022 earnings released: €0.10 loss per share (vs €0.09 loss in 3Q 2021) Third quarter 2022 results: €0.10 loss per share (further deteriorated from €0.09 loss in 3Q 2021). Revenue: €371.0k (down 80% from 3Q 2021). Net loss: €6.99m (loss widened 14% from 3Q 2021). Over the last 3 years on average, earnings per share has fallen by 14% per year but the company’s share price has fallen by 21% per year, which means it is performing significantly worse than earnings. Announcement • May 26
Paion AG Announces Board Changes Paion AG announced that Michael Schlenk and Gregor Siebert were elected to the Supervisory Board, replacing Dr. Irina Antonijevic and Dr. Jörg Spiekerkötter. Mr. Schlenk will take over the chairmanship of the Supervisory Board from Dr. Spiekerkötter. Michael Schlenk has extensive experience in marketing, sales, finance and general management and has held senior positions in the pharmaceutical and life science industry for over 35 years. He started his international career at Sandoz/Novartis and then worked for Abbott, where he inter alia spent 15 years as Country and General Manager for Asia, Austria and Brazil. After that, Michael Schlenk held CEO positions for almost 20 years at the biotechnology companies ProBioGen, Centogene, Curasan and as co-founder of Arcensus in Germany. Gregor Siebert started his career in the pharmaceutical industry in 1985 with a strong focus on commercialisation and marketing in the hospital and injectables business. For more than 30 years he held sales and marketing management positions at Abbott, Hikma, Pfizer, GL-Pharma and Curasan. Major Estimate Revision • Apr 06
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from €36.1m to €33.8m. 2022 losses expected to reduce from -€0.23 to -€0.18 per share. Biotechs industry in Germany expected to see average net income growth of 20% next year. Consensus price target of €3.92 unchanged from last update. Share price fell 9.6% to €1.13 over the past week. Reported Earnings • Apr 02
Full year 2021 earnings: EPS exceeds analyst expectations while revenues lag behind Full year 2021 results: €0.31 loss per share (down from €0.034 profit in FY 2020). Revenue: €7.13m (down 64% from FY 2020). Net loss: €21.8m (down €24.0m from profit in FY 2020). Revenue missed analyst estimates by 12%. Earnings per share (EPS) exceeded analyst estimates by 3.3%. Over the next year, revenue is forecast to grow 406%, compared to a 129% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has fallen by 17% per year whereas the company’s share price has fallen by 20% per year. Announcement • Mar 31
Paion AG Announces CFO Changes Paion AG announced that Sebastian Werner has been appointed by the Supervisory Board as a new member of the Management Board in the position as Chief Financial Officer with effect from 1 June 2022. Sebastian Werner will succeed Abdelghani Omari, who, at his own request and by mutual agreement, will resign from his Management Board mandate, which expires on 31 December 2022 ahead of schedule on 31 August 2022, and will leave the Company's Management Board to pursue new management opportunities in the future. Announcement • Mar 30
Paion AG Provides Earnings Guidance for the Year 2022 Paion AG provided earnings guidance for the year 2022. The company expects revenues of approximately EUR 32 million to approximately EUR 35 million in 2022. Announcement • Jan 29
Paion AG Announces Board Changes PAION AG announced that the Supervisory Board and the Management Board of PAION AG have unanimously proposed the appointment of Michael Schlenk as member of the Supervisory Board to the district court of Aachen. Michael Schlenk is thus to succeed Dr. Dr. Irina Antonijevic, who is resigning her mandate in order to allow for the appointment of Mr. Schlenk as a candidate for the succession of the chairmanship of the Supervisory Board at an early stage. The long-standing Chairman of the Supervisory Board, Dr. J-rg Spiekerk-tter, will retire from the Supervisory Board at the next Annual General Meeting in May 2022 after 15 years with expiry of his mandate. Michael Schlenk has extensive experience in marketing, sales, finance and general management and has held senior positions in the pharmaceutical and life science industry for over 30 years. He started his international career at Sandoz/Novartis and then worked for Abbott, where he inter alia spent 15 years as Country and General Manager for Asia, Austria and Brazil. After that, Michael Schlenk held CEO positions for almost 16 years at the biotechnology companies ProBioGen, Centogene, Curasan and as co-founder of Arcensus in Germany. Since the early 2000s, being a business graduate and holding an MBA (UK), he has been active as a strategic management consultant, investing as a business angel in young IT and life science companies and, in some cases, actively participating in their development as CEO. Mr. Schlenk is a member of various supervisory boards. Reported Earnings • Nov 15
Third quarter 2021 earnings released: €0.09 loss per share (vs €0.18 profit in 3Q 2020) The company reported a poor third quarter result with weaker earnings, revenues and control over costs. Third quarter 2021 results: Revenue: €1.88m (down 88% from 3Q 2020). Net loss: €6.14m (down 152% from profit in 3Q 2020). Over the last 3 years on average, earnings per share has increased by 20% per year but the company’s share price has fallen by 10% per year, which means it is significantly lagging earnings. Announcement • Aug 25
Paion AG Provides Revenue Guidance for the Full Year of Fiscal 2021 Paion AG provided revenue guidance for the full year of fiscal 2021. For the year, the company expects revenues of about EUR 8 million to about EUR 9.5 million. Reported Earnings • Aug 25
Second quarter 2021 earnings released: €0.09 loss per share (vs €0.06 loss in 2Q 2020) The company reported a solid second quarter result with improved revenues and control over costs, although losses increased. Second quarter 2021 results: Revenue: €412.6k (up €392.8k from 2Q 2020). Net loss: €6.68m (loss widened 54% from 2Q 2020). Over the last 3 years on average, earnings per share has increased by 62% per year but the company’s share price has fallen by 9% per year, which means it is significantly lagging earnings. Price Target Changed • Jul 06
Price target decreased to €4.21 Down from €4.83, the current price target is an average from 4 analysts. New target price is 113% above last closing price of €1.97. Stock is down 31% over the past year. Announcement • Jun 30
PAION AG Receives UK MHRA Approval of BYFAVO (Remimazolam) for Procedural Sedation PAION AG announced that the UK Medicines & Healthcare products Regulatory Agency has approved Byfavo in adults for procedural sedation. Byfavo is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic. The decision follows the approval of the European Commission in the EU (including European Economic Area (EEA) countries) in March 2021. The MHRA approval for Byfavo(R) is based on data from a comprehensive U.S. Phase III clinical program in procedural sedation in patients undergoing bronchoscopy or colonoscopy. The safety and efficacy of Byfavo(R) was evaluated in three pivotal studies in 984 patients undergoing colonoscopy (two studies) or bronchoscopy (one study), of whom 639 received Byfavo(R) .
Remimazolam is also in development for general anesthesia. Based on the positive results in the European Phase III trial in this indication, PAION plans to submit an extension variation to the Marketing Authorization for remimazolam for general anesthesia by the end of 2021. The approval process for an extension variation is generally faster than for a Marketing Authorization Application (MAA). Major Estimate Revision • May 19
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 revenue forecast fell from €12.1m to €10.7m. EPS estimate increased from -€0.26 to -€0.25 per share. Biotechs industry in Germany expected to see average net income growth of 2.4% next year. Consensus price target down from €4.83 to €4.73. Share price was steady at €1.70 over the past week. Reported Earnings • Apr 02
Full year 2020 earnings released: EPS €0.03 (vs €0.11 loss in FY 2019) The company reported a strong full year result with improved earnings, revenues and profit margins. Full year 2020 results: Revenue: €19.7m (up 146% from FY 2019). Net income: €2.22m (up €9.24m from FY 2019). Profit margin: 11% (up from net loss in FY 2019). The move to profitability was driven by higher revenue. Over the last 3 years on average, earnings per share has increased by 52% per year but the company’s share price has fallen by 2% per year, which means it is significantly lagging earnings. Valuation Update With 7 Day Price Move • Mar 25
Investor sentiment deteriorated over the past week After last week's 18% share price decline to €1.92, the stock trades at a trailing P/E ratio of 56.8x. Average forward P/E is 24x in the Biotechs industry in Europe. Total loss to shareholders of 16% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €1.53 per share. Announcement • Mar 20
Paion AG to Report Fiscal Year 2020 Results on Mar 30, 2021 Paion AG announced that they will report fiscal year 2020 results on Mar 30, 2021 Announcement • Mar 06
PAION AG Enters into License Agreement with TTY Biopharm Company Limited PAION AG and TTY Biopharm Company Limited announced that they have entered into a license agreement for remimazolam with PAION granting TTY an exclusive license for the development and commercialization of PAION's lead drug candidate, remimazolam, in Taiwan. Under the terms of the agreement, TTY has the right and obligation to further develop remimazolam in all indications in Taiwan with PAION's support. TTY will bear all cost for market authorization and distribution. PAION will receive a EUR 1.1 million upfront payment and will supply drug product at a percentage of the net selling price in Taiwan with minimum supply price guarantees. Is New 90 Day High Low • Feb 24
New 90-day low: €2.34 The company is down 7.0% from its price of €2.51 on 25 November 2020. The German market is up 9.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 8.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €1.60 per share. Announcement • Jan 31
Paion AG Receives Positive Chmp Opinion Recommending Approval of Byfavo in Procedural Sedation Paion AG announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Byfavo(R) (remimazolam) in procedural sedation in adult patients. The European Commission will review the CHMP recommendation and a final decision on the Marketing Authorization Application (MAA) for Byfavo(R) in the EU (including European Economic Area (EEA) countries) is expected in the first half of 2021. The UK Medicines & Healthcare products Regulatory Agency (MHRA) will also consider the positive opinion for a potential approval in the United Kingdom. Announcement • Jan 13
La Jolla Pharmaceutical Company Announces Exclusive Licensing Agreement with Paion Ag for Giapreza (Angiotensin Ii) and Xerava (Eravacycline) in Europe La Jolla Pharmaceutical Company announced that it and certain of its wholly owned subsidiaries (collectively, La Jolla) have entered into an exclusive licensing agreement with PAION AG and its wholly owned subsidiary (PAION) for GIAPREZA™ (angiotensin II) and XERAVA™ (eravacycline) in the European Economic Area, the United Kingdom and Switzerland (the Territories). Under the terms of the exclusive licensing agreement, La Jolla will be entitled to receive: (i) an upfront cash payment of $22.5 million; (ii) potential commercial milestone payments of up to $109.5 million; and (iii) double-digit tiered royalty payments based on net sales of GIAPREZA and XERAVA. In exchange, La Jolla granted PAION an exclusive license to commercialize GIAPREZA and XERAVA in the Territories. GIAPREZA is approved by the European Commission as a vasoconstrictor indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. XERAVA is approved by the European Commission for the treatment of complicated intra-abdominal infections in adults. GIAPREZA (angiotensin II) for injection is approved by the U.S. Food and Drug Administration (FDA) as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. GIAPREZA is approved by the European Commission (EC) for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. GIAPREZA mimics the body’s endogenous angiotensin II peptide, which is central to the renin-angiotensin-aldosterone system, which in turn regulates blood pressure. XERAVA (eravacycline) for injection is a novel fluorocycline of the tetracycline class of antibacterials that is approved by the U.S. Food and Drug Administration (FDA) for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. XERAVA is approved by the European Commission (EC) for the treatment of cIAI in adults. Announcement • Dec 02
Paion AG Announces Juergen Beck to Leave the Management Board, Effective December 31, 2020 Paion AG announced that Dr. Juergen Beck will leave the Management Board of the company as planned at the end of his term of office on 31 December 2020. Is New 90 Day High Low • Nov 26
New 90-day high: €2.74 The company is up 4.0% from its price of €2.63 on 28 August 2020. The German market is up 2.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs 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 €1.71 per share. Announcement • Nov 20
PAION AG Reports Positive Remimazolam Topline Data in EU Phase III Trial in General Anesthesia PAION AG announced positive topline data from the pivotal remimazolam EU Phase III trial in general anesthesia. In the trial with 424 patients, remimazolam met both the primary and key secondary endpoints. The randomized, single-blind, propofol-controlled, confirmatory Phase III trial enrolled 424 ASA III/IV patients (American Society of Anesthesiologists classification III to IV) undergoing planned surgery at more than 20 European sites. The primary objective of the trial was to demonstrate non-inferiority of remimazolam compared to propofol for the induction and maintenance of general anesthesia during elective surgery. The primary efficacy endpoint was defined as the anesthetic effect of remimazolam and propofol assessed as a percentage of time of a Narcotrend (NCT) index below 60 (depth of anesthesia) during the maintenance phase of general anesthesia. In the final analysis, non-inferiority was demonstrated with an NCT index below 60 with 95.7% (n=235) of the time with remimazolam and 99.1% (n=92) with propofol at a significance level of p=0.0001. The key secondary objective was to show improved hemodynamic stability compared to propofol. Hemodynamic stability is measured by avoidance of intraoperative drop in mean arterial blood pressure (MAP) between start of anesthesia and 15 minutes after the first skin incision, as well as usage of vasopressors. Although adjustments in the statistical testing were required based on the nature of the obtained data, a statistically significant superior hemodynamic stability of remimazolam compared to propofol could be shown with a number of hemodynamic events per patient of 62.62 ± 39.46 (n=270) with remimazolam and 71.03 ± 41.12 (n=95) with propofol at a significance level of p=0.0151. Remimazolam is currently under regulatory review in the EU in procedural sedation. Assuming approval in procedural sedation, PAION plans to submit an extension of the marketing authorization for remimazolam for general anesthesia. A decision on market approval in procedural sedation is currently expected in the first half of 2021 with a CHMP opinion (Committee for Medicinal Products for Human Use) expected by the end of January 2021. Is New 90 Day High Low • Oct 29
New 90-day low: €2.09 The company is down 12% from its price of €2.38 on 30 July 2020. The German market is down 5.0% over the last 90 days, indicating the company underperformed over that time. However, it outperformed the Biotechs industry, which is down 15% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €3.87 per share. Announcement • Oct 08
PAION AG Reports Progress with BYFAVO(TM) (remimazolam) by its Licensee Acacia in the US PAION AG reported that Acacia Pharma (Acacia), remimazolam licensee for the U.S., announced that the U.S. Drug Enforcement Administration has designated the procedural sedative BYFAVO(TM) (remimazolam) as a Schedule IV medicine. This designation is the schedule for drugs with a low potential for abuse and low risk of dependence and is consistent with drugs like midazolam and diazepam (Valium(R)). On July 2, 2020, the U.S. Food and Drug Administration granted market approval for BYFAVO(TM) for the induction and maintenance of procedural sedation in adults undergoing procedures lasting up to 30 minutes. Scheduling by DEA represents the final requirement for BYFAVO(TM) to be marketed in the U.S., with launch expected by the end of 2020. Is New 90 Day High Low • Sep 22
New 90-day low: €2.32 The company is down 8.0% from its price of €2.53 on 24 June 2020. The German market is up 4.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 5.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Announcement • Aug 06
Paion AG to Report First Half, 2020 Results on Aug 12, 2020 Paion AG announced that they will report first half, 2020 results on Aug 12, 2020 
