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Paion AG (0NF3.L)

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2.3800+0.0200 (+0.85%)
At close: 3:16PM BST
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Previous close2.3600
Open2.3800
Bid0.0000 x 0
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Day's range2.3800 - 2.3800
52-week range2.3800 - 2.3800
Volume500
Avg. volumeN/A
Market cap151.259M
Beta (5Y monthly)0.67
PE ratio (TTM)N/A
EPS (TTM)-0.2090
Earnings dateN/A
Forward dividend & yieldN/A (N/A)
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1y target estN/A
  • EQS Group

    PAION REPORTS PROGRESS WITH BYFAVO (REMIMAZOLAM) BY ITS LICENSEE ACACIA IN THE U.S.

    DGAP-News: PAION AG / Key word(s): Miscellaneous06.10.2020 / 17:23 The issuer is solely responsible for the content of this announcement.PAION REPORTS PROGRESS WITH BYFAVO(TM) (REMIMAZOLAM) BY ITS LICENSEE ACACIA IN THE U.S.- Licensee Acacia clears final hurdle on path to commercial launch in the U.S.- BYFAVOTM designated as a Schedule IV medicine by Drug Enforcement Administration- BYFAVOTM expected to be commercially available in the U.S. before the end of 2020Aachen (Germany), 06 October 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) reports that Acacia Pharma (Acacia), remimazolam licensee for the U.S., today announced that the U.S. Drug Enforcement Administration (DEA) 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 2 July 2020, the U.S. Food and Drug Administration (FDA) 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.Dr. Jim Phillips, Chief Executive Officer of PAION AG, stated: "BYFAVOTM has now cleared the final hurdle on its path to commercial launch in the U.S. We are very pleased that our partner Acacia can now complete the final preparations of the launch in the U.S.""We are grateful to DEA for its timely determination of the scheduling of BYFAVOTM and are excited to bring this novel product to the U.S. market," commented Mike Bolinder, Acacia Pharma's CEO. "We will start the process of labeling and packaging our stock of commercial product immediately so that we can make BYFAVOTM available to patients as soon as possible. We anticipate the product being available for sale in the U.S. prior to the end of the year. Our first product, BARHEMSYS(R) (amisulpride injection) for postoperative nausea & vomiting, was launched in August and we are already registering product sales. We are delighted to be able to provide these two medicines to physicians and their patients in the United States."###About remimazolamRemimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic. In the human body, remimazolam is rapidly metabolized to an inactive metabolite by tissue esterases and is not metabolized by cytochrome-dependent hepatic pathways. Like other benzodiazepines, remimazolam can be reversed with flumazenil to rapidly terminate sedation or anesthesia if necessary. In clinical studies, remimazolam demonstrated efficacy and safety in around 2,900 volunteers and patients. Data so far indicate that remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile.In Japan, licensee Mundipharma received market approval in general anesthesia in January 2020. In the U.S., former licensee Cosmo Pharmaceuticals received market approval in procedural sedation in July 2020. In China, licensee Yichang Humanwell received market approval in procedural sedation in July 2020. In South Korea, licensee Hana Pharm filed for market approval in general anesthesia in December 2019. In Europe, PAION submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in procedural sedation in November 2019 and topline data of an EU Phase III trial in general anesthesia are expected in the second half of 2020.In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation is another possible indication for remimazolam.Remimazolam is partnered in the U.S. (brand name BYFAVOTM) with Acacia Pharma, in Japan (brand name Anerem(R)) with Mundipharma, in China (brand name Ruima(R)) with Yichang Humanwell, in Canada with Pharmascience, in Russia/CIS, Turkey and the MENA region with R-Pharm, and in South Korea and Southeast Asia with Hana Pharm. For all other markets including parts of the EU, remimazolam is available for licensing.About PAIONPAION AG is a publicly listed specialty pharmaceutical company focused on developing and commercializing innovative drugs for out-patient and hospital-based sedation, anesthesia and critical care services. PAION's lead compound is remimazolam, an intravenous, ultra-short-acting and controllable benzodiazepine sedative/anesthetic. Remimazolam is partnered in multiple territories outside of Europe. Remimazolam was approved in the U.S. and China for procedural sedation in July 2020 and in Japan for general anesthesia in January 2020. In South Korea, a market application for remimazolam in general anesthesia was filed in December 2019.In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation. PAION submitted a Marketing Authorization Application (MAA) for procedural sedation in November 2019. The topline data of a Phase III trial in general anesthesia are expected in the second half of 2020.PAION's mission is to be a leading specialty pharmaceutical company in the fields of anesthesia and critical care by bringing novel products to market to benefit patients, doctors & other stakeholders in healthcare.PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).ContactRalf PennerVice President Investor Relations/Public RelationsPAION AGMartinstrasse 10-1252062 Aachen - GermanyPhone +49 241 4453-152E-mail r.penner@paion.comwww.paion.comDisclaimer:This release contains certain forward-looking statements concerning the future business of PAION AG. These forward-looking statements contained herein are based on the current expectations, estimates and projections of PAION AG's management as of the date of this release. They are subject to a number of assumptions and involve known and unknown risks, uncertainties and other factors. Should actual conditions differ from the Company's assumptions, actual results and actions may differ materially from any future results and developments expressed or implied by such forward-looking statements. Considering the risks, uncertainties and other factors involved, recipients should not rely unreasonably upon these forward-looking statements. PAION AG has no obligation to periodically update any such forward-looking statements to reflect future events or developments.06.10.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.The issuer is solely responsible for the content of this announcement.The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.de Language: English Company: PAION AG Martinstr. 10-12 52062 Aachen Germany Phone: +49 (0)241-4453-0 Fax: +49 (0)241-4453-100 E-mail: info@paion.com Internet: www.paion.com ISIN: DE000A0B65S3 WKN: A0B65S Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange EQS News ID: 1139118   End of News DGAP News Service

  • EQS Group

    Original-Research: PAION AG (von First Berlin Equity Research GmbH)

    Original-Research: PAION AG - von First Berlin Equity Research GmbH Einstufung von First Berlin Equity Research GmbH zu PAION AG Unternehmen: PAION AG ISIN: DE000A0B65S3 Anlass der Studie: H1-Ergebnisse Empfehlung: Kaufen seit: 17.08.2020 Kursziel: €4,90 Kursziel auf Sicht von: 12 Monaten Letzte Ratingänderung: - Analyst: Simon Scholes, CFA First Berlin Equity Research hat ein Research Update zu PAION AG (ISIN: DE000A0B65S3) veröffentlicht. Analyst Simon Scholes bestätigt seine BUY-Empfehlung und bestätigt sein Kursziel von EUR 4,90. Zusammenfassung: Die Ergebnisse des ersten Halbjahres lagen nahe an unseren Erwartungen. Der Umsatz betrug €3,5 Mio. (FBe: €3,5 Mio.; H1/19: €7,5 Mio.), während das EBIT bei €-6,8 Mio. lag (FBe: -€6,6 Mio.; H1/19: €-0,6 Mio.). Im vergangenen Monat wurde Remimazolam in Japan zur Indikation Allgemeinanästhesie und in China zur Kurzsedierung eingeführt. Remimazolam wurde im Juli von der FDA für die Kurzsedierung zugelassen, und der US-amerikanische Marketingpartner Acacia erwartet, das Medikament im vierten Quartal auf den Markt zu bringen. Die EU-Zulassung von Remimazolam zur Kurzsedierung wird 2021 erwartet. Die Zulassung in der Allgemeinanästhesie sollte darauf folgen, sofern die später in diesem Jahr fälligen Daten der Phase-III-Studie positiv sind. Bis Ende dieses Jahres wird PAION auch entscheiden, ob Remimazolam für die Intensivstation entwickelt werden soll oder nicht und ob ein eigenes Vertriebsnetz in Europa aufgebaut werden soll oder nicht. In beiden Fällen erwarten wir positive Entscheidungen. PAION schätzt, dass der Remimazolam-Umsatz USD500 Mio. pro Jahr für jede der drei Indikationen Kurzsedierung, Allgemeinanästhesie und Sedierung auf der Intensivstation erreichen könnte. Die beiden Hauptprodukte in den oben genannten Indikationen sind Midazolam, das hauptsächlich bei bewusster Sedierung verwendet wird, und Propofol, das hauptsächlich bei tiefer Sedierung verwendet wird. Remimazolams Vorteil gegenüber Midazolam ist das kürzere An- und Abfluten der sedierenden Wirkung und gegenüber Propofol klinisch bedeutsame geringere kardiodepressive und respiratorische depressive Wirkungen. Wir behalten unsere Kaufempfehlung sowie unser Kursziel von €4,90 bei. First Berlin Equity Research has published a research update on PAION AG (ISIN: DE000A0B65S3). Analyst Simon Scholes reiterated his BUY rating and maintained his EUR 4.90 price target. Abstract: H1/20 results were close to our expectations. Revenue was €3.5m (FBe: €3.5m; H1/19: €7.5m) while EBIT came in at €-6.8m (FBe: €-6.6m; H1/19: €-0.6m). Over the past month remimazolam has been launched in Japan in the indication general anaesthesia and in China in procedural sedation. Remimazolam was approved by the FDA in procedural sedation in July and US marketing partner, Acacia, expects to launch the drug in Q4. EU approval of remimazolam in procedural sedation is expected in 2021. This should be followed by approval in general anaesthesia provided that phase III trial data due later this year are positive. By the end of this year PAION will also take decisions on whether or not to develop remimazolam for the ICU and whether or not to build up its own distribution network in Europe. We expect positive decisions in both cases. PAION estimates the peak sales opportunity for remimazolam at USD500m annually for each of the three indications procedural sedation, general anaesthesia and ICU sedation. The two main incumbent products in the above-mentioned indications are midazolam which is used mainly in conscious sedation, and propofol which is used mainly in deep sedation. Remimazolam's advantage over midazolam is shorter onset/offset times and over propofol clinically meaningful lower cardiodepressive and respiratory depressant effects. We maintain our Buy recommendation and price target of €4.90. Bezüglich der Pflichtangaben gem. §34b WpHG und des Haftungsausschlusses siehe http://firstberlin.com/imprint/ oder die vollständige Analyse. Die vollständige Analyse können Sie hier downloaden: http://www.more-ir.de/d/21357.pdf Kontakt für Rückfragen First Berlin Equity Research GmbH Herr Gaurav Tiwari Tel.: +49 (0)30 809 39 686 web: www.firstberlin.com E-Mail: g.tiwari@firstberlin.com -------------------übermittelt durch die EQS Group AG.------------------- Für den Inhalt der Mitteilung bzw. Research ist alleine der Herausgeber bzw. Ersteller der Studie verantwortlich. Diese Meldung ist keine Anlageberatung oder Aufforderung zum Abschluss bestimmter Börsengeschäfte.

  • EQS Group

    PAION AG REPORTS FINANCIAL RESULTS FOR THE FIRST HALF-YEAR 2020

    DGAP-News: PAION AG / Key word(s): Half Year Results 12.08.2020 / 07:30 The issuer is solely responsible for the content of this announcement. PAION AG REPORTS FINANCIAL RESULTS FOR THE FIRST HALF-YEAR 2020 \- Significant progress with remimazolam with marketing approvals in the important markets U.S., Japan and China\- Successful launch of Anerem(R) (remimazolam) by licensee Mundipharma in Japan\- Patient recruitment completed in EU Phase III trial\- Remimazolam license for Southeast Asia granted to Hana Pharm\- Approval of compassionate use for remimazolam in Belgium and in Italian hospital\- Cash and cash equivalents of EUR 12.4 million as of 30 June 2020\- Conference call today at 2:00 p.m. CEST (1:00 p.m. BST/8:00 a.m. EDT)Aachen (Germany), 12 August 2020 - The specialty pharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today reports its consolidated financial results according to International Financial Reporting Standards (IFRS) for the first half-year 2020.Dr. Jim Phillips, CEO of PAION AG, commented: "With the approval of remimazolam in three major markets - the U.S., Japan and China - in the first half of the year, we are at a pivotal time in PAION's history as our product is launched and begins to generate sales revenues, with royalties of up to 25% for PAION, depending on the market. In addition, we are making good progress with remimazolam in our home territory of Europe. Despite the coronavirus pandemic, we were able to complete patient recruitment for the European Phase III study in general anesthesia and are currently analyzing the data. If all goes as planned, we expect to submit an extension to the MAA that is under review for procedural sedation next year. We look forward to providing updates on our own progress and plans and those of our partners in the coming months." Update and outlook on remimazolam development and commercialization activities U.S. In the U.S., the FDA (U.S. Food & Drug Administration) granted market approval of BYFAVOTM (remimazolam) for procedural sedation in July 2020.In January 2020, Cosmo Pharmaceuticals (Cosmo) sublicensed BYFAVOTM U.S. rights to Acacia Pharma (Acacia). In July 2020, after market approval of BYFAVOTM, PAION, Cosmo and Acacia agreed to assign the BYFAVOTM license agreement signed in 2016 between Cosmo and PAION to Acacia. The terms of the license agreement remain unchanged but will now be between PAION and Acacia, with Cosmo no longer being a party to the agreement.Acacia plans to launch BYFAVOTM in the U.S. in the second half of 2020. As a prerequisite, BYFAVOTM will need to be classified by the Drug Enforcement Administration (DEA) under the so-called Controlled Substances Act. The drug classification schedule classifies drugs into groups based on risk of abuse. Midazolam, for example, is included in Schedule IV. Substances in this schedule have a lower potential for abuse relative to substances in Schedule III. PAION expects that remimazolam will receive the same classification as midazolam. EU In Europe, PAION is seeking approval for remimazolam in procedural sedation and in general anesthesia.Procedural sedation: PAION submitted a Marketing Authorization Application (MAA) for procedural sedation to the European Medicines Agency (EMA) in November 2019. A decision on market approval is currently expected in the beginning of 2021 at the earliest.General anesthesia: PAION is currently evaluating the data from a Phase III study in general anesthesia evaluating ASA III/IV (American Society of Anesthesiologists classification III to IV) patients. The randomized, single-blind, propofol-controlled, confirmatory Phase III trial was originally planned to enroll approximately 500 ASA III/IV patients undergoing planned surgery. Due to the coronavirus pandemic, patient recruitment was completed in April 2020 with 424 patients enrolled, as agreed to by the Data Monitoring Committee. The topline data are expected in the second half of 2020. Assuming approval in procedural sedation and positive results in the Phase III trial in general anesthesia, PAION plans to submit an extension of the MAA for remimazolam for general anesthesia as soon as the MAA for procedural sedation is approved. The review process for an extension application is generally faster than for an MAA.Commercialization plans: PAION continues to conduct pre-commercialization activities. The build-up of its own distribution structure in Europe is dependent on PAION's ability to add more products to its commercial portfolio. Thus, PAION is also considering out-licensing remimazolam for commercialization in Europe.Compassionate use: San Raffaele Hospital in Milan, Italy, one of the clinical sites for the Phase III trial for remimazolam in general anesthesia, had contacted PAION about providing remimazolam for the sedation of five intensive care unit (ICU) patients with COVID-19 due to a shortage of propofol and midazolam caused by the coronavirus pandemic. In June 2020, approval for compassionate use was granted by the local ethics committee for those patients, and PAION supplied the material free of charge. With currently significantly fewer COVID-19 patients on the ICU, an extension to additional patients is not planned for now.In August 2020, the Belgian Federal Agency for Medicines and Health Products (FAMHP) granted approval for the compassionate use of remimazolam in Belgium. Under the program, remimazolam can be used for sedation of intensive care unit patients with COVID-19, and as a substitute for current standard of care in general anesthesia for which there are currently shortages due to the coronavirus pandemic. The use is limited to physicians who have experience with remimazolam. PAION had been contacted by the Belgian regulatory authority as to whether remimazolam could be delivered nationwide because of the current shortages of propofol and midazolam due to the coronavirus pandemic. PAION will fulfill requests from hospitals as quickly and as much as possible and will deliver the material initially free of charge.Licensee activities in other territories In Japan, licensee Mundipharma received market approval for Anerem(R) (remimazolam) for general anesthesia in January 2020 and has successfully launched Anerem(R) in mid-2020 with first commercial product sales.In China, licensee Yichang Humanwell received market approval for Ruima(R) (remimazolam) in procedural sedation by the Chinese National Medical Products Administration (NMPA) in July 2020 and has recently launched Ruima(R). Also in July 2020, Yichang Humanwell started a Phase III trial with remimazolam in general anesthesia in China. The Phase III study is a multicentre, single-blind randomized comparative clinical trial of efficacy and safety of remimazolam versus propofol in induction and maintenance of general anesthesia in 516 elective surgery patients.In South Korea, licensee Hana Pharm submitted a market approval dossier in general anesthesia in December 2019. Market approval is currently expected in 2020. In January 2020, PAION and Hana Pharm extended their license agreement for remimazolam to include Southeast Asia (Indonesia, Malaysia, Philippines, Singapore, Thailand, Vietnam); Hana Pharm is responsible for development and the market approval process in these territories.In Russia, licensee R-Pharm announced the successful completion of a Phase III trial in general anesthesia in November 2018. R-Pharm is currently preparing first market approval dossiers for the licensed territories.In Canada, PAION expects its licensee Pharmascience to use the U.S. market approval dossier as the basis for filing for market approval for remimazolam.Supply chain activitiesPAION is building up the supply chain in order to be able to regularly provide remimazolam product to the licensees as well for PAION's potential own commercialization. Activities include establishing structures and processes and obtaining all necessary pharmaceutical permits.Results of operations, financial position and net assetsRevenues in the first half-year 2020 amounted to KEUR 3,520 (prior-year period: KEUR 7,500) and mainly resulted from milestone payments in connection with the market approval of remimazolam in Japan and the license extension for remimazolam signed with Hana Pharm in January 2020 to include six additional countries in Southeast Asia.Research and development expenses amounted to KEUR 6,399 in the first half-year 2020 (prior-year period: KEUR 6,173) and mainly relate to the EU Phase III trial in general anesthesia for which the data analysis is currently ongoing.General administrative and selling expenses increased by KEUR 1,289 to KEUR 3,610 in the first half-year 2020 compared to the prior-year period. General administrative expenses decreased by KEUR 105 to KEUR 1,685 while selling expenses increased by KEUR 1,394 to KEUR 1,925. The increase of selling expenses particularly relates to pre-commercial activities and the set-up of a supply chain for remimazolam.Income taxes amounted to KEUR 740 in the first half-year 2020 (prior-year period: KEUR 1,166) and relate to tax claims for reimbursement of parts of the research and development expenses from the British tax authorities. The decrease in comparison to the prior-year period despite slightly increased research and development expenses is mainly due to a cap of the claim based on the net result of PAION UK Ltd.The net loss for the first half-year 2020 amounted to KEUR 6,052 compared to a net income of KEUR 586 in the prior-year period. This corresponds to a decrease of the net result in the amount of KEUR 6,638 compared to the first half-year 2019 which is mainly attributable to lower revenues and higher selling expenses than in the prior-year period.Compared to 31 December 2019, cash and cash equivalents decreased by KEUR 6,373 to KEUR 12,414 at the end of the current reporting period.The decrease in equity of KEUR 2,999 compared to 31 December 2019 mainly results from the net loss of the first half-year 2020 on the one hand and the issue of a total of 1,530,327 new shares on the other hand, thereof 1,525,327 from the conversion of a part of the convertible notes issued in the prior year. As of 30 June 2020, the equity ratio was 56.3% (31 December 2019: 59.1%).Risks and opportunities Material risks and opportunities relating to future development are presented in detail in the group management report for the fiscal year 2019. The overall evaluation of opportunities and risks has not changed significantly in the first half-year 2020. Outlook 2020PAION's focus for the remainder of 2020 is on the analysis of the European Phase III study data in general anesthesia, market approval processes in Europe and other regions, the build-up of the supply chain and commercial manufacture of remimazolam, as well as the market preparation and launch of remimazolam in various territories.Financial outlook PAION expects revenues of about EUR 20 million in 2020, thereof EUR 15 million from Cosmo for market approval of remimazolam in the U.S. Further revenues relate to the market approvals of remimazolam in Japan and China, the license extension signed with Hana Pharm in January 2020 to include six additional countries in Southeast Asia as well as a milestone payment in connection with a possible market approval in South Korea. Royalties from the commercialization of remimazolam in the U.S., Japan and China are expected to be less than EUR 1 million in total in 2020.Research and development expenses are expected to amount to between approximately EUR 10 million and approximately EUR 12 million, depending on the progress of development. General administrative and selling expenses are expected to amount to between approximately EUR 7 million and approximately EUR 9 million depending on the progress of the build-up of the supply chain and the volume of pre-commercial activities. Income from tax credits on parts of the research and development expenses from British tax authorities is expected in an amount of approximately EUR 1 million to approximately EUR 1.5 million. The previously expected amount of up to approximately EUR 0.5 million was mainly based on a change in calculation and capping rules already enacted for which implementation was postponed by one year at short notice during the reporting period. Net result is expected to amount to between approximately EUR 0.5 million and approximately EUR 4 million in 2020.This outlook assumes that PAION and licensee activities progress as expected. In case of delays, in particular essential cost blocks and/or partly revenues would shift into 2021 or subsequent periods. Plans are also based on the current status of discussions with regulatory authorities. Additional unexpected requirements by regulatory authorities could lead to higher costs than planned and to delays in approvals and revenues based thereon. Also, potential effects of the coronavirus pandemic on PAION's business and the business of its partners could lead to delays and a shift of revenues and/or costs, although currently, no material effect of the pandemic on the results of operations, net assets and financial position of the PAION group is expected.Based on current planning, cash and cash equivalents at hand secure a liquidity runway at least into the second half of 2021.Additional funds could be required for a potential own commercialization of remimazolam in selected European markets, the execution of the multi-year pediatric development plan as well as for potential portfolio extensions. The total magnitude of potentially required funds will be dependent on PAION's decision on building up an own distribution and what an actual setup would look like, as well as on the magnitude and timing of incoming milestone and royalty payments from licensees. A final decision on building up an own distribution has not been made yet. The financing agreement of up to EUR 20 million concluded with the European Investment Bank (EIB) in 2019 and milestone and royalty payments expected in the next years could partially or completely cover a potential financing requirement depending on the decision on an own commercialization. The first tranche of EUR 5 million from the financing agreement with the EIB, which is already available, has not been drawn down yet. Availability of the further two tranches is dependent on certain conditions as e.g. the achievement of operational milestones. The loan can be drawn until mid-2021. A further utilization of the financing agreement on convertible notes with Yorkville in addition to the first tranche issued in September 2019 and entirely converted into new PAION shares until 8 July 2020 is not planned. The magnitude of royalties from licensees will depend on the success of commercialization in the U.S., Japan and the other territories and on remimazolam's price level and pace of market penetration. However, this can only be evaluated with sufficient certainty after the launch phase.Key Consolidated Financial Figures, IFRS(all figures in KEUR unless otherwise noted) Q2 2020 Q2 2019 H1 2020 H1 2019 Revenues 20 7,500 3,520 7,500 Research and development expenses -2,669 -3,110 -6,399 -6,173 General administrative and selling expenses -1,746 -1,336 -3,610 -2,321 Result for the period -4,341 3,827 -6,052 586 Earnings per share in EUR for the period (basic) -0.06 0.06 -0.09 0.01 Earnings per share in EUR for the period (diluted) -0.06 0.06 -0.09 0.01 H1 2020 H1 2019 Cash flow from operating activities -6,360 1,990 Cash flow from investing activities -2 -4 Cash flow from financing activities -22 -25 Change in cash and cash equivalents -6,373 1,965 Average number of employees in the Group 43 44 30 June 2020 31 Dec. 2019 Intangible assets 1,906 2,137 Cash and cash equivalents 12,414 18,787 Equity 11,733 14,732 Current liabilities 9,071 10,154 Balance sheet total 20,824 24,912 The full half-year financial report will be available as of 12 August 2020 on PAION's website at https://www.paion.com/medien-und-investoren/investorcenter/finanzberichte/.Conference call and webcast In addition to the publication of results, the Management Board of PAION AG will host a conference call (conducted in English) on 12 August 2020 at 2 p.m. CEST (1 p.m. BST, 8 a.m. EDT) to present the financial results of the first six months of 2020 and provide a pipeline and strategy update and financial outlook.To access the call, please dial:* Germany +49 (0) 30 3001 90612,* UK +44 (0) 20 3003 2666 and* U.S. +1 212 999 6659* Other countries: please use the UK numberWhen prompted, please provide the password "PAION". The conference call will be supplemented by a webcast presentation which can be accessed during the call at the following link: http://view-w.tv/819-1574-23002/en. About PAION PAION AG is a publicly listed specialty pharmaceutical company focused on developing and commercializing innovative drugs for out-patient and hospital-based sedation, anesthesia and critical care services. PAION's lead compound is remimazolam, an intravenous, ultra-short-acting and controllable benzodiazepine sedative/anesthetic. Remimazolam is partnered in multiple territories outside of Europe. Remimazolam was approved in the U.S. and China for procedural sedation in July 2020 and in Japan for general anesthesia in January 2020. In South Korea a market application for remimazolam in general anesthesia was filed in December 2019.In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation. PAION submitted a Marketing Authorization Application (MAA) for procedural sedation in November 2019. The topline data of a Phase III trial in general anesthesia are expected in the second half of 2020.PAION's mission is to be a leading specialty pharmaceutical company in the fields of anesthesia and critical care by bringing novel products to market to benefit patients, doctors & other stakeholders in healthcare.PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).Contact Ralf Penner Vice President Investor Relations/Public Relations PAION AG Martinstrasse 10-12, 52062 Aachen - Germany Phone +49 241 4453-152 E-mail r.penner@paion.com http://www.paion.comDisclaimer: This release contains certain forward-looking statements concerning the future business of PAION AG. These forward-looking statements contained herein are based on the current expectations, estimates and projections of PAION AG's management as of the date of this release. They are subject to a number of assumptions and involve known and unknown risks, uncertainties and other factors. Should actual conditions differ from the Company's assumptions, actual results and actions may differ materially from any future results and developments expressed or implied by such forward-looking statements. Considering the risks, uncertainties and other factors involved, recipients should not rely unreasonably upon these forward-looking statements. PAION AG has no obligation to periodically update any such forward-looking statements to reflect future events or developments. * * *12.08.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.de * * * Language: English Company: PAION AG Martinstr. 10-12 52062 Aachen Germany Phone: +49 (0)241-4453-0 Fax: +49 (0)241-4453-100 E-mail: info@paion.com Internet: www.paion.com ISIN: DE000A0B65S3 WKN: A0B65S Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange EQS News ID: 1115025 End of News DGAP News Service