DGAP-News: PAION AG reports financial results for the first half-year 2022

PAION AG reports financial results for the first half-year 2022

• Transformation into commercial specialty pharma company continues
• Financial position strengthened to support commercial activities in Europe by sale of Chinese remimazolam patents and future royalties to Humanwell for EUR 20.5 million
• Expansion of partner networks through licensing and cooperation agreements for Latin America and Eastern Europe
• Cash and cash equivalents of EUR 17.7 million as of 30 June 2022
• Conference call today at 2:00 p.m. CEST (1:00 p.m. BST/8:00 a.m. EDT)

Aachen (Germany), 31 August 2022 – 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 2022.

Business performance in the first half of 2022 and highlights from the European product portfolio

PAION has already launched remimazolam (Byfavo^®) in UK, Denmark and Netherlands. Remimazolam is planned to be launched for procedural sedation in most key European markets by the end of 2022/beginning of 2023. In Germany, remimazolam will not be available until the first quarter of 2023 at the earliest, once the marketing authorization extension for general anaesthesia has been granted, which is expected in the first quarter of 2023.

In April 2022, PAION was informed that the Federal Joint Committee (G-BA) voted in favor of PAION’s application for eravacycline (XERAVA^®) as a reserve antibiotic. This means that eravacycline is considered to provide added benefit to standard of care. PAION is now exempt from providing a full benefit dossier and is only required to provide an abbreviated dossier by 1st August 2022. Eravacycline subsequently has been launched and is now commercially available in Germany for order and delivery to customers through direct sales.

The sale of angiotensin II (GIAPREZA^®) was expanded from Germany to the Netherlands and Austria in early 2022.

Based on the positive results from the EU Phase III trial in general anaesthesia, PAION submitted an extension application to the marketing authorization for remimazolam for general anaesthesia to the European Medicines Agency (EMA) in December 2021. A decision by the EMA is expected in the first quarter of 2023. This application also will be submitted to the MHRA (Medicines and Healthcare products Regulatory Agency) via the ECDRP (European Commission Decision Reliance Procedure) to obtain approval in the UK.

Expansion of remimazolam activities in licensed territories in the first half of 2022

Licensees generated remimazolam revenues totalling EUR 2.7 million (without China Sales) in the first half of 2022, amounting to royalties for PAION of EUR 0.3 million.

In China, PAION entered into a patent assignment agreement with Humanwell at the beginning of 2022. Under the agreement, PAION assigned all its Chinese remimazolam patents and related future royalties on sales in China under the license agreement with Yichang Humanwell to Humanwell for EUR 20.5 million. EUR 16 million were received in the first quarter of 2022, and the remaining EUR 4.5 million have been paid in June 2022. Yichang Humanwell was released from any future royalty payments to PAION, and the license has been terminated.

In the U.S., remimazolam (BYFAVO^TM) has been marketed by Acacia for procedural sedation since the beginning of 2021. Recently, Eagle Pharmaceutical, a well-established US specialty pharma company has acquired Acacia. The license agreement for remimazolam remains unchanged and will be transferred to Eagle Pharmaceutical. Eagle Pharmaceutical is a publicly traded U.S. specialty pharmaceutical company with revenues of over USD 170 million in critical care, oncology and rare diseases. PAION expects, that this transaction will have a positive impact on the sales development of remimazolam in the U.S.

In April 2022, PAION and Cristália signed an exclusive license agreement for the development and commercialization of remimazolam in Latin America. Cristália intends to commercialize remimazolam in procedural sedation and general anaesthesia and expects to obtain marketing authorization for both indications in Brazil in 2024.

In February 2022, PAION entered into an exclusive cooperation agreement with Medis, d.o.o. for the supply, distribution, marketing and sale of remimazolam, angiotensin II and eravacycline in Eastern Europe (Estonia, Latvia, Lithuania, Czech Republic, Slovakia, Hungary, Croatia, Slovenia and Bulgaria).

Dr. Jim Phillips, CEO of PAION AG, commented: "The first half of 2022 has brought further progress in our transformation into a specialty pharma company. Following the successfully concluded agreement with Humanwell on the sale of the remimazolam patents in China, we are placing a focus on further expanding our commercial organization in Europe. In the first months of the current fiscal year 2022, we succeeded in launching our three products in additional European countries. Given the unmet and growing medical need in anaesthesia and critical care there, we see attractive growth opportunities there."

Results of operations, financial position and net assets

Revenues in the first half-year 2022 amounted to EUR 25.2 million of which EUR 24.2 million resulted from milestone payments and EUR 1.0 million from remimazolam API sales to licensees (EUR 0.6 million), royalties (EUR 0.4 million) and commercial product sales (KEUR 84). In the prior-year period, revenues amounted to EUR 3.6 million and mainly resulted from milestone payments.

Cost of sales amounted to EUR 0.6 million in the first half-year 2022.

Research and development expenses in the first half-year 2022 amounted to EUR 3 million (prior-year period: EUR 2.9 million). The increase was mainly due to pediatric development and the processing of so-called "post-approval commitments" and "life cycle management" for remimazolam.

General administrative and selling expenses increased by EUR 1.6 million to EUR 10.3 million in the first half-year 2022 compared to the prior-year period. General administrative expenses increased by EUR 0.03 million to EUR 2.6 million. Selling expenses increased as planned by EUR 1.5 million to EUR 7.7 million, mainly due to commercialization activities for the three products remimazolam, angiotensin II and eravacycline in Europe.

Earnings before interest and tax amounted to EUR 11.1 million in the first half-year 2022 and increased by EUR 19.7 million compared to the prior-year period (earnings before interest and tax in the prior-year period: EUR -8.6 million).

The financial result amounted to EUR -1 million in the first half of 2022 (prior-year period: EUR -2.2 million). The improvement in the financial result is mainly due to the revaluation of the performance-related interest component of the EIB loan.

Income taxes amounted to EUR - 0.5 million in the first half-year 2022 (prior-year period: EUR 0.4 million) and mainly relate to corporate tax liability to the British tax authorities due to the significant increase in milestone payments. In the prior-year period it was mainly tax claims for reimbursement of parts of the research and development expenses from the British tax authorities.

The net result for the first half-year 2022 amounted to EUR 9.6 million compared to a net result of EUR -10.4 million in the prior-year period. This corresponds to an increase of the net result in the amount of EUR 20.1 million compared to the first half-year 2021. The increase in profit for the period is due to increased milestone payments.

Compared to 31 December 2021, cash and cash equivalents increased by EUR 11.3 million to EUR 17.7 million at the end of the current reporting period.

Equity amounted to EUR 16.8 million as of 30 June 2022 (31 December 2021: EUR 6.9 million). As of 30 June 2022, the equity ratio was 36.9% (31 December 2021: 19.0%).

Outlook 2022

PAION confirms the outlook for the full year 2022 announced with the Annual Report 2021. In the further course of the year, PAION will continue to focus on the commercialization of remimazolam, angiotensin II and eravacycline and the further build-up of a sales infrastructure in selected European countries necessary for this purpose. Commercialization is expected to start in these countries by the end of 2022/early 2023. In addition, PAION expects the EMA's decision on the extension application of the marketing authorization for remimazolam for general anaesthesia in the first quarter of 2023.

###

Key Consolidated Financial Figures, IFRS

The full half-year financial report will be available as of 31 August 2022 on PAION’s website at https://www.paion.com/medien-investoren/investorcenter/finanzberichte/.

About PAION

PAION AG is a publicly listed specialty pharmaceutical company with innovative drugs to be used in hospital-based sedation, anaesthesia and critical care services. PAION’s lead compound is remimazolam, an intravenous, ultra-short-acting and controllable benzodiazepine sedative/anesthetic. PAION is rolling out remimazolam (Byfavo^®) in selected European markets. Remimazolam is partnered in multiple territories outside of Europe. Remimazolam is approved in the U.S., the EU/EEA/UK, China and South Korea for procedural sedation and in Japan and South Korea for general anaesthesia.

In addition, PAION markets two intensive care products in selected European countries: Angiotensin II (GIAPREZA^®), a vasoconstrictor indicated for the treatment of refractory hypotension in adults with septic or other distributive shock, and eravacycline (XERAVA^®), a novel fluorocycline type of antibiotic indicated for the treatment of complicated intra-abdominal infections in adults.

PAION’s mission is to be a leading specialty pharmaceutical company in the fields of anaesthesia and critical care by bringing novel products to market to benefit patients, doctors and other stakeholders in healthcare.

PAION is headquartered in Aachen (Germany).

PAION contact:

Investor Relations
cometis AG
Thorben Burbach
Tel.: +49 (0) 611 205855 23
E-Mail: [email protected]
www.paion.com

Disclaimer:

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.