PAION AG reports financial results for the First Half-Year 2023 – Biotech Investments

PAION AG reports financial results for the First Half-Year 2023

• Byfavo^® approval by European Commission for general anesthesia in April 2023, launch followed in August 2023
• Hana Pharm received approval for Byfavo^® in general anesthesia in the Philippines in July 2023
• TTY Biopharm filed in general anesthesia in Taiwan in March 2023
• Combined revenues of EUR 6.8 million.
• Cash and cash equivalents of EUR 4.6 million as of 30 June 2023
• EBIT in the amount of EUR -7.9 million.
• Full half-year financial report 2023 to be published by end of September 2023

Aachen (Germany), 30 August 2023 – The specialty pharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today reports its preliminary consolidated financial results according to International Financial Reporting Standards (IFRS) for the first half-year 2023.

Business performance in the first half of 2023 and highlights from the European product portfolio

PAION continued to expand its commercialization infrastructure for commercialization activities in selected target markets in the first half of 2023, including the necessary production, supply and distribution structures as well as the marketing and sales processes for the entire product portfolio.

Feedback on the usage of the products continues to indicate good market acceptance. Since the beginning of 2023, PAION has received positive feedback from customers about their experience with PAION’s products, which has increasingly been reflected in product sales in recent weeks.

After the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on 27 January 2023, recommending approval of Byfavo^® for the induction and maintenance of general anesthesia in adults, this was finally followed by approval by the European Commission on 03 April 2023.

In addition, the UK Medicines & Healthcare Products Regulatory Agency (MHRA) is currently reviewing a marketing authorization in the United Kingdom. A decision is expected in the near future.

Based on the approval of Byfavo^® for general anesthesia in adults by the European Commission, PAION had started commercialization in general anesthesia in Europe in August 2023 and is now available for ordering and delivery to customers in the Netherlands. PAION has thus reached another important milestone for the commercial distribution of its innovative products in Europe.

PAION has continued to commercialize GIAPREZA^® in 2023. It is currently commercially available in Germany, the Netherlands, Austria, UK, Denmark, Sweden, Norway and Finland. The commercialization of XERAVA^® was also intensified in 2023. It is currently commercially available in the Netherlands, Germany, Austria, UK, Denmark, Sweden and Finland.

The build-up of commercial sales with the involvement of experienced distribution partners has shown successive effects in 2023, accompanied by an increase in product sales. Since the beginning of 2023, PAION has received positive feedback from customers about their experience with PAION’s products, which has been increasingly reflected in product sales in recent weeks. Viatris and Medis are also preparing product launches and are subject to pricing and reimbursement approvals in most countries.

Progress of Byfavo^® activities in the license areas in the first half of 2023

Licensees generated product sales of EUR 4.4 million in the first six months of 2023 (H1 2022: EUR 2.7 million), resulting in royalties for PAION of EUR 0.5 million (H1 2022: EUR 0.3 million).

In the U.S., Eagle Pharmaceutical had announced in early May 2023 that the Centers for Medicare & Medicaid Services (“CMS”) has introduced a unique, product-specific billing code for Byfavo^®. The introduction of a unique so-called “J-code” (reimbursement code) for Byfavo^® in the U.S. on 1 July 2023 is an important step to facilitate reimbursement and expand patient access to Byfavo^®. On 8 August 2023, Eagle reported Q2 2023 numbers, reporting that Byfavo^® sales in Q1 2023 increased nearly 70% quarter-over-quarter and then doubled in the final quarter Q2 2023 compared to Q1 2023.

In Japan, Mundipharma had successfully completed clinical trials (Investigator Initiated Clinical Trials) in 2022 to evaluate the efficacy and safety of Byfavo^® (brand name Anerem^®) in Japanese patients undergoing gastrointestinal endoscopy. These studies are a prerequisite for the planned regulatory submission in  procedural sedation, which is scheduled for 2023.

In Taiwan, TTY Biopharm had submitted the marketing authorization application in general anesthesia in March 2023 and expects approval by the end of 2023.

Hana Pharm, licensee of Byfavo^® for South Korea and Southeast Asia had received approval from the Philippine FDA in July 2023 for Byfavo^TM 50mg for the induction and maintenance of general anesthesia. Hana Pharm plans to launch the product in the Philippines in the fourth quarter of this year.

Results of operations, financial position and net assets

Revenues in H1 2023 amounted to EUR 6.8 million, of which EUR 1.0 million related to milestone payments and EUR 4.7 million to remimazolam active ingredient sales to licensees (H1 2022: EUR 1.1 million), EUR 0.5 million to royalties (H1 2022: EUR 0.3 million) and EUR 0.6 million (H1 2022 EUR 0.1 million) to commercial product sales to wholesalers and hospitals in selected European markets. In the prior-year period, revenues amounted to EUR 25.2 million and resulted mainly from milestone payments.

Cost of sales amounted to EUR 3.6 million in the first half of 2023.

Research and development expenses in the first half of 2023 amounted to EUR 1.65 million (prior-year period: EUR 3.1 million) and were reduced as planned compared to the prior-year period due to strict cost control.

General, administrative and selling expenses decreased by EUR 0.9 million year-on-year to EUR 9.35 million in the first half of 2023, with general and administrative expenses increasing by EUR 0.5 million to EUR 3.0 million and selling expenses decreasing by EUR 1.4 million to EUR 6.3 million.

Earnings before interest and taxes in the first half of 2023 amounted to EUR -8.0 million and decreased by EUR 19.1 million compared to the same period of the previous year (earnings before interest and taxes in the same period of the previous year: EUR 11.1 million).

The financial result amounted to EUR -1.7 million in the first half of 2023 (prior-year period: EUR -1.0 million) and mainly comprises expenses in connection with the EIB loan from the previous year. The deterioration of the financial result mainly results from the revaluation of the performance-based interest component of the EIB loan.

Cash and cash equivalents decreased by EUR 6.0 million compared to December 31, 2022 to EUR 4.6 million at the end of the current reporting period.

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Selected Group financial figures in accordance with IFRS

Tilmann Bur was appointed as the new CEO with effect from 1 September 2023. The full half-year financial report 2023 with financial outlook will be available at https://www.paion.com/media-and-investors/investorcenter/financial-reports by the end of September 2023. This gives Mr. Bur the opportunity to help shape the outlook for the remainder of the fiscal year. On the day of publication of the half-year report, Mr. Tilmann Bur will introduce himself as the new CEO and explain the outlook for the remainder of the fiscal year in a public conference call.

About PAION

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

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 anesthesia and critical care by bringing novel products to market to benefit patients, doctors and other stakeholders in healthcare.

PAION is headquartered in Aachen (Germany).

Contact

Ralf Penner

Senior Vice President Investor Relations & Corporate Communications

PAION AG

Heussstrasse 25

52078 Aachen – Germany

Phone +49 241 4453-152

E-mail r.penner@paion.com

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 PAION AG’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.