On February 28, 2023 PharmaMar (MSE:PHM) reported today total revenues of €196 million in 2022, compared with €229 million in the previous year (Press release, PharmaMar, FEB 28, 2023, View Source [SID1234627872]). This difference is mainly due to the non-recurring revenues recorded in 2021 and, to a lesser extent, to the change in regulations in France governing the prices of drugs made available through the compassionate access authorization (L’autorisation d’accès compassionnel, AAC) system. Of the total revenues generated by the Company, 92% originated outside of Spain.
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Of the total revenues recorded in 2022, recurring revenues (sales plus royalties), total €156.0 million compared with €164.8 million recorded in 2021.
Of the total recurring revenues in 2022, royalty revenues and raw material sales to our partners grew. Regarding the former, royalties increased 23% during 2022 to €50.3 million driven by sales of Zepzelca (lurbinectedin) in the US through our partner, Jazz Pharmaceuticals, reaching €46.9 million[1] (€38.0 million in 2021). Raw material sales of both Yondelis (trabectedin) and Zepzelca increased by 11.6% to €21.4 million at year-end.
The 5% period-over-period difference in total recurring revenues is mainly due to the change in revenues from Zepzelca in Europe under the compassionate access program and, to a lesser extent, the decrease in revenues from Yondelis sales as a result of the entry of generic products in the market in the last quarter of the year.
Revenues under the compassionate access program totaled €15.5 million at December 31st, 2022, compared with €30.2 million in 2021. It should be noted that this amount includes the impact of the entering into force in France of the regulations governing the prices of compounds available under the compassionate access authorization (L’autorisation d’accès compassionnel, AAC) system, under which lurbinectedin is distributed in that territory, and which has led to the application of significant discounts from the beginning of 2022.
Net sales of Yondelis amounted to €63.8 million through December 31st, compared with €69.4 million in the previous year. Although gross sales of Yondelis in Europe increased by 2% in 2022, price pressure, as a result of the entry of generic products into the European market is responsible for the 8% difference in net sales.
The Group’s non-recurring revenues, which are those from licensing agreements, totaled €40.2 million at year-end 2022, compared to €64.8 million at December 2021. In 2022, this revenue mainly corresponds to the income of €10 million in relation to Yondelis for the fulfillment of a commercial milestone, under the licensing agreement signed with Janssen (Johnson & Johnson) in 2001, and to the recognition in income of amounts received in 2020 as a result of the lurbinectedin licensing agreement with Jazz Pharmaceuticals ($300 million), amounts that are being recognized in the income statement depending on the degree of progress of the contractual commitments.
At December 31st, 2022, PharmaMar Group’s R&D expenditure amounted to €83.4 million, up 16% with respect to the previous year. This increase is due to the progression in the development of the different research areas. Thus, the oncology area accounted for the largest investment, with a total of €68.1 million, 12% more than in 2021. In 2022, the Company has launched up to 4 Phase III trials in the different therapeutic areas, including the LAGOON trial, which is the registration trial with Zepzelca for the treatment of relapsed Small Cell Lung Cancer. A new marine-derived anti-tumor compound, PM534, entered the clinic in 2022.
In 2022, R&D investment in the area of interfering RNAi also increased to €13 million, compared to €9.5 million in the previous year, as a result of the two phases III trials underway for the treatment of Dry Eye. In addition, a Phase II for the treatment of macular degeneration, among other developments, was initiated in this business area.
At the end of 2022, the PharmaMar Group had generated €38.3 million in cash from operating activities and had reduced total debt to €39 million. As a result, at December 31st, 2022, the group’s cash and cash equivalents position stood at €231.8 million, compared with €212.6 million at the end of the previous year, and net cash amounted to €192.8 million, 15% higher than at the beginning of the year.
On September 27th, the Board of Directors of PharmaMar Group decided to cease the activity of the diagnostics area, which was carried out through its wholly-owned subsidiary Genomica, S.A.U. Consequently, it agreed to initiate the corresponding procedures for the dissolution and liquidation of Genomica, S.A.U.
The PharmaMar Group will close 2022 with a net profit of €49.3 million as a result.
The Board of Directors of PharmaMar Group will propose to the Shareholders’ Meeting that a dividend of €0.65 gross per Pharma Mar, S.A. share be paid to shareholders against 2022 earnings.