On October 29, 2024 PharmaMar Group reported total revenue of €126.5 million for the nine months ending September 30th, 2024, representing an 8% increase over revenue reported in the same period of the previous fiscal year (Press release, PharmaMar, OCT 29, 2024, View Source [SID1234647487]). Recurring revenue, which includes net sales plus royalties received from our partners, were €99.2 million, compared to €98.3 million as of September 30th, 2023.
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Oncology sales amounted to €57.0 million, compared to €59.1 million in the previous year. Total Zepzelca (lurbinectedin) sales during this period (€29.3 million) include commercial sales in Europe totalling €5.5 million, plus revenues under the compassionate use program, mainly in France, totalling €17.9 million, and sales of raw materials totalling €5.9 million. As of September 30th, 2023, total lurbinectedin revenues amounted to €32.8 million, due to the reversal of a provision for discounts that were not applied, amounting to €10.4 million. Without this accounting adjustment, lurbinectedin’s total sales in the first nine months of 2024 would have grown by approximately 30%.
Yondelis (trabectedin) sales increased in the period to €27.8 million with commercial sales in Europe of €15.7 million, along with sales of raw materials to our partners totalling €12.1 million. As of September 30th, 2023, total trabectedin sales amounted to €26.4 million. Higher sales of raw materials to our partners have offset the price impact of the entry of generics.
Meanwhile, as of September 30th, 2024, royalty revenue reached €42.2 million, representing a 10% increase compared to the same period in the previous fiscal year. This growth is driven by royalties received from our partner Jazz Pharmaceuticals for lurbinectedin sales in the U.S., which have increased by 8% to €38.4 million.
The royalties corresponding to the third quarter of 2024 are an estimate, as information on Jazz Pharmaceuticals’ sales is not available at the time of this financial report publication. Any discrepancies will be adjusted in the following quarter.
In addition to the royalties received from Jazz Pharmaceuticals up to September 30th, royalties from trabectedin sales by our partners in the U.S. and Japan totalled €3.5 million. This figure represents a 25% increase over the total royalties received in the same period of the previous year.
Regarding non-recurring income from licensing agreements, as of September 30, 2024, a total of €26.9 million was recorded, representing a 42% increase compared to the same period of the previous year. Of this total, €17.2 million corresponds to the deferred income from the 2019 agreement with Jazz Pharmaceuticals related to lurbinectedin, and €8,7 million corresponding to a payment received under the license agreement with Janssen regarding trabectedin.
R&D investment reached €76.0 million during the first nine months of 2024, an increase of 8% compared to the same period of the previous year.
Of the total R&D allocation as of September 30th, 2024, the oncology segment saw an 17% increase to €70.0 million. This increase is primarily due to progress in ongoing clinical trials, mainly the SaLuDo trial (Phase IIb/III clinical development for Leiomyosarcoma) and the LAGOON trial (Phase III clinical development for second-line treatment of Small Cell Lung Cancer). The latter trial is expected to complete recruitment by the end of 2024.
Additionally, the Company continues to invest in the clinical development of other molecules in earlier stages. In this regard, there are two ongoing Phase II clinical trials with ecubectedin in solid tumors, as well as Phase I trials with PM534 and PM54 for the treatment of solid tumors.
Thanks to increased revenue, as of September 30th, 2024, PharmaMar Group achieved an EBITDA of €6.2 million, representing a 14% growth compared to the same period of the previous year.
As a result, the Company’s net profit reached €7.4 million as of September 30th, 2024.
At the end of the quarter, PharmaMar Group reported cash and equivalents of €148.2 million and increased its debt position by €11.0 million due to a long-term bank loan of €15.0 million. Thus, following the completion in September of the share buyback program totalling €5.0 million and the dividend payment in June amounting to €11.4 million, the net cash position stands at €97.3 million.
Lastly, it is worth noting that on October 15th, 2024, PharmaMar and its partner Jazz Pharmaceuticals announced positive preliminary results from the Phase III IMforte trial, evaluating lurbinectedin in combination with atezolizumab (Tecentriq), compared to atezolizumab monotherapy as a first-line maintenance treatment for adults with Small Cell Lung Cancer. The combination of lurbinectedin and atezolizumab demonstrated a statistically significant and clinically meaningful improvement in the primary objectives of overall survival (OS) and progression-free survival (PFS) compared to atezolizumab monotherapy.
PharmaMar will submit a marketing authorization application (MAA) to the EMA in the first half of 2025 to seek approval in Europe.