Madrid - PharmaMar (MSE:PHM) held its Ordinary Shareholders' General Meeting today, exclusively by webinar, at which it took stock of the 2020 financial year and also mentioned the most important milestones expected for the coming years.
In 2020, the PharmaMar Group obtained the best results in its history. In 2020, PharmaMar recorded total revenues of EUR270 million, up 215%, compared with EUR85.8 million in 2019.
At the operating level, PharmaMar Group EBITDA stood at EUR163 million at December 31st , 2020. The Group closed 2020 with a total cash and cash equivalents position of EUR216 million and a grossl debt of EUR53 million.
The important milestones achieved by the Company in recent years have been reflected in the stock pricet. Thus, in addition to the 227% revaluation recorded in the financial year 2019, there is another significant revaluation of 65% in the financial year 2020. This increase in the Company's value and the increase in the average daily trading volume, among other decision factors, led the Ibex Technical Advisory Committee to decide to include PharmaMar in the Ibex-35 index in September 2020.
Among the items on the agenda approved at the meeting was the resolution to distribute an ordinary dividend payment of EUR0.60 gross for each of the Company's shares. This dividend will be paid on April 30th, 2021.
Oncology Business Unit
In January 2020, PharmaMar collected the US$200 million (EUR181 million) upfront payment under the agreement with Jazz Pharmaceuticals. Subsequently, in June 2020, the FDA granted accelerated approval for the marketing of lurbinectedin in the US, which led PharmaMar to collect a regulatory milestone from Jazz Pharmaceuticals to the amount of US$100 million (EUR88 million).
PharmaMar Group's royalty revenues increased by 405% in 2020, to EUR15.7 million. This increase was mainly due to royalties from the sales of Zepzelca (lurbinectedin) in the US.
In 2020, new research with lurbinectedin in different combinations with immunotherapy was initiated. Two new Phase I-II trials using lurbinectedin in combination with atezolizumab, and lurbinectedin in combination with pembrolizumab were launched. Both are aimed at determining the recommended dose and efficacy of these combinations
In early 2021, the results of the Phase I trial using the combination of lurbinectedin with irinotecan were shown in an oral presentation at the IASLC 2020 World Conference on Lung Cancer,. This combination proved to be effective in patients with small-cell lung cancer, after relapse in first-line, with remarkable activity in patients with resistant disease and in 3rd line of treatment.
PharmaMar also plans to commence two new Phase III trials with lurbinectedin this year, one for the treatment of small-cell lung cancer in monotherapy, which will be used both to seek approval in Europe and as a confirmatory trial in the US. The second trial would be for the treatment of relapsed mesothelioma.
In addition, the Company plans to commence one or two Phase II trials with its PM14 compound, which is currently in Phase I, this year. PharmaMar also plans to include one or two new Phase I molecules in the oncology pipeline in 2021.
Virology Business Unit
The year 2020 was marked by the coronavirus pandemic, which had a major impact on society and the economy. In early 2020, as a result of PharmaMar's commitment to providing novel treatment options for COVID-19, the new Virology Unit was created to research, develop and provide drugs for viral diseases for which there are still no effective treatments.
The unit's current priority is to find an effective treatment for COVID-19. In this regard, the Company is at the clinical development phase with its molecule plitidepsin as a treatment fort COVID-19.
Plitidepsin has already shown efficacy against SARS-CoV-2 and other types of coronavirus in various preclinical studies.
PharmaMar's molecule has also been investigated in in vitro trials at several worldleading research centers, including the CSIC's National Biotechnology Center (CNBCSIC), led by Dr. Luis Enjuanes; the Emerging Pathogens Institute at Mount Sinai Hospital in New York, with Dr. Adolfo Garcia Sastre; the Germans Trias i Pujol Barcelona Hospital, led by Dr. Bonaventura Clotet; and the Institut Pasteur in Korea.
In October 2020, positive results were presented from the APLICOV-PC trial with plitidepsin for the treatment of patients with COVID-19, in which the primary safety and efficacy targets were met.
The journal Science published in January 2021 a research article entitled 'Plitidepsin has potent preclinical efficacy against SARS-CoV-2 by targeting the host protein eEF1A '. The article states that 'the antiviral activity of plitidepsin against SARS-CoV-2 is mediated through inhibition of the known target eEF1A' and notes that in vitro plitidepsin showed strong anti-viral potency, compared to other antivirals against SARS-CoV-2.
In February 2021, the British Medicines and Healthcare products Regulatory Agency (MHRA) authorized the start of the Phase III NEPTUNO trial, which is primarily aimed at determining the efficacy of plitidepsin for the treatment of hospitalized patients with moderate COVID-19 infection. It is also expected that this trial will soon be approved for initiation in other European countries.
The Phase III NEPTUNO trial is expected to enroll more than 600 patients, in different European centers and around the world.
Sylentis
PharmaMar Group's Company dedicated to researching therapeutic applications of gene silencing (RNAi) has received FDA approval to initiate a Phase III study to evaluate the efficacy and safety of tivanisiran on the signs and symptoms of patients with dry eye disease associated with Sjogren's Syndrome. This study will involve 200 patients in more than 30 hospitals in the United States.
In addition, the first Phase I study has been initiated with the investigational compound SYL1801 for the treatment and/or prevention of choroidal neovascularization, a common cause of retinal diseases such as age-related macular degeneration (AMD) or diabetic retinopathy. The study will involve 36 healthy volunteers and is being conducted at the Ramon y Cajal University Hospital in Madrid. The study will evaluate the safety of SYL1801 at different doses and the pharmacokinetic profile of the product.
GENOMICA
In March 2020 with the onset of the pandemic, GENOMICA developed a diagnostic test for SARS-CoV-2, with a sensitivity and specificity of 100% and validated at the Instituto de Salud Carlos III. With this test, GENOMICA was the first Spanish biotechnology company to obtain the CE mark of conformity for its COVID-19 (SARSCoV2) coronavirus diagnostic kits. The CE mark certifies that GENOMICA complies with the essential requirements described in Directive 98/79/EC on in vitro diagnostic medical devices.
In addition, GENOMICA's qCOVID-19 diagnostic kit was the test recommended by the Instituto de Salud Carlos III for PCR testing in nursing homes in the Community of Madrid.
GENOMICA was one of the companies awarded the Framework Agreement of the Ministry of Health that the National Institute of Health Management (INGESA) tendered for the supply of up to 7.5 million COVID-19 molecular diagnostic tests, which were supplied at the request of the participating hospitals and/or diagnostic laboratories.
Continuing with the development of its diagnostic kits, in November 2020, GENOMICA launched the PCR test, qCOVID-19 Respiratory COMBO, which allows differentiation of the SARS-CoV-2 virus, causing the current COVID-19 pandemic, from other viruses, which is clinically important due to the similarity of symptoms caused by such common respiratory diseases: influenza A, influenza B, as well as infections caused by respiratory syncytial virus.
In 2021, GENOMICA announced a new update of its qCOVID-19 Respiratory COMBO kit for the use of direct saliva samples. This kit is capable of detecting SARS-CoV-2 from saliva samples, which simplifies the sample collection process and reduces contact with healthcare personnel, reducing their exposure and potential risks of contagion during the collection process. Once in the laboratory, the direct use of saliva for PCR eliminates the need to perform the extraction step, a bottleneck in many laboratories.
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About PharmaMar
PharmaMar is a biopharmaceutical company focused on the research and development of new oncology treatments, whose mission is to improve the healthcare outcomes of patients afflicted by serious diseases with our innovative medicines. The Company is inspired by the sea, driven by science, and motivated by patients with serious diseases to improve their lives by delivering novel medicines to them. PharmaMar intends to continue to be the world leader in marine medicinal discovery, development and innovation. PharmaMar has developed and now commercializes Yondelis in Europe by itself, as well as Zepzelca (lurbinectedin), in the US; and Aplidin (plitidepsin), in Australia, with different partners. In addition, it has a pipeline of drug candidates and a robust R&D oncology program. PharmaMar has other clinical-stage programs under development for several types of solid cancers: lurbinectedin, PM184 and PM14. Headquartered in Madrid (Spain), PharmaMar has subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar also wholly owns other companies: GENOMICA, a molecular diagnostics company; and Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com.
About Yondelis
Yondelis (trabectedin) is a novel, synthetically produced antitumor agent originally isolated from Ecteinascidia turbinata, a type of sea squirt. Yondelis exerts its anticancer effects primarily by inhibiting active transcription, a type of gene expression on which proliferating cancer cells are particularly dependent.
About lurbinectedin
Lurbinectedin (Zepzelca), also known as PM1183, is an analog of the marine compound ET-736 isolated from the sea squirt Ecteinacidia turbinata in which a hydrogen atom has been replaced by a methoxy group. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent. Together with its effect on cancer cells, lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor. Transcriptional addiction is an acknowledged target in those diseases, many of them lacking other actionable targets.
Contact:
Media
Alfonso Ortin
Communications Director
E: aortin@pharmamar.com
Mobile: +34 609493127
Miguel Martinez
Cava
Communication Manager
mmartinez-cava@pharmamar.com
Mobile: +34 606597464
Phone: +34 918466000
Jose Luis Moreno-
Capital Markets & Investor Relations Director
Maria Marin de la Plaza
Capital Markets & Investor Relations
investorrelations@pharmamar.com
Phone: +34 914444500
PHARMA MAR, S.A. 
