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Eugene Pharma
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Develops solutions for the treatment of orthopedic cancer and unique cancers. The company reports on the results of the fourth quarter of 2021 as well as the results of the entire year, and the latest developments in the company.
There are three products in the company’s backlog. The first, designed to replace existing surgical treatment, has been commercially launched since June 2020 and shows impressive growth, with the company, according to analysts, estimating its market potential at $ 350 to $ 375 million.
Second The additional products, which are also designed to replace a surgical procedure, have a market potential of over $ 1 billion according to the company’s estimate, and are in various experimental stages.
According to the company’s announcement, it has received a financing transaction for a loan of up to $ 100 million that is expected to support the company’s operations until the cash flow balance in 2025.
The company also reports a first patient treated in the ENVISION trial, a Phase 3 clinical trial and testing the drug known as UGN-102 for the treatment of bladder cancer. The study will include about 220 patients at 90 sites, and is expected to complete patient recruitment by the end of 2022. The company believes the trial is highly likely to demonstrate a clear benefit to patients and will form the basis for applying for a new drug approval in 2024.
The company’s additional treatment – UGN-301 for bladder treatment has been in pre-clinical trials and has shown positive results in the toxicity test, and the company is progressing towards the first Phase 1 clinical trial in humans in the first half of 2022.
Financial results
Net revenue from the Jelmyto product in the fourth quarter ended December 31, 2021, amounted to approximately $ 16.2 million, a growth of 42% compared to the previous quarter. Net revenue from the product in all of 2021 amounted to approximately $ 48.0 million, compared to approximately $ 11.8 million in the corresponding period last year, following the launch of Jelmyto in June 2020.
Research and development expenses in the fourth quarter amounted to approximately $ 13.1 million, compared with approximately $ 12.4 million in the corresponding quarter in 2020. Research and development expenses in all of 2021 amounted to approximately $ 47.6 million. This is compared to about $ 47.3 million in the corresponding period in 2020.
Selling, administrative and general expenses in the fourth quarter amounted to approximately $ 21.4 million. This is compared to about $ 22.2 million in the corresponding period in 2020. Selling, administrative and general expenses in 2021 amounted to about $ 87.5 million. This is compared to expenses of about $ 90.2 million in 2020.
Prepaid Financial Commitment Financing: Eugene reported a $ 7.3 million financing obligation related to RTW Investments in the fourth quarter of 2021. Financing expenses for this commitment to RTW Investments totaled approximately $ 17.3 million in 2021. Rate The calculation in 2022 will be 13% based on Jelmyto’s net sales of approximately $ 48 million in 2021.
Net loss: Eurogen reported a net loss of approximately $ 28.5 million or a net loss per share diluted by approximately $ 1.27 in the fourth quarter of 2021, compared to approximately $ 30.5 million or a net loss per share diluted of approximately $ 1.38 in the corresponding period Of 2020. Eurogen reported a net loss of approximately $ 110.8 million or a net loss per share with a full dilution of approximately $ 4.96 in 2021, compared to approximately $ 128.5 million or a net loss of an ordinary, basic and diluted share of approximately $ 5.90 in 2020.
The Company’s cash balances, cash value and marketable securities as of December 31, 2021 amounted to approximately $ 89.8 million. This amount does not include the first tranche of the loan, which stands at $ 75 million.
forecast Revenue, operating expenses and expenses from the RTW transaction in 2022: The company expects net income from the Jelmyto product in 2022 to be in the range of approximately $ 70 million to approximately $ 80 million. The company expects operating expenses in 2022 to be in the range of about $ 140 million to about $ 160 million. In addition, the Company anticipates that its financing expenses in respect of the liability to RTW Investments will be in the range of approximately $ 22 million to approximately $ 26 million, of which approximately 9.1 to approximately 10.4 million will be in cash.
“I am proud of the progress we have made in 2021 for patients by expanding access to Jelmyto and laying the foundations for commercial and clinical milestones for the coming year,” said Liz Barrett, President and CEO of Eurogen. “Our vision is to completely change uro-oncology . We look forward to realizing this vision with our improved capital position, Jelmyto’s steady adoption of upper urinary tract cancer treatment, clinical advances in administering UGN-102 to patients in the pivotal ENVISION trial, Phase 3, conducted in a single arm and submitting an application for approval of a new experimental drug (INN). 301, our anti-CTLA4 antibody. ”