According to an analysis conducted by BioWorld of the first quarter 2020 financial reports filed by the top 100 public biopharmaceutical companies ranked by market cap, and excluding big pharma companies, the amount that was invested in research and development (R&D) during the period increased by 13% compared to the same period last year.
The elevated investment is reflective of the cash resources available to companies. For example, in the first quarter, follow-on offerings generated approximately $8.5 billion compared to $6.9 billion raised in the same period last year.
The analysis found that the 100 biopharmaceutical companies collectively invested a total of $9.7 billion on R&D compared to $8.6 billion invested during Q1 2019.
The top 20 companies, ranked by total R&D spending, spent a combined $6.9 billion, or 69%, of the group’s total R&D expenses. (See Top 20 biopharmaceutical companies by R&D spending in 1Q 2020, below.)
Foster City-based Gilead Sciences Inc. took the top spot, with $1.1 billion in recorded R&D expenses, an increase of 4% over last year’s first-quarter spending. That was primarily due to its ramp up of work on remdesivir, an investigational antiviral for the treatment of COVID-19. The total included approximately $50 million of manufacturing scale-up and clinical trial costs, partially offset by lower clinical trial expenses as a result of the company’s pause or postponement of other clinical trials resulting from the pandemic.
At the beginning of the month, the FDA issued an emergency use authorization (EUA) for the antiviral. Remdesivir is authorized for the treatment of hospitalized patients with severe COVID-19 disease and, under the EUA, a 10-day dosing regimen of the drug is suggested for patients requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation. By contrast, a five-day dosing duration is suggested for patients not requiring either or both of those interventions.
The EUA is based on available data from two global trials, the National Institute for Allergy and Infectious Diseases’ placebo-controlled phase III study in patients with moderate to severe symptoms of COVID-19, including those who were critically ill, and Gilead’s phase III SIMPLE study, evaluating both the shorter and longer-duration treatment approaches.
Incyte Corp. was the other company to record more than $1 billion in R&D expenses in the quarter, up a whopping 301% compared to the same period in 2019. The jump was attributed to up-front payments of $805 million related to a collaborative agreement struck with Morphosys AG. The Wilmington, Del.-based company received a 50% interest in U.S. rights to the CD19-targeting antibody tafasitamab (MOR-208) and for 100% of the rights in all other territories. Planegg, Germany-based Morphosys could receive up to $1.1 billion in milestones and the deal also includes the provision for tiered royalties on sales.
The R&D expenses of Breda, the Netherlands-based Argenx SE increased by €60.1 million, or 174%, during the three months ended March 31, to reach €94.9 million (US$102 million), compared to €34.8 million (US$38 million) in 2019. That increase was mainly the result of increased external expenses reflecting higher clinical trial costs and manufacturing expenses related to the development of its product candidate portfolio, the company explained. That includes efgartigimod, for which the top-line data readout from its phase III ADAPT trial in generalized myasthenia gravis remains on track for mid-2020, with a biologics license application filing planned for the end of the year. All patients in the study have completed the primary 26-week trial and patients continue to be dosed in the ADAPT+ one-year, open-label extension study.
Beigene Ltd. also increased its spending in the period to $304 million, compared to $178 million in the same period of 2019. The increase in R&D expenses, the company reported, was primarily attributable to continued increases in spending on ongoing and newly initiated late-stage pivotal clinical trials and development expenses associated with its Amgen Inc. collaboration, in which it is commercializing the Thousand Oaks, Calif.-based company’s Xgeva (denosumab), Kyprolis (carfilzomib) and Blincyto (blinatumomab) in China.
The agreement also covers advancing 20 medicines from Amgen's oncology pipeline in China and globally. Beigene will share global R&D costs and contribute up to $1.25 billion to advance those medicines.
An increase in clinical trial costs elevated Exelixis Inc.’s R&D expenses for the quarter, with approximately $102 million invested, compared to $63 million for the comparable period in 2019. The company reported an expansion of its clinical trial program for cabozantinib, which includes COSMIC-312, COSMIC-313 and COSMIC-021. In January, the South San Francisco-based company said it was planning to further expand an existing metastatic castration-resistant prostate cancer cohort (cohort 6) of COSMIC-021, the phase Ib trial of cabozantinib in combination with atezolizumab in patients with locally advanced or metastatic solid tumors. Cohort 6, which was previously expanded from 30 to 80 patients in July 2019, will now include up to 130 patients.