Humasis, Growth 'No Problem' This Year Following Last Year

Self-Test Kits Obtain Sales Approval Domestically Following Europe
Sales Surge Last Year Thanks to COVID-19 Diagnostic Kits

The government has authorized the sale of self-test kits that allow individuals to collect their own specimens and check for COVID-19 infection. The Ministry of Food and Drug Safety conditionally approved the sale of COVID-19 self-test kits from Humasis and SD Biosensor. Both products have received emergency approval for self-testing overseas and are being used in Europe and other regions.

Seoul Metropolitan Government and Seoul Metropolitan Office of Education have decided to use self-test kits on a limited basis in call centers, logistics centers, dormitory schools with over 100 students, and schools with sports teams. As self-test kits began to be sold at pharmacies, expectations for improved performance of the respective companies have grown. With the steady increase in new COVID-19 cases, demand for self-test kits is expected to be considerable. However, demand may decrease after achieving herd immunity through COVID-19 vaccination. Health authorities anticipate achieving domestic herd immunity by November. Asia Economy examines the financial structure and management status of Humasis and Sugentech, which developed self-test kits, to gauge their future growth potential.

[Asia Economy Reporter Park Hyungsoo] Humasis, a developer of in vitro diagnostic devices, saw a sharp increase in sales after developing COVID-19 diagnostic kits. This year, it secured additional growth momentum by obtaining export approval and domestic sales authorization for self-test kits.

Humasis launched its COVID-19 self-test antigen diagnostic kit domestically after receiving conditional sales approval from the Ministry of Food and Drug Safety on the 16th of last month. It is sold online and through pharmacies.

A Humasis representative explained, “Currently, production is underway at the Anyang and Gunpo factories, which have obtained Good Manufacturing Practice (GMP) certification, with a maximum daily production capacity of about 1 million units. We supply both domestic and overseas markets.”

◆ Self-test kits approved in four European countries = Earlier, on the 22nd of last month, Humasis also obtained approval for export of its COVID-19 self-test antigen diagnostic kits. Starting with certification in the Czech Republic in February, it has already received conditional approval for personal use in Austria, Denmark, and Sweden, totaling four countries.

A Humasis representative said, “We recently completed clinical trials in the United States for self-diagnosis use of the COVID-19 diagnostic kit. We are currently registering the product in countries with demand for self-test kits such as the U.S. and Germany according to their procedures.”

Although COVID-19 vaccination is progressing worldwide, demand for self-test kits is expected to increase for the time being. The Danish Medicines Agency, which approved conditional sales for self-use of Humasis products, allows medical devices to be sold and used under administrative orders for in vitro diagnostic medical devices in certain situations. Danish health authorities require students at schools and other educational institutions to regularly test themselves using antigen tests to maintain infectious disease control and enable students to return to school.

The Statens Serum Institut (SSI), Denmark’s disease prevention and surveillance agency, stated in the approval letter sent to Humasis, “Humasis’s antigen diagnostic kit products have completed self-testing under supervision and are sufficient to control the epidemic and maintain the Danish education system.”

This year, self-test kits are likely to become an important product driving Humasis’s performance improvement. Additionally, sales of rapid antigen diagnostic kits are expected to contribute. Humasis recently obtained emergency use authorization from the U.S. Food and Drug Administration (FDA) last month for the COVID-19 rapid antigen diagnostic kit ‘DiaTrust,’ co-developed with Celltrion. DiaTrust is approved for professional use and will enter the U.S. market through exclusive supply by Humasis to Celltrion. Clinical trials conducted on early infected patients in the U.S. confirmed a sensitivity of 93.3% for detecting positive cases and a specificity of 99.1% for identifying virus-free individuals. Humasis’s rapid diagnostic kits also support serial testing, conducting COVID-19 tests twice a week at intervals of three days or 24 to 36 hours. Serial testing enables follow-up testing for early asymptomatic patients, allowing rapid on-site identification of infected individuals from the early stages of infection. Humasis has also confirmed detection effectiveness against over ten different variants of the virus.

◆ COVID-19 diagnostic kits elevate company scale = Humasis, which quickly launched COVID-19 self-test kits domestically and internationally, is an in vitro diagnostic device developer and manufacturer established in 2000. It merged with HiGene No. 2 Special Purpose Acquisition Company and was listed on the KOSDAQ market in 2017. By focusing research capabilities on point-of-care diagnostics, a branch of in vitro diagnostic testing, it succeeded in commercializing diagnostic reagents and quantitative analyzers in various formulations.

Humasis has secured core technologies in equipment, reagents, and raw materials for point-of-care diagnostics. It has released products that meet market demands in terms of user convenience, test accuracy, discovery of new biomarkers, rapid response systems for infectious diseases, and diversity of test items. Products for cardiovascular diseases, infectious diseases, and obstetrics and gynecology have been recognized for their technology and quality through overseas patent applications and certifications.

The diagnostic kits developed to determine COVID-19 infection status offer high sensitivity and rapid result confirmation. Humasis quickly supplies these through its existing sales network. Last year, Humasis recorded sales of 45.7 billion KRW, operating profit of 25.4 billion KRW, and net profit of 20.9 billion KRW. Sales increased 400% year-on-year, and operating and net profits turned positive.

Before launching COVID-19 diagnostic kits, Humasis’s sales hovered around 8 to 9 billion KRW, and it suffered losses over the past three years. The cost of sales ratio decreased from 61.9% in 2018 to 56.9% in 2019, but selling and administrative expenses increased, and operating income was further worsened by increased interest expenses and derivative instrument valuation losses.

Last year, large-scale profits reduced accumulated deficits, and the exercise of convertible bond conversion rights lowered the debt ratio from 114.5% at the end of 2019 to 10.7% last year.