ViroGates announces its Interim Report for Q1-Q3, 2023: Revenue for the first nine months (Q1-Q3, 2023) was affected by a rough start to the year, despite Q3 itself represented Year-on-Year growth of 40%

COMPANY ANNOUNCEMENT - No. 16-2023 - Inside information - 09 November 2023

BIRKERØD, DENMARK – ViroGates A/S announces its Interim Report for the period 1 January 2023 – 30 September 2023, as approved today by the company’s Board of Directors.  

In Q1-Q3, 2023, ViroGates’ revenue totaled TDKK 4,780, representing a decline of 39% compared to the same period in 2022 (TDKK 7,882). The third quarter itself represented a Year-on-Year growth of 40% (from 1,587 in Q3, 2022 to TDKK 2,228 in Q3, 2023). Despite this growth and the upward trend in revenue, ViroGates continues to operate in an uncertain environment, where the conversion of the previous COVID-19 customers is still challenging, and many customer activities need to be restarted.

ViroGates reports 16 recurring customers by the end of Q3, 2023 (as of 30 September 2023), representing a slight increase since the end of H1, 2023. Of the 16 customers, 9 are using suPARnostic® in clinical routine, and 7 are using suPARnostic® for research purposes. As introduced in the H1, 2023 report (cf. company announcement no. 14 from 17 August 2023), ViroGates report recurring customers as customers within both clinical routine and research, who have 1) placed at least two purchasing orders during the last 12 months with 2) an accumulated value of the two (or more) purchasing orders above EUR 10.000.

In addition, in Q3, 2023, ViroGates announced positive results from a randomized controlled clinical trial on suPAR-guided antibiotic treatment in sepsis (SUPERIOR study), presented by the Hellenic Sepsis Group at the annual European Shock Conference. These results are important to ViroGates, as they underline the value added by using suPARnostic® in guiding the early treatment of sepsis patients and present a new application to promote within the acute care segment. Furthermore, in Q3, 2023, ViroGates continued efforts to approach the health clinics and longevity segment and booked the first sales of the new finger-prick product, the suPARnostic® POC+, for patient triaging in acute care.

Despite the above, ViroGates adjusts full-year financial guidance for 2023 to 5.5 to 7 DKKm in revenue (previously 8 to 11 DKKm) and -12 to -14 DKKm in EBIT (previously -10 to -13 DKKm). The revised guidance is based on a Q4 with a high degree of uncertainty. This relates to the success rate of the conversion of previous COVID-19 customers, end-of-year sales to research customers, and emerging sales to the newly targeted longevity segment.

Accordingly, ViroGates can no longer reach cash flow positiveness in 2025 with existing cash at hand. To this end, management and the Board of Directors will promptly propose a plan on how to ensure sufficient runway going forward.

Financial results in Q1-Q3, 2023

The financial results in Q1-Q3, 2023 are reported below (Q1-Q3, 2022 results in brackets):

• Revenue decreased by 39% to TDKK 4,780 (TDKK 7,882)
• Operating expenses decreased by 16% to TDKK -14,157 (TDKK -16,846)
• Operating loss increased by 5% to -9,377 (TDKK -8,964)
• Net loss increased by 12% to TDKK -8,781 (TDKK -7,865)
• Cash and cash equivalents at the end of the period amounted to TDKK 6,420 (TDKK 11,173)

Business highlights in Q1-Q3, 2023

The business highlights of Q1-Q3, 2023 included:

• Announcement of the appointment of Josephine Baum Jørgensen as the new Chief Financial Officer
• Announcement of the development and CE-IVD accreditation of suPARnostic® TurbiLatex on the Roche Diagnostics PURE and PRO platforms
• Commercial launch of the finger-prick blood-testing product, suPARnostic® POC+, and booking of the first sales to commercial partners
• Revision of the guidance for 2023 and cash flow expectations based on the preliminary results of Q1, 2023 and amended policy on disclosing routine customers to make it a better reflection of recurring revenue
• Announcement of an agreement with Sobi for the development of suPARnostic® for commercial use in the US in combination with Sobi’s Kineret® treatment for COVID-19-related pneumonia
• Grant of warrants to Denmark's Export and Investment Fund (EIFO) as part of the finalization of the debt financing agreement and receipt of the first tranche
• Announcement of positive results from a randomized controlled clinical trial on suPAR-guided antibiotic treatment in sepsis (SUPERIOR study), presented at the European Shock Conference in Vienna, Austria

Jakob Knudsen, CEO of ViroGates, says: “The start to Q3 was rough, as it built upon two previous quarters with customer activity much lower than expected going into the year. Although Q3 performance represents the continuation of an upward revenue trend for the year, we are still experiencing challenges in converting previous COVID-19 customers and re-engaging with pre-COVID-19 customers, and realize that many customer engagements need to be restarted. To this end, the announcement of the results from the SUPERIOR study during Q3 provided additional use cases for our sales team and distributors, in that we can now approach previous and new acute care customers with this important application of our suPARnostic® products. At this point in time, however, we do not believe we can achieve our previous guidance for the year.”

This announcement is a summary and should be read in connection with ViroGates’ Interim Report for Q1-Q3, 2023, published on 09 November 2023. A downloadable PDF version will be available on the company’s website.

For further information, please contact:

ViroGates A/S:

CEO, Jakob Knudsen

Tel. (+45) 2226 1355, email: jk@virogates.com

Certified Advisor:

Västra Hamnen Corporate Finance

Per Lönn

Tel. (+46) 40 200 250, email: per.lonn@vhcorp.se

About ViroGates

ViroGates A/S is an international medical technology company developing and marketing blood test products under the suPARnostic® brand for better triaging in hospitals to improve patient care, reduce healthcare costs and empower clinical staff.

The company was founded in 2000. Headquartered in Denmark, ViroGates’ sales force covers Spain, France, and Benelux, while distributors serve other markets. ViroGates’ shares (VIRO) are listed on Nasdaq First North Growth Market Denmark. For more information, please visit www.virogates.com.

About suPAR and suPARnostic®

suPAR is the biomarker detected by ViroGates’ suPARnostic® products and is a protein in plasma, measurable in every human being. suPAR is considered a general risk status biomarker indicating disease presence, disease severity and progression, organ damage and mortality risk across disease areas such as cardiovascular diseases, kidney diseases, type 2 diabetes, cancer, etc. Strong scientific evidence from more than 850 clinical trials and studies show that the higher the level of suPAR, the worse the prognosis for the patient.

The suPARnostic® products can be used to support healthcare professionals in making clinical decisions on hospitalization or discharge of acute care patients. The increasing demands on health systems globally and tightening healthcare budgets necessitate efficiency improvements and innovative solutions in hospitals. The use of suPAR in clinical routine in emergency departments can improve patient care and reduce healthcare costs by increasing the number of discharges by up to 34% and reducing the average hospital length-of-stay by up to 6% without affecting mortality. suPARnostic® TurbiLatex is currently available on Roche Diagnostics’ cobas® instruments, Siemens Healthineers ADVIA® XPT and Atellica® instruments, the Abbott Labs Architect™ and Alinity™ instruments and the Beckmann Coulter AU 5800 instrument. ViroGates works with partners to develop solutions for other platforms. ViroGates has recently launched its Point of Care suPARnostic® POC+ product, a platform that uses only a few drops of finger-prick blood instead of plasma for full quantitative suPAR results in less than 20 minutes.