•Developed direct commercial relationships with US payers and healthcare providers as well as extended collaboration with pharmaceutical industry
•Significant acceleration in investment to:
O strengthen organization and commercial capabilities, in line with increased interest in Voluntis’ digital therapeutics
O pursue technological developments
•H1 2018 revenue of €2.2 million, reflecting the evolution of the revenue structure, and EBIT of -€7.9 million due to an increase in staff costs
•Successful initial public offering, establishing cash of €28.6 million at end-June 2018
Paris, France, September 20, 2018, 5:40 pm CEST – Voluntis (Euronext Paris, ticker: VTX - ISIN: FR0004183960), a digital biotech specialized in digital therapeutics, announces its revenue and results for the first half of 2018, closed as of 30 June 2018.
Pierre Leurent, Chief Executive Officer of Voluntis, commented: "Following our successful IPO, which enabled us to finance our future development, we have continued to invest, in particular to strengthen our operational teams, mainly in the United States. In addition to strengthening our organization, we have also signed a contract with a US payer, a key stage in our development in this market, consolidated our product portfolio and extended our partnerships in oncology. In diabetes, we are planning to sign contracts with other payers in the United States and to expand our innovative solutions to other European countries."
Key events of the first half
•As it executes the strategy announced at the time of the IPO, Voluntis has focused its investments:
O In diabetes, to consolidate the organization and strengthen its commercial capabilities. During the first semester, these efforts led to:
O Signing an agreement in the United States with a payer, WellDyneRx, and continuing to deploy Insulia in healthcare centers.
O Extending the sales network through a distribution partnership with Monarch, thanks to its inpatient presence, and extending the product offering through a partnership with WellDoc, which aims to combine its coaching platform with Insulia.
O Launching a new version of Insulia, now available in Spanish and with enhanced user experience.
O Supporting the promotion of Insulia and Diabeo in France.
O Preparing the launch of Insulia in Canada, for which Insulia received regulatory clearance by Health Canada.
• In oncology, to continue technological, clinical and regulatory developments. Recently, Voluntis has:
O Strengthened its partnership with Roche, aiming to expand the indications covered by the Zemy app, and initiating a clinical study to evaluate the use of Zemy in breast cancer.
O Extended its agreement with AstraZeneca to implement a new clinical evaluation phase of the eCO digital therapy.
O Announced the publication of clinical results in the eCO (eCediranib-Olaparib) feasibility study, developed in partnership with AstraZeneca and the National Cancer Institute, in the Journal of Clinical Oncology (JCO®) Clinical Cancer Informatics.
O Enhanced its Theraxium Oncology digital platform, dedicated to cancer treatments.
H1 2018 revenue of €2.2 million, reflecting the evolution of Voluntis’ revenue structure, and EBIT of -€7.9 million due to an increase in staff costs
• Application of IFRS 15, the new revenue recognition standard: Voluntis has applied the standard since January 1, 2018, with no prior period restatement. A major evolution in the revenue recognition standard, the transition to this new model has nonetheless had a minor impact on the semester’s revenue, specifically less than €0.1 million.
• Variation in milestone payments: Voluntis reported first-half revenue of €2.2 million versus €5.7 million in first-half 2017, which benefited from €3.5 million of milestone payments compared with €0.1 million this year.
• Evolution of the revenue structure: The total revenue reduction reflects, per management expectations, the transition to a revenue model based more on recurring revenue from product sales and less on pre-launch revenue related to product development and approval. In the first semester, direct sales to payers and providers have yet to affect revenue.
In parallel, Voluntis continued to bolster its teams, particularly in the United States, to support the marketing and deployment of Insulia. The €1.5 million increase in operating expenses to €9.8 million was therefore due to growth in staff costs, which amounted to €6.7 million, including a €0.5 million impact related to IFRS 15. This new standard also takes into account the costs of contract execution with clients, of which a large part was recognized in personnel costs this semester.
On that basis, EBITDA came to -€7.0 million and EBIT to -€7.9 million.
After the IPO on Euronext Paris and the resulting capital increase, free cash amounted to €28.6 million on June 30, 2018 versus €1.8 million on December 31, 2017. Voluntis also issued a €4.0 million bond to Kreos during the period.
Voluntis will continue to invest during the second half to support its growth.
Initiatives already underway include:
• Stepping up sales and marketing actions in the United States to extend the deployment of Insulia
• Finalizing the development of a proprietary multi-cancer solution in oncology
• Continuing to strengthen its teams by bringing in new skills, in particular new experts in the US market
Furthermore, the company foresees further strengthening its Board of Directors with additional well-known and deeply experienced US healthcare executives.
Medium-term targets unchanged
Voluntis has not changed its medium-term target of €50 million in revenue in 2021 after achieving breakeven at EBITDA level in 2020.
Voluntis creates digital therapeutics that empower people suffering from chronic conditions to self-manage their treatment every day, thus improving real-world outcomes. Combining mobile and web apps, Voluntis’ solutions deliver personalized recommendations to the patient and the care team that so that they can, for example, adjust treatment dosage, manage side effects or monitor symptoms. These real-time recommendations are based on digitized clinical algorithms. Leveraging its Theraxium technology platform, Voluntis has designed and operates multiple digital therapeutics. These include Insulia and Diabeo in diabetes as well as eCO and ZEMY in oncology. Voluntis has long-standing partnerships with leading life science companies such as Roche, AstraZeneca, Sanofi and Onduo. Based out of Boston and Paris, France, Voluntis is a founding member of the Digital Therapeutics Alliance.
For further information: http://www.voluntis.com
Diabeo® is a registered trademark of Sanofi. Insulia® is a registered trademark of Voluntis.
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