Voluntis, a company specialized in digital therapeutics, today announced the registration of its document de baseby the Autorité des marchés financiers (AMF, French financial markets regulator) under no. I-18.-016 dated 14 April 2018, thus launching its initial public offering process on Euronext’s regulated market in Paris.
The registration of the document de baseis the first step towards Voluntis’ initial public offering (IPO) on Euronext’s regulated market in Paris. It remains subject to market conditions and compliance with the requisite regulatory formalities, including the AMF’s visa on the prospectus to be prepared in connection with the IPO.
Voluntis, a digital therapeutics pioneer
Voluntis’ primary mission is to empower people suffering from chronic conditions to self-manage their treatment every day, thus improving real-world outcomes.To do so, Voluntis develops and markets digital therapeutics, which personalize treatment and support patients in the day-to-day management of their condition. Its therapeutic solutions, which work in real time thanks to digitized clinical algorithms, provide patients with tailored recommendations via a mobile app and equip their care team with patient data via a web app (so they can adjust treatment dosage, manage related symptoms, etc.). Voluntis’ digital therapeutics can enhance real life treatment efficacy and patient adherence, addressing a major medico-economic challenge.
Voluntis’ digital therapeutics are next-generation health solutions that:
- have undergone clinical evaluation,
- are subject to regulatory approvals (FDA, CE),
- require a medical prescription and aim to be reimbursed by payers (as in France, where its diabetes solutions are covered by the French national health insurance system).
Leveraging its Theraxium platform, the technological cornerstone underpinning its solutions, Voluntis has developed digital therapeutics primarily targeting diabetes and cancer.
Voluntis, as part of the emerging digital health sector, which aims to transform the healthcare industry, possesses strong assets to become one of its world leaders.
Voluntis’ principal assets
Relying on its 120 employees located in Paris and Boston and its advanced software and medical expertise (over 10 years of clinical trials), Voluntis has built several key assets:
A portfolio of solutions targeting the world’s two top therapy areas: diabetes and cancer
About 425 million people around the world suffered from diabetes in 2017. Voluntis has developed two distinct solutions to meet patient needs at key points during their insulin therapy pathway. Insulia®supports type II diabetes patients treated with long-acting basal insulin (the first phase of insulin therapy). Diabeo®supports type I and II diabetes sufferers treated with basal and bolus insulins (the second phase of insulin therapy).
Cancer is one of the world’s leading causes of morbidity and mortality. According to World Health Organization estimates, it causes almost 1 in 6 deaths around the world. In oncology, Voluntis’ digital therapeutics aim to enhance patient care through daily symptom management, which contributes to improving treatment adherence. They help to meet a major challenge for cancer treatment centers: the frequent symptoms caused by treatments and their consequent effect on patients’ quality of life, interruptions to treatment regimens and unscheduled hospital admissions. Accordingly, Voluntis is developing a proprietary multi-cancer solution as well as specific solutions under agreements with pharmaceutical groups. Examples of this approach include the ZEMY solution for breast cancer, developed in partnership with Roche, and the eCO solution for ovarian cancer, developed in partnership with AstraZeneca.
Partnerships with leading players in several areas:
Scientific development: Development strategy and clinical algorithms are elaborated with scientific advisors and highly renowned institutions such as the CERITD (Centre d’Études et de Recherches pour l’Intensification du Traitement du Diabète – a leading French not-for-profit organization active in diabetes prevention and treatment), chaired by Dr. Guillaume Charpentier, and the National Cancer Institute (NCI) in the United States.
Business development and commercialization: Voluntis has entered into major partnerships with global healthcare industry players that have unparalleled clinical development and distribution capabilities such as Sanofi, Roche, AstraZeneca and Onduo, a joint venture between Sanofi and Verily (formerly Google Life Sciences).
Technological development: Voluntis’ solutions can be integrated with existing suppliers’ technological ecosystems, such as blood glucose meters, including those of Livongo and Ascensia, thus automating the collection of blood glucose data.
Theraxium, the digital therapeutics technology platform:
Voluntis’ digital therapeutics are all founded on the Theraxium platform, designed and developed by Voluntis. This platform delivers the features common to all of their digital therapeutics, such as the algorithm engine and software security components, and facilitates the rapid development of new solutions, including for new indications.
A vast program of clinical trials, with 5 successfully completed and 2 in progress:
In diabetes, Voluntis’ solutions have undergone several multi-center randomized clinical trials. Between 2006 and 2013, Voluntis and the CERITD enrolled 370 patients in the Telediab1 and Telediab2 studies. The highly positive results of these studies, with a significant reduction in A1C, the glycemic control marker, demonstrated the clinical efficacy of Voluntis’ therapeutic solutions. In addition, Sanofi is conducting the Telesage study, one of the largest medico-economic and clinical trials in diabetes leveraging telemedicine, on 667 patients. Building on these solid foundations, Voluntis has secured regulatory clearances and already started the commercialization of its therapeutic solutions for people with diabetes.
In oncology, the eCO solution developed by Voluntis is being assessed in ovarian cancer, with clinical trials conducted by the National Cancer Institute under a cooperation agreement with AstraZeneca. An initial study revealed a high level of patient adherence and satisfaction. In breast cancer, the medical, organizational and economic benefits of the ZEMY app will be assessed in 2018 through a clinical trial in six French hospitals.
Commercial launch underway for Diabeo®and Insulia®:
Diabeo®is being introduced in France under the national telemedicine trial program to improve healthcare treatment pathways, after receiving the first reimbursement approval for a software medical device from the Haute Autorité de Santé(the French national health authority). Diabeo®is marketed in France by Sanofi under an exclusive partnership.
Insulia®has been launched in France and North America by Voluntis and its non-exclusive partners Sanofi and Onduo. Voluntis also plans to launch Insulia®in Europe’s main markets.
During the commercialization phase, Voluntis earns revenue arising from the reimbursement of its solutions by payers, either directly from them, or indirectly from the royalties paid by its industrial partners for the use of its digital therapeutics.
An IPO to accelerate commercial and clinical development
Voluntis’ IPO on the Euronext’s regulated market in Paris will enable the company to accelerate the commercialization of its diabetes products (both indirectly through its partnerships with pharmaceutical groups and directly with payers) as well as complete the development of and commercialize its range of solutions in oncology. Voluntis then plans to expand its portfolio of digital therapeutics to new areas, by leveraging its Theraxium platform.
Availability of the document de base: Voluntis’ document de base is available for download from the AMF’s website (http://www.amf-france.org) and the Company’s website (http://www.www.voluntis.com), and hard copies are available free of charge upon request from the Company at its registered office, 58 avenue de Wagram, 75017 Paris, France. The Company draws investors’ attention to Chapter 4 “Risk factors” of the document de baseregistered with the AMF.
About Voluntis
[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.www.voluntis.com
Diabeo® is a registered trademark of Sanofi. Insulia® is a registered trademark of Voluntis.
Disclaimer
No communication and no information in respect of the offering by Voluntis of the shares (the “Shares”) may be distributed to the public in any jurisdiction where a registration or approval is required. No steps have been or will be taken outside of France in any jurisdiction where such steps would be required. The offering and subscription of the Shares may be subject to specific legal or regulatory restrictions in certain jurisdictions. Voluntis assumes no responsibility for any violation of any such restrictions by any person.
This announcement is not a prospectus within the meaning of Directive 2003/71/EC of the European Parliament ant the Council of November 4th, 2003, as amended, in particular, by Directive 2010/73/EC of the European Parliament and the Council of November 24th, 2010, as amended and as implemented in each member State of the European Economic Area (the “Prospectus Directive”).
The offer will be open solely to the public in France after the delivery by the AMF of a visa on the Prospectus.
With respect to the member States of the European Economic Area other than France which have implemented the Prospectus Directive (each, a “relevant member State”) no action has been undertaken or will be undertaken to make an offer to the public of the securities requiring a publication of a prospectus in any relevant member State. As a result, the Shares may only be offered in relevant member States: (a) to legal entities that are qualified investors as defined in the Prospectus Directive; (b) in any other circumstances that do not require the publication by Voluntis of a prospectus pursuant to Article 3(2) of the Prospectus Directive.
For the purposes of this paragraph, the notion of an “offer to the public of Shares” in each of the relevant member States, means any communication, to individuals or legal entities, in any form and by any means, of sufficient information on the terms and conditions of the offering and on the Shares to be offered, thereby enabling an investor to decide to purchase or subscribe for the Shares, as the same may be varied in that Member State by any measure implementing the Prospectus Directive.
This selling restriction comes in addition to the other selling restrictions applicable in the other member states.
The distribution of this press release is not made, and has not been approved, by an “authorised person” within the meaning of Article 21(1) of the Financial Services and Markets Act 2000. As a consequence, this press release is directed only at persons who (i) are located outside the United Kingdom, (ii) have professional experience in matters relating to investments and fall within Article 19(5) (“investment professionals”) of the Financial Services and Markets Act 2000 (Financial Promotions) Order 2005 (as amended) (the “Order”), (iii) are persons falling within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations, etc.) of the Order or (iv) are persons to whom this press release may otherwise lawfully be communicated (all such persons together being referred to as “Relevant Persons”). The securities are directed only at Relevant Persons and no invitation, offer or agreements to subscribe, purchase or otherwise acquire securities may be proposed or made other than with Relevant Persons. Any person other than a Relevant Person may not act or rely on this document or any provision thereof. This press release is not a prospectus which has been approved by the Financial Services Authority or any other United Kingdom regulatory authority for the purposes of Section 85 of the Financial Services and Markets Act 2000.
This press release does not constitute or form a part of any offer or solicitation to purchase or subscribe for securities nor of any offer or solicitation to sell securities in the United States. The securities mentioned herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”), and may not be offered or sold, directly or indirectly, within the United States except pursuant to an exemption from or in a transaction not subject to, the registration requirements of the Securities Act. Voluntis does not intend to register any portion of the proposed offering in the United States nor to conduct a public offering of securities in the United States.
The distribution of this document in certain countries may constitute a breach of applicable law. The information contained in this document does not constitute an offer of securities for sale in the United States, Canada, Australia or Japan.
This press release may not be published, forwarded or distributed, directly or indirectly, in the United States, Canada, Australia or Japan.