- Strategic prioritization of the oncology business.
- Signature of a major agreement with Bristol-Myers Squibb to
develop digital therapeutics based on the Theraxium Oncology
platform.
- Significant contribution of the new oncology collaborations
to revenues as of 2020.
- Reorientation of the diabetes business towards a new
partnership strategy and discontinuation of direct
commercialization.
- Reduction of operational expenses and update of the
objectives communicated by the Group in line with the new
roadmap.
Regulatory News:
Voluntis (Paris:VTX) (Euronext Paris, Ticker: VTX - ISIN:
FR0004183960) announces today its new strategic roadmap.
Pierre Leurent, CEO of the Voluntis Group (« Voluntis » or « the
Group »): “We recently executed major new partnerships that
reinforce Voluntis' lead in the field of digital therapeutics, with
one of the largest portfolios of pharmaceutical collaborations. Our
commercial momentum in oncology demonstrates both the relevance of
our approach and the unique profile of the Group's assets. With
regard to diabetes, we are suspending investments linked to direct
commercialization in the United States, as their profitability
horizon proves to be too distant in view of the Group's objective
of financial break-even. However, Voluntis' diabetes solutions
address significant unmet needs and we aim to execute new
commercial partnerships that can fully exploit the potential of
these assets. The primary focus on the oncology business, the
renewal of the partnership approach in diabetes and the adaptation
of the cost structure are the key levers of Voluntis' path to
profitable growth.”
Strong commercial traction of the oncology business with new
major collaborations
Voluntis recently inked two new partnerships related to its
Theraxium Oncology platform with Novartis and Bristol-Myers
Squibb1. In addition to these new collaborations, which complement
the existing partnership with AstraZeneca, Voluntis is in
discussion with several other pharmaceutical companies to improve
patients’ experience with many types of cancer treatments.
These commercial successes confirm, in the Group’s opinion, the
unique value of the Theraxium Oncology platform to accelerate the
development of digital therapeutics. Indeed, the platform
integrates a standard library of clinical algorithms, which can be
customized with specific modules to accelerate the design,
development and validation of these algorithms. Theraxium Oncology
also includes modules for optimizing the ergonomics of
applications, analyzing data collected from patients and operating
digital therapeutics.
The new commercial partnerships signed by the Group will
generate upfront and, as the case may be, milestones payments, and,
in the case of a commercial rollout, annual payments linked to the
number of users. These collaborations will have a significant
contribution to the Group’s revenues as of 2020.
1 Please refer to the news released today by Bristol-Myers
Squibb and Voluntis
Strategic Prioritization of the Oncology business
The Group's offer is perfectly adapted to the new models of
cancer care.
Cancer remains one of the leading causes of death worldwide:
every year, more than 14 million cancers are diagnosed2. The
development of outpatient care and personalized medicine is leading
to a rethinking of healthcare pathways. In addition, the symptoms
associated with the disease and its treatments affect nearly 90% of
patients and alter their quality of life. This can result in
temporary or permanent treatment interruptions and unplanned
hospitalizations. Improving the management of these symptoms is a
priority in terms of clinical practice and cost optimization for
healthcare teams.
Voluntis' digital therapeutics are in line with these market
trends and are designed to address these challenges. They
contribute to improving care by supporting personalized symptom
management at home, thanks to recommendations automated by
intelligent clinical algorithms. These digital therapeutics enable
a collaborative approach between patient and healthcare team thanks
to remote monitoring and identification of situations requiring the
intervention of healthcare professionals.
Oleena, Voluntis' proprietary multi-cancer digital therapy,
which targets a wide range of cancer-related symptoms, uses the
technological foundation of Theraxium Oncology. The Group plans to
make Oleena available to several cancer centers in the U.S. in the
first half of 2020 to generate new real-world data and reinforce
its experience with integration into clinical workflows.
The Group is now prioritizing its oncology business with a
view to asserting its position in this sector with high growth
potential.
Reorientation of the diabetes business towards a new
partnership strategy
Discontinuation of investment in direct commercialization in
the United States
For direct distribution of Insulia in the United States, the
introduction of reimbursement schemes in January 2019 by the Center
for Medicare and Medicaid Services has been a key success factor.
In the second half of 2019, the Group started contracting with
healthcare providers by leveraging this new framework.
However, the effective implementation of these reimbursement
schemes within medical practices, which has significant operating
costs, takes longer than the Group initially anticipated.
Given the more distant horizon than expected for return on
investment of this approach, which undermines its financial
sustainability, the Group has decided to suspend all investments
related to direct commercialization in the United States of its
products in the field of diabetes. These investments represent
approximately 15% of the Group's operating expenses.
In this context, the Group also decided to postpone the
additional developments required by the Food and Drug
Administration's feedbacks on the version of Insulia adapted to
insulin NPH during the process of application of this product in
the United States. The Group reserves the right to file a new
application of this version of the product at a later stage.
Evolution of the partnership with Sanofi
With regards to Insulia, the scope of the global distribution
contract with Sanofi has been refocused on the French territory
only, in line with Sanofi's new strategic directions in diabetes.
The partnership related to Diabeo, a solution developed with Sanofi
France and CERITD, will end in December 2020, in accordance with
its contractual term. The results of the Telesage study, conducted
in France, were also the subject of a first communication at the
last ATTD congress in the form of abstracts.
2
https://www.cancer.gov/about-cancer/understanding/statistics
Prioritizing a new partnership approach to roll out the
Group’s diabetes solutions at scale
The Group intends to establish new privileged partnerships to
distribute its Insulia solution on a large scale, primarily in
North America and Europe. The Group has already initiated new
discussions to this end.
In the event of a new partnership, the Group may contemplate the
development of a version of Insulia extended to patients treated
with a combination of basal and bolus insulin, as well as
integrating NPH insulins for the US market.
Reduction of operational expenses and update of the
objectives communicated by the Group in line with the new
roadmap
In view of the priority allocation of resources to oncology and
the projected operating loss for the 2019 financial year, which is
of a similar order of magnitude to 2018, the Group is contemplating
the implementation of a significant cost reduction plan in order to
achieve its objective of financial break-even in 20213. The
information and consultation process starting with the work council
in the coming days will enable the Group to present its proposals
for achieving this objective.
Voluntis therefore confirms its objective of financial
break-even (EBITDA) in 2021, for invoiced revenues in 2021 ranging
between Euro 8 and 12 million and an annual cost base of the same
order, following the prioritization of the oncology business and
the adaptation of the cost structure.
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 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, especially
in diabetes and oncology. Voluntis has long-standing partnerships
with leading life science companies. Based out of Boston and Paris,
France, Voluntis is a founding member of the Digital Therapeutics
Alliance. For more information, please visit: www.voluntis.com
Mnemo : VTX - ISIN : FR0004183960
3 See section 12.2 of Voluntis reference document registered
with the French Financial Markets Authority (Autorité des Marchés
Financiers) under number R.19-013 on April 26, 2019 (in French)
(stating an objective of financial break-even (EBITDA) reached in
2021 on the basis of 2021 revenues of Euro 40 million).
Disclaimer
This press release contains certain forward-looking statements
concerning Voluntis group and its business, including its prospects
and product candidate development. Such forward-looking statements
are based on assumptions that Voluntis considers to be reasonable.
However, there can be no assurance that the estimates contained in
such forward-looking statements will be verified, which estimates
are subject to numerous risks including the risks set forth in the
reference document of Voluntis registered with the French Financial
Markets Authority (Autorité des Marchés Financiers) under number
R.19-013 on April 26, 2019 (a copy of which is available on
www.voluntis.com) and to the development of economic conditions,
financial markets and the markets in which Voluntis operates. The
forward-looking statements contained in this press release are also
subject to risks not yet known to Voluntis or not currently
considered material by Voluntis. The occurrence of all or part of
such risks could cause actual results, financial conditions,
performance or achievements of Voluntis to be materially different
from such forward-looking statements. Voluntis expressly declines
any obligation to update such forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20200303006066/en/
NewCap Media relations Nicolas Merigeau
voluntis@newcap.eu +33 (0)1 44 71 94 98
NewCap Investor relations Louis-Victor Delouvrier
voluntis@newcap.eu +33 (0)1 44 71 94 94
Voluntis Matthieu Plessis Directeur Administratif et
Financier investisseurs@voluntis.com +33 (0)1 41 38 39 20