• New milestone partnerships signed with 2 pharmaceutical companies in 2020
  • Near fourfold increase in annual sales invoicing to € 10.2 million, and IFRS based sales up 20%
  • Redeployment plan completed, driving a 17% Opex reduction
  • Strong improvement of free cash flow, at € -2.1 million compared to € -14.3 million a year earlier, and € 11.0 million of cash available at the end of 2020

Regulatory News:

Voluntis (Euronext Growth Paris, Ticker: ALVTX - ISIN: FR0004183960), a leader in the field of digital therapeutics, today announced its full year 2020 results as approved by the Board of Directors at its March 29, 2021 meeting. The audit procedures on the accounts have been performed. The certification report will be issued after completion of the procedures required for the publication of the Annual Financial Report.

€m

 

2019

2020

Sales invoicing

 

2.7

10.2

 

 

 

 

Revenues

 

3.7

4.4

Adjusted EBITDA

 

(13.4)

(3.4)

EBITDA

 

(12.5)

(9.1)

Operating income

 

(14.8)

(11.1)

Net income

 

(15.8)

(12.1)

 

 

 

 

Free cash flow

 

(14.3)

(2.1)

 

 

 

 

Shareholders’ Equity

 

1.7

(4.6)

Available cash

 

5.1

11.0

Cash and cash equivalents net of financial debts

 

(2.5)

2.9 

On this occasion, Pierre Leurent, CEO of Voluntis, said: "One year after the presentation of our new strategic roadmap, I am very proud of the progress we have made. We are on track on all key indicators, whether it is the conclusion of agreements, with new milestone partnerships with two leading pharmaceutical companies, the improvement of our results, thanks to the optimization of our cost structure, or our financial visibility with a growing cash flow. I would like to take this opportunity to congratulate all our employees who actively participated in this success.

This is just a step and we are more focused than ever on our medium-term goals, with the desire to bring new digital therapeutics to market and to expand our portfolio of innovative solutions, both with our current partners and with new ones. We operate in a market for digital therapeutics that will be worth nearly $ 9 billion by 2025 and in the two largest therapeutic areas in the global pharmaceutical industry, oncology and diabetes.

With our robust and widely replicable digital therapeutics platform, we have the capability to go much further, notably through the efficient and responsible use of the data collected. The recent discussions initiated with potential new partners confirm this ambition and give us the prospect of significant value creation for our shareholders. »

Implementation of the new strategic plan

As part of the new strategic roadmap presented in March 2020, Voluntis is committed to establishing major partnerships with leading pharmaceutical companies to commercialize its digital therapeutics, with a priority on oncology.

This ambition led to the collaboration with Bristol-Myers Squibb, announced in March 2020, to develop digital therapeutic solutions for the management of cancer patients' symptoms and their remote monitoring by healthcare professionals. This collaboration complements the portfolio of programs in development in oncology based on Theraxium Oncology, Voluntis' platform for digital therapies in oncology.

In parallel, the company announced in July 2020 a global licensing agreement with Biocon Biologics in diabetes, the second priority therapeutic area. This global agreement is based on Insulia®, the FDA-cleared and CE-marked digital therapeutic developed by Voluntis for patients with type 2 diabetes treated with basal insulin.

These collaborations add to the company's portfolio with a total of 10 digital therapeutics co-developed and/or commercialized with pharmaceutical partners, demonstrating the power and replicability of the Theraxium platform.

Strong increase in sales invoicing

Thanks to these large-scale partnerships, sales invoicing, consisting primarily of all upfront payments, milestone payments and recurring commercialization-related license revenues, have increased 3.8 times compared to 2019 (€ 2.7 million) to reach € 10.2 million in fiscal year 2020.

After application of the accounting adjustments related to the spreading of a portion of revenues over the duration of contracts (IFRS 15), 2020 revenues amounted to € 4.4 million (€ 3.7 million in 2019). The difference between commercial invoicing and revenue is recognized in deferred income, which amounted to € 9.9 million at the end of 2020, compared with only € 3.8 million at the end of 2019, and will be progressively recognized in revenue over the coming years.

Improvement across all income statement indicators

The roadmap presented in 2020 also called for a redeployment of the company's human resources and an adaptation of its organization, both in France and in the United States, in connection with the repositioning of the commercial strategy towards indirect sales by partner pharmaceutical companies. This move has resulted in an adjustment of the workforce, from 113 employees at the end of 2019 to 72 at the end of 20201, while preserving the innovation capacity of the Group.

Thanks to higher revenues and lower operating expenses, Voluntis recorded a significant improvement in its adjusted EBITDA, to € -3,4 million from € -13,4 million in 2019.

Despite the impact of the IFRS 15 accounting standard, the net loss amounted to € -12.1 million, a significant improvement of € +3.7 million year-on-year, with a net loss halved in H2 2020 (€ 4.0 million) vs H1 2020 (€8.1 million).

Strengthening the financial structure

The increase in cash flow linked to partnerships and the strategic reduction in the cost structure have led to a very significant improvement in free cash flow, which stands at € -2.1 million in 2020 compared with € -14.3 million in 2019.

In addition, Voluntis has put in place new financing to consolidate its financial structure and obtained a net total of € 11.7 million in 2020, including € 6 million in non-dilutive financing (PGE French state-guaranteed loan and R&D innovation loan from Bpifrance Financement) and € 5.7 million in a fundraising from Debiopharm Innovation Fund, a corporate fund of the Swiss company Debiopharm, and Indigo, the personal holding company of Eric Carreel, Chairman and co-founder of Withings. This capital increase allowed to partially offset the impact of the net loss on shareholders’ equity, which amounted to € -4.6 million at the end of the year.

At the end of 2020, Voluntis had a cash position of € 11.0 million, compared with € 5.1 million at the end of 2019. Thanks to this solid cash position and taking into account the cash flows expected in 2021, Voluntis believes it has the necessary resources to cover its financial needs, at least over the next 12 months.

Confirmation of financial objectives

Thanks to the good commercial dynamics and the respect of the roadmap, Voluntis confirms its short- and medium-term financial objectives:

- On the commercial side, Voluntis is aiming to sign new cooperation agreements in 2021.

- On the financial side, based on its current available information, the company confirms its annual commercial invoicing objective of between € 8 and 12 million, and still targets a positive free cash flow in the second half of the year.

Beyond that, Voluntis confirms the commercial potential of the agreements signed since December 2019.

Thus, all the agreements signed since December 2019 could generate, subject to compliance with certain contractual conditions, up to € 25 million in cumulative commercial billings between 2020 and 2024 (including a significant portion of the € 10.2 million billed in 2020), mainly consisting of upfront and milestone payments.

The commercial launch of the co-developed solutions, anticipated to occur gradually between 2021 and 2024, would also enable Voluntis to receive licensing revenues for the use of its Theraxium platform and proprietary digital therapeutics. These could cumulatively represent tens of millions of euros per year, based on negotiated revenues per patient and the projected number of end-users.

About Voluntis

Voluntis creates digital therapeutics that empower people with chronic conditions to self-manage their treatment every day, thus improving real-world outcomes. Voluntis’ solutions, combining mobile and web apps, use clinical algorithms to deliver personalized recommendations to patients and their care teams. For example, these recommendations are used to adjust treatment dosage, manage side effects or monitor symptoms.

Leveraging its Theraxium technology platform, Voluntis has designed and operates multiple digital therapeutics, especially in oncology and diabetes. Voluntis has long-standing partnerships with leading life science companies. Based in Cambridge, MA, and Paris, France, Voluntis is a founding member of the Digital Therapeutics Alliance. For more information, please visit: www.voluntis.com

Mnemo: ALVTX - ISIN: FR0004183960

Alternative Performance Indicators :

Commercial invoicing: reflects commercial activity and the achievement of technical or regulatory milestones during the period, which are often deferred or spread out in accordance with IFRS 15 (Upfront payments, exclusivity fees and perpetual licenses + Development and integration services + Saas fees, royalties, maintenance & support)

EBITDA: recurring operating income before depreciation, amortization and provisions.

Adjusted EBITDA: corresponds to the EBITDA amended with the variation in prepaid income and deferred charges pursuant to the application of IFRS 15 (income invoiced for items over which control has not been transferred, expenses for the execution of items produced under customer contracts and not yet transferred).

Free cash flow: cash flow from operations + cash flow from investing activities

Consolidated income statement

€ 000'

31/12/2020

31/12/2019

Revenue

4 398

3 660

Other Operating Income

791

1 012

Total Income

5 189

4 672

Labor Costs

(9 133)

(11 430)

Other Operating Expenses

(5 108)

(5 758)

Operational Depreciations

(2 052)

(2 312)

Operating profit

(11 103)

(14 827)

Financial income

(718)

(986)

Taxes

(303)

(0)

Net income (group share)

(12 124)

(15 813)

Cash flow statement

€ 000'

31/12/2020

31/12/2019

Operating activities

 

 

Net income

(12 124)

(15 814)

Depreciation, amortisation and provisions

2 155

1 363

Depreciation, amortisation and provisions - IFRS 16

381

754

Other elements without cash impact

952

648

Net change in operating working capital requirements

7 265

881

Net cash flows from/(used in) operating activities

(1 372)

(12 168)

Investment activities

 

 

Proceeds/(purchase) from/(of) tangible and intangible assets

(679)

(2 019)

Proceeds/(purchase) from/(of) non-current financial assets

(70)

(128)

 

-

-

Net cash flows from/(used in) investing activities

(749)

(2 147)

Financing activities

 

 

Proceeds from capital increase

5 723

-

Proceeds/(repayment) from/(of) borrowings and interests paid

2 727

362

Proceeds/(repayment) from/(of) borrowings and interests paid - ifrs 16

(429)

(709)

Net cash flow from/(used in) financing activities

8 021

(347)

CASH FLOW VARIATION

5 900

(14 662)

Net foreign exchange difference

(11)

2

OPENING CASH BALANCE

5 121

19 783

CLOSING CASH BALANCE

11 010

5 122

Consolidated balance sheet

€ 000'

31/12/2020

31/12/2019

Assets

 

 

Intangible assets

2 071

2 694

Tangible assets

405

3 313

Non-current financial assets

251

258

Other non-current assets

1 091

364

Non current assets

3 817

6 629

Receivables

844

541

Other current financial assets

-

-

Other current assets

2 180

4 984

Cash on hand

11 010

5 121

Current assets

14 035

10 647

Total

17 852

17 277

 

 

 

 

31/12/2020

31/12/2019

Liabilities

 

 

Shareholder equity

(4 629)

1 742

Financial debt (non current)

6 062

4 452

LT provisions and other non current liabilities

7 219

852

Non current liabilities

13 281

5 304

Financial debt (current)

2 088

3 201

Payables and other current liabilities

7 112

7 029

Current liabilities

9 200

10 230

Total

17 852

17 277

Warning

This press release contains forward-looking statements about the Voluntis Group and its business, including its prospects and product development. Voluntis believes that these forward-looking statements are based on reasonable assumptions. However, forward-looking statements are not guarantees of future performance, as they relate to future events and depend on circumstances that may or may not occur in the future, and on various risks and uncertainties, including those described in the 2019 Annual Financial Report and the 2020 Half Year Financial Report published by Voluntis on April 30, 2020 and September 29, 2020, respectively, a copy of which is available on the Group's website (www.voluntis.com), and on changes in economic conditions, financial markets and markets in which Voluntis is present. The forward-looking statements contained in this press release are also subject to risks that are unknown to Voluntis or that Voluntis does not consider material at this time. The occurrence of some or all of these risks could cause the actual results, financial conditions, performance or achievements of Voluntis to differ materially from the results, financial conditions, performance or achievements expressed in such forward-looking statements. Voluntis disclaims any responsibility to update these forward-looking statements.

1 Excluding subcontractors

ACTUS Media relations Vivien Ferran vferran@actus.fr +33 (0)1 53 67 36 34

ACTUS Investor relations Jérôme Fabreguettes-Leib voluntis@actus.fr +33 (0)1 53 67 36 78

Voluntis Chief Financial Officer Guillaume Floch investisseurs@voluntis.com +33 (0)1 41 38 39 20