- As of June 30, 2023
- Cash position of €12.1 million (€17.4 million as of December
31, 2022)
- Revenue of €1.6 million, mainly from partnership with Tonghua
Dongbao
- Clinical programs progressing according to plans: finalization
of clinical studies on BioChaperone Combo and continuation of Phase
3 of BioChaperone Lispro
- As of August 31, 2023: Adocia strengthened its cash position to
€16 million, resulting from previously announced transactions:
- Receipt of €10 million from Sanofi, following the exclusivity
agreement related to M1Pram
- Financing operation of €10 million
- Repayment in full of €10.2 million venture loan
Regulatory News:
Adocia (Euronext Paris: FR0011184241 – ADOC), a clinical-stage
biopharmaceutical company focused on the research and development
of innovative therapeutic solutions for the treatment of diabetes
and other metabolic diseases, announces today its financial results
for the six months ended June 30th, 2023, and provides a business
update.
Half-year consolidated financial statements, expressed according
to IFRS guidelines, underwent limited review by the statutory
auditors and subsequently have been approved at the Board of
Director’s meeting held on September 14th, 2023.
“With my appointment as Chief Executive Officer, my short-term
priorities were to conclude a partnership on M1Pram and renegotiate
our commitments with our lenders. The first half of the year was
marked by a difficult period during which we had to suspend the
trading of shares. I am delighted that, in the end, we came out
stronger as a company and succeeded in clearing our debt,
strengthening our financial position and, above all, taking an
important step towards a partnership with Sanofi on M1Pram. We are
working on the clinical and regulatory fronts to accelerate the
development of this product, notably with the preparation of a
Phase 2b trial in the United States for people suffering from
obesity and type 1 diabetes. Our strategic priority is now to
finalize a worldwide licensing agreement for M1Pram", says Olivier
Soula.
"At the same time, the good conduct of BioChaperone Lispro Phase
3 trials in China confirms Adocia's dual expertise in innovation
and pharmaceutical development of major products. This maturity and
expertise are the keys to our future success", concludes Olivier
Soula.
Key financial results of first half 2023
The table below compares the condensed consolidated financial
statements prepared for the six-month periods ended June 30, 2023,
and June 30, 2022, respectively:
In (EUR ) thousands, Consolidated
financial statements, IAS/IFRS
06/30/2023 6 months
06/30/2022 6 months
Operating revenue
3,901
10,418
Revenue
1,627
7,349
Grants, research tax credits and
others
2,274
3,069
Operating expenses excluding
additions and reversals
(10,961)
(15,215)
Additions to and reversals of
depreciation, amortization and provisions
(238)
(294)
CURRENT OPERATING INCOME
(LOSS)
(7,298)
(5,090)
Other operating revenue and
expenses
0
11,199
OPERATING INCOME
(LOSS)
(7,298)
6,108
Financial income
63
227
Financial expenses
(2,155)
(1,605)
FINANCIAL INCOME
(LOSS)
(2,092)
(1,379)
PROFIT (LOSS) BEFORE
TAX
(9,389)
(4,730)
Tax expenses
(2)
(478)
NET INCOME (LOSS)
(9,392)
4,252
The financial results of the Company as of June 30, 2023, are
characterized by the following main elements:
- Revenue of €1.6 million, mainly from licensing and
collaboration agreements signed with Tonghua Dongbao (THDB). For
the first half of 2023, sales include €1 million in services
provided by Adocia teams as part of the collaboration signed with
THDB on the BioChaperone® Combo project for the conduct of three
clinical trials in Europe. Revenues for the half-year also reflect
€0.5 million from the ongoing feasibility study on the AdOral®
project. In 2022, over the same period, sales were impacted to the
tune of €4.8 million by the receipt in May 2022 of the milestone
payment generated following the recruitment and dosing of the first
patient in the Phase 3 program launched with BioChaperone® Lispro
by THDB in China.
- Other current operating revenues of €2.3 million,
comprising the CIR (Research Tax Credit) of €1.8 million related to
Adocia’s R&D expenses for the first six months of the 2023
financial year, and the waiver of €0.5 million from Bpifrance on
the Hinsbet program initiated in 2012 and discontinued.
- Operating expenses of €11.2 million, down €4.3 million
compared with the first six months of 2022. This reduction was
mainly due to lower external R&D expenditure, reflecting
reduced activity on preclinical and clinical studies, in particular
the BioChaperone® Combo studies carried out under the collaboration
agreement with THDB.
- Financial expenses of almost €2.1 million, mainly due
to interest on loans (including IPF for €1.1 million) and the
impact of the revaluation at fair value of the OC1023 and OC1124
bonds (€0.6 million).
- A before-tax deficit which, taking into account the
above items, amounts to €9.4 million, compared with a profit of
€4.3 million for the same period last year. It should be noted that
the profit for the first half of 2022 included non-recurring
operating income of €11.2 million, linked exclusively to the
capital gain realized from the sale of Adocia’s headquarter
building in March 2022.
- Cash position of €12.1 million as of June 30, 2023,
compared with €17.4 million as of December 31, 2022. This position
includes €4.3 million received in February 2023 as part of the
mobilization of the 2022 research tax credit (CIR). On a comparable
basis, cash consumption from operations for the first six months of
the year came to €10.7 million, slightly higher than last year's
figure for the same period (€10.2 million).
- Net financial debt (excluding IFRS 16 impacts and
derivative instruments) stood at €19.6 million at end-June 2023,
compared with €24.1 million as of December 31, 2022. The €4.6
million decrease in debt over the first half is essentially due to
(i) the repayment of the quarterly maturity (March) of the IPF
Partners loan, offset by the costs and interest associated with the
early repayment of the debt made at the beginning of July, (ii) the
conversion (for an amount of -€3.7 million at the end of June 2023)
of the bonds convertible into shares known as "OC 1124" issued by
the Company in December 2022, (iii) the repayment of maturities of
PGE1 loans (-€0.7 million) and (iv) the waiver of €0.5 million from
Bpifrance on the Hinsbet program initiated in 2012 and
discontinued.
Post-closure events
In July 2023, Adocia signed an exclusivity agreement with Sanofi
for M1Pram for €10 million, which the Company received on July 20,
2023. This agreement secured a €10 million financing operation
consisting of a €5 million private placement subscribed in
particular by Gérard Soula, Chairman of Adocia's Board of
Directors, and Bpifrance, supplemented by the issue of €5 million
in convertible bonds underwritten by Vester Finance and European
investors.
Following these agreements, at the beginning of July, the
Company proceeded with the early repayment of its loan with IPF
Partners for €10.2 million, including all debt and associated legal
fees.
On August 4, 2023, an agreement was signed with the lenders of
the PGE or a 12-month grace period on principal repayments from
that date, generating a saving of €1.7 million.
Lastly, IPF Partners exercised part of its warrants for 409,838
shares, for which the Company received €1 million.
Consequently, since June 30, 2023, the company has significantly
reduced its debt. Indeed, debts, which stood at €24.1m at the end
of December 2022, amounted to €5.4m at the date of the half-year
report (excluding IFRS 16 impacts and derivative debts).
"Over the past few weeks, the transactions we have carried out
have enabled us to significantly improve our cash position and put
our financial situation on a sounder footing,” comments Valérie
Danaguezian, Chief Financial Officer. “Firstly, the full repayment
of our debts to IPF Partners has enabled us to regain our financial
independence. In addition, the rearrangement of PGE debt with a
12-month deferral gives us additional flexibility of €1.7 million.
We are also particularly pleased to announce that Vester Finance
has converted the entirety of its convertible bonds, thereby
settling our financial debts (known as OCs) and their dilutive
impact. We would like to thank Vester Finance for its renewed
confidence in Adocia and its investments over the last few
years”.
First Half 2023 Program Update
The first half of 2023 was rich in partnerships, with the
signing of an exclusivity agreement with Sanofi for M1Pram
(combination of a prandial insulin and an amylin analog). At the
same time, the collaboration with Tonghua Dongbao continued, with
the progress of Phase 3 for BioChaperone® Lispro
(ultra-rapid-acting insulin) and the completion of three
qualification studies for BioChaperone® Combo (combination of basal
and prandial insulins), paving the way for direct entry into Phase
3. A feasibility study is currently underway using the AdOral®
technology platform on a partner's (undisclosed) peptide.
BIOCHAPERONE® LISPRO
Adocia's partner in China, Tonghua Dongbao, is currently
conducting a pivotal Phase 3 program with BioChaperone Lispro. The
clinical program, fully funded by Tonghua Dongbao, involves over
1,300 type 1 and 2 diabetes patients recruited from over 100
centers across China. With the first patient dosed in May 2022,
this Phase 3 program should be completed in 2024. The last visit of
the last patient (LPLV) would trigger a milestone payment of $10
million. Additional development milestone payments of up to $20
million remain on the contract, as well as double-digit royalties
on future sales.
BIOCHAPERONE® COMBO
In April 2022, Tonghua Dongbao and Adocia initiated 3 clinical
studies in Europe (CT046 - 47 and 48) with BioChaperone Combo, to
qualify Tonghua Dongbao's insulins. The clinical part of these
studies has now been completed, and the results are currently being
analyzed. The data obtained should enable Tonghua Dongbao to submit
the BioChaperone Combo dossier to the Chinese Drug Agency (CDE), in
order to obtain authorization to start a pivotal Phase 3 program in
China. The start of Phase 3 would give way to a payment of $10
million to Adocia. Under the terms of the agreement, a further $40
million in milestone payments are still to be expected, as well as
double-digit royalties on future sales of the product in China and
other territories licensed to Tonghua Dongbao.
M1PRAM
In the first half of 2023, discussions were initiated with
Sanofi. These led to the granting of exclusive rights to negotiate
a worldwide licensing agreement for M1Pram (and related
insulin-pramlintide combinations developed by Adocia). This
agreement was accompanied by a payment of €10 million on July 20,
2023. The objective is to conclude a licensing agreement by the end
of 2023.
M1Pram is the only insulin developed to date for people
suffering from obesity and insulin-dependent diabetes. With a
weight loss of -5.5 kg achieved in 16 weeks in people with type 1
diabetes and a BMI>30kg/m², M1Pram is the first drug to deliver
this level of performance in patients on intensive insulin therapy.
A Phase 2b clinical program for people with obesity and Type 1
diabetes is currently in preparation in the USA.
ADOSHELL® ISLETS, FOR CELL THERAPY OF DIABETES
AdoShell® Islets is an immunoprotective synthetic biomaterial
containing islets of Langerhans for the treatment of type 1
diabetes by cell therapy. Preclinical work carried out in the first
half of 2023 demonstrated the efficacy of AdoShell Islets®, as well
as its excellent biocompatibility and tolerance. Results presented
at the ADA (83rd Scientific Sessions of the American Diabetes
Association) showed that, after a 7-month implantation period in
the peritoneal cavity of rats (immunocompetent diabetic models),
AdoShell® Islets containing rats islets demonstrated excellent
tolerance without triggering inflammatory reactions or fibrosis. In
particular, no biodegradation or penetration of immune cells was
observed, reinforcing its potential as a novel solution for
patients suffering from type 1 diabetes.
Adocia is actively working to initiate clinical trials and is
preparing interactions with the EMA (European Medicines Agency) in
order to validate the proposed development plan. At the same time,
Adocia is pursuing its search for partners for AdoShell®.
ADORAL®: ORAL PEPTIDE DELIVERY
In response to a strong market need for new formulations to
improve patient compliance and quality of life, Adocia has
developed AdOral®. This technological platform aims to increase
peptide absorption in the gastrointestinal tract, based on a new
family of permeation enhancers.
Applied to semaglutide, AdOral® technology increases its oral
bioavailability by up to 5 times, compared with the reference
technology used on Rybelsus® (oral semaglutide, Novo).
These groundbreaking results have led to discussions with a
number of players potentially interested in the oral GLP-1
market.
The innovative AdOral® technology has also been tested on a
pharmaceutical partner's peptide, to study the feasibility of an
oral formulation. This study could lead to the conclusion of a
licensing agreement.
Governance
On May 15, 2023, Adocia announced the appointment of Olivier
Soula as Chief Executive Officer and Gérard Soula was renewed as
Chairman of the Board of Directors.
Olivier Soula, PhD, MBA, co-founder of Adocia, is co-author of
over 40 patents on protein delivery, and has worked for over 20
years in the field of innovative formulations. He has also played a
central role in the signing of numerous partnerships. Olivier's
first objectives in his new role as CEO were to sign a partnership
agreement for M1Pram and to renegotiate agreements with Adocia’s
lenders.
The General Shareholder Meeting set on May 11th, 2023 has
appointed Mads Dall as a Director of Adocia, decided by the
Company's Board of Directors on December 14, 2022, and renewed his
term of office for a further 3 years. Mads Dall is CEO and founder
of Dall & Company, a strategic business development company in
the life sciences field, based in Copenhagen. Mads has extensive
international experience of the diabetes industry and has worked
with pharmaceutical, biotech and MedTech companies in executive,
advisory and board positions.
Participation in investor events
Adocia will be taking part in a number of investor events over
the coming months:
- Lyon Pôle Bourse (September 27,
2023, Lyon) - Investor Access (October 9-10, 2023, Paris) -
Investir Day (November 28, 2023, Paris) - ODDO BHF
Forum (January 15-16, 2024, Virtual) - JPM 2024 - 42nd
Annual Healthcare Meeting (January 8 - 11, 2023, San Francisco)
During these professional meetings with the financial community,
through one-to-one formats or plenary presentations, Adocia's
management will review Adocia's latest news and outlook.
Availability of the half-year financial report
The 2023 half-year financial report of Adocia has been filed
with the French Financial markets authority (Autorité des marchés
financiers). It is available to the public and can be consulted on
the www.adocia.com website in the Financials - Documentation
section.
About Adocia
Adocia is a biotechnology company specializing in the discovery
and development of therapeutic solutions in the field of metabolic
diseases, primarily diabetes and obesity.
The company has a broad portfolio of drug candidates based on
four proprietary technology platforms: 1) The BioChaperone®
technology for the development of new generation insulins and
products combining insulins with other classes of hormones; 2)
AdOral®, an oral peptide delivery technology; 3) AdoShell®, an
immunoprotective biomaterial for cell transplantation, with a first
application in pancreatic cells transplantation; 4) AdoGel®, a
long-acting drug delivery platform.
Adocia holds more than 25 patent families. Based in Lyon, the
company has about 100 employees. Adocia is listed on the regulated
market of EuronextTM Paris (Euronext: ADOC; ISIN:
FR0011184241).
Disclaimer
This press release contains certain forward-looking statements
concerning Adocia and its business. Such forward-looking statements
are based on assumptions that Adocia considers as being reasonable.
However, there can be no guarantee that the estimates contained in
such forward-looking statements will be achieved, as such estimates
are subject to numerous risks including those which are set forth
in the “Risk Factors” section of the universal registration
document that was filed with the French Autorité des marchés
financiers on April 26, 2023 updated by the amendment of 26 July
2023 (D.23-0346-A01) and amendment of 13 September 2023
(D.23-0346-A02), available at www.adocia.com, in particular
uncertainties that are linked to research and development, future
clinical data, analyses, and the evolution of the economic context,
the financial markets and the markets in which Adocia operates. The
forward-looking statements contained in this press release are also
subject to risks not yet known to Adocia or not considered as
material by Adocia as of this day. The occurrence of all or part of
such risks could cause that actual results, financial conditions,
performances, or achievements of Adocia be materially different
from those mentioned in the forward-looking statements.
1 PGE : Prêt Garanti par l'Etat - State Guaranteed Loan
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version on businesswire.com: https://www.businesswire.com/news/home/20230918502469/en/
Adocia
Olivier Soula CEO
contactinvestisseurs@adocia.com +33 (0)4 72 610 610
www.adocia.com
Ulysse Communication
Adocia Relations Presse et Investisseurs Pierre-Louis
Germain Bruno Arabian
adocia@ulysse-communication.com + 33 (0)6 64 79 97 51
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