Regulatory News:
MedinCell (Paris:MEDCL):
The 2022-23 Universal Registration Document (URD) filed with
the French market authority (Autorités des Marchés Financiers, or
AMF) under the reference D.23-0628 includes:
- the Annual Financial Report for the year ending on March 31,
2023
- the management report
- the CSR report
- the report on corporate governance
- the proposed text of the resolutions to be submitted to the
Shareholders' Meeting of September 12, 2023
The URD can be consulted on the Company’s website
(medincell.com) and on the AMF’s website
(www.amf-france.org).
Updated selected financial information for the year
2022-2023
Following the completion of the audit procedures on the
Company’s 2022-23 consolidated financial statements by the
Company’s statutory auditors, some changes in figures have been
made compared to those communicated by the Company on June 26,
2023.
Selected financial information for the year 2022-2023
Key consolidated data - IFRS (In
thousands of €)
31/03/2023 12
months
31/03/2022 12
months
PROFIT AND LOSS ACCOUNT
Revenue
9 889
4 090
Other income from ordinary activities
3 766
4 247
Current operating loss
(24 025)
(23 812)
Operating loss
(24 046)
(23 814)
Financial result
(7 964)
(992)
Net result
(32 010)
(24 806)
CASHFLOW
Net cashflow used by operating
activities
(21 005)
(21 362)
Net cashflow from investing activities
1 298
(316)
Net cashflow from financing activities
1 556
(800)
BALANCE SHEET
Equity of the consolidated group
(42 294)
(13 371)
Total non-current liabilities
14 608
19 433
Total current liabilities
57 025
38 241
Total non-current assets
9 772
10 229
Of which financial assets and other
non-current assets
1 460
1 519
Total current assets
19 568
34 074
Of which cash and cash equivalents
6 467
24 617
FINANCIAL DEBT
Financial debt, non-current portion
11 708
16 249
Financial debt, current portion
39 757
27 764
Derivative liabilities
3 055
-
GROSS FINANCIAL DEBT
54 520
44 014
Cash and cash equivalents
6 467
24 617
Capitalization contract *
-
2 560
NET FINANCIAL DEBT **
48 053
16 837
* The Group had funds immobilized in a capitalization contract
and euro funds given as collateral for a bank loan of €7.0m, the
balance of which was repaid in 2022/2023. ** Lease liability
excluded (IFRS 16)
Cash position significantly strengthened
On March 31, 2023, MedinCell had € 6.5 million of cash and cash
equivalents (compared to € 24.6 million of cash and cash
equivalents and € 2.6 million of current and non-current non-risky
financial assets a year ago).
The financial strategy of the Company was adjusted following
FDA’s Complete Response Letter received by Teva on April 19, 2022,
which resulted in commercialization of MedinCell’s first product
approximately one year later than expected.
In November 2022, the Company signed a loan agreement for € 40
million with the European Investment Bank (EIB). The two first
tranches of the credit facility, for a total amount of € 30
million, have been drawn in Q4 2022 and Q1 2023, of which around €
23.3 million have been used to repay the existing EIB loan from
2018 as specified in the agreement. Disbursement of the last € 10
million was conditioned to approval by U.S. FDA of UZEDY that
occurred on April 28, 2023. On July 21, 2023, the company thus
obtained formal approval from the EIB to release Tranche C of the
loan agreement for an amount of €10 million. The funds are expected
to be received on July 31, 2023, at the same time as 313,607
warrants are issued to the EIB. In addition to the new EIB loan,
the Company successfully completed a € 23.2 million net capital
raise in May 2023 through an offering to French and international
investors via a Private Placement and to retail investors in
France.
Considering these financing operations and anticipated revenues
from existing collaboration, MedinCell has the resources to
continue its portfolio development.
As of March 31, 2023, one of the EIB loan covenants had not been
met, giving EIB the right to ask for partial or total early
repayment of the existing loan. On June 12, 2023, the Company
obtained a waiver from EIB, in which it abandons this right. In the
Company's current base-case cash forecast, that does not include
potential new partner service or licensing revenue, or new funding
sources, it is likely that this covenant may not be met again
during the 2023/2024 financial year. If this happens and in the
absence of a new waiver from EIB, and if EIB decides to exercise
its right to ask for partial or total early repayment of the
existing loan, the company may, depending on of the amount asked,
not having the means to meet the EIB's request. This is a
significant uncertainty on the going concern. To avoid this, the
Company is continuing its discussions with the EIB to modify or
remove this covenant.
Consolidated cashflow statement
(In thousands of €)
31/03/2023 12
months
31/03/2022 12
months
A
Net cashflow used by operating
activities
(21 005)
(21 362)
B
Net cashflow from investing activities
1 298
(316)
C
Net cashflow from financing activities
1 556
(800)
Impact of non-monetary items and foreign
exchange rate changes
-
-
Change in net cash position
(18 150)
(22 478)
Cash and cash equivalents - opening
balance
24 617
47 095
Cash and cash equivalents - closing
balance
6 467
24 617
A- Net cashflow used by operating activities
During the year, the Company's cash consumption was similar to
the previous year at € 21 million. Over the same period, operating
expenses increased from € 32.2 million to € 37.7 million, mainly
due to the increase in Research & Development activities.
The Company points out that the first revenues directly linked
to product sales should be royalties from the commercialization of
UZEDY. In the meantime, due to the product development cycle and
depending on the financial parameters set up in the context of
partnerships (which may or may not include certain elements such as
invoicing for formulation services, milestone payments, royalties,
cost sharing, profit sharing, etc.), revenues may vary
significantly from one year to the next.
B- Net cashflow from investing activities
The increase of € 1.6 million compared to previous year
corresponds to the end of the capitalization contract in Q1 2023 (€
2.6 million) partially offset by the acquisition of machinery and
fixed instruments, improvements at the Jacou site for € 0.6
million, and the acquisition of intangible assets for € 0.5 million
related to intellectual property.
C- Net cashflow from financing activities
The net cashflow from financing activities is driven by the new
contract with the EIB signed in November 2022, of which € 30
million have been withdrawn as of March 31, 2023. This cash has
been partly used to early repay the 2018 EIB loan in January 2023
of € 23.3 million.
Profit and loss account
Income from ordinary activities: € 13.7 million
For the year ended March 31, 2023, revenues correspond to:
Development services of € 5.8 million, mainly related to
activities for mdc-WWM and mdc-STM products financed by
international health foundations and agencies, compared to €4.0
million in the previous year.
- The development of a long-acting injectable malaria product
supported by the Unitaid health agency generated revenue of € 2.2
million compared to € 1.3 million in the prior year.
- The development of a long-acting contraceptive product
supported by the Bill & Melinda Gates Foundation generated
revenue of € 2.0 million compared to € 2.4 million in the prior
year.
- Reflecting the intensification of Business Development, R&D
activities related to new partnered programs (proof of feasibility)
generated € 1.6 million revenue compared to € 0.3 million in the
prior year.
In addition, the Company received a milestone payment from Teva
of € 2.9 million after their decision in August 2022 to start Phase
3 clinical activities for mdc-TJK, the second schizophrenia product
candidate.
The Company also received a € 1.2 million royalty payment from
the joint venture, CM Biomaterials, dedicated to the sale of
polymers to the Company's partners, significantly higher than the €
0.1 million the year before.
The Research Tax Credit recognized during the period amounted to
€ 3.7 million (€ 4.2 million in the prior year).
Current operating expenses aligned with the Company's plan: €
37.7 million
Current operating expenses increased by 17% compared to the
previous year. This increase was mainly driven by R&D
activities, which accounted for 74% of operating expenses, reaching
€ 27.9 million, compared to € 23.6 million in the previous year.
This increase is driven by the advancement of the current portfolio
and increased cash requirements in the preclinical stages and the
clinical study conducted during the year.
Resuming to normal activities after the pandemic crisis led to a
14% increase in marketing and business development costs, as travel
is no longer as restrictive as it was in the recent past. Also,
G&A expenses increased by 14%, driven by additional consulting
fees and salaries and benefits increase.
Financial result: € (7.9) million
The financial result is mainly composed of interest expenses on
the EIB loan for € 3.5 million as of 31 March 2023 compared to €1.3
million as of March 31, 2022. The change in fair value of the EIB
loan amounts to € 5.2 million and is composed of:
- Following the renegotiation of the EIB loan carried out on
November 22, 2022, the extinguishment of the old loan and the
accounting for the new loan generate a net expense of € 0.1
million.
- Change in the estimation of variable remuneration has an impact
of € 2.0 million.
- Fair value of the put option related to the EIB loan stock
warrants "BSA" component has an impact of € 3.1 million in
financial expenses.
Consolidated income statement
(In € thousands)
March 31, 2023
March 31, 2022
Net sales
9 889
4 090
Other income from continuing
operations
3 766
4 247
Revenue
13 655
8 338
Costs of goods and services sold
-
-
Research and development costs
(27 925)
(23 607)
Sales and marketing costs
(2 588)
(2 272)
General and administrative costs
(7 167)
(6 271)
Current operating income /
(expense)
(24 025)
(23 812)
Other non-current operating expenses
(99)
(112)
Other non-current operating income
78
110
Operating income / (expense)
(24 046)
(23 814)
Interest income
41
46
Gross borrowing costs
(9 138)
(1 844)
Other financial expenses
(57)
(23)
Other financial income
1 190
829
Financial income / (expense)
(7 964)
(992)
Share of net income / (loss) of
associates
-
-
Income / (loss) before tax
(32 010)
(24 806)
Tax income / (expense)
-
-
NET INCOME / (LOSS)
(32 010)
(24 806)
- Attributable to owners of MedinCell
(32 010)
(24 806)
- Attributable to non-controlling
interests
-
-
Earnings / (loss) per share (€)
(1.27)
(1.00)
Diluted earnings / (loss) per share
(€)
(1.27)
(1.00)
Balance sheet
March 31, 2023
March 31, 2022
Equity of the consolidated group
(42 294)
(13 371)
Total non-current liabilities
14 608
19 433
Total current liabilities
57 025
38 241
Total Equity and Liabilities
29 339
44 303
Total non-current assets
9 772
10 229
Of which financial assets and other
non-current assets
1 460
1 519
Total current assets
19 568
34 074
Of which cash and cash equivalents
6 467
24 617
Total Assets
29 339
44 303
About MedinCell
MedinCell is a commercial-stage technology pharmaceutical
company developing long-acting injectable drugs in many therapeutic
areas. Our innovative treatments aim to guarantee compliance with
medical prescriptions, to improve the effectiveness and
accessibility of medicines, and to reduce their environmental
footprint. They combine already known and used active ingredients
with our proprietary BEPO® technology which controls the delivery
of a drug at a therapeutic level for several days, weeks or months
from the subcutaneous or local injection of a simple deposit of a
few millimeters, entirely bioresorbable. The first treatment based
on BEPO technology, intended for the treatment of schizophrenia,
was approved by the FDA in April 2023, and is now distributed in
the United States by Teva under the name UZEDY™ (BEPO technology is
licensed to Teva under the name SteadyTeq™). We collaborate with
leading pharmaceutical companies and foundations to improve global
health through new treatment options. Based in Montpellier,
MedinCell currently employs more than 140 people representing more
than 25 different nationalities.
UZEDY™ and SteadyTeq™ are trademarks of Teva Pharmaceuticals
This press release contains forward-looking statements,
including statements regarding Company’s expectations for (i) the
timing, progress and outcome of its clinical trials; (ii) the
clinical benefits and competitive positioning of its product
candidates; (iii) its ability to obtain regulatory approvals,
commence commercial production and achieve market penetration and
sales; (iv) its future product portfolio; (v) its future partnering
arrangements; (vi) its future capital needs, capital expenditure
plans and ability to obtain funding; and (vii) prospective
financial matters regarding our business. Although the Company
believes that its expectations are based on reasonable assumptions,
any statements other than statements of historical facts that may
be contained in this press release relating to future events are
forward-looking statements and subject to change without notice,
factors beyond the Company's control and the Company's financial
capabilities.
These statements may include, but are not limited to, any
statement beginning with, followed by or including words or phrases
such as "objective", "believe", "anticipate", “expect”, "foresee",
"aim", "intend", "may", "anticipate", "estimate", "plan",
"project", "will", "may", "probably", “potential”, "should",
"could" and other words and phrases of the same meaning or used in
negative form. Forward-looking statements are subject to inherent
risks and uncertainties beyond the Company's control that may, if
any, cause actual results, performance, or achievements to differ
materially from those anticipated or expressed explicitly or
implicitly by such forward-looking statements. A list and
description of these risks, contingencies and uncertainties can be
found in the documents filed by the Company with the Autorité des
Marchés Financiers (the "AMF") pursuant to its regulatory
obligations, including the Company's registration document,
registered with the AMF on September 4, 2018, under number I.
18-062 (the "Registration Document"), as well as in the documents
and reports to be published subsequently by the Company. In
particular, readers' attention is drawn to the section entitled
"Facteurs de Risques" on page 26 of the Registration Document.
Any forward-looking statements made by or on behalf of the
Company speak only as of the date they are made. Except as required
by law, the Company does not undertake any obligation to publicly
update these forward-looking statements or to update the reasons
why actual results could differ materially from those anticipated
by the forward-looking statements, including in the event that new
information becomes available. The Company's update of one or more
forward-looking statements does not imply that the Company will
make any further updates to such forward-looking statements or
other forward-looking statements. Readers are cautioned not to
place undue reliance on these forward-looking statements.
This press release is for information purposes only. The
information contained herein does not constitute an offer to sell
or a solicitation of an offer to buy or subscribe for the Company's
shares in any jurisdiction, in particular in France. Similarly,
this press release does not constitute investment advice and should
not be treated as such. It is not related to the investment
objectives, financial situation, or specific needs of any
recipient. It should not deprive the recipients of the opportunity
to exercise their own judgment. All opinions expressed in this
document are subject to change without notice. The distribution of
this press release may be subject to legal restrictions in certain
jurisdictions. Persons who come to know about this press release
are encouraged to inquire about, and required to comply with, these
restrictions.
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version on businesswire.com: https://www.businesswire.com/news/home/20230731855452/en/
MedinCell David Heuzé Head of Communications
david.heuze@medincell.com +33 (0)6 83 25 21 86
NewCap Louis-Victor Delouvrier/Alban Dufumier Investor
Relations medincell@newcap.eu +33 (0)1 44 71 94 94
NewCap Nicolas Merigeau Media Relations
medincell@newcap.eu +33 (0)1 44 71 94 94
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