April 2022 - March 2023
Regulatory News:
MedinCell (Paris:MEDCL):
2022-23 Highlights
- Launch of UZEDY™, first commercial product based on
BEPO® technology in May 2023 (post-closing)
- Successful financing strategy: European Investment Bank loan
(November 2022) and fundraising (May 2023, post-closing)
- Products for schizophrenia and post-operative pain based on
BEPO, entered Phase 3 clinical trials, and the rest of the pipeline
has progressed with three new programs expected to enter Phase 1
clinical trials in 2024
Consolidated FY 2023 financials
- Income from ordinary activities: € 13.7 million, +64% vs
previous year
- Operating expenses: € 37.7 million, +14% vs previous
year, 74% of the expenses are devoted to R&D
- Cash consumption from operating activities: € 21.2
million, -1% vs previous year
Note: audit procedures on the Company’s 2022 consolidated
financial statements by the Company’s statutory auditors are in
progress.
Cash situation increasing significantly post year-end, with a
total of € 40.8 million, including cash received post-closing and
additional cash inflow anticipated in 2023-24, not including
potential new partner service or licensing revenue:
- € 6.5 million in cash and cash equivalents as of March 31,
2023
- € 30.8 million cash received since year-end
- € 4.0 million of 2021 Research Tax Credit partially
pre-financed in April 2023
- € 3.6 million ($ 4 million) milestone payment from Teva
following UZEDY approval by U.S. FDA on April 28, 2023
- € 23.2 million net from capital raise on May 12,
2023
- € 10 million withdrawable from EIB financing, as the last
condition, approval of UZEDY, is now met
Jaime Arango, CFO of MedinCell, commented: “The U.S. FDA
approval of our first product is a major step for MedinCell. We can
now expect royalties and commercial milestones, they could cover
our operational expenses as soon as 2025. In addition, the recent
capital raise provides us cash visibility beyond mdc-TJK and
mdc-CWM Phase 3 key results.”
Development of the product portfolio based on BEPO
technology
mdc-IRM (schizophrenia)
- Complete Response Letter (CRL) from the U.S. FDA received by
MedinCell’s partner, Teva, in April 2022
- Resubmission of the marketing application announced on November
3, 2022, by Teva
- U.S. FDA approval achieved on April 28, 2023
- Commercial launch under the brand name UZEDY by Teva in the
U.S. in May 2023
- First commercial product based on MedinCell’s long-acting
injectable technology, BEPO
mdc-TJK (schizophrenia)
- Decision by MedinCell’s partner, Teva, to move to clinical
Phase 3 in the U.S. announced in August 2022
- Phase 3 clinical study initiated in the U.S. in January
2023
- If approved, mdc-TJK would be the first long-long-acting
injectable olanzapine with a favorable safety profile offering a
valued treatment option as a complement of UZEDY for severe
schizophrenia patients
mdc-CWM / F14 (post-operative pain)
- Initiation of a first Phase 3 clinical trial being conducted
and funded by MedinCell’s partner, Arthritis Innovation Corporation
(AIC), in November 2022 It is a 150-patient, multi-center,
randomized, double-blind, safety and efficacy trial designed by AIC
post consultation with the U.S. FDA
- Recruitment ongoing as anticipated and is expected to be
completed in Q3 2023
- mdc-CWM is designed to provide pain relief for patients over an
extended period post-surgery
Early-stage pipeline progression
- Progress of preclinical activities for three programs in
preparation to enter Phase 1 clinical trials in 2024: mdc-GRT
(immunosuppressor/organ transplant), mdc-WWM (contraception) with
the support of the Bill & Melinda Gates Foundation, and mdc-STM
(malaria) with the support of Unitaid
- Launch of formulation activities for two new internal products
(kept confidential at this stage)
- Several collaborations with pharmaceutical partners are at
technical feasibility stage, the first step of formulation
activities
- In addition, MedinCell continues to work on expanding its
internal programs portfolio
“Prime” ISS ESG rating received as a recognition of the
embedment of Corporate Social Responsibility across the
Company
- Institutional Shareholder Services (ISS) awarded MedinCell a
“Prime” Environmental, Social, and Governance (ESG) rating in
January 2023
- Rating places MedinCell among the top 10% in the
Pharmaceuticals & Biotechnology sector
- ISS, one of the world’s leading ratings agencies for
sustainable investments, provides a highly relevant, material
assessment of ESG performance to investors
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 profit
(24 025)
(23 812)
Operating profit
(24 046)
(23 814)
Financial result
(5 452)
(992)
Net result
(29 498)
(24 806)
CASHFLOW
Net cashflow from operating activities
(21 029)
(21 362)
Net cashflow from investing activities
1 298
(316)
Net cashflow from financing activities
1 577
(800)
BALANCE SHEET
Equity of the consolidated group
(39 781)
(13 371)
Total non-current liabilities
17 662
19 433
Total current liabilities
51 458
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
14 762
16 249
Financial debt, current portion
37 245
27 764
GROSS FINANCIAL DEBT
52 008
44 014
Cash and cash equivalents
6 467
24 617
Capitalization contract *
-
2 560
NET FINANCIAL DEBT
45 541
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.
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).
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. This last tranche is available immediately. 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. The Company points out that, with its
current base cash forecast, that does not include potential new
partner service or licensing revenue, the covenant may not be met
again as of March 31, 2024. This is a significant uncertainty on
the going concern. To avoid this, the Company continues having
discussions with the EIB. With a positive outcome, the cash
visibility of the company’s current base cash forecast is estimated
until at least Q4 2025.
Consolidated cashflow statement
(In thousands of €)
31/03/2023 12
months
31/03/2022 12
months
A
Net cashflow from operating activities
(21 029)
(21 362)
B
Net cashflow from investing activities
1 298
(316)
C
Net cashflow from financing activities
1 577
(800)
Impact of non-monetary items and foreign
exchange rate changes
-
-
Change in net cash position
(18 149)
(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 in 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
products developed with Teva, mainly 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: € (5.5) million
The financial result is mainly impacted by the new EIB financing
signed in May and November 2022, partially offset by forex gains of
€ 1.2 million.
About MedinCell
MedinCell is an innovative pharmaceutical company developing a
portfolio of long-acting injectable products in various therapeutic
areas - from development to commercialization - by combining its
proprietary BEPO technology (licensed to Teva under the name
SteadyTeq™) with active ingredients already known and marketed.
Through the controlled and extended release of the active
pharmaceutical ingredient, MedinCell makes medical treatments more
efficient, particularly thanks to improved compliance and to a
significant reduction in the quantity of medication required.
MedinCell's proprietary BEPO technology makes it possible to
control the delivery of a drug at a therapeutic dose for several
days, weeks or months, from the subcutaneous or local injection of
a simple, fully bioresorbable deposit just a few millimeters in
size. The first treatment based on BEPO technology for the
treatment of schizophrenia was approved by the FDA in April 2023
and is now commercialized in the United States by Teva under the
name UZEDY™. MedinCell collaborates with leading pharmaceutical
companies and foundations to improve global health through new
therapeutic options. Based in Montpellier, MedinCell currently
employs over 140 people representing more than 25 different
nationalities. www.medincell.com
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/20230626735708/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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