Regulatory News:
MedinCell (Paris:MEDCL):
Commercial launch by Teva of UZEDY™, the first product
based on BEPO® technology, in the United States, and collect of
first royalties representing €635K (June-September 2023).
Christophe Douat, CEO of MedinCell, said:
"Commercial revenues will transform MedinCell for the long term,
especially as the first trends in UZEDY prescriptions and feedback
from professionals and patients are very promising. Another good
news is that revenues from UZEDY could soon be complemented by
those from mdc-TJK, with phase 3 results now expected in 2024.
Considering these factors, our goal is to achieve operational
profitability as soon as possible and to generate additional
revenue with new partnerships to extend our cash visibility until
this horizon."
Other key highlights in the first half of fiscal year
2023-24
- Acceleration of the phase 3 clinical trial of mdc-TJK, the
second antipsychotic developed with Teva, with results now expected
in the second half of 2024
- End of recruitment for the phase 3 clinical trial of the
mdc-CWM program (post-operative pain), with analysis of efficacy
results expected in the first quarter of 2024
- Progress in the rest of the portfolio, with clinical trials
of several programs scheduled to start in 2024
- Financing:
- €23.2 million net of costs from the capital increase of May
12, 2023
- €10.0 million representing the final tranche of the European
Investment Bank loan
Consolidated financial statements for the first half of the
2023-24 financial year
- Income from ordinary activities: €8.2 million (+6.1% vs.
first half of previous year, of which €7.0 million in revenue,
+15.9%)
- Operating expenses: €17.1 million (-11.5% vs. first half
of previous year)
- Net result: €-8.2 million (vs. €-13.7 million in first
half of previous year)
- Available cash: €26.8 million (of which €15.0 million in
non-risky current financial assets)
Main cash payments received after the
closing +€4.2 million from the 2022 Research Tax Credit
+€2.7 million from the Gates Foundation for collaboration on the
mdc-WWM program
Marketed product: UZEDY (risperidone – schizophrenia)
UZEDY is the first product based on MedinCell's long-acting
injection technology, BEPO, to reach commercial stage
- US marketing authorization obtained from the FDA on April 28,
2023
- Commercial launch under the UZEDY brand by our partner, Teva,
in the United States in May 2023
- Teva's positive comments on the commercial launch:
- On the basis of agreements already concluded and ongoing
negotiations with US private and public insurance systems, our
partner expects to be well positioned for market access in
2024
- Feedback from healthcare professionals and patients has been
very positive about the product's features: subcutaneous injection,
immediate action, pre-filled, ready-to-use syringe, etc.
- Teva anticipates significant sales growth in 2024
- During the first half, UZEDY generated a €3.6 million milestone
payment following FDA approval, as well as the very first royalties
of €0.6 million, calculated on Teva's net sales from mid-May to end
of September.
Development of product portfolio based on BEPO
technology
Programs in clinical Phase 3
mdc-TJK (olanzapine - schizophrenia)
If approved by the FDA, mdc-TJK would be the first long-acting
injectable olanzapine product with a favorable safety profile
potentially elevating this product to " first-in-class" status.
mdc-TJK offers a complementary treatment solution to UZEDY for
patients with more severe forms of schizophrenia.
- The Phase 3 clinical trial conducted by our partner, Teva,
began in the United States in January 2023.
- On November 13, 2023, Teva announced that it had reached an
agreement with Royalty Pharma to accelerate the development of
mdc-TJK.
- On November 29, 2023, Teva reported that over 600 patients (out
of 640 planned in the study) had already been enrolled, and that no
post-injection delirium/sedation syndrome (PDSS) had been observed
on over 1400 injections. Teva also announced that all data
(collected after 3600 injections) are expected in the second half
of 2024 (as opposed to the previous expectation of H1 2025). These
data will include the study's primary endpoints and safety
data.
mdc-CWM / F14 (celecoxib - postoperative pain)
Conducted and funded by MedinCell's partner, Arthritis
Innovation Corporation (AIC), the first Phase 3 clinical trial of
this locally administered treatment to relieve patients' pain for a
prolonged period after surgery began in November 2022.
- Recruitment of the 151 patients was completed in August 30,
2023 with the last patient completing the 3 month follow-up period
end of November 2023.
- Data base lock and topline results are expected in the first
quarter of 2024.
Programs in formulation and preclinical
- Progress in preclinical activities for three programs with a
view to starting clinical trials in 2024: mdc-GRT
(immunosuppressant/organ transplant), mdc-WWM (contraception) with
support from the Bill & Melinda Gates Foundation and mdc-STM
(malaria) with support from Unitaid.
- Several collaborations with pharmaceutical partners are
currently in formulation.
- MedinCell continues to expand its portfolio of in-house
programs.
Selected financial information for the first half of the
2023-2024 fiscal year
Consolidated key figures - IFRS (In
thousands of €)
PROFIT AND LOSS ACCOUNT
09.30.2023
6 months
09.30.2022
6 months
Revenue
6 985
6 027
Other income from ordinary activities
(Research Tax Credit)
1 195
1 682
Current operating profit
(8 957)
(11 652)
Operating profit
(8 981)
(11 657)
Financial result
823
(2 090)
Net result
(8 158)
(13 747)
CASHFLOW
09.30.2023
6 months
09.30.2022
6 months
Net cashflow from operating activities
(11 759)
(9 962)
Net cashflow flow from investing
activities
(190)
(230)
Net cashflow from financing activities
32 260
(2 700)
BALANCE SHEET
09.30.2023
03.31.2023
Equity of the consolidated group
(25 747)
(42 294)
Total non-current liabilities
56 414
14 608
Total current liabilities
19 821
57 025
Total non-current assets
11 093
9 772
Of which financial assets and other
non-current assets
3 262
1 460
Total current assets
39 397
19 568
Of which cash and cash equivalents
26 779
6 467
FINANCIAL DEBT
09.30.2023
03.31.2023
Financial debt, non-current portion
53 659
11 708
Financial debt, current portion
9 418
42 812
GROSS FINANCIAL DEBT
63 077
54 520
Cash and cash equivalents
26 779
6 467
NET FINANCIAL DEBT
36 298
48 053
Profit and loss account
Income from ordinary activities: €8.2 million
Increased by 6% compared to the previous period, revenues for
the first half of the 2023-2024 financial year were generated by
(i) a milestone payment of €3.6 million for UZEDY's marketing
approval by the US FDA, (ii) services rendered as part of the
Company collaborations, (iii) royalties received from Teva on the
first sales of UZEDY (€0.6 million) and from CMB for the supply of
copolymers.
The Company's research and development (R&D) activities are
eligible for the Research Tax Credit. It has decreased compared to
last year by 29% due to lower R&D expenses, particularly for
expenses with CDMO and clinical CROs.
Current operating expenses in line with the development of
the Company’s portfolio: €17.1 million
Operating expenses were down by 12% compared to the same period
last year. This was mainly due to lower R&D expenditure, which
accounted for 65% of operating expenses. This is the consequence of
the reorganization of teams and optimization of internal skills,
and of the nature of outsourced activities, which differ from the
previous year.
Marketing and sales expenditure was up by almost 8% on the same
period last year, due in particular to the promotional campaign
launched after the approval of UZEDY.
Overheads, meanwhile, rose by 37% over the period, mainly due to
the increase in salaries and bonuses for members of the Executive
Board, higher legal and accounting fees, and the deployment of our
investor strategy in the United States.
Net financial income: €0.8 million
The change in the financial result is explained by the
renegotiation of the EIB loan on November 22, 2022, which led to an
increase in the average indebtedness following the issuance of
tranches B and C and to a reduction in the interest rate from
16.28% to 13% on tranche A, and to the re-estimation of the
variable remuneration and the fair value variation of the BSA put
options linked to the EIB loan as of September 30, 2023.
Consolidated cash flow statement
(In thousands of €)
09.30.2023 6 months
09.30.2022 6 months
Net cash from operating activities
(11 759)
(9 962)
Net cash flow from investing
activities
(190)
(230)
Net cash flow from financing
activities
32 260
(2 700)
CHANGE IN NET CASH AND CASH
EQUIVALENTS
20 312
(12 889)
Cash and cash equivalents – opening
balance
6 467
24 617
Cash and cash equivalents – closing
balance
26 779
11 728
As of September 30, 2023, MedinCell had cash and cash
equivalents of €26.8 million, of which €15.0 million in non-risky
current financial assets, compared with €6.5 million in cash and
cash equivalents at March 31, 2023.
The Company completed a capital increase of €23.2 million net in
May 2023 and received the final €10 million tranche of the loan
from the European Investment Bank.
During the first semester, the Company also received the first
royalties calculated on Teva's net sales of UZEDY. The Company
expects these royalties to increase progressively over the next few
years, until this first product reaches peak sales. In addition,
MedinCell is still eligible to receive up to $105 million in
commercial milestones related to UZEDY.
Medincell’s cash position has also been strengthened since the
year-end by several significant incomes, including €4.2 million of
the 2022 Research Tax Credit and €2.7 million under the grant
awarded by the Bill & Melinda Gates Foundation for the mdc-WWM
program.
In the Company's baseline forecast scenario, MedinCell is fully
able to meet its contractual financial commitments to the EIB
within the next twelve months in terms of projected cash flow. This
time horizon could increase considerably with the signature of new
licensing agreements currently under discussion. The pace of UZEDY
sales ramp-up, which depends in particular on Teva's commercial
strategy, as well as the date of eventual approval of mdc-TJK and
its launch on the market, may also have a significant impact on the
Company's financial visibility.
About MedinCell
MedinCell is a clinical and commercial-stage biopharmaceutical
company developing long-acting injectable drugs in a wide range of
therapeutic areas. Our innovative treatments aim to ensure
compliance with medical prescriptions, improve efficacy and
accessibility of medicines, and reduce their environmental
footprint. They combine already known and used active ingredients
with our proprietary BEPO® technology which controls the release of
a drug at a therapeutic level for several days, weeks or months
from the subcutaneous or local injection of a simple, fully
bioresorbable deposit measuring just a few millimeters. The first
treatment based on BEPO technology, intended for the treatment of
schizophrenia, was approved by the U.S. 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, France, MedinCell currently employs over 140
people representing more than 25 different nationalities.
UZEDY™ and SteadyTeq™ are registered trademarks of Teva
Pharmaceuticals.
This press release may contain forward-looking statements,
particularly concerning the progress of the Company's clinical
trials. Although the Company considers that its forecasts are based
on reasonable assumptions, any statements other than statements of
historical fact that may be contained in this press release
relating to future events are subject to change without notice, to
factors beyond the Company's control and to the Company's financial
capabilities.
These statements may include, but are not limited to, any
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"intend", "may", "anticipate", "estimate", "plan", "project",
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Forward-looking statements are subject to inherent risks and
uncertainties beyond the Company's control which may cause actual
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materially from those anticipated or implied by such
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A list and description of such risks, hazards and uncertainties
are included in the documents filed by the Company with the
Autorité des Marchés Financiers (AMF) pursuant to its regulatory
obligations, including in the Company's document de base,
registered with the AMF on September 4, 2018 under number I.
18-062, as well as in documents and reports to be published
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version on businesswire.com: https://www.businesswire.com/news/home/20231219262828/en/
David Heuzé - Head of Communications
david.heuze@medincell.com / +33 (0)6 83 25 21 86
Investors Relations France Louis-Victor
Delouvrier/Alban Dufumier medincell@newcap.eu / +33 (0)1 44 71
94 94
Media Relations Nicolas Mérigeau
medincell@newcap.eu / +33 (0)1 44 71 94 94
US Financial & IR Strategy Grace Kim
grace.kim@medincell.com / +1 (646) 991-4023
Medincell (EU:MEDCL)
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Medincell (EU:MEDCL)
過去 株価チャート
から 6 2023 まで 6 2024