- TWYMEEG sales in Japan for Sumitomo Pharma Fiscal Year 20221
exceeded guidance2 by more than 20%, and TWYMEEG’s FY 2023
forecast3 from Sumitomo Pharma would represent a 90% increase over
the prior year sales
- Cash runway extended through Q2 2025 through debt
restructuring and assuming full drawdown of the equity-linked
financing facility with IRIS
- Company actively pursuing additional financing to initiate
adrenoleukodystrophy (ALD) Phase 2 Proof-of-Concept (POC)
studies
- As of March 31, 2023, cash and cash equivalents were EUR
10.6 million (USD 11.6 million)4
Regulatory News:
POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage
biopharmaceutical company developing innovative treatments for
chronic serious diseases with metabolic pathophysiology, including
non-alcoholic steatohepatitis (NASH) and rare metabolic disorders,
today provided a corporate update and announced its cash position
and revenue for the first quarter ended March 31, 2023.
Thomas Kuhn, Chief Executive Officer of Poxel, stated: “This
quarter we successfully restructured our debt obligations and
increased our financial flexibility with a new equity-linked
financing with IRIS. Together these actions significantly extend
our financial visibility through Q2 2025. Our lenders agreed to
postpone initiation of repayments until Q1 2025, based on future
potential royalties from increasing TWYMEEG net sales which will be
directed towards debt repayments. Sumitomo Pharma, our partner
commercializing TWYMEEG in Japan, recently reported the total sales
for their fiscal year 2022, which significantly exceeded the
forecast they had just increased by more than 20% a few months
before. We are of course extremely pleased with this trajectory
that confirms the value of TWYMEEG and gives us confidence in the
timing of future expected positive royalties and sales-based
payments. This also allows us to fully dedicate ourselves to our
strategy, including the launch of Phase 2 proof-of-concept studies
in adrenoleukodystrophy, pending additional financing. We continue
to believe that our strategy in rare diseases has great potential
for value creation.”
Corporate Update
- On March 23rd, the Company announced that it had restructured
its existing debt with its lenders, IPF and the banks that are part
of the French Government Guarantee Loan (PGE Loan). In both
agreements, amortization payments under the existing debt facility
have been postponed and will reinitiate when the Company starts
receiving positive net royalty flows from TWYMEEG® (Imeglimin)
sales in Japan. Based on the conservative forecast agreed upon by
the Company and its lenders, amortization payments would be
postponed until Q1 2025. During Sumitomo Pharma’s (Sumitomo) fiscal
year (FY) 2024 (ending March 31, 2025), Poxel expects TWYMEEG net
sales in Japan to reach at least JPY 5 billion (EUR 34.4 million)4,
entitling Poxel to receive 10% royalties on all TWYMEEG net sales
and a sales-based payment of JPY 500 million (EUR 3.4 million)4.
Positive net royalties and sales-based payments will be directed to
the debt reimbursement until the loans are fully repaid, which the
Company expects in Q2 2029, at the latest. After this time,
subsequent net royalties and sales-based payments will revert back
to the Company. In addition to the postponement of debt repayments
mentioned above, the Company and IPF have agreed to new financial
covenants5.
- Concurrent with this debt restructuring, the Company entered
into a new equity-linked financing arrangement with IRIS in the
form of bonds redeemable for new or existing shares, in order to
provide additional liquidity and flexibility intended to support
its ongoing regulatory and development activities, as well as
general corporate purposes. An initial amount of EUR 3.5 million
was drawn down, and the Company has the option, at its sole
discretion subject to certain condition precedent, to draw
additional tranches up to the remaining EUR 11.5 million (for a
total of EUR 15 million) over 2 years6. Upon conversion of the
equity-linked instruments, IRIS will be issued Poxel shares to be
created from the Company’s authorized capital and/or will receive
existing ordinary shares of the Company and is expected to sell
these shares on the market or in block trades.
- As part of refocusing its activities, the Company reviewed the
organization of its Board of Directors and decided to reduce the
size of the Board. Since March 31st, Poxel’s Board of Directors is
comprised of 4 members: Khoso Baluch as Chairman of the Board,
Thomas Kuhn as CEO of Poxel, Pascale Boissel and Richard Kender as
independent members. IPF remains an observer on the Board.
Commercial Update
TWYMEEG® (Imeglimin)
- For the quarter ended March 2023, TWYMEEG gross sales in Japan
increased 23% to JPY 0.9 billion (EUR 6.2 million)4 over the prior
quarter sales of JPY 0.8 billion (EUR 5.5 million)4 as reported by
Sumitomo. As a result, for Sumitomo’s FY 2022, TWYMEEG gross sales
reached JPY 2.2 billion (EUR 15.0 million)4, exceeding Sumitomo’s
most recent FY 2022 forecast2 by 22%.
- The sales in recent quarters have accelerated due to the end of
initial launch year restrictions for TWYMEEG in September 2022,
which limited new products to two weeks prescriptions, and
Sumitomo’s commercial efforts to leverage TWYMEEG’s potential. Due
to its unique mechanism of action and safety profile, TWYMEEG can
be used both as a monotherapy and in combination with other
treatments, such as DPP4 inhibitors, the most prescribed treatment
for Japanese Type-2-Diabetes patients, and SGLT2 inhibitors, which
is growing strongly in Japan. These factors have resulted in a much
higher increase in demand for TWYMEEG than expected by Sumitomo,
and thus inventories are temporarily tight. Sumitomo is working
diligently to increase capacity over the summer.
- For its FY 2023, Sumitomo announced a forecast for TWYMEEG of
JPY 4.2 billion3 (EUR 28.9 million)4 which would represent a 90%
increase over FY 2022 TWYMEEG gross sales.
- For the Sumitomo FY 2023, as a conservative assumption in line
with Sumitomo’s forecast, Poxel expects to receive 8% royalties on
TWYMEEG net sales. As part of the Merck Serono licensing agreement,
Poxel will pay Merck Serono a fixed 8% royalty based on the net
sales of TWYMEEG, independent of the level of sales.
- During Sumitomo FY 2024 (ending March 31, 2025), Poxel expects
TWYMEEG net sales in Japan to reach at least JPY 5 billion (EUR
34.4 million)4 entitling Poxel to receive 10% royalties on all
TWYMEEG net sales and a sales-based payment of JPY 500 million (EUR
3.4 million)4. Beyond 2024, Poxel expects to receive escalating
double-digit royalties as well as additional sales-based payments
upon achievement of contractually based sales thresholds.
- As part of the Sumitomo’s ongoing efforts to communicate
TWYMEEG’s unique mechanism of action and safety profile, 9
abstracts based on Imeglimin Phase 2b and Phase 3 clinical trials
were accepted for oral presentations at the 66th Annual Meeting of
the Japanese Diabetes Society (JDS), held in Kagoshima, Japan, May
11-13, 2023.
- For territories not covered by its agreement with Sumitomo,
Poxel is in ongoing discussions with various potential partners for
Imeglimin, including in India, where local companies have recently
received approval and have launched Imeglimin. At the date of this
press release, no agreement has been established, and Poxel
continues to be committed to asserting its rights in connection
with its assets.
Rare metabolic diseases
- In adrenoleukodystrophy (ALD), PXL770 and PXL065 are prepared
to advance, subject to additional financing, into a Phase 2
biomarker proof-of-concept (POC) clinical trials in male patients
with adrenomyeloneuropathy (AMN), the most common ALD subtype. The
12-week study will evaluate pharmacokinetics, safety and potential
for efficacy based on relevant disease biomarkers, such as the
effect on very long chain fatty acids (VLCFA), the characteristic
plasma marker of the disease.
- The European Commission granted orphan drug designation (ODD)
for PXL770 and PXL065 for the treatment of ALD. The U.S. Food and
Drug Administration (FDA) has previously granted ODD and Fast Track
Designation to both PXL770 and PXL065 for the treatment of
ALD.
- Preclinical study results in autosomal dominant polycystic
kidney disease (ADPKD) for PXL770 that support Phase 2 development
in this indication were published in the life sciences journal,
Kidney International. To access the online publication, please use
the following link: A novel direct adenosine monophosphate kinase
activator ameliorates disease progression in preclinical models of
Autosomal Dominant Polycystic Kidney Disease.
(kidney-international.org)
NASH
- Positive results for DESTINY-1 (Deuterium-stabilized
R-pioglitazone [PXL065] Efficacy and Safety Trial In NASH), a
36-week dose-ranging Phase 2 trial, were published in the Journal
of Hepatology. The online publication can be accessed with the
following link: Evaluation of PXL065 – Deuterium-Stabilized
(R)-Pioglitazone in NASH Patients: a Phase 2 randomized
placebo-controlled trial (DESTINY-1) - Journal of Hepatology
(journal-of-hepatology.eu)
Significant Event after the Period
- At the end of April, Noah Beerman, Executive Vice President,
Business Development and President of U.S. Operations, and David
Moller, Chief Scientific Officer, left the Company to pursue other
endeavours.
First Quarter 2023 Financial Update
As of March 31, 2023, cash and cash equivalents were EUR 10.6
million (USD 11.6 million), as compared to EUR 13.1 million (USD
14.0 million) as of December 31, 2022. Net financial debt
(excluding IFRS16 impacts and derivative debts) was EUR 34.8
million as of March 31, 2023, as compared to EUR 29.5 million as of
December 31, 2022.
EUR (in thousands)
Q1 2023
Q4 2022
Cash
10,629
13,058
Cash equivalents
-
-
Total cash and cash equivalents
10,629
13,058
Unaudited data
On March 23, 2023, the Company finalized agreements with its
lenders to restructure its existing debt facility and established a
new equity-linked financing with IRIS, including an initial
drawdown of EUR 3.5 million.
Based on (i) this cash position on March 31, 2023, (ii) the full
drawdown of the tranches available under the equity-linked
financing with IRIS, (iii) the current research and development
plan, excluding the initiation of Phase 2 clinical POC biomarker
studies for PXL065 and PXL770 in AMN, and (iv) a strict control of
its operating expenses, Poxel expects that its resources will be
sufficient to fund its operations and capital expenditure
requirements through Q2 2025.
First Quarter 2023 Revenue
Poxel reported EUR 449 thousand revenue for the quarter ended
March 31, 2023, as compared to 32 thousand revenue during the
corresponding period in 2022.
Revenue for the first quarter of 2023 reflects JPY 67.0 million
(EUR 449 thousand) of royalty revenue from Sumitomo, which
represents 8% of TWYMEEG net sales in Japan. Based on the current
forecast, Poxel expects to receive 8% royalties on TWYMEEG net
sales in Japan through the Sumitomo Pharma fiscal year 20232. As
part of the Merck Serono licensing agreement, Poxel will pay Merck
Serono a fixed 8% royalty based on the net sales of Imeglimin,
independent of the level of sales.
EUR (in thousands)
Q1 2023
Q1 2022
3 months
3 months
Sumitomo Pharma Agreement
449
32
Other
-
-
Total revenues
449
32
Unaudited data
Planned Presentation and Participation at the Following
Upcoming Event
- 2023 ULF Family Conference, Itasca, Illinois, USA, June 23-24,
2023
Next Financial Press Release: 2023 Second Quarter
Financial Update, on August 30, 2023
About Poxel SA
Poxel is a clinical stage biopharmaceutical company
developing innovative treatments for chronic serious diseases
with metabolic pathophysiology, including non-alcoholic
steatohepatitis (NASH) and rare disorders. For the treatment of
NASH, PXL065 (deuterium-stabilized R-pioglitazone) met its
primary endpoint in a streamlined Phase 2 trial (DESTINY-1). In
rare diseases, development of PXL770, a first-in-class
direct adenosine monophosphate-activated protein kinase (AMPK)
activator, is focused on the treatment of adrenoleukodystrophy
(ALD) and autosomal dominant polycystic kidney disease (ADPKD).
TWYMEEG® (Imeglimin), Poxel’s first-in-class product that
targets mitochondrial dysfunction, is marketed for the treatment of
type 2 diabetes in Japan by Sumitomo Pharma and Poxel expects to
receive royalties and sales-based payments. Poxel has a strategic
partnership with Sumitomo Pharma for Imeglimin in Japan, China, and
eleven other Asian countries. Listed on Euronext Paris, Poxel is
headquartered in Lyon, France, and has subsidiaries in Boston, MA,
and Tokyo, Japan.
For more information, please visit: www.poxelpharma.com
All statements other than statements of historical fact included
in this press release about future events are subject to (i) change
without notice and (ii) factors beyond the Company’s control. These
statements may include, without limitation, any statements preceded
by, followed by or including words such as “target,” “believe,”
“expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,”
“project,” “will,” “can have,” “likely,” “should,” “would,” “could”
and other words and terms of similar meaning or the negative
thereof. Forward-looking statements are subject to inherent risks
and uncertainties beyond the Company’s control that could cause the
Company’s actual results or performance to be materially different
from the expected results or performance expressed or implied by
such forward-looking statements. The Company does not endorse or is
not otherwise responsible for the content of external hyperlinks
referred to in this press release.
Glossary
You will find below a list of words and/or expressions that are
used in this press release or in Poxel’s communication, with the
aim to bring clarification and transparency:
- Sumitomo Pharma fiscal year runs April to March. As an
example, Fiscal Year 2022 is April 1, 2022 through March 31,
2023.
- TWYMEEG royalties: As per the Sumitomo’s agreement,
Poxel is entitled to receive royalties from the sales of TWYMEEG
(Imeglimin) in Japan
- TWYMEEG royalties are calculated on net sales, while Sumitomo Pharma communicates only
TWYMEEG gross sales.
- Poxel entitled to receive escalating royalties of 8-18% on
TWYMEEG net sales from Sumitomo
Pharma.
- Positive net royalties: refers to royalties Poxel
receives from TWYMEEG net sales after
paying Merck Serono the first 8%, once Poxel starts to receive 10%
royalties upon TWYMEEG net sales exceeding JPY 5 billion in a
fiscal year.
1 Sumitomo Pharma fiscal year 2022 ends March 31, 2023. 2
Sumitomo increased its FY2022 forecast to JPY 1.8 billion from JPY
1.5 billion on January 31, 2023. 3 As per Sumitomo Pharma FY23
forecast of JPY 4.2 billion published on May 15, 2023. 4 Converted
at the exchange rate as of March 31, 2023. 5 New covenants require
that the Company maintain: i) a minimum cash position between EUR 1
million and EUR 9 million, ii) a gearing ratio, as measured by
total net debt to the market capitalization value of the Company,
at a level lower than 150% (vs 50% initially), The complete details
and conditions of the debt restructuring agreement are presented on
the dedicated press release issued on March 23, 2023 and in the
Company’s 2022 Universal registration Document. 6 The drawdown of
additional tranches will be subject only to a maximum cumulative
outstanding amount of redeemable bonds owned by IRIS at any time
not to exceed EUR 7.0 million.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230517005540/en/
Investor relations / Media
Aurélie Bozza Investor Relations & Communication Senior
Director aurelie.bozza@poxelpharma.com +33 6 99 81 08 36
Elizabeth Woo Senior Vice President, Investor Relations &
Communication elizabeth.woo@poxelpharma.com
NewCap Nicolas Fossiez and Arthur Rouillé poxel@newcap.eu +33 1
44 71 94 94
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