- TWYMEEG sales in Japan for the last quarter (April-June)
grew 23% over the prior quarter, in line with Sumitomo Pharma’s FY
2023 forecast1, which would represent a 90% increase over the prior
year sales
- Company actively pursuing additional financing to initiate
ALD Phase 2 Proof-of-Concept (POC) studies and execute its rare
diseases strategy
- As of June 30, 2023, cash and cash equivalents were EUR 7.6
million (USD 8.2 million)2; cash runway through Q2 2025, assuming
full drawdown of the existing equity-linked financing facility with
IRIS
Regulatory News:
POXEL SA (Euronext: POXEL - FR0012432516) (Paris:POXEL), 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 second quarter and
first half of 2023.
Thomas Kuhn, Chief Executive Officer of Poxel, stated:
“During this past semester, we have diligently worked to improve
our financial flexibility, and this has been a success through the
combination of the restructuring of our existing debt obligations
and the setup of a new equity-linked financing with IRIS. Now that
our financial visibility extends through Q2 2025, we can
concentrate on our strategy, which includes the launch of Phase 2
proof-of-concept studies in rare diseases, starting with
adrenoleukodystrophy, subject to additional financing. The recent
trajectory of TWYMEEG sales has also been key in the restructuring
of our debt. Sumitomo Pharma, our partner commercializing TWYMEEG
in Japan, recently reported gross sales for its Q1 2023, which
shows a 23% increase over the prior quarter, and gives us
confidence in the ability to meet Sumitomo Pharma’s FY 2023
forecast.”
Commercial Update
TWYMEEG® (Imeglimin)
- For the quarter ended June 2023, TWYMEEG gross sales in Japan
increased 23% to JPY 1.16 billion (EUR 7.4 million)2 over the prior
quarter sales of JPY 0.9 billion (EUR 6.2 million)2 as reported by
Sumitomo Pharma (Sumitomo).
- 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.
Thanks 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 are growing strongly in Japan, and contributes to
the increase in sales. 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 the production and secure inventory capacity to meet
this increasing demand.
- For its FY 2023, Sumitomo announced a forecast for TWYMEEG of
JPY 4.2 billion1 (EUR 28.9 million)3 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)3 entitling Poxel to receive 10% royalties on all
TWYMEEG net sales (on which the first 8% will still be paid to
Merck Serono) and a sales-based payment of JPY 500 million (EUR 3.4
million)3. Beyond Sumitomo FY 2024, Poxel expects to receive
escalating double-digit royalties as well as additional sales-based
payments upon achievement of contractually based sales thresholds.
As per the debt restructuring agreements established with its
lenders in March, positive net royalties and sales-based payments
will be directed to Poxel debt reimbursement until the loans are
fully repaid (which Poxel expects in Q2 2029, at the latest). After
this time, subsequent net royalties and sales-based payments will
revert back to Poxel.
- 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.
- A Phase 4, 52-week, Open-label, Long-Term Study of Imeglimin in
Japanese Type 2 Diabetic Patients with Renal Impairment is
currently ongoing in Japan to strengthen TWYMEEG profile in this
key subpopulation, and top line results are expected in 2024.
- 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 two Phase 2
biomarker proof-of-concept (POC) clinical trials in male patients
with adrenomyeloneuropathy (AMN), the most common ALD subtype. The
12-week studies 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.
- In line with its mission, Poxel aims to bring therapeutic
options to treat ALD, and supported the Alex Leukodystrophy Charity
during their Community Weekend, which took place from April 28th to
May 1st in Birmingham, England. This event brings together
leukodystrophy sufferers and their families, alongside doctors,
researchers and scientists from around the world to discuss
leukodystrophies.
- On June 23rd and 24th, Poxel participated virtually at the ULF
(United Leukodystrophy Foundation) Scientific Symposium and Family
Conference in Itasca, Illinois, USA. Sophie Bozec, Poxel Senior
Vice President, R&D Pharmacology and Scientific Communication
presented Poxel’s status and plans for PXL770 and for the
deuterium-modified TZD platform, using PXL065, based on robust
scientific rationale and a complete preclinical package.
Corporate Update
- On June 21st, the Company held its ordinary annual and
extraordinary general meeting of shareholders. The shareholders
approved all the resolutions that were recommended by the Board of
Directors, including the renewal of Mr. Khoso Baluch, Mr. Thomas
Kuhn et Ms. Pascale Boissel as Board members.
- During the first semester, the Company pursued its corporate
savings plan initiated in 2022 aiming at adapting the Company’s
resources to the current clinical development plan while preserving
critical resources and competencies. At the date of this press
release, there are 16 employees at Poxel compared to 37 at the end
of December 2022.
- At the end of June, Elizabeth Woo, Senior Vice President,
Investor Relations & Communication, left the Company to pursue
other endeavours.
Significant Events after the
Period
On July 5th, Poxel was chosen as the winner of the 2023 edition
of the I-nov contest for its program in ALD. Financed by the French
State via the France 2030 plan, the prize of this contest includes
a grant which will contribute in part4 in the financing of the two
phase IIa proof-of-concept clinical studies for PXL770 and PXL065,
which are ready to be launched, subject to additional funding,
which the Company is actively working on.
In July 2023, the European Patent Office (EPO) granted Poxel a
new patent for PXL065, a novel, proprietary deuterium-stabilized
R-stereoisomer of pioglitazone, which describes a specific form of
PXL065 with unique properties. This recently issued patent provides
additional protection through 2041, with the potential for an
additional 5 years through patent term extension. In 2022, Poxel
had been granted the same patent for PXL065 from the US Patent
Office.
Second Quarter and First Half 2023 Cash and Cash
equivalents
As of June 30, 2023, cash and cash equivalents were EUR 7.6
million (USD 8.2 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 37.7 million as of June 30, 2023, as compared to EUR
29.5 million as of December 31, 2022.
EUR (in thousands)
Q2 2023
Q4 2022
Cash
7,599
13,058
Cash equivalents
-
-
Total cash and cash equivalents
7,599
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:
- this cash position on June 30, 2023,
- the full drawdown of the tranches available under the
equity-linked financing with IRIS,
- the current research and development plan, excluding the
initiation of Phase 2 clinical POC biomarker studies for PXL065 and
PXL770 in AMN, and
- 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.
The full drawdown of the IRIS equity linked facility can be made
subject to certain conditions described in the Company’s Universal
Registration Document. At the date of this press release and only
based on the tranches already drawn5 or fully available6, the
Company expects that its resources will be sufficient to fund its
operations and capital expenditure requirements until January
2024.
Second Quarter and First Half 2023 Revenue
Poxel reported revenue of EUR 955 thousand for the six months
ended June 30, 2023, as compared to EUR 83 thousand revenue during
the corresponding period in 2022.
Revenue for the first half of 2023 reflects JPY 148 million (EUR
955 thousand) of royalty revenue from Sumitomo Pharma 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 fiscal year 2023 (April 2023 to
March 2024). 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
Q2 2023
H1 2023
Q1
2022
Q2
2022
H1 2022
3 months
3 months
6 months
3 months
3 months
6 months
Sumitomo Pharma Agreement
449
506
955
32
51
83
Other
-
-
-
-
Total revenues
449
506
955
32
51
83
Unaudited data
Planned Presentation and Participation at the Following
Upcoming Event
- 23rd edition of the European MidCap Event, Paris, September
21-22
Next Financial Press Release: 2023 First Half Results, on
September 26, 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 As per Sumitomo Pharma FY23 forecast of JPY 4.2 billion
published on May 15, 2023. 2 Converted at the exchange rate as of
June 30, 2023. 3 Converted at the exchange rate as of March 31,
2023. 4 Up to 45% of the estimated eligible costs. 5 Since March
31, 2023, 2 additional tranches of EUR 600,000 each have been drawn
in May and July. 6 At the date of this press release, the amount of
redeemable bonds owned by IRIS is EUR 5,980,000, and the Group has
the ability to drawdown EUR 1 020 000
under the additional tranches.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230830205409/en/
Investor relations / Media
Aurélie Bozza Investor Relations & Communication Senior
Director aurelie.bozza@poxelpharma.com +33 6 99 81 08 36
NewCap Nicolas Fossiez, Aurélie Manavarere / Arthur Rouillé
poxel@newcap.eu +33 1 44 71 94 94
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