- 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
The management team will host webcast conference calls on
Tuesday, September 26 at:
- 1:00 pm CEST, Paris time (7:00 am ET) in French
and
- 8:30 am ET, New York time (2:30 pm CEST) in
English.
A presentation will be available after the event on Poxel's
website in the Investor section.
To register for the webcast in French: click here
To register for the webcast in English: click here
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 announced its financial results for the period ended June 30,
2023 and provided a corporate update.
Thomas Kuhn, Chief Executive Officer of Poxel, stated:
“During the first semester of 2023, TWYMEEG strong sales momentum
has been confirmed, with a total growth sales amount for the year
2022 that exceeded Sumitomo Pharma’s forecast by 20%, and a 23%
increase for the first quarter of Sumitomo Pharma fiscal year. This
trend has been key to the success of our recent debt restructuring
with our lenders. Our debt restructuring, along with the potential
full drawdown of a new equity-linked financing with IRIS, extended
our cash runway through Q2 2025. We are now concentrating our
resources to actively work on other financing options to allow us
to pursue our strategy in rare diseases, which includes the launch
of Phase 2 proof-of-concept studies in this area, starting with
adrenoleukodystrophy.”
First Half 2023 Key Events
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.
- 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
Pharma’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 contribute to the increase in
sales. These factors have resulted in a much higher increase in
demand for TWYMEEG than expected by Sumitomo Pharma, and thus
inventories are temporarily tight. Sumitomo Pharma is working
diligently to increase the production and secure inventory capacity
to meet this increasing demand.
- For its FY 2023, Sumitomo Pharma 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 Pharma FY 2023, as a conservative assumption
in line with Sumitomo Pharma’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 Pharma 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 Pharma 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 Pharma’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
Pharma, Poxel is having active discussions with various potential
partners for Imeglimin, in several countries. Those discussions
also involve India, where local companies have received approval
and have launched Imeglimin, in monotherapy only. 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 15 employees at Poxel compared to 37 at the end
of December 2022.
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.
First Half 2023 Financial Results (IFRS standards)
Revenue
EUR (in thousands)
H1 2023 6
months
H1 2022 6
months
Sumitomo Pharma Agreement
955
83
Other
-
-
Total revenues
955
83
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 Pharma 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.
Income Statement
EUR (in thousands)
2023 6 months
2022 6 months
Revenue
955
83
Cost of sales
(955)
(83)
Gross margin
-
-
Research and development expenses*
(2,772)
(7,882)
Depreciation and amortization of
intangible assets
(16,572)
-
General and administrative expenses
(4,278)
(4,295)
Operating gain (loss)
(23,274)
(12,178)
Financial income (loss)
(2,968)
(1,223)
Income tax
-
-
Net income (loss)
(26,243)
(13,401)
*Net of R&D tax credit.
In the first half of 2023, the amount of amortization and
depreciation of intangible assets includes exclusively the
impairment of PXL065 for EUR 16.6 million. This impairment aims to
best reflect the current value of PXL065, taking into account the
Company's need to obtain additional financing to pursue its
development plan in NASH or ALD, its current market capitalization
and the macroeconomic context in which it operates. However, the
Company considers that the potential of PXL065 in its targeted
indications remains unchanged and very promising. Depending on the
evolution of ongoing discussions for a partnership for PXL065, the
Company will reassess the value of the PXL065 asset at the end of
the second half of 2023.
R&D expenses totaled EUR 2.8 million for the first half of
2023, as compared to EUR 7.9 million for the corresponding period
in 2022. The 2023 decrease primarily reflects the end, in 2022, of
the Phase 2 DESTINY study evaluating PXL065 in NASH.
R&D expenses are net of the R&D Tax Credit (CIR) that
resulted in an income of EUR 0.3 million for the first half of 2023
as compared to EUR 0.9 million for the corresponding period in
2022.
General and administrative expenses totaled EUR 4.3 million for
the first half of 2023, unchanged compared to the corresponding
period in 2022.
The financial loss amounted to EUR 3.0 million for the first
half of 2023, compared to EUR 1.2 million during the first half of
2022. It primarily reflected the interests attached to the Company
indebtedness.
The net result for the financial period ending June 30, 2023,
was a net loss of EUR 26.2 million, as compared to a net loss of
EUR 13.4 million in the corresponding period in 2022.
First Half 2023 Cash and Cash equivalent
EUR (in thousands)
H1 2023
Q4 2022
Cash
7,597
13,058
Cash equivalents
-
-
Total cash and cash equivalents
7,597
13,058
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.
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.
Planned Presentations and Participations at the Following
Upcoming Events
- 12th International Meeting on AMPK, October 5 (virtual)
- 7th Annual H.C. Wainwright NASH Investor Conference, October 24
(virtual)
- Healthtech Innovation Days (HTID), HealthTech For Care, October
24-25 (in Paris and virtual)
Next Financial Press Release: Third Quarter 2023 Results
and Corporate Update, on November 8, 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 2023 is April 1, 2023 through March 31,
2024.
- TWYMEEG royalties: As per the Sumitomo Pharma’s
agreement, Poxel is entitled to receive royalties from the sales of
TWYMEEG (Imeglimin) in Japan
- Sumitomo Pharma communicates gross
sales TWYMEEG, while TWYMEEG royalties are calculated on
net sales.
- Net sales represent the amount of gross sales to which are
deducted potential rebates, allowances, and costs such as prepaid
freight, postage, shipping, customs duties and insurance
charges.
- Poxel is entitled to receive escalating royalties of 8-18% on
TWYMEEG net sales from Sumitomo
Pharma.
Positive net royalties: 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. All royalties that Poxel receives from TWYMEEG net sales
above that 8% level are considered as positive net royalties. Net
royalties will therefore be positive for Poxel when TWYMEEG net
sales exceed JPY 5 billion in a fiscal year and royalties reach 10%
and above.
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 5,545,000, and the Group has
the ability to drawdown EUR 1,155,000
under the additional tranches.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230925488334/en/
Contacts - 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
Poxel (EU:POXEL)
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