- TWYMEEG sales in Japan for the last quarter (July-September)
grew by 28% over the prior quarter. Current trajectory, if
maintained, would lead to higher TWYMEEG annual sales than Sumitomo
Pharma’s FY 2023 forecast1, which would already represent a 90%
increase over the prior year sales
- Company in active discussions with various investors and
potential partners with the objective to receive additional
financing and pursue the execution of its rare diseases
strategy
- As of September 30, 2023, cash and cash equivalents were EUR
5.3 million (USD 5.6 million)2; assuming full drawdown of the
existing equity-linked financing facility with IRIS, cash runway
through Q2 2025
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 third quarter and the nine months ended
September 30, 2023.
“We are extremely satisfied with TWYMEEG strong growth
trajectory over this past quarter, with an almost 30% growth
reported by our partner, Sumitomo Pharma. It is a sustained
confirmation of the value of TWYMEEG to treat patients with
type-2-diabetes. Also, if the current trend is maintained, we could
expect to exceed Sumitomo Pharma’s FY 2023 forecast, which would
entitle us to higher royalties on all TWYMEEG net sales and a
sales-based payment of EUR 3.4 million2 sooner than expected,”
stated Thomas Kuhn, Chief Executive Officer of Poxel. “We are still
in active discussions with investors and potential partners as we
are focused on securing additional fundings to move forward our
rare diseases strategy and launch Phase 2 Proof-of-Concept (POC)
studies in ALD.”
Third Quarter and Nine Months Ended September 30, 2023, Cash
and Revenue
Cash
As of September 30, 2023, total cash and cash equivalents were
EUR 5.3 million (USD 5.6 million), as compared to EUR 7.6 million
as of June 30, 2023.
EUR (in thousands)
Q3 2023
Q2 2023
Q1 2023
Q4 2022
Cash
5,265
7,597
10,629
13,058
Cash equivalents
-
-
-
-
Total cash and cash
equivalents*
5,265
7,597
10,629
13,058
Unaudited data
* Net financial debt (excluding IFRS 16
impacts and derivative debts) was EUR 41.4 million at the end of Q3
2023 as compared to EUR 37.7 million at the end of Q2 2023.
Based on:
- this cash position on September 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 drawn3 or fully available4, the
Company expects that its resources will be sufficient to fund its
operations and capital expenditure requirements until January
2024.
Nine Months 2023 Revenue
Poxel reported revenues of EUR 1,619 thousand for the nine
months ended September 30, 2023, as compared to EUR 286 thousand
during the corresponding period in 2022.
Revenue for the first nine months of 2023 mostly reflects the
JPY 253 million (EUR 1,619 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.
EUR
(in thousands)
Sept. 2023
9 months
Q3 2023
3 months
H1
2023
6 months
Sept. 2022
9 months
Q3
2022
3 months
H1
2022
6 months
Sumitomo Pharma Agreement
1,619
664
955
286
203
83
Other
-
-
-
-
-
-
Total revenues
1,619
664
955
286
203
83
Unaudited data
Commercial Update
TWYMEEG® (Imeglimin)
- For the quarter ended September 2023, TWYMEEG gross sales in
Japan increased by 28% to JPY 1.48 billion (EUR 9.4 million) 2 over
the prior quarter sales of JPY 1.16 billion (EUR 7.4 million)5 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 has worked
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)6 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)6 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)6. 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.
- 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 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.
- In adrenoleukodystrophy (ALD), PXL770 and PXL065 are prepared
to advance, subject to additional financing, into two Phase 2a
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.
Corporate Update
- 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 part 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.
Next Financial Press Release: Fourth Quarter 2023 Cash
and Revenue update, on February 15, 2024
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 now 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 of 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
September 30, 2023. 3 Since March 31, 2023, 4 additional tranches
have been drawn for a total amount of EUR 2,3 million. 4 At the
date of this press release, the amount of redeemable bonds owned by
IRIS is EUR 6,917,500, and the Group has the ability to drawdown
EUR 82,500 under the additional tranches. 5 Converted at the
exchange rate as of June 30, 2023. 6 Converted at the exchange rate
as of March 31, 2023.
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version on businesswire.com: https://www.businesswire.com/news/home/20231108626731/en/
Investor relations / Media
Aurélie Bozza Vice-President, Investor Relations & Corporate
Communications 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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