- TWYMEEG® sales continue to increase in Japan for the last
quarter (July-September) by 5% over the prior quarter and by 23%
over the 3rd quarter 2023
- Poxel expects TWYMEEG® net sales in Japan in the near term
to reach at least JPY 5 billion (EUR 30.6 million)1 entitling the
Company to receive 10% royalties on all TWYMEEG® net sales and a
sales-based payment of JPY 500 million (EUR 3.1 million)
1
- Continued discussions with potential partners in parallel of
reviewing the clinical development strategy for PXL770 and PXL065
for the treatment of multiple rare diseases
- As of September 30, 2024, cash and cash equivalents were EUR
13.1 million (USD 14.7 million)2
- Following the non-dilutive financing agreement with OrbiMed,
cash runway extension until end of 2025, including the full
residual drawdown of the equity-linked financing facility put in
place with IRIS
Regulatory News:
POXEL SA (Euronext : POXEL - FR0012432516), a clinical stage
biopharmaceutical company developing innovative treatments for
chronic serious diseases with metabolic pathophysiology, including
metabolic dysfunction-associated steatohepatitis (MASH) 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, 2024.
“We are pleased to see the good sales trajectory for TWYMEEG® in
Japan, which should lead to the achievement of JPY 5 billion net
sales in the coming months, at which point, Poxel will be entitled
to 10% royalties on all TWYMEEG® net sales and a sales-based
payment of JPY 500 million (EUR 3.1 million)1 . These amounts,
based on our recent royalty monetization agreement, will serve to
start repayment of bonds to OrbiMed. Additionally, Poxel will
benefit from the residual amount of the reserve deposit made under
the terms of the agreement with OrbiMed, in addition to the USD
42.5 million proceeds received upon closing. This deposit amount
will be used to further reduce our debt obligations towards IPF
Partners,” stated Thomas Kuhn, Chief Executive Officer of
Poxel.
TWYMEEG® (Imeglimin)
- For the quarter ended September 2024, TWYMEEG® gross sales in
Japan increased by 5% to JPY 1.8 billion (EUR 11.4 million) 2 over
the prior quarter sales of JPY 1.7 billion (EUR 10.1 million)3 as
reported by Sumitomo Pharma.
- During Sumitomo Pharma FY 2024, Poxel expects TWYMEEG® net
sales in Japan to reach at least JPY 5 billion (EUR 30.6 million)1,
entitling Poxel to receive 10% royalties on all TWYMEEG® net sales
and a sales-based payment of JPY 500 million (EUR 3.1 million)1.
Based on the recent royalty monetization agreement with OrbiMed,
these proceeds for FY2024, net of Poxel's obligation to Merck
Serono, will be directed to the reimbursement of the bonds
issuance. Beyond 2024, Poxel expects to receive escalating
double-digit royalties as well as additional sales-based payments
upon achievement of contractually based sales thresholds.
- Sumitomo Pharma has announced an early retirement program in
Japan that could impact their organization, including Sales &
Marketing division. However, to support TWYMEEG® sales trajectory,
Sumitomo Pharma is implementing measures to minimize potential
impact from this program.
- As announced on August 7, 2024, topline results obtained from
the post-marketing clinical study, TWINKLE (TWYMEEG® in diabetic patients with renal impairment: A post-marketing long-term
study) conducted by Sumitomo Pharma in Japanese type 2 diabetic
patients with renal impairment confirmed TWYMEEG®’s safety and
tolerability profile, which is consistent with prior clinical
studies in the general type 2 diabetes population. Based on these
results, Sumitomo Pharma has initiated discussions with the
regulatory authorities in Japan for revising TWYMEEG® package
insert for patients with renal impairment with eGFR (estimated
glomerular filtration rate) less than 45 ml/min/1.73m2.
- In parallel of the non-dilutive financing agreement with
OrbiMed announced on September 30, 2024, Poxel recovered the
Imeglimin rights for Asian countries other than Japan4 from
Sumitomo Pharma. The Company has already initiated discussions to
develop and market Imeglimin in China, the world's second largest
type 2 diabetes market.
Third Quarter and Nine Months Ended September 30, 2024,
Revenue and Cash
Revenue
Poxel reported revenues of EUR 854 thousand for the third
quarter 2024, bringing the revenues for the nine months ended
September 30, 2024, to EUR 2,016 thousand as compared to EUR 1,619
thousand during the corresponding period in 2023.
Revenue for the first nine months of 2024 mostly reflects the
JPY 328 million (EUR 2,016 thousand)2 of royalty revenue from
Sumitomo Pharma which represents 8% of TWYMEEG® net sales in Japan.
Based on the current forecast, Poxel expects to receive 10%
royalties on TWYMEEG® net sales in Japan through the Sumitomo
Pharma fiscal year 2024 and a sales-based payment of JPY 500
million (EUR 3.1 million)1. 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.
According to the Royalty Monetization agreement with OrbiMed, the
positive net Royalties will be fully dedicated to the repayment of
the bonds.
EUR
(in thousands)
Sept. 2024
9 months
Q3 2024
3 months
H1
2024
6 months
Sept. 2023
9 months
Q3
2023
3 months
H1
2023
6 months
Sumitomo Pharma Agreement
2,016
854
1,162
1,619
664
955
Other
-
-
-
-
-
-
Total revenues
2,016
854
1,162
1,619
664
955
Unaudited data
Cash and cash equivalents
As of September 30, 2024, total cash and cash equivalents were
EUR 13.1 million (USD 14.7 million)2, as compared to EUR 2.8
million as of June 30, 2024.
EUR (in thousands)
Q3 2024
Q2 2024
Q1 2024
Q4 2023
Cash
13,149
2,812
2,460
2,341
Cash equivalents
-
-
-
-
Total cash and cash equivalents
13,149
2,812
2,460
2,341
Unaudited data
Following the non-dilutive financing agreement with OrbiMed, and
according to Poxel's current forecasts, including in
particular:
(i) The Company’s cash position as of
September 30, 2024, at EUR 13.1 million; (ii) the partial
redemption of the PGE loans for a total amount of EUR 2.8 million;
(iii) the advisory fees linked to the transaction; (iv) the full
residual drawdown of the equity-linked financing facility put in
place with IRIS5; and (v) the anticipated business plan including
strict control of its operating expenses;
the Company expects that its resources will be sufficient to
finance its operations and capital expenditures until the end of
2025.
Next Financial Press Releases:
- First Half Results, on December 9, 2024
- Fourth Quarter 2024 Cash and Revenue update, on February 12,
2025
About Poxel SA
Poxel is a clinical stage biopharmaceutical company
developing innovative treatments for chronic serious diseases
with metabolic pathophysiology, including metabolic
dysfunction-associated steatohepatitis (MASH) and rare
disorders. For the treatment of MASH, 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. 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 2024 is April 1, 2024, through March 31,
2025.
- 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 Converted at the exchange rate as of March 31, 2024 2
Converted at the exchange rate as of September 30, 2024. 3
Converted at the exchange rate as of June 30, 2024. 4 China, South
Korea, Taiwan, Indonesia, Vietnam, Thailand, Malaysia, The
Philippines, Singapore, Republic of the Union of Myanmar, Kingdom
of Cambodia and Lao People's Democratic Republic. 5 Since March 31,
2023, 15 additional tranches have been drawn down for a total of
EUR 7.8 million. 5 tranches are currently secured for a total of
EUR 2.5 million. and an additional amount of 1.2 million euros
could be drawn down by the Company depending on the liquidity and
exposure conditions under the contract.
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version on businesswire.com: https://www.businesswire.com/news/home/20241106155932/en/
Contacts - Investor relations / Media
NewCap Nicolas Fossiez, Aurélie Manavarere / Arthur Rouillé
investors@poxelpharma.com +33 1 44 71 94 94
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