- TWYMEEG® (Imeglimin) recent growth trajectory confirmed with
a 90% increase in sales in Japan over the prior quarter, leading to
a 20% increase of the fiscal year 20221 forecast2
- Phase 2 NASH Trial (DESTINY-1) for PXL065 met its primary
efficacy endpoint for liver fat content reduction at 36 weeks for
all doses
- The Company is in advanced discussions with its lenders to
restructure its debt and further extend its cash runway by aligning
debt repayments with future net positive TWYMEEG royalty flows. The
Company has obtained a standstill of its current debt obligations
from IPF Partners until March 31, 2023
- As of December 31, 2022, cash and cash equivalents were EUR
13.1 million (USD 14 million)3; Revenue of EUR 0.674 million for
FY2022
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 announced its cash position and
revenue and provided a corporate update for the twelve months ended
December 31, 2022.
Thomas Kuhn, Chief Executive Officer of Poxel, stated: “We are
very pleased with the most recent figures of TWYMEEG sales in
Japan. These strong sales results support the trend we have
observed since the end of the first year of commercialization
restrictions, and above all, we believe that TWYMEEG's benefit to
type 2 diabetes patients is recognized more and more among
prescribing doctors. We expect this royalty stream from TWYMEEG
sales to continue to grow and generate significant revenue for
Poxel and we have reached a preliminary agreement with IPF to align
the debt repayments with future net positive TWYMEEG royalty flows.
We are actively working to finalize our debt restructuring in the
coming weeks. We are concurrently working to secure additional
financing to launch our POC studies for PXL770 and PXL065 in ALD to
start the next chapter of Poxel’s strategic focus in rare metabolic
diseases.”
Commercial Update
TWYMEEG® (Imeglimin)
- For the quarter ended December 2022, TWYMEEG sales4 in Japan
increased 90% to JPY 0.8 billion (EUR 5.5 million)3 over the prior
quarter sales of JPY 0.4 billion (EUR 2.9 million)3 as reported by
Sumitomo Pharma (Sumitomo).
- The recent acceleration in sales reflects both 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 in combination with other treatments, such as DPP4i’s,
which are the most prescribed treatments for Japanese
Type-2-Diabetes patients, and as monotherapy.
- Based on sales trends and cumulative TWYMEEG sales of JPY 1.3
billion for the first nine months, Sumitomo has increased its
fiscal year 20221 forecast by 20% to JPY 1.8 billion2 (EUR 12.8
million)3.
- For the Sumitomo fiscal year 2023 (ending March 31, 2024), as a
conservative assumption 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.
- Before the end of Sumitomo fiscal year 2024 (ending March 31,
2025), Poxel expects TWYMEEG net sales in Japan to reach JPY 5
billion (EUR 35.6 million)4 entitling Poxel to receive 10%
royalties on all TWYMEEG net sales and a sales-based payment of JPY
500 million (EUR 3.6 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.
- 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.
Clinical Updates
NASH
- Positive topline results were announced for the Phase 2 trial
for the treatment of NASH (DESTINY-1) for PXL065 stating that the
primary efficacy endpoint was met. PXL065-treated patients achieved
statistically significant improvements in the relative decrease in
liver fat content measured by magnetic resonance imaging estimated
proton density fat fraction (MRI-PDFF) at 36-weeks for all doses.
Histology findings from paired liver biopsies showed strong
improvement in fibrosis without worsening of NASH, consistent with
dose-dependent reduction of all biomarkers related to
fibrinogenesis and fibrosis risk scores. Additional dose-dependent
benefits on glucose control and indices of insulin sensitivity were
also observed. PXL065 was observed to be safe and well tolerated
with no dose-dependent increase in body weight and no increased
lower extremity edema vs. placebo. The safety profile is consistent
with reduced PPARg-mediated side effects vs. published results of
pioglitazone.
Rare metabolic diseases
- In adrenoleukodystrophy (ALD), PXL770 is prepared to advance
into a Phase 2a biomarker proof-of-concept (POC) clinical trial 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. Considering the
DESTINY-1 results for PXL065 in NASH, which validated the
deuterium-modified thiazolidinedione (TZD) platform, a second
identical study is planned to assess the potential of the
deuterium-modified TZD platform with PXL065 in ALD. Both ALD
studies are poised to initiate, subject to additional
financing.
- The European Commission granted orphan drug designation (ODD)
for PXL770 and PXL065 for the treatment of adrenoleukodystrophy
(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.
- PXL770 was granted ODD by the U.S. FDA for the treatment of
patients with autosomal-dominant polycystic kidney disease
(ADPKD).
Corporate Update & Significant Events after the
Period
- The Company aims to restructure its debt and further extend its
cash runway and has recently entered into a memorandum of
understanding with IPF Partners and is in advanced discussions with
the banks that provided the French Government Guarantee Loan (PGE
Loan), obtained in 2020 in the context of the COVID-19 pandemic,
for a debt restructuring. The Company expects to reschedule and
align debt repayments with future net positive TWYMEEG royalty
flows expected to start before the end of Sumitomo fiscal year 2024
(ending March 31, 2025). The Company anticipates finalizing its
debt restructuring in the coming weeks and will provide the details
of the agreements upon closing.
- The Company has obtained a standstill of its current debt
obligations from IPF until the earlier of the finalization of its
debt restructuring with IPF or March 31, 2023.
- In Q4 2022, Poxel initiated a corporate savings plan which
includes a significant workforce reduction. This saving plan aims
to adapt the Company’s resources to the current clinical
development plan while preserving critical resources and
competencies.
- In December, the Company announced the drawdown of the
remaining two tranches, representing a total of EUR 2 million, of
the convertible bonds as part of the equity-linked financing
facility with Iris Capital Investment (IRIS).
- After 6 years as Chief Financial Officer of Poxel where she has
been instrumental in the Company’s development, Anne Renevot has
recently left Poxel to pursue another opportunity. The Company
plans to launch the search for a new CFO and, in the interim, can
rely on its experienced finance team.
Full-Year Cash and Revenue ended December 31, 2022
Cash
As of December 31, 2022, total cash and cash equivalents were
EUR 13,1 million (USD 14 million)3, as compared to EUR 32,3 million
at December 31, 2021 and EUR 17.1 million at September 30,
2022.
EUR (in thousands)
Q4 2022
Q4 2021
Cash
13,058
28,753
Cash equivalents
-
3,534
Total cash and cash
equivalents*
13,058
32,287
Unaudited data.
*Net financial debt (excluding IFRS 16 impacts and derivative
debts) was 29.5 million euros at the end of Q4 2022 (including debt
obligations with IPF and the banks parts of the French PGE loan, as
well as the equity-linked financing with IRIS) and EUR 2.6 million
at the end of Q4 2021.
The Company has obtained a standstill of its current debt
obligations from IPF Partners until the earlier of the finalization
of its debt restructuring or March 31, 2023. The Company
anticipates finalizing its debt restructuring in the coming weeks.
However, in the absence of debt restructuring and based on the
Company’s cash position at December 31, 2022, certain financial
covenants related to the Company’s debt with IPF Partners could be
breached after March 31, 2023.
The Company is actively pursuing additional financing options
which together with its debt restructuring would significantly
extend its cash runway.
Full-Year 2022 Revenue
Poxel reported revenues of EUR 0.674 million for the year ended
December 31, 2022, as compared to EUR 13.4 million during the
corresponding period in 2021, which mainly reflected the EUR 13.2
million milestone payment for the approval of TWYMEEG in Japan on
June 23, 2021.
Revenue for 2022 mainly consists of JPY 93 million (EUR 0.673
million) of royalty revenue from Sumitomo Pharma which represents
8% of TWYMEEG net sales in Japan. Based on its current forecast,
Poxel expects to receive 8% royalties on TWYMEEG net sales in Japan
through the Sumitomo Pharma fiscal year 2022 (April 2022 to March
2023). 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)
2022
Q1
3 months
2022
Q2
3 months
2022
Q3
3 months
2022
Q4
3 months
FY 2022
12 months
FY 2021
12 months
Sumitomo Pharma Agreement
32
51
203
388
673
13,377
Other
-
-
-
1
1
20
Total revenues
32
51
203
389
674
13,397
Unaudited data
Planned Presentations and Participation at the Following
Upcoming Events
- JMP Securities Life Sciences Conference, New York, NY, May
15-16
Next Financial Press Release: 2022 Annual Results, on
March 22, 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.
1 Sumitomo Pharma fiscal year 2022 ends March 31, 2023.
2 As per Sumitomo Pharma forecast published on January 31,
2023.
3 Currency exchange rate at December 31, 2022.
4 Sumitomo Pharma reports gross sales
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Contacts - 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 Emmanuel Huynh or Arthur Rouillé poxel@newcap.eu +33 1 44
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