- Company reports revenues of EUR 13.4 million for the year
ended December 31, 2021
- As of December 31, 2021, cash and cash equivalents were EUR
32.3 million (USD 36.6 million)
- TWYMEEG® (Imeglimin hydrochloride) launched in Japan in Q3
2021 for the treatment of type 2 diabetes. Poxel entitled to
receive sales -based payments and escalating royalties of 8 - 18%
on net sales of TWYMEEG
- Results of PXL065 Phase 2 (DESTINY-1) trial in NASH expected
in Q3 2022
- Fast Track Designation (FTD) granted to PXL065 for
adrenoleukodystrophy (ALD); Phase 2a clinical Proof-of-Concept
(POC) biomarker program, subject to additional financing, planned
to start midyear with results to follow in early 2023
The management team will host webcast conference calls on
Tuesday, March 22 at:
- 6:00 pm CET, Paris time (1:00 pm ET) in French
and
- 2:00 pm ET, New York time (7:00 pm CET) in
English.
A presentation will be available on Poxel's website in the
Investor section.
To register for the webcast in French:
https://us02web.zoom.us/webinar/register/WN_4dWeP9qBSrObHPWD97xKQQ
To register for the webcast in English:
https://us02web.zoom.us/webinar/register/WN_4tH24fDcSxqoG5OoCu2vSA
POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage
biopharmaceutical company developing innovative treatments for
serious chronic diseases with metabolic pathophysiology, including
non-alcoholic steatohepatitis (NASH) and rare metabolic disorders,
today announced its results for the year ended December 31, 2021
and provided a corporate update.
“The year 2021 was a pivotal year in Poxel’s evolution, first
noted by the marketing approval in June for Imeglimin in Japan,
followed by commercialization since September under the name
TWYMEEG®. This approval is strong validation of our R&D
capabilities and the result of many years of effort by our team in
close collaboration with our partner, Sumitomo Dainippon Pharma,”
stated Thomas Kuhn, CEO of Poxel. “Secondly, Poxel initiated its
strategic shift with a new emphasis on rare metabolic diseases,
starting with ALD. We have made significant progress preparing for
our Phase 2a Proof-of-Concept clinical studies for PXL065 and
PXL770 in ALD. These studies, subject to additional funding, are
planned to start in the middle of 2022, with results expected in
early 2023. We are also extremely pleased that the FDA recently
granted Fast Track status to PXL065 in ALD which confirms our
strategic direction and has the potential to substantially
accelerate the approval timeline for PXL065 in ALD.”
“In 2022, we look forward to sharing topline results of
DESTINY-1, our Phase 2 study in NASH for PXL065, expected in the
third quarter. We are actively pursuing a number of funding
initiatives in parallel to extend our cash runway, prioritizing
non-dilutive options. We are in advanced discussions with several
parties and are confident that we will close a transaction in a
reasonable timeframe to execute our strategic plan with the goal of
bringing innovative treatments to patients with chronic serious
metabolic diseases,” continued Thomas Kuhn.
Commercial Update
TWYMEEG® (Imeglimin)
- As of December 31, 2021, royalty revenue to Poxel based on
TWYMEEG net sales in Japan under the Sumitomo Dainippon Pharma
(“Sumitomo”) license agreement has been limited following TWYMEEG’s
recent commercial launch on September 16, 2021. TWYMEEG’s initial
commercial uptake has been impacted by prescribing restrictions for
new products during the first year of sales and COVID-19
conditions. This has also impacted the frequency of physician
visits and limited the significant market education efforts
required for an innovative new product with a new mechanism of
action.
- Sumitomo has made significant progress establishing high
awareness of TWYMEEG amongst prescribing physicians, thanks to its
comprehensive launch activities and ongoing promotional efforts.
TWYMEEG has the potential to 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.Moreover, based on the Phase 3 TIMES program having
shown robust efficacy with a favorable safety and tolerability
profile, TWYMEEG offers potential for populations with limited
treatment options, including elderly and patients with renal
impairment. Sumitomo recently initiated a Phase 4 study targeting
Type-2-Diabetes patients with chronic kidney diseases (CKD) 3b/4 /
5.
- In accordance with the Sumitomo license agreement, Poxel is
entitled to receive escalating royalties of 8 - 18% on net sales of
TWYMEEG and sales-based payments of up to JPY 26.5 billion
(approximately EUR 200 million)1. In parallel, as part of the Merck
Serono licensing agreement2, Poxel will pay Merck Serono a fixed 8%
royalty based on the net sales of Imeglimin, independent of the
level of sales. As a result, based on the current forecast, Poxel
expects net royalties to be cash neutral through Sumitomo FY2022
(through March 2023). Once TWYMEEG achieves the next commercial
threshold, the royalty rate will increase to double-digits and
Poxel will retain all net royalties above 8%.
- Throughout 2021, Poxel and Sumitomo have continued to pursue
strong patent protection for Imeglimin. The patent estate for
TWYMEEG would extend to 2036 (including potential 5-year patent
term extension), with other patent applications ongoing.
- In 2021, the Company conducted and completed a comprehensive
evaluation of partnering options for the U.S. and Europe and does
not expect to enter into a broad strategic partnership for these
geographies in the near term. The Company is now considering
opportunities to leverage the Imeglimin data package in specific
territories, including those resulting from inbound interest.
- Results from all three Phase 3 clinical trials of Imeglimin
were published in the medical journals Diabetes Care and Diabetes
Obesity and Metabolism:
- The TIMES 1 publication entitled: "Efficacy and safety of Imeglimin monotherapy vs. placebo
in Japanese patients with Type 2 diabetes (TIMES 1)
: A Double-Blind, Randomized,
Placebo-Controlled, Parallel-Group, Multicenter Phase 3
Trial” was published in April 2021.
- The TIMES 2 publication entitled: “Long-term safety and
efficacy of Imeglimin as monotherapy or in combination with
existing antidiabetic agents in Japanese patients with type 2
diabetes (TIMES 2): A 52-week, open-label, multicentre phase 3
trial” was published in December 2021.
- The TIMES 3 publication entitled: “Efficacy and safety of
Imeglimin add-on to insulin monotherapy in Japanese patients with
type 2 diabetes (TIMES 3): A randomized, double-blind,
placebo-controlled phase 3 trial with a 36-week open-label
extension period” was published in January 2022.
Clinical Development Updates
NASH (PXL065 and PXL770)
- In September 2021, the PXL065 Phase 2 trial (DESTINY-1) in NASH
completed enrollment with 123 noncirrhotic biopsy-proven NASH
patients across multiple clinical sites in the US. Results from
this 36-week, randomized, double-blind, placebo-controlled,
parallel group, dose-ranging study designed to assess efficacy and
safety are anticipated in Q3 2022. The goal of DESTINY-1 is to
identify the optimal dose or doses of PXL065 to advance into a
Phase 3 registration trial for the treatment of noncirrhotic
biopsy-proven NASH patients.
- In November 2021, Poxel presented new clinical analysis on
PXL065 DESTINY-1 screening data at the AASLD The Liver Meeting®
2021.
- PXL770, a first-in-class, oral direct adenosine
monophosphate-activated protein kinase (AMPK) activator, has
successfully completed a Phase 2a Proof-of-Concept trial for the
treatment of NASH, which met its objectives. Future development of
PXL770 in NASH will be assessed pending results from the PXL065
Phase 2 trial in NASH and the Phase 2a POC studies in ALD.
Rare metabolic diseases (PXL065 and PXL770)
- The Phase 2a clinical Proof-of-Concept (POC) biomarker program
in X-linked adrenoleukodystrophy (ALD), subject to additional
funding, is anticipated to begin midyear, followed by results in
early 2023.
- In December 2021, Poxel announced the formation of its
Scientific Advisory Board (SAB) for rare metabolic diseases as part
of its strategy to increase its focus on rare diseases. The first
meeting of this SAB included productive discussions that informed
the design of the upcoming ALD POC Phase 2a studies and provided
insights into pivotal trial concepts.
- Poxel participated in several scientific and patient advocacy
conferences related to ALD and presented its programs, including
the comprehensive preclinical pharmacological package, targeting
this severe orphan neurometabolic disease with no approved
therapies. This included presentations at three major advocacy
organizations, Alex The Leukodystrophy Charity in the United
Kingdom, United Leukodystrophy Foundation and ALD Connect in the
U.S.
Early Stage Development
- During the year, Poxel pursued its evaluation of internal
opportunities from its adenosine monophosphate-activated protein
kinase (AMPK) activator platform and deuterated TZD platform and
completed a series of studies, including a preclinical assessment
of PXL770 and AMPK activation for an orphan kidney disease,
autosomal dominant polycystic kidney disease (ADPKD), which
demonstrated a robust effect to attenuate disease in established
model systems. Additionally, the Company is conducting studies in
other rare diseases including mitochondrial disorders.
Corporate Update
- In July 2021, Poxel announced a new strategic direction to
focus its pipeline on high value, rare metabolic indications and
NASH, with the goal of creating pipeline synergies, maximizing
resources, and driving shareholder value. Rare metabolic
indications represent the intersection of high unmet medical need,
promising pre-clinical and clinical data, opinion leader
enthusiasm, significant commercial opportunity, and attractive time
horizons.
- In 2021, Poxel finalized a one year review and comprehensive
evaluation of its existing Corporate Social Responsibility (CSR)
actions. As a result, the Company has defined a solid CSR strategy
supported by three pillars (social, governance and environmental)
and will commit to measure, assess and communicate its progress
over time, starting with the publication of its new CSR report
which will be included in the 2021 Universal Registration Document.
In order to enhance CSR as a corporate priority, Quentin Durand,
Executive Vice President, Chief Legal Officer, has been appointed
Head of CSR.
Significant Events after the Period
- In February 2022, the U.S. Food and Drug Administration (FDA)
granted Fast Track status to PXL065 for ALD in patients with
adrenomyeloneuropathy (AMN). Fast Track Designation (FTD) is
awarded by FDA to investigational drugs which treat a serious or
life-threatening condition, and which fill an unmet medical need.
FDA notes that 'the purpose [of the Fast Track program] is to get
important new drugs to the patient earlier’3.
Financial Statements for Full Year 2021 (IFRS
Standards)
Income statement
EUR (in thousands)
FY
FY
2021
12 months
2020
12 months
adjusted**
Revenue
13,397
6,806
Cost of sales
(59)
Gross margin
13,339
6,806
Net research and development expenses*
(25,174)
(26,702)
General and administrative expenses
(10,627)
(9,923)
Operating income (loss)
(22,463)
(29,819)
Financial income (expenses)
(1,297)
(1,975)
Income tax
(2)
(36)
Net income (loss)
(23,763)
(31,831)
*Net of R&D tax credit and other subsidies. **Change in
accounting policies related to the application of IAS19. The audit
procedures are ongoing.
Poxel reported revenues of EUR 13.4 million for the year ended
December 31, 2021, as compared to EUR 6.8 million during the
corresponding period in 2020.
The revenues for 2021 include the following payments from
Sumitomo Dainippon Pharma (“Sumitomo”) under the Sumitomo license
agreement:
- JPY 1.75 billion (EUR 13.2 million) milestone payment for the
approval of TWYMEEG in Japan on June 23, 2021, and
- JPY 7.5 million (EUR 58 thousand) of royalty revenue which
represents 8% of TWYMEEG net sales in Japan.
Cost of sales amounted to EUR 58 thousand, corresponding to the
8% royalties on net sales of Imeglimin in Japan due to Merck
Serono, as part of the Merck Serono license agreement.
R&D expenses totaled EUR 25.2 million in 2021, as compared
to EUR 26.7 million in 2020. R&D expenses in 2021 primarily
reflected the clinical costs incurred for the ongoing PXL065 Phase
2 DESTINY-1 trial.
R&D costs are net of the R&D Tax Credit (CIR) and other
subsidies that resulted in income of EUR 2.3 million in 2021, as
compared to EUR 2.5 million in 2020.
General and administrative expenses totaled EUR 10.6 million in
2021, as compared to EUR 9.9 million in 2020.
The financial loss amounted to EUR 1.3 million in 2021, as
compared to a loss of EUR 2.0 million in 2020.
The net result for the financial period ending December 31, 2021
was a net loss of EUR 23.8 million, as compared to a net loss of
EUR 31.8 million in 2020.
Cash
As of December 31, 2021, total cash and cash equivalents
amounted to EUR 32.3 million (USD 36.6 million), as compared to EUR
40.2 million (USD 49.4 million) as of December 31, 2020. Net
financial debt (excluding IFRS16 impacts and derivative
instruments) amounted to EUR 2.6 million at December 31, 2021,
compared to EUR (17.2) million at December 31, 2020.
Based on:
- the cash position at December 31, 2021,
- the current development plan of the Company including 1) the
completion of its ongoing Phase 2 NASH trial for PXL065 (DESTINY-1)
) but 2) excluding the two identical Phase 2a clinical
proof-of-concept (POC) biomarker studies for PXL065 and PXL770 in
adrenomyeloneuropathy (AMN),
- the cash forecast for the year 2022 approved by the Board of
Directors of the Company, that 1) does not include, as a
conservative approach, any net sales from Imeglimin in Japan and 2)
includes an amount of EUR 4,813 thousands for the repayments of the
loan with IPF partners until December 2022, and
- a strict control of its operating expenses,
the Company expects that its resources will be sufficient to
fund its operations and capital expenditure requirements through at
least December 31, 2022, representing 12 months from the reporting
date. However, the Company is subject to certain financial
covenants4 related to its debt with IPF Partners which could be
potentially breached in Q3 2022. This situation could lead the
Company’s auditors to issue an audit opinion which would include a
paragraph related to the going concern.
The Company is actively pursuing various financing options which
would extend its cash runway and avoid any breach of financial
covenants through at least 12 months from the reporting date. These
financing options include dilutive and non-dilutive sources, as
well as discussions with IPF partners, and the Company reasonably
expects that at least one of the pursued options would be completed
before Q3 2022. As a consequence, the Company’s 2021 financials are
presented on a going concern basis.
Planned Presentations and Participation at the Following
Upcoming Events
- Annual Meeting of the Japanese Diabetes Society, Kobe, Japan,
May 12-14
- European Renal Association Congress, Paris, France, May
19-22
- Global NASH Congress, London, UK, May 26-27
- Jefferies Global Healthcare Conference, New York, NY, June
8-10
- JMP Securities 2022 Life Sciences Conference, New York, NY,
June 15-16
Next Financial Press Release: First Quarter 2022
Financial Update, May 17, 2022
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. Poxel has clinical and earlier-stage programs from
its adenosine monophosphate-activated protein kinase (AMPK)
activator and deuterated TZD platforms targeting chronic and rare
metabolic diseases. For the treatment of NASH, PXL065
(deuterium-stabilized R-pioglitazone) is in a streamlined Phase 2
trial (DESTINY-1). PXL770, a first-in-class direct AMPK activator,
has successfully completed a Phase 2a proof-of-concept trial for
the treatment of NASH, which met its objectives. For the rare
inherited metabolic disorder, adrenoleukodystrophy (ALD), the
company intends to initiate Phase 2a proof of concept studies with
PXL065 and PXL770 in patients with adrenomyeloneuropathy (AMN).
TWYMEEG® (Imeglimin), Poxel’s first-in-class lead product that
targets mitochondrial dysfunction, has been approved and launched
for the treatment of type 2 diabetes in Japan. Poxel expects to
receive royalties and sales-based payments from Sumitomo Dainippon
Pharma. Poxel has a strategic partnership with Sumitomo Dainippon
Pharma for Imeglimin in Japan, China, South Korea, Taiwan and nine
other Southeast Asian countries. The Company intends to generate
further growth through strategic partnerships and pipeline
development. 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 Converted at the exchange rate at the date of the agreement
(30 Oct 2017). 2 As described in the “2.3.1. Merck Serono
Agreement” section of the Poxel 2020 Document d’Enregistrement
Universel. 3
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.
4 Under these financial covenants the Company should maintain
minimum cash position of the higher of i) ten million euros and ii)
the sum of the consolidated debt service of the Company plus the
amount of cash required to be spent by the Company as part of its
operations, in each case for the following 6-month period.
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version on businesswire.com: https://www.businesswire.com/news/home/20220322005980/en/
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
71 94 94
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