Nxera Pharma Operational Highlights and Consolidated Results for the Second Quarter and First Half 2024
09 August 2024 - 4:30PM
Tokyo, Japan and Cambridge, UK, 9 August
2024 – Nxera Pharma (“the Company” or “Nxera”; TSE: 4565)
provides an update on operational activities and reports its
consolidated results for the second quarter and first half ended 30
June 2024. The full report can be found here.
Chris Cargill, President and CEO of
Nxera, commented: “The reception we have received to our
new name, branding and evolved strategy from all our stakeholders
has been fantastic. In transitioning from Sosei Heptares to Nxera
Pharma, we are united under a single identity with a clear purpose
to become a leading technology driven biopharmaceutical company
bringing new medicines to patients in Japan and globally.
“In Japan, we have made good progress building
sales for PIVLAZ® alongside preparing for its commercialization in
South Korea, with launch expected in 2025. Similarly, our
preparations to commercialize daridorexant in Japan are progressing
well in anticipation of a positive regulatory decision later this
year.
“In addition, throughout 2024, we have continued
to advance our internal programs into clinical trials, and to
support the progress of our partnered programs through multiple
preclinical and clinical development milestones, with further data
and progress anticipated in the third quarter of 2024 and beyond.
These are programs that our R&D team and powerful NxWave™
discovery platform have played a major role in creating, further
reinforcing our position as the partner of choice for GPCR-targeted
drug design, while generating significant value in terms of
realised and future potential revenues.
“Overall, it is a very exciting time for Nxera,
and with multiple important commercialization and development
milestones anticipated in the near and medium term, we are
confident that we have the right strategy to deliver success and
value for our stakeholders as we seek to build a globally
competitive next-generation biopharma company.”
Operational Highlights for Q2
2024
Corporate highlights
- Nxera Pharma, the new name for Sosei Heptares, came into effect
on 1 April 2024 along with the launch of a new corporate brand and
identity designed to capture the Group’s ambition to be at the
forefront of the next era of biopharmaceuticals and medicine
- Joined the World Orphan Drug Alliance (WODA) to represent WODA
in Japan and South Korea
- Through WODA and its global networks, Nxera will gain access to
a pipeline of novel medicines targeting rare or orphan diseases as
potential licensing opportunities (with no obligation) for its late
clinical stage and commercialization operations in these
regions
- Senior team strengthened with appointment of experienced senior
strategy consultant Patrick Branch as Head of Business Development
for Japan and APAC
Progress with in-house
programs
- Exclusive supply and distribution agreement with Handok for
PIVLAZ™ (clazosentan sodium) 150 mg in South Korea
- PIVLAZ™ is the first drug approved in South Korea for the
prevention of Cerebral Vasospasm in patients with Aneurysmal
Subarachnoid Hemorrhage (aSAH) and is expected to become
commercially available in South Korea in early 2025
- Nxera and PrecisionLife announced an expansion of their 2022
strategic R&D partnership into auto-immune disorders with the
potential to identify new drug targets and subsequently potential
precision targeted therapies for complex, chronic conditions.
Progress with partnered
programs
- US$15 million payment from Neurocrine Biosciences triggered by
successful development progress of partnered schizophrenia
candidate NBI-1117568
- NBI-1117568 is an oral, selective muscarinic M4 receptor
agonist advancing through Phase 2 clinical development under a
multi-program collaboration
- Successful completion of long-term preclinical toxicity program
supports safe, chronic dosing of NBI-1117568 in future clinical
trials
- Topline clinical results from Neurocrine’s Phase 2 study are
expected in Q3 2024
- Neurocrine also announced that it had initiated its Phase 1
first-in-human clinical study to evaluate the safety, tolerability,
pharmacokinetics, and pharmacodynamics of NBI-1117567 in healthy
adult participants
- NBI-1117567 is an investigational, oral, M1 preferring agonist
discovered by the Group and licensed to Neurocrine that may have
the potential to treat symptoms of cognition in patients with
neurological and neuropsychiatric conditions
- First R&D milestone reached under Nxera’s multi-target
discovery collaboration with AbbVie, resulting in a payment of
US$10 million to the Company
- Collaboration aims to leverage Nxera’s NxWave™ platform to
discover, develop and commercialize new medicines targeting novel
GPCR targets associated with neurological disease
- US$4.6 million in milestone payments received from Centessa
Pharmaceuticals following approval of an Investigational New Drug
(IND) application for ORX750 and its progression into a Phase 1
clinical trial
- ORX750 is an investigational, orally administered, highly
potent and selective orexin receptor 2 (OX2R) agonist designed
utilizing Nxera technology to directly target orexin neuron loss in
narcolepsy and other sleep-wake disorders.
Financial Highlights for the Six-month
Period ended 30 June 2024
- Revenue totalled JPY 12,720 million (US$83.6 million*), an
increase of JPY 10,574 million (US$67.7 million) vs. the prior
corresponding period. The increase was primarily due to the
inclusion of Nxera Pharma Japan Co., Ltd. (“NPJ”) in the scope of
consolidation from July 2023, which resulted in the inclusion of
PIVLAZ® sales.
- R&D expenses totalled JPY 5,487 million (US$36.1 million),
an increase of JPY 1,448 million (US$6.1 million) vs. the prior
corresponding period. This increase primarily reflects an increased
investment in discovery activities, but also reflects the impact of
the weaker Yen. JPY 813 million (US$5.3 million) has been included
for R&D expenses relating to NPJ/Nxera Pharma Korea Co., Ltd.
(“NPK”).
- G&A expenses totalled JPY 8,022 million (US$52.8 million),
an increase of JPY 5,451 million (US$33.7 million) vs. the prior
corresponding period. This increase was primarily due to
incremental spend on personnel and professional fees to strengthen
organizational capabilities, as well as the cost of integrating IT
systems and unifying the Group under the Nxera Pharma brand. JPY
4,740 million (US$31.2 million) has been included for G&A
expenses relating to the NPJ/NPK businesses, including an
amortization charge on Idorsia related intangible assets.
- Operating loss totalled JPY 3,654 million (US$24.0 million) vs.
an operating loss of JPY 4,168 million (US$30.9 million) in the
prior corresponding period. This decrease reflects the combined
effect of all movements explained above.
- Loss before income tax totalled JPY 3,158 million (US$20.8
million) vs. a loss before income tax of JPY 3,760 million (US$27.9
million) in the prior corresponding period. This decrease reflects
the combined effect of all movements explained above.
- Net loss for the six-month period ended 30 June 2024 totalled
JPY 4,703 million (US$30.9 million) vs. a net loss of JPY 2,060
million (US$15.3 million) in the prior corresponding period. This
increase reflects the combined effect of all movements explained
above.
- Core operating profit** totalled JPY 1,176 million (US$7.7
million) vs. a core operating loss of JPY 2,720 million (US$20.2
million) in the prior corresponding period.
- Cash and cash equivalents as at 30 June 2024 amounted to JPY
50,984 million (US$316.9 million) having increased by JPY 1,919
million (decreased by US$31.0 million) from the beginning of the
year.
*Convenience conversion to US$ at the following
rates: FY 2024: 1US$ =152.12 JPY; FY 2023: 1US$ =134.82 JPY; 30 Jun
2024: 1US$ = 160.91 JPY; 31 Dec 2023: 1US$ = 141.03 JPY ** Core
operating profit / loss is an alternative performance measure which
adjusts for material non-cash costs and one-off costs in order to
provide insights into the recurring cash generation capability of
the core business.
–END–
About Nxera PharmaNxera Pharma
(formerly Sosei Heptares) is a technology powered biopharma
company, in pursuit of new specialty medicines to improve the lives
of patients with unmet needs in Japan and globally.
In addition to several products being
commercialized in Japan, we are advancing an extensive pipeline of
over 30 active programs from discovery through to late clinical
stage internally and in partnership with leading pharma and biotech
companies. This pipeline is focused on addressing major unmet needs
in some of the fastest-growing areas of medicine across neurology,
GI and immunology, metabolic disorders and rare diseases, and
leverages the power of our unique and industry leading
GPCR-targeted structure-based drug discovery “NxWave™” platform to
provide a sustainable source of best- or first-in-class
candidates.
Nxera employs over 350 talented people at key
locations in Tokyo and Osaka (Japan), London and Cambridge (UK),
Basel (Switzerland) and Seoul (South Korea) and is listed on the
Tokyo Stock Exchange (ticker: 4565).
For more information, please visit
www.nxera.lifeLinkedIn: @NxeraPharma | X: @NxeraPharma | YouTube:
@NxeraPharma
Enquiries:
Nxera – Media and Investor
RelationsKentaro Tahara, VP Investor Relations and
Corporate StrategyShinichiro Nishishita, VP Investor Relations,
Head of Regulatory DisclosuresMaya Bennison, Communications
Manager+81 (0)3 5210 3399 | +44 (0)1223 949390 |IR@Nxera.life
MEDiSTRAVA Consulting (for International
Media)Mark Swallow, Frazer Hall, Erica Hollingsworth+44
(0)203 928 6900 | Nxera@medistrava.com
Forward-looking statementsThis
press release contains forward-looking statements, including
statements about the discovery, development, and commercialization
of products. Various risks may cause Nxera Pharma Group’s actual
results to differ materially from those expressed or implied by the
forward looking statements, including: adverse results in clinical
development programs; failure to obtain patent protection for
inventions; commercial limitations imposed by patents owned or
controlled by third parties; dependence upon strategic alliance
partners to develop and commercialize products and services;
difficulties or delays in obtaining regulatory approvals to market
products and services resulting from development efforts; the
requirement for substantial funding to conduct research and
development and to expand commercialization activities; and product
initiatives by competitors. As a result of these factors,
prospective investors are cautioned not to rely on any
forward-looking statements. We disclaim any intention or obligation
to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.