Nxera Pharma Operational Highlights and Consolidated Results for the First Quarter 2024
09 Mayo 2024 - 1:30AM
Tokyo, Japan and Cambridge, UK, 9 May
2024 – Nxera Pharma (“the Company” or “Nxera”; TSE: 4565)
provides an update on operational activities and reports its
consolidated results for the first quarter ended 31 March 2024. The
full report can be found here.
Chris Cargill, President and CEO of
Nxera, commented: “We entered 2024 with a clear vision to
capitalize on a number of strategic opportunities and build on the
strong foundations we have created, positioning the business for
the next stage of its journey to become a leading biopharmaceutical
company in Japan. The last three months, defined by our bold
actions, have been a testament to this.
“A key milestone this quarter has been the
change of company name from Sosei Heptares to Nxera Pharma and the
unveiling of a bold new brand and identity that captures our
ambition to be pioneers of the next era of biopharmaceuticals and
medicine. The decision to make this change was driven by the
significant growth and development of the business, which has been
accelerated through several key strategic acquisitions in recent
years, and progress made advancing our extensive pipeline both
in-house and with our partners.
“I extend my gratitude to our brilliant team in
Japan, the UK, South Korea and Switzerland whose dedication and
expertise has enabled these significant achievements and will
empower our future success.”
Operational Highlights for Q1
2024
Corporate highlights
- Change of company name to Nxera Pharma
- Approved on 27 March at the Company’s 34th Annual Shareholders’
Meeting and came into effect on 1 April 2024
- Appointment of Chief Operating Officer, Toshihiro Maeda
- Mr Maeda, an experienced pharmaceutical executive, is leading
the post-acquisition integration of the Nxera Pharma Japan (“NPJ”)
and Nxera Pharma Korea (“NPK”) businesses into Nxera and will be
responsible for all technical operations
Progress with in-house
programs
- First subject dosed in a Phase 1 trial with NXE0033744, a
novel, potent, selective and gut-restricted EP4 receptor agonist
discovered by Nxera in development for the treatment of
Inflammatory Bowel Disease (IBD)
- Regained full ownership from GSK of NXE0027477, a clinic-ready,
highly selective, first-in-class, oral GPR35 agonist in development
as a potential new treatment for IBD
- Nxera expects to determine the optimal strategy for further
clinical development of the program, which could include in-house
development and/or re-partnering
Progress with partnered
programs
- Entered a global collaboration and exclusive option-to-license
agreement with Boehringer Ingelheim to develop first-in-class
treatments targeting all symptoms of schizophrenia
- Single-target agreement focused on development of novel, small
molecule agonists of GPR52 discovered by Nxera with the potential
to simultaneously address positive, negative and cognitive symptoms
of schizophrenia
- Nxera received EUR 25 million upfront from Boehringer Ingelheim
and is eligible for an option exercise payment of EUR 60 million
and further milestone payments totalling up to EUR 670 million plus
tiered royalties
- US$2.5 million milestone payment received from Formosa
Pharmaceuticals for US approval of APP13007 (originally designed
and developed at Activus Pharma, formerly a wholly owned subsidiary
of the Company), for the treatment of post-operative inflammation
and pain following ocular surgery
Post-period events
- 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
- 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
- Joined the World Orphan Drug Alliance (“WODA”) to represent
WODA in Japan and South Korea
- Through the Alliance 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
Financial Highlights for the Three-month
Period ended 31 March 2024
- Revenue totalled JPY 4,611 million (US$31.1 million*), an
increase of JPY 3,668 million (US$23.9 million) vs. the prior
corresponding period. The increase is primarily due to the
inclusion of NPJ in the scope of consolidation from July 2023,
which resulted in the addition of PIVLAZ® sales.
- R&D expenses totalled JPY 3,163 million (US$21.3 million),
an increase of JPY 1,206 million (US$6.5 million) vs. the prior
corresponding period. This increase reflects an increased
investment in discovery activities, but also reflects the impact of
the weaker Yen. JPY 414 million (US$2.8 million) has been included
for R&D expenses relating to NPJ/NPK.
- G&A expenses totalled JPY 3,650 million (US$24.6 million),
an increase of JPY 2,541 million (US$16.2 million) vs. the prior
corresponding period. This increase was primarily due to
incremental spend on personnel and professional fees to strengthen
our organizational capabilities, as well as the cost of integrating
our IT systems and unifying the Group under the Nxera Pharma brand.
JPY 2,049 million (US$13.8 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 3,076 million (US$20.7 million) vs.
an operating loss of JPY 1,964 million (US$14.8 million) in the
prior corresponding period. This increase reflects the combined
effect of all movements explained above.
- Loss before income tax totalled JPY 2,796 million (US$18.8
million) vs. a loss before income tax of JPY 1,863 million (US$14.1
million) in the prior corresponding period. This increase reflects
the combined effect of all movements explained above.
- Net loss for the three-month period ended 31 March 2024
totalled JPY 3,281 million (US$22.1 million) vs. a net loss of JPY
1,402 million (US$10.6 million) in the prior corresponding period.
This increase reflects the combined effect of all movements
explained above.
- Core operating loss** totalled JPY 931 million (US$6.3 million)
vs. a core operating loss of JPY 1,465 million (US$11.1 million) in
the prior corresponding period.
- Cash and cash equivalents as at 31 March 2024 amounted to JPY
46,515 million (US$307.3 million) having decreased by JPY 2,550
million (US$40.6 million) from the beginning of the year.
*Convenience conversion to US$ at the following
rates: FY 2024: 1US$ =148.40 JPY; FY 2023: 1US$ =132.32 JPY; 31 Mar
2024: 1US$ = 151.35 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.
- FY24Q1 E_Tanshin_Final_0509