“We continue to accelerate business integration following the acquisition of Idorsia Pharmaceuticals Japan Ltd (“IPJ”) and
Operational Highlights for Q4 2023
- Landmark investment of
~JPY8 billion (~USD54m ) intoSosei Group from new OPF1 fund operated byJIC Venture Growth Investments Co., Ltd. , an affiliate ofJapan Investment Corporation – in conjunction with a share offering and convertible bond restructuring to finance the Group’s strategic growth initiatives; to extend the maturity profile of its debt; and further strengthen its financial base. - Marketing approval for PIVLAZ® in
South Korea – for the prevention of cerebral vasospasm and related conditions after aneurysmal subarachnoid hemorrhage (“aSAH”) securing. - New Drug Application submitted in
Japan for the approval of daridorexant, a novel dual orexin receptor antagonist, for the treatment of adult patients with insomnia – in relation to the submission, the Group receivedJPY 1.5 billion , which has been recognized as revenue in Q4 2023. - Partner Neurocrine confirmed its plans to evaluate two new muscarinic agonist candidates in Phase 1 studies – both NBI-1117569 (a muscarinic M4-preferring agonist) and NBI-1117567 (a muscarinic M1-preferring agonist) are oral compounds that may have the potential to treat neurological and neuropsychiatric conditions. A Phase 1 study of NBI-1117569 has begun and a Phase 1 study of NBI-1117567 is expected to begin in 2024.
- Partner Pfizer entered a new oral small molecule GLP-1 receptor agonist into a Phase 1 clinical trial targeting metabolic diseases – PF-06954522 was discovered by Pfizer scientists during a multi-target research collaboration in which Pfizer had access to Sosei Heptares’ StaR® technology.
- Discussions underway with GSK to regain full ownership of GSK43814061, a clinic-ready, first-in-class, oral GPR35 agonist targeting Inflammatory Bowel Diseases (“IBD”) – upon regaining ownership, the Group expects to proceed with a planned
UK Phase 1 trial of GSK43814061 while determining the optimal strategy for the further clinical development and/or re-partnering of the program. US$3.75 million milestone payment received from partnerGenentech – the discovery-based payment is related to progression of a potential first-in-class project targeting an undisclosed GPCR.Genentech will now be responsible for further development and commercialization of this potential new medicine.- Strong progress in collaborations with leading technology companies
Kallyope – identification, validation and nomination of a first GPCR target to enter a therapeutic discovery program for gastrointestinal diseases,- Verily – launching a new discovery program based on the successful validation and nomination of a GPCR target for immune-mediated diseases with an initial indication focus of IBD, and
- PharmEnable Therapeutics – expansion of a collaboration to drive discovery of novel small molecule drug candidates against a second neurological disease target.
Operational Highlights for Full Year 2023
- Transformational acquisition of Idorsia’s pharmaceutical business in
Japan and APAC – achieves key strategic milestone to become a fully integrated biopharmaceutical company:- Adds complementary late-stage clinical development capability with profitable and fast-growing commercial operations in
Japan . - Brings highly experienced team, with proven clinical development and commercial launch track record.
- Lean, go-to-market commercial model, well positioned to scale rapidly to generate significant value from
Japan and APAC geographic expansion. - Includes
Japan and APAC (ex-China ) rights to two medicines with significant growth potential (PIVLAZ®) and daridorexant, as well as exclusive options and selected rights to up to seven other products from Idorsia’s clinical development pipeline. - Purchase price of
JPY65 billion is fully funded from existing cash (JPY25 billion ) and newJPY40 billion long-term, low-rate corporate loan.
- Adds complementary late-stage clinical development capability with profitable and fast-growing commercial operations in
- First subject dosed with wholly owned HTL0048149 in Phase 1 trial – HTL’149 is a first-in-class GPR52 agonist designed by the Company as a once-daily oral treatment to address positive and negative symptoms and cognitive impairment in schizophrenia patients without the adverse effects typically associated with existing antipsychotic drugs.
- First patient dosed with cancer immunotherapy candidate HTL0039732 in Phase 1/2a trial – HTL’732 is an orally available small molecule EP4 antagonist for advanced solid tumors being evaluated under an agreement with
Cancer Research UK . - Partner Neurocrine Biosciences initiated Phase 1 clinical study with NBI-1117570 – an investigational, oral, muscarinic M1/M4 selective dual agonist that may have the potential to treat neurological and neuropsychiatric conditions.
- Partner Tempero Bio received FDA clearance to advance clinical development of TMP-301 for alcohol and substance use disorders – TMP-301 (formerly HTL0014242) is a selective, orally available mGluR5 negative allosteric modulator (NAM) candidate discovered by Sosei Heptares and out-licensed to Tempero Bio.
- Sosei Group’s share listing elevated to the Tokyo Stock Exchange Prime Market – shortly after,
Sosei Group shares were included in the Tokyo Stock Price Index (TOPIX). - Changes to Board and Executive Management team – Ms.
Eiko Tomita , a highly experienced pharmaceutical executive, was elected as an Independent External Director. Ms.Candelle Chong was promoted to Executive Vice President and Chief of Staff.
Post-period Highlights
- Appointment of Chief Operating Officer – Mr.
Toshihiro Maeda was appointed to this newly created role at Sosei Heptares to lead the post-acquisition integration of IPJ, and global technical operations, including manufacturing, supply chain and quality assurance, for the enlarged business inJapan and theAsia-Pacific region .
Financial Highlights
- Revenue totalled
JPY 12,766 million (US$90.8 million *), a decrease ofJPY 2,803 million (US$27.7 million ) vs. the prior corresponding period. The decrease is primarily due to the decrease in revenue related to upfront fees and milestone income due to signing no new partnership agreements and the occurrence of four milestone events in the current period vs. two upfront fee and five milestone events in the prior corresponding period, partially offset by the increase in pharmaceutical product sales due to the inclusion of IPJ in the scope of consolidation inJuly 2023 , which resulted in the addition of PIVLAZ® sales. - R&D expenses totalled
JPY 10,075 million (US$71.7 million ), an increase ofJPY 2,621 million (US$14.9 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 881 million (US$6.3 million ) has been included for R&D expenses relating to IPJ and IPK. - G&A expenses totalled
JPY 9,965 million (US$70.9 million ), an increase ofJPY 5,588 million (US$37.6 million ) vs. the prior corresponding period. This increase is primarily due to the inclusion of non-recurring M&A related costs.JPY 3,755 million (US$26.7 million ) has been included for G&A expenses relating to IPJ/IPK. - Operating loss totalled
JPY 9,526 million (US$67.8 million ) vs. an operating profit ofJPY 3,436 million (US$26.2 million ) in the prior corresponding period. This increase reflects the combined effect of all the movements explained above. - Loss before income tax totalled
JPY 10,680 million (US$76.0 million ) vs. a profit before income tax ofJPY 1,078 million (US$8.2 million ) in the prior corresponding period. This increase reflects the combined effect of all the movements explained above. - Net loss for the year ended
31 December 2023 totalledJPY 7,193 million (US$51.2 million ) vs. a net profit ofJPY 382 million (US$2.9 million ) in the prior corresponding period. This increase reflects the combined effect of all the movements explained above. - Core operating loss** totalled
JPY 3,076 million (US$21.9 million ) vs. a core operating profit ofJPY 5,856 million (US$44.6 million ) in the prior corresponding period. - Cash and cash equivalents as at
31 December 2023 amounted toJPY 49,065 million (US$347.9 million ) having decreased byJPY 17,492 million (US$159.1 million ) from the beginning of the year. This decrease was primarily due to the transaction with Idorsia.
*Convenience conversion to US$ at the following rates: FY 2023:
** 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.
-ENDS-
About Sosei Heptares
Sosei Heptares is a fully integrated biopharmaceutical company focused on bringing life-changing medicines based on world-class science to patients globally. Our vision is to become one of Japan’s global biopharmaceutical champions.
Our global business combines our world-leading GPCR-targeted StaR® technology, structure-based drug design and early development capabilities in the
We are leveraging these capabilities to generate and advance a broad and deep pipeline of novel medicines across multiple therapeutic areas, including neurology, immunology, gastroenterology and inflammatory diseases. We intend to develop these opportunities for patients in
Sosei Heptares operates from key locations in
“Sosei Heptares” is the corporate brand and trademark of
For more information, please visit https://soseiheptares.com/
LinkedIn: @soseiheptaresco | X: @soseiheptaresco | YouTube: @soseiheptaresco
Enquiries:
Sosei Heptares – Media and Investor Relations
Shinichiro Nishishita, VP Investor Relations, Head of Regulatory Disclosures
+81 (0)3 5210 3399 | +44 (0)1223 949390 | IR@SoseiHeptares.com
+44 (0)203 928 6900 | SoseiHeptares@medistrava.com
Forward-looking statements
This press release contains forward-looking statements, including statements about the discovery, development, and commercialization of products. Various risks may cause Sosei Group Corporation’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.
Attachment
- FY23YE_Tanshin_ Sosei Heptares
Source:
2024 GlobeNewswire, Inc., source