Nxera Pharma (4565) Q2 2024 earnings summary

Executive summary

• Revenue for 1H FY2024 surged to JPY 12.72 billion, up from JPY 2.1 billion year-over-year, driven by PIVLAZ sales, new partnerships, and milestone revenues, notably with Boehringer Ingelheim, Neurocrine, Centessa, and AbbVie.

• Core operating profit reached JPY 1.18 billion, reversing a prior loss of JPY 2.72 billion, while IFRS operating loss narrowed to JPY 3.65 billion from JPY 4.17 billion.

• PIVLAZ sales contributed JPY 6.5 billion in H1, with a full-year NHI sales target of JPY 16 billion or more.

• Cash and cash equivalents stood at JPY 51 billion as of June 30, 2024, supporting ongoing investment and growth.

• Strong execution on strategic objectives, including new partnerships, clinical progress, and post-merger integration.

Financial highlights

• Revenue increase attributed to PIVLAZ sales, Boehringer Ingelheim option-to-license, and milestones from Neurocrine, Centessa, and AbbVie.

• One-off non-cash cost of JPY 1.6 billion related to PIVLAZ inventory impacted operating profit but will not recur in Q3.

• R&D expenses guided at JPY 12–14 billion and SG&A at JPY 18–20 billion for FY2024, reflecting full-year costs and investment in clinical programs.

• Non-core costs included PIVLAZ inventory adjustments, amortization, and integration costs.

• Royalty income declined to JPY 1.03 billion, down JPY 221 million year-over-year.

Outlook and guidance

• FY2024 goals include achieving JPY 16 billion or more in PIVLAZ sales, NDA approval for daridorexant in Japan, and adding a late-stage program for Japan/APAC.

• Anticipated key events: Phase II data for M4 agonist (NBI-111568) and NDA approval for daridorexant in Japan in the second half.

• Incremental investment in R&D and SG&A aimed at medium- to long-term returns.

• No consolidated full-year forecast provided due to unpredictability of milestone and partnership revenues.