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Financial results presentation4598Delta-Fly Pharma,Inc.Pharmaceuticals

Supplementary Explanatory Materials for the First Quarter Financial Results for the Fiscal Year Ending March 2027

In the first quarter of the fiscal year ending March 2027, the Company generated no business revenue, while operating loss, ordinary loss and net loss widened year on year due to higher research and development expenses. Meanwhile, the Company advanced clinical trials across multiple development pipelines and raised funds through stock acquisition rights and corporate bonds.

Worth reading
46Recurring
0–100. This measures how worthwhile something is to read, not how good or bad the company is.
Direction
Mixed performance
Direction inferred from the company’s description.
Scale
62
¥ million (year-on-year increase in business expenses)
Wording
Conditional
How definitive the wording is.

Contents of this document

Financial results presentationFirst quarter of the fiscal year ending March 20275 items taken from the company’s own explanation
Financial Results Figures (The key points of this material are explained below)
Operating profit¥-420 million
Ordinary income¥-422 million
Net income¥-422 million
Selling, general and administrative expenses¥54 million
Results for the three months of the current quarterBusiness revenue: ¥0 million; business expenses: ¥420 million; research and development expenses: ¥365 million; general and administrative expenses: ¥54 million; operating loss: ¥420 million; ordinary loss: ¥422 million; net loss: ¥422 million
Full-year earnings forecast
Operating Costs
¥1,330 million
Research and development costs
¥1,070 million
General and administrative expenses
¥260 million
Operating profit
¥-1,330 million
Ordinary income
¥-1,340 million
Net income for the current fiscal year
¥-1,350 million
Progress against full-year forecast 通期の予想に対して、いまどこまで進んだかの割合です。
Operating Costs32%
Research and development costs34%
General and administrative expenses21%
Operating profit32%
Ordinary income31%
Net income for the current fiscal year31%
What the company explained in this material
Self-assessment against the planThe company's self-assessment against its own plan.
Overall, results were broadly in line with expectations
Breakdown of Factors Affecting the ChangeReasons cited by the Company for the change in the figures.
  • Research and development costs¥80 million increase year on year
  • General and administrative expenses¥19 million decrease year on year
  • Research and development expenses related to DFP-10917Breakdown amount: 非開示
  • Research and development expenses associated with increased patient enrollment for DFP-14323 and DFP-17729Breakdown amount: 非開示
Assumptions Underlying the Business OutlookThe assumptions used by the company in preparing its forecast.
In light of the uncertainty surrounding the timing of out-licensing negotiations and development progress, no business revenue is included at this time. Research and development expenses are expected to decline as certain clinical trials are completed, but investment in key pipelines is expected to continue. Numerical assumptions: Not disclosed
New initiatives
  • Preparing for consultations with the U.S. FDA regarding a conditional new drug application for DFP-10917 monotherapy
  • Preparing to initiate a Phase 3 trial of DFP-10917 plus VEN combination therapy
  • Preparing to transition DFP-17729 to Phase 3 trials
  • Raising approximately ¥1.27 billion through the 12th Series of Stock Acquisition Rights and the 3rd Series of Unsecured Corporate Bonds
  • Acquisition and cancellation of the 9th and 11th Series of Stock Acquisition Rights
Key KPIsA metric the company considers important as a management benchmark.
  • Number of development pipelines6 bottles
  • Pipelines in clinical trials5 bottles
  • Number of sites in the Phase 3 comparative trial of DFP-14323Approximately 30
Contents of this document
ItemDetails
Document typeFinancial results presentation
Fiscal Period CoveredFirst quarter of the fiscal year ending March 2027
Operating profit¥-420 million
Ordinary income¥-422 million
Net income¥-422 million
Selling, general and administrative expenses¥54 million
Results for the three months of the current quarterBusiness revenue: ¥0 million; business expenses: ¥420 million; research and development expenses: ¥365 million; general and administrative expenses: ¥54 million; operating loss: ¥420 million; ordinary loss: ¥422 million; net loss: ¥422 million
Full-year earnings forecastBusiness profitability Not disclosed / Operating Costs ¥1,330 million / Research and development costs ¥1,070 million / General and administrative expenses ¥260 million / Operating profit ¥-1,330 million / Ordinary income ¥-1,340 million / Net income for the current fiscal year ¥-1,350 million
Progress against full-year forecastBusiness profitability Not disclosed / Operating Costs 32% / Research and development costs 34% / General and administrative expenses 21% / Operating profit 32% / Ordinary income 31% / Net income for the current fiscal year 31%
Self-assessment against the planOverall, results were broadly in line with expectations
Breakdown of Factors Affecting the ChangeFactors Research and development costs / Amount ¥80 million increase year on year, Factors General and administrative expenses / Amount ¥19 million decrease year on year, Factors Research and development expenses related to DFP-10917 / Amount Breakdown amount: Not disclosed, Factors Research and development expenses associated with increased patient enrollment for DFP-14323 and DFP-17729 / Amount Breakdown amount: Not disclosed
Key KPIsIndicator name Number of development pipelines / Value 6 bottles / Year on year against the same period last year Not disclosed, Indicator name Pipelines in clinical trials / Value 5 bottles / Year on year against the same period last year Not disclosed, Indicator name Number of sites in the Phase 3 comparative trial of DFP-14323 / Value Approximately 30 / Year on year against the same period last year Not disclosed
Assumptions Underlying the Business OutlookIn light of the uncertainty surrounding the timing of out-licensing negotiations and development progress, no business revenue is included at this time. Research and development expenses are expected to decline as certain clinical trials are completed, but investment in key pipelines is expected to continue. Numerical assumptions: Not disclosed
New initiativesPreparing for consultations with the U.S. FDA regarding a conditional new drug application for DFP-10917 monotherapy, Preparing to initiate a Phase 3 trial of DFP-10917 plus VEN combination therapy, Preparing to transition DFP-17729 to Phase 3 trials, Raising approximately ¥1.27 billion through the 12th Series of Stock Acquisition Rights and the 3rd Series of Unsecured Corporate Bonds, Acquisition and cancellation of the 9th and 11th Series of Stock Acquisition Rights
Items this document does not state (17)
Net SalesGross Profit MarginOperating profit marginSegment resultsUnit price and quantity metricsNumber of stores and locationsNumber of employeesRisk amount incorporated into the outlookMedium-term management plan targetsFinancial targetsAnnual DividendPayout ratioAcquisition of treasury sharesCapital expendituresOrders received and order backlogMarket Size / ShareKey points of the Q&A

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

The Company explained that the increase in business expenses was mainly attributable to research and development expenses related to DFP-10917 and research and development expenses associated with increased patient enrollment for DFP-14323 and DFP-17729.

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Supplementary Explanatory Materials for the First Quarter Financial Results for the Fiscal Year Ending March 2027 | Delta-Fly Pharma,Inc. (4598) timely disclosure | Komori