BeyondSpring Inc. Q2 FY2020 earnings call

• Plinabulin's PROTECTIVE-2 Phase 3 study for CIN completed 221 patients in July ahead of schedule, with top line data expected in Q4 2020. The DUBLIN-3 NSCLC Phase 3 trial's second interim analysis supported continuation. At AACR, data on triple I/O and Plinabulin combo was presented.
• Management appointments: Paul Friel as Chief Commercial Officer and Dr. Ravi Majeti on the Board.
• Commercial strategy includes addressing unmet CIN need, market forces in oncology, and five core components for successful launch: awareness building, guideline adoption, account outreach, insurance coverage, and healthcare support.
• R&D focus on CIN, NSCLC, and triple combination strategy, with medical affairs outreach and publication plans.

BeyondSpring's main focus is on the lead asset Plinabulin. R&D expenses in Q2 2020 were $11 million, up from $5.2 million in Q2 2019, driven by clinical trial expenses. SG&A expenses were $2.6 million in Q2 2020, up from $2.1 million in Q2 2019, due to pre-launch preparation for Plinabulin. Plinabulin is in late-stage development for CIN prevention and non-small cell lung cancer treatment, with key Phase 3 trials ongoing.

• Expect to file NDA for CIN to US FDA by end of 2020, with rolling NDA submission for China NMPA in Q1 2020.
• Top line Phase 3 data for CIN expected in Q4 2020. NSCLC Phase 3 final data expected in first-half 2021.
• Cash of $38.1 million at end of Q2 2020 sufficient for CIN submission and ongoing activities, projecting burn rate of ~$15 million per quarter going forward.

• COVID-19 impact on timelines, though minimal.
• Uncertainties in payer reimbursement and NCCN guideline adoption.
• Challenges in commercial launch, including competition from biosimilar G-CSFs and market dynamics.

Q: Discuss NCCN guidelines submission prep for CIN, timing, and reimbursement.

A: NCCN submission is a two-page process, scheduled in advance with next meeting in mid-October. Payers follow NCCN guidelines, and reimbursement is payer-specific.

Q: Impact of COVID on NSCLC trial timeline.

A: COVID had minimal impact, enrollment closing this year, final data in first-half 2021.

Q: CIN label expectations, FDA discussions.

A: FDA discussions ongoing, broad label expected for combination with all G-CSFs.

Q: Burn rate, clinical trial cost reduction, commercial cost increase.

A: Cash sufficient for next quarters, clinical costs reducing, commercial costs increasing with launch preparation.

Q: PROTECTIVE-1 update, EAP program, revenue from EAP.

A: PROTECTIVE-1 is a supportive trial, EAP launched to help patients, not a revenue driver.

Q: Biosimilar G-CSF price war impact.

A: Price war creates headspace for Plinabulin pricing, favorable for commercial launch.