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BeyondSpring(BYSI) - 2021 Q2 - Earnings Call Transcript
2021-09-10 18:20
BeyondSpring Inc. (NASDAQ:BYSI) Q2 2021 Earnings Conference Call September 10, 2021 8:00 AM ET Company Participants Monique Kosse - LifeSci Advisors Lan Huang - Co-Founder, Chairman and Chief Executive Officer Ramon Mohanlal - EVP, Research & Development and Chief Medical Officer Richard Daly - Chief Operating Officer Elizabeth Czerepak - Chief Financial Officer Conference Call Participants Josh Schimmer - Evercore ISI Jason Gerberry - Bank of America Maurice Raycroft - Jefferies Andy Hsieh - William Bla ...
BeyondSpring(BYSI) - 2021 Q1 - Earnings Call Transcript
2021-06-16 18:36
BeyondSpring Inc. (NASDAQ:BYSI) Q1 2021 Results Conference Call June 16, 2021 8:30 AM ET Company Participants Ashley Robinson - LifeSci Advisors Dr. Lan Huang - Co-Founder, Chairwoman and Chief Executive Officer Dr. Ramon Mohanlal - EVP, Research and Development and Chief Medical Officer Richard Daly - Chief Operating Officer Elizabeth Czerepak - Chief Financial Officer. Conference Call Participants Jason Gerberry - Bank of America Maury Raycroft - Jefferies Andy Hsieh - William Blair Operator Good morning, ...
BeyondSpring(BYSI) - 2020 Q4 - Earnings Call Transcript
2021-05-01 20:39
Financial Data and Key Metrics Changes - Research and development expenses in Q4 2020 were $8.4 million, down from $12.6 million in the same period last year, primarily due to decreased preclinical and clinical trial expenses [37] - General and administrative expenses increased to $10.4 million in Q4 2020 from $2.7 million in Q4 2019, driven by higher employee salaries, pre-commercialization expenses, and noncash share-based compensation [38] - Net loss attributable to BeyondSpring Inc. was $17.6 million in Q4 2020, compared to $14.1 million in the same period last year [39] - For the full year 2020, net loss was $61.0 million, up from $38.1 million in 2019 [39] - As of December 31, 2020, cash and cash equivalents were $109.5 million, sufficient to support ongoing clinical programs for the next year [40] Business Line Data and Key Metrics Changes - The company is focused on developing plinabulin for chemotherapy-induced neutropenia (CIN) prevention and as an immune anti-cancer agent, with significant progress made in 2020 [7][8] - Plinabulin's combination with G-CSF received breakthrough designation from both U.S. and China FDA, indicating its potential to address severe unmet medical needs in CIN [9][10] Market Data and Key Metrics Changes - The addressable population for CIN prophylaxis has more than doubled to over 70% of the entire chemotherapy patient population due to recent NCCN guideline changes [26] - Each year, over 650,000 patients receive chemotherapy, with G-CSFs being used more than 1.4 million times annually in the U.S. [26] Company Strategy and Development Direction - The company aims to position plinabulin as a standard of care in CIN prevention, leveraging its unique mechanism of action to fill the neutropenia vulnerability gap [29][30] - BeyondSpring is preparing for the commercial launch of plinabulin, focusing on awareness of unmet medical needs, positioning with decision-makers, and activating key accounts [27][33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming milestones for 2021, including the anticipated anticancer efficacy data from the DUBLIN-3 study [41] - The company is optimistic about the success of its NDA filings after extensive interactions with regulatory agencies [17] Other Important Information - The company completed financing of approximately $86.3 million in November 2020, strengthening its balance sheet and extending its cash runway by 12 to 15 months [15][16] Q&A Session Summary Question: Will there be a placeholder for a late-breaking abstract at ASCO regarding DUBLIN data? - Management confirmed that there will be no DUBLIN-3 data presented at ASCO, guiding the market to expect results mid-year [45] Question: What additional analyses will be shown beyond the topline PROTECTIVE-2 Phase III CIN data? - Management indicated that additional analyses will include clinical meaningful endpoint correlations and reductions in febrile neutropenia and hospitalization [47] Question: How are payers responding to launch pricing in light of positive Phase III CIN data? - Management noted that payers are responding positively to the CIN benefits and believe that the potential for improved cancer outcomes will enhance pricing power [51] Question: How is the company preparing for launch readiness? - Management stated that they are hiring sales representatives on a contingency basis and are focused on ensuring a targeted launch strategy [56][59] Question: What is the rationale for the small cell lung cancer study? - The rationale is to demonstrate that plinabulin can provide additional survival benefits and reduce immune-related adverse effects when added to existing I/O regimens [65][66]
BeyondSpring(BYSI) - 2020 Q2 - Earnings Call Transcript
2020-09-03 18:29
Financial Data and Key Metrics Changes - R&D expenses in Q2 2020 were $11 million, up from $5.2 million in the same period last year, primarily due to a $4.9 million increase in clinical trial expenses [40] - SG&A expenses were $2.6 million in Q2 2020, compared to $2.1 million for the same quarter last year, mainly due to pre-launch preparation costs for Plinabulin [40] - Net loss attributable to BeyondSpring in Q2 2020 was $12.8 million, compared to $7.4 million for the same period last year [40] - Cash and cash equivalents at the end of Q2 were $38.1 million, sufficient to support clinical trials and NDA submissions [41] Business Line Data and Key Metrics Changes - The company is preparing for the NDA filing for Plinabulin for chemotherapy-induced neutropenia (CIN) by the end of 2020, with significant clinical data supporting its efficacy [8][10] - The PROTECTIVE-2 trial for CIN has completed enrollment ahead of schedule, with top-line data expected in Q4 2020 [10] - The DUBLIN-3 trial for non-small cell lung cancer (NSCLC) continues without modification based on favorable benefit-risk ratios [11][20] Market Data and Key Metrics Changes - The CIN market is significant, with over 1.3 million cycles of G-CSF administered annually, indicating a strong unmet need [29] - The NCCN guidelines have expanded prophylaxis to include both high and intermediate-risk patients, increasing the addressable market by over 100% [31] Company Strategy and Development Direction - BeyondSpring aims to transform into a commercial-stage company within the next 6 to 18 months through significant clinical and NDA catalysts [42] - The company is focusing on a triple combination strategy in oncology, which includes Plinabulin as a dendritic cell enhancer [24] - The company has initiated an Expanded Access Program (EAP) for Plinabulin to assist patients during the COVID-19 pandemic [25] Management's Comments on Operating Environment and Future Outlook - Management acknowledges that while COVID-19 has impacted timelines, the effect on ongoing trials is minimal, with expectations for data analysis in early 2021 [20][53] - The company is optimistic about the potential for Plinabulin to improve patient outcomes in oncology, particularly in combination with existing therapies [39] Other Important Information - The company has appointed Paul Friel as Chief Commercial Officer and Dr. Ravi Majeti to the Board of Directors, enhancing its leadership team [14][15] - Plinabulin's patent protections extend until 2036 in multiple jurisdictions, providing a substantial runway for commercialization [13] Q&A Session Summary Question: Can you discuss the NCCN guidelines submission prep for CIN? - The guidelines submission process is straightforward, and the next meeting is scheduled for mid-October [46][48] Question: Is it possible to get reimbursement for use ahead of official approval? - Payers will follow the label and NCCN guidelines, which will influence their reimbursement policies [50][51] Question: Can you provide more granularity on the timeline shifts related to COVID for non-small cell lung cancer? - COVID-19 has had minimal impact on timelines, with enrollment expected to finish this year [53] Question: What are the expectations for the CIN label? - Discussions with the FDA suggest a broad label for Plinabulin in combination with G-CSF across various cancers [55][56] Question: Any update on PROTECTIVE-1? - PROTECTIVE-1 has completed its interim analysis and is a supportive study for the combination label [64]