Earnings Labs

BeyondSpring Inc. (BYSI)

Q4 2018 Earnings Call· Sun, May 5, 2019

$1.49

-4.40%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.
Transcript

Operator

Operator

Good day, everyone, and welcome to BeyondSpring Inc.'s Fourth Quarter and Full-Year 2018 Financial Results Conference Call. My name is Aerial, and I will be the operator on today's call. Please be advised that today's call is being recorded. At this time, I would like to turn the call over to the host for today, Stephen Kilmer, Investor Relations. Please go ahead.

Stephen Kilmer

Management

Thank you, operator, and thank you, everyone for joining today's call. I would like to advise listeners that remarks made on today's call may reflect forward-looking statements relating to such matters as BeyondSpring's clinical and preclinical research and development activities and results, regulatory and commercial plans, industry trends, market potential, collaborative initiatives and financial projections, among others. These statements are based on currently available information and management's current assumptions, expectations and projections about future events. While management believes that its assumptions, expectations and projections are reasonable in view of the currently available information, you're cautioned not to place undue reliance on these forward-looking statements. The company's actual results may differ materially from those discussed during today's call for a variety of reasons, including those described in the forward-looking statements and risk factors section of the Company's 20-F and other filings with the SEC, which are available from the Investors section of BeyondSpring's website. Joining us on today's call is Dr. Lan Huang, Chairman and Chief Executive Officer, who will begin the call and provide a brief overview; Dr Ramon Mohanlal, Executive Vice President of Research and Development and Chief Medical Officer, who will provide the clinical update; Richard Daly, Chief Operating Officer, who will discuss BeyondSpring's marketing and partnership strategy; and Edward Liu, Chief Financial Officer, who will provide a financial update. And it's now my pleasure to turn the call over to Dr. Lan.

Lan Huang

Management

Thank you for joining today's call, ladies and gentlemen. 2018 was a truly historic year for BeyondSpring, as we strive to develop transforming medicine for cancer patients with severe unmet medical need. We continue to generate strong flow of data for our lead asset Plinabulin, a first-in-class immune agent. Over 540 patients use Plinabulin globally with good tolerability. The two lead pivotal trials for Plinabulin in non-small cell lung cancer and chemotherapy induced neutropenia or CIN, have well advanced to late stage Phase III development with a steady stream of positive data readout. In second and third line non-small cell lung cancer with EGFR wild type accounting for 70% to 85% of patients, there are currently only four approved therapies available with limited survival benefit at around eight to 10 months median OS and certain SAEs such as severe neutropenia. Even PD-1 antibody for nivolumab only had 2.8 months median survival benefit compared to docetaxel, the standard of care in this patient population. In CIN, the current standard of prevention care is G-CSF, such as Neulasta. However, the mass majority of patients with high risk chemotherapy still develop Grade 3 or 4 neutropenia, some over 90% after using Neulasta. Grade 3 or 4 neutropenia requires that chemotherapy dose be reduced, the next cycle be delayed, the regime be downgraded or discontinued altogether, we call them the 4Ds. All of this results in significantly were survivor outcome for patients. As a result, both indications present significant unmet medical needs. Plinabulin has the potential to disrupt, the current treatment landscape and with the improved overall patient outcome. We reached the first pre-specified interim analysis of Study 103 Plinabulin, in the second and third line treatment for non-small cell lung cancer, with the EGFR wild type with the Data and Safety Monitoring Board,…

Ramon Mohanlal

Management

Thanks Lan. We have made significant progress in our clinical trials in 2018. We evaluated Plinabulin's effect of anticancer and prevention of chemotherapy induced neutropenia in three studies, Study 103, Study 105 and Study 106. First, Study 103, is a 554 patient Phase III registrational study, evaluating the anticancer effect of Plinabulin in combination with docetaxel compared to docetaxel alone in the second and third line non-small cell lung cancer with its primary endpoint of median overall survival. To-date, we have enrolled more than 400 patients in the U.S., Australia and China. The study has two pre-specified interim analysis. The first at one-third of 146 patient death event and the second a two-thirds of 293 patient death events. We read the first interim analysis and the DSMB recommended the trial to continue. The second interim analysis is expected in the fourth quarter of 2019. If the P value for the median overall survival at the second interim analysis is less or equal to 0.012, the trial may stop early. If the P value is greater than 0.012, the trial will continue and final results of the trial and the death event of 439 patients are expected to be available in 2020. If the P value for median overall survival for the final results is less than or equal to 0.05, the study can be claimed successful. Second, Study 105 and Study 106 evaluate Plinabulin's effect in the prevention of chemo-induced neutropenia. Study 105 is a Phase II/III registrational trial of Plinabulin after the standard regimen of docetaxel in approximately 160 advanced breast cancer hormone refractory prostate cancer and advanced non-small cell lung cancer patients in the U.S., China, Russia and the Ukraine. The primary endpoint of this trial is duration of severe neutropenia or DSM in the first cycle of…

Richard Daly

Management

Thanks Ramon. As you've heard, the data released in 2018 is only serve to increase our confidence and the ability of Plinabulin to positively improve on the standard of care and affect the lives of patients with cancer. Those who required the prevention of neutropenia and those seeking options in the treatment of non-small cell lung cancer. And we look to continue to advance the organization toward commercialization. This morning, I'll be addressing three components of our commercialization prospects. The CIN opportunity, the evolving non-small cell lung cancer market and our business development strategy that supports the excellent work of our clinical team. First, CIN. This is a vast global opportunity. 4 million cycles of monotherapy G-CSF are used worldwide each year to prevent CIN. And as we have noted, there is an opportunity to improve on the current standard of care and improve the outcomes for patients. The clinical profile that both Lan and Ramon referred to presents a clear case for superiority in the prevention of CIN and the potential for increasing compliance and persistency with chemotherapeutic regimens. With the hope that the outcomes will be improved. We know that our messages resonate with providers, our proprietary market research indicates that oncologists have a very favorable response to the Plinabulin product profile, also the physicians quickly grasp the logic of the complementary MOAs of both Plinabulin and G-CSFs. As a result, the oncologist understood the rationale for Plinabulin plus G-CSF combination use for the immediate clinical benefit prevention of neutropenia and bone pain as well as the potential long-term benefits of keeping patients on planned chemotherapy regimens, dosing and cycle time. Scientific literature indicates that neutropenia is the number one cause of changes in chemotherapy regimens. The combination of Plinabulin plus G-CSF shows great promise in enabling oncologist…

Edward Liu

Management

Thanks Rich. I'll now briefly review our fourth quarter and full year 2018 financial results and for greater details related to our fourth quarter and full year of 2018 financial results. I'll refer you to our press release issued this morning and our 20-F filing both of which can be accessed at our IR section of our website. Our R&D expenses decreased by $1.4 million and $37.3 million in the fourth quarter and full year 2018. In 2017, we issued approximately 2.1 million shares to Nereus Trust at our initial public offering in exchange for the termination of the royalty payment obligations in relation to Plinabulin's global rights outside of China. This transaction was recorded as a non-cash expense of $42.3 million. Without this non-cash expense, our R&D expenses in full year 2018 would have increased by $5 million, as a result of increased clinical trial costs Our G&A expenses increased by $0.4 million in the fourth quarter of 2018 and decreased by $3.2 million in full year 2018. The decrease in G&A expenses in full year 2018 was primarily due to a decrease in non-cash share-based compensation. The net loss attributable to BeyondSpring was $14.7 million and $54.9 million for the fourth quarter and full year 2018, compared to $7.8 million and $91.8 million for the same period in 2017. Cash and short-term investment were $3.9 million as at the end of 2018, compared to $30.6 million as at the end of 2017. Subsequent to year-end 2018, we entered into loan agreements totaling approximately RMB37 million, and RMB27 million of this loss has been drawn down with the remainder expected to be drawn down during the second quarter of 2019. BeyondSpring has a unique business model that integrates the clinical resources in both U.S. and China. We believe this dual development strategy provide us the ability to conduct trials in the time and the cost efficient manner and to maximize value for shareholders and investors. With that, I'll now turn the call back to Lan. Lan?

Lan Huang

Management

Thank you, Edward. I'm extremely proud and grateful to the entire BeyondSpring team who are our family members. I also want to recognize other contributors to our journey including our investors and Board of Directors, as well as our extended partners, including CROs, CMOs and investment bankers. And last but not least, I would like to thank the patients who participating in our trials. It truly takes a village to raise a child and Plinabulin is our first child. We name our company BeyondSpring for the following reasons, one, is beyond borders, we strive to integrate global resources to develop transforming medicine in the time and cost efficient manner. The second is beyond seasons, where we'll like to go from the sowing and hope season of spring directly into the harvest season of NDA. Living up to our company name BeyondSpring, we're very pleased with the significant amount of clinical data generated in 2018 to support our planned NDA submissions in China and U.S. in the next 12 to 18 months. Looking ahead, BeyondSpring is poised for significant milestones in the coming months, which would transform BeyondSpring into a commercial stage company and I look forward to keeping you updated. Finally, I would like to thank you for your interest in our company and your time for listening in. That concludes our call today.

Operator

Operator

This concludes today's conference call. You may disconnect your lines. Thank you for participating, and have a pleasant day.

Q -

Management