NORTHPOINTE BANCSHARES INC
NORTHPOINTE BANCSHARES INC Q2 FY2021 earnings call
August 31, 2021 · fiscal period ended 2021-06
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2021-08-31
Management highlights
- Corporate focus is twofold: advancing clinical pipeline towards product portfolio and building future as a global biopharma. - Pipeline progress: 13 milestones since年初, including 7 new INDs/trial starts and 4 positive data readouts. Felzartamab on track for BLA submission in Q4 2021. TJ101 registrational trial enrollment to complete by early 2022. Lemzoparlimab has multiple clinical trials in U.S. and China. Uliledlimab Phase 1 trial completed, Phase 2 trials ongoing. - Manufacturing facility in Hangzhou under construction, commercialization capability built. - Awards received for innovation and growth, and efforts in corporate governance and social responsibility.
Segment performance
For the six months ended June 30, 2021, net revenues were RMB 17.8 million (US$2.8 million) compared to nil in 2020, solely from the collaboration with AbbVie. Total R&D expenses were RMB 593 million (US$91.8 million) in H1 2021, an increase from RMB 442.3 million in 2020, driven by CRO fees for advancing the pipeline. Administrative expenses were RMB 451.5 million (US$69.9 million) in H1 2021, up from RMB 171.4 million in 2020, due to higher share-based compensation and professional fees. GAAP net loss was RMB 8 billion (US$166.7 million) in H1 2021, compared to RMB 582.9 million in 2020.
Guidance
- Felzartamab BLA submission expected in Q4 2021. - TJ101 registrational trial enrollment to complete by early 2022. - Dual listings in Shanghai STAR Market and Hong Kong Chapter 18A Market expected to be completed by end of 2022. - Expect to receive three milestone payments from AbbVie totaling $175 million in next 12-18 months.
Risks
- Geopolitical concerns and regulatory uncertainties in China, but management believes biotech is supported by the government and efforts are in place to diversify listings to mitigate risks.
Q&A highlights
Q: Kelly Shi asked about the level of detail for lemzoparlimab's early China trial topline readout at ASH and efficacy bar for the program, and about AbbVie's next milestone payment.
A: Jingwu Zhang Zang said lemzoparlimab's U.S. trial showed excellent clinical results with good safety, and Jielun Zhu mentioned expecting a $50 million milestone payment in the second half of 2021 and two more totaling $175 million next year.
Q: Jennifer Kim asked about navigating regulatory uncertainty in China and fundamental value as an innovative biotech.
A: Jielun Zhu stated biotech is a supported high-tech industry in China, our assets are highly differentiated and insulated from some market pressures, and dual listings are planned to mitigate geopolitical risks.
Q: Joe Catanzaro asked about BD deals in 2021 and early stage pipeline value creation.
A: Jingwu Zhang Zang said active in BD discussions for assets like TJD5, uliledlimab, and TJ101, and early stage assets like TJ107 and Enoblituzumab have promising data with potential for registrational trials in the near future.
Key numbers
Reported versus consensus
Earnings calendar feed
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Transcript
August 31, 2021Full transcript unavailable for redistribution
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