Earnings Labs

Northpointe Bancshares, Inc. (NPB)

Q4 2022 Earnings Call· Fri, Mar 31, 2023

$17.68

+0.63%

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Transcript

Tyler Ehler

Operator

Good morning to everyone and thank you for joining us this morning. Thank you all for standing by. And I'd like to take this opportunity to welcome you all to the I-Mab BioPharma Full Year 2022 Financial Results and Business Update Conference Call. This is Tyler Ehler here. I-Mab's Senior Director of Investor Relations. At this time, all participants are in a listen-only mode. At the end of this call, we'll conduct a Q&A session and instructions will follow at that time. Earlier today, we issued a press release providing a review of our financial results for the full year ended December 31, 2022, as well as an overview of our recent corporate highlights and upcoming milestones. The press release can be accessed on the Investor Relations tab on our website at ir.i-mabbiopharma.com. Joining me today on the call from I-Mab senior management team are Dr. Jingwu Zang, our Founder and Chairman; Dr. Andrew Zhu, our Acting CEO; and Mr. Richard Yeh, our Interim CFO and COO. Dr. Andrew Zhu will provide a high level overview of our recent achievements and upcoming milestones and also provide an update on our R&D progress. Mr. Yeh will then provide a summary of our financial results for the full year ended December 31, 2022 before we turn the call over to the operator to take your questions. Please note that today's discussion will contain forward-looking statements relating to the company's future performance and are made under the Safe Harbor provisions of the US Private Securities Litigation Reform Act of 1995. Such statements are not guarantees of future performance and are subject to certain risks and uncertainties, assumptions as well as other factors. Some of these risks are beyond the company's control and could cause actual results to differ materially from those mentioned in today's press release and in today's discussion. A general discussion of the risk factors that could affect I-Mab's business and financial results is included in certain filings of the company with the Securities and Exchange Commission. The company does not undertake any obligation to update this forward-looking information except as required by law. We also discuss specific non-GAAP financial measures during today's call. The presentation of which is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with US GAAP. Please see the financial results press release issued today for a definition of non-GAAP financial measures and a reconciliation of GAAP to non-GAAP financial results. And with that, I'll now turn the call over to Dr. Andrew Zhu, our Acting CEO. Dr. Zhu. Please go ahead.

Andrew Zhu

Analyst

Thank you, Tyler. It's a pleasure to welcome all of you to our call today. I want to take this opportunity to discuss our key business update and major progress in core asset development for the year ended December 31st, 2022. Since the start of 2022, the company faced multiple challenges, including, but not limited to geopolitical issues such as ADR delisting risks, macroeconomic factors, including interest rate hikes and COVID-19 pandemic. In response to these challenges, the company made several strategic efforts to reposition the overall business and prioritize its pipeline. These measures resulted in a streamlined corporate structure and workforce as well as focused development of five key assets, leading to a significant reduction in the cash burn rate in 2022 and beyond. These efforts have allowed us to achieve critical milestones for our prioritized pipeline and deliver near-term value. In terms of the ADR delisting risk, on December 15th, 2022, the PCAOB issued a report that vacated the previous determination and removed mainland China and Hong Kong from the list of jurisdiction where it is unable to inspect or investigate completely registered public accounting firms. For this reason, the company does not expect to be identified as a commission identified issuer under the HFCAA after it files the annual report on Form 20-F for the fiscal year 2022. This has removed a significant headwind the company faced in 2022. With the above mentioned strategic efforts on the pipeline development front in 2022, we achieved 13 key clinical milestones, including positive results, including positive data readouts for three of our key assets lemzoparlimab, uliledlimab and givastomig. Here we highlight the five key clinical assets that we have prioritized. These assets are novel, highly differentiated and among the frontrunners globally and all in China. First of all eftansomatropin alfa,…

Richard Yeh

Analyst

Thank you, Andrew. Let me turn to review our financial results for the full year ended December 31st, 2022. As of December 31st, 2022, our cash and cash equivalents and short-term investments were RMB3.5 billion or US$514 million compared with RMB4.3 billion or US$671 as of December 31st, 2021. I-Mab's strong cash balance is expected to provide the company with adequate funding to support its key business operations over the next three years. Total revenue for the full year of 2022 were RMB-221.6 million or US$32.1 million compared with RMB88 million for the full year of 2021. The decrease in 2022 net revenue was primarily due to a one-off accounting treatment of US$48 million recorded in the second half 2022, following the amendment to the original licensing and collaboration agreement with AbbVie in August 2022. Further details can be found in our annual financial results. The decrease was partially offset by the revenue of RMB92.6 million or US$30.4 million from licensing and collaboration arrangements and the supply of pipeline products. Now let me turn to the R&D expenses. Research and development expenses for the full year of 2022 were RMB904.9 million or US$131 million compared with RMB1.2 billion for the full year of 2021. The decrease was primarily due to the reduced demand for pipeline products as the company prepared to procure the sufficient stock for the pipeline products in 2021 and a lower share-based compensation expenses. Administrative expenses for the full year of 2022 were RMB720 million or US$104.4 million compared with RMB899 million for the full year of 2021. The decrease was primarily due to lower share-based compensation expenses in relation to the management personnel and optimized control of operation and administrative expenses. Net other expenses for the full year of 2022 were RMB126.6 million or US$18.4 million…

Tyler Ehler

Operator

Thank you, Richard and thank you Dr. Zhu for your time and for your insights today. Next, we will begin our Q&A session. If you do have any questions please use Zoom's Raise Your Hand feature and we'll unmute you for your questions. First question we see is from Kelly Shi. Kelly, please go ahead.

Kelly Shi

Analyst

Thank you, Tyler, and thank you for taking my questions. My first question is, has I-Mab been able to resolve its delisting risks fully and also have follow-up. Thanks.

Jingwu Zang

Analyst

Yeah. Hey, Kelly, thank you for your question. I think most of the delisting risk has been mitigated by our -- working with our current auditor through the PCAOB new rules. So our delisting risk has been largely mitigated throughout last year.

Kelly Shi

Analyst

Thanks. And also regarding the Phase 2 trial of CD73 antibody in Stage 4 non-small cell lung cancer. You updated 70 patients has been enrolled by the end of last year. I'm curious, could you share more information regarding the patient baseline characteristics regarding PD-L1 expression level and also prior PD-1 treatment? Are they like refractory or relapsed from any PD-1 other PD-1 agents? Thank you.

Andrew Zhu

Analyst

Yeah, let me take that question. So, Kelly, as I indicated in my presentation, the data that I presented, the one with 70 patient cohort that's specifically targeting the treatment naive Stage 4 non-small cell lung cancer. So they are definitely naive to all the treatments, including PD-1. And so our date, yeah.

Kelly Shi

Analyst

Sorry. Go ahead.

Andrew Zhu

Analyst

You have a follow-up question?

Kelly Shi

Analyst

No, sorry. Go ahead. I'm okay with that.

Andrew Zhu

Analyst

Yeah. So basically, I think, you know, our study exclusively look at that particular population, you know, for our activity and also tolerability in our Phase 2 trial.

Kelly Shi

Analyst

Okay. Thank you.

Tyler Ehler

Operator

Thank you, Kelly. And I'm showing Joe Catanzaro. Joe, please go ahead.

Joseph Catanzaro

Analyst

Hey, guys. Hopefully you can hear me okay. Maybe just one quick one from me on givastomig. I know you touched on this a bit in the prepared remarks, but the Claudin18.2 space is obviously become highly competitive. So maybe for two questions around this. First, how do you think about the data that we've seen for zolbetuximab and the implications around Claudin18.2 as a target? And then second, given the competitiveness with a lot of different modalities, how do you think givastomig is positioned here? Thanks.

Andrew Zhu

Analyst

Yeah. So, Joe, great question. I think with the data from SPOTLIGHT and GLOW, you know, two Phase 3 trials in the first line metastatic gastric cancer space. With the addition of zolbetuximab to the standard chemo backbone both studies, you know, convincingly demonstrated the improved benefit. And I think, you know, clearly we have validated Claudin being a relevant therapeutic target in gastric cancer. So I think that part, you know, I personally feel that, you know, there's absolutely no argument. I think anti- Claudin18.2 antibody has a role. This will definitely benefit patients with metastatic gastric cancer. But also, as you know, both trials select patients based on Claudin18.2 expression. And the criteria they use is actually two plus, plus three plus of at least 75%. So you can imagine, I think, if you look at this population very carefully, this probably will be applicable for about 30% of the patients with high Claudin18.2 expression. So my feeling is that, you know, I think zolbetuximab will define -- will have the role in certain patients. And also for those who have low PD-L1 expression. This may become the major target therapy in combination with chemo. But having said that, you know, we also feel strongly that givastomig has a very, very unique position in a very Claudin, you know, Claudin18.2 therapeutic target space in gastric and potentially maybe in other tumor types. Because, you know, the unique molecular design really allow this molecule to cover a wider population with different levels of Claudin18.2 expression. In particular the lower Claudin18.2 expression. And we demonstrated that in preclinical models, you know, clearly it behaves favorably with more robust antitumor activity in comparison with other Claudin18.2 target antibody. Our ongoing Phase 1 trial also gives us the initial confidence that, you…

Tyler Ehler

Operator

Thank you, Dr. Zhu and thank you, Joe, for that question. Next, we'll have Louise Chen. Louise?

Louise Chen

Analyst

Hi. Thank you. Hi. Thanks for taking my question. So do you have any concerns regarding the toxicity of 4-1BB agonists? These features have prevented high target engagement in past programs. So can we expect more results from this dose escalation study? Thank you.

Andrew Zhu

Analyst

Yeah. I think Louise I'll take your question. Again, it's a very, very important question when it comes to the tolerability, the safety of any bispecific antibody particularly comes to the T cell engager modality. I think as I was trying to answer to Joe's question earlier, I did mention that our bispecific design is unique in a sense that we can only induce 4-1BB activation upon Claudin18.2 engagement at the tumor site. So for this reason, we actually spare the systemic toxicity commonly associated with 4-1BB and also other agonist treatment. So in that sense, the toxicity concern associated with other 4-1BB antibody or actually other T cell engager including CD3 based, definitely we actually have a very favorable safety profile as shown in our Phase 1 ongoing Phase 1 trial. Because, you know, we're not actually seeing the systemic toxicity, including hepatic toxicity, cytokine release syndrome and also the added bonus for our bispecific is that our GI toxicity also is on the mild side.

Tyler Ehler

Operator

Thank you, Dr. Zhu. Thank you, Louise for that question. We'll take one last one since we're a bit over time. Andres Maldonado. Andres, please go ahead.

Andres Maldonado

Analyst

Hi, guys. Thanks for taking my question. Quick one from me. Could you provide additional color on how we should be thinking about your expected cash burn rate in 2023? And a quick follow-up to that is obviously you've been focusing on the four highlighted programs from your prepared remarks. So just curious from a timing wise and a financial perspective, where do you expect to feel comfortable and bringing in additional assets to the clinic in the future? Thank you.

Richard Yeh

Analyst

Yeah. Let me thank you for your question, Joe. And let me start with the financial the burn rate question and Andrew can answer the pipeline question. So with this regard, as we have mentioned, that in 2022, we actually spent a lot of time actually optimizing our cost structure is mostly. So first of all, we actually focus on the five key assets and second, really optimizing the organizational structure. So this year we further going to reduce the overall cost as we just mentioned in the call that our expected current net burn rate for 2023 is expected to be in the range of US$130 million to US$140 million. This will further optimize our operational structure, so that our cash position can retain us at least for an additional three years or more years of cash operations. So given that we have other pipeline products that Andrew will discuss to develop and we really focus on our key assets.

Andrew Zhu

Analyst

Yeah. So I think Andres it's a very, very important question for the R&D operation. I think a few things that I would like to share with you. As you know that I-Mab actually has a very, very innovative discovery engine. We actually produce quite a lot of innovative assets internally, but also for reasons that we discussed today. We've been actually really trying to focus on the key assets that we can actually generate more value, you know, move the program to the next level faster, but also realize the value of these assets hopefully earlier so that, you know, the company will benefit, the shareholders will benefit, or more importantly, patients will benefit from this strategy. But having said that, we never stop looking at innovative assets from outside. It's just, you know, right now with the current situation, our bar is higher. You know, we definitely want to take a more critical look when it comes to, you know, the licensing efforts from outside. But this, you know, this is a dynamic process. Clearly we are aiming to also generate additional cash flow with our BD deal. So I think clearly, you know, we will reassess the strategy as we proceed with the new year in 2023. But right now, you know, we definitely want to make sure we focus on the internal assets. But definitely we will actually look at the key assets that potentially have value and also have potential market more critically. This is our current position.

Tyler Ehler

Operator

Thank you, Dr. Zhu and thank you, Richard. With that, we will conclude today's call. I'd like to thank you all for dialing into today's Financial Results and Business Update Conference Call. Thanks, everyone, for joining in. You may now disconnect.