Q1 2021 BeyondSpring Inc Earnings Call
Ladies and gentlemen, thank you for standing by please continue to hold beyond Springs program will begin shortly once again, ladies and gentlemen, thank you for standing by beyond Springs Conference will begin shortly.
[music].
Good morning, and welcome to be on Springs first quarter 2021 financial results Conference call. At this time all participants are in a listen only mode. Following management's prepared remarks, we will hold a brief question and answer session as from.
Binder of this call is being recorded today June 16th 2021.
I'll now turn the call over to Ashley Robinson of lifestyle Advisors. Please go ahead.
Thank you everyone for joining today's call on.
Goodbye.
Comments made on today's call may reflect forward looking statements that are related to such matters as the I think clinical and preclinical research and development activities and the salt.
Regulatory and commercial plans industry trends market potential collaborative initiatives and financial projections among others.
While management believes.
That is the assumptions expectations and projections are reasonable and view of the currently available information you are cautioned not to place undue reliance on these forward looking statements. The company's actual results may differ materially from those discussed during the call for a variety of reasons, including those described.
And the forward looking statements and risk factors section of the company's 20-F, and other filings with the FTC, which are available on the investors section of the on Springs website.
Joining us on today's call is Doctor 1 Quad fiancee co founder Chairman and Chief Executive Officer, Dr. Riemann Mahalo, Executive Vice President Research and development and Chief Medical Officer.
Richard Daly, Chief operating officer, and all of the Fab.
Chief Financial Officer.
Now my pleasure to turn the call over to the Doctor Lollipop launch.
Thank you Ashley.
Hello, everyone and thank you for joining today's call.
And how it's being a very short time since we last spoke with you on all comprehends the you and earnings call.
So I will keep today's remarks for you.
I would like to take time to highlight the key activities and continued progress as we keep moving towards commercializing and define the Ping our lead asset first in class agent novel and the pipeline.
Hi, fly in the DUC well.
Well, yeah, and prevention, non small cell lung cancer and potentially of many other kinds of indications.
In the past culture, you asked FDA file our NDA filing and we have the anticipated, but do but take that with the agency of November of study.
Yeah.
And we're very pleased and the grateful to receive priority review from the agency.
Prior to review is glad and should I S. T. A true applications from Madison and that's.
If approved.
And what provides technical center in pool of buttons and.
The effectiveness and safety of the treatment.
And those days of prevention of serious conditions, when compared to the standard of care.
We of course believe Dodge and never meet the definition and looking forward now to our November but you've got day.
Actually wait Oh, what for 2 of IP, we have made progress in developing the Babylon and said you.
Iraq and cancer treatment inkjet.
And the global Phase III, non small cell lung cancer study or dumping Street.
And the various checkpoint inhibitor combination studies and 7 different cancers.
In the coming months, we are looking forward to further validating the Netherlands direct anti cancer T with topline overall survival data from all the shopping streets study in non small cell lung cancer.
This phase III registration trial being conducted globally and 60 clinical sites.
Hutch, the nursing enrollment of 559 patients.
It is designed to evaluate the novel and in combination with Docetaxel and patients with second and third line non small cell lung cancer with measurable long lesion and Egfr wild type.
Which is around 85% worse than lung cancer patients.
This is the severely unmet medical need indication.
That's the only for sort of a piece of pool.
With limited survival benefit and.
And the severe side effects such as.
The view of neutropenia ease of the actual based therapies.
The study had achieved 2 successful interim analysis.
It's the positive result in the study is achieved we would anticipate seeking FDA approval.
And moving towards commercialization in the stack.
The indication well canavalin.
In addition resistance to immunotherapy is the severe unmet medical needs and we believe novelette and they have a potential and that.
Thick and take care of things back when combined with checkpoint inhibitors.
First our vision of developing and Avalon at the treatment in the oncology is supported by the compelling data all.
The scientific team presented at the recently called Cool debt High School counseling.
At the school, what cause that and catch phase 1 data that showed the Netherlands in combination with you but on a map.
And the U P little on map at 46% all of our in sucking patients with PD, 1 PD, 1 naive or resistant tumors in second line and beyond in small cell lung cancer.
Additionally, the day that showed that the Netherlands combination.
On April 2 research and by tumors that had progressed on prior PD, 1 PDL, 1 inhibitors and third line small cell lung cancer with 43% of Wow.
The Street PR patients in PD, 1 resistant patient population of tumor reduction over 50%.
And the long duration of treatment was 1 patient she the 18 months.
Second we have initiated and investigator initiated phase 1 phase 2 trial, you about 18 of the safety and Tolerability and efficacy of Canavalin and Triple combination.
With both PD, 1 or PDL, 1 antibody and the radiation therapy, and 7 advanced cancer, who failed PD, 1 and PDL 1 inhibitors at M. D Anderson the.
The first patient was dosed in non small cell lung cancer.
And the true that your early June.
I'm very proud of our team and state policy execute on those programs all.
All of us are committed to raising the standard of care.
Kinds of patients and the largest global markets with the first in class treatment.
We now draw closer than ever.
To achieving this mission and look forward towards the banking phenomenon and.
Well no I think the power of many opportunities to succeed.
I will now turn the call over to the Doctor the moment I know for a very important and amongst buttons of all upcoming R&D day you bet.
Ramon and.
The long.
I'm sorry, the pace of the knowledge and that'll be hosting on all of the D day.
On Friday of next week June 26th and.
8 a M.
We hope you will be sharing with you all.
And the cancer development.
G.
Some of them.
Yeah.
Oh events of a feature presentation from both of them.
The on Florida.
Let me talk on the.
On the phone.
And the type of financing.
Oh, the Dublin, 3 scope of PR from.
On the people kind of of Sun.
On her.
All of team will also for the board do you feel okay all of our Cobra.
Yeah.
And the other.
First in class agent.
The back of the miscible Hudson.
And so that's the spine, but the truth of it.
And therefore released from the broth amusements.
Okay.
H 1.
And its novel mechanism of action and grades in English.
From school and the whole data.
All right.
The data and small cell lung cancer patients.
Please proceed from Sanford.
The school.
And so all of this mechanism of action and that's all of the issues.
Good day.
Of course, we all know it's a company of developers and all of its yeah. The poll.
And with combining the zone.
And for that matter.
Uh huh.
And so the Hudson.
Yeah.
And without increasing the life of the Iraq.
And part of that conclusion.
And so from that then.
And on the R&D day, you the outlines of the company.
Right.
The focus on the street.
Yes.
The number 1.
Peripheral and push the.
I am proud of them.
On the true.
Well first of all the co 2 huh.
It's true.
And of the core of Io Cleveland.
It's simple.
And as well.
Which we expect will be called the kinds of the Colorado setup.
On the screen.
Preparing for the.
With that.
And just kind of of course approximately 40%.
A great Prescore huh.
On leap over the contemplation of the Io agents.
We will share more about and that's all.
All of them.
And I would like and cartoon kinds of events.
Yes.
And that I will now turn the call all of her converge.
We will discuss our commercial and partnership.
Rich.
Thank you all of them.
Our prelaunch activities and preparations for a commercial launch and the CIA and market are building with our <unk> day clearly set for November.
Over the next several months our seasoned commercial leadership team is preparing to deliver a fully integrated market preparation and launch program to support the successful launch of Snapple and early 2022 complete with elements such as driving awareness of the unmet medical need.
And we call the neutropenia vulnerability GAAP.
Continuing on our large accounts outreach.
Preparing for Etsy and guidelines submission.
Hey, all development speed.
Most of the mobilization.
Key stakeholder outreach, including patient groups and federal state and local legislative initiatives.
Medical symposia and education.
Publication.
Targeted advisory boards, and finalizing our patient support services to ensure broad access at launch.
Specifically, we plan for a dedicated and focused team for the U S market.
Importantly, we will have a field reimbursement liaison team.
Supported by our patient services hub in place to ensure effective reimbursement from day, 1 to provide support for both providers and patients.
We believe this extensive commercial strategy will position us well the successful launch of <unk> combination therapy to capture of long term commercial success.
And look forward to updating you on our progress with our prelaunch activities over the coming months.
And China, we're taking a parallel path, having dedicated and focused commercial team build out and.
And partnership discussions with potential synergistic commercial partners.
I'll now turn the call over to listen and provide the financial update.
How much of it.
Thanks Rich.
I'll now briefly discuss our first quarter 'twenty 'twenty 1 financial results.
For greater detail to these results I refer you to our press release issued this morning and to our 6K filing both of which can be accessed under the investors section of our website.
With that I will now highlight some of the key financial results.
R&D expenses and the first quarter of 2021 were $11.3 million compared to $13.7 million and the same period last year.
The decrease of $2.4 million was primarily due to a decrease and clinical trial expenses and noncash stock based compensation.
Which was partially offset.
By and increase and manufacturing costs and cost related to the poll and that'd be 1 regulatory filings.
G&A expenses were $6.4 million and the first quarter of 'twenty 'twenty 1.
Third the $2.9 million for the same quarter of 2020.
The $3.5 million dollar increase was primarily due to higher personnel costs and noncash stock based compensation as well as pre commercialization activities for cannot be of them.
Net loss and the first quarter of 'twenty 'twenty, 1 was 17.0 million compared to $16.1 million for the same period last year.
Our cash balance at the end of Q1 was $96 million, which we believe will be sufficient to support our ongoing clinical programs over the next year, including our immune oncology pipeline and to prepare for the potential launch of pull on the abiel on and see I N.
And early 2020.2.
With that I'll now turn the call back over to Lon to conclude.
1.
Thank you and let the bus.
We have had and extremely productive current and have you want inside the company feel of the momentum that's all of vision of commercializing the Netherlands, and expanding all the indications comes closer.
From treating chemotherapy side effects cheating kinds of directly the Nava.
And it's truly a pipeline in the drug whereas the encouraging data. So I think we're thinking of many indications.
And that alone could be a game changer in cancer treatment and eye combining with checkpoint inhibitors.
We intend to capture this value for shareholders and the continue advancing our programs through clinical testing.
And to potential commercialization as novel cancer treatment options in the mountains and years of hat.
And finally.
I would like to thank the patients and our dedicated team.
The shareholders and all the hard too much what day of continuous support as we work towards improving the current standard of care because of patients worldwide.
This concludes our prepared remarks today.
I will now ask the operator to begin our Q&A session.
The Ada.
Thank you at this time, we'll be conducting a question and answer session. If you'd like to ask a question. Please press star 1 on your telephone keypad of confirmation tone will indicate your line is and the question to you May Press star 2 if you'd like to remove your question from the Kim from participants using speaker equipment and it may be necessary to pick up your handset.
Before pressing the star keys.
Our first question comes from the line of Jason <unk> with Bank of America. Please proceed with your question.
Hey, guys. Good morning, Thanks for taking my questions.
2 from me just your confidence level that when that bill and well have an FDA Advisory Committee I know that so far they have not asked or requested that and add can be scheduled but given that it is a new mechanism of action, which is the typical trigger for convening of panel I'm curious if you can share your thoughts on maybe why and.
And then I'd come wouldn't be necessary and in this particular instance, and then my second question is just.
As you look at the data generated with the the Triple play tabular and plus I O.
<unk> and.
And tumors that have progressed beyond PD, 1 therapy and the small cell lung context, what what are your thoughts about looking at this combination and non small cell lung.
And a bigger market opportunity and I assume youre going to want to wait till you see the Dublin results before making any investment decisions, but just sort of curious on.
Your outlook there for the utility and non small cell lung cancer.
Yeah. Thanks, Jason This is law and let me answer the first question regarding you know what the all confidence regarding the outcome and then the second question I think the triple I owe to be extrapolated on later to have studies potentially in non small cell lung cancer I will give the sofa.
2 of them on and to also as he is search and on coal.
And behind all of the study design.
Well the no outcome you know meeting we did have in the sort of a letter from FDA and staying there specifically theres no outcome of planned at this moment, we think that probably the due to 2 very positive element during the 2 months reveal a number 1.
<unk> is FDA inspection, it's happened in our New York office in the beginning of May and we do not have any full 80 streak of after the inspection and then secondly is we also had a large <unk> and me.
With the F D a.
The meeting is the orientation meeting for M. D E applications from MTO side. They usually are given to the agent, which had breakthrough designation and also have like orphan disease, and which are you know truly helping with some of that to me so that meeting had.
Huge support from the FDA decided to have almost 40.
And clinical leaders and CMC and preclinical all of those you know experts coming to the call and we had a pretty nice meeting there so potentially day war.
Happy with what the here and another thing I think will add to the confidence potentially know and calm is and should see from our earlier press release. We did show that you know AMC based endpoint such as the pretty much no grade 4 neutropenia is color they did to the reduction of clinical.
And Oh com, such as the incidents and duration and severity of type of Neutropenia and also have foundation. So that is the key element, which we think gives F. D. A and also later on the clinical community and confidence that the combination of a phenomenon of adding just as that is providing me.
Meaning full and there and kind of hold meaningful benefit for patients compared to the center of care Peg Filgrastim alone and preventing yeah, and which does lift the standard of care for the first time and the last 30 years.
As the answer your question.
Yeah, no definitely thank you so much for the thoughtful answer.
Thank you so I'm going to give the second question to Ramon.
Yes, Thank you Tom.
Yeah, that's certainly on.
The goal is indeed together now.
Listen the happening what's it called.
The proof of concept evidence.
That's the true and.
Specific Io combination.
And then of the next step will be definitely move the combination of interest. So so moving into the north wells have all kinds of Sydney.
The plan.
The next steps there.
The 2 big of Io combination strategies currently employed.
We have the Buick approach with the PD, 1 inhibitor of combining that with chemo.
And that's all sort of as a proof of course.
So on non small cell lung cancer.
And we see an excellent opportunity for canavalin to be added to the sort of asking them.
The 2 therefore get better.
The FIFO benefit.
And they're also and that's the.
Those are important points, we are making from that and not only adds to the overall survival benefit.
Also cramps.
The important type of thing.
With the people of course that debt this neutropenia and the.
And I O agents at the same.
And for.
The event.
From that and and therefore, it is very uniquely positioned to help the only increase overall survival and it also.
And.
Both neutropenia and immune related.
You bet the all the big iron ore of Triple gravity, that's being employed.
And by BMS.
And with a combined 2 different Io agents the people.
All of <unk> inhibitor.
All of that.
The iffy.
The there is no chemo and the mix.
However, they are much more of immune related aes.
Against the Nab and he's very well positioned to both.
Kris the overall harmful.
But also to reduce the and the related.
And so so the staff here with small cell lung cancer, yes, the bid.
And then the next step and it'll be we will move it to sort of fine tune.
And the non small cell and and and the other cancer types and adding to the Nab leads to these different oh triple combos that are currently employed by the.
Big pharma.
Thank you got it great. So yeah look forward to our R&D day next week, maybe maybe a figure and a little bit more of the clarity around the pathway would that be next steps and sort of the clinical pathway of it'd be helpful to learn more about.
Thanks.
Thank you Joseph 1 of your support.
Thank you. Our next question comes from the line of Maury Raycroft with Jefferies. Please proceed with your question.
Hi, good morning, everyone. Congrats on the progress and thanks for taking my questions. First question is just for phase III, Dublin. If you can provide any specifics on where you're at and respect to reaching the 439 events needed for the final analysis and you've guided to top line data mid year, but do you think this will be more of an August or September.
Update.
Oh, so probably I can this is long and I can't answer just a quick question. So as of now what did the beach and these 429, Betsy lens, which is the final analysis of you know of.
And I'm quite yet so it's still kind of in the data no.
Analysis has been done yet so I think we guided the market that it's mid year on because you know when you do the cleaning to make sure. The raw data is the same you know.
And the E. D. C systems that is the extensive process and also there's additional sensitive and that the says so it's still you know guiding is midyear.
Got it Okay and then.
Awesome.
Yes.
And then.
Oh, thank you.
Okay and then the other question was was also related to phase III, Dublin, and just wondering if there's anything additional you can say on the patient baseline characteristics at this point, including the proportion of patients who are PD, 1 failure patients and how baseline characteristics factor into your efficacy expectations or is this something we.
And learn more about at your R&D day event next week.
The first is I think on D. Next week will be very comprehensive so we're going to go into details into the designs.
And also primary and secondary endpoint for the Dove and 3 studies. So I think that's the right platform to review the details on.
And then secondly on you know for the base on how to assist the Oh you know balanced. So we are selecting the a measurable.
The measurable on Asian patients, which is the mechanism of enriched population pretty specifically and secondly, this has been the Egfr wild type, which is 85% of the non small cell lung cancer. This is much larger than the Egfr mutant all of the raws all alk mutation population and this is the you know.
The right sick patients as you know that placebo the TK I geez, that's not even work as well as docetaxel in the Egfr Wild type patient population. So we do the study 5 patients who had previous PD, 1 PD L..1 experience of dose arms.
On the balance, but we have a limited a percentage and those patient in this study.
Okay, that's helpful and.
And likewise looking forward to the R&D day event next week, thanks for taking my questions.
Thank you for the insightful question.
Thank you, ladies and gentlemen, and as a reminder, if you'd like to join the question queue. Please press star 1 on your telephone keypad at this time. Our next question comes from line of Andy <unk> with William Blair. Please proceed with your question.
Oh, great. Thanks for taking my questions and congratulations on all of the regulatory milestones that you've achieved in the past us 6 to 9 months.
So my question.
The deal with kind of the regulatory.
The sentiment.
So and.
So the question is the.
The basis of the question that has to do with you know during the Covid pandemic I think MPC and was really.
On aggressive in terms of updating guidelines regarding.
The management of Cie and patients I'm just wondering.
Through the breakthrough designation and discussions with the FDA priority review is the agency bring up kind of on that sector or the benefits that the snapple and can provide.
Especially maybe in the U S. We're probably.
60% over but I guess on the global level, where we're still very much in the pandemic.
And thanks for this great question, let me probably start the first half the answer and I'm going to give the baton to rich who had she also has done a lot of market research to see how this and you see on guideline update is going to affect the market reach was the pineapple and she says the combination so of.
First is I think of you know FDA is kind of independent from the NCC and guidelines.
Members, but as you see we did get breakthrough right. This is for the all my companies and also to raise the scent of cash. So that's the 2 quad tariff with the breakthrough and secondly, it will also the wasteful, but day to give us part of true with you. That's another you know help all in the way supported from FDA, saying that this is a true.
And medical need and we like to has the expedited review time, so that if the drug is proven to be effective you don't want to get to the market issuance of possible right. So that's the backdrop.
Backdrop, so part of that can give the baton to rich to talk about how does the interesting kind of I think is affecting how pitched the all the doctors using just SaaS and later our market penetration potential great. Thanks, a lot and thanks, Andy for the question.
With the Mtc and guideline change last March we have seen the physicians actually begin to go deeper into the intermediate risk category and are just ongoing discussions with the Kols community many of whom are deeply engaged with and CCN.
Indicate that they do not believe that the NCC and will revert back to the guy that the old guidelines, which is high risk only.
Anytime soon so they believe that this is ongoing mostly a couple of factors..1 there was a belief that the patients are people the community in general the need boosters and the long run number to cancer patients are among the most immuno compromised patients. We have obviously, we intentionally immuno compromise them with chemotherapy.
And so they need the added protection and this kind of and environment.
So the guidelines and appear to be with US for these updated guidelines is going to be with us for quite some time and.
And the physicians are getting quite comfortable with it as all of the payers.
So we see the obviously the the addressable market has grown by more than 100% because of these updated guidelines the high risk patients represent 35% of the patient population and intermediate risk represents 37%. So we think this bodes well for the opportunity because the can have on is the only drug that can actually raise the standard of care.
And see I and so.
So we're pretty excited about the opportunity to help out and improve the standard of care. So.
We believe this is of great opportunity for us for the put and providers and for the patients as well.
Yes.
Oh, great and.
Maybe just a follow up the rich.
Well and and also the Elizabeth.
From a modeling standpoint, how do you think about.
On the ramp any of the rich in your prepared remarks, you did talk about.
You've kind of building and integrated infrastructure here in the United States of the how should we sort of think about that S. GSA build.
Babies basically from now to produce and maybe from producers to 2 launch.
Yes, the great question, so where we have a threefold preke.
Launch.
The approach and we've talked about this before we're talking about addressing the driving the awareness of this neutropenia vulnerability gaps of day once a day 7 and 8.9 and so this is where <unk> has its effect and is the perfect partner for of G. CSF with $1.4 million units of G CSF being used and at this basis growing over time.
Of obviously, this FCC and situation and the opportunity to improve the standard of care. So addressing this neutropenia vulnerability of GAAP and being the perfect partner for G. CSF, because it really good opportunity and the positioning with the <unk>.
And with the key decision makers and payers and large accounts anyone affected by.
Contracting we can actually talk to now and so we are out talking to them right now and making them aware of the the potential debt at the.
The drug does in fact have and and activating these key accounts, making sure that they know who beyond spring is they know that the drug is in fact coming and then being prepared for broad access availability and access for patients so making sure that our systems are up and running so as we think about the infrastructure Bill and we're well on our way were really.
Confident we have the the avail of the.
Ability because of the the as Juan mentioned of deeply season. The commercial team that has done this many times before.
And when you think about our SG&A ramp we will.
The hiring our sales of identifying our sales team and only hiring them after.
We have a <unk>.
Guaranteed approval and because it's difficult to launch of product during the holiday season, and that's why we referred to launching this and the first quarter, we don't want to the.
We have the physicians distracted by the holiday it's not good for the product is not good for the company and it's really not good for patient care, we want to make sure that and bring them product to market. When we can attract the attention of the physician and get their full attention and that's generally after the holidays. So that's what we'll be doing so with that I'll turn it over towards the best for any additional comments.
Yes, Thank you and I just want to continue to assure everyone that we're.
Making all of the plans to make sure that the company is well funded during this time period of prelaunch as well as preparing for the launch and you'll note and our statements that we've just filed that we are sufficiently funded for the next year. However that said we are always evaluating.
Options for getting other funding into the company and our preference at this point is some form of non dilutive financing to just boost the balance sheet as well as at the right time to consider our partnerships.
Okay.
Okay. Thank.
Thank you very much for answering all my questions.
Thank you Andy for your continued support.
Thank you ladies and gentlemen, this concludes our question and answer session I'll turn the floor back to the Doctor Hong for any final comments.
Thank you again to everyone for joining us for the call today, whether a proud of all of accomplishment and look forward to speaking with you again on how R&D day on June the 25th next Friday. Thank you.
Thank you. This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation.