Q4 2021 Beyondspring Inc Earnings Call
Good morning, and welcome to beyond Springs, fourth quarter and year end 2021, and financial results Conference call.
At this time all participants are in a listen only mode.
Following managements prepared remarks, we will hold a brief question and answer session.
As a reminder, this call is being recorded today April 14th 2022.
I will now turn the call over to Ashley Sergio of life side Visors.
Thank you everyone for joining today's call.
I'd like to advise listeners that comments made on today's call may reflect forward looking statements that are related to such matters as the osprey clinical and preclinical research and development activities.
All regulatory and commercial plans industry trials.
Probably chalk collaborative initiative.
And other financial protection.
Among others.
While management believes that its assumptions expectations and projections are reasonable in view of the currently available information you are cautioned not to place undue reliance on these forward looking statements.
Company's actual results may differ materially from those discussed during this call for a variety of reasons well, creating those described in the forward looking statements and risk factors sections of.
The company's 20-F and other filings with the FTC, which are available on the investors section of Giannis Springs website.
Joining us on today's call is Doctor long Fong beyond spring co founder Chairman and Chief Executive Officer.
Doctor among mahalo exec.
Executive Vice President Research and development and Chief Medical Officer and.
Mr Burke Chief Financial Officer, It's now my pleasure to turn the call over to soccer Longhorn one.
Good morning, everyone and thank you for joining today's call.
It's a pleasure to be here today reporting our fourth quarter and year end results.
And providing an update on our progress in the past few months.
After the company response letter from the U S. FDA last November we took steps to streamline our operations in order to extend the cash runway.
Now West coast are executing near term opportunities for value creation.
First we're pleased with our ongoing discussions with China M. P. Eight under review of Annapolis and D. A in combination with G. CSF for the prevention of chemotherapy induced neutropenia or yeah.
But she says that market in China is the deficit.
With $1.2 billion in sales in 'twenty, 'twenty and around 30% annual growth things 2017.
In addition, we continue our discussions with the FDA regarding the clinical and regulatory pathway for Panera Evelyn E. Yeah and in the U S.
Second.
Moving to our <unk> program in non small cell lung cancer, what we announced in August and September 20, trying to one ads.
As small home first positive topline data from our phase III doubling three study.
In the second and third line non small cell lung cancer with Egfr Wild type.
Which represents severe unmet medical need with limited treatment options.
<unk> and Docetaxel combination showed significant improvement in overall survivor, especially in doubling the two year and three year survival rate compared to Docetaxel alone.
We believe the data supports the roll off the Netherlands, as a potential anti cancer treatment option in this indication.
Well I'm moving floor to target an NDA filing in China by year end.
Dr. Ramon <unk>, our Chief Medical Officer will provide additional details during his remarks shortly.
Finally, we continue to develop the Netherlands as a potential pipeline in the drug.
Using cost effective investigator initiated studies, we'll continue our development plans for <unk>.
And I've learned in immuno oncology combinations in various cancers.
To target all match medical need in patients who have failed PD one PDL one inhibitors.
We continue to see strong interest by investigators and we'll share additional data and updates as they become available.
Overall, we're proud of the support we have received as we continue our efforts to bring phenomenon to market.
One of our validating steps wasn't bouncing last fall.
Glad to Jac partnership Bitching bunch of bullying, our 58% owned China subsidiary and high rate Pharmaceuticals.
Leading oncology R&D and commercialization company in China.
For the development.
And commercialization of novel and in greater China.
Hi, Ray is a well respected company with over 10000 salespeople in China.
I'm trying to trying T. The company had $1 $2 billion in sales of which $2 $4 billion was for oncology drug status.
In addition, Hawaii has a leading market position was this long acting G CSF in China.
In September China, trying to one well receive a 200 million.
Does that mean be estimate to be around $31 million upfront payment from heart rate and it will be eligible to receive up to $1 1 billion I mean be estimated to be $171 million in regulatory and sales milestones.
Well, we've received all proceeds from sales of cannabinoid products and pay a high rate of predetermined percentage of such sales.
We will provide updates on commercialization plans as we get closer to potential approval in China.
In conclusion, we remain committed in bringing <unk> to market.
As in the Avalon has a long patent life with patent protection to 2037 and 40 jurisdictions.
Which includes 19 granted patents in the U S.
What would have a long long way to realize and Abbott has potential to help many patients in need.
One more note, we're making good progress in our subsidiary <unk> Therapeutics.
Seed for of course is a differentiated molecule blue technology in the targeted protein degradation field.
We signed the R&D collaboration agreement on the number of targets with Eli Lilly in November of 2020.
Now I will turn the call over to Dr. Ramon behind all our Chief Medical Officer.
Some additional details on our development programs Ramon.
Thank you Laura.
I would like to make the following comments regarding this program.
Sure.
We believe that the Rockville and scan.
Yeah.
We have clinical evidence that the NAV increases neutrophil counts.
Rapid mechanism of action.
Active within 24 hours of chemotherapy.
This clinical evidence.
Yes last year.
Yeah.
Okay.
We have posted.
Every single clinical study for Cin.
We have conducted totaling over telephone the patients in these studies.
The things that has led to multiple presentations at leading scientific conferences.
That's where all our fabrication and highly regarded peer reviewed journals.
Uh huh.
Although we have also clinical trial data.
We do for sure and satisfy the U S F D a requirement.
At this time.
And the more data will be needed.
The second phase III study will be required.
We are currently in.
Discussions with U S FDA to align on the design of this study.
We are highly committed to.
When you and Avalon, well see I am sense into the market.
Well, if I don't get the tool.
To better protect.
You can see on.
This continues to be conditioned the medical need.
The D C area continues to call for Fencible more policy.
And some optimal treatment due to chemotherapy dose reduction.
Necessitated by the broker fee.
This opinion.
Moving all the long haul.
How long can.
I would like to make the following points.
Bethany.
We firmly believe the Rockville and non small cell lung cancer as.
As well as all the kinds of indicators.
We have strong mechanistic evidence that's 11 has a dual mechanism of action and cancer.
Firstly for NAFTA has abused enhancing effect.
And they do the immune system to better fight off the kenzie.
Secondly.
I haven't had direct anti cancer effect.
Agents in a number of kind of attach.
The second point I would like to make.
We have positive data.
While data is the key.
Phase III study.
He is non small cell lung cancer.
And if the phase one trial in small cell lung cancer.
Because we had the big 10 consortium.
Data from this trial with a 7% asphalt and ESCO last year.
As Lee.
Notably in the non small cell lung cancer trial.
We have more surviving patients over the time span of four years.
With the Netherlands, plus those combination comparison.
Of course those sofitel.
It is small cell lung cancer trials the.
The additional from that is if all of that and if you live in that.
More than doubled objective response rate O R. R.
At more than 40% compared to historical controls of the volatile back and if you live in basketball.
Of note, we still have one patient in the trial.
Who failed prior checkpoint inhibitors.
And yet continues to benefit from families often more than 58 typhoon.
Ritual second line small cell lung cancer is highly exceptional.
The first point I would like to make.
Regarding the path to approval.
What is relevant is the patient population of this trial.
In Dublin, three around 87% of the.
That was derived from China.
This has brought into question whether this data sets applicable to the U S population.
Without U S FDA discussion.
This is a topic that's not only affects us that affects many companies revised their data primarily from China.
As of February Olga Beauty, the review of our BLA.
For Syn 10 and Matt.
The FDA committed publicly noted that.
While it was convinced about the effects and safety of the data centers.
They will require additional data that is applicable to the U S population.
I think around 87% of the patient derived from China.
Uh-huh instead.
It's a distinct advantage for us.
<unk> approval in China.
It's hardly applicable for Chinese patients.
The NDA filing for non small cell lung cancer in China.
We will therefore be our NAV to priority.
However, we will remain committed to continuing our clinical and regulatory discussions in the U S and other regions.
In addition to the development of novel N C I N and non small cell lung cancer.
We are developing with Avon and immunotherapy combinations.
To a number of phase well see less too.
I I T trials.
Currently ongoing.
And we will share the data as we receive it.
With that I will now turn the call over to Elizabeth.
CFO .
For a review of our financials.
Elizabeth.
Thank you Ramon.
I will now briefly discuss our fourth quarter and year end 2021 financial results.
For greater detail to these results I refer you to our press release issued this morning and to our 20-F 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 in the fourth quarter of 2021 .
We're $5.8 million compared to $8 4 million in the same period last year.
The decrease of $2 6 million was primarily due to lower clinical development expenses and personnel costs, including noncash share based compensation expenses.
Which were partially offset by higher preclinical and professional expenses.
G&A expenses were 5.0 million in the fourth quarter of 2021 .
And included a noncash credit of 2.0 million related to the reversal of share based compensation expense.
This compares to 10.4 million.
For the prior year.
Which included $2 $1 million in nonrecurring personnel costs.
The decrease was primarily driven by lower share based compensation expense.
The net loss attributable to the company in the fourth quarter of 2021 was $9 $5 million compared to $17 $6 million for the same period last year.
For the full year 2021.
<unk> expenses were $36 $9 million compared to 41.8 million for the prior year.
The $4 9 million dollar decrease was primarily due to lower clinical development expense and noncash share based compensation expense.
Partially offset by higher personnel costs preclinical.
And professional services expenses.
As well as a 2.9 million dollar N D E application fee paid to F. D. A which is expected to be refunded during the second quarter of 2022.
Yeah.
G&A expenses for the full year, 2020 , one with $37 million compared to $22 6 million for the prior year.
The majority of the $8 1 million dollar increase was due to higher pre commercialization expenses for pull nabila them, which we do not expect to continue this year.
There were also increases in personnel costs.
Administrative expenses and other costs, which were partially offset by lower noncash share based compensation expense.
The net loss attributable to the company for the full year was $64 $2 million compared to 61.0 million for the prior year.
Our cash balance at December 31, 2021 was $41 $6 million and we had short term investments of $37 million for a total of $72 4 million.
Which we believe will be sufficient to support our ongoing operations and clinical programs over the next year.
With that I'll now turn the call back over to Juan for closing remarks.
One.
Thank you and as a bus.
And thank you to every one was on the call for your strong support.
Fully committed to bring phenomenon to market to help many patients in need and it would continue to believe in its great potential.
I would like to open the call for Q&A now.
Later.
Thank you well now be conducting a question and answer session. If you'd like to ask a question today. Please press star one from your telephone keypad and a confirmation tone will indicate your line is in the question queue.
You May press Star two if you like to remove your question from the queue.
For participants that are using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
One moment. Please we poll for questions. Thank you.
Thank you and our first question is from the line of Maury Raycroft with Jefferies. Please proceed with your question.
Hi, good morning, Thanks for taking my questions.
To check on the China approval for Cin you've.
You've mentioned that you're in ongoing discussions with China's and MPA for cin, what kind of feedback and a potential approval decision have you received so far and is there an update on what the time frame for approval could look like.
Oh, Thank you so much maury and that cause bolting us over the years.
So that's yeah, India application is currently under independent reveal whereas the China again P. E. I should say actually I'm currently in China to work with our China team under review process.
So far we have had multiple positive meetings with C. D E, which is the center of drug evaluation in the M. P. A.
And we remain hopeful after potential approval in China, but it's also you know anything dealing with regulatory process has its inherent uncertainties. However, our optimism is based on the strong data generated in Asian patients in the <unk>.
While six phase III studies.
And we will provide a pro glass after discussions with China and MPA in due course.
Okay understood.
For non small cell lung for cin and United States, you mentioned running an additional study can you elaborate on conversations with FDA on what the additional study in cin can look like and when that could start.
Yeah.
Yeah. So I would just turn this question to Ramon Ramon would you like to answer this.
Yes, Thank you Lauren.
Yes. This is an important question.
Yes.
Cautions going with the U S. S. D E on the design of that study.
Sure.
When we have more clarity then of course, we will disclose that.
We are at 50 discussing this study.
Okay.
Understood and then maybe last question for me just for non small cell lung cancer is there still a path forward in the United States and.
When will you learn more about what that path could look like.
Yes, so also for most small cell lung cancer.
There are in excess of discussions with the U S. F D. A.
Those discussions are ongoing.
Obviously as I mentioned, the data is positive and will remain to be positive.
I also pointed out that most of the data must be biased from the Chinese population.
Rich.
This is an important topic.
Our discussions with U S F D a.
Got it Okay, I guess I guess.
Another study be needed there or could be I O studies potentially expand and.
Would that be more of the path forward for non small cell lung cancer.
So so non small cell lung cancer second line is still tremendous unmet medical need because you will be aware that most of the I O agents move into first line.
In essence creates an opportunity in second and third line.
That's where we are positioned so we have processed data with one study and.
Discussions are ongoing.
Regarding also positioning in second line.
With separately also su.
As you indicate our interests also is it.
In first line.
A number of our Io combinations, we are active on both fronts.
But focus on second half two times, but also some attention to first line.
<unk> combinations.
Okay. Okay. Thanks for taking my questions.
Yeah.
Thank you so much maury.
Our next question comes from the line of Jason <unk> with Bank of America. Please proceed with your questions.
Hi, Good morning, everyone. This is chi on for Jason Thanks for taking my questions.
The first one on the.
U S. Non small cell filing I just wanted to come from it's the second half 2022 filing guidance is off the table right now as you can to your discussion with D. S. P. A and I'm curious if you have any sort of early feedback from the FDA about what the gating factor for you.
S filing I understand they're set up the dynamic of evolving FDA view about the preference for a multi regional clinical trials I'm curious if that's set up that they take.
A big driver for that discussion and and I guess certainly there is at the middle East and have an AD com I think why do you think the F. D. A tokyo was sort of data generated in China was based on Oh.
To report several years ago, I think from 2016 that maybe there is some data compromise a China trials. So one of the questions. They ask the sponsors their work if theres any overlap with their trial sites compared to you know what is documented and that 2016 report I understand there are like a few years have gone by as things have changed.
Just curious if there's any overlap between your trial sites and that list of China trials.
Document thank you.
Well. Thank you so much cheap although I can't answer just quickly I guess or a mall has offered a lot on the non small cell lung cancer are previously. So first is yeah would come from that the second half of tiny tiny to filing for non small cell lung cancer is what China.
For the U S. I think the current discussion is around the relevance of the wall Street patient population to the U S. Ah patients. So thanks for asking the question regarding the P. D. One H and from Lilly and in November that Oh, that's meeting, but as we know that its trying not to.
I'll provide a good date I wish that G. C. P. A qualities. So would you not see any issues with our data is we also use icon, which is a global shallow to conduct this study globally.
In China. There study sites there are four that all that well respective sites, which has passed the.
Yeah inspections. So we were very confident with the quality of our data from China.
Got it and if I may just ask one quick follow up has the F. D. A setup initiate a conversation that you may need a second trial.
With some flavor of multi region no representation or have that discussion that comes up yet.
No. This this discussion did not come up.
Thank you.
Yeah.
Thank you. Our next question is from the line of Joel Beatty with Baird. Please proceed with your question.
Hi, Thanks for taking the questions.
First one is on <unk> and in the U S and you mentioned that there'll be a second study needed there.
For clarity could you point out would study the FDA considers is the first study for that setting.
Oh, Thank you so much Joe and thanks for your support and just it's a great question. So the first study would be considered is the wild Saks Fifth Street study.
Well, that's a combination of label.
Yeah.
Makes sense.
FDA explicitly said that they consider that study to be a success.
Yeah.
I think they consider this asset to just data.
Yeah.
Oh, okay. So it sounds like.
Maybe.
You had a positive tone.
There'll be a review issue at a future point in time.
Yes, but currently we used a wow six phase III interim data at you got us the breakthrough and the final data is consistent with the interim data, which is a positive data from the primary end point and also we showed the relevant clinical.
Benefit in the combination compared to the pet film glass that long.
So that is absolutely, yes, and also it's a safe from.
It sounds from what we see from the data Panera Blaine in disaster and dose.
Well, you want to add a little bit more.
Yeah.
But if not did I answer your question Joe.
Okay.
Oh, sorry go ahead Robin.
Oh, sorry, I was on mute.
Hi.
Yes.
I would like to add.
So anyone who thinks it's a combination study with snap and backfill the same.
We met the primary endpoint the data is positive.
The data is positive in many different directions, so that.
As this study.
On its own.
This is a positive study.
Obviously.
With a new concept, a new paradigm vehicle mutation the coast and C. I N.
The FDA would like to have a level of Washington is what we already have.
Communicate it with you.
And two to reach that level of robustness. The second study will be needed.
The way the data will be looked at is of course.
In totality.
Once that data off the second study has been obtained.
Those discussions are ongoing with the USDA in particular regarding the design of the second study.
Got it thanks for that.
Maybe switching to non small cell lung cancer in the U S for a trial to support the indication would it be a matter of conducting a trial similar to Dublin, three but with the U S and global patients or would there be differences in trial design compared to <unk> three.
So a second study is not mentioned was in our discussions with U S. FDA. So the the current discussion.
Discussion point is the relevant himself that whilst we study for the U S population, but Eva as you'll see from the or that meeting with the FDA. After PD one from inorganic Lilly updated to say there is a certain regulatory flexibility in street parts number one is yes.
All Macanese number two is rare disease and potentially our drug is not in the real disease point number three is novel mode of action and Netherlands does have novel modes of action potentially that's that's our area of interest.
Interest as well.
I see got it thank you.
Our next question comes from the line of Joe Thank goodness with H C. Wainwright. Please proceed with your question.
Hi, everybody. Good morning, Thanks for taking the question. So I wanted to just focus on C. I N as well so let's start with China. So I just wanted to get a sense, what's the role that hung Ray is playing in the regulatory filing discussions in China, and maybe a little more detail as you feel as part of your discussions is what you are currently view as the <unk>.
Limiting steps.
Oh. Thank you so much Joe Thanks for the Great question. So Homeaway is really ideal partner for us in China, because they have many drugs approved.
In China and also a lot of them are innovative drugs, so crunchy well working together to prepare the answers, but a M. P. A review questions and do they also do attend.
The meetings with US what was the C D E.
And is there anything to talk to you guys.
What the key factor is that it still needs to be addressed.
Oh was answering some of the review questions from the Us yesterday.
So after those questions I'll start and then they will have signed up with you.
But it's a step wise approach sure sure. Thank you for that and then regarding the FDA I can certainly.
We respect and understand obviously not being able to provide any guidance regarding the design or scope of the second study. So I guess I'll ask this question and I'm not sure. If you can answer it at this point.
What are the chances that beyond spring will conduct this study on your own versus someone else or in partnership.
Well after the design is done I think we plan to do it ourselves if there's a pattern they'll come along I think would also be happy to do it together.
Okay, great. Thank you.
Thank you there are no further questions I'll now turn the call over to Dr. Huang for her closing remarks.
Well. Thank you everyone for joining the call today and thank you for your support.
We will keep you posted in our upcoming progresses. Thank you I have a nice day.
This will conclude today's conference. Thank you for your participation you may now disconnect your lines at this time.
Yeah.