Q2 2020 BeyondSpring Inc Earnings Call
[music].
Good morning, and welcome to be on Springs second quarter 2020 financial results Conference call. My name is cabin and I'll be your operator for today's conversation.
Please be advised this call is being recorded.
At this time I'd like to trickle over to Scott Eckstein, Vice President at Tcs say strategic Communications Scott. Please go ahead.
Thank you for joining todays call.
I'd like to advise listeners that comments made during today's call reflect forward looking statements related to such matters as beyond screens clinical and preclinical research and development activities and results regulatory and commercial plans industry trends market potential collaborative initiatives and financial projections among others.
Well I imagine leaves that its assumptions expectations from objections are reasonable inbuilt currently available information.
Caution not to place undue reliance on these forward looking statements.
He's actual results may differ materially from those discussed during this call for a variety of reasons, including those described in the forward looking statements enriched axis sections of the company's 20 up another filings with the FCC, which are available on the investor section or beyond Springs website.
Joining us on today's call is Dr. <unk>.
Beyond spring co founder Chairman and Chief Executive Officer.
Dr. Ramon Mohan Executive Vice President Research and development and Chief Medical Officer.
Richard Daly Chief operating officer.
And Edward Lu Chief Financial Officer.
It's now my pleasure to turn the call over to talk to long one long.
Yes. Thank you so much Scott.
Good morning, ladies and gentlemen, thank you joining today's call.
That's great Michigan has thing to develop innovative try some make too much to send stacking cool clinical outcomes in high unmet medical needs for the global market.
Without me as.
First in class H M connect blends in late stage development into large oncology market opportunities.
Well chemotherapy induced neutropenia.
And prevention.
Non small cell lung cancer.
Sure.
We believe that well as a significant.
That's quite.
Well potentially without in helping many patients need.
I think tremendous value for our shareholders.
The combination of 10 years, some hard work at beyond spring without dedicated and makes great team and I'll talk to nurse globally.
In addition, we have a developing clinical and preclinical pipeline, what's the Madeleine in multiple Oh combo canceling became shows.
You could kind of cool I O agent.
Ward, leading pocketed coaching degredation TPP platform to fuel future gross.
The harsh goal Nobel Prize winner seem to fill.
Oh, well scientific advisor.
Finally, we talked about global capabilities, so strong clinical add new records I mean that work.
If I was hoping commercial infrastructure to drive ongoing innovation.
What can happen its bursting became strained yeah.
We expect to five and be able to the U.S. XT eight <unk> and 2020.
We have initiated noting M.D. submission for try not <unk> eight in quarter 120 20.
Yeah, I indication has only one drug yes, that's approved in the last 30 years.
He said that class, which has annual revenue of over 9 billion globally and over 7 billion in the U.S. symbol.
Even with the use of she says that cancer patients undergoing chemos steel frame thing over 80% of brief one due to a p. no or very low like lots out, which what caused the very infection maybe into that.
The need to reduce the lake Chemos, those well outweighed chemo Richie you later cycles, Oh, that's a fact chemos anti cancer benefit.
Yes for yeah, and it's still a severity unmet medical need.
So first I'd meeting with the U.S. XT eight in September 2016, and the first patient enrolled in the U.S. equaled 27 team. We have evolved around 500 patients. He does yeah and study to arrive at there's never a sense.
<unk> filing I end up together.
A long before year journey.
The blame me and Dr. Crawford U.S., Yeah, and NCCN guideline founding member and foremost chairman.
I think I do us what the trial design and Ptwop caught it peaks.
Not that and she said that combination has been shown to be superior Elkins yacht and prevention no clinical studies.
What's your what's potentially translate to reduce infection and hospitalization after chemotherapy and enable doctors to provide chemotherapy to dept patients without compromise.
Thanks.
Well doses.
The thing cycles.
The strongest regime.
First of all showed that patients can stay the course with their treatment for potential survival.
No I'm not sure what do some detailed coking coal and the preclinical achievement in the second quarter Twentytwenty.
First the positive topline pre specified interim phase three data well from a lot for captive to start you want most it.
Continues to support just apparel profile using put that blend in combination with you last stuff versus using that last that long.
Fault protection against Yeah.
And demonstrates the potential of the Napoli button and keep that SAP combination to become the first superior ill start be significant enhance then took uses fab.
Preventing your tripping out you, all chemo and or no mileage handsets in the last 30 years.
I'm also excited to report to you that enrollment of a total 221 patients. He was fixed rate Street study has been completed in July ahead of schedule.
We expect topline phase three data will be available in quarter four punchy 20.
Second.
I want toppling three trial, a wall Street's study achieved not don't major milestone.
Then interim analysis for non small cell lung cancer treatment with snapple on.
That's you May recall that Ministry is a global phase three trial, what can happen in combination with docetaxel versus Docetaxel alone.
For the treatment of second and third line each outside wild type non small cell lung cancer.
Nobilis mechanism based measurable long lesion targeted patients.
This is a highly unmet medical need indication that's only four therapies have been approved with limited survival benefits and Tom was it but they pay TV side effects, such as well, but 40% severe neutropenia.
A power booting efficacy and safety data more than 500 patients.
At around 300 patients that's too bad.
The SMB recommended that the trial continue without any modification based on favorable benefit risk racial.
We think that the positive to try and saying in two interim analysis, except it's justified by now, but I O mechanism you activating Emil defense protein keep at it twice.
The positive phase two subset analysis based on mechanism targeted patients.
We look forward to the final topline data for first half tons you can do one at.
Hi, just 39 pass you back.
Alright.
If you are meeting in June we presented they that triple idle and mapping uncomfortable demonstrating 100% complete response rate in PD, one non responsive to more models conduct X.M.D. Anderson.
We plan to start a trickle <unk>, Oh, and now that I'm combo study at MD Anderson in second half Twentytwenty listing tension to reverse progressive disease of previous PD, one antibodies failed patients.
[laughter] potential success off the study what showcased nobilis potent activity you antigen presenting cells ATP action, serving as a potential cornerstones sharpie in cancer treatment.
This study was set the stage well phenomenon as a pipeline in the job well multiple cancer indications.
Finally, we believe the foundation boy no bid that company is active and tablets fault monopolize the composition that APAC can add the multiple usage patch and I've touched yet to the year 2036 in 36 jurisdictions, including south.
One team granted patents in the U.S.
It gets substantial runway books Nab lunch realize its commercial potential as a pipeline in the truck.
And well company, we made some significant additions to our what cost management and our board of directors in this quarter.
In August the outspent announced appointment pool real to the role of Chief commercial officer.
Paul has nearly 40 years of experience seem to pharmaceutical and biotech industry and successfully launched over talk drugs.
Has child positions as general manager and the President at Picky about Canada, and Vice president of cells for viral.
For was also instrumental in building Pap Pharmaceuticals, and picky done most Americans to more than 5000 employees and.
And then cells in less than 10 years during the merger Oh. It's companies. We're very excited about says Oh plane button and look forward to pause continued to contribute to them in his new role to help all company transform from R&D to arm B and C.
Oh, sorry in August.
Okay Levine Mcclatchy coupons are at a formal bought number 47.
<unk> Chief of Division of Hematology data for University joined our board of directors.
Something Mcclatchy coupon did what he said then being 24 team and the was a major countries odor tutor research and technology that to 47 4.9 billion a condition five gilead.
Sciences this past March.
Lets his extensive background and experience subset MACI can help guide us to translate saw the science and clinical data to medicine for patients and where it deserved shareholder that.
We look forward to his contributions I saw in basketball new member.
Yeah.
In summary, after 10 years of hard work researching phenomenons unique mechanism and enrolling over a thousand patients we have a clearer understanding of collaborates kimco profile and the abandonment trajectory.
The next six to 18 months, we expect the commitments and clinical and NGL catalyst, which will drive beyond springs transformation into a commercial stage company.
With that I would now turn the call all that to adopt program Omar I know well discuss recent kinda coaches I've been in more detail the mall.
Thank you Laura.
[laughter] I will talk about this yeah program.
In the past talked here, we have brought the sand program to fruition.
And Islam indicated we are faring well no.
Even as we speak we are preparing this year in India.
[laughter] cryo, okay, who witnessed how who enroll.
During its completion.
[laughter] Formational time for all the call me, Phil and the a filing.
We had inaugural often with the FDA, who grow actually call viewers, who are probably be fine.
If you all protocol prior to enrollment.
We have her in the discussion with the FDA regarding changing the primary endpoint.
Property or soon to the more meaningful endpoint raised upgrade for developing a friendship.
And the Preplanned interim analysis [laughter].
We have met.
Not only the new primary endpoint, great for the bidding Uh huh.
It also met the criteria for the old endpoint.
And then maybe fill the final dataset that too.
We now have softened the preparation of the CIO Andy.
We will also include data from broker Wong.
While the new Kopin has decided to map them.
Include Savi, well, how long will create long far.
We had a combined they said we believe we have to data points needed.
That's a hard you fix CMC requirements.
Well all the section.
Required by the idea.
The color they simplify things so for core AD after having an effect.
Just a different mechanisms of action.
To draw a complementary to each other.
Our international predominantly in parts of Texas.
Spiegel Heiko.
[laughter] predominantly in the second Regal cycle.
Combining these two agents.
Superior see I am action compared to each of them no.
Together these two egan.
Oh, no call with a more favorable safety profile.
Huh it would make sense that every time oncologists prescribed spectrum state artesia.
They should consider adding tamaddon into that.
The indication we are targeting say draw.
Include all chemotherapy.
And all more myeloid cancer.
[laughter] earlier, we believe our collective clinical trial data has all the data point require.
I want to see I guess.
I see a submission which is flat Raul December of this year.
Combined we have collected data in more than 12 home the patients.
Oh, it's more than seven home with patients happy goes to happen.
Now I will move to the ball small cell lung cancer off day.
We recently had all the time before the second Preplanned interim analysis.
We ended the Smbs up only reviewed safety data in Oh session.
But also the efficacy data in a close [laughter].
The benefit [laughter], having those sell me nation.
Based on their review the DSMB be recommend the prior to continue without Cody.
We view that very possible.
And are currently moving ahead, we completed patient enrollment.
Which we expect real good this year.
Just all pharmaceutical companies go over 90 Dizzy pair.
Can you see impact all time line.
However, we believe the impact will be minimal since we are the two ample trial.
The final they thought Dallas, it'll be krieger by reaching the car even longer haul home to the high industry G.
Yes, we expect.
The first talk to haul went the wrong.
I would like to remind you of the following.
Yes.
But madness unique.
Mechanism office leasing de after age wall.
Exactly David and to sell defaults paper.
[laughter].
You know facing Savi.
We show the oil benefit Fourq Onesix mall.
Yeah, It's our four Oh, yes, Oh 0.76.
And I'll talk a population of having a message the long lesion resist criteria in the long.
Right.
[laughter] Preplanned interim analyses.
The phase three trial was <unk> three in the wrong on the 50 patients that's even.
We show, possibly Fran Oh, yes.
They are less than all 0.75.
For.
The target product profile, having those so <unk> is to demonstrate superior efficacy.
Superior C.
The quality of life.
Oh self care.
Second.
Fine.
No go I mean, they buy it though so regimen.
[laughter] offline.
We see improved survival.
However at the expense tasty.
This more toxicity.
<unk> expenses quality of life.
We had to put them in those so combination not only do you expect to be Fixie overdose sell Mo.
It also reduces the and improved quality of life.
We believe the lab, though so combination has potential to be called the market leader second answer offline non small cell lung cancer.
As a reminder.
Approximately 50% on small cell lung cancer patients will have to cease progression.
But the checkpoint inhibitor regimen in first line.
[laughter] will be in need of second line treatment option.
But having to do so combination will be an ideal treatment option for these patients.
Now I will provide some R&D update.
I will soften see I am.
The good focus its or more myeloid cancer.
[laughter] combinations Ramsey.
And we envision that the Navajo will be added.
The artesia.
Every time these agents will do you.
From a medical [laughter], we see only Oh, sorry, no downside.
Before you see I am protection and without the toxicity.
As likely with less toxicity.
We estimate this formulation product, we'll talk to approximately 65, so let's see I end market.
There are significant market segment. We are currently [laughter] smoked indicated for you.
Our listed in the warnings and precaution section publicly.
These statements include he methodological malignancies and vision so to speak sell disorder.
These omar segments that we will now talk to address.
That's all moved on quality.
Our future direction, we'll focus on triple combination strategies in first line.
We're in we will have an agent that can generate immunogen.
This could be a chemo or radio therapy.
But having said that did accelerate hanson.
Huh.
<unk> PD, one PD L. One inhibitor.
Proof of concept triple combination rather than with an Avenue has sent to the AC are.
All right.
Doing three preparations are underway to initiate a number of these trial.
Regarding our pipeline, we continue to advance our preclinical programs BP idle to a BTI all four.
I will now take the opportunity.
Well update you on medical faster 50.
Paul the commercial.
Yes, so to the culprit 90 pandemic the national comprehensive cancer network assets yen recently updated its guideline.
To maximize your answer huh.
This is intended to minimize patients potential exposure.
We recently any chase it expanded access program EAP.
Which allows the bulk of across the U.S., who used to navigate false Yan offensive.
We are proud to do all par unhealthy August doing pandemic.
Yeah believes that you'd be chasing this program will assist patients and health care system.
To me the challenges.
[laughter] both of them by the current coal 19 pardon.
Yes, [laughter] roll outs me.
Rabbits effort.
With the man it's yeah.
Yeah me programs indicated.
Okay, well advisory board eating have command.
We have initiated this call since mid to asses yeah.
Yes, [laughter] resell crescent.
Thing [laughter].
Influential scientific meeting.
We are initiating a number of I see Saudi.
Yeah, Yeah, I can sit indication.
With that leaving town center in the United States.
Publication strategy.
Oh, I'm, sorry, Suzanne data.
Has recently been accepted for publication in the major do you know.
They should be viewed as an important external validation.
Additional massive audio paraphrasing targeted at major general.
We have clinical abstracts accepted that ethical.
I see our asphalt.
Im sorry.
During the second quarter of this year.
We continue to advance I'll see I am and non small cell lung cancer program.
This call.
We are now getting ready.
The big these programs to fruition.
Good to see Iran, and the applications this year.
And the non small cell lung cancer and the application next year.
In support of our commercial preparation.
We have initiated Ross Medical affairs recent I'll be.
Ram is Uh huh.
I have continued advancing our pipeline program.
With that.
I'll now turn the call O rig.
Who will discuss our commercial and partnership strategy.
Right.
Thanks remote.
As we've discussed for clinical program is robust continues to generate strong public data for potential role that now that can play cancer care.
I'd like to add my congratulations to our clinical team.
We're incredibly excited about the opportunity to improve cancer care for patients.
Equally encouraging our extensive market research has shown on colleges are excited about that as potential clinical benefits for their patients.
Today, I'll discuss three elements that drive our excitement.
First the unmet clinical need second the changing market forces in oncology and third cabins commercial strategy for successful launch.
During our discussion I'll be referencing our ongoing market research that supports our strategy.
First let me see is significant and recognized.
With more than 1.3 million cycles Jews yourself, given each year. This year end market remains an underserved market.
She is the number one reason for changes in chemotherapy regimens.
These changes take form of decrease dosage.
Great cycles.
Discontinuation of chemotherapy.
Even modest changes in chemotherapy regimens have potentially devastating effects on patient treatment outcomes.
In our market research oncologist crystal clear as to the importance of preventing see I am.
Three quarters Oncologist said it was very two extremely important to prevent see I am.
Monotherapy Gcs G CSF personal care, but they are simply not enough to prevent and manage the idea.
This is where perhaps it could become a game changer.
In our market research more than 100 practicing oncologists told US three most important characteristics subsea in therapy were one keep absolute neutrophil count for AMC as high as possible.
To reduce sport minimize don't pay.
Three improves compliance is persistency with chemotherapy.
In other words avoid afford D.
As you heard earlier this is the clinical profile could happen.
Oh, just walk therapy that hope that can help them provide more consistent sustain chemotherapy.
Our goal is to provide them with the tools to flip before these to the for US is to improve management and controls the I Oh.
A therapy that will help them provide stable doses.
Sustained cycles, the strongest regimen possible and help them to stay the course.
The vast majority of oncologist, 74%.
It was he asked about combination therapy approach with an album.
Oh, yes, the same 100 oncologists, how likely they are to use benevolent in combination with that she's yes, yes, yes.
Nearly two thirds or 64% stated they were highly likely to use the combination therapy.
Clearly oncologists are looking for improvement in standard of care.
Our second topic, the changing market forces in oncology.
You see I end market is undergoing significant changes, which strongly favorites Annapolis introduction its long term prospects.
Good epic is driving a desire for more effective therapies beyond monotherapy GCA itself.
Next the addressable market expansion.
As Ramon mentioned.
Earlier, we reference the NCCN guidelines and their update and see how Ya.
The guidelines expanded profile access from high risk patients, which account for 32% of chemotherapy patients to both high intermediate risk patients.
Which now accounts for 69% of call chemotherapy patients.
This is an increase in the addressable market.
More than 100%.
The next change oncology is the clinical pathway.
Called you practices use clinical pathway standardize care public hearing to evidence based guidelines.
Clinical pathway as have the potential to improve the effectiveness and efficiency of care.
Giardia practices base their clinical pathways NCCN guidelines.
Next.
See I didn't use concentration.
G CSF are highly concentrated.
360 oncology workouts.
Represent more than 80% or G CSF use.
This is among the most highly concentrated businesses in oncology.
So how do these factors help us build up in outlet strategy.
Based on the clinical data we generated.
Our market research and current oncology market trends, we believe that tablet medication that improves therapy by complying with the standard of care is well positioned to improve patient care and for successful commercialization.
Recent see US study found that 70% of company similar to be on spring.
I told you focused watching their first product well likely launch on their own U.S.
This is due to the relative strength in oncology products have on their piano statements that is favorable pricing well cost of goods and focused cost of sales.
We've already initiated our pre launch activities to prepare us for success of the market Importantly, this will enable us to optimize shareholder return as we explore partnership opportunities.
So our commercial strategy involves five core components.
First we were driving awareness over the next 12 months with top payers key opinion leaders through and physicians educational outreach.
Second.
I won't mention what we'd go in the case for guideline adoption.
We believe that benevolent data presented earlier by law that remote represents a significant advancement in the standard of care, that's renting see out yet.
Based on this we believe we're well positioned for inclusion in updated NCCN guideline.
NCCN submission is being prepared and we will be ready prior to after year pool per NCCN submission recommendations.
Third.
Account customer outreach.
As a combination therapy that builds on the standard of care can happen that is unique in the field.
No other product on the market or in development has the potential to make this claim.
We want to be sure that customers are aware of our clinical program.
To give you a sensor the concentration in magnitude or the opportunity and why we are confident we can execute this plan, let's look at the value of the top accounts.
As noted earlier, 80% of all G. CSF use comes from 360 accounts.
This is a highly concentrated opportunity.
Once in a company like ours can focus on and win.
Further the top 50 accounts represent $1.2 billion of gcs refuse.
On the top 100 accounts represent $1.8 billion of G CSF use.
Recall that in market research on Paul's had a very favorable response, not when combined with G. CSF.
Hi users are G. CSF, how didn't even more favorable response to using put Abbott and were more inclined to use the combination.
Thanks for that one is used in combination with G. CSF the perfect target list for US is the G CSF use.
Rob each has already begun.
Fourth.
Ensuring insurance coverage and access.
And our market research more than 90% or payers told that they plan to recoup Annapolis and their formulary is PERC NCCN guidelines due to its ability to improve the standard care.
[noise] payers understand that have always unique molecule.
One that creates value in combination with GE see ourselves.
And payers indicate that they would treat it as such in contracting and formulary discussions.
To ensure appropriate reimbursement, we plan to watch a field <unk> reimbursement liaison team from day one.
Finally.
With care practitioners inpatient commercial support.
Over the next year at leading up to and through launch.
Fully integrated market preparation that launch program sport successful launch it for that one.
Elements include our season commercial launch gene and leadership team, we're experiencing building and scaling organizations as well as launching products and leading partnerships we're prepared for all alternatives.
Well execute well defined in targeted prelaunch market shaping program to prepare the market for the watch a tablet.
Some of the key elements include large account outreach.
NCCN guideline outreach as mentioned earlier disease awareness key opinion leader development Speaker mobilization.
Physician education see a me and on CRB Congress support medical symposia publications, as Ramon mentioned and targeted advisory boards.
Once approved what to look at launch support to drive rapid appropriate uptake open tablet.
This would include 60 to 80 feels representatives to drive pull through and broad oncologist and payer coverage.
The old reimbursement team to ensure effective reimbursement as I mentioned earlier that could be from day one [laughter].
[laughter] patient support service to ensure ease of use bought access and improve care was patient education co pay support programs.
In summary.
Only for that one has demonstrated the village at clinically complement the standard of care and improve and see.
Reduce great Fortetropin here, where do you just don't pay and give oncologist Tuesday to enhance treatment outcomes.
And how those clinical performance along with the evolving medical needs to the oncology community bode well for this successful launch and long term commercial success of our drug.
In summary.
But I believe it's delivering on the promise elevating chemotherapy.
With that I'd like to turn it over to Edward will provide the financial uptick at work.
If you rich.
Now I'll briefly discuss our second quarter 2020 for initial results.
Greater detail related to these results I'd refer you to our press release issued this morning, and our 6K, probably most of which can be accessed under the investors section about website.
With that said Oh, no highlights some of the key numbers.
R&D expenses in the second quarter on 2020 were 11 million compared to 5.2 million in the same period last year.
The 5.8 me the increase was largely attributable to a 4.9 billion increase in clinical trial expenses.
SGN. They expenses were 2.6 million in the second quarter or 2020 compared to 2.1 million what are the same quarter last year.
The 0.5 million increase was mainly due to the increase in cost related to pre launch preparation of phenomena.
Net loss attributable to be on spring in the second quarter, Tony Tony was 12.8 million compared to 7.4 million for the same period last year.
Our cash and cash equivalents at the end up through two was 38.1 billion.
We are confident our current cash resources are sufficient to support our clinical trials and India submission in the U.S. noblin for the C.I. indication as well as to advance our immune oncology pipeline and protein Degredation research platform.
As long as noted earlier in June and July we closed the public offering and a private placements I searching dollars per share and raised gross proceeds of 33.9 billion.
These transactions continue to strengthen our balance sheet and diversified all shareholder base.
We intend to use the net proceeds to support the commercialization Nablus continue clinical and preclinical development and for general corporate purposes.
With that.
I'll turn the call back over too long for closing remarks.
Uh huh.
That's at work.
In closing I would like to say the patients our educate team oh shareholders and I'll touch nurse well, you'll Scott's support in helping us to deliver innovative medicines that can potentially provide superior results than the current standard of care for patients across the war.
What's it really unmet medical needs.
This is especially important during the cold in banking era I saw was health care system is experiencing unprecedented challenges.
Looking ahead in the next six to 18 months beyond sprang wealthy transforming into a commercial stage company through multiple significant kinda in coal and be a cat.
Well welcome you to embark on this exciting and meaningful journey with us actually how many patients in need.
Oh, great. That's open for question and answers. Thank you.
Thank you and I'll be conducting a question answer session.
To be pretty silly question could you. Please press star one under telephone keypad, a confirmation told would indicate your line is in the question you can be press star to if he'd like to <unk> question from the Q.
For participants using speaker equipment they'd be necessary to pick up your handset before pressing star one one moment. Please what we pull for questions. My first question today is coming from Maury Raycroft from Jefferies. Your line is not a lot.
Hi, good morning, everyone in dark congrats on the progress and thanks for taking my questions. I guess first question just on a if you could talk more about the NCCN guideline submission prep for Xian any thoughts on timing on when do you might submit and when the guidelines could get updated and once updated I was wondering if you if you play not pursue.
We named patient use and reimbursement.
Yeah. Thank you so much Marshall just quick question I think I know a rich to start and end of my mom could add a few more insights which please sure sure. Thanks. Thanks for the question Moissanite. They guidelines are pretty clear and there are posted on the NCCN. Our website you can basically said.
Processes to page application, so very straight forward and you can apply up to six weeks prior to your approval and the meetings for each advisory Committee are scheduled to advance. However, they will if necessary as they did with cobot 19 call in emergency.
Meeting and if they say they deem that the.
The opportunity represents a significant advancement so.
So for instance, the next meeting is middle of October scheduled meetings in middle of October So as Ramon talked about we.
We got our preparation and we understand the process and we are fully prepared.
For the opportunity to get on those guidelines, so with that I'll I'll turn it over to remote obviously for any type of named patient program or further commentary on.
Got it.
Yes, thanks switch.
Yes, as we speak we have started discussions.
It did the NCCN.
Uh Huh leadership, and it's rich pointed out those hub timeline that the will follow thank you.
Got it and.
Is it possible to potentially get or reimbursement for for years I had.
Having a head of into an official approval.
Oh, that's that's a really really good question. So that's a payer question more than in NCCN question, but payers will.
Follow obviously the label and look at the label NCCN. It's again on their website is very clear that they will actually go outside of label a they'll do what they think isn't the best interest to the patient and then the payers have told us and we've done extensive research with payers, we talked to more than 40 regional and national payers.
And they told US that NCCN is the thing that they will that will drive their their or their policy in there there.
Oh, no priorities for what they will reimburse so they'll look at the label first and then they'll look that's usually have a cancer. Obviously, it's one of those areas, where there really interested in making sure they're not seen as walking therapy.
I want to be sure that there are seen as very patient friendly, especially something instead of sitting as cancer. So [noise]. It's it's obviously.
Very sensitive situation with cancer, sorry, we can't really address each payer or the pay or a space and total prior to approval. So that's just difficult question I think that's payer by payer question and we really haven't addressed so at this point in time.
Got it Okay, and then for non small cell lung cancer can you provide more granularity into how much the timeline chips are related to co bid versus that event rate or other contributing variables.
Yeah, So how backend start in a remote.
You know insights so yeah actually covered matching does impact the in you know a timeline right because everybody gets affected but I think it had minimum seems without doing global enrollment and also just what China I think after March everything seems to back to.
I'm also not like in the U.S., so it's not really much impact.
You see from Ramones presentation of the 479 patients that's C bench, which is the school that event is going to be expected for first half a flat next year.
I know at closing almost at the end of Uh Huh, finishing all stay home at the fully rolled out.
Yes, yes.
Got it Okay. And then last question is just if you can talk more about the CIA and label expectations. I guess you have you had any discussions with FDA to see if they'll accept USIP whenever you want in combination with all other gcs, that's broadly and you see any potential boundaries for walk whenever you want it could be combined.
[music].
Yeah, So probably I can start among them on to add additional insights. So I wasn't able to especially of course. This has to wait until the pre NDA meeting, which route flattening out in the coming in.
And that but from where we are seeing from that's an aberration profile and also what stuff I'm missing link for that she says that would you project a broad label Oh for up to that but man and he says that combination you. All my lot concept and was for yeah chemo.
So can be combined was stuff you guys have class other meaning that no matter what chemo what cancer. There you know and Ah yeah actually used up all matter pop right. So and some other that you're sure. If you look at it either way, but use that you just as well.
Matter, what kinds of what chemo, they always have didn't seem at Yale between basics and they because it takes eight day to mature neutrophil and she says it is getting a bit too. So all of the new neutrophils called me out Metro one just after the eight or nine right and come out of the mechanism is catching the first week and it has been shown.
Being a multiple cancer and multiple chemo, so with that profile to come to mentality of the too.
Hey, Jeff it's going to protect the fourth cycle no matter what tends to [laughter] no matter what people, it's going to use.
<unk>, she's asset classes or that say right and they will approved about similar she says have absolute base out, yes, and he'll also those lashed out Oh neupogen. So we don't see much different. This thing that you said that cost versus last out which is what drives using in.
Colin coach study.
So that's a lot so [laughter]. So I don't know it's I answer your question.
No. That's helpful perspective, okay. Thanks for taking my questions.
Yes. Thank you.
Thank you and its question today is coming from Joe Pigeons for me. She Wainwright. Your line is that a lot.
Good morning, everyone. Thanks for taking the question and thanks for all the color thus far I'm, especially you know coming up had a very nice catalyst for the company I really have a logistical question that I think is targeted more towards Edward and that's I'm looking at the burn and potential offsets that we should consider so obviously some of these phase threes.
Or the phase threes are winding down so you're gonna have a significant drop in clinical trial costs. There. But then you know we anticipating any significant boost in say personnel costs or how how was how should we view the burn going forward and potential offsets.
Right. Thanks, Joe for this question I do know, we had about $38.1 million and all June thirtyth.
As we said in the press release, that's sufficient what's yard and submission in the U.S. and they'll be currently projected <unk> submission.
End up this year I'm, sorry, our current cash will last for a while at the next three quarters or so.
As you will see the of the clinical expenses will be a largely a reduced a compared to the previous quarters or as you correctly pointed out all the clinical trials are coming down trend and however are the commercial cost will start you Oh.
ER increased over the next several quarters and asked was headcount has to be Oh prepare the organization are ready for it commercial launch I'm. So I guess, a we're projecting about a burn all around $50 million EUR $15 million.
Quarter going forward.
However.
We will need additional cash for the commercialization Uh huh.
Towards the end of next year in preparation for commercial launches towards the end of next year.
Perfect. Thanks for that color.
Thank you.
Thank you as a reminder, that star one to be placed into question Q or that's question today is coming from Andy She from William Blair. Your line is alive.
Oh excellent thanks for taking my question.
So so I've a couple one is or I, just kind of housekeeping any update on protective one I think you on the call you talked extensively about protected to and it's a you know exelon data from looking for most.
Michael profile advocacy clinical profile perspective, so any update on that and second.
I think it's really interesting that you or allowing expanded access to the NAV when I'm just given the fact that it.
Probably close this thing to real world experience prior to approval or maybe some commentary on that motivation behind that.
And maybe early feedback from participating physician or institution, and maybe kind of.
We completed question for rich how do you think about a potential revenues from the expanded access program.
And I I have a follow up after the.
Yes. Thank you so much and before the great questions and thank you for your support Oh.
Said the quick also put a protective wash and Dambulla I'll start on but yet <unk> and then ritual and stuff like your revenue you know question. So.
Back to one yeah. This our interim analysis out what the first 105 Acacia has completed I think last year I know, we had a press release and dust collection 18, showing that would that be it.
The statistical significance for the primary I'm blanking, showing that yes, and I don't see are a key fault monopoly versus last that long. So just things were going Oh. So what was the combination they <unk> label for <unk> and to put that burden. So for the protective one as a mono therapy, it's up.
It's a supportive study what this label so and they has also shown to first week how early onset.
Mechanism often that plan in multiple cancer types. So that's that he is saying is basically compete to to be disappointed if I try so we're not doing anything like that.
That's his answer your question.
Yeah, any sort of publication strategies are presenting strategies for that trial or or the focus is gonna be unprotected to going forward.
That's helpful. Then they bought keep the pivotal trial is the patuxet too right and that's what that's one is supportive trial and that's what Ramon just mentioned a protective one to phase two portion has being accepted in the major drew I know a deal for publication in the coming along.
And of course, what does the phase three study will also be on planning for a publication as well so you will see but.
Excellent alright, that's helpful. Thank you.
Okay. So ramon can comment on that yet p., which is really very instrumental for them on to set this up really took half cancer patients remote.
Yes. So so the 80 program. It's all we already have a long investigator who approached US. That's that's you maybe where are we already have superstation, who was a dose it benevolent.
In the context of this EAP program.
The Oh, we continue to see Oh.
Interest.
And so we will Oh.
S.S.S., we go accommodate Oh, the investigators who haven't interest I think the Nab Lynn.
Two G CSF.
The the Coke at 19 and farm. It as you know a has impacted or the health care dynamics or which tends to be different from state to state or so so we continue to have a interested this program we continue to build.
Program or two to the benefit of the Oh.
Patient and medical community.
Okay great.
Hi, Rich you on the outside the revenue question.
Yes. So I think this is a really interesting question. So thanks for thanks Repurposing. It I think it's really timely <unk>. So we see this as an opportunity to its remain alluded to.
To help address the concerns our market research so they're in the midst of.
Doing market research right now it's all the market research I referenced on the limit my comments on the call were pre coded and so we're doing market research right now to get a sense of how things might change in this environment.
And actually that the concern has ramped up considerably we see on the first three months of the pandemic <unk> the number or the percentage of.
Chemotherapy cycles have dropped by 20% to 40% depending on where you are in the country and then on average about 20% overall.
That has recovered or to a great deal almost almost back to normal across the board, but that was really driven by the concern over exposing patients and putting them in immuno compromised state. So our thought here was lets get out there in much beat a good corporate citizen and much help physicians and help patients who are concerned so it's not our.
Intention to use this as a revenue driver, we don't see it as being that broad based and so it's it's really more or less to just say hey, there appears a helping hand, you know should you need it and we think you know there's gonna be some opportunity here, we also understand that.
If we do this it from a revenue perspective.
We're gonna have to justify the.
Sure cost based on.
What we charge based on the cost of goods and I don't think there's any value in that for us in covering our costs because obviously the exposure. That's there. So we really just have no interest in doing that I think it's not good for us and the long.
Okay. That's helpful.
Yeah, Yeah, that's super helpful and Yeah, that's a that's.
That's great from a [laughter] visibility and you know potentially political standpoint, so maybe last question for rich there appears to be.
A a price war going on in the Biosimilar Dcfs deal.
As new products come on line, just curious about your thoughts on.
That.
That implication to the commercial launch Oh in that one.
So this is one of the Tailwinds that long alluded to in her commentary you know when we talk to two to payers.
And it gets back to one of the questions. I was asked earlier you know what about the label payers are excited about the opportunity to have multiple.
Yes, I have some market as you would expect I mean, that's not a surprise for anybody and it's really important <unk> for all of us to realize that payers do see us as do see can have on as unique and we'll treat it as such they see the value. That's created because it is the only product that can do what we said it could get raises standard of care, the only product and on the market or in development.
And so they say well, we're gonna treated as such so we're going to treat that way for formulary consideration for contracting situation, which is very favorable for us first and foremost secondly, it creates this opportunity you see the first two Biosimilar has launched a list price at a 33% discount.
Third one launch at 37% discount and we all know that these drugs are reimbursed on average selling price or HST and.
And we see me A.S.P. dropped considerably for the first two price is not enough data for the third one yet you know S.P. as reported two quarters in arrears. So it was not enough data yet to see exactly what's happening what the trend is whats third product, but the first new products long lead product its average selling price or the first part that was launched.
Rather its average selling prices dropped by 22% and the second product, which is actually the market leader its average selling prices dropped by 18%. That's the way. They said we have so that's more indicative of what's actually happening in the contracting space and as that average selling price drops the reimbursement for physicians and oncologists make their living based on ASP.
Plus 4.5%.
So this is hurting the physician. So you know we're looking at this opportunity is creating head space for pricing and when we talk about this with payers payors are favorably inclined to that approach. We don't bring it up we say you know what do you think is an appropriate place on the pricing continuum for it.
And the payers come back and say this looks like an appropriate place affiliates head space. So we're pretty excited about that because as you get more and more of these the biosimilars have two choices. They can try and tranche the market and go for smaller and smaller slices, which doesn't seem very appealing or they can play a price game, which to us where it now.
We want to play with everybody. So this is all favorable for us. So we're pretty excited about it and we see payers, taking greater and greater control over the bio similars, which will again caused them to contract.
Much more rigorous basis, which again will drive prices Dow, creating greater has faced so we're excited about that you think it's good for us does that help.
Yeah Yeah.
That's very helpful. Thank you.
Sure. Thank you.
Thank you we reach of our question answer session I like to turn the floor back over to management pretty for closing comments.
Thank you operator. This concludes our call today I think at the one way of outdoor time have a nice day.
Thank you that does conclude today's teleconference. You may disconnect. Your lines at this time and have a wonderful day, we thank you for your participation today.