Q4 2020 BeyondSpring Inc Earnings Call
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Okay.
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Pardon me interruption. This is the operator. Please standby this call will begin shortly thank you for your patience.
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Good morning, and welcome to be on Springs fourth quarter, and full year 2020 financial results Conference call.
At this time, all participants are in listen only mode.
Following managements prepared remarks, we will hold a brief question and answer session to join the question queue. You May Press Star then one on your telephone keypad.
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As a reminder of this call is being recorded today April 32021, I would now like to turn the conference over to Andrew Erickson Investor Relations. Please go ahead.
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 beyond springs, clinical and preclinical research and development activities and results regulatory and commercial plans industry trends market potential collaborative initiatives from commercial production.
Among others, while management believes that the assumptions expectations and projections are reasonable.
Currently available information you are cautioned not to place undue reliance on these forward looking statements the.
The company's actual results may differ materially from those discussed in this call for a variety of reasons, including those described in the forward looking statements and risk factors section of the company's 20-F filing.
With the SEC, which are available on the investors section of the on Sprint's website.
Joining us on today's call is Dr. Longhorn the entrepreneur co founder chairwoman and Chief Executive Officer, Dr. Ramon <unk> Executive Vice President Research and the government and Chief Medical Officer, Richard Daly, Chief operating officer and allows the bit Sarahpac Chief Financial Officer, It's now my pleasure to turn the call.
Over to Dr. Longhorn volume.
Well, thank you Andrew.
Hello, everyone and thank you for joining today's call I'm very pleased to be here with the update of the tremendous progress. We have made in 2020 and to provide an update of our upcoming milestones for 2021.
2020 was of truly momentum year in setting up the future of value creation.
Quickly we had key accomplishments in building kind of been called evidence for our lead asset Netherlands.
The NDA for our lead program in two major global markets U S and China the only.
Our pipeline, adding key scientific and the business leadership and bolstering our balance sheet to execute on our vision.
Let me briefly share with you our street key areas of value creation.
First we continue to develop canavalin as a pipeline in the drug not only as the agent to prevent chemotherapy induced neutropenia OCI N, but also as the email anti cancer agent for potential durable anti cancer benefit.
Well our lead program in the Cin prevention indication <unk> and G. CSF combination of regime was granted breakthrough designation from both U S and China FDA in September of 2020, we're excited about this explanation as of.
The signal is the severe unmet medical needs.
The Ann and that of regime could be superior to stand up the care.
But the last five years, we have worked closely with regulatory agencies to advance the Avalon in combination with G. CSF for the prevention of Cin. We're also grateful to have the support of Dr. <unk> and Dr. Crawford you asked the and Tcs.
The guidelines founding member and flow more chairman, who have guided us for trial design and quality.
Overall, we had all of the 1200 patients you one pivotal trial, which is protect the two and five supportive clinical studies, demonstrating <unk> consistent or the onset of action in protecting neutrophils in various chemo and various Kansas.
In week, one where over 75% of clinical consequences of occur all of the neutropenia.
The T GAAP.
The recognized severe unmet medical need.
By combining canavalin required benefit was that of just SaaS, including taxpayer classes with to benefit the combination can maximize the neutrophil protection in the full chemo cycle.
This combination of superior benefit compared to two sets of long was also confirmed in protected to our pivotal global study with data released in November of 2020.
Based on that we filed an NDA in the U S and China in March this year.
And then now moving forward towards becoming a commercial stage company with a differentiated therapy that really has the potential to improve lives and the clinical outcomes for millions.
And Netherlands, and just as a combination could potentially reduce the incidence and duration of febrile neutropenia and authorization, which we will present at the upcoming Astro meeting in June.
With consistent improvement in clinically meaningful endpoints and AMC based endpoint on the.
Combination of collaborate and enters the SaaS compare to two sets of long. We believe we can deliver our promise of raising the standard of care for Cin prevention in cancer patients treated with chemotherapy with or without checkpoint inhibitors. This is the first <unk>.
Through in 30 years things just SaaS was approved in 1991.
Very importantly, 2020 of while will be a defining year, where we expect to showcase canavalin anticancer efficacy data, including topline overall survival data in the doubling of <unk> study in mid year.
It took us five years to enroll all of 559 patients in approximately 60 centers in the U S, Australia and China.
Dublin Street comparison, Canavalin and Docetaxel versus Docetaxel alone in the second and third line non small cell lung cancer for Egfr wild type patients, which compromises approximately of 75 of Asian patients all of approximately.
85% of western lung cancer patients.
This is the severely unmet medical needs indication, where teekay <unk> tyrosine kinase inhibitors.
Do not work.
And only for therapies, having being proved with the limited survival benefit and the severe side effects such as over 40% incidence of severe neutropenia.
In addition, we continue to round out the Netherlands, anticancer profile by adding it to the mix in Triple I O therapies as the Netherlands is a potent antigen presentation agent.
With potential synergy with checkpoint inhibitors, and the chemo or radiation.
And help to revert PD, one sale of patients to resume responding to treatment.
At the upcoming Astro meeting or release promising anti cancer efficacy data I don't know.
The phase one study of <unk>, and adding two new Evo and EP in second and third line small cell lung cancer patients who of checkpoint inhibitor naive of payout.
The study included 10 U S, leading clinical centers and the BMS provided evo and EPS for free for the study.
In addition, while conducting another triple I O combo study canavalin, adding to PD, one of PDL, one inhibitor and radiation.
At MD Anderson from seven cancers in PD, one PDL, one antibody failed patients.
Second we are building out our pipeline in our subsidiary <unk> therapeutics, using our unique molecular growth targeted protein degradation of TPB platform. This platform demonstrated.
Validation through our 800 million R&D collaboration with Eli Lilly.
In November 2020, including a substantial upfront payment and investment from Lilly.
Currently we are moving forward with ladies first target and our internal targets, including K Ras <unk>.
Third.
On the business front, we have strengthened our board and management team and the growth third our balance sheet to enable the execution of our vision.
In 2020, we have added key scientific and business leadership to our board.
In December 2020, Dr. Jeff <unk> joined our board adopted the <unk> is the board certified Hematologists and oncologists and served as CEO and chairman of the board of New York cancer in the blood specialists and as a board member of <unk>.
The collagen <unk>, which treats around half of million tens of patients a year in the U S.
His wealth of expertise.
And the demonstrated ability to collaborate with different groups of stakeholders within the oncology market will be instrumental in helping guide the company as we seek commercial approval of collaborators.
We also added additional industry leaders in 2022 our board.
We added Doctor Ravi <unk>, Chief operating mythology at Stanford Medical School, and the co founder of <unk> 47.
He is helping us in translating <unk> loans compelling scientific and clinical data into business value as his former company 47 was acquired by Gilead for $4 9 billion.
And the Doctor Dobrowski was the veteran business development executive in large pharma, including formal global head of pharma partnering at Roche, where he led over 300 partnership deals.
He has been helping us with business development and the partnership strategies.
And we are proud and honored to have our pharmaceutical and biotech veteran analysts at the Sarahpac joining us last September as our CFO.
Elizabeth's has over 30 years of senior loans.
Leadership Board and the venture capital experience in both large pharma, including Roche and Merck and high growth stage companies.
And of Elizabeth's leadership in November 2020, we successfully completed the financing of approximately $86 3 million in growth.
Proceeds before deducting underwriting discounts and commissions and other estimated offering expenses.
This financing strengthened our investor base and extended the cash runway by another 12 to 15 months.
I will now turn the call over to Dr. Ramon <unk>.
Well discuss our recent clinical developments in more detail Ramon.
Thank you Lon.
I would like to provide an overview of the results of our Registrational trials of the Netherlands for the prevention of Cin.
Both of the last five years, we have advanced our program and Islam indicators the test.
COVID-19 days and our recent filings of.
From the NDA to the U S FDA and China and the <unk>.
Yeah.
We are very confident and optimistic about the success of our filings.
After lengthy extensive interactions with regulatory agencies.
We have proactively contributed to our saw the designs and wish you all solid protocols prior to enrollment.
Filing has been of many more flow preparation.
And includes data from the pivotal trial protective too.
Well, if all of the support this trial.
Much of protective warm.
Bob you want of one and Dublin three.
We have collected data in more than 12 from the patients of which more than seven home of patients had been dosed with from happening.
We believe this represents sufficient data needed to satisfy the efficacy and safety requirements.
All of the sections as required by the NDA.
We believe this collective day fifth provides very strong score for adding the NAV to backfill the space.
By combining <unk> with <unk>.
Not only demonstrate the superior cin.
Efficacy, but also superior safety.
And quality of life first respectful of the simple.
The average has a complementary mechanism of action from G. CSF.
Protests against the yen.
The first week of the chemotherapy cycles.
It has been well established the G. CSF is not very effective in the first week of the cycle.
Which represents the treatment gap with significant unmet medical needs.
With the use of DCSS.
More than 75% of all CIM related complication of.
During the first week of the cycle.
G CSF surface favorable shame, however is very effective in the second week of the cycle.
Therefore, it makes sense to actually happen two picture of the Shin Oak.
All of us to fill the first report with US the picture of the Standalone.
In recognition of the unmet medical need still exist with picture of the SIB alone.
The FDA granted the breakthrough designation to the P&L of the texture combination.
<unk>, which we are targeting all chemotherapies and all non myeloid Kansas.
Most recently, we presented top line data from our Phase III study.
<unk> two <unk>.
The 106 with the.
The Netherlands picture of the same combination in breast cancer patients at the San Antonio breast cancer Symposium.
The study met the primary and all key secondary objectives.
Demonstrating superior efficacy and safety of its an average picture of the <unk> combination.
We also demonstrated a significant benefit with pro forma neutropenia.
Well known risk factor for increased rates of infection febrile neutropenia.
And hospitalization.
With specifically.
The 53% reduction in the incidence of profile with the opinion.
The 50% reduction in the mean duration profile with the opinion.
And the 41% reduction in the <unk>.
All of.
Of experiencing febrile neutropenia.
Moving to backfill of the ship loans.
The Netherlands also has anticancer activity.
That is currently evaluated in the number of phase one two and three cancer trials.
Okay.
The <unk> is currently being evaluated in combination with dose excel.
<unk> three of <unk>.
<unk> III global Multicenter clinical trial in the U S, China and Australia.
For the treatment of advanced non small cell lung cancer.
With a measurable long lesion.
Approximately 50% of non small cell lung cancer patients will have the cease progression with the checkpoint inhibitor <unk> in first line.
And this will need.
The second line and possibly a third line treatment option.
Those structural regimens currently dominate in second and third line non small cell lung cancer.
Our objective is to demonstrate that the <unk> the dose of shell combination.
It has superior efficacy superior safety.
And superior quality of life of.
The current second and third line standard of care.
As a reminder, we showed the positive trend of.
And overall survival hazard ratio of less than <unk> 75.
In our pre planned interim analysis of the <unk> three in.
In around on the 50 patient death events.
We have just recently completed enrollment and are now getting ready for database lock.
And expect to report final topline proud of salts in midyear.
Regarding our other cancer trial.
The planned 2% initial phase one data on the <unk> plus the volume at plus <unk> combination in small cell lung cancer of ESCO.
And to advance the trial into phase II.
We have also initiated the new triple combination trials with PD, one PD lone inhibitors, plus from the Avalon plus radiotherapy in solid tumors.
As for our early stage pipeline, we remain focused on advancing our preclinical candidates in triple combination settings.
Taken together we.
We expect that to net of immune enhancing anticancer activity.
Together with the CIA and preventive effect.
Will position us to become a universal at home to anticancer treatments in general.
With that ill.
I'll now turn the call over to rich, who will discuss our commercial strategy.
Rich.
Thanks Raimo.
Congratulations from loan to your team for filing the NDA for <unk> in both the U S in China of tremendous payer of the accomplishments.
The very exciting times for not only beyond spring, but also our future customers and their patients.
We are thrilled to be turning our attention to the market and the opportunity to tell the story of unmet medical need in the <unk> space.
As we go forward with our discussion today.
We'd like you to keep two.
Two key concepts in mind first.
Avalon plus G. CSF has the potential to provide improved protection against cin across all solid tumors and all chemotherapy regimens.
<unk> has broad applicability across cancer types and chemotherapy regimens.
Second <unk>.
<unk> is the only therapy that has the potential to elevate the standard of care in cin.
Chemotherapy is a large market each year more than 650000 patients receive chemo.
With the recent end CCN guideline change recommended that high and intermediate risk patients receive prophylaxis for cin.
Addressable population has more than doubled to over 70% of the entire chemotherapy patient population.
<unk> remains the number one cause of chemotherapy regimen changes and top of mind for oncologists.
G CSF of the current standard of care and are used more than one 4 million times each year in the us.
However.
As good of G. CSF are they are not good enough.
The dabbling in combination with G. CSF has the.
Potential to elevate the standard of care.
Confident in the strength of our clinical data from <unk> and the significant market opportunity. We are advancing our preparations for commercial launch into the cin market.
To execute the successful commercialization of <unk>, we are focusing our efforts on three key initiatives number one.
Driving awareness of the unmet medical need for neutropenia vulnerability GAAP.
Number two.
In addition to the Abilene with key decision makers.
The three <unk>.
Activating key accounts and ensuring broad access and availability for patients.
Let's begin with the unmet medical need.
The neutropenia vulnerability GAAP.
As I mentioned before managing Cin is a top priority of the <unk>.
Accessible treatment of cancer.
G CSF of hard good medicine.
However, they are limited by their mechanism of action as the Beacon working about day nine or 10 after chemotherapy.
As the results.
G CSF are unable to manage cin well in the early days post chemotherapy.
The first 10 days after chemo is the neutropenia vulnerability GAAP.
That is this is the time when neutrophils are at their lowest and patients have the highest risk of infection free.
Neutropenia, ER visits and hospitalization.
75% of all Ci unrelated life threatening events happened in the first 10 days at the receiving chemotherapy.
Ci enforces oncologists to modify cancer care.
Slight modifications can have a devastating impact on outcomes.
Even with the availability of Gcses true.
30% to 50% of patients still experience significant dose of <unk> or dose reductions of their chemotherapy.
Dose reductions of small as 15% or dose delays of as little as 15 total days of a four to six cycles of chemotherapy can result in the decrease in overall survival of as much as 50%.
Only canavalin with its unique mechanism of action as of selective Immunomodulating microtubule binding agent or Simba can.
It can help manage Ci end of the first 10 days post chemotherapy.
Addressing the neutropenia vulnerability to GAAP.
The only thing that one in combination with G. CSF has the potential to elevate the standard of care in addressing the CIM.
Our second area of focus is positioning to the Avalon with key decision makers.
Our outreach is underway.
Our disease awareness campaign, and risk Dot com and our presence at major medical meetings is building awareness.
Our efforts to the website <unk> dot com paid search and educational outreach.
<unk> 6 million impressions about the medical unmet needs to date.
Additionally.
Our publication strategy is bringing forward the clinical data supporting the <unk> benefits.
We are building our Kols support network through our educational Council.
<unk> of global experts in cancer care, and CN, who are actively getting our approach messaging and educational efforts.
Finally, we are in the field meeting with National and regional decision makers to drive a deeper understanding of the risks associated with cin and the potential for improved prevention.
And average unique mechanism of action.
As of selective Immunomodulating microtubule binding agent, where simba has the potential to provide oncologists and patients with the additional protection against Cin raise.
Raising the standard of care.
Good to have them has the potential for <unk>.
The significant benefits for providers payers and patients when combined with the Gcs F.
For providers and payers canavalin that can help reduce the potential for infection febrile neutropenia, ER visits and hospitalization with the goals of reducing cost and improving control over patient care.
Additionally, by avoiding the cin patients may stay on chemotherapy at the right dose and on the right cycle time, giving them. The best help from a positive outcome in their cancer care and minimize the risk of G CSF associated bone pain.
Let's move onto our third initiative activating accounts.
As I mentioned, our outreach is underway and we plan to ensure broad access and availability to canavalin at launch and beyond.
Oncologists are excited about the potential of <unk> one.
And multiple rounds of market research each round with more than 100 U S based board certified oncologist.
<unk> seen an overwhelming positive response, but out of this profile and the potential for <unk> in their practices.
And our most recent survey with more than the 100 U S oncologist or the two thirds of our role for <unk> in combination with G. CSF from the prevention of Cin.
Additionally, more than three quarters stated a high likelihood to use <unk> in combination with G. CSF.
Our intention is to bring to an avalanche of market as a therapeutic partner to G. CSF to elevate the standard of care for the benefit of cancer patients in need.
We will work Synergistically with oncologists, who believe in G CSF therapy, and who want more protection for their patients.
As you saw in our market research. This represents the majority of oncologists.
Concentration of abuse is a hallmark in the G CSF market with over 80% of Cin therapy focused in 360 multicenter accounts.
We believe that this concentration of benefits of our strategy of combination therapy.
And our focused efforts on the as an emerging company.
The high volume of G. CSF user the lever is our main customer.
And we have already identified these accounts.
The majority of G. CSF use of occurs in four cancers breast cancer lung cancer colon cancer and pancreatic cancer.
This dual concentration of business that is account.
And cancer type concentration in.
Enables beyond spring to target our efforts through effective and efficient commercial efforts from <unk>.
<unk> will benefit patients providers payers.
And shareholders.
Consequently, our commercial structure can be lean and highly targeted.
A critical element of <unk> success will center on our availability access to patients in need.
We are on track for commercialization and our focus is now on developing our systems to ensure appropriate access.
These include.
Targeting rapid inclusion of in Abilene key therapeutic guidelines.
The immediate filing for a permanent J code.
Focused selling into the clinical pathways that drive the utilization of drug to the larger oncology practices.
Outreach to payers and GPO is to ensure appropriate preapproval of awareness.
And targeted contracting for optimal coverage after launch.
Developing of our patient services hub, including patient assistant program and dedicated field reimbursement specialists from launch until the assignment of the permanent J code.
As mentioned earlier all of these efforts will be supported by a highly effective and efficient commercial team armed with the state of the our promotional tools.
Programs focused on oncologists, who believe in the benefits of greater control of our cin.
In summary, we're excited about the demonstrated clinical profile and potential of tablets.
Moreover, we remain excited by the market opportunity.
Market is large robust and expanding.
The unmet medical need is real the.
Neutropenia vulnerability GAAP, Ken for the first time be addressed through the kannapolis unique send the technology.
The the Abilene paired with G. CSF has the potential by keeping ANC or absolute neutrophil count.
Out of the danger zone and reducing cin.
Keep patients on their prescribed dose.
And their cycle times on time.
Our market research indicates that payers will cover <unk> and oncologists intend to use can add one in combination with G. CSF because of the potential benefits to the Abilene brings to patient care.
In short we're excited we think the opportunities are fantastic.
With that I'll turn over the session to Elizabeth.
As of yet.
Thank you rich.
I will now briefly discuss our fourth quarter and full year 2020 financial results.
For greater detail related 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 said I will now highlight some of the key financial results.
Research and development expenses in the fourth quarter of 2020 were $8 4 million compared to $12 6 million in the same period last year.
The decrease of $4 2 million was primarily due to a decrease of preclinical and clinical trial expenses.
General and administrative expenses were $10 4 million in the fourth quarter of 2020.
Compared to $2 7 million for the same quarter of 2019.
The $7 7 million increase was primarily due to an increase of $3 million in employee salaries and benefits, including new hires and onetime bonuses relating to a transaction.
An increase of $2 6 million in pre commercialization expenses.
An increase of $1 8 million and noncash share based compensation.
And the increase in legal and other costs related to the seed subsidiary.
Net loss attributable to beyond Spring, Inc. In the fourth quarter of 2020 was $17 6 million compared to $14 $1 million for the same period last year.
R&D expenses were $41 $8 million for the year ended December 31, 2020, compared to $31 3 million for the year ended December 31 2019.
The $10 $5 million increase was mainly due to an increase of $3 $8 million in clinical trial expenses.
An increase of $3 5 million in noncash share based compensation.
And an increase of $2 $7 million mainly due.
The amounts paid to consultants and others to support the NDA filing.
G&A expenses were $22 $6 million for the year ended December 31, 2020 compared to $9.0 million for the year ended December 31 2019 the.
$13 6 million increase was primarily due to an increase of $5 6 million in pre commercialization expenses.
An increase of $4 $5 million and salaries and benefits for commercial and executive personnel.
The one time performance bonuses related to the closing of the transaction.
An increase of $2 6 million in non cash share based compensation.
The increase of $9 million in consulting and other professional services.
Net loss attributable to beyond Spring, Inc. Was 61.0 million for the year ended December 31, 2020, compared to $38 $1 million for the year ended December 31 2019.
As of December 31, 2020, we had cash and cash equivalents of $109 $5 million on hand.
The company believes it has sufficient cash to support its ongoing clinical programs over the next year, including its our immuno oncology pipeline and to prepare for a potential launch of <unk> in 2022.
With that.
I'll now turn the call back over to Lon to conclude.
Ron.
Thank you Elizabeth.
We are very proud of the accomplishments we had an extremely productive 2022 sets of <unk>.
Up well for value generation in 2021.
We are well positioned for the future with our pipeline in the drug Canavalin already filed NDA ECR and prevention indication.
With anticipated near term potential anti cancer efficacy data from our phase III doubling the street's study measuring overall survivor in non small cell lung cancer patients.
And from early trials in several I O regime in checkpoint inhibitor naive of.
Sales of patients.
After the successful completion of our equity financing in the fourth quarter, we have strengthened our balance sheet as we head into our upcoming milestones.
Here I would like to thank the patients our dedicated team our shareholders and our partners for their continued support as we work towards improving the current standard of care for cancer patients worldwide.
Ill now ask the operator to open the call for question and answer session operator.
Thank you we will now begin the question and answer session to join the question queue. You May Press Star then one on your telephone keypad Youll hear a tone of acknowledging your request if.
If you are using a speakerphone. Please pick up your handset before pressing any keys to withdraw. Your question. Please press Star then two we will pause for a moment as callers join the queue.
Our first question comes from Maury Raycroft of Jefferies. Please go ahead.
Hi, good morning, everyone and congrats on the progress and thank you for taking my questions. First one is just a quick one on the Dublin data readout expected mid 'twenty. One just wondering if you can say if you submitted a placeholder for a late breaking abstract at <unk> or could we expect to see a press release around <unk>.
Thanks, Maury. This is lance thanks for your continuous support yes. So we don't have the Dublin Street data yet so in the late.
Breaking the finish time was March at the end of March So the answer is.
The C.
Any data from Dublin Street in the ESCO meeting.
We're guiding the market midyear.
Okay, Okay, and then for the ESCO titles that posted.
And the data Youre going to have there just wondering if you can elaborate on what additional analyses youll show beyond the topline protective to phase III.
The data.
Thanks for the Great question.
For the protected to everyone would love to see the clinical meaningful endpoint correlation with the AMC based endpoint, which we show.
Very high statistical significance so in the.
As gold coming out of presentation, we're going to show additional.
The reduction in FN hospitalization.
Pipe both of our clinical meaningful endpoint for the protected to flow combination treatment versus patio glass stand alone.
Got it and will there be anything on bone pain.
Dose intensity of quality of life.
So part of it I should give this to them all on the bond Pan other quality of life endpoint.
Yes, yes, yes.
Yes. Thank you for the question, yes, we have the poll.
<unk> expenses.
On quality of life as well with the.
Combination of NAV.
Backfill the spin.
Finish.
<unk> of the Findlaw and yes, we have.
Of the.
Overall.
The safety.
That includes both <unk> as well.
That's correct.
Got it Okay and just last question on.
Just wondering what the latest is the youre hearing from payers regarding launch price in light of the positive phase III data alone or launch price that can also be supported by positive.
Dublin Phase III data showing the anticancer benefit so I guess, how do you think about those two situations from the.
The value of having the two different modalities translating the price of the drug.
Well. Thanks for this fantastic question Maury I think this question the best answer is from a rich rich.
Thanks, Marty So our market research continues to show that on its own the cin benefit.
In combination with G. CSF G CSF as I said on the call.
It's as robust they liked the profile they like the opportunity to reduce the.
The neutropenia and the potential for reduced febrile neutropenia emergency room visits hospitalization et cetera, and keep the patients on their chemotherapy. So they like that all of its own.
The response to the potential for improvement.
Cancer outcome in and of itself I think is an additive.
They are looking for we think we would have improved pricing power with that so we see a really strong response favorable response on price because of the profile of the product in and of itself with Cin and then obviously should the data bear out with Dublin, three we think we have an opportunity for greater.
The value creation for patients for payers and obviously for providers. So.
We'd love to be able to bring net forward.
Got it that's helpful. Thank you for taking my questions.
Thank you Maury.
Our next question comes from Jason <unk> of Bank of America. Please go ahead.
Hey, good morning, guys. Thank you for taking my questions.
I guess first one for me is just trying to think about.
How are you thinking about launch readiness, particularly in a scenario, where you get accelerated review and could be in a position to launch in the second half of this year.
And thinking about that versus the cash and cash burn commentary, obviously I can appreciate that at the fluid situation, but just kind of curious how you're approaching things.
Given given the cash considerations and are you hiring reps on the contingency basis, and then as we think kind of of longer term with the.
With the rollout is it fair to look at sort of a standalone one product cancer biotech companies like ex Alex. This is the good comparable for SG&A build out for you guys in your story.
Well. Thanks, Jason This is a very key question as we finish the successful NDA filing in the gang vacation ourselves based on the breakthrough designation of the regime. So potentially the NDA approval is coming soon so that is a key question on the commercial ready.
This was the rich and his team has been working tirelessly on this effort. So I am going to turn the baton to rich to answer your question.
Yes. This is this is a fundamental question for us and we look at the timing of the approval and we also look at.
What we want to do and be judicious with our resources. So to your question about are you hired kind of contingency basis. So we want to be sure that we have an approval. We wanted to ensure that we can go forward and then we want to integrate that with the structure of the P&L. So we believe going back to <unk> question. We believe that we're going to have a favorable price we love.
The structure of this P&L because again as I said on the call. We think that this can be of highly targeted launch we know exactly where the accounts are we know who the the.
Physicians are who'd like the <unk>.
The CSF profile of want more control. So we think of it can be really targeted in our in our approach to the market the <unk>.
The timing is a really interesting one launching of product late in the year. When you get into the holidays is always a dicey proposition. If you look at <unk> as an example, they've got the accrual in September and weighted to launch into January I think thats, probably a wise decision because going into the holidays is never a good thing in the.
The 10 or 12 launches I've done the never really want to be launching late in the fourth quarter. You just can't get anybody's attention that you really want that attention in the first 13 to 20 weeks of launch.
So the timing of it really matters on a contingency basis, we think we want to be sure. We have the launch so we're going to hire we will be out interviewing we will be ready to pull the trigger when we get the approval. So we will have identified all of the sales representatives. We want we will make the offer on approval, we will bring them onboard. So we will not be carrying those costs set risks.
We think thats important, but as we work our way down the P&L, we think we'll get a very.
Very solid price based on the value will be delivering to the marketplace.
Cost of goods are very very small here because this is a small molecule free step synthesis and the cost of sales again very lean. So we think that this is a really solid model and.
And we think it can the company can move forward appropriately aggressively with one molecule and its bag and the very successful. So we're really excited about that so we think there are other models out there that you can look at and say, yes. This is a good one to take off of a buildup of P&L for the Osprey.
Okay.
Great.
And then just obviously the next big topic for you guys, Dublin trial and top line, when we get <unk> and PFS data as well with the top line update and the reason I ask is we've seen some data for second line Iot AI agents and obviously the markets are going to want to compare your results to.
Those approaches that we've seen from data and we don't have OS data for those of those approaches yet. So just wondering what will have at our disposal at the start to make those cross trial comparisons.
Yes, Thanks for the square question, So Dublin Street, we don't have the data yet right so as the.
The data is coming then we will decide how to present this data at the at the right time, but.
But I do see your appointment.
Comparison purposes part of it is also very important to show the <unk> and the PFS, but of course, we have to make sure. The data is claimed before we show it.
Sure sure. Okay, Yes, just I guess, that's the commentary for us at least in the markets our kind of start to look at that data and then I guess the last one from me just ahead of <unk> can you just remind me the rationale I know this was an investigator sponsored trial, but the rationale for small cell lung I think PD one.
<unk> four combo failed in the setting before so I know that there's sort of a broad based the Io combination strategy here, but your thoughts and rationale for small cell that'd be helpful. Thanks.
Yeah. Thank you. So I think I should turn this question to Ramon to start them.
I think you have the instrumental the started this small cell lung cancer study based on <unk> immune benefit.
Yes, Thank you Ron.
Some of the rationale for adding from happening.
The whole of the math, because even met in small cell lung cancer is debt.
Also of lung cancer.
The loss indicators for diesel in AP.
Yes, the guideline court of very long time.
So it sort of got confused that combination.
We are interest in adding some of the admin to existing Io.
Excellent.
So Kevin say debt.
From that would bring.
And the benefit of top of those.
So so that's commvault being the phase.
The SEC guidance last quarter.
Swaths of lung cancer.
Of the vehicle.
Net.
Debt.
The Capex clearly for the show debt behalf of.
The additional survival benefit.
Net.
But it also.
One of them.
The first.
The retrofit.
<unk> debt.
Immunotherapy, especially with the combination could you walk from <unk> four inhibitors.
One of them.
The biggest reason.
One of the risk, but the biggest reason for treatment of this integration.
Immune related adverse events or 30% of patients.
So it hasnt been happening to the price.
The not only amplifies the benefit but also of the adoption immune related to the tune of success so debt.
Collectively became the rationale.
Yes.
Yes. Thank you.
Yes, so Ajay I just wanted to add one more item to the loans.
Linking so why is this chip of Io combo of not only well.
Looking into the safety benefit the meal Aes, but also the.
Efficacy benefit which is the.
Bounce rate in addition, but as you see for the second and third line small cell lung cancer treated with checkpoint inhibitor.
Response rate is between top to 18% so we can see better.
Our debt that <unk>.
He is going to.
Speaks well of collaborating Neil of benefit, but very importantly for the study will also in the patients who failed checkpoint inhibitor right. So if we can re sensitize the softer.
With another and adding to the checkpoint inhibitor combination that's going to answer a lot of the unmet medical need for the checkpoint inhibitor of failed patients. So this is a very important presentations I hope you guys stay tuned and look at this.
And also of the presentation of data in June Thank you.
Yes.
Okay. Thanks, guys.
Our next question comes from Andy His day of William Blair. Please go ahead.
Oh, great. Thanks for taking my questions and congratulations on all of the progress as the so yes very stellar 2020.
So the question for rich.
Actually I'm happy to report the rich that the AAN risk dot com, but absolute showed up on my personal of quarter. So congratulations on a very successful outreach.
Outreach campaign. So the first question is.
Kind of Richard if you think about the cin indication how would you characterize as kind of of the breakout between commercial pay and Medicare Medicaid paid.
And also I am curious to know about your perspective as you think about.
Reimbursement discussions with the hospital.
How would you use the cash.
Hospitalization endpoint.
That's going to be presented at <unk>.
To kind of leverage your strategic positioning.
So Andy Great question. So when we think about when you look back on the historic norms for Gcs. That's utilization. So again, we're partnered with the G. CSF to elevate the standard of care. So we look at how Gcses. Our use of this is a fundamental question for us. So everybody talks about are you going to be covered what's your pay coverage.
And all of that so J codes become really important temporary J codes today about 50% of G. CSF use is covered by Medicare and Medicaid the.
And that's the most recent data which is about 2018.
About 2018, so this is predominantly.
The population, which makes sense cancer predominantly over the age of 65 that totally makes sense right. So when we look at that we're gonna have coverage from day, one bylaw will have coverage. So we're excited about that and then it becomes a question of.
Driving the opportunity and this is where we get into the three things we talked about on the call was driving that neutropenia vulnerability cabinet, helping people understand that unmet medical need.
Talking about the positioning for the product and then the key account activation and key accounts not only of the community oncologists, but also the hospitals that you talked about so looking at the split between those as well and predominantly the use of gcs asking we're talking about Pegylated G. CSF, because one dose equals one cycle non <unk>.
<unk>, sometimes one dose obviously those are daily to get one we get for you get seven you get 10, it's hard to equilibrate the dose so.
Predominantly non <unk> our hospital used.
It's the.
The hospital to use dose if you will so you see the predominant use of the peg weighted in the community opportunity. So we're really focused our efforts there and in helping those physicians understand how to avoid that hospitalization right. Because again, we're elevating that standard of care in where you can keep debt patient away from profound neutropenia.
Keeping away from that febrile neutropenia in the out of the emergency room, we're going to be focused on cost reduction.
And keeping the patient on their therapy and then avoiding.
The dose changes for chemotherapy and improving that standard of care. So we're looking at our focus is where we can make a difference. Obviously, we think we can make a difference in the hospital setting as well, but we think that might be a little bit further down. The line. So we're going to really be targeted in our effort again, where we can drive that difference.
Helpful.
Yes, that's very helpful. Thank you.
I look forward to that.
In the future so I.
I guess this is a question for the team I think.
If I remember correctly, I think Elizabeth kind of.
Provided the guidance that the launch will likely happen in 'twenty 'twenty. Two so so just wanted to make sure that rich I think you've kind of said that even in the end of the approval.
You might want to kind of wait until the early part of the next year to launch is that correct I'm, just kind of asking about from a modeling perspective.
I think it all depends on the timing of the approval. So I gave the coherence example, only to give of framing for it.
If we're going to wait to higher of our folks. So we didn't have to give them. The offer they have to accept they have to give notice et cetera. We have some train them. So you are talking about a months or maybe more before they can actually get on board and then you are into depending on when we get the approval. So its all depends and so we're just trying to help.
Everybody understand how we're thinking about it we don't want to take on that untoward risk of hiring a full team and then weighted we don't think that's appropriate to do so.
But we also don't think it's appropriate to launch.
Just prior to Thanksgiving that just wouldn't be effective it just wouldn't work in my experience those are because of very difficult times to get anybody's attention in any marketplace. So.
I hate to play the NBA here, but it all depends on when we get the approval.
Given that we.
Filed at the end of the first quarter.
Are we submit at the end of the first quarter and we're looking for the submission to the accepted right 60 days later, it just sort of thinking about the timing of when that six months. If it was a priority review when that might come we start talking about if we were to get that priority review you start talking about you're right on the bubble. There. So again, we're just trying to set that expectation.
<unk> net.
It's probably a 2022 opportunity.
No.
That makes sense.
Yeah, Yeah for sure and then I guess lastly for.
Thank you for one.
Yeah.
Your question is cutting App and Andy Andy are you there.
Andy Your line is live.
Okay.
This concludes the question and answer session.
I would now like to turn the call over to Dr. Wang for any closing remarks.
Yes.
Thank you again for everyone to participate in today's call and thank you for the insights and a great question and also of Youll continue to support. So we look forward to keeping you updated the milestones to come this year and beyond Thank you have a nice day.
Yes.
This concludes today's conference call you may disconnect. Your lines. Thank you for participating and have a pleasant day.
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