BeyondSpring Inc. (BYSI) CEO Dr. Lan Huang on Q4 2020 Results - Earnings Call Transcript
BeyondSpring Inc. (NASDAQ:BYSI) Q4 2020 Results Conference Call April 30, 2021 8:30 AM ET
Andrew Ericsson - Investor Relations
Dr. Lan Huang - Co-Founder, Chairwoman and Chief Executive Officer
Dr. Ramon Mohanlal - EVP, Research and Development and Chief Medical Officer
Richard Daly - Chief Operating Officer
Elizabeth Czerepak - Chief Financial Officer.
Conference Call Participants
Maury Raycroft - Jefferies
Jason Gerberry - Bank of America
Andy Hsieh - William Blair
Good morning, and welcome to BeyondSpring's Fourth Quarter and Full Year 2020 Financial Results Conference call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a brief question-and-answer session. [Operator Instructions] As a reminder, this call is being recorded today, April 30, 2021.
I would now like to turn the conference over to Andrew Ericsson, 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 as BeyondSpring's clinical and preclinical research and development activities and results, regulatory and commercial plans, industry trends, market potential, collaborative initiatives and financial projections, 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. The Company'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 and Risk Factors section of the Company's 20-F and other filings with the SEC, which are available on the Investors section of BeyondSpring's website.
Joining us on today's call is Dr. Lan Huang, BeyondSpring's Co-Founder, Chairwoman and Chief Executive Officer; Dr. Ramon Mohanlal; Executive Vice President, Research and Development and Chief Medical Officer; Richard Daly, Chief Operating Officer; and Elizabeth Czerepak, Chief Financial Officer.
It is now my pleasure to turn the call over to Dr. Lan Huang. Lan?
Dr. Lan Huang
Well, thank you, Andrew. Hello, everyone, and thank you for joining today's call. I'm very pleased to be here with an update of the tremendous progress we have made in 2020 and to provide an update on our upcoming milestones for 2021. 2020 was a truly momentous year in setting us up for future value creation. Specifically, we had key accomplishments in building clinical evidence for our lead asset, plinabulin.
Filing NDA for our lead program in two major global markets, U.S. and China, building our pipeline, adding key scientific and business leadership and bolstering our balance sheet to execute on our vision.
Let me briefly share with you our three key areas for value creation. First, we continue to develop plinabulin as a pipeline in the drug, not only as an agent to prevent chemotherapy-induced neutropenia, or CIN, but also as an immune anti-cancer agent for potential durable anticancer benefit. For our lead program in the CIN prevention indication, plinabulin and G-CSF combination regime was granted breakthrough destination from both U.S. and China FDA in September 2020.
We're excited about this destination as this signal the severe unmet medical needs in CIN and that our regime could be superior to standard of care. For the last five years, we have worked closely with regulatory agencies to advance plinabulin in combination with G-CSF for the prevention of CIN. We are also grateful to have the support of Dr. Blayney and Dr. Crawford, U.S.
CIN NCCN guideline funding member and former Chairman, who have guided us for trial design and quality. Overall, we had over 1,200 patients in one pivotal trial, which is protected, too and F5 supportive clinical studies, demonstrating plinabulin's consistent early outset of action in protecting neutrophils in various chemo and various cancers in week 1, where over 75% of clinical consequences occur or the neutropenia vulnerability gap, but recognized severe unmet medical need.
By combining plinabulin, we will benefit with that of G-CSF, including pegfilgrastim, with two benefits. The combination can maximize the neutrophil protection in the full chemo cycle. This combination superior benefit compared to G-CSF long was also confirmed in PROTECTIVE-2, our pivotal global study with data released in November 2020. Based on that, we filed an NDA in the U.S.
and China in March this year. And now moving forward towards becoming a commercial stage company with a differentiated therapy that really has the potential to improve lives and clinical outcomes for millions. Plinabulin and G-CSF combination could potentially reduce incidents and duration of febrile neutropenia and [indiscernible], which we will present at upcoming ASCO meeting in June.
With consistent improvement in clinically meaningful endpoint and A&C based endpoints on the combination of plinabulin and G-CSF compared to G-CSF long, we believe we can deliver on 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 breakthrough in 30 years since G-CSF was approved in 1991.
Very importantly, 2021 will be a defining year where we expect to showcase plinabulin's anti-cancer efficacy data, including topline overall survival data in the DUBLIN-3 study in midyear. It took us five years to enroll all of 559 patients in approximately 60 centers in the U.S., Australia and China. DUBLIN-3 compares plinabulin and docetaxel versus docetaxel alone in second and third line non-small cell lung cancer for EGFR wild-type patients, which compromises approximately 75 of Asian patients or approximately 85% of western lung cancer patients.
This is a severely unmet medical need indication where TKI, tyrosine kinase inhibitors, do not work, and only four therapies having been approved with limited survival benefit and severe side effects such as over 40% incidence of severe neutropenia.
In addition, we continue to round out plinabulin's anticancer profile by adding it to the mix in triple I/O therapies as plinabulin is a potent antigen presentation agent with potential synergy with checkpoint inhibitors and chemo or radiation, and help to revert PD-1 failed patients to resume responding to treatment.
At upcoming ASCO meeting, we'll release promising anticancer efficacy data on a Phase I study of plinabulin, adding to nivo and ipi in second and third-line small cell lung cancer patients, who are checkpoint inhibitor naïve or failed. This study included 10 U.S. leading clinical centers and BMS provided nivo and ipi for free for the study.
In addition, we are conducting another triple I/O combo study, plinabulin adding to PD-1 or PD-L1 inhibitor and radiation at MD Anderson in seven cancers in PD-1 PD-L1 antibody failed patients.
Second, we are building out our pipeline in our subsidiary, the therapeutics, using our unique molecular group targeted protein degradation, or TPD 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 Lilly's first target and our internal targets, including KRAS.
Third, on the business front, we have strengthened our Board and management team and bolstered 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 Vacirca joined our Board. Dr.
Vacirca is a board-certified hematologist and oncologist and served as CEO and Chairman of the Board of New York Cancer and Blood Specialist, and as a Board member of One Oncology, which creates around 0.5 million cancer patients a year in the U.S. His wealth of expertise and 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 plinabulin. We also added additional industry leaders in 2020 to our Board.
We added Dr. Ravi Majeti, Chief of Hematology at Stanford Medical School and a Co-Founder of 47. He's helping us in translating plinabulin's compelling scientific and clinical data into business value as his formal company, 47, was acquired by Gilead for $4.9 billion. And Dr.
Zabrowski was a veteran Business Development Executive in large pharma, including former Global Head of Pharma Partnering at Roche, where he led over 300 partnership deals. He has been helping us with business development and partnership strategies. And we are proud and honored to have a pharmaceutical and biotech veteran, Elizabeth Czerepak, joining us last September as our CFO.
Elizabeth has over 30 years of Senior Leadership Board and Venture Capital experience in both large pharma, including Roche and Merck, and high-growth stage companies. Under 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 Mohanlal, who will discuss our recent clinical developments in more detail. Ramon?
Dr. Ramon Mohanlal
Thank you, Lan. First, I would like to provide an overview of the results of our registrational trials of plinabulin for the prevention of CIN. Over the last five years, we have advanced our program. And as Lan indicated, it has culminated in our recent filing of an NDA to the U.S. FDA and China NMPA. We are very confident and optimistic about the success of our filings after lengthy, extensive interactions with regulatory agencies, who have proactively contributed to our study designs, and we filled all protocols prior to enrollment.
Filing has been a many months long preparation and includes data from the pivotal trial, PROTECTIVE-2, as well as other supportive trials such as PROTECTIVE-1, Study 101 and DUBLIN-3. We have collected data in more than 1,200 patients, of which more than 700 patients had been dosed with plinabulin. We believe this represents sufficient data needed to satisfy the efficacy and safety requirements as well as other sections as required by the NDA.
We believe this collective data set provides very strong sport for adding plinabulin to pegfilgrastim. By combining plinabulin with pegfilgrastim, we not only demonstrated superior CIN efficacy, but also superior safety and quality of life versus pegfilgrastim.
Plinabulin has a complementary mechanism of action to G-CSF and protects against CIN in the first week of the chemotherapy cycle. It has been well-established that G-CSF is not very effective in the first week of the cycle, which represents a treatment gap with significant unmet medical need.
With the use of G-CSF, more than 75% of all CIN-related complications occur during the first week of the cycle. G-CSF, such as pegfilgrastim, however, is very effective in the second week of the cycle. Therefore, it makes sense to add plinabulin to pegfilgrastim in order to fill the first week void with use of pegfilgrastim alone.
In recognition of the unmet medical need that still exists with pegfilgrastim alone. The FDA granted the breakthrough designation to the plinabulin pegfilgrastim combination, with which we are targeting all chemotherapies in all nonmyeloid cancers. Most recently, we presented topline data from our Phase III study, PROTECTIVE-2, Study 106 with the plinabulin pegfilgrastim combination in breast cancer patients at the San Antonio Breast Cancer in Pulse.
The study met the primary and all key secondary objectives, demonstrating superior efficacy and safety of the plinabulin pegfilgrastim combination. We also demonstrated a significant benefit with profound neutropenia, a well-known risk factor for increased rates of infection, febrile neutropenia and hospitalization, with specifically a 53% reduction in the incidence of profound neutropenia.
The 50% reduction in the mean duration of profound neutropenia and a 41% reduction in the arts of experiencing febrile neutropenia comparing to pegfilgrastim. Plinabulin also has anticancer activity that is currently evaluated in a number of Phase I, II and III cancer trials. Plinabulin is currently being evaluated in combination with those excel in DUBLIN-3, a Phase 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 seas progression with a checkpoint inhibitor in first line, and this will need a second line and possibly, a third-line treatment option. Those regimens currently dominate in second and third-line non-small cell lung cancer. Our objective is to demonstrate that the plinabulin docetaxel combination has superior efficacy, superior safety, and superior quality of life over current, second and third-line standard of care.
As a reminder, we showed a positive trend of an overall survival asset ratio of less than 0.75 in our preplanned interim analysis of DUBLIN-3 in around 150 patient death events. We have just recently completed enrollment and are now getting ready for database lock and expect to report final topline trial results in midyear. Regarding our other cancer trials, we plan to present initial Phase I data on the plinabulin plus nivolumab plus ipilimumab combination in small cell lung cancer at ASCO, and to advance this trial into Phase II. We have also initiated a new triple combination trial with PD-1, PD-L1 inhibitors, plus plinabulin, 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 expect the plinabulin's immune-enhancing anticancer activity, together with its CIN preventive effects, will position it to become a universal add-on to anticancer treatments in general.
With that, I'll now turn the call over to Rich, who will discuss our commercial strategy. Rich?
Thanks, Ramon. Congratulations, Ramon, to your team for filing NDAs for plinabulin in both U.S. and China, a tremendous pair of accomplishments. This is a very exciting time for not only BeyondSpring, 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 CIN space.
As we go forward with our discussion today, we'd like you to keep two key concepts in mind. First, plinabulin plus G-CSF has the potential to provide improved protection against CIN across all solid tumors and all chemotherapy regimens. Plinabulin has broad applicability across cancer types and chemotherapy regimens. Second, plinabulin 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 650,000 patients receive chemo. With the recent NCCN guideline change, recommending that high and intermediate risk patients receive prophylaxis for CIN, the addressable population has more than doubled to over 70% of the entire chemotherapy patient population. CIN remains the number one cause of chemotherapy regimen changes and top of mind for oncologists.
G-CSFs are the current standard of care and are used more than 1.4 million times each year in the U.S. However, as good as G-CSFs are, they are not good enough. Plinabulin in combination with G-CSF has the potential to elevate the standard of care. Confident in the strength of our clinical data for plinabulin and the significant market opportunity, we are advancing our preparation for commercial launch into the CIN market.
To execute the successful commercialization of plinabulin, we are focusing our efforts on three key initiatives: number one, driving awareness of the unmet medical need or a neutropenia vulnerability gap; number two, position plinabulin with key decision makers; number three, activating key accounts and ensuring broad access and availability for patients. Let's begin with the unmet medical need, the neutropenia vulnerability gap.
As I mentioned before, managing CIN is a top priority of the successful treatment of cancer. G-CSFs are good medicine. However, they are limited by their mechanism of action. As the beacon working about day 9 or 10 after chemotherapy, as a result, G-CSF are unable to manage CIN well in the early days post chemotherapy. The first 10 days after chemo is the neutropenia vulnerability gap. That is, this is the time when neutrophils are at their lowest and patients have the highest risk of infection, febrile neutropenia, ER visits and hospitalization. 75% of all CIN-related life-threatening events happened in the first 10 days after receiving chemotherapy.
CIN forces oncologists to modify cancer care. Like modifications can have a devastating impact on outcomes, even with the availability of G-CSF, 30% and 50% of patients still experience significant dose delays or dose reductions of their chemotherapy. Dose reductions as small as 15% or dose delays of as little as 15 total days over four to six cycles of chemotherapy can result in a decrease in overall survival of as much as 50%.
Only plinabulin, with its unique mechanism of action as a selective immunomodulating microtubule binding agent, or SIMBA, can help manage CIN in the first 10 days post chemotherapy, addressing the neutropenia vulnerability gap. Only plinabulin, in combination with G-CSF, has the potential to elevate the standard of care in addressing CIN.
Our second area of focus is in positioning plinabulin with key decision makers. Our outreach is underway. Our disease awareness campaign, cininvest.com, and our presence at major medical meetings is building awareness. Our efforts through the website, cininvest.com, paid search and educational outreach have resulted in 6 million impressions about the medical unmet need to date.
Additionally, our publication strategy is bringing forward the clinical data supporting plinabulin's benefits. We are building our KOL support network through our educational council, a group of global experts in cancer care in CIN, who are actively vetting 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. Plinabulin's unique mechanism of action, as a selected immunomodulating microtubule binding agent, or SIMBA, has the potential to provide oncologists and patients with the additional protection against CIN, raising the standard of care.
Plinabulin has the potential to provide significant benefits for providers, payers and patients when combined with the G-CSF. For providers and payers, plinabulin 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 CIN, patients may stay on chemotherapy at the right dose and on the right cycle time, giving them the best hope for a positive outcome in their cancer care and minimize the risk of G-CSF-associated bone pain.
Let's move on to our third initiative, activating accounts. As I mentioned, our outreach is underway, and we plan to ensure broad access and availability to plinabulin at launch and beyond. Oncologists are excited about the potential of plinabulin.
In multiple rounds of market research, each round with more than 100 U.S.-based board-certified oncologist, we have seen an overwhelming positive response to plinabulin's profile and the potential for plinabulin in their practices. In our most recent survey with more than 100 U.S. oncologists, more than 2/3 saw our role for plinabulin in combination with G-CSF in the prevention of CIN. Additionally, more than 3/4 stated a high likelihood to use plinabulin in combination with G-CSF.
Our intention is to bring plinabulin to 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 use is a hallmark in the G-CSF market with over 80% of CIN therapy focused in 360 multi-center accounts. We believe that this concentration benefits our strategy of combination therapy and our focused efforts on as an emerging company.
A high-volume of G-CSF user or lever is our main customer, and we have already identified these accounts. The majority of G-CSF use 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 enables BeyondSpring to target our efforts through effective and efficient commercial efforts for optimal benefit to patients, providers, payers and shareholders.
Consequently, our commercial structure can be lean and highly targeted, a critical element of plinabulin's 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 plinabulin in key therapeutic guidelines, immediate filing for a permanent J-code, focused selling into clinical pathways that drive the utilization of drugs with larger oncology practices, outreach to payers and GPOs to ensure appropriate pre-approval awareness and targeted contracting for optimal coverage after launch.
Developing our patient services hub, including patient assistant program and dedicated field reimbursement specialists from launch until the assignment of a permanent J-code, as mentioned earlier, all of these efforts will be supported by a highly effective and efficient commercial team along with state-of-the-art promotional tools and programs focused on oncologists, who believe in the benefits of greater control over CIN.
In summary, we are excited by the demonstrated clinical profile and potential of plinabulin. Moreover, we remain excited by the market opportunity. The market is large, robust and expanding. The unmet medical need is real. The neutropenia vulnerability gap can, for the first time, be addressed due to plinabulin's unique SIMBA technology.
Plinabulin paired with G-CSF has the potential by keeping ANC, or absolute neutrophil count, out of the danger zone and reducing CIN to keep patients on their prescribed dose and their cycle times on time. Our market research indicates that payers will cover plinabulin, and oncologists intend to use plinabulin in combination with G-CSF because of the potential benefits plinabulin 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. Elizabeth?
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 in noncash share-based compensation and an increase in legal and other costs related to the Seed subsidiary.
Net loss attributable to BeyondSpring Inc. in the fourth quarter of 2020 were $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 to 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 in salaries and benefits for commercial and executive personnel and onetime performance bonuses related to the closing of the transaction, an increase of $2.6 million in noncash share-based compensation and an increase of $0.9 million in consulting and other professional services. Net loss attributable to BeyondSpring 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 immuno-oncology pipeline and to prepare for a potential launch of plinabulin in 2022.
With that, I will now turn the call back over to Lan to conclude. Lan?
Dr. Lan Huang
Thank you, Elizabeth. We are very proud of the accomplishments we had in our extremely productive 2020 to set us up well for value generation in 2021. We're well positioned for the future with our pipeline in drug, plinabulin, already filed NDA in CIN prevention indication with anticipated near-term potential anticancer efficacy data from a Phase III DUBLIN-3 study, measuring overall survival in non-small cell lung cancer patients, and from early trials in several I/O regimes in checkpoint inhibitor naive or failed 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.
I will now ask operator to open the call for question-and-answer session. Operator?
Thank you. We will now begin the question-and-answer session. [Operator Instructions] Our first question comes from Maury Raycroft of Jefferies. Please go ahead.
Congrats on the progress. First one is just a quick one on the DUBLIN data readout expected mid '21. Just wondering if you can say if you submitted a placeholder for a late-breaking abstract at ASCO? Or could we expect to see a press release around ASCO?
Dr. Lan Huang
Thanks, Maury. This is Lan. Thanks for your continued support. Yes, so we don't have the DUBLIN-3 data yet. So -- and the breaking the finish time was March -- at end of March. So the answer is, you will not see any data from DUBLIN-3 in the ASCO meeting. We're guiding the market is midyear.
Okay. Okay. And then for the ASCO titles that posted and the data you're going to have there. Just wondering if you can elaborate on what additional analyses you'll show beyond the topline PROTECTIVE-2 Phase III CIN data?
Dr. Lan Huang
Thanks for the great question. So for the PROTECTIVE-2, 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 ASCO coming out presentation, we are going to show additional reduction in FN and hospitalization, those type of meaningful endpoint for the PROTECTIVE-2 for our combination treatment versus pegfilgrastim alone.
Got it. And will there be anything on bone pain, dose intensity or quality of life?
Dr. Lan Huang
So probably, I should give this to Ramon on the bone pain and other quality for life standpoint. Ramon?
Dr. Ramon Mohanlal
Yes. Yes, we have. Yes. Thank you for the question. Yes, we have an abstract accepted on quality of life as well with the combination plinabulin plus pegfilgrastim versus pegfilgrastim alone.
And yes, we have other overall safety that includes bone pain as well. That's correct.
Got it. Okay. And just a last question on -- just wondering what the latest is that you're hearing from payers regarding launch price in light of the positive Phase III CIN data alone or launch price that can also be supported by positive DUBLIN Phase III data showing the anticancer benefits. I guess, how do you think about those two situations from the value of having the two different modalities translating to price of the drug?
Dr. Lan Huang
Well, thanks for this fantastic question, Maury. I think this question -- the best answer is from Rich. Rich?
Thanks, Maury. So our market research continues to show that on its own, the CIN benefit in combination with G-CSF, as I said on the call, is robust. They like the profile. They like the opportunity to reduce 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 on its own.
The response to the potential for improvement in cancer outcome in and of itself, I think, is an additive. They're looking for -- we think we would have improved pricing power with that. So we see a really strong response, a 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-3, we think we have an opportunity for greater value creation for patients, for payers and obviously, for providers. So we'd love to be able to bring that forward.
Our next question comes from Jason Gerberry of Bank of America. Please go ahead.
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 it's a fluid situation. But just kind of curious, how you're approaching things given cash considerations? And are you hiring reps on a contingency basis? And then as we think kind of longer term, with the rollout, is it fair to look at sort of standalone, one product cancer biotech companies like Exelixis? Is it good comparable for SG&A build-out for you guys and your story?
Dr. Lan Huang
Well, thanks, Jason. Yes, this is a very key question. As we finish the successful NDA filing, it is an indication also based on the breakthrough definition of the regime. So potentially, the NDA approval is coming soon. So that is a key question on the commercial readiness for us. So Rich and his team has been working tirelessly on these efforts. So I'm going to turn it over to Rich to answer your great question.
Yes. 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 hiring on a contingency basis. So we want to be sure that we have an approval.
We want to be sure 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 Maury's 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 a highly targeted launch. We know exactly where the accounts are. We know who the physicians are, who like G-CSF profile and want more control.
So we think it can be really targeted in our approach to the market. The question of timing is a really interesting one. Launching a product late in the year when you get into the holidays is always a dicey proposition. If you look at Coherus, as an example, they got approval in September and waited to launch into January. I think that's probably a wise decision because going into the holidays is never a good thing. And the 10 or 12 launches I've done, you never really want to be launching late in the fourth quarter.
You just can't get anybody's attention, and 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 the sales representatives we want. We will make the offer on approval, we will bring them on board.
So we will not be carrying those costs at risk. We think that's 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 we'll be delivering to the marketplace. The cost of goods are very, very small here because this is a small molecule, three-step synthesis. And the cost of sales, again, very lean.
So we think that this is a really solid model, and we think it can -- the Company can move forward appropriately aggressively with one molecule in its bag and be 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 peg off of and build a P&L for BeyondSpring.
Great. And then just -- obviously, the next big topic for you guys, DUBLIN trial and topline. Will we get ORR and PFS data as well with the topline update? And the reason I ask is, we've seen some data for second line I/O TKI agents. And obviously, the markets are going to want to compare your results to those approaches that we've seen some data in. And we don't have OS data for those approaches yet. So just wondering what we'll have at our disposal to start to make those cross-shop comparisons.
Dr. Lan Huang
Yes. Thanks for this great question. So DUBLIN-3, we don't have the data yet, right? So as the data is coming, then we will decide how to present this data at the right time, but I do see your point. For comparison purpose, probably it is also very important to show ORR and PFS. But of course, we have to make sure the data is clean before we show it.
Sure. Sure. Okay. Yes. Just I guess as a commentary for us, at least in the markets, how we're going to start to look at that data? And then I guess last one for me. Just ahead of ASCO, 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-1, a CTLA-4 combo had failed in the setting before. So I know that there's sort of a broad-based I/O combination strategy here, but your thoughts and rationale for small cell would be helpful.
Dr. Lan Huang
Yes. Thank you. So I think I should turn this question to Ramon to start. Ramon, I think you have instrumentally started this small cell lung cancer study based on plinabulin's benefit.
Dr. Ramon Mohanlal
Yes. Thank you, Lan. So the rationale for adding plinabulin to nivolumab and ipilimumab in small cell lung cancer is that for small lung cancer was indicated for nivo and ipi on the NCCN guideline for a very long time. So it -- so doctors use that combination. We are interested in adding plinabulin to existing I/O residents to demonstrate that plinabulin would bring tremendous benefit on top of those I/O regimens.
So that combo being available through the NCCN guidelines of small lung cancer was sort of the vehicle to add plinabulin to that. The objective clearly for us to show that we have additional survival benefit with adding plinabulin, but also that plinabulin will present the use related adverse effects. You will be aware that with immunotherapy, especially with combination PD-1 and CTLA-4 inhibitors, one of the biggest reason -- not one of the reasons, but the biggest reason for treatment is continuation is immune-related at versus more than 30% of the patients. So -- and plinabulin through this regimen, we hope to see not only survival benefit, but also a reduction in immune-related adverse effect. So that collectivity became the rationale.
Dr. Lan Huang
Just to -- Yes. So actually, I just want to add one more item to Ramon's thinking. So why is this triple I/O combo not only we're looking into the safety benefit, the immune AEs, but also the efficacy benefit, which is the response rate in addition. But as you see, for the second and third-line small cell lung cancer treated with checkpoint inhibitor, its response rate is between 12% to 18%. So if we can see better ORR than that, that definitely is going to speak for plinabulin immune benefit.
But very importantly, for the study, we also enroll patients who failed check contributor, right? So if we can re-sensitize the system with plinabulin adding to this checkpoint inhibitor combination, that's going to answer and a lot of the unmet medical needs for the checkpoint inhibitor failed patients. So this is a very important presentations. I hope you guys will stay tuned and look for this abstract and also the presentation later in June.
Our next question comes from Andy Hsieh of William Blair. Please go ahead.
Congratulations on all of the progress, especially a very stellar 2020. So I have a question for Rich. Actually, I'm happy to report to Rich that cinrise.com had actually showed up on my personal Twitter. So congratulations on a very successful outreach campaign.
So the first question is kind of, Rich, if you think about the CIN indication, how would you characterize as kind of the breakdown between commercial pay and medicare, medicaid paid? And also, I'm curious to know about your perspective as you think about reimbursement discussions with the hospital. How would you use the cost of end point that's going to be presented at ASCO to kind of leverage your strategic positioning?
So Andy, great question. So when we think about -- when we look back on historic norms for G-CSF utilization. So again, we're partnered with a G-CSF to elevate the standard of care. So we look at how G-CSFs are used, and this is a fundamental question for us. So everybody talks about, are you going to be covered? What's your pay coverage and all that.
So J-code become really important, temporary J-codes. Today, about 50% of G-CSF use is covered by Medicare and Medicaid. And that's the most recent data, which is about 2018 and roughly about 2018. So this is predominantly an elderly population, which makes sense. Cancer predominantly over the age of 65, that totally makes sense, right? So when we look at that, we're going to have coverage from day one.
By law, we'll have coverage. So we're excited about that, and then it becomes the question of driving the opportunity. And this is when we get into the three things we talked about on the call was driving that neutropenia vulnerability gap, making -- helping people understand that unmet medical need, talking about the positioning for the product and then a key account activation. And key accounts, not only are 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 G-CSF -- and we're talking about PEGylated G-CSF because one dose equals one cycle.
Non-PEGylated sometimes one dose. Obviously, those are daily. You get one. You get 4. You get 7. You get 10. It's hard to equilibrate the dose. So predominantly, non-PEGylated are hospital used. It's the hospital use dose, if you will.
So you see the predominant use of the PEGylated 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, and you can keep that patient away from profound neutropenia, keeping him away from that febrile neutropenia and out of the emergency room, we're going to be focused on cost reduction and keeping that patient on their therapy and then avoiding the dose changes for chemotherapy and improving that standard of care.
o 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.
Is that helpful?
Yes, that's very helpful. I look forward to that discussion in the future. So 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 [indiscernible] likely happen in 2022. So I just wanted to make sure that, Rich, I think you kind of said that even in the event of approval, you might want to kind of wait until the early part of next year to launch. Is that correct? I'm just kind of asking that from a modeling perspective.
I think it all depends on the timing of the approval. So I gave the Coherus example only to give a framing for it because if we're going to wait to hire our folks, so we don't have to give them the offer. They have to accept. They have to give notice, et cetera. We have to train them.
So you're talking about a month or maybe more before they can actually get on board. And then you're into -- depending on when we get the approval, so it 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 waiting. 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 very difficult times to get anybody's attention in any marketplace. So if -- I hate to play the NDA here, but it all depends on when we get the approval. Given that we filed at the end of the first quarter or we submit at the end of the first quarter, and we're looking for the submission to be accepted, right? 60 days later, it's just you start thinking about the timing of when that 6-month, if it was a priority review, when that might come.
We start talking about if we were to get that prior year view, you start talking about -- you're right on the bubble there. So again, we're just trying to set that expectation that it's probably a 2022 opportunity. So does that make sense?
Yes. Yes, for sure. And then I guess, lastly for Lan.
Dr. Lan Huang
Your question is cutting out.
And Andy, are you there?
This concludes the question-and-answer session. I would now like to turn the call over to Dr. Huang for any closing remarks.
Dr. Lan Huang
Thank you again for everyone to participate in today's call and thank you for your insights and a great question and also your continuous support. So we look forward to keeping you updated on our significant milestones to come this year and beyond. Thank you. Have a nice day.
This concludes today's conference call. You may disconnect your lines thank you for participating and have a pleasant day.
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