Q1 2021 Global Blood Therapeutics Inc Earnings Call
Greetings and welcome to the global Blood Therapeutics Conference call. At this time, all participants are on a listen only mode. A brief question and answer session will follow the prepared remarks.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
As a reminder, this conference is being recorded I would now like to turn the call over to Stephen M or got please go ahead.
Thank you and welcome to <unk> conference call to discuss the company's financial results from the first quarter 2021 and to provide a business update on.
Steve I never got head of Communications and Investor Relations joining me on the call are Dr. Ted Love, our President and CEO, who will provide an update on our progress in the first quarter.
Jeff Farrow, our Chief Financial Officer will review, our financial results, David Johnson, or DJ Our Chief commercial officer will give an update on the ox bright on launch.
Ted will then introduce Dr. Kim Smith, Whitley, who joined GBT This week.
<unk>, Vice President and head of R&D.
Kim will provide a view on the current environment for sickle cell patient care.
Ted will then close with an update on our pipeline and efforts to expand our access to okta brighter.
Earlier. This afternoon, we issued a press release announcing gbt's business progress and financial results from the first quarter ended March 31 2021.
Before we begin I would like to remind you that certain statements. We make on this call that are not historical facts may be forward looking statements that are subject to risks and uncertainties.
Information concerning factors that could cause actual results to differ materially from those expressed or implied by such forward. Looking statements are contained in our SEC filings, including but not limited to our most recent quarterly report on form 10-Q, as well as in today's press release.
Copies of our SEC filings and press releases can be obtained from the investors page of our company website at GBT Dot com.
Forward looking statements made on this call are only as of the time. They are made and you should not place undue reliance on such statements future events or simply the passage of time may cause our beliefs to change and we disclaim any obligation to update any forward looking statements other than as required by law.
With that I'll turn the call over to Ted.
Thank you Steven and good afternoon, everyone.
In the first quarter, we continued to make progress on our mission to discover develop and deliver life changing treatment for people with sickle cell disease.
The fundamentals of the ox quite a launch remains strong.
We continue to see patients benefiting from ox Friday.
In increasing real world experience from health care professionals.
I'd like to start by highlighting a real world evidence study presented just two weeks ago at the annual meeting of the American Society of pediatric.
Hematology oncology.
Dr Allen Anderson and colleagues from Greenville, South Carolina.
Presented data on 76 occupied of patients aged 12 to 17.
But these patients on average hemoglobin increase by two grams per deciliter.
Ridiculous I per cent decrease from 11, 6% to $6 five per cent.
And total bilirubin decrease by 1.4 milligrams per deciliter.
These results are consistent with and exceed the clinically important benefit seen in the hope study.
Adverse events were rare two patients had diarrhea, and one patient had a rash and all were resolved with dose modification.
The real World evidence, it's consistent with what we've been hearing from many hcp's and adds to our confidence in the long term potential of box right.
However, as we expected the COVID-19 pandemic continues to disrupt the daily lives of sickle cell patients and limit their access to health care.
Sickle cell patients continue to have fewer visits to their physician.
And fewer hospital admissions compared to pre pandemic.
In addition, while we are optimistic that the availability of vaccines will improve the environment for sickle cell patients. This will take time.
Initial data indicate that the majority of patients are wary of being vaccinated in the early phase of the rollout.
All of this is important because the greatest impact to the ox rider lunch has been the lack of growth of new prescriptions due.
Due to COVID-19.
Jbt's product sales like many companies on our industry were impacted by the increasing infection rate during the first quarter.
We had approximately 950, new prescriptions in the quarter consistent with the expectation we provided.
Let me make an important point.
While changes such as inventory levels and gross to net can impact revenues. We recognized in the early stage. We are pleased to see the net number of patients on X Friday, increasing quarter over quarter.
We feel there is light at the end of the tunnel.
As we all know every day more people in the United States are being vaccinated, making progress toward herd immunity.
For those with sickle cell disease, we believe that with time sentiment toward the vaccine will improve.
Based on these trends and the momentum our commercial team is building with patients N. H C piece. We continue to believe we will see accelerated growth when sickle cell patients are more comfortable re engaging in person with the health care system, which we think should begin to happen.
In the second half of 2021.
Our focus on supporting sickle cell patients.
Educating patients and physicians on a Friday.
In developing our innovative pipeline of potential treatment options is stronger than ever.
With that I will turn the call over to Jeff to provide an update on our first quarter results.
Thank you Ted.
Total net revenue from sales of ox brighter was 39 million for the first quarter of 2021.
An increase of $24 9 million or 177% year over year.
As a reminder, GBT recognizes revenue in the U S. When ox bride is received by our specialty distributors or specialty pharmacy partners.
First quarter revenue came in below our expectations due in part to more of the new patient scripts coming in towards the latter part of the quarter driven by the higher COVID-19 infection rates in the first two months of the quarter.
On a sequential basis first quarter revenue decreased by five per cent from the fourth quarter.
There were two other key factors that impacted the sequential comparison.
First inventory.
In the first quarter, our distributors drew down inventory that was built up in the third and fourth quarters of 2020.
At the end of the first quarter days on hand at our distributors was approximately four days lower than at year end.
And second gross to net.
In the first quarter as expected gross to net increased incrementally to 15 per cent compared to 12% in the fourth quarter.
The increase was driven by shifts in payer mix and increased patient co pay support as commercial insurance out of pocket deductibles reset for patients.
Also as a reminder, gross to net in the fourth quarter of 2020 included a 600000 return reserve benefit.
Net effect of these items more than offset growth in the number of patients taking ox Friday.
Which as Ted mentioned has increased every quarter since launch.
Bite flat enrollments over the past couple of quarters and potentially in the second quarter of 2021.
In previous quarters, we have not given specific revenue guidance. However, as the pandemic continues to evolve and have an impact we want to be clear about our expectations for the second quarter.
For the second quarter, we anticipate modest sequential revenue growth in the 10 to 15 per cent range compared to the first quarter.
Now turning to expenses.
Cost of sales for the first quarter was 584000 as compared to 135000 for the first quarter of 2020.
And consistent on a gross margin basis year over year.
Cost of sales was low in both years as the majority of the manufacturing costs related talks Friday sales were incurred prior to FDA approval and thus were recorded as R&D expense.
We continue to expect that the cost per box brine sales as a percentage of revenue will increase fully expense product manufactured prior to FDA approval is completely utilized which we anticipate will occur during the first half of 2022.
R&D expense for the first quarter of 2021 was $51 million compared with 40 million from the same period in 2020.
The increase in R&D expense in the first quarter was primarily due to costs related to our preclinical programs.
Alluding the upfront expense related to the Sanofi and license.
Our continued research collaboration with <unk> Pharmaceuticals.
And an advancement of our on clock on that program.
We anticipate a sequential increase in R&D expense in the second quarter as we continue to advance our plan to initiate two phase III studies for <unk> clock, a mab later this year, which will trigger a 5 million dollar milestone payment by GBT.
We also expect incremental increases in R&D expense in both the third and fourth quarter of 2021, driven by the clock a map program as well as the advancement of 601 studies and our other expected pipeline related activities.
SG&A for the first quarter 2021 was $59 million compared with 48 million per the same period in 2020.
The increase in SG&A expense was primarily due to increased employee related costs.
<unk> noncash stock compensation and other professional and consulting services associated with the commercialization efforts for ox brighter.
<unk> increased spending on marketing materials.
We anticipate a sequential increase in SG&A expense in the second quarter as we continue ramp up the rollout of new materials to support Ox Friday.
We further expect to see a step wise increase in SG&A expense in the second half of 2021, driven by the rollout of occupied ox bright on materials, our measured expansion into Europe.
And the initiation of multiple investigator sponsored studies.
Net loss for the first quarter was $75 million compared to $73 million for the same period in 2020.
Basic and diluted net loss per share for the first quarter was $1 21 per share compared with $1 20 per share for the same period in 2020.
We ended the quarter with a continued strong balance sheet and with cash cash equivalents and marketable securities of $482 million compared with 561 million at December 31 2020.
We continue to believe that we are operating from a position of strength with a significant opportunity for growth from the future.
And with that I will now turn the call over to D. J.
Thank you, Jeff and good afternoon, everyone. The commercial team kicked off 2021 with continued progress despite the impact of the ongoing pandemic.
As I've done in prior quarters, I will provide an update around the three key metrics combined with net revenues will give you further insight into our progress these metrics are.
New prescriptions per ox, brighter, which informs underlying patient demand.
The number of health care providers prescribing ox brighter, which captures the progress we are making in adoption.
And payer coverage, which speaks to the access environment for ox brighter.
First new prescriptions.
Our approximately 950, new prescriptions for <unk> during the quarter was in line with our expectations and reflects the ongoing headwind of the pandemic.
Here are some data points that demonstrate the current environment first.
First as Ted mentioned vaccine hesitancy is a real issue in the sickle cell disease community in the first quarter, we conducted a survey of more than 120 sickle cell patients on.
On the results indicate that about one third are waiting potentially much longer to be vaccinated and an additional quarter have no current plans to get vaccinated.
We are actively educating and helping others to educate the sickle cell community around vaccine confidence.
Second while the use of telemedicine has been helpful for the routine monitoring of our patients. Our research shows that health care providers in general are less comfortable making treatment decisions such as starting a new therapy via telemedicine.
And third looking across the industry new to brand prescriptions were down about 10% to 20% year over year in the fourth and the first quarters.
Despite this environment our commercial team has been building momentum to increased demand as we come out of the pandemic in the second quarter, we expect flat to modest sequential growth in new prescriptions and we continue to anticipate more significant growth in new prescriptions once the pandemic subsides.
Our efforts are focused on educating health care providers and patients on ox brighter and providing support to help patients start and stay on therapy.
In order to drive demand for ox brighter our field teams are actively highlighting the long term 72 week analysis of the phase III Hope study, which was presented at Ash in December and published in the Lancet Hematology last month.
And in line with our plans, we stepped up our digital campaigns, which are efficiently, reaching our target audiences in the first quarter. There was a 30% increase in the visits to walk right in dot com and our sickle cell speaks disease awareness campaign had 111% increase in website visits and has more than 62005.
500 followers on Facebook higher than any other S. A D page.
We are seeing a positive impact from these campaigns for patients who viewed our digital advertising in the first quarter more than 3300 patients visited hematologists within one month after seeing an ad.
Turning to adherence.
Which includes both compliance and persistence ox brighter trends continue to be well within the range of our analogs. In addition, we continue to focus on ways to increase adherence, including by recently launching new gets started guides and brochures that support patients discussions on ox brighter.
We also introduced new patient kits for those starting therapy, which includes treatment journals side effect management tip sheets smart bottle kept stickers, a smartphone app and alarms.
In addition, we transitioned GBT source solutions to a 100% high touch model, resulting in better conversion and adherence rates data from our experience in supporting patients has been submitted to the foundation for sickle cell disease Research conference to be held later this month.
To complement this in February we launched our GBT source dotcom website.
Which provides information about starting and staying on ox brighter.
We continue to learn and invest in patient support and are motivated by the high levels of satisfaction reported in our patient and healthcare provider surveys.
In order to extend the benefits of GBT source and our support tools to as many patients as possible. We are working with our specialty pharmacy partners to provide key services during their interactions with sickle cell patients on ox brighter so that patients have multiple avenues to receive the support that they deserve.
Overall, we believe these initiatives will continue to build awareness with patients as well as support more physicians prescribing ox brighter while also helping them keep their patients on therapy.
Our market research also continues to support the strong fundamentals of ox brighter for example, when we ask Ark right of patients about their experience a high majority believes it is easy to take works well and increases hemoglobin.
Looking at the profile of ox bright of patients. We continue to see a broad range of baseline hemoglobin N V O C burden among our patients from claims and lab data covering over 2500 patients encouragingly 50 per cent of the occupied or patients have baseline hemoglobin levels greater than eight grams per deciliter, suggesting that health care providers are inc.
Increasingly recognizing the importance of addressing polymerization and long term health.
Which leads me to my second metric health care provider penetration.
As we entered the first quarter in person interactions with health care providers by patients and our field team continued to be limited by the increase in new COVID-19 cases as.
As we progressed into March the environment gradually improved and we had a 15% increase in overall field engagements compared to the several months prior mainly driven by improved in person access to health care providers.
During the first quarter, we also completed more speaker programs than any quarter since launch.
Our field teams have been actively engaging with existing and potential new prescribers to highlight our new data and educational support materials the engagement and feedback on this activity has been encouraging.
We added about 170, new prescribers in the first quarter, bringing our total prescribers to around 1550 since launch.
When we look at the breakdown of writers, we continue to see prescriptions being written by both specialists and non specialists, which we believe is a positive trend for the long term trajectory of the launch.
And there continues to be tremendous opportunity to go deeper with these riders and to develop new riders from our large target list.
Turning to the payer coverage as we previously reported in 2020, we achieved broad coverage with 90% of covered lives in the United States.
Our focus is now on working to optimize coverage and we recently received great news from Texas, a state with one of the largest sickle cell disease patient populations that they voted to add ox Friday to their preferred drug list going forward on.
On a related note. We are also sharing data supporting the potential clinical and economic value box brighter and raising hemoglobin levels in April a poster presented by Dr. Bill Arcelor at the Academy of managed care pharmacy meeting highlighted a large scale longitudinal analysis, demonstrating the increased hemoglobin levels significantly reduce the <unk>.
<unk> of end organ damage for sickle cell patients.
In summary.
We are well positioned to drive and support incremental growth as more sickle cell patients begin to reengage with their physicians in person aligned with our ongoing confidence in the long term potential of box brighter.
I will now turn the call back over to Ted.
Thank you D J.
It's exciting to hear about all the new materials campaigns and initiatives, we are deploying in the field.
Before I get to our pipeline.
Leads to brain in the newest member of Gbt's leadership team.
Dr. Kim Smith Whitley.
Kim is on day three at G B team.
And she joined the call to say a few words Kim.
Thanks Ted.
I am thrilled to be here today as part of the GTT team.
Over the years I've developed a great respect for the company as an investigator a clinician and an advocate for patient.
The share dedication to sickle cell disease across the organization has made for a smooth transition and I am proud to be joining GTT in its journey.
And once you provide some additional perspective on the current environment for treating sickle cell patients based on my experience and feedback from my peers.
So many patients including those that I have seen in the clinic. The challenges created by the pandemic has severely impacted their daily lives unemployment.
New health care to family life and beyond.
This dynamic extent day care seeking behavior.
I am fortunate to have spent the last 29 years at children's hospital of Philadelphia or chop.
Which is unique as a comprehensive tertiary care academic center that is very well staffed.
Recently the team there has seen some patients come back in for their routine visits.
That is encouraging news.
Most sickle cell care setting this is going to take more time.
I would validate with Ted and D. J said about COVID-19 vaccination amongst sales that patient.
And my practice and others. It has been common for sickle cell patient to be hesitant initially about taking the vaccine.
However, we are hopeful as with other vaccines that this will improve.
That said as.
With increasing momentum and information more opportunities to get vaccinated and a decreasing the risk of transmission over time I do expect that a broader group of patients will return for in person care.
It's hard to say, how long that will take it will vary based on geography and care setting and may lag the general population.
But one thing that I am extremely confident on is Friday place in the treatment armamentarium for sickle cell disease.
With more experience using the medicine I believe on Friday will continue on its path to becoming a standard of care for these patients.
And while I'm very excited about X bright I'm, even more excited about the future of JBT with an exceptional pipeline that I aim to continue to build and grow.
I will now turn the call back to Ted.
Thank you Kim and welcome. We're so excited to have you as part of GBT.
Now, let's get to the pipeline.
First and clock, a mab or P. Selectin inhibitor that has the potential to be dose quarterly.
This is a very meaningful improvement for patients compare to the current option, which requires monthly dosing.
We are on track to initiate two phase III studies, Frank lack of map by mid year.
One is focused on reducing V O sees over a 48 week treatment period and the other is focus on focused on reducing 90 day hospital readmission following an initial VLC hospitalization.
These two studies are designed to potentially enable two independent regulatory submissions for separate indications.
Moving to GBT fix out one our next generation hemoglobin polymerization inhibitor.
We have enrolled participants in a healthy volunteer study.
And our goal is to have proof of concept data in sickle cell patients by year end.
If the preclinical data for GBT circa one play out in the clinic, we believe it would be position as a best in class therapy.
With the potential to provide a functional cure in a once daily pill.
In the first quarter, we also bolstered our pipeline with the in license of two early stage small molecule programs from Santa Fe.
The mechanisms targeted by these programs are distinct from ox Friday.
Expanding our long term potential to just four to transform treatment of sickle cell with multiple complementary therapies.
Turning now to our other growth initiatives in.
In the United States, we are seeking to expand the occupied a label to include children age four to 11.
Expanding to younger patients is a top priority as we believe that mitigating red blood cells cycling and instruction early in life could modify the course of disease and alleviate serious and life threatening complications.
Turning to Europe, we remain on track with the European Medicines agency's continuing the review of our marketing approval application.
Which we anticipate will be completed in the first half of 'twenty 'twenty two.
Currently physicians can gain experience with <unk>.
Through our early access program for eligible patients in Europe, and other regions outside the United States.
In the six Gulf Cooperation Council countries in the Middle East, we are working with our partner Biopharma EMEA to make ox Friday available and we have a goal to establish a similar partnership in Latin America, including Brazil, where the bulk of the region sickle cell patients live.
<unk>.
Altogether, our label and geographic expansion plans are intended to give us the opportunity to reach more than 350000.
<unk> cell patients around the world over the next several years.
And as we make progress against this goal we continue to explore strategies to bring occupy day to patients in limited resource geographies, such as Africa and India.
In clothing GBT continues its leadership in sickle cell disease and is well position for long term success.
We have near term opportunities to expand into younger patients in the U S.
And to secure regulatory approval in Europe.
We also have a robust pipeline and two potential best in class medicine inning, Clacker Mab and G. B T 601.
I am proud to be part of the GPT team and want to thank our employees for their passion and dedication, which is essential to realizing the potential of our medicines.
We are unified in our commitment to the sickle cell community and every day, we are getting closer to our goal of transforming sickle cell disease into a well managed condition.
With that we'd like to open the call for questions on.
Operator.
At this time, we'll be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad.
I ask that you please limit to one question and re queue.
A confirmation tone will indicate your line is in the queue. You May press star two if you like to remove yourself from the queue.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.
Our first question comes from Alethia Young with Cantor Fitzgerald. Please proceed with your question Hey.
Hey, guys. Thanks for taking my question, obviously, it's around the launch so insane March you've seen now April you know it sounds likes trends were softer in the first two months I guess you know this like maybe growth in news news scripts next quarter like what do you think kind of anecdotally kind of has the.
It happened or continue to happen.
It's one part of that question obviously, the second part of that question is just you know what you were seeing in March and April.
Hi, Alicia this is Ted.
So obviously, we don't want to report on the next quarter quite yet, but I would just emphasize that we.
We continue to feel very encouraged about where this is ultimate like on a go.
The biggest headwind for us continues to be.
That patients are not interacting with their doctors in fact, we are.
Have good evidence that in.
In Florida, and other places so physicians are actively telling the patient stay home.
Not risk getting on public transportation not risk being around people that increasingly are not wearing masks and get impacted but all of this is kind of a turnaround.
So we feel great about the long term teacher.
But we don't want to Fedex set expectations too early but we've said all along is that we thought the second half of the year was really where we would expect growth. We really felt like the first half of the year would likely be flat and we basically fading that although.
We do feel that.
Debt, we can signal that we think 10% to 15% growth in revenues in the second quarter versus the first quarter. We think that's very realistic for us and.
And we wanted to let everyone know that and we are growing prescriptions as we mentioned.
In the script, we we are actually increasing the number of patients each quarter that our on X Friday.
Great. Thank you.
Our next question is from a cash tomorrow with Wolfe Research. Please proceed with your question.
Okay.
Hugh.
Yes.
Stepping back why has been occupied in the kind of launch well on severe patients who have high transfusion burden.
And theoretically you're keeping these patients out of the hospital has never been any effect on the Novartis launch.
Where are you kind of have a more immediate impact on DST that may have limited uptake Brooks bright out.
Number two.
For 601, how come that compound it hasnt been one head to head with ups Ryder in preclinical assays and it seems like.
In terms of H b occupancy topped out kind of going below 30.
But it does seem to have a pretty big difference in red blood cell half life and hemoglobin levels. So what is going on specifically with that compound that's allowing you to do that and why are kind of the occupancy rate topping out in the low 30, and then kind of lastly, just you mentioned sequential growth of 10% to 15% in Q2.
You're also noting that there is a lot of vaccine hesitancy and particularly on the African American community. So what specifically gives you confidence on that 10% to 15% growth.
Then you got to keep today. Thank you.
A lot of questions I want to make sure I tried to walk through the mall.
So not a lot of sickle cell patients are.
On chronic transfusion that can necessarily be stopped.
We have seen many people that are on chronic transfusion discontinuing Kim feel free to to add to this from your experience.
But for example, if somebody is on chronic transfusions due to a stroke.
Those individuals.
On may need to really stay on your on translation that we prove.
As we're trying to do in the hope kids two study that we're providing protection against stroke.
But we have many many patients are.
And we've reported on this that many patients have reduced and or completely come off of transfusions on ox brighter and those are patients that typically your trends using them because you're trying to maintain hemoglobin levels that are more acceptable says the patient can have.
Adequate energy to get around there not the patients that are necessarily on protocol.
Our prior stroke. So I think we are having success there.
Your question about hemoglobin occupancy.
It didn't pop out that was the highest dose that we started it was 150 <unk>.
Milligrams a day.
We can actually get 100% modification and we readily do and in fact, many of the animals and our Tox studies actually have 140 per cent modification, we can we can.
On dose high enough safely that.
40% of the hemoglobin is actually accept to 601 molecules. So we have a lot of luxury and capability to dose as high as we want the reason we stopped at 30 percentage you can see the animals are effectively cured.
There are ridiculous card counts are normalizing their hemoglobin levels are actually higher than the animals with sickle trait. So the data really looks like you've essentially true. These animals, but we can go higher but the data is unlikely to get much better than then curative.
Perfect.
And then finally on the 10% to 30% maybe al just deferred to.
Jeff you want to add any comments on that sure hi, all cash.
There's a couple of things that are really impacting our comfort on that 10% to 15% range.
The first one is is really what Ted alluded to earlier in the in the prepared remarks is that there is a growing net number of patients that continue to be on ox brighter and as that number grows in the aggregate basis. We continued to see revenue growth. So that's one aspect that we'll see as we emerged from Q1 into Q2 the other aspect.
As we do anticipate relatively flat in Rx is although we've seen that.
That is improving coming out of the latter half of March.
So given the trends, we don't think with some of the infection rates coming down that that is going to impact us on a negative basis. So those are the real two major items and then it seems like we're at we don't have a long enough history at this point to sort of point to but we do think days on hand is gonna somewhere hover around the 'twenty to 'twenty.
Two days as opposed to what we saw at the year end and having enough, resulting drawdown that impacted us here on this first quarter, we don't expect that in the second quarter.
And Kim do you want to add anything about our garden transfusions.
No Ted I think that really you said on the.
<unk>.
Named features of what we've seen I just want to reiterate that those.
Those individuals who are on a regular on chronic red cell transfusion free or indications other than preventing neurologic complications have really been able to come off of transfusions altogether with expert at or significantly reduced.
The number of units or the frequency with which they receive transfusion on X Friday, so very encouraged by what we see on.
In this population.
Thanks, so much.
As a reminder, we ask that you please limit to one question and re queue.
Our next question comes from Ritu <unk> with Cowen and company. Please proceed with your question.
Hi team Mr can have on onto retail and thank you for taking the question.
I love it.
And just to quickly and ask you to follow up on the current trends that you're seeing with adherence now you've kind of put in the range of chemical analogs day, how you've seen an improvement in impact and through the high touch model and then what's the question you're asking me for that growth of 10% to 15% in Q2 was driven by improvements in underlying compliance.
Thank you.
Vijay you want to take that share highlight low.
We are a seeing adherence rates stable in Q1 to previous quarter. So not a lot of news there were well within the range of the analogs that we've talked about in the past that 50% to 70% one year adherence rate so that hasn't changed you're referring to a bunch of tactics that we've talked about that we rolled out.
But most of those tactics rolled out in late Q4 or in Q1, so things like that get started guides and brochures. The starter kits that include a bunch of adherence tools such as the you know the smart bottle caps stickers on the smartphone apps that sort of thing and then.
And then the high touch model that we've implemented for all patients that come through our hub. Those all started really in earnest in Q1. So it's a little early to have data on that but.
But we do have insights we know for example, the high touch model worked better than the low touch model or no touch model last year, we saw a lift in adherence for those patients that went through that that program. So that's why we've shifted to that this year. So we fully expect all of these tactics to have a positive impact.
As we as we get into the second half of this year, we'll be sure to update you on that.
All right. Thank you that's very helpful. On so does that mean you're modeling.
And in Q2 straight debt.
15% interest just want to make sure I understood you correctly.
Yeah. It yes, absolutely that's a it's a it's the same adherence rates are that we've been talking about we would expect that in Q2.
Okay. Thank you very helpful.
Our next question comes from Gregory <unk> with RBC capital markets. Please proceed with your question.
Hi, This is ingo on for Greg. Thank you for taking my question on it it's great to see the broad payer coverage for expedite us from far and I was wondering since there isn't usually a six to 12 months limit for access how do you think about keeping patients on therapy. When you know there the authorizations are potentially coming up thank you.
I don't think that's actually been an area of concern, but D. J you may want to elaborate on that sure yeah, the reauthorization or actually a really good story for us you.
Most payers do you want to check in at the six month, Mark or sometimes the one year mark to see how patients are doing and and it's usually a light prior.
Prior authorization, where they checking with the physician usually there's a list of things that they ask and in our case since we have a lot of really good metrics in our label around hemolysis and hemoglobin that if any one of those things are is in the positive direction than they have been approving therapy to continue so I'm not aware of any patients being discontinued.
<unk>.
Through a reauthorization process at this time it's been.
Really good coverage and in our ability to work through those and then our hub.
Our patient support hub GBT source solutions helps with the process in the sense that at year end for example, a reauthorization of insurance of Copays that sort of thing. We are we were able to manage that ahead of the year of the year at year end last year.
So that patients were aware that we could reset their co pay assistance cards through our hub and so we really didn't see a significant drop off because of the re.
Re initiation of co pays on that sort of thing at year end. So you know.
We just plan ahead with our hub and enabled to see it coming so hopefully that helps.
Great. Thank you very much.
Our next question comes from Jason <unk> with Bank of America. Please proceed with your question.
Hey, guys. Thanks, so much for taking my question. So my question is you know as we talk to physicians it sounds like the coverage of occupied as good if there's one challenge for some it's that it's an either or decision between ataxia on ox brighter.
So if you have physicians, who might be more favorable to adapt theo it may be challenging to get occupy debt and so I'm just curious you know.
Is that mirrors your your feedback your understanding and then as we look longer term.
Just trying to get your sense of the value of having on prior to Ana selecting blocker, both in house with your own portfolio and being able to kind of manage.
Both of those and perhaps drive better access that way just curious thanks.
Right right.
Well TJ you may want to comment on anything you've seen in the field, but I would just say that.
That the first one to keep them on is that drug actually each drug that have different indications.
So there really isn't a scientific reason.
A reason that a payer would object.
Because <unk> is indicated to reduce.
The number of V O fees.
Ox brighter is actually approved to treat the underlying nature of sickle cell disease really with the intent that you will improve oxygen delivery.
Protect organs from the inevitable depth that we see of organs.
On the premature death of the patient so they are truly different indications and I know there are patients that are being prescribed both drugs now a physician might think that the V. O C is the bigger issue that they want to focus on first and they want to use a DAC via first but.
That really shouldn't I think deter a physician from wanting to treat the underlying disease because.
Now these patients typically are a dying.
In their forties in their thirties, and forties and that's really what we're trying to change by fundamentally trading the polymerization, but D day.
If you had any at one of the thing at from a payer perspective.
Yeah, just to remind folks that we have about 40 to 50 per cent of our utilization of <unk> is in combination therapy.
And it's a lot of that Hydroxyurea, but a fair amount of that is already with a DAC V O. The low double digit percent is actually in combination with a DAC V. O. So Ted is exactly right. There's no kind of mechanistic reason these can't be used or indication reason they can't be used together and in fact, they are being used together in some pay.
Actions that said theres not a lot of clinical data of them being used together and so our payer will oftentimes ask a lot of questions about new therapies without a lot of data. So yes, there tends to be prior authorizations and maybe a couple of extra steps to get approval oftentimes a an appeals process, but generally when the physician.
On patient really want to get that combination used and they work with our hub and our patient team. We're generally able to get it approved it just takes a few a few more steps until we have more data.
Got it thanks.
Our next question comes from Andrea AGA rights with Wedbush Securities. Please proceed with your question.
Thanks, operator, good afternoon guidance.
Sanjay is on Philly on the surplus.
My question or questions around the telemedicine how much.
Yourselves and.
The first quarter can be attributed to telemedicine and then it's the pandemic persists longer than anticipated what are your.
Strategic plans too.
Yes.
Leverage telemedicine message from that cancels.
It's a great question I mean, we we've actually always assumed that we would work to make telemedicine work.
Because because physicians are using it in fact I think many people think telemedicine is going to continue to be a.
Part of medicine going forward after the pandemic, so making that work while it's something that's important as there is.
Some limitations however, among physicians.
A round starting completely new drugs.
In the setting of telemedicine, some physicians are perfectly comfortable with that and we've obviously had more success with those physicians then with physicians that are reluctant to do it but now quantitatively D. J probably have some data on that that you could share with you.
Yeah, and just a few of the figures that we have seen an increase in our overall engagements with physicians in Q1.
March was our strongest month in Q1.
And our field activity in general both telemedicine and face to face did go up in Q1 actually our engagements are back to pre COVID-19 levels. So the number of interactions with health care providers in Q1 reached.
Reached pre COVID-19 levels now the majority of those interactions still are through telemedicine, we are getting more and more face to face depending on COVID-19 dynamics in the geographies.
But we are fully set up and operationalize and we're very early on in the last year on the pandemic at becoming operational in a telemedicine world. So all of our materials all of our education are our strong focus on social media and digital are for education as well as all you know set up.
This environment, but ted's exactly right our preference is to do some more in person because that tends to also meet patients or in person and we do have our internal data. This that shows that both when our reps are in personnel on the patients who are in person it's easier for a physician to get educated and to prescribe ox brighter. So that's our preference is to work.
Diligently to to have more in person engagements, but should the pandemic continue to.
You know to proceed as is where we're fully ready and able to continue to operate in this environment as long as necessary.
When you and this is not on.
On extra question just.
Reiterating the prior one can you break out.
Sales from telemedicine or.
No we really can't we can't really so when a prescription comes in there's no way of knowing if the physician was seeing the patient through telemedicine or not on the prescription itself. What we do know is we saw a significant increase through the pandemic in electronic submissions of prescriptions to our hub.
And generally that we are in.
Talking to physicians, we that's associated with having more.
Virtual engagements with patients, where they're doing everything digital and so clearly they're doing more prescriptions through telemedicine than they ever have before.
But the preference is still to do in person.
Understood.
Our next question comes from the line of Danielle Brill with Raymond James. Please proceed with your question.
Hey, guys. Thanks, so much for the question so I.
I guess.
Maybe if you could just help me understand on wasn't that more about your guidance for flat at Rx into Q. If if you were seeing an uptick on the majority of the euro on our ex came on March 19.
You mentioned is on the uptick.
Late in March I'm, just curious why you're not confident that that trend will continue over the course of two key or are.
Are you just being conservative or is there margin this dynamic that I'm not understanding.
No I think I mean, the truth is Daniel Hi, Daniel This is Ted.
I mean, these things are very choppy and and and obviously, we're not getting the kind of growth that give you a.
Confidence to predict.
Predict the numbers will go up quarter over quarter, and and we think it's really prudent to kind of stay with what we've been saying which is the enrollment.
Are likely to stay on this 1000 range. We may be we may be a little longer we were 950.
Thank God the last two quarters, we might be a lover, but but we're not going to get to the kind of growth that we need to get to until patients start going back into doctors and quite frankly doctors allow their patients to come back in.
To be seen directly so we think that that number is not really conservative we think it's realistic.
And we've proven our capacity too.
B F. Those numbers in the setting of the of the pandemic.
What we need to happen quite frankly is not only is not just for COVID-19 cases to go down we need patient behavior to change.
The COVID-19 cases could go down because the patients are still not going in to the doctor that's really be the triggering event for us and we expect all that to happen, but we don't know the exact timing. So we're comfortable holding to a thousand as DJ said, which is really through.
Telemedicine, primarily.
Our next question comes from E on and who with Wells Fargo. Please proceed with your question.
Hi, Thanks for taking my question just have a quick one I think in the past you provided the number of patients on therapy.
I might have missed this but did.
Did you gave the number of patients on therapy this quarter.
Nope, you've never Miss that because we've never given that.
[laughter] any any reason for it.
No longer providing that number.
Well I mean, we have obviously like many companies a thoughtful process for figuring out which metrics you report and we kind of worked through that.
Quite frankly, with our board as well on the metrics and we continue to talk about it but that's not a metric that.
We've ever contemplated reporting on the metric that we want to get too quite frankly as revenue guidance. That's what we're trying to get and that's going to be a much simpler Matt.
Metric, it's just hard for us to get there in the midst of the pandemic, but the metric you want to give you quite frankly looking forward is revenue.
Our next question comes from Ben Burnett with Stifel. Please proceed with your question.
Hi, Good afternoon. This is Neil Carnahan on for Ben.
I was just wondering if you guys could provide some color on the refill rate that youre seeing and maybe the average number of bottles.
Per patient during the quarter.
Again, I think those are metrics that we have not reported in the past and I don't know if Geoff do you want to add anything to that but but those are non metrics that we've reported and want to take on as an obligation to report every quarter.
Yeah, maybe one thing I will add this is D J.
Is that we continue to have good.
Process times and cycle times are two weeks or less from the time. The prescription comes in to get fully worked out prior offs and shipments to our patients our conversion rate from a script to a to a bottle is still high 75% or so and our compliance rate is still high meaning that.
We've always said that once a patient starts on therapy. They generally take it as prescribed in refill that bottle within that 30 day window, we continue to see that persist.
Persistency is the other piece of adherence that we look very closely at and that's something that every chronic therapy is always working on and that's those two things together compliance and persistency makeup that adherence range that we talked about that 50% to 70%. So hopefully that's helpful.
Our next question comes from Paul Child with Goldman Sachs. Please proceed with your question.
Hi, Thanks for taking our questions on good afternoon.
It's great to have came on the call and Kim I guess as a clinician transitioning too.
Interest rate here could you, maybe just sort of comment on what.
As a clinician you'd like to see for the early six on one data later this year and then as your trends as we go into patients after healthy volunteers, just sort of framing from some guideposts there. Thank you very much.
Thank you for that question, Paul I really would like to say that the hope for six cell line is that we will continue to fool day.
Ada that suggest good better.
Comparisons to what we saw with Oxford.
And I think that we hope that we will see data that support that fixed outline them. We'll continue to have a saying that stronger impact to ox brighter and we may even look to see whether or not there are changes in some of the side effect profile. So I think that that's what we're going to be.
Focusing on them for the end of this year.
Yes.
Our next question comes from teens Sonya with Guggenheim Partners. Please proceed with your question.
Okay. Our next question comes from John Newman with Canaccord Genuity. Please proceed with your question.
John are you there.
Yeah.
Okay. Our next question comes from you obtain Sonya with Guggenheim Partners. Please proceed with your question Hey, guys.
Thank you for taking my question can you hear me now.
We cannot yet.
Perfect. Yeah can you provide some color on the penetration you might be or you might have achieved in various subsets of patients like patients that have hemoglobin below eight are patient below 10 on a half on maybe above that if you can give some sort of a commentary there and then maybe a broader question if we step back and think.
About let's say a peak market share do you envision auctions.
On a treating a similar number of patients.
Patients that get Hydroxyurea I think it is on understanding that about 25 to 30000 patients are on Hydroxyurea.
Hydroxyurea in any given year. So can you reach that level with docs Britt on and in what timeframe. Thanks.
Those are great questions, Jason So I would say at a high level, we've always felt that getting to those levels.
Is achievable because quite.
Quite frankly.
On the data suggest black Friday has a better safety efficacy profile. It doesn't have a black box warning around cancer risk.
Patients feel better on the drug very quickly.
And the side effect profile as as you know is is better so we definitely think long term.
Getting to that level is achievable. It's obviously all been delayed significantly by COVID-19, but we do think that's that's the bogie long term in terms of penetrations in the various subgroups.
My sense is that we're very early in all of these that's good news we've still got a lot of growth in every segment by the people with high hemoglobin, they're low hemoglobin, but as T. J said, we're already seeing the prescriptions Frocks Friday began to really reflect the label, which is it's for treatment of individuals'.
Above 12 years old to treat their underlying sickle cell disease, and quite frankly, your hemoglobin should not be a barrier and.
And then we ultimately think it won't be a barrier, but did you want to speak anything quantitatively about subgroups I know it's early yeah, We do a chart audit and and claims database audit with over 2500 patients and that's where we get our figures that are over 50 per cent or approximately 50% of our patients on ox Friday had a base.
On hemoglobin greater than eight grams per deciliter, so about 50% were less than that and so it looks like physicians are comfortable.
Using ox brighter in many different hemoglobin levels. We have patients that are above 10.5 are in our in that database baseline hemoglobin. We have patients that are between nine and 10.5 and we have patients of course between eight and and and 10.5. So if.
We have a broad utilization of Okta Friday, which we think is great. We certainly are indicated for all patients with sickle cell disease.
Other penetration number we're certainly excited about is that only about 25 per cent of the patients.
In the practices of the physicians that have tried occupied a debate that 1550 prescribers are.
Only about 25 per cent of their patients have been.
[noise] utilized ox brighter on so we still have 75% of our existing treaters patients.
For ox rider to be used in and that's a great opportunity to go deeper with physicians that already have experience with ox Friday. So you can imagine that's a that's a big focus of ours and we also are looking to penetrate into more physicians coming on line is in this quarter to prescribe ox rider for the very first time. So we have a large target list, but new prescribers were.
Still developing.
Our next question comes from Matthew Harrison with Morgan Stanley. Please proceed with your question.
Great. Good afternoon, thanks for taking the question.
I guess I have a sort of I'm just looking from your perspective on sort of a longer term question, which is as follows so.
We've obviously been talking about throughout the whole pandemic cow.
Patients aren't going in and but it does sound like physicians have some sort of interaction with patients and so I guess my real question is once patients start to go back into the office, but why isn't there going to be a large bolus or a significant backlog that has been.
And you know our physicians keeping lists.
Things like that and I'm, just wondering why we wouldn't see a a very significant snapback in terms of growth. Once you start to see large numbers of vaccinated patients heading heading into the office.
Yeah.
Yeah no it it's.
It's a nice aspirational question, and we love that and and Matthew that May happen.
Instead as from a guidance perspective, we're not really sure what's kind of happened after the pandemic. We're not really sure. If people are going to continue to be somewhat conservative for a while I do think that you are right that as we educate more and more physicians about ox Friday and they have.
Have the intention of using it and they have a group of patients they havent seen that that would represent.
Certainly a potential.
On a reservoir of individuals we just don't know what the curve looks like and that's why we want to be thoughtful about not trying to set expectations that we don't deliver on because at the end of the day. This is going to really be driven by the patients getting back into the office and I'll end and.
Having that interaction to get prescriptions.
Our next question is from Joon Lee with true with Securities. Please proceed with your question.
Hi, Thanks for taking our questions and.
A lot of a lot of the questions have been asked but maybe.
Any.
The recent deal with vertex.
That they did with that for a genome editing drugs for sickle cell disease and beta thalassemia.
Yeah. So one specifically imply that the opportunity for that drug must be large Eva foreign expensive genome editing drugs and imply possibly tens of thousands of sickle cell disease patients maybe addressed is that a reasonable interpretation and if so should we be trimming down the total addressable market for sickle cell disease.
And this also applies to five or so other additional companies pursuing similar functional chores. So I'm just curious what your perspectives are.
On that thank you.
Yeah, Jim how are you doing thanks for the question.
You know, it's hard for me to comment on vertex on how they model their business.
I can tell you that.
From my perspective, I think if you could provide effectively a cure with a pill.
That's very say that's going to be extremely attractive.
And that's what we're really focused on doing.
And as Ken said earlier, we think we can figure a lot of that out quite frankly fairly quickly because the evidence that she chaired a patient is really pretty much ascertainable by looking at their red blood cell health and Red blood cell function. So we think we're gonna figure.
Net out fairly quickly.
If we could make gene therapy.
As simple and safe as vaccination for example, I think that would be very very attractive, but unfortunately that technology does not exist.
And when that technology exists quite frankly, GBT is likely to be involved in that.
But right now given the.
Ablation given.
Given the long hospitalization give.
Given the.
The risk of cancer and other things after these big Ablator procedures are we.
We think of.
On a safe.
He'll based curative therapy would be the winning therapy.
And our last question comes from Rajiv Prasad with William Blair. Please proceed with your question.
Hi, there. Thanks for taking our question. This is sandy entourage and I was wondering if you could provide.
A data point on the average number of prescription day Cingal prescriber is prescribing.
And then I guess, if you could provide any color on the two small molecules. He recently licensed from by their teeth and how they complement our overlap with <unk>.
Media stocks by that Orient paper.
On an asset thank you.
Okay, Hi, Sandy so I'll take the first one and then.
Deferred to T. J on the second part on the first question I'll take the second so the Santa free molecules that we.
Brought in our small molecule targets.
And the program actually already has.
Uh huh.
On molecules, which are active against the target and significant amount of data supporting debt activity.
We don't disclose the specifics of our targets, but I would say that they are both.
Ali complementary with ox rider and would be complementary with tic. So on so they worked through a distinct mechanism.
One is really more focused on.
Polymerization and.
And the other is more focused on.
On inflammation.
Which we think would have a more of a darker relationship to a V. O sees the pain crises. So there are two distinct and complementary target, even though we haven't really delivered.
Publicly what exactly the targets everywhere, we're very excited about them, but they are early stage, but complementary.
T J yeah in terms of a number of prescriptions per per rider. So in totality about half of our existing riders have written for more than one patient, but that's really being driven by kind of the low deaths aisles in that sample that are just getting started at using ox Friday. When you look at the higher decile physicians with <unk>.
More experience and more patients it's much higher than that it's greater than 75% of them have prescribed box brighter from more than one patient on average writers' write it for over or about three and a half patients.
Launch to date and that's still growing.
Those higher decile doctors, it's over six patients per prescriber. So it's one of these situations of course physicians that have more patients in more urgent need are going to get more experience and they seem to like the response as the real world evidence would support because they write up for multiple patients.
We have reached the end of the question and answer session. At this time I'd like to turn the call back over to Ted Love for closing comments.
Thank you everyone for joining the call today, let.
Let me close by re emphasizing that all of us at G. P. T are very optimistic about the future.
We look forward to further expanding adoption of <unk> <unk>.
Advancing our pipeline and supporting the sickle cell disease community as we work to transform the lives of patients for the better.
We hope you continue to stay safe and healthy please reach out if you have any additional questions.
This concludes today's conference you may disconnect your lines at this time and we thank you for your participation.