Q1 2020 Earnings Call
Greetings and welcome to the global Blood Therapeutics Conference call.
At this time all participants are in a listen only mode. A brief question answer session will follow 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'd now like to turn call over to Stephanie.
Please go ahead.
Thank you and welcome to the E Conference call to discuss the Companys financial results for the first quarter 2020. After provided an update I 70 out senior director of Investor Relations and corporate communication joining me on the call our Dr. Tesla, our president and Chief Executive Officer, who will provide.
Overview of the progress in the first quarter and yet they are out our chief financial Officer will provide an overview of our financial results.
We'll be followed by David Johnson, or DJ Our Chief commercial officer to give an update on all right and wash had will then provide an update on our research activities and other long term growth initiatives.
Earlier. This afternoon, we issued a press release announcing GE business progress and financial results for the first quarter ended March 31 Twentytwenty.
Before we begin I would like to remind you that certain statements made on this call that are not historical facts, maybe forward looking statements that are subject to risks and uncertainties information regarding 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 annual report on form 10-K, as well as in today's press release copies of our SEC filings and press releases can be obtained on the investor page of our company website at <unk> Dot com.
Forward looking statements made on call our only adds at the time the army and you should not place undue reliance on such statements.
Future events or simply the passage of time may cause our leased to change and we disclaim any obligation to update any forward looking statements other than as required by law.
That I will turn the call over.
Thank you Stephanie and good afternoon, everyone.
Welcome to the global Blood Therapeutics first quarter 2020 conference call.
Well GDP was founded we set out on mission to transform the way sickle cell disease is treated.
Last November Mark and major breakthrough with the approval of box Brian.
The first and only medicine that directly into the mid cycle, even loving polymerization.
The processing cost is red blood cell just circling breakdown.
Red blood cell signaling and disruption our primary pathology faced by every single person living with sickle cell disease.
This is consistent with our broad label and our focus on expanding ox prior to approval for patients younger than 12 years of age.
Your one was the first full quarter that we delivered off credit for patients.
Our performance has exceeded our expectations and demonstrate outstanding execution across our entire organization and our found commitment to patients.
Early feedback has been encouraging, particularly as we hear from more and more patients and physicians were excited about the impact they are seeing but I'm right.
In addition.
Expanding access is a top priority and we're pleased with response from payers thus far.
Well talk about the impact of coking 19.
But first I want to say that our hearts go out to the thousands of patients and families directly impacted.
We're also deeply grateful to the frontline workers, who are working to keep a healthy I'd say.
On March 17, GBT announced the suspension of in person interactions barfield teams and the implementation of a remote working policy.
This decision was difficult, but it was the right decision to protect patients health care providers and our employees.
It's difficult to project the precise impact of Cobiz 19.
But we know it has created a temporary headwind for our watch.
However, based on our first quarter performance, we do not believe the condemning will impact on Friday this long term potential.
We view, our strong performance as a reasonable proxy for what we might see posts and damage.
We're pleased with the progress we've made to date.
We remain on track with our key launch activities.
We are particularly encouraged by the following three trends.
Number one with increasing clinical experience the demand probably have aggressively increased in the first quarter and with a growing number of new prescriptions and enrollment into GBC source, our patient support program.
New prescriptions were after our highest right before the World Health organization did declare toby's 19 of endemic.
While new prescriptions have subsequently decrease we believe this is temporary and expect them to rebound as patients resumed in person did that with their doctors.
Number two our field team are successfully engaging with health care providers.
Even in a virtual setting.
These engagements have translated into numerous first time ox freida prescribers.
Based on market research awareness about credit continues to increase.
In health care providers are increasingly leveraging each have a mouse and interact with patients.
And finally number three our payer meetings are proceeding according to plan.
We've already secured coverage and multiple key geographies and we are pleased with the rate at which patients are being covered through medical exception.
We reiterate that we believe we will meet our go abroad hair coverage by the end of the year.
Like most in our industry, we decided to pause new patient screening and enrollment in our clinical status.
However, we are in close contact with our clinical sites and investigators and we are following FDA guidelines intended to maintain studying integrity.
We remain confident that we will report topline results from our kids to post approval confirmatory study by 2025.
We are well positioned to resume enrollment in all our clinical trials as soon as practical.
Sadly.
That makes has had a significant impact on the FTC maybe.
We are proud that we were able to quickly provide support during this crisis, including more than $350000 in funding to SPD nonprofit organizations.
That's the thing is rolled off spread your independent me has been a growing topic adventures for.
For example, the American Society of Hematology recently issued recommendations listing on Friday as an option for ASCII patients with symptomatic anemia, our patients who are difficult to trends fees.
We believe that occupied oral tablet administration and favorable safety profile.
Coupled with services like electronic enrollment and home medication delivery are well suited to help FTD patients in the current environment.
In summary.
He is doing well and the lots of on spread it is off to an excellent start.
In many ways overnight team has increased our focus and dedication to ensure that every patient who can benefit from on Friday has access to it.
Our entire team is a line to the admission and its thrilling to see our early success.
With that I will turn the call over to Jeff to provide an update on our first quarter 2020 financial results.
Thank you Ted.
GBT had an outstanding start to the year in the first quarter and we continue to maintain a healthy balance sheet.
Total net revenue for the first quarter 2020 was 14.1 million, resulting from sales last Friday.
This compares to 2.1 million in the fourth quarter of 2019 from the initial large box brighter, which we began in late November.
Each first quarter revenues were driven by strong underlying patient demand as well as good early payer coverage, including for medical exceptions.
Additionally, our gross to net adjustment was 12% in the first quarter, which is lower than we anticipated future steady state.
Gross to net Johnson, each quarter will be driven bifurcation insurance coverage.
Patient utilization of Threeforty be pharmacies.
Medicare part D coverage gap.
And patient co pay assistance.
The 24% gross to net in the fourth quarter of 2019 was higher primarily due to our accrual for the Medicare part D coverage gap in the fourth quarter.
As previously stated.
We anticipate that over time or gross to nets stabilize at around 25% to 30% once we reach our expense airbags.
Cost of sales the three months ended March 31st 2020 135000.
Cost of sales low in the first quarter as the majority of the manufacturing costs related off quite a sales were incurred prior to FTC approval and thus were recorded as R&D expense.
We expect the cost of off price sales as a percentage of revenues will increase in future periods as fully expensed product manufacturer prior to the approval is utilized.
It's important to point out that we believe we have enough commercial supply last Friday to sustain estimated patient need to the remainder of this year and into 2021, and we are continuing to produce additional I try to tablets.
Research and development expenses for the first quarter 2020 were 39.8 million compared with 34.5 million for the same period in 2019.
The increase in R&D expense in 2020 was primarily due to increased costs related to the development of the clock map and other preclinical research activities.
An increase employee costs, including noncash stock compensation.
The increase was partially offset by a decrease in manufacturing cost frogs freida that were Expensed R&D.
Following the approval locks freida by the FDA, we now capitalized manufacturing to inventory.
Sales General and administration expenses for the first quarter 2020 were 47.7 million compared with 18.1 million same period in 2019.
The increase in SGN expenses was primarily attributable to increased employee related costs, including noncash stock compensation and increased professional and consulting services associated with the build out of our commercial operation and launch Hawks bright.
Net loss for the three month ended March 30, Onest 2020, 73 million compared 48.9 million for the same period in 2019.
Basic and diluted net loss per share for the three months ended March 31st 20, $20 20 per share compared with 87 cents per share for the same period in 2019.
We ended the first quarter with a strong balance sheet and with cash cash equivalents and marketable securities of 615.2 million.
Paired with 695 million.
Number 31st 2019.
The decrease of 79.8 billion included the onetime upfront payment of 20 million related to the collaboration we entered into serious pharmaceuticals in 2019.
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We continue to believe our existing cash and investments and access to the additional 75 million under our existing term loan facility have the potential to provide the necessary runway for up to achieve positive cash flow, while enabling continued advancement of clinical development programs and other earlier stage product candidates.
As we look at the remainder of the year, especially if the uncertainty, but the current global situation has injected into the financial markets. We feel confident that we are operating from a position of strength and we will continue to execute on our plans to get us Friday the patients.
With that I will now turn the call over the DJ for an update on the outside the launch.
Thank you Jeff Good afternoon, everyone I'm excited to provide an update on the launch of oxide as Ted mentioned, we had an exceptional first quarter as cobot 19 escalated. We are proud that we were able to quickly transition to a virtual working environment and minimize potential disruption to the launch.
I can take a moment to recognize our field operations marketing Medical affairs diabetes, all of them worked tirelessly to enable us to support our virtual interactions.
Today I'd like to share three metrics, but combined with net revenues will give you further insight into our progress. These metrics are new prescriptions for us bretaa, which informs underlying patient them in a number of health care providers prescribing on Friday, which captures the progress, we're making good adoption and payer coverage measured by or set of covered.
Lives.
First new prescriptions, we saw approximately 1650 patients prescribed on Friday during the first quarter for a total of approximately 2007 launch.
Vast majority of new prescriptions were enrollments in GBP source, our high touch patient support program that provides a wide range of real time impractical support including educated financial support that's customized each patient's needs. We're encouraged by this level of activity and believe it's indicative of the positive interested on Friday.
The new prescriptions include patients who have received early payer coverage generally through the medical exception process as well as patients without insurance for receiving free medicine under our patient assistance programs.
They also include patients whose insurance is not currently providing coverage and are unable to secure a medical exception. In these cases, we're able to provide free drug to eligible patients or coverage is established and we're pleased that GE sports team has successfully moved patients through the process and secured insurance coverage for that.
In order to better understand the impact of Cobot 19 on practices in April we surveyed approximately 50 sickle cell disease physicians, primarily hematology as our practice dynamics as it relates to patient and Salesforce interactions.
We were encouraged to see that more than 90% of practices are using some form of tele medicine, either bone or video. We also are encouraged to see that most positions nearly 70% report having some level of comfort prescribing any new product sickle cell disease treatment without a lot of visit in fact, 25% of those survey reported how.
Being prescribed box right up following a virtual visit.
On the other had nearly 75% of position survey reported a decrease in daily sickle cell disease patient volume since the Kobin 19 endemic began.
As reinforces what we're seeing across the industry.
The majority of medical practices are experiencing a decline in overall patient volumes and as a result and reduction in new prescriptions.
Specific to GBT.
We have seen as much as a 60% decrease in weekly new prescriptions for Aucs brighter from the peak in early March.
We expect the rate of new prescriptions to continue to remain lower as the second quarter progresses through the third quarter and potentially longer.
However, we are encouraged that even during this time, we continue to be new prescriptions. Each week as such we remain confident about the long term potential for our freida.
Turning to healthcare provider penetration, we continue to actively engaged with positions. The majority of interactions for the first quarter work conducted in person before the transition to virtual interactions in the second half a march due to covert IP.
Feedback from the field team and our survey indicates that many practices are receptive to virtual discussions back. The survey show many positions are participating in it gave us by phone and video with sales reps.
We are regularly sharing learnings and best practices across our teams and are prepared to continue with virtual interactions for as long as necessary.
We have adapted our existing material to create a new material to support the virtual interactions.
Lisa we originally launched our new branded patient marketing campaign help educate about our friends at the facts on hemoglobin polymerization.
We've also receive F JV back on our brand health care provider marketing campaign, and anticipate launching it in the coming months.
Well go the of these campaign materials come at a critical time to support our digital interactions with patients and physicians.
Based on updated market research, we're encouraged that aided awareness much brighter among top sickle cell specialists remains above 90%. Additionally, we continue to see strong interest not freida with over 90% of physician, indicating they will use on Friday in their practice and almost 60%, indicating they plan to initiate our prior to within the next three months.
Through March our therapeutic specialists have reached approximately 90% of our highest that's health admissions and overall reached nearly 60% of the approximately 6000 healthcare providers, we're targeting in the United States.
Our team has visited our high Def L. target for an average of six times and have had nearly 18600 total customer interactions since launch.
As a result, approximately 525 unique health care providers have written a prescription drug freida during the first quarter for a total of approximately 660 unique healthcare providers prescribing since launch.
As expected the majority of prescribers argument colleges, but we're encouraged that our growing percentage of primary care physician that pediatrician are also prescribing arthritis importantly, prescribers have written multiple prescriptions.
Averaging approximately three prescriptions per prescriber since launch.
Assistant what the decrease in new prescriptions of Coca 19, the number of new prescribers of occupied it has also slowed we continue to monitor to assess any potential impact to our long term launch plan, we'll adjust accordingly.
Regarding payers were pleased that we have been able to continue payer meeting many of which were already scheduled as virtual meetings before kobin Nike pandemic consistent with our expectations. We now if we have reimbursement coverage for next Friday in place with payers, representing 25% of covered lives specifically, we have coverage in place representing.
30% of commercialize 9% of Medicaid lives and 8% of Medicare lives.
Notably we have secured coverage policies with the centralized fee for service Medicaid plans in 11 of the 17 priority States. This was an important step given the influence the fee for service Medicaid plans have or the overall coverage picture in the states fee for service Medicaid in Texas, and New York are good examples of.
These days with large sickle cell population that are now covering occupied.
In addition, it's important to note that even if I try to have not yet on formulary payers are covering many patients through the medical exceptions process.
We're pleased with the progress we've made with payers we remain on track to complete most payer meetings during the first half the 2020 and we continue to believe we will meet our goal of a pretty broad coverage by the end of the year I'll now turn the call over to Ted to provide an update on our clinical development activity and pipeline.
Thanks DJ.
GBTA Spamming research and development has been the backbone of our company.
The teams discover and develop a breakthrough and ops brighter in record setting time.
And approval of concurred, Jeff five years after clinical testing began.
However, we are only just beginning as we plan to continue to deliver major renovations for FTD.
I want to thank Josh where our former Chief Medical officer for his contributions to the success of GBP and Aucs Brian.
Dr. Gregory Bell, who brings extensive experience from his career at Merck, Hi, Pharmaceuticals, and Genentech has stepped in to lead our development organization and is doing a fantastic job.
Great and joint GBT earlier, this year as a senior Vice President.
We believe GBP as well position to change the course of FTD for millions of individuals around the world.
In order to achieve this we will need to evolve Jeff as we get at Genentech during my career there.
Consistent with this we've decided to recruit a head of research and development.
This individual will bring major experience in global R&D strategy and operations.
Clinical and non clinical research.
Regulatory affairs and lifecycle management.
Our focus on line and deep expertise in FTD sets GBT apart and we believe this positions us to become the leader in FCD and deliver on our commitment to patients.
In the immediate term we are working to expand occupied as approval for FCD patients younger than 12 years of age.
We are scheduled to leave with the U.S.M.D.A. soon and we will provide an update later this quarter.
In parallel we are working to potentially make outspread available in regions like the middle leave Latin America and Europe.
We're in discussions with the M&A on the regulatory pathway for occupied in Europe.
We expect to provide an update later this quarter on our go forward plan for this region.
As a reminder, FCB is geographically concentrated in Europe.
Which should allow for an efficient commercial infrastructure and launch if approved.
Look into our pipeline our plans remain on track to initiate a pivotal clinical study for and clock AMAP our novel fully human monoclonal piece selected inhibitor in the first half of 2021.
We believe in clock AMAP has the potential to become the best in class treatment for Veeco booked a crisis.
Finally, we also continue to conduct additional research in our labs and in collaboration with zeros with the goal of developing more breakthrough therapies for FCB.
DVT in class have extremely talented.
Dedicated and passionate employees from top to bottom end coast to coast.
As a result, we're off to an excellent start with Aucs bright.
Providing a new treatment option and comprehensive patient support for FTD patients.
While we have a lot of work ahead of US we're confident we will succeed in realizing our vision to make FCD, a well managed disease.
Give me patients the opportunity to live long and prosperous lives.
With that we'd like to open the call for questions operator.
Thank you we will now be conducting a question and answer session. Just start please limit yourself to one question. If we have time remaining we will take follow up questions. If you would like to ask the question. Please press star one on your telephone keypad. It confirmation total indicate your line is in the question Q you.
Chris start to if you'd like to remove your question from the Q for participants using speaker equipment and may be necessary to pick up your handset before pressing the star keys, one moment, please while we pull for questions.
Your first question comes from line of Jim Birchenough with Wells Fargo. Please proceed with your question.
Yes, hi, guys. Thanks for taking the questions and congratulations on the terrific launch.
I guess just my question would be if you could break out what the inventory contribution was to the first quarter sales number and then DJ If you have a sense of the type of patients that are receiving aucs bright out of the gate. If if they're below that eight grams per deciliter threshold of higher unmet need or if you're seeing a broader distribution.
Okay, Im above and I guess any insights on the type of patients being prescribed demand just a quick one on on any inventory commentary. Thanks.
Hey, Jim.
Quick question unheard of in the line fit pretty hard to kind of accounted for inventory at this stage. We don't think it's been a significant contributor.
In terms of the types of patients that were saying.
The data that we get from the hub is fairly limited, but we don't we do note that gender looks like you would expect in sickle cell disease about 60% female 40% mail. The age distribution is pretty typical very similar to what you saw.
In the host study, we don't collect hemoglobin levels, but we know anecdotally from interacting with physicians that some physicians have focused initially on lower hemoglobin patients locations are all over the map Oh, we have patients that have started up above 10.
And actually people that completely normal hemoglobin is that starting up there. So there is a broad distribution a actually we expect.
Jim maybe ill add to that to did.
In the specialty pharma channel inventories purchase pretty much on adjusted time basis and regular ordering going on on a weekly basis. We are aware that some companies noted that there was some stocking as it related to Covidien. So we did take a look at that as a possibility in short answer is we did not see anything material there and really the way we look.
And it because we don't have a year trend just sort of compare to prior year as we looked at the refill that we're going through the other refill request from the patients and it was sort of standard in the 30 day range. So you patients were ordering multiple lump sum inventory, but then we also looked at days on hand at our specialty pharma and inventory.
Levels were diminishing at the regular rate. So one would imagine if in fact, they purchased more in anticipation of stockpiling. The days on hand would have been higher than what we typically see and we just did not see that.
Okay.
That's great thanks, guys and that congrats again.
Thank you.
Your next question comes from line Oh.
Let's see a young with Cantor Fitzgerald. Please proceed with your question.
Hey, guys. Thanks for taking my question is congrats on the very good quarter launch, it's good to standby attack.
I guess I just want to talk a little bit more about what we've got what's been done how you've been really seen in detail in April I know I think in your script, you said potential from the peak down 60%. So isn't a factor of new pay is a factor of the patients coming forward adopters ban has that kind of start I'm just give us some more color on that that'd be great. Thank you.
Oh, Yeah, hi, thanks for joining like yeah.
These are really trying to get at kind of the overall covidien pack.
And yet what we essentially said in the call is that we kind of qualitatively and quantitatively, saying a dip in prescription oney or a 50%.
Ah and the way, we basically get that is to know what our peak prescriptions were.
In a given week and then look at what they've done subsequent to that so there hasn't been.
Clear I had when it's really too early to be giving too much details about about about this early in the launch, but we definitely think theres a row headwind that should go away.
It is driven to some extent by patients not going to the Doctor we've talked a number of physicians.
Who would have in fact told their patients that they want them to shelf and place and some physicians are beginning to prescribe hoxbar to a telephonic they have using zoom other technology, but some have not moved to that and so I think that combine to create.
Great a situation, where they're headed there is a headwind we expect it to get better as a pandemic.
Subsides. We also think we can make progress we are making progress even with the sharper in place or worse.
Your next question comes from line no yeah, and so Najah with Guggenheim Partners. Please proceed with your question.
Hey, guys, let me add my congratulations as well congrats on a very good quarter can you just comment on a big success rate using the medical exception and then you know overall, what the piano pool wasn't array testing and then if you could also comment on you know all these 16 50 or 2000 patients that have received.
The prescription how many what actually paid patients what it was just the most justification that put us using free drug.
[noise] TJ you want to take that sure yeah, Hi on thinks the question. Yeah. We're very pleased with how the payer interactions are going and as we talked about.
Many of the pair interactions prior to the Kobe pandemic were already virtual lot engagements in meetings that worries that up so we've been able to maintain interactions through the pandemic and continue with with those with those payer meeting. So so we're very pleased with that the the payer.
A response is you don't get changing on a weekly basis now because we've always talked about the first half of this year and specifically Q2 would be a time when we would be having a lot of formulary review meetings and those are happening now so we haven't payers coming on every week that it having their formulary meetings, and that's where things. So Q3 Q4 as when we expect.
You know many more formulary is to be published and or coverage to be brought by the end of this year and work and we're you know we're standing by that goal and we think that there were on track to deliver that as well in second half of year.
In terms of medical exceptions, we're very pleased with that process. You know why we're not giving a rate not exact numbers because again, it's very fluid or we can tell you that we said in in our prepared comments that about 25% of covered lives.
Our have published coverage now in the payer environment and being in Q1 of your of your lunch. Your first quarter launch that's right in line with our expectation. So we're really pleased with that but clearly we're getting many more patients paid for based on net revenues at our demand numbers that we provided it's clear that the medical.
Exception process. It is also working very well as well. So we're pleased that GBP source is able to help clinicians and patients get access.
Either from medical exception or in some cases through our a patient assistance free drug program.
Anything you would like to add on the paid washes be pretty tough patients based on the big done, but you have given the 60 52 presentation. Thank I'll get back into queue.
Yes, yes, yes, so we're really not Jonathan I think for the question, we're really not focusing on detailed like that we do obviously have some free patients.
But it's important to recognize that those patients will be converting over to pay patients overtime as we get more and more coverage.
In place and that didn't back as part of the rationale for the free drug.
He has to make sure that when a prescriber rights to drive that patient can get on the drought even if the full payment process has not worked his way through so we're committed to making the drug available overtime those patients will be converted.
Hey, patients, but we're not really focusing on disposing the specific metrics or am I right now because.
As needed to have these numbers are all very fluid.
Your next question comes from lineup Liana Moussatos with Wedbush Securities. Please proceed with your question.
My other question for Jeff about the impact of co lid on operations expense from Q2 on word does it go down with revenues as well.
You are rightly ought to just given a it will have some organic savings we were continuing to keep you know our focus on building out the commercial side and pushing forward as much as we can only clinical side, but there will be some natural savings due to the clinical trial delays that we have in particular other TCD study and then we then is it.
Starting yacktman study a little bit earlier, so overall, we expect it to ramp up a little bit in the second quarter or that sort of stabilize out for the rest of year.
Your next question comes from line of Danielle Brill with Piper Sandler. Please proceed with your question.
Hi, guys. Good afternoon, and congrats on a shock stacking the launch I just have a quick clarifying that position on the 2000 and Oh I guess prescriptions ended the Hagi said the vast majority of <unk>, who are I guess the vast majority were enrolled in the hub can you just can you give us a little.
That more clarity on the exact numbers that and how representative that is actual patients on drug. Thanks.
Yeah, I know there's the DJ.
Institutions.
Do you have the ability to order directly from our specialty distributor. So there's a small percentage of patients that would go directly through the free 40, B program again that has to be a small percentage because as you know our product being an outpatient product patients preferring to have the ship to their house. The GBP source solution oftentimes is preferred.
But that's why we say not 100% are going to go to GBP source, but the vast majority are either way we have visibility into the demand. So we see the demand we know exactly the shipments.
Because it's very controlled distribution system, so that 2000 sense approval or new patient prescriptions and that is encompasses.
The entire I'd universe.
Your next question comes from line of Redo Baral with Cowen. Please proceed with your question.
Hey, guys congratulations on them on the print really remarkable couple of questions from me can you talk about hmm in the plans that you think your shaded are negotiating what prior authorizations.
Could end up being what are what are their requirements.
And then also can you talk about what.
What doctors want to do what you plan to require around.
Lab valleys first Mclendon response, whether we're talking like right now with pandemic or sort of longer term any here. They might you know when the plane little coverage guidelines are.
Drawn up.
Maybe I'll ask DJ Richard Thanks to the question good hearing your voice maybe.
Maybe I didn't write the prior and I'll, maybe talk a little bit awful lot battles for solar prior outside yeah. We've had some really good conversations with payers over well since approval and we're happy to you know to to inform you that most of the approval that have happened already with payers have been broad coverage just like we had.
Hope that includes open access, which really means a prior off to label and that's Oh, we have a very broad label. So that's certainly our goal and we've had many that have have approved us only access to label. The second most comedy as a P.A. to label and clinical criteria. So that's the.
Wait following the IPO study criteria that in our label and that's fairly common as well. So that's you know hemoglobin 5.5 to 10.5, that's not uncommon to see an upright off as well and so the vast majority of plant. We consider both of those very broad criteria in the vast majority of plan, we see come online have been back one of those two.
Categories.
Periodically we have seen plans come out with more restrictive criteria and that might include a required for example to be O C. B documented be overseas before the drugs to indicate and of course, that's outside of our label that's outside of our indication that's outside of our really our profile.
Our product so we're able to successfully go back in and educate in those situations in one of the process of doing that in the handful of plans whenever a pop up to go in and make sure. They see the data and and we've had success in reversing some of those prior off so those still are are they a minority of plants that have a more restrictive policy and we are able to.
Reverse that successfully.
Maybe the Olympic I'm, an added periodically you view here H. you being a standard of care drugs at the payers, who are aware of a they often ask or maybe even put in a prior authorization that issue has been considered for the patient and of course as you know most all patients have already been considered freight you. So that's a pretty easy soft.
Step edit and so so we're fine with that and as well.
And with regard to the lab values rich to as you know many lab values are actually.
Recommended or required by labeling.
On Friday is very fortunate in that Theres no label recommendation for anything many drugs call elevation of Lsts, though we have to fall out too, but that's not been anything it's ever seen so there's no labeling follow the lsts.
Positions many times out of curiosity want to follow in hemoglobin, but there's nothing in our label about even following the hemoglobin because we know that the.
Responds to the drug.
In terms of how people feel for example doesn't even necessarily directly relate to the hemoglobin response itself.
In addition, we know many times people want to give this drug to protect patients and actually one of the story that I learned about over the weekend.
Was a patients who unfortunately develop cobot 19.
And then hemoglobin a for the patient was falling was.
Near our are getting close to going below five.
Hi, This is actually last Thursday.
I'm very proud that the physician reached out to GBP, we literally have drug shifted that patient.
So they should get began taking on Saturday.
And I, just got an email from the physician today, saying im hoping that over eight already.
So so that's an example of somebody using my values, but quite frankly, the patient put it pole position they feel much better which is what they are to total fish and even without the lab that so the land values can be follow but they're not part of any kind of requirement even recommendation from the lights.
Your next question comes from minor, but Matthew Harrison with Morgan Stanley. Please proceed with your question.
Oh, great. Good afternoon. Thanks for taking my question I was wondering if you could talk a little bit about.
Prescription trends, you're seeing a continuing I think a lot of other companies that have reported have talked about seeing a bottoming in a.
Second or third week of April and starting to see some recovery then so maybe could you put in context.
What you that comment around what you had in in March in terms of new starts.
And if you're starting to see a at least the bottoming relative to what some other companies have commented on.
You should probably ask more detail, but I would say that we've definitely seen a decrease.
And we don't know how long that decrease last so we don't want to underestimate the impact that coping 19 could have on the future. Obviously feel we feel great about the start in the long term potential, but we don't want to underestimate the index.
The impact of Kobe as long as it continues to restrict patients access to think of physicians and other issues.
Yeah, I would just add that Ah first of all we are still getting new patient prescriptions every single week, so even during the pandemic and even with.
A significant drop we're still getting new patient starts and that includes new prescribers as well it's not at the rate. It was obviously before kobin decades, but every week, we have new prescribers coming online and new patients getting on Friday, so that that's the good news.
Too early to tell it's early days as to how the trends going to play out we definitely saw the reduction happened pretty rapidly. It dramatically just like the industry did and it's been less dramatic lately last few weeks it start.
Thank you good with a little bit of Squint say, it's flattening out, but Tom So have we hit the bottom yet maybe it's hard to tell but we should know over the coming weeks.
Your next question comes from line of Mark Breidenbach with Oppenheimer. Please proceed with your question.
Hey, guys. Congrats on the very strong early numbers and.
I was I was wondering maybe maybe touching her following up on the on one of the or their questions on the Q with regard to the types of patients that are in the early on spread or user population I'm curious what fraction of these patients are already compliant on hydroxy area.
Is there a big discrepancy between us by the users and meet you users, but also it I don't know if I heard it earlier in the call, but have you commented on the prescription refill rate or that you've seen so far thanks for taking the question.
So I'll start with the types of patient in after you today to talk about the retail.
We don't collect a lot of details about the patients in the hub and we don't want to the reason, we want to make going into the hub as simple and easy as possible for the physician or the patient. So that's why we don't collect that kind of information in the future, we likely will be doing chart audience.
Ah that we'll get the kind of detailed that you're you're you're thinking about mark, but we don't have that information through GBT source.
Anecdotally, we do know that some patients are on combination therapy on HQ.
We know patients are also getting as axio, ER and and box and occupied at the same time. So we know this combination you we don't have quantitative data at this stage.
Yeah, Mark just to add to that on the refill side and by the way we will have a data in the future you know where do we have always might do chart all that that will get out the combination use and the hemoglobin levels and now that we have a substantial group of patients Starbucks right up well be able to conduct those toward audits and we'll have that data for you with the future appetites exactly.
Right, we hear anecdotally from positions a combination therapy is pretty color.
Regarding the refills are you know it's early days, but we're encouraged by the early rebuilt data we know it signifies the that our patients are being compliant and that's good and the retail the vast majority of our patients are refilling on time that is third within 30 days, a tight time window and that does suggest that the adherence.
Is as good as we had hoped it would be so what is really gave we're watching it closely but the rebuild seem to be happening on time for most of our patients.
Your next question comes from line over Matthew Hole with JP Morgan. Please proceed with your question.
Hey, guys. Thanks for taking my question Congrats on the quarter just wanted to go back to the question around free and paid script breakdown I'm curious if you can say a little bit about what the free drug to paid scrip conversion rate has been what your expectations are for this dynamic in the near future.
Oh I'm sorry.
So I don't think we really have enough information DJ you can add to but I don't think we have enough information that really get that's kind of insight. We at least it's clear that the vast vast majority of patients on free drug are going to convert to Pedro.
Ninee more than 90% would be my prediction.
But that number is changing particularly early in a launch where the number of patients is no patients or new.
But overtime, we would expect 90 plus percent of those patients to convert over to Pedro.
Yeah, and I would say that you know the metrics. We're giving you now we think are the best metrics to determine underlying.
Demand and and launch success. So a total prescriptions really is underlying demand our physicians and patients ready to start box brighter and that's that that enrollment more prescription number a number of physicians that have prescribed docs freida and the penetration into the prescriber base. We provided then of course.
Covered lives how are the payers doing so we're really focused on both the other metrics really are much more variable and change from day to day I can't tell you. That's important to note that we believe we will achieve the broad coverage by yearend and able to convert many of free drug patients at that time. The other thing I would just mentioned dynamic wise isn't.
The early days of wallet half is generally a much higher that's the patient assistance program at a free drug program is the highest will ever be and then it comes down over time and we certainly are already seeing that dynamic I think it's fair to say that the number of patients on free drug far less than we had expected.
Your next question comes from line of Paul Choi with Goldman Sachs. Please proceed with your question.
I'll try your line is now live. Please proceed with your question.
Our next question comes from line of Christopher Myride with Nomura Instinet. Please proceed with your question.
Hey, guys. This is Jackson Harvey on for Chris for MRI I was just hoping maybe you could give a little more insight on any regional or geographic trends.
Do you see maybe some more high impact areas being less affected by.
On the coast at 19, pandemic or vice versa, and how does that overlap with any inroads team made with state Medicaid.
So thanks, everyone for the question.
I would just to go back and novel side again, we we've previously shared that.
About 85% of our patients are from 17 space.
And those big being in the northeast the southeast around California.
Hi, and we've had enrollment quite frankly, a in a manner that kind of reflect for the population lives.
We have not really had enough cobot experience I think too.
Yeah make any sophisticated.
Statements around the impact of commit Kobe, but we have had Ah ah patients being an ROE from all the geography that we would expect and in Rob.
Portion.
To the population that exist in those states.
Your next question comes from line of Raj Group facade with William Blair. Please proceed with your question.
Thanks for taking the question I'm just wondering if you could provide a little more color on a you know what gross that you're seeing in a Medicaid coverage.
Discussions and kind of what mix of the current quarter was ER was Medicaid versus commercial thing. Thanks.
Yeah, So hi, Raj already doing.
This is Jeff just wanted to give you a little sense of that the pair mix is going to change dynamically over the year.
Yeah, and fourth quarter, we'd highlight is that we had on a large number of Medicare part D patients come through and were reimburse.
This quarter, we seen a decrease in Medicaid can we expect that to increase.
As time goes on given the fact that we'll get more payers on onboard there. So we do expect our our gross to net increase next quarter and continue through the red remainder of the year up to that steady state of 25 30, we are seeing a little more commercial covered earlier than say the Medicaid, but other than that.
The dynamics will be changing until we get it steady state.
Your next question comes from lineup Yun Zong with Janney. Please proceed with your question.
Hi, Thank you very much more to the question. So this is a full person on the 60% dropped and weekly prescription, but you also said that up to 70% of prescription closer to health care providers are comfortable.
Pardon truck without patients. That's the doesn't you also see if a person is one where we'd like to get the correct is there anything then the physician from prescribing the truck and you said that the.
Like the quarter 92 months dependable third quarter essentially longer so is there anything thats your plan to potentially proved that.
Groups and great. Thank you.
Well, so the 60% number of things for the question, 60% number was really a comparison of the PD.
Week to kind of the lowest week that weve observed since cobot 19, and what's driving things there are things moving in both directions. As you point out one is that some physicians are not.
Fully implemented yet.
In terms of going telemedicine as physicians come online and they patient come on line that could be a mechanism of recovery and were facilitating that.
Some physicians are clearly dominion.
Thats why we continue to see scripts.
But I think it's a little bit hard for us to conclude that the world is gonna be as efficient as it was.
During the pandemic I I think we expect there to continue to be some headwinds for us. We're obviously going everything that we can do.
With our force, which is also working remotely with physicians to try to stimulate more used but part of the issues that if you're not seeing your patient.
In patients aren't doing tele medicine, with you and it's hard to prescribe. It did you I know if you want to add anything specific beyond that but.
I just wonder if as we do expect.
There to be a continued headwinds yeah. That's just been a decrease in volume of interactions between physician and patient during this time, but as Ted said it is getting better every week as physicians operationally and patient operationally and become more comfortable with ER with doing virtual meetings and the survey we talked about was 70 per.
He said actually 90% of physicians. So they are comfortable doing tele medicine and have already started 70% said they are willing to start new therapy. This way. So we're encouraged by that we've already seen to give an example of what we can do to reduce any big operational barriers I receive every single day best practices from the field teams by just received one.
From a representative in Pennsylvania, She did assume session with five health care providers last week and also included our patient navigators and they were able to go through a whole ox Bretaa package insert review and a whole GBT source distribution review it keeps the office how to access.
How much brighter remotely and virtually and answered all their question and we've already seen in that clinic enrolled a new patient sense that interaction last week. So it's just about getting out and kind of reminding people about GBP source, how everything can be done remotely and a and then they given a tried so we're in the process of doing that across the country now.
Your next question comes from line of Justin Zeland with Canaccord. Please proceed with your question.
Hi, Good afternoon. This is nothing going on for John Newman first congrats mushroom corner and it's good to see the Medicaid fee for service plans are starting to come online I was wondering if you check could give us some color on the experience with states are predominantly offer Medicaid through managed Medicaid plans. Thanks.
Yeah, Justin Thanks for the question Yeah, absolutely. So we said in his script that Ah you know the fee for service are very important because for a couple of reasons. One is in the 17 top state for sickle cell patients that really cover approximately 80% of the patients in the U.S. There are some critical stakes there that have very high.
Fee for service centralized Medicaid plans I think about North Carolina, I think about Alabama, no. These are areas where fee for service really wins today and so it's really important to have those those interactions and those coverages in those states, but in addition, the state but have high managed Medicaid the new York's the Texas, Florida.
These are also very important to have fee for service onboard because in many of those states.
They either mandate were simply influenced the managed Medicaid plans to not have more restrictive policies and the fee for service state Medicaid. So in Texas for example, or you want to make sure that the centralized Texas Medicaid.
It's giving good covered for your product because they will help mandate that across the managed Medicaid. So we feel really good about the fee for service plans coming onboard 11 of the 17 key states.
Our covering our Freida, we talked about Florida, Texas, Alabama, New York to name a few so that's why that's important managed Medicaid sometimes take a longer you have to go to every single plan and where the process of doing that but we have had patients importantly be covered in the key managed Medicaid plans as well I think a 17.
I think of anthem. Some of these are large managed Medicaid plans. We're also getting a patient pay for as well. So we're in the process with most of those United Wellcare is Molina. These are all really important payors and we're having really good meetings with them as well, but in the interim.
The medical exception processes working there too.
Your last question comes from Ben Burnett with Stifel. Please proceed with your question.
Hey, Thank you hi, good afternoon, and also congrats and good quarter, especially under the circumstances.
I guess I just wanted to ask if you could provide or offer any additional color on the treatment setting where you're seeing early adoption of Bucks Freida I'd just in terms of what the mix is between tertiary care versus PCP, thus far.
And I guess, how do you see that evolving particularly through this.
Filtering place mandates that are that are in place.
Yeah. This is DJ so us so early on in the launch as we expected. The special that's really been hematology as were the primary prescribers of box plant and they remained strong throughout Q1, and the dominant prescribers of occupied and they have a lot of patients and they are 10.
To be the ones that are closest to the data and whatnot. They also get referred the more difficult patients in need and those are patients, but really I need access to arthritis. So so the specialist clearly you know about half the prescriber prescriptions have come through the specialty channel that said as you.
Progressed with your launch you want it to go deeper and deeper into the into the physician targets and we're seeing that happened as well so nurse practitioners and physician assistant our big prescribers of arthritis, Pcps managed a lot of sickle cell patients, especially Medicaid where they don't have access to specialist, we're seeing more and more primary care doctors write ups brightest.
It is starting to make that natural transition as the pcps learn from the specialist.
So we're still focusing on both we built our teams to be able to call on primary care and specialists.
We're doing educational programs in both those communities.
So I hope that helps provide a little clarity on that.
Ladies and gentlemen, there no further questions at this time and I would like to turn the floor back over to Dr., Ted Love for closing comments.
I'd like to stand by first thanking everybody for joining the call.
Second wish everyone, a stay safe and say, how big and family. If there are other questions feel free to reach out.
It's definitely yeah. After the call. Thank you.
This concludes today's teleconference. You may disconnect your lines at this time. Thank you.
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