Intra-Cellular Therapies - Q1 2020
May 7, 2020
Transcript
Speaker 0
Good morning, ladies and gentlemen, and welcome to cellular Therapies First Quarter ended March 31, 2020 Financial Results Conference Call. As a reminder today's call is being recorded. Questions. May be recorded. I'd now like to turn the conference over to your host, Doctor.
Juan Sanchez, Vice President, Corporate Communications And Investor Relations. Please go ahead.
Speaker 1
Thank you, operator. Good morning, and thank you all for joining us for today's conference call. Our earnings press release providing a corporate update detail, so the company's financial results for the first quarter ended March 31, 2020. Across the world short time ago and is available on our website at intracellulartherapies.com. Joining me on the call today are Doctor.
Sharon Knight's Chairman and Chief Executive Officer Doctor. Andrew Soplin, Executive Vice President And Chief Medical Officer Mark Newman, Executive Vice President and Chief Commercial Officer, Larry Hineline, Senior Vice President and Chief Financial Officer and Michael Hosten. Executive vice president and general counsel. As a reminder, during today's call, we will be making certain forward looking statements. These statements may include statements regarding among other things, the efficacy, safety and intended utility of the company's product development candidates, our clinical and non clinical plans, our plans to present and report additional data, the anticipated conduct and results of ongoing and future clinical trials, plans regarding regulatory Falliance, future research and development, our plans and expectations regarding the commercialization of Keplyta, potential impact for the COVID-nineteen pandemic on our business and possible uses of existing cash and investment resources.
These forward looking statements are based on current information, assumptions and expectations that are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward looking statements. These and other risks are described in our periodic filings made with the Securities And Exchange Commission, including our quarterly and annual reports. You're cautioned not to place undue reliance on these forward looking statements, and the company disclaims any obligation to update such statements. I will now turn the call over to Sharon.
Speaker 2
Thanks, Juan. Good morning, everyone, and thanks for joining us on today's call. Confronts the ongoing COVID-nineteen pandemic. It's hard to imagine that since the last time we gathered for the reporting of our year end results, so many changes would have occurred. Yet we know for certain one thing hasn't changed.
There still remains a high unmet medical for new treatment fees remain steadfast in our scientific and clinical efforts to meet that need for patients. These are extraordinary times that require adaptability. COVID-nineteen has created near term disruption in our healthcare system and in our industry. Despite these disruptions, we have adapted and successfully executed on the launch of Keplyta in this COVID-nineteen environment. I will summarize the steps development programs and summarize our financials.
Following my remarks, I will ask Mark Newman, our Chief Commercial Officer, provide further details on our commercial activities and Andrew Satlin, our Chief Medical Officer, to provide an update of our clinical development programs. Larry Hineline, our CFO, will then provide details of our Q1 financials. As a reminder, Keplida is an oral medication taken once a day that does not require titration. So a patient can start and stay on the apeutic dose. The Kepleiter label reflects a compelling clinical profile, having demonstrated efficacy and changes in weight, fasting glucose, total cholesterol, triglycerides, and extrapyramidal symptoms, including a that are similar to Placebo in our short term trials.
In our long term safety study, patients on Keplata an average weight loss of 3.2 kilos at day 3 50. Based on this profile and our commercial efforts, we believe Kepleiter will be a leading treatment choice for adult patients with schizophrenia. In these unprecedented times, we prioritized the health and well-being of patients, healthcare providers, and our employees, and still successfully launched applied us. I am very proud of the ability of our team to rapidly adapt to this fluid environment. We successfully from an in person launch meeting to a highly interactive fully virtual national launch meeting followed by the initiation of remote promotional activities.
The promotion of Kepalaita began the week of March with approximately 2 providers. As well as Lydallink, our comprehensive patient access and reimbursement program. In addition to our promotional launch activities, we are particularly pleased with as payer channels. To date, we have achieved formulary coverage for 90% of covered lives under Medicare Part plans, including unrestricted coverage in 2020 by CAVS SilverScript, 1 of the largest Medicare Part D insurers. We remain on target with our other channel coverage goals and continue to expect broad access for Keplyta across payer channels to be fully established by year end.
Mark will provide further detail on are fully operational, and we have substantial product supply in the United States to support expected demand. I would now like to provide a brief depression. We have completed patient enrollment in Study 4 2, our phase 3 study evaluating Lumateperone adjunctive therapy in bipolar depression and anticipate reporting top line results from this study in mid-twenty 20. With regard to our 214 development program, clinical conduct in our phase 1two clinical trial of ITI-two fourteen, our phosphodiesterase 1 or PDE1 inhibitor in patients with chronic systolic heart has been completed. This study evaluates the hemodynamic profile and safety of single ascending doses of ITI-two fourteen.
We anticipate reporting top line results from this trial later this quarter. Andy will provide further detail on this 2020 with 4 and look forward psychiatric to
Speaker 3
a few weeks ago, and I'm happy to provide an update on our progress to date. I could not be more proud of our team's execution against the backdrop created by COVID-nineteen. This environment required the team to be agile and creative, while making significant adjustments to for their program was converted from in person speaker training and programs to a virtual platform Additionally, to supplement our virtual sales force and medical education activities, we have significantly expanded our non personal tactics including healthcare provider and consumer digital advertising to drive additional awareness of Keplyta amongst our target audience. Following a highly effective and successful virtual national launch meeting, our neuroscience specialist team began actively engaging with prescribers on March 30th and educating them about CAPLIDA. Our team is focusing on the approximately 23,000 healthcare providers to account for 80% of the branded antipsychotic schizophrenia prescriptions.
In the early weeks of our launch, we are encouraged by the The large number of participants we've attracted to our virtual expert panel medical education programs The substantial progress we have made in our market access activities as reflected by the timing and quality of coverage determination outcomes across all channels and in particular, by Medicare Part D Insurers and the positive feedback we are hearing from some healthcare providers regarding patient response from those and initial market reception, we continue to believe that Keplyta will become a leading choice for healthcare providers treating adult patients with schizophrenia time. I'd now like to take a few minutes to further elaborate on Sharon's remarks about our substantial progress in our market access activities. Payers across all channels, including Medicare Part D, Medicaid and commercial plans, have been actively reviewing CAPLIDA as part of their formulary review activities and coverage determinations. The timing of these coverage determinations been consistent with or ahead of represent our largest payer channel have finalized And I'm pleased to report that we have now achieved formulary coverage for 90% of covered lives under Medicare Part D Plans. Medicaid coverage determinations are progressing according to plan end quarter and completing in Q3.
Some commercial plans have already made their coverage decisions while others will do so throughout the course of 20 20. Overall, we continue to expect broad access for CAPLIDA across payer channels to be fully established by year end. We have also successfully launched Lytleink in support of patient access and affordability. The program offerings are comprehensive and consists of coverage and reimbursement services out of pocket co pay support for commercially insured patients, medication compliance communications, and patient assistance relief pandemic has created unique challenges for new product commercialization. We are pleased with the trajectory of prescription growth in the early days of our launch.
Based on our market research with early adopters, the initial patient experience with Caplida has been positive and in line with subscription performance will In summary, we are the
Speaker 4
tech. Handy? Thanks, Mark, and good morning, everyone. I joined Sharon, Mark, and the rest of the team in our collective enthusiasts about Keplyta now being available to patients. I also want to congratulate Mark and his team for the remarkable job they have done getting the word out about applied at in the current environment.
The pandemic has not changed the need for ongoing treatment of patients with schizophrenia. These patients still continued treatment or seek treatment changes as a result of side effects such as weight gain, metabolic disturbances, and movement disorder Keplida provides physicians and their patients an important new treatment option for this serious disorder. We continue to make presented robust safety and efficacy results from Study 404, a Phase III trial of Lumateperone in patients with a depressive episode associated with either bipolar 1 or bipolar 2 disorder. In addition, we anticipate top line results 5 20 patients with depressive episodes associated with either bipolar 1 or bipolar 2 disorder who were randomized 1 to 1 to 1 to 1 to receive Lumateperone 42 milligrams, 28 milligrams, or placebo once daily for 6 weeks, while being maintained on lithium or valfroate as mood stabilizers. To remind you, primary endpoint is changed from baseline on the Madras Total Score at Week 6.
As part of our bipolar depression program, we commenced US patient enrollment in Q1 in Study 4 3, a Phase 3 global study evaluating Lumateperone's monotherapy in the treatment of depression in patients with bipolar I or bipolar II disorder. While patient enrollment in the U. S. Has been impacted COVID-nineteen, ex U. S.
Country regulatory review processes and other preparatory activity timelines, we continue to anticipate reporting top line results by the second half of twenty twenty one. In our phosphodiesterase 1 inhibitor program, we have completed clinical conduct in our phase 1two of ITI-two fourteen in patients with chronic systolic heart failure. This study evaluates the hemodynamic profile and safety of single ascending doses of ITI-two fourteen. We anticipate reporting top line results from this trial later this quarter. Our fosyloidasterase 1 or PDE1 inhibitor program provides opportunities to pursue innovative treatment for multiple can inhibit In a paper published last year, we elucidated the details of the intracellular signaling pathway by which PDE1 inhibition reduces inflammation via regulation of microglia movement.
Ongoing preclinical studies are testing whether our PDE1 inhibitors, when given alone or in combination with approved drugs, act by controlling macrophage function and are effective in various disease models, including models of hyperimmune responding or cytokine on programs, while ensuring safety and well-being disorder, our Lumateperone long acting injectable program, our ITI-two fourteen program in Parkinson's disease and the initiation of early stage clinical studies of new opioid and serotonin receptors for the treatment of opioid and other substance use disorders, pain and disorders. I will now turn the call over to Larry who will review the financial results.
Speaker 5
Larry? Thanks, Andy. I will be reviewing our financial results for the quarter ending March 31, 2020 and provide an overview of our expectations for the use of our cash and investments. We recorded net product sales of Kapilator for the first quarter of 2020 of approximately $882,000 no net product sales were reported in the same period of 2019. Research And Development expenses for the first quarter of 2020 were $16,000,000 compared to $25,000,000 for the first quarter of 2019.
The $9,000,000 decrease is primarily due to lower clinical and non clinical related costs for Lumateperone, lower manufacturing costs and is partially offset Sales, general and administrative SG and A expenses were $34,100,000 for the first quarter of 2020, compared to $11,700,000 for the same period $15,600,000 The increase in selling related costs are due primarily to hiring a sales force resulting in an increase in labor of approximately $9,900,000 and commercialization cost of $5,800,000. The increase in general and administrative costs is due primarily to an increase in professional fees labor related expenses and information technology expenses. Cash, cash equivalents, restricted cash and investment securities totaled $450,400,000 at March 31, 2020 compared to $224,000,000 at December 31, 2019. On January 10, 2020, we completed a $295,000,000 public offering resulting in net proceeds to the company of approximately $277,000,000 from the sale This concludes our prepared
Speaker 2
Thank
Speaker 6
questions. And our first question comes from Charles Duncan with Cantor Fitzgerald. Your line is now open.
Speaker 7
Thank you. Sharon and team, good morning and, congratulations on the recent progress, as well as the cover determination. Appreciate you taking our questions. Did have 1 commercial 1 and 1 pipeline 1. With regard to the commercial question, I wanted to ask you in terms of the engagement thus far.
Mark did a pretty good job characterizing that, but I'm wondering if you've gotten any specific feedback with the payer and prescriber engagement regarding, you know, the differentiation of Kipla And then the targeting of certain patients for its use, where do you think it'll be best early prescription?
Speaker 2
Great. Hi, Charles. Good morning and thank you for your questions and glad to hear your voice. And I hope everybody who's asking questions and everyone on the call has, remained and continues to remain safe and healthy. During this time.
I will ask Mark to, start with the answer on engagements as far. And Frankly, I think that probably both of his questions are really directed to you, Mark. So, would you like to, answer?
Speaker 3
Yes, sure, Sharon. And good morning, Charles. Thanks for the question. What I would say is the feedback that we have gotten early on in the launch both from payers as well as prescribers is very consistent with the market research that we had conducted prior to the launch, which is to say that the safety and tolerability profile for Caplida is a very differentiating feature. And in addition, we've also been pleased to hear a lot of positive feedback on the single 42 milligram dose where patients can be started on the effective dose and maintained on that same dose.
And that feedback in the market research that we've done with early prescribers of kaplyta has been very consistent So we're pleased to see that it's playing out in the marketplace similar to what we would have expected based on the market research we had done prior to the launch. In terms of the types of patients, it is still very early on in the process. We are hearing different patient types that physicians are considering Keplyta-four. And again, I would just characterize that as being very consistent with where we thought the patient types would come from as we did our market research before the launch. So I hope that answers your question.
I know you had one additional question, Charles, on the pipeline.
Speaker 2
Yes, I did. Sorry. I think it's really, the target population is any adult patient that's not adequately treated, and for whom the physician is considering the switch. It was quite bad.
Speaker 7
And we've heard that psych is particularly well suited for a telemedicine world. Is that consistent with what you're seeing these early days?
Speaker 3
Yes. Charles, I think across, we've been monitoring that, I'm sure, in many of the same kinds of surveys and all that you all are looking at and we have seen a shift from in person patient visits to telemedicine across the different therapeutic areas and psychiatry is no outlier on that. So I think that is being effectively deployed during this pandemic time and believe that patients who require these types of visits, are being effectively treated, it seems through telemedicine channels as they would if they were doing in patient in person visits.
Speaker 7
Okay. That's helpful. And if I could just ask the pipeline question, quickly because I've been getting investor questions on this. Regarding the bipolar indication and supporting a supplemental NDA, I'm assuming that the primary strategy is to use the results from 401 and 404 in addition to the 402 data that you anticipate coming here soon as the basis of filing. And that 403 is a nice to have, but not a need to have for moving forward Certainly, it depends on the results of 402, but is that still consistent with your thinking?
Speaker 2
I'll start. This is Sharon, and then I'll ask Andy, to chime in. Yes, if 4 2 is positive, then, of course, 402 will be used in the application. The as you know, we, we have a 3 pronged we have a very broad strategy as to our filing. But what you said is correct, but Andy, do you want to add anything?
Speaker 4
Yes. No, Charles, hi, Andy. Thanks for the question. You're right. There hasn't been change overall in our strategy.
So we are planning to speak to FDA with regard to the possibility of a filing based on a single your single study with supportive data, and we'll also be awaiting the results of the 402. And those are the different prongs of our strategy this point.
Speaker 7
So actually 3 prongs. Appreciate you taking the questions and the added color. Congrats on the recent progress. I'm persistent.
Speaker 6
Our next question comes from Jessica Fye with JPMorgan.
Speaker 8
And if not, do you plan to wait until after or you get the results from 4 2 to have that discussion?
Speaker 2
So, Jessica, we didn't hear you. We just heard the very end of what you were saying. So I think Oh, sure.
Speaker 8
Let me let me repeat that. Yeah.
Speaker 2
Yep. Have have you met with
Speaker 8
the FDA already to discuss the possibility of filing based on the positive results from Study 404. And if not, do you plan to wait until after you get the results from 402 to have that discussion?
Speaker 2
Andy, do you want to answer that or you want me to?
Speaker 4
Yes, no, that's fine. Hi, Jessica, it's Andy. So we have not yet had these discussions with FDA, but the timing is not dependent on our having the results of 4 or 2.
Speaker 6
Great. And
Speaker 8
just as a follow-up question, just curious if you could elaborate on whether you think the lack of need for titration could be helpful in the current environment where patients are maybe trying to minimize their interactions.
Speaker 2
Andy's shaking his head. Yes. I see him. Andy, why don't you go ahead and then, Mark, if you want to answer?
Speaker 4
Well, I think the lack of need for titration is definitely an advantage and we've already heard that from psychiatrists who are there treating patients in both before and now after the launch, as well. So I think anything that does facilitate the ability to use this drug safely and effectively is going to be an advantage in any environment, including this one. I don't know, Mark, have you heard anything more about that?
Speaker 3
Yes. No, we've actually heard comments very similar to what Andy just described that in this environment having the single dose and being able to start at the effective dose is being viewed as a positive. But I think across the board, whether we're in this type of environment or not, as Andy said, we do view it very much as a benefit for patients.
Speaker 6
Thank you. Our next question comes from Bo Chen with Evercore ISI. Your line is now open.
Speaker 9
Hi, thank you for taking our questions. We'd like to focus on the adjunct trial. First question is based on the pandemic situation, should we expect that the patient follow-up will mostly be through teleconference or for interview? And if so, how would that add any variability in the primary endpoint assessment? And also related to this trial is what should we expect on the placebo effect?
Thank you.
Speaker 2
Andy, do you want to take that? But I'll give you the overall statement and that is that so far, we haven't been very it hasn't been affected very much at all. The 402 study. We've been very fortunate there, but for the particulars about what you're asking, I'll ask Andy to give you the update?
Speaker 4
Yes. Yes. So Sharon's absolutely right. We've really seen very little impact to this point on the conduct or for completing Study 40two. So as you know, we completed, the clinical portion in the U.
S. The remaining, clinical portion of the study is in Europe. We did allow for flexibility based on the FDA guidelines in case there was a need to do that in order to be able to complete the trial with good data integrity as well as good patient safety. But as Sharon says, what we've seen so far is very little need to use that flexibility. So vast majority of visits are still being done as they were before.
We don't anticipate any issue with that. And then we are on track as we've said before, to complete this trial and be able to provide, top line results by midyear. And with regard to Placebo effect, we don't think that there's any, again, we're most of the trial is complete. We don't think that there's any impact of the current environment or any changes that may occur from here to the end of the study that could have any impact on that.
Speaker 9
Thanks a lot. Just for the second part of the question, we're not trying to compare or get any estimate of the impact from the pandemic, but also in but just in general, what's the placebo effect we should expect compared to the 2 finished in monotherapy trials?
Speaker 2
Yes. So,
Speaker 4
you know, we had a very high placebo response in Study 401, which therefore, was not a successful trial and the placebo response was managed quite well in Study 404, which was positive. We think that, the there are a number of aspects of Study 40two, including the global, distribution of the study, that are in favor of having a well controlled placebo response We have no reason to have any additional concern about that. So and in other respect, we're adequately powered in Study 40two for a range of outcomes and to be able to detect the clinically meaningful results. So we don't think that there's a we're not concerned about you there.
Speaker 9
Our next
Speaker 6
question comes from Sumant Kulkarni with Canaccord. Your line is now open.
Speaker 10
Good morning. Thanks for taking my questions. The first one is on the bipolar depression trial and then I a follow-up. So on bipolar depression, is it fair to assume that you will wait until you have the results of the global adjunct therapy trial before we put in a request to speak with the agency on a path to an SNDA filing. And do you have any specific expectations on when that meeting might occur?
Speaker 4
So, no, as I mentioned before, the 2 are not dependent on each other. We are still planning to meet with FDA again to discuss the potential for filing under a number of different scenarios particular with a single positive trial in supportive data, and that we're moving ahead with that.
Speaker 10
And then a question on the commercial front for Mark, it's a bit of a big picture question. So do you think this environment levels the playing field more for a relatively small company and we see any fundamental long term changes in the classic therapeutic sales and marketing model, especially in the neuropsychiatric space that lends itself relatively well to telemedicine?
Speaker 3
Yes. Thanks, Sumant, for the question. Yes, the as Sharon mentioned, this environment has caused a lot of changes in the healthcare industry as well as in our own industry. We successfully converted many of our selling activities in our medical education activities over to virtual platforms. And in some ways, on the medical education side, we're actually able to attract even a larger audience for these programs because they are being done virtually than we would have in a more traditional environment We've also had the opportunity to really expand in a variety of areas and a variety of tactics.
The non personal types of promotion through digital means that we may not have done in our original plan. I do think, Sumant, too, that when companies are faced with this type of a challenge, it is important to be able to be nimble and adapt and be creative and innovative. And I think that will carry through even beyond this pandemic situation as the country begins to reopen. As things begin to return to normal, I'm sure there's going to be, approaches that we creatively took during the pandemic that will continue even when we get back to more normal types of operating procedures. Got it.
Thank you.
Speaker 6
Thank you. Our next question comes from Mark Goodman with SVB Link.
Speaker 11
Yes, good morning. Mark, can you talk about, just schizophrenia patients in general in this environment? Are we seeing as many starts virtually as you expected? I mean, trying to get a sense for, how much this environment has really impacted, what your expectations were kind of going in and if you think about like all doc programs that you were expecting to do, in person, for instance, and now they're virtual is the participation level the same? Is it significantly worse better?
Just trying to get a sense for the reaching out and how much you're touching the doctors is well. And, give us a sense of, of whether the patients that are starting on Caplide, are these switches, are these new patients, maybe just a little more color, if possible, on what's happening behind the scenes? Thanks.
Speaker 3
Yes. Thanks, Mark, for the question. And I'll try to answer it the best I can. What I would say across all of the that you asked is we are in very early days of the launch. We have been out there for about a month now.
Don't have a lot of data yet coming back in on the types of patients that we're seeing. We are getting some anecdotal information in the market research that we are doing with those prescribers who have had the opportunity to prescribe Kaplida. And as Sharon mentioned, before, we do believe that really any physician and any patient looking to switch is an opportunity for them to be considering Caplide on. So we're seeing across the board different types patients being tried on Caplida. As it relates to the programs and our interactions, with physicians.
As I mentioned before in the last question, I think one of the silver linings in this situation is we are actually attracting a larger audience to these virtual programs than we would have expected if these were being done in person in cities around the country. So our reach from a medical education perspective has been even better than we were in more of a traditional environment. And as far as the overall schizophrenia patient physician interaction. I think what we've read has been consistent with what we've heard is that overall there are fewer in patient in person patient visits, that's being offset to some degree by the increase in telepsychiatry. But I think across the board, across different categories, including the antipsychotic category.
There are fewer new to brand prescriptions in the early going here. We would expect that as the country begins to reopen as our operations, including our Salesforce operations, normalize, we would expect to see an acceleration in those prescription And as I mentioned in my prepared remarks, we don't see any negative impact on the long term potential of Caplata.
Speaker 11
Are there plans to do DTC on the television?
Speaker 3
We are looking at that and we're considering that as part of our marketing mix.
Speaker 11
Thanks.
Speaker 6
Thank you. Our next question comes from Brian Abrahams with RBC Capital Markets. Your line is now open.
Speaker 12
I guess first off, I'm curious how providers have been virtually monitoring for side effects for patients on existing antipsychotics to potentially find patients eligible to switch to Caplida and what's been the perception there for overall of the potential efficacy profile? And then I had a quick follow-up. Thanks.
Speaker 2
Mark, do you want to take that? I think we addressed this in part before, but may expand.
Speaker 3
Yes, let me start with the second part of the question first. The feedback that we've received, again, with the market research that we've done with the early adopters is, it is still very early on in the process but they are satisfied with the efficacy that they are seeing in the patients that they've been able to try this on. And again, that would be consistent with what we would have expected from the marketing research. And as far as monitoring of the side effects, Again, there's a variety of ways in this environment that patients are being seen by the physician. Some continue to do in office visits, while others have switched to telemedicine.
We haven't gotten a lot of feedback on that other than to say that the telemedicine, the telepsychiatry has been working very effectively and providers can monitor any side effects that the patients are having that might require a switch It seems as effectively through telepsychiatry as they could within person visits. But again, this is all anecdotal And for us very early on in the launch, so we hope over the next couple of months, certainly to have a lot more useful data that we could share with you, but that's what we're hearing at this point.
Speaker 12
Got it. Maybe I could actually just clarify the latter part of my question. I know you guys have talked about positive feedback from physicians who have experienced with Capline. I guess I was wondering if you're seeing what the overall perception among physicians who maybe had not used the agent yet? Are there, I know there's been some back and forth in literature, are there is there a perception that there may be efficacy, any efficacy trade offs for some of the improved safety profile?
Are there any skeptical physicians out there that take additional education around the robustness of the data to prescribe the agent.
Speaker 2
No, I would I would remind you, this is Sharon, and I'll start and I'll turn it over to Mark, end to Andy. But I would remind you that our approval was based on the efficacy and safety seen with KepalaIDA in 2 positive studies. And the FDA has deemed this an effective product. And that is what the FDA remarks on, on products that they approve in this area. And our side effect profile, again, as demonstrated in the label, has been a very favorable side effect profile.
So, so the short answer to your question is, no, we're not, we're not seeing anything like what you have suggested. And Mark, do you want to comment more or Andy, do you want to comment more?
Speaker 3
I would just reinforce what you said and say that it's certainly in our market research before the launch and nothing has changed that view since the launch and the feedback that we've been getting from our sales representatives. When we ask them receptivity to the message. And that is, all of the antipsychotics are generally considered to be efficacious and similarly so. And it just depends. There is patient to patient variability.
And there's been nothing that we've heard back from our sales representatives that would indicate that physicians have any kind of concern about the efficacy of KepalaIDA. As I mentioned, they are very much seeing the differentiated safety and tolerability profile and seem to have really been pleased with the single dose where they can start at the effective dose and maintain the patient on that same dose.
Speaker 12
That's great. Sounds like great receptivity. One quick follow-up. Any expected inventory build or other staggered buying patterns just to be aware of as we model the quarterly cadence of the throughout 2020. Thanks again and
Speaker 4
congrats on all departments.
Speaker 3
So Sharon, I'll take that. Yes, I wouldn't expect anything out of the ordinary you've seen our first quarter results, which is largely the initial stocking of the wholesalers the supply chain in our industry has become very efficient and product flows very effectively from manufacturer to wholesaler. And then as to pharmacies where most pharmacies, certainly within 24 hours, can get product whenever they have patients who come into the pharmacy and need to be filled. So to answer your question, no, I wouldn't expect anything unusual.
Speaker 4
Thanks again.
Speaker 6
Thank you. Our next question comes from Andrew Siegel with Jefferies. Your line is now open.
Speaker 9
Thanks. Good morning and glad to hear that everyone's seeing well. So first question is just prescribing dynamic so far. Can you speak to just how much sampling is going on and what percentage of scripts coming in are being blocked by payers. Maybe just speak to that dynamic a little bit.
And then second part of my question is really just what in terms of a long term drivers, longer term drivers for second half twenty twenty or even twenty twenty what do you think it'll take for Scripps to inflect just a little bit more? What more needs to be done on your end? Is it DTCS? Is it more marketing? Is it more calling?
Yeah, if you can just speak to the drivers a little bit,
Speaker 4
that'd be very helpful. Thank you.
Speaker 2
I'm not sure any of us captured all of them. I would just start by saying, We don't expect, payers to block, scripts. However, again, we're very early in the launch So, I think right now, we're not commenting on that. And then for the other questions, since I would turn, I think, over to Mark for the answers.
Speaker 3
Yes. And so maybe, maybe just a follow on Sharon's comment about the payers, as we both mentioned in our prepared remarks, we are very pleased with the progress that we're making with payers and the coverage determination outcomes. And we highlighted Medicare Part D where we have 90% of the covered lives now have access on formulary to Caplida. And the other channels we expect, it's going very much according to plan as we expected it would. In addition, what I would say where there are prior authorizations in place.
We have an industry leading reimbursement support program that can be utilized by physicians and their staff to help navigate that process. But as Sharon said, very early on in our launch. It's too early to tell any kind of patterns or have any kind of useful data. Associated with that, but we have been pleased with the progress that we're making on the access side. From a sampling perspective, I guess what I would say there is In this environment, it has caused us to adapt and be creative in how we get samples to physicians they can provide them to patients.
And I would just say that regardless of whether the physician continues to practice in their office or they're participating from their home remotely in telemedicine and regardless of whether patients are coming in in person or patients are taking advantage of the telepsychiatry, we have procedures in place that allow us to get samples to the physician and for them to be able to distribute that to the patient. So we have innovated our way through that process. I think the last part of your question was, as we proceed through the year, what more will it take? I think with any new product launch, it is a matter of raising awareness, communicating an effective message. And providing the kind of programs where physicians can be appropriately educated on CAPLIDA as what the benefits are and the types of patients that they may want to consider Keplyta in.
And I would just say we have a full marketing mix where right now in the pandemic environment, as I mentioned, we are in a virtual environment for our sales force, a virtual environment for our medical education, as the company as the country begins to reopen. And as our field force begins to normalize once again, I think the interactions with physicians will return to normal levels. And I think that will contribute to what we believe to be will be an acceleration of further acceleration of the prescription performance. So I hope that answers your question. If there was a part that we didn't answer, just let us know.
Speaker 9
Thanks for the color. It's perfect.
Speaker 6
I am not showing any further questions in the queue.
Speaker 2
Well, okay. Then I would just, thank everyone for participating today, on our call. And we look forward to updating you. And we hope that, during these challenging times, everybody remains safe, remains healthy, and, and that we return that our country returns to a new normal as soon as possible. So thanks everybody.
Operator, you can now disconnect.
Speaker 6
Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.