Q2 2023 Rhythm Pharmaceuticals Inc Earnings Call
Unknown Executive: Good day, and thank you for standing by. Welcome to the Rhythm from a shirt of Close's Q2, 2023 earnings conference call. At this time,
Unknown Executive: At this time, all participants are in a listen mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press TAR-1-1 on your telephone. You will then hear an automated message advising that your hand is raised.
Unknown Executive: To withdraw your question, please press TAR-1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Dave Connolly, Executive Director of Investor Relations and Corporate Communication. Please go ahead.
David Connolly: Thank you, Bella. I'm Dave Connolly here at Rhythm Pharmaceuticals of the world. For those of you participating in the conference call, our slides can be accessed and controlled by going to the investors section on the investors page of our website at ir.rhythmtX.com. This morning, we issued a press release that provides our second quarter, 2023 financial results and a business update, which is available on our website. As listed here on slide two, our agenda.
David Connolly: Here with me today in Boston are David Meeker, chair, chief executive officer, and president of Britain Pharmaceuticals; Jennifer Chen, executive vice president, head of North America; Hunter Smith, our chief financial officer; and Jan Mazabro, executive vice president, head of international, are on the line joining us from Europe.
David Connolly: And on slide three, I'll remind you that this call contains Remarks Concerning Future Expectations, Plans, and Prospects, which constitute forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in our most recent annual or quarterly reports on file with the FCC. In addition, any forward-looking statements represent our views only as of today, and they should not be relied upon as presenting our views as of any subsequent date. We specifically disclaim any obligation to update the Materials.
David P. Meeker: to update such statements. With that, I'll turn the call over to David Meeker, who will be going on slide five. Thank you, Dave, and good morning. Thank you all for joining us today. Q2 was a very good quarter. So we're going to dive into the details behind the quarter in our presentation, but before we do that, let me try to put these results in a larger context. We recognize, and we think all of you recognize, that Rhythm has two main drivers of value creation: BBS commercial execution and HO clinical development.
David P. Meeker: On top of that, we have a number of additional efforts that offer potential upside that may be significant. The fundamentals, which we have discussed multiple times, are strong. The biology is well understood. Impairment in signaling through the MC4 pathway leads to hyperphasia, that uncontrolled hunger that stems from not getting a signal that you are full, coupled with a decrease in energy expenditure, which all leads to obesity.
David P. Meeker: The community is increasingly recognizing that not all obesity is the same, and that patients with impaired signaling through the pathway have a distinct disease which requires a specific approach. Moreover, the unmet medical need is clear. Treatments for patients with general obesity may have some effect in individual patients. For example, my craving for ice cream may go down on a GLP1, but I have not addressed the fundamental problem. Impairment in MC4 pathway signaling leads to a decrease in the endogenous hormone alpha melanocyte stimulating hormone. Semulantite is an analog of alpha-MSAH.
David P. Meeker: We are precision medicine that happens to be a hormonal replacement. Why wouldn't you replace the hormone if there were a death? Three, our drug works. Approved for multiple genetic diseases and with strong proof of concept data for hypothalamic obesity, we are now increasingly seeing the real world effect. Patients are choosing to go on treatment and are largely staying on treatment. So now to the quarter. We are one year post-approval for BBS in the U.S. We have discussed each quarter whether we can trend the quarterly-on-quarter script numbers, and I'm sure we will again today. The answer will be the same.
David P. Meeker: No, don't trend the quarterly-on-quarter numbers, but you can look at a full year now of data and conclude BBS is evolving into a very meaningful rare disease opportunity. The patient community is engaged. The number of doctors writing scripts continues to grow. The payer community is listening and recognizing this is a unique rare disease and not simply an extension of the population of patients living with general obesity. The teams are executing, and our confidence is growing. We hope yours is growing as well.
David P. Meeker: We're making good progress on our phase three study for hyperphalamic obesity. We have moved up our timeline for completing enrollment to the end of the year, based on good progress getting sites up and going. I wish no one took so many vacations, but the patients are there and waiting.
David P. Meeker: Our six-month long-term extension data show continued reductions in BMI at six months, and we look forward to updating you on the 12-month data in the fall. I will speak briefly about our Phase 2 long-term extension data and present a couple of slides. Finally, we have a number of trials reading out in the second half of this year with daybreak, pediatric, and weekly switch studies. We will highlight these results at an upcoming R&D session in Q4 of this year.
David P. Meeker: And we are excited to introduce you to our next generation program, RM718, which I will discuss in slide 6. RM718 is a more specific and potentially more potent molecule. It is MC4R specific in its targeting. It does not hit MC1R and therefore eliminates the hybrid pigmentation effect we see with MC1R agonism.
David P. Meeker: And it is a weekly formulation with patent protection out to 2041. We are preserving the option of continuing with our current weekly program, but we will push out the initiation of the weekly study into 2024 when we will make a final decision on our weekly strategy pending further development with 718. Our goal, quite simply, is to develop a better drug which happens to come with significantly longer patent protection. We look forward to providing more details about the upcoming R&D Day. So on slide seven, slide seven is to remind you of the overall opportunity. We started small with POMC and LEPR.
David P. Meeker: BBS and HO represent meaningful rare disease populations with the major advantage being they can be diagnosed more easily. And the HO population, as you know, is largely diagnosed today. On top of that, a significantly larger world potentially opens up with the M&A trial population.
David P. Meeker: Moving to slide 8. We remain laser focused on getting our global phase three trial up and running. As previously discussed, the challenge was not patient interest but clinical trial site bureaucracy. We are breaking through all of that with one-third of the sites open and about a quarter of the patients screened. Screening is a good indicator because very few patients screened fail.
David P. Meeker: The physicians have their lists of patients, they know the entry criteria, and they invite patients to participate accordingly. Based on our progress to date, we are moving up our targeted enrollment completion date from Q120. On slide 9, we remind you of the six-month data we presented at Endo, which shows continued BMI reductions over time in the majority of patients. The blue bars represent the 16-week data, and the red bars represent the six-month data.
David P. Meeker: On slide 10, we have the summary of this data, and you can see the mean change for the 11 pediatric patients moving from minus 18% at 16 weeks to minus 22% at six months. The two adults, we broke out separately with one patient moving from minus 14% to minus 21%, and the other patient who was up and down on our drug dose, gaining as the dose was decreased and losing again as the dose was increased.
David P. Meeker: She has now again lost approximately 10%, at 6%. So on slide 11, I'll finish my section on this slide, which shows an increasingly robust portfolio indications which are progressing. More to come later this year on our pediatric program, weekly program, and day break open-label results in the 12-month data from the H.O. patients in the long-term extensions. I'll now turn the call over to Jennifer. Thank you.
Jennifer L. Chien: We are now one year into our BBS commercial launch firm, Sivry, which was approved by FDA in June 2022. We are very pleased with how the launch has progressed, and I am proud of the team for all we have accomplished. And, most importantly, Sivry is now making a positive impact on the lives of hundreds of patients and families in the United States. Now beginning here on slide 13.
Jennifer L. Chien: Throughout the year since launch, we have heard from many patients with BBS who have benefited from inscivious therapy. Just last week, we hosted a patient summit in our office to formally launch our patient ambassador program. We welcomed eight patients and or their caregivers, all who are active participants in our live or virtual speaker program, designed to continue building the BBS community and offer peer-to-peer support. Hearing and learning from other patients with BBS or their caregivers can be tremendously powerful, as each patient and family is on their own journey with BBS and emissivary therapy.
Jennifer L. Chien: On this slide, you see a picture of Catherine, who was diagnosed with BBS when she was six years old and struggled throughout her teens and early 20s with hyperphasia, that pathological hunger that leads to abnormal food-seeking behaviors and severe obesity. She tells us how she was hungry all day long and snuck food every night.
Jennifer L. Chien: Now at age 28, having been on end uprovery since last September, that hunger no longer, through her words, consumes her energy, and she is able to enjoy life more. She learned about MCIVERI through our digital, non-personal promotion efforts, attended one of our programs to learn about MCFRI, and began participating in our in-tune patient support service program. Almost one year in, she tells us how she is sleeping better, able to focus more and participate in a number of activities, and is currently writing a book about her experiences. She is a remarkable young woman, a truly inspiring and powerful advocate, and we are very grateful to her and others who continue to share their stories and voices.
Jennifer L. Chien: Next slide. Our experienced teams continue to execute at a high level, and we couldn't be more pleased by all the progress we have made throughout this first year of operations. We are seeing strong, continued demand for emphyry, the first and only approved precision medicine for BBS patients with hyperphasia and severe obesity.
Jennifer L. Chien: Throughout the launch from June 16, 2022, through the end of the second quarter of 2003, we now have received more than 425 new BBS prescriptions, which includes robust growth through the second quarter when we received more than 125 prescriptions. In addition, more than 250 physicians have written prescriptions, and we have received approval for reimbursement for more than 250 prescriptions. We continue to identify more BBS patients and work to speed diagnosis.
Jennifer L. Chien: Physicians continue to recognize the benefits of misdivry and prescribe it for their patients. Additionally, additional patients continue to initiate and maintain on insivary and pay or see the value and differentiation of insivary as they approve reimbursement. Moving to the next slide with some details on physicians who are writing slippery prescriptions, the specialty breakdown remains consistent with what we reported at the end of the first quarter of this year.
Jennifer L. Chien: Launched to date, endocrinology, both pediatric and adults, remains the top specialty at a combined 45% since launch, while pediatricians and general or primary care combined come in at just under 40%. Also, the portion of new to rhythm prescribers, or physicians or territory managers that we had not previously called on directly prior to prescription, accounts for about 26% of our prescriber base. This continues to give us confidence in our non-personal promotion efforts as an effective supplement to our field team by educating a broader physician and patient population.
Jennifer L. Chien: Lastly, on prescribers, since launch, more than 25% of them have written two or more prescriptions, which is a growing percentage of repeat prescribers. This is our goal to have greater breadth in prescribers over time, as well as more and more ACPs who identify additional patients and prescribe because they see the value of insulin for their patients through their own experiences. Next slide.
Jennifer L. Chien: On access and reimbursement, last quarter we shared a similar slide during the breakdown of states where we've had success on MCFRI Medicaid coverage, as well as those we have not had success, based on covered lies. I'm pleased to report that we have seen incremental improvement in gating access over the last quarter. According to Medicaid, there are approximately 85 million individuals enrolled in Medicaid in all 50 states, plus Puerto Rico and the District of Columbia.
Jennifer L. Chien: Laws to date, approximately 80% of Medicaid-covered lives are in states with a positive and slippery policy in place, or in a state where we have been able to get at least one positive coverage decision in the absence of an insolvency policy.
Jennifer L. Chien: The remaining 20% of Medicaid lives represents a mix of states in which we either have not yet had a prescription for Sivry that would trigger a coverage decision, or we are still working to secure access to a prescription, or, finally, where we have not been successful in gaining access through the appeals process. This marks a 5% shift in our favor over last quarter, where we reported at 75, 25% breakdown. Additionally, the pair mix for BBS does remain consistent as almost 90% of prescriptions since launch fall under commercial or Medicaid plans. The average time frame for approval is approximately one to three months, with some tails extending out several months, consistent with our previous report. Overall, we are pleased with the achievements to date and securing approval. Next slide.
Jennifer L. Chien: Here are some details on patients with BBS, with prescriptions, and on drugs. Adults now account for approximately 54% of prescriptions received for a long time. This speaks to an opportunity identified up front. In the Crows Registry, we knew approximately 80% of participants were 18 years of age or younger, which is not representative of the age distribution of the overall BBS population.
Jennifer L. Chien: We believed many older patients may have been lost to follow-up or lost in the system. So we put plans in place to find them through non-personal promotions, educational webinars, engagement with the BBS Foundation, and more. Catherine, the woman on my opening slide today, is a prime example of this.
Jennifer L. Chien: She found us with a little digital help after Amcifery was approved. Lastly, on access, and this becomes more important as we look ahead to the coming quarters, is our reauthorization rate. While the majority of the reauthorization decisions are made at 12 months on therapy, some plans do have three or six-month reauthorization requirements. We are very pleased to report that since launch, we have seen 50 reauthorization approvals with only one patient who did not meet criteria. This was a patient who was not compliant with his medications.
Jennifer L. Chien: The next slide is my final slide on patient identification. With our growing confidence in the need for a targeted therapy like MCFRI and the benefit it can provide, we remain focused on educating the community to find already diagnosed patients while expediting the identification of individuals with BBS who do not yet have a diagnosis. Our efforts over the last several quarters have shown to be effective, and we continue our engagement with all key stakeholders, along with our overall community building efforts. We are excited about our progress over the last year and the opportunities we have ahead of us. With that, I'll hand it over to Yon.
Yann Mazabraud: Thank you, Jennifer, and good morning. Slide 20.
Yann Mazabraud: I will start with a reminder that Europe is a key market for rare diseases and for rhythm. As we have spoken before, European countries typically are better organized for rare diseases and more centralized in their approach to care than the United States. With single-payer healthcare systems, government-funded genetic testing, more established networks of experts and referral patterns, multiple centers of excellence, and patient advocacy groups. Even though these diseases are quite rare, the opportunity is meaningful for us in both Poncillipar deficiencies and Bardi Bardie syndrome.
Yann Mazabraud: In the EU4 plus UK, we estimate the prevalence for Biali Polypsi and Lipar to be between 6,500 patients, and we have identified approximately one of the patients being cared for in these countries. For Barbabilis syndrome, our estimated prevalence in the EU4 plus UK is 4,000 to 5,000 patients, which is a prevalence similar to the US, and we have already more than 1,500 patients identified in this country. With our growing international team, we remain focused on identifying more patients and continuing to collaborate with country level authorities and centers of excellence to gain reimbursement and access for these patients.
Yann Mazabraud: Overall, on a global level, the series is now available in more than 10 countries outside the United States. We are now approved and available for both POMCilipar and BBS in Germany. In France, we are available for these same indications under a paid early access program. We also have full coverage for InSivory for POMC and Lipar in England, Italy, and the Netherlands, and we are dancing with pricing negotiations for BBS in the UK, Italy, Spain, and the Netherlands, with BBS launches planned in Italy and Spain for this year, and in 2024, in the UK and in the middle. We also have achieved Nampician cells in Spain, Austria, Turkey, the United Arab Emirates, and early access in Argentina, and we have initiated reimbursement processes in Belgium and the Nordic countries. Next slide.
Yann Mazabraud: Lastly, an update on our launch for BBS in Germany, where the GBA, which is the German Federal Joint Committee, did recognize the fact that inceivory is precision medicine, excluded emceivory with an anonymous vote from its lifestyle exemption list, and made it eligible for full reimbursement by the statutory health insurances for patients with BBS and PPSPCSK1 and Lipar deficiency. Our launch in Germany, which kicked off in late April 2023, is off to a strong start, and our focus remains on collaborating with leading experts to educate the physician community on the MC4 pathway and overcome the typical German physician's conservative mentality when it comes to new drugs.
Yann Mazabraud: Patient identification also is a key focus. We estimate that the prevalence of BBS in Germany is approximately 1,200 patients. We believe that there are about 800 patients diagnosed, and of those 800, we have identified physicians caring for more than 250 of them, and we are focused on identifying more. Our physician engagement and MC4 our pathway education efforts are focused initially on major university hospitals across the country, and we have already received many prescriptions from several of them.
Yann Mazabraud: Lastly, similar to the Rhythm-Inchune patient support program in the United States, we have a new patient support program in Germany called Rizm at Home. This program is tailored to each patient, designed to educate patients and caregivers to set expectations for in-scribery and to maintain adorn.
Hunter C. Smith: With that, I will turn the call over to Hunter.
Hunter C. Smith: with robust demand for insulin in the United States and our growing international business. Our focus remains on building long-term value for our shareholders through excellence and execution alongside a strong commitment to financial discipline.
Hunter C. Smith: Here on slide 24 are the highlights of the Q2P and L. Rhythm recorded 19.2 million in net product revenue in the second quarter versus 2.3 million during the same quarter last year, an increase of 16.9 million. We received FDA approval for BBS on June 16th last year, at the tail end of Q2, so that quarter preceded the BBS law. On a sequential quarterly basis, product revenue increased by approximately 7.8 million, or 68%, over the first quarter.
Hunter C. Smith: The primary driver of this growth was the increase in reimbursed BBS patients on MCBRI therapy in the United States. In addition, inventory at our specialty pharma partner increased, both due to the larger number of patients on therapy and an increase in days on hand. Days on hand began Q1 at a lower-than-normal level of five days and ended Q2 at a more normalized level of 12 days.
Hunter C. Smith: This impact contributed $1.6 million to Q2 revenue. Gross to net for U.S. sales improved slightly quarter over quarter to 85% versus 83% in the first quarter; growth in international sales contributed approximately 0.8 million to quarter over quarter, and while the German launch began late in the quarter, it began to have more of an impact in the future. Cost of goods sold during the first quarter was 2.2 million, or approximately 12% of net product revenue, representing a slight decrease versus Q22, as well as versus Cost of sales consisted primarily of product cost and 5% royalty duty under our original licensing agreement for sent melanotide, as well as amortization of previously capitalized sales-based milestone payments.
Hunter C. Smith: R&D expenses were 33.5 million for the second quarter of 2023. This compares to 31.5 million during Q22. Compared to 37.9 million in the first quarter of this year, there was a decrease of 4.4 million.
Hunter C. Smith: Most of this decrease was driven by the 5.7 million in one-time costs and fees associated with the Shinvento acquisition recognized in the first quarter. There also was a decrease of 2.8 million associated with a reduction in CMC expenses, given the shift to commercial products. These decreases were partially offset by increased clinical trial expenses of $1.8 billion and expenses of $1.3 million related to our RM718 programs. SG&A expenses were $30 million for the second quarter this year versus $22.3 million for the second quarter of 22.
Hunter C. Smith: On a sequential basis, SG&A increased by $5.4 million versus Q123. This increase was primarily due to an increase of $2.4 million in U.S. marketing spend, as well as a $1.9 million increase in stock compensation. For the second quarter, the common share is outstanding worth 56.7 million in quarterly net loss per share with 82 cents. Turned to slide 25.
On the $19 2 million in reported revenue of 86% of revenues were generated from sales of <unk> in the United States, a slight increase from the 83% of net revenues in Q1.
Hunter C. Smith: We closed the second quarter of 2023 well capitalized with $24.4 million in pro forma cash on hand. This amount includes the anticipated net proceeds of $24.4 million from the third and final tranche of our health care royalty financing agreement with health care royalty partners. This cash on hand is sufficient to fund all planned activities into 2025. Of the 19.2 million in reported revenue, 86% of revenues were generated from sales of MCI in the United States, a slight increase from the 83% of net revenues in Q1.
International sales growth continues to be robust, albeit from a smaller base than the growth rate of <unk> sales in the U S.
But none of our international markets that full reimbursement for Bbs throughout Q2, Germany's first full quarter of launch as Q3.
Q2 operating expenses included total stock based compensation of $8 9 million as compared to $1 $6 4 million in the first quarter of 'twenty three the quarter over quarter increase was primarily due to recognition of stock based compensation associated with company performance Awards.
Hunter C. Smith: International sales growth continues to be robust, albeit from a stronger, smaller base than the growth rate of emcivary sales in the U.S. Of note, none of our international markets have full reimbursement for BBS and throughout Q2, Germany's first full quarter of launch is Q3. Q2 operating expenses included total stock-based compensation of $8.9 million as compared to $6.4 million in the first quarter of 23. The quarter over-quarter increases were primarily due to the recognition of stock-based compensation associated with company performance awards. Finally, our non-gap operating expense guidance for 2023, which we initiated last quarter, remains unchanged at $220 million. This guidance excludes the non-cash impact of stock-based compensation.
Finally, our non-GAAP operating expense guidance for 2023, which we initiated last quarter remains unchanged at $200 million to $220 million.
This guidance excludes the noncash impact of stock based compensation with that I'll turn the call back over to David.
Thank you Hunter.
As you hopefully have.
<unk>, we're really excited about the progress we're making on slide 27 highlights that we have a lot coming up and we look forward to updating you on those events and subsequent calls and our last slide 28, simply a reminder of our strategic priorities, which remain unchanged and we will continue to focus on execution.
That will open the call up for Q&A.
As a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced.
David P. Meeker: With that, I'll turn the call back over to David.
David P. Meeker: Thank you, Hunter, and as you hopefully have heard, we're really excited about the progress we're making. Slide 27 highlights that we have a lot coming up, and we look forward to updating you on those events and subsequent calls. And our last slide, 28, is simply a reminder of our strategic priorities, which remain unchanged, and we will continue to focus on execution. With that, we'll open the call up for Q&A.
To withdraw your question. Please press star one again.
Please limit your questions to one and one follow up only thank you.
Goodbye.
<unk> roster.
Okay.
Perfect.
And our first question comes from the line of Dave Euro with TD Cowen. Your line is now open.
Good morning, guys. Thanks for taking our question I'm Davita on for Phil.
Two for Mark one on DAYBREAK.
Unknown Executive: As a reminder, to ask a question, please press Tar-1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press Tar-1-1 again.
Could you provide any color on the scope of the presentation, that's coming in the second half maybe like how many cohorts that.
Unknown Executive: Please limit your questions to one and one follow-up only. Thank you. Please stand by while we'll compare the Q&A roster. Thank you. And our first question comes from the line of Diviora with T.D. Coyne.
Do you expect to present and also patients per cohort.
Yes, I think so the DAYBREAK is repeat what I said earlier this will only be the openly the open label results. The blinded randomized withdrawal portion is ongoing what I anticipate is we'll report out on a probably on the order of four to five.
Unknown Executive: with T.D. Cohen. Your line is now open.
Unknown Executive: Good morning, guys. Thanks for taking our question. I'm Didia from Spurf. So just two from us, one on daybreak. Could you please provide any color on the scope of the presentation that's coming in the second half, maybe like how many cohorts that you expect to present and also patients per cohort?
Different genes again, not all of those genes necessarily will be ones, where we've seen a positive result come we'll report out on those where we think we've got enough data to conclude either its working or not working at some level.
The number of patients per gene cohort again, it's highly variable as you might expect in this kind of basket trial again I would like to think we'll be in the range of 10, plus or minus patients for the genes that we report out.
David P. Meeker: Yeah, I think that's it. So the daybreak, as I'm going to repeat what I said earlier, these will only be the open label results. The blinded, randomized withdrawal portion is ongoing. What I anticipate is we'll report out on, probably on the order of four to five different genes. And again, not all of those genes necessarily will be ones where we've seen a positive result. We'll report out on those where we think we've got enough data to conclude.
That's helpful. And then just one more question for Mike.
Sure.
In terms of the number in terms of the patients who have yet to be reimbursed.
How many of those are on the free drug program Mbd.
David P. Meeker: Either it's working or not working at some level. The number of patients per gene cohort is highly variable, as you might expect in this kind of basket trial. But I would like to think, you know, we'll be in the range of 10 plus or minus patients for the genes that we report out. That's helpful.
Jennifer.
So we do have a free drug program available for patients.
<unk> would be eligible for the free jobs. They have to go through several steps in terms of.
The reimbursement process.
David P. Meeker: That's helpful. And then just one more question from us: in terms of the number of patients who have yet to be reimbursed, how many of those are on the free drug program in BV?
To date, the number of patients who are on afraid Jack still remains at approximately 20% of scripts.
And how do you expect that to change.
David P. Meeker: So we do have a free drug program available for patients, but to be eligible for the free drug, they have to go through several steps in terms of, you know, the reimbursement process to date. The number of patients who are on a free drug still remains at approximately 20% of scripts.
And the long term.
To be relatively consistent.
Okay.
So we have made incremental progress just in terms of securing access forums Jeffrey as outlined in terms of the Medicaid question.
And that is a work that is ongoing in terms of growing payer by payer to educate them and differentiate our patient population as well as in <unk>.
David P. Meeker: And how do you expect that to change in the long term? to be relatively consistent. So we have made incremental changes.
The fray.
And we have seen success on that end.
David P. Meeker: So we have made incremental progress just in terms of securing access for MCFRI, as outlined in terms of the Medicaid portion. And that is work that is ongoing in terms of going pair by pair to educate them and differentiate our patient population as well as MCFRI. And we have seen success with that, and, you know, we're not going to give up in terms of those efforts overall.
We're not going to give up in terms of those efforts overall.
Approximately 10% of the scripts are Medicare patients.
Where we do not have access and.
While we are still investigating potential options in terms of opening up access for those patients that would be a longer term type of.
David P. Meeker: All, you know, approximately 10% of the scripts are Medicare patients where we do not have access. And, you know, while we are still investigating potential options in terms of opening up access for those patients, that would be a longer-term type of ongoing dialogue with CMS and patients. And I would say that in terms of commercial patients, the ones that are on our free drug program, similar to other rare disease therapies, coverage from large commercial plans is quite good in terms of reimbursement. It's the smaller, you know, really small self-insured plans that, you know, I think, in general, rare diseases may have difficulty gaining reimbursement for, you know, the cost of therapies.
Dialogue with CMS and <unk>.
And I would say that in terms of commercial patients.
The ones that are on our free drug program similar to other rare disease.
Therapies there are.
Our coverage from large commercial plans is quite good in terms of reimbursement.
Smaller really small self insured plan that.
I think in general rare diseases may have difficulty gaining reimbursement for.
The cost of therapy.
Unknown Executive: Got it. Thank you so much. Thank you, David. Next question. Your next question comes from the line of Derek Archillo with Wells Fargo. Your land is now open.
Got it thank you so much.
Thank you David.
Next question.
Your next question comes from the line of Derek <unk> with Wells Fargo. Your line is now open.
Unknown Executive: Hey, good morning, and thanks for taking the questions. Congratulations on the progress. Just our first question from us, just any updates on the overall discontinuation rates you're seeing within Sivry, I guess across all indications, but maybe Bar-Beedle specifically. And then secondly, I know, you know, the amount of sales currently, OUS, is small and growing, but I guess how should we think about the sales ramp in Germany now that you're there? And just curious, like, is that going to mimic the U. Thanks.
Hey, good morning, and thanks for taking my questions. Congrats on the progress just first question from US just any updates on the overall discontinuation rates youre seeing within sebree, I guess across all indications, but maybe below.
Typically and then secondly, I know the amount of sales currently <unk> is small and growing but I guess, how should we think about the sales ramp in Germany now that youre, there and just curious like is that going to mimic the U S or should it be or should we think about it differently. Thanks.
Yes, Jennifer and discounts.
Jennifer L. Chien: Yep, Jennifer, Disconz.
Overall, we're very pleased with the discount rate.
Jennifer L. Chien: Overall, we're very pleased with the discount rate, which is now approximately 10% of patients have started therapy. There was an incredible amount of cross-functional team effort just in terms of really getting patients through the initial titration stage and through the initial nausea and vomiting, and we have had very, very low discounts from that perspective.
She is now approximately 10% of patients have started therapy. There was an incredible amount of cross functional team effort in terms of really getting patients through the initial titration stage through the initial nausea, vomiting, or we have had very very low discount from that perspective.
Jennifer L. Chien: And I think that there are a variety of different reasons that patients discontinue their treatment, some due to AEs, others for other personal reasons, and we continue to monitor those patients. And some of these patients may be interested in getting back on therapy, you know, as their situations may evolve over time as well.
And I think that there are a variety of different reasons that patients do this con.
Due to Aes.
Others for other personal reasons and we continue to monitor those patients and some of these patients may be interested in getting back on therapy.
Yann Mazabraud: Great, and Jan, you want to comment on the expected German ramp or how you think about that? Sure, sure, thank you. We had a strong start in Germany with
As their situations may evolve over time as well.
Great.
Want to comment on the expected Europe , German ramp or how you're thinking about that sure. Thank you.
Yann Mazabraud: Sure, thank you. We had a strong start in Germany with a very experienced team in the field. It is a bit difficult to project the next quarters. What I can tell you is that first, we did add many prescriptions from several major centers, and that will continue. The second thing is that, back to your questions, we don't expect a fast ramp-up as we had in the US because of the German conservative mindset, but for sure, we have all the signals that will tell us that we will build solid growth in the long run.
A strong start in Germany revisited the experienced team in the field.
It's difficult to project.
First question, what I continue with that since we did that.
Maybe prescription considerable imaging center.
We continue the second thing is that back to your questions. We don't expect a fast ramp up as we had in the U S because of that.
Gentlemen, conservatism.
The mindset, but.
We are all sort of signals that.
Unknown Executive: One moment. And your next question comes to the line of Corian Jenkins with Golden Sacks. Her line is now open.
Our feeling is that we will build a solid growth on the long run.
Perfect. Thank you.
Eric next question.
One moment.
And your next question comes from the line of Karen Jenkins with Goldman Sachs. Your line is now open.
Unknown Executive: Good morning, everyone. Maybe a couple from me. First, just how quickly can you move forward with that weekly formulation you announced today? And should we look for you guys to move directly into a Phase 3 study?
Good morning, everyone.
Maybe a couple from me first just how quickly post IND can you move forward with that weekly formulation, you announced today and should we look for you guys to move directly into phase III studies with.
Unknown Executive: into phase three studies with those assets.
David P. Meeker: So again, the timing of how quickly you move after filing an I&D is dependent on regulatory input, of course. So all we're communicating today is that we're filing the I&D, and we will obviously meet with the regulators and get further input. The strategy for developing the drug, again, all we'll say today is that we will start with a phase 1-2 type of effort, which will be initially in healthy volunteers. I think we have a big advantage here in having developed setmalanotide and understanding the populations we're studying and what needs to be done to successfully get a drug through for these indications. So we'll leverage that learning as we go forward. But step one is pretty conventional with phase one.
With that asset.
So again the timing on how quickly you move after filing the IND is dependent on regulatory input of course. So all we're communicating today is where we're filing the IND and we will obviously meet with the regulators and get further input.
The strategy for developing the drug again, all we will say today is that we will start with a phase one two type of effort, which will be initially in healthy volunteers I think we have a big advantage here in that having developed certain Atlanta tied in.
Understanding populations, we're studying and what needs to be done to successfully get a drug through for these indications. So we'll leverage that learning as we go forward, but step one is pretty conventional with a phase one.
Unknown Executive: Okay. And then in terms of the epidemiology, just overall, what portion of patients would be expected to be adults with BBS versus
Hi, Barry.
Okay, and then in terms of the <unk>.
The DMA allergy just overall what portion of patients would be expected to be adults with bvs versus children pediatric population.
Unknown Executive: Children or the pediatric population.
David P. Meeker: I'll take that. These are the things we know.
Yes.
I'll take that I think.
David P. Meeker: These are the things we know. One is, if you look at the Cribs registry in the U.S., on the order of 80% plus of those individuals were pediatric, that doesn't mean that 80% of the patients are pediatric. It just means that of those patients who stay engaged with the registry, often probably with the help of their families, they're disproportionate. That's number one. Number two, we have been focused disproportionately on the pediatric call point, if you will, so that also would skew us toward perhaps finding more peds.
These are the things we know one is if you look at the Cribbs registry in the U S. On the order of 80% plus of those individuals with pediatrics that doesn't mean to 80% of the patients are pediatric it just means that those patients who stay engaged with the registry often probably with the help of their families. They are disproportional peds, that's number one number.
Two we have been focused disproportionately on the pediatric.
<unk> point, if you will so that also would skew us to perhaps finding more peds whats been really encouraging and maybe then sorry, the last one before I get to the encouraging part is that the these.
David P. Meeker: What's been really encouraging, maybe the last thing before I get to the encouraging part is that these patients don't die. They may die early, the mortality rate. We don't have good, good data on overall life expectancy here, but they certainly don't die necessarily at a young age. And therefore, there's no reason not to expect a significant number of patients who are now adults. And if you look at the population and distribution overall, a quarter of all children, three-quarters adults, What's really encouraging about, you know, the information that Jennifer presented is that we are penetrating to a significant degree that adult population. They're finding us. They want to go on therapy, and they're staying on therapy.
These patients they don't die they may they may die early the mortality, we don't have good good data on overall life expected seat here, but they certainly don't die necessarily at a young age and therefore, there is no reason not to expect a significant number of patients who are now now adults and if you look at the population and.
Overall, our quarter peds three quarter adults, what's really encouraging about the information that Jennifer presented is that we are penetrating to a significant degree of that adult population. They are finding us they want to go on therapy and they are staying on therapy.
Great. Thank you.
Okay.
Good question.
Unknown Executive: Your next question, Counselor on the line is Daggonha, with Steeville. Your line is now open.
Your next question comes from the line of Doug <unk> with Stifel. Your line is now open.
Unknown Executive: Great, thanks very much for taking our questions and congratulations from us as well on a strong quarter. Just looking at the overall strategy as you continue to roll out BBS in the U.S., I guess how much more confidence do you now have about the estimated prevalence of BBS?
Alright, thanks, very much for taking our questions and congrats from us as well on a strong quarter just looking at the overall strategy as you continue to rollout Bbs in the U S.
I guess, how much more confidence do you now have towards the estimated prevalence on Bbs that you initially projected some couple of months ago.
Unknown Executive: that you initially projected some couple of months ago that was realized up and
That wasn't realized up and I guess, given the strong ramp up this quarter I guess, how are you kind of projecting the rest of the year, you mentioned no quarter over quarter trend line drawing but.
Unknown Executive: I guess given the strong ramp-up this quarter.
Unknown Executive: I guess, how are you kind of projecting the rest of the year? You mentioned no quarter over quarter trend line drawing.
Unknown Executive: But there seems to be a little bit of an inflection this quarter, so does that portend anything in your view or any color on that would be great? And then, in terms of the H.O. Trial timeline, recognizing there's approximately a third that you've activated right now.
There seems to be a little bit of an inflection this quarter. So does that portend anything in your view or any color on that would be great and then in terms of the <unk> trial timeline.
Recognizing there is approximately a third that you have activated right. Now is is the one thirds still out of the 35 do you still anticipate 35 to be activated or do you think you can kind of muster with maybe two thirds of that 35 to satisfy your overall 120. Thanks so much.
Unknown Executive: Now, is the one-third still out of the 35? Do you still anticipate 35 to be activated, or do you think you
Unknown Executive: I can kind of muster with maybe two-thirds of that 35.
David P. Meeker: of that 35 to satisfy your overall 120. Thanks so much. Maybe I'll take the last question first. So on the number of sites, I think the number of sites will probably end up opening, given the strong patient interest and the like, isn't the full 35, so we expect it'll be somewhat less than 30. So that's the answer to that, and Jennifer.
Yes, maybe I'll take the last question first just on the number of sites.
I think the number of sites will probably end up opening given the strong patient interest and the like is it the full 35. So we expect it will be somewhat less than 30.
So that's the answer that Jonathan.
Okay.
Just relating to the projections for the rest of the year, but what else to say right. Now is that we are extremely excited about the opportunity and feel that there is still.
Jennifer L. Chien: So just relating to the projections for the rest of the year, what I was just saying right now is that we are extremely excited about the opportunity and feel that there is still, you know, a lot of room just in terms of growth for this product, and just the feedback we're receiving in terms of patients benefiting from therapy just gives us so much more energy in terms of really moving forward with, you know, finding these patients. We have been pleased overall in terms of the targeted ways that we have identified patients, and we feel like there's still a lot more that we can do there.
A lot of room, just in terms of growth for this product in just.
The feedback we're receiving in terms of patients benefiting on therapy, just gives us so much more energy in terms of really moving forward with <unk>.
Finding these patients.
We have been pleased overall in terms of the targeted ways that we have identified patients and feel like there's still a lot more that we can do there. In addition to the breadth as well as what I outlined in terms of the depth of physicians, writing more than one square because of the conviction that they have.
Jennifer L. Chien: In addition to the breath, as well as what I outlined in terms of the depth of physicians writing more than one script because of the conviction they have around the drug itself, I will say, though, that things take time in our disease. You know, it takes time for patients to go and see their physicians. It takes time for some of these physicians and patients to have the conviction to initiate therapy. I mean, some of these scripts that we saw come in; it was, you know, many, many months of interaction and education that our TMs had before that script actually came through.
Around the drug itself.
I will say, though that things take time and legislation.
It takes time for patients to go and see their physician.
Time for some of these physicians and patients to have that conviction to initiate therapy I mean some of these.
Scripts that we saw come in it was many many months of interaction and education that our TM pad before that script actually came through.
Jennifer L. Chien: And, you know, even like physicians who are now educated, it will take time for the patients to come in so that they can actually suspect the patients back and then test and get patients an accurate diagnosis. So overall, like I said, it's a rare disease. It really is dependent in terms of what happens within that quarter, but we are very, very happy in terms of what we've achieved, and we have a lot more to do. Great. Yeah, and Dekon, I think.
And.
Even like physicians, who are now educated it will take time for the patient to come in so that they can actually back and then test and get patients to an accurate diagnosis. So overall like I said there.
Right.
It really is dependent in terms of what happens within that quarter, but we are very very happy in terms of what we've achieved and we have a lot more to do.
David P. Meeker: Great. Yeah, and Dacon, I think maybe just to amplify one short thing on Jennifer's answer there about the overall prevalence numbers, all those things that Jennifer highlighted and the progress we've made to date. It does, not surprisingly, increase our confidence in the overall epidemiology. It's 4 to 5,000. Again, we're learning more and more, you know, much, much more than we did, of course, when we first launched. So confidence there is extremely high. And, you know, not to beat this, of course, too much.
Okay great.
Maybe just to amplify one short.
Thing on Jennifer's answer there.
The overall prevalence numbers all of those things that Jennifer highlighted and the progress we've made to date.
Does not surprisingly increased our confidence in the overall epidemiology, there's $4 to 5000.
Again, we're learning more and more much much more than we did of course my first launch some confidence there is extremely high.
That's it.
Or beat this horse too much.
David P. Meeker: It's the quarter and quarter piece. You know, again, the nature of rare diseases, which is why we keep reiterating this, is going to be variable. It'll be up. It'll be down. I mean, but that's not what we hope you're looking at. We hope what you're looking at is a slightly longer view. Again, we've got a one-year view here, and our confidence that this is going to continue to grow meaningfully over the next several quarters is very high.
Quarter on quarter piece.
Given the nature of rare diseases, which is why we keep reiterating this sum it is going to be variable it'll be up it will be down, but that's not what we hope you are looking at we hope that you are looking at is a slightly longer view again, we've got a one year view here and our confidence that this is going to continue to grow meaningfully over the next subsequent quarters is very high.
Unknown Executive: And your next question comes from the line of Michael Higgins, Wattinburg.
Sounds good congrats.
Thanks.
And your next question comes from the line of Michael Higgins with Ladenburg Thalmann. Your line is now open.
Unknown Executive: with Liden Rout Coleman. Your line is now open. Thanks, Drick.
Unknown Executive: Thanks, Dr. Good morning, guys. Thanks for taking the questions, and I'll share my congratulations on the continued success with the launch of BBS enrollment progress in HO. Dave breaks one of the bigger drivers here this back half.
Thanks, Good morning, guys. Thanks for taking the questions.
Sure My congrats on the continued success with the launch of Bvs enrollment progress and HBO.
They've reached one of the bigger drivers here. This back half you've got a lot of things going on of course, but just wanted to poke in a bit.
Unknown Executive: You've got a lot of things going on, of course, but just wanted to poke in a bit as a follow-up to a previous question and understand what we are to be looking for. I assume it's some efficacy readings, whether that's BMI, BMI Z scores, or hyperphasia scores. We're curious if we're going to see this as an overall mean, any patient-specific data, and also your decision to advance specific genetic patient types. Does it matter by the prevalence of that specific patient type? Yeah, Michael, so there is more to come.
A follow up from a previous question understand what we are to be looking for I assume at some point.
Efficacy readings, whether that's <unk> Z scores hyperphagia scores.
We're curious if you do if we're going to see this as an overall means any patient specific data and also your decision to advance specific genetic patient types does it doesn't matter by the prevalence of that specific patient types. Thanks.
Yes, Michael.
So more to come.
David P. Meeker: I think, you know, what we will put out. So the data cuts, you know, we're looking at now are still left and not final ones, so caveat. Two, we'll determine how best to present the data. Again, instead of individuals, I mean, if there's a small number of patients in a specific cohort, we'll probably present those patients specifically, and for those where we have a slightly larger number, maybe we
I think what.
We will put out.
So the data cut some we're looking at now are still not final one so caveat too.
Two.
Determine how best to present the data.
Instead individuals I mean, if there is a small number of patients in a specific cohort will probably present those specific and for those where we have a slightly larger number maybe will mean those but.
David P. Meeker: But that's, again, to be determined. I think the decision-making around what we might do next depends, number one, on the strength of the data. What we would consider for sure, as you indicated, is A, how robust is the response, and two, how prevalent is that particular deed. If we have a gene where we've only been able to find a small handful of patients, even though the gene itself looks potentially interesting, we may not feel we have the ability to recruit and actually run a trial, just given a small prevalence.
Again to be determined I think the decision, making around what we might do mix depends on the strength of the data number one what we would consider for sure as you indicated.
How robust is the response and two how prevalent is that GE.
If we have one we have a Jim where we've only been able to find a small handful of patients even though the gene itself looks potentially interesting. We may not feel we have the ability to recruit and actually run a trial just given that small prevalence. So we'll take all that into consideration I do want.
David P. Meeker: So we'll take all that into consideration. But I do want, you know, to remind everybody that the bar for taking things forward is high. So just because we see a signal, we'll want to have some confidence that it's robust and that we can execute on the trial relative to all the other things that we have to do. And, you know, you heard about the 7-1A program today. We're going to be incredibly focused on pushing that forward.
Mind, everybody that the bar for taking things forward is high.
Okay.
Okay.
Just because we see a signal will want to have some confidence that it is robust and that we can execute on the trial and relative to all the other things that we have to do.
You've heard about the <unk> program today, we're going to be incredibly focused on pushing that forward as well.
Unknown Executive: Yes, you are so long.
Next question.
Yes sure.
Unknown Executive: Sorry, did we, is there another question or not?
Alright.
Is there another question or.
Unknown Executive: Bella? Oh, we can hear Michael. I can hear Michael. Oh, yes, we can.
Operator.
Yes Philip.
Alright, Thank you Mike.
Unknown Executive: Oh, we can't. We can't hear, Michael. Michael, are you still there? Okay, I've got you.
I can hear Michael.
We can re weekend here Michael.
Michael I use my line is still there okay got you.
Unknown Executive: We got you. We're back on. Just one follow up here, and really one for you, David, is on the state of the markets here.
Okay, sorry about that.
Got you.
Back on just one follow up here and really one for you David is given the state of the markets here.
David P. Meeker: is given the state of the markets here, slightly improving, but still assets are relatively cheap. Wanted to get your sense for and your appetite for expanding the pipeline. Obviously, you've got 17 going forward. You've got some bento activities.
Slightly improving but still assets are relatively cheap.
To get your sense for your appetite for expanding the pipeline obviously, you've got 718 going forward you've got some <unk> activity.
David P. Meeker: But I am curious to hear your appetite for expanding the pipeline. Thank you. Yeah, again, answer. I will be the same at this point. A very, very high bar to do anything. We are not actively looking, but we will be opportunistic in the sense that if, in our engagement with the world outside, things are of particular interest, and we see a real opportunity to add value, then, of course, we would look. But basically, we're just very focused on executing on these near-term value drivers, and we'll continue to assess other opportunities as they might arise, but we have no specific focus on additional acquisition
But curious to hear your appetite for expanding the pipeline.
Yes, again, I am sorry, I will be the same at this point very very high bar to do anything we are not actively looking but we will be opportunistic in the sense that if an.
And our engagement with the world outside of things that are of particular interest and we see a real opportunity to add value then of course, we would look but.
Basically we're just very focused on executing on these near term value drivers.
We will continue to assess other opportunities as they might arise, but no specific focus on additional acquisitions.
Unknown Executive: Appreciate that. Thanks again. Thank you. Next question. Your next question calls on the line of Joseph Treyer with Dietam and Koah.
I appreciate that thanks again.
Yes.
Thank you.
Next question.
Your next question comes from the line of Joseph Stringer with Needham and Cowen. Your line is now open.
Hi, good morning, Thanks for taking our question.
Just curious what percent of patients on <unk> have titrated back down to the lower daily dose down either into the one day go that can make dose and how has that evolved over time.
Unknown Executive: Your next question calls on the line of Joseph's Trayor with Didaman Coa. Your line is now open.
Jennifer L. Chien: Yeah, BBS in the US is probably our best shot at that, Jennifer. So, overall, in terms of
Yes.
In the U S is probably our best shot at that.
So.
Overall and.
In terms of.
Jennifer L. Chien: So Overall, in terms of, you know, the doses, the majority of these patients are getting to the target 3-MIG dose. I will say that just in terms of the percentages that you break down the different segments, whether adults versus, you know, pediatric patients, there is a slightly higher percentage of adults that get to the 3-Mig dose. It may also be because there's basically one titration step from two to three to get to them at the dose of adults.
The doses.
Yes.
The majority of these patients are getting to the targets remain Joe.
I will say that Jeff.
Just in terms of the percentages that you break down the different segments, whether adults versus.
Pediatric patients there is a slightly higher percentage of adults that get to the three Meg. It may be also because there is basically one titration stat from two to three to get to the Max dose of adult but overall, even within each of the segments. The majority of the patients are getting to the three.
Jennifer L. Chien: But overall, even within each of the segments, the majority of the patients are getting to the three-make dose. And we want them to also be able to work with their physicians to take the time to titrate appropriately so that they can manage through and maintain on the drug and receive the benefits.
<unk> dose and we want them to also be able to work with their physicians to take the time to titrate appropriately so that they can manage through and maintain our dragon receive the benefit.
Unknown Executive: Great, thanks for the Dishone Color and thanks for taking our question. Thanks, Julie. Next question. Your next question. Compton the line of Jeffreycom. With Morgan Stanley, your line is now all.
Great. Thanks for the additional color and thanks for taking my question.
Thanks Sharon.
Next question.
Your next question.
Comes from the line of Jefferies.
With Morgan Stanley . Your line is now open.
Unknown Executive: Hi, this is Michael Riyad on behalf of Jeff Hung. Thank you for taking our questions and congratulations on the quarter. Can I just ask for a little bit more clarification on a previous comment for the one to three months period for translating scripts to sales? You had said that there was a tail end for some patients, and it could extend out several months. What factors come into play there, and what makes those patients more likely to have a longer process? Thanks.
Hi, This is Michael on for Jeff hung. Thank you for taking my questions and congrats on the quarter.
Can I just ask for a little bit more color on the previous comment for the one to three months.
For translating scripts. The sales you had said that there was a tailwind for some patients that it could extend out several months what factors come into play there and what makes those patients more likely to have a longer process.
So.
Jennifer L. Chien: So, you know, the reasons just in terms of the length of time to gain reimbursement are not always relating to the payer itself. Sometimes it's just also delays on the HCP side from a process standpoint, whether they're working through, you know, multiple patients and doing things a bit sequentially or for other reasons. With that said, I mean, we have definitely gotten approvals even within those groups of talent, of patients, and the patient support group as well as our access groups and our TEMS on the ground really continue to be persistent in terms of working that process through.
The the reasons, Jeff in terms of the length of time to gain reimbursement is not always.
Relating to the payer itself, sometimes it's just also delays in terms of HCP side from.
From a process standpoint, whether they're working through multiple patients.
And doing things a bit sequentially or for other reasons.
With that said I mean, we have definitely gotten approvals.
Even within those groups of tailwind.
Sure.
Patients.
Support group as well as our access group.
Jan San ground really continue to be persistent in terms of working that process through.
Unknown Executive: Okay, thank you, that's very helpful. And then maybe just a follow-up, maybe more of a housekeeping question. Your reiterated guidance on OPEX, and it seems like for SG&A, it would have to be somewhat lower in the second half to stay within guidance. How should we be thinking about expenses in the second half, particularly SG&A given the launches happening in the EU?
Okay. Thank you that's very helpful. And then maybe just a follow up on maybe more of a housekeeping question.
You reiterated guidance on Opex and it seems like for SG&A. It would have to somewhat lower than second half to stay within guidance, how should we be thinking about expenses in second half, particularly SG&A given the launches happening in EU.
Hunter C. Smith: Sure, good question. And, you know, we certainly have factored that in. I think there are a variety of factors that can be a bit lumpy within SG&A, particularly in the compensation area. So, you know, we're quite comfortable that we will still be on track to meet our guidance. Thank you very much.
Sure Good question.
We certainly have factored that in I think there are a variety of factors that are that can be a bit lumpy within SG&A, particularly in the compensation area.
So.
We're quite comfortable that we would still be.
On track to meet our guidance.
Unknown Executive: Thank you very much, and I got the gun on the quarter.
Thank you very much and congrats again on the quarter.
Great. Thanks, Michael.
Unknown Executive: Again, ask a question.
Again good assets.
Yeah.
Unknown Executive: Again, to ask a question, please press Tar-11 on your telephone and wait for your name to be called. And we have a follow-up question here from Michael Hogan, from LEMB, not in Ritzelma.
Please.
Again to ask a question. Please press star one on your telephone and with journey to Pan out.
And we have a follow up question here.
Rob.
Michael Hogan.
Alright got it.
Unknown Executive: Thanks, Dr. Can you hear me, guys? Fantastic.
Yes.
Thanks, Operator can you hear me guys.
Yes, okay.
Unknown Executive: Just a follow-up here on 718, obviously it's early, I&D is not cleared yet, but just looking further down the road as to how this would be developed, given your experience with St. Melanatine. Of course, it's fair to assume the control arm is different, but how do you expect to run 17, 18? Would that be up against Stemalantide, considering it's approved now? And then after the healthy volunteers are tested, it's something positive, of course. Would you be fair to assume that it opened up a broad basket study with all the patient types you've tested and possibly additional patients?
Fantastic just to follow up here on 2018, obviously, it's early and it's not cleared yet, but just looking further down the road as to how this would be developed given your experience with central last time and of course. It is fair to assume the control arm is different but how do you expect to run $17 17 would that be up against the Atlanta tied considering.
It's approved now.
And then after the healthy volunteers are tested assuming positive of course would you is it fair to assume you would open up a broad basket study with all the patient types, you've tested and possibly additional patients.
David P. Meeker: Michael, all good questions. Don't have the answers today. I mean, those are things we'll think about. A number of choices, you've highlighted some of them about how you develop an asset such as this, but the first step, again, is not much to negotiate there.
Michael all good questions don't have the answers today I mean, those are things, we'll think about the number of choices you've highlighted some of them about how your development assets.
But first step again, it's there is not much to negotiate there will just get through that and while we're doing that we'll evaluate that you've highlighted as I said those are those are good questions in terms of strategy.
David P. Meeker: We'll just get through that. And while we're doing that, we'll evaluate it. As I said, those are good questions in terms of strategies. I appreciate it. Thanks, guys.
I.
Thanks, guys.
Thank you Michael.
Okay.
David P. Meeker: And I see no further questions at this time. I will now turn the call back over to David Meeker.
And I see no further questions at this time I will now turn the call back over to David nature.
David P. Meeker: Great, thank you. Thank you all for turning in on the early day of August here, and we, as you hopefully have heard today, had a really good quarter. A lot of momentum here in rhythm, and very much look forward to the next earnings call and updating you further on the progress this weekend.
Great. Thank you. Thank you all for joining in.
Early day of August here, and as you hopefully you've heard today, a really good quarter.
A lot of momentum here and rhythm and very much look forward to the next earning call and updating you further on the progress we can make.
Thank you.
Okay.
Unknown Executive: Please complete today's conference call. Thank you for your participation. You may now disconnect.
This concludes today's conference call. Thank you for your participation you may now disconnect.
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