Q2 2020 Zogenix Inc Earnings Call
Good day I'm looking to be so genetics second quarter Twentytwenty earnings call. Today's conference is being reported I, just I always like to trying to accomplish over to Brian Ritchie like say advisors.
Go ahead.
Thank you operator, thank you all for joining us this.
On today's call, our Chief Executive Officer, Dr. shooting for.
Commercial officer, she should waqar.
Financial Officer, Michael Smith, as well as Dr. drilling Conte, Chief Medical Officer Motors Therapeutics.
This afternoon Genesis issued a news release, providing additional shopping I don't think financial results for the second quarter ended June.
2020.
No that's certain information discussed on the call today is covered under the Safe Harbor provision the private Securities Litigation Reform Act.
We caution listeners during this call so genomics management will be making forward looking statements.
Actual results could differ materially from no stated or implied by these forward looking statements due to risks and uncertainties associated with the company's business.
These forward looking statements are qualified.
And every state which contains or drugs. This press release issued today and the company's actually seen filings, including in the annual report on form 10-K. Subsequent filings. This conference call also contains time sensitive information that's accurate only as of the date Thislife broadcast August 2020.
Suggests undertakes no obligation to revise or update any forward looking statements trueflex events or circumstances. After the date of this conference call now I'd like to turn the call over to Steve.
Steve.
Thank you Brian good afternoon to everyone.
We ended the previous calls or with a great years. That's your truck will have pursued FTC approval for the treatment of Caesars associated with your very syndrome.
You can go first drug approval since we put all strategy to focus on developing and commercializing transformative therapies for rare diseases.
Results will be tremendous work and dedication all my colleagues so drugs.
Once again I would like to find the patients families any bassett graduates who participated in our clinical program over your Dunkin' helped us achieve this tremendous milestones.
[noise] disapproval neighborhoods entry, what's your called <unk>, <unk> integrated commercial borrower policy or country.
Especially if you watch logically chopper occurred last week on July 27.
We're excited that commercial product has been shipped its first patients enrolled they try weapons program.
Sure sure provides an update on whatever you want to progress like commercial activities well come back to discuss what I'm going to Belton program before my could Scrooge <unk> financials for the cool.
You should start with you.
Thank you Steve.
But I did you said all the new superdelegates on the launch of subjects in the U.S., which is going extremely well follow your speed up the one Oh Gee bloody field.
Since then we can be she is very high level of enthusiasm that's been done up that's both physicians and get to give us reflecting the media can discover that they come to potentially that's been does not have suppose I think seizure control more patients with Kelway said.
Have you mentioned previously strong interest from the builder community why did you have to them yet to be more local fold extended expanded access program.
This call them and their big dogs establish jump is fine I just wanted to get Dolphins who's been on specialty pharmacy distribution not too because.
We don't give I supposed to ensure that I'd like to watch.
To be outstanding be more coffee and by the Virgin excuse me in the United States and Yodle finished friend does not thought it wasnt did they get blog distribution hub within just a few weeks fall into wind up doing.
This is especially not bid them doing this I'm confident that global pandemic.
Yeah I'm in the objective or do you feel commercial launch do you skip that you'd be educate the I'd get the why does that could give us on the compelling efficacy and safety profile of the.
Everybody has good for why does on the bosses are becoming said before this garbage and stuff.
This is different but my Buck on the other gets like social video themselves. That's been done then start Guam All went live in early July.
I'm very happy to report, but to date wouldn't want isn't Toby, yes, healthcare providers, who have maybe given to patients I'm glad that you have successfully a middle can defend but not on still done and I've said before I'd describe some debt.
Yes, so different fishing is an important so it's good for physicians to begin describing crept up lot commutations of into yes, I've been asked for transmission patients will go into your thinking from picking up yet on the open label extension study that expanded access program for the commercial product.
This heart level of engagement, but this douglas has exceeded our expectations, especially given the getting good market I'm glad that underpin foursixty substantially improved in the product that we acquired from the community for sometime now.
You could be conducted an education, but do not felt piano do worse in collaboration with the balloon syndrome Foundation.
This was up into the by more than 80 members of the other committed.
This was an opt for why the medical information about some depth love them to mediate although vision, except vacation said he says our golf anticipation support hub and specialty pharmacy.
Actually we mentioned last week on July 27th lot of fees. They seemed somebody can love it skewed the fund launch will still get lucky they all knowledge it getting physicians on the efficacy and safety go far enough went up.
This one facility and then that's been going slow, but yeah, yeah, that's what you're getting it should be office stop on but it seems to try the Liberals Didnt get gives you an extension.
A key account managers have successfully contacted all baked goods the largest what kind of heat treating patients get all open label extension studies and expanded access program within the first few weeks following DFT airports.
Yeah, No continues our promotional focus to be approximately 400, I'm 50 physicians get about 80% off that you did give it some decisions can be United States.
The other little to deal with Liberty has also allowed us to out of them often does not cover this discussion with the diversity of spend but to get out of an exchanges.
Got it could be up meeting, we had the opportunity to meet with substantial number what else.
Educate them all the potential benefits off and keys 50 information, but if it's just not the discussions on coverage decisions. Good all could well be off the b S. The approval.
I'll be happy where do you have to give the pool, but we have already started receiving 70, Bobby just double digit determinations recognizing that some companies are diminishing skills. They thought they didn't just give me should launch studiod visually central we've continued to assist on individual cases, you know that's what the expedited the coverage.
In summary, we got off to a video so I think struck a.
We are really talk to bring this well then should talk so maybe pedal putting together they should and their families in the U.S.
Yeah.
This becomes I misspoke adoption reviews. The mumbling lifted features these stations to begin to get students.
I wanted to conquer wake up every do for their ongoing support and finally I get the widest who have already become certified some double up his father's.
He is getting what Steve said I like for like the bombed out you would be on television mix did well what Bartlett sleep lots from that block maybe just few weeks off if you didn't get the approval and Btwob game called it doesnt impact of its.
Well I tend to go back to Steve Steve.
I like your shoes for Great summary.
And probably the U.S. electric if you go to huge described.
We continue to work with record shortfall, just the Bronx grew chop Intravase syndrome, and other key regions.
In Europe. The your major review of our marketing application is on growing.
Based on reaching its not encouraging progress, we anticipate future into providing that opinion by the end of this year.
You're not piece a picture of a public opinion, we are preparing for the Churchill launch all three chopper enough shirts European countries, Germany in the first quarter of 2021.
Additionally, in Japan, we expect to have topline data from our phase three pivotal trial in the full quarter. This year to support a planned jagan to guard submission in the first half of Twentytwenty block.
Now I'd like to true to our program for top line and then of course dose and go more out of yes.
Oh, yes, it's another great and severe form of Charles with onset epilepsy.
I like your basin drilling, which is strongly correlated to variations of the specific dream.
You guys could arise from multiple different calls is making seizure get services without U.S. among the most difficult to sector do treat.
Let me think we'd love to get your husband scheduled for September.
During which we will seek the agencies few buck on the long clinical and clinical requirements to support all plunge supplemental India, Youre, a certainty or faltering chop Larkin LG, yes.
As previously communicated we have successfully completed a pivotal safety and efficacy phase three trial.
Currently conducting special populations trade one.
Pharmacokinetic trials and a two year costing you see study and brokers.
So you need to exit from these studies are required.
Actually picked submitting or that shouldn't be a full field trip or did I answer yes during the second quarter towards each once you want.
As a reminder, yes, the Iraqi tournament the based on an approval from salt and pepper into Big syndrome, only want me probably phase three trial is required for LG, yes.
San Diego.
Now I'd like to switch to and T 16, Trekkie work.
Our investigational therapy for the treatment of a devastating and frequently shakes will like to cultural DNA diffusion disorder core funding kinda, it's true deficiency, what she takes you do.
And to 60 tricky one it's an all fixed dose combination treatment or be oxycyte today.
Oxy funding that serves as substrate enhancements that occurred to restore might you called European I am treat the progressive deficits in nature, it's true that spirit tree I'm feeling functions. The categorize this devastating disease.
I think he 60 trends you weren't <unk> breakthrough therapy designation in like states.
Right got it makes you in Europe as well its orphan designation in both regions.
During second quarter, we met twice weekly after the I discussed the development path to supports a planned and be a submission for up to 16 to what you want.
We're very pleased with the outcome from the discussions which supports our proposal, but the survival benefit of treated patients as compared to external historical control group is a reasonable base gets fully on board.
As a reminder, we previously completed study you want to one a retrospective study of the combination of part really three sites and 58 patients with Teekay to do.
Which demonstrated a statistically significant sector treatment on survival compared your untreated control group.
Do you treat you deficiency patients from the literature.
In addition to this analysis. The after you gave requested that we obtain integration on any additional treated patients. We did not participate in Mogas sponsored study.
Good to have a complete survival analysis for you got to be here.
No. In addition to our country gets better you want to one we intend to preclude our ongoing perspective open label study, one or two that's probably going to get submission.
Study, one or two provides country treatments were going to 16 21 for patients who participated in study one of one.
Unfortunately study one or two has been impacted by covered my to.
Some patients, particularly those from outside the U.S. in New York.
Well restricted from trophy answer critical insights to complete study assessments.
However, patients have been able to concern you uninterrupted treatment, we're going to 60 tricky one during the spent there.
With respect to other feedback from the regulatory meetings, you actually had requested that we conduct these phase one renal impairment from Socratic study to provide Gulfstream recommendations in the second given peregrino friendship.
Regarding no clinical toxicology, we recently completed a six month toxicology study congrats.
That's the are you also requested big toxicology studies and dogs, but was ready to accept this study of a minimum of students duration versus the typical nine months should we have concerns that the longer duration study, which substantially delay the I'd be a submission.
In addition, you have to your accepted or all CMC like your plans for the future submission.
Let's see many relaxation of certain restrictions related to cope with like <unk>.
We anticipate good old data for 90, I will be available by the end of threat to try to warm in order to support the submission in the first half its rights each registered.
With that let me handover the call somebody for his financial review like.
Thanks, Steve and good afternoon, everyone today, we issued a press release.
In financial results for the second quarter ended June 30, 2020, which I'll now run through.
We recognize $1 million in revenue during the second quarter 20 Twond.
The result of our exclusive distribution in collaboration with Nippon sheet Yaki for can talk long delays in German LG, yet in Japan.
Your next 1.1 million revenue for the corresponding period, it's one that too.
R&D expenses for the first quarter were $34.1 million, an increase of approximately 7 million from 27.1 million corresponding period of 2019.
This increase is attributable to a modest increase and spending when I've studied 60, no one else, yes phase three study development expenses related to our late stage clinical candidate and T 16, 21, and an increase in person.
Eat operational costs, all partially offset by decreases spending in our survey syndrome program.
As a number of studies in that area that's come to closure.
That's doing expenses for the first quarter ended June 30, 2020 totaled $24.4 million compared with 15.5 month for the second quarter of the prior year.
The increase of approximately $9 million is primarily driven by the continued investment related to the lots at the top left for the treatment of devices in the last which began in the third quarter and.
For the purpose preparation related to prospectively launching in Europe.
At the beginning of 2021.
One of them, that's an all important I didn't highlight in the quarter, we were seeking it from UK government, a $19.7 million Bucks R&D tax credit related to a.
Department activities in 2017 of the way to qualify under the UK small and medium sized enterprises R&D tax release.
It's $20 million payment contributed to our quarter end crossbones.
Net loss for the second quarter ended June 30, 20 to one was $53.3 million or 96 cents per share and this compares to the net loss of 37.8 million or 89 cents per share <unk> second quarter ended June 32019.
Well, we ended the second quarter with a strong balance sheet cash cash equivalent in marketable securities totaling $309 million, but significant caf two years and allows us to ends up in a robust and successful lots of tableau Intravase engine in the U.S. and Europe and simultaneously and advance our key late stage programs for for example in LG, Yes.
And then P 60, 21, what keeps you do.
With that.
I'll now turn the call over to the operator to start our Q any session.
Operator can you please open the alone.
Sure.
Thank you so you'd like to ask a question the signal by pressing star one on your telephone keypad, if you're using a speaker phone. Please make sure your mute function as turned off to like a signal to reach our equipment again, not a star wanting to ask your question. There pause after just a moment hello, everyone an opportunity to signal for questions.
[noise] optimistic our first question.
Comes from Paul Matteis Upcycle.
Hi, guys. This is based on for Paul that's putting a question.
Maybe first one real quick what what launch metrics that you guys plenty of providing patient starts or something else.
Let's see what you'd like to take that question.
But she is your mute.
I'm sorry.
Hi.
Thanks for the question Weve evaluating various might take someone experience that the patients conditions out there like it appears that can provide reliable source of information on trend.
That's you know the jets launch last week and as we've said today.
Thank you Shannon building banks and completing certification.
Still drop.
But keep bucket, which is what can you shed yeah and in the upcoming communication, we expect to go like more appropriate measures that can just like the probably that's helped the lunch.
Gotcha and then.
You said about 250 Threerd you the patients a in the U.S. and to drive they welly, what's the average dose there on a per kilogram basis, and how quickly do you think you're going to transition over the commercial drug.
Yeah, I think you have to pay TV or open label extension W.W. access still about patients did I get back hard.
Yeah exactly.
Yeah. So we want to what do you on board transitioning these stations so something to keep in mind is that most of these patients.
Then not need to be a baseline pickup and to start the tenda has the lastly could they have done in the European royalties to really be part of that a baseline.
Yeah, I'm proud to say that he'd been able to reach almost all the physicians in beach programs and they haven't <unk> build into the jobs.
It's really working gone dog transitioning them as they have leap opt into coverage jammed and be able to get them to the a and b closure process that they need to be said the clinical trial.
Although most important because it's hard here. He is back does not have gonna be any interruption maker studios to buy the patients during this transition.
We do have applied this program and that will allow patients to continue the sitting therapy.
Outside the public in the nation is being decided.
Gotcha, whatever social deal.
So do you have it goes up you talked last time was the evidence based was 54.5 and the others dose watch swipe slide two milligram per kilogram.
Got it thanks very much.
Thanks for your questions.
Thank you.
Can I live tour next question. This comes from Marco been of SCB Leerink.
Hi, This is Ron on the line from Mark. Thanks for taking my question I too first I didn't quite caught this during your prepared remarks, but for the M. T 16, 21 asset could you clarify what the FDIC with requiring for the clinical data portion I know motors is done somewhere.
Previously and what extra work you're doing.
Yeah, I I'd be happy to talk to the opposite also Joe on caught out you've Gotta go some notices on <unk> on the line. It's you can also obviously something about missing here. So troubling from the clinical perspective. We competed study one or one which will be a major based itself.
San Diego, that's where we've been able to establish a survival benefit versus natural history control Oh, we also or would be including information from study one or two which is are you an extension studies. All those patients are not shrinking M. T 16, 21 for the treatment of their disease.
In addition to the jobs as I said in prepared remarks, Oh, Gee lawn and her team that will be obtaining information I'm sorry.
Other patients web clumping treated with a deoxi leukocytes. It we're not parts of our of the noticed studies or I was studies. That's it will be attending information from those patients in order to complete the survival analysis for the idea.
In addition to adopt and do you have to get Oscars to conduct a.
A a a study in Reno impairment. So that's a phase one studies show that will also be part of the critical package for the idea.
John Let me know if I've missed anything but you'd like Gerard.
No I think I think that's good did that address your question.
Yep that helps and then one quick one on switching back to some capital a must be ramps enrollment and certification over time can you talk a bit about obviously this is nothing from like academic centers or other sites and how did it look I'm going into July.
Yeah. Thanks for the question going up I think the claim to be subject here. Since we have so far they are mixed data from the Academy accent does data from the community that does.
Yeah. These Douglas said in my prepared remarks, well around 450 stepping up the largest yeah, maybe I could not a largest peak about that 80% duffy into their patients.
I think we've been able to each and get diagnosed at half of them. So besides kill this process.
I'll put that out that's your question.
Yep and just if you have any anecdotal comments about July.
Oh, I, just try and no because we just launched last week and be the watching but Chad yeah and.
One thing I would say is you really excited would get a sponsor that we have got some distributions caregivers and also for market. They are certainly I loved the conversation so be it really feeling very confident that we'll be able to bring this therapy to most of the patients.
As we go through the launch process.
Sorry can I ask what your question on July is.
Oh, sorry, I was just wondering about the Rand cadence over time basically.
Yeah. So said another way to do what kinda basically there are folks on the what happens.
The together with 36.
That's all.
Okay. Thanks on the two it that's correct yes.
Yeah, I did it the other way to sit around and so that's obviously, we've seen a really a great movements old physicians into the Rems program, Arctic, which underscores the other reports they see if this is drugs in the treatment. So spoke to raise syndrome, so getting 230 plus.
Positions enrolled into the runs in less than a run project is a really good stuff for us.
Sounds good thanks.
Thank you.
Yeah.
Thank you I loved your next question. This comes from Yatin Suneja of Guggenheim Partners.
Hey, guys to do better young for yacht and congrats on the launch I was just wondering if you could give us a sense of how long it'll take to get.
The broader reimbursement for perfume tablet and is there certain states that can get its first and how long it will take some of the slower states like Texas and wanted to get reimbursement and then.
What are your expectations for gross to net methodology was about 20% is at a reasonable assumption for <unk>. Thanks.
She still hadn't tickers questions.
Yep.
So far the Bothers me investment perspective.
As you know as alongside the best State Dot and it's generally what do you have seen in some of that he sent launches Gotta got steak and up to six months to get the about coverage.
You have some states like Texas, which they pick up to six months, Yeah, I'm Gonna have some states may happen in Mexico bonds and then we also have a private payors are they have their own PMT reviews. You have now we have got to get in London do you have stepped into beeping I'm delighted that information.
So I think over the next six months, we didn't see a huge increases in the coverage so that piece on the career site.
From the girls to hit I think it'd be very premature babies or provide any guidance I just want implied I'll leave evaluating how would be up but how the launch goes but more importantly, how we get the coverage and based on that in future, we get the like guidance on that.
Thanks, and just one last one for the Medicaid population and have you seen that number increased given the pandemic instead of the increases that are seen in the country unemployment do you expect that Medicaid a ratio to change.
Yes.
Generally if you look at a population did which you can I try to look up the numbers and say, yes, so maybe get patient population should increase.
In terms of lot of population went out what the yet to see.
It's too if you can see anything because it's been just want to keep working days since we have started promoting.
But can we expect that DMP sped up will be similar to what do you have seen in sum up the other cloud of smoke that you've done this product that up to 55% to 60% of the patients thought on Medicaid or some form of government. They did a initiatives.
I guess so much.
Thank you.
<unk>.
Thank you.
And we can I moved your next question just comes from Difei Yang of Mizuho.
Hey, good afternoon, everyone I get this is Alex for Oh for the sake I just had another question I'm not sure its coverage just to try to get the coverage determinations and noted that few.
ER positive the terminations already can you just comment that that's tracking sort of along your expectations are a little bit ahead.
Additional color on that helpful.
Yeah. Thanks for the question Alex Yes. This point in time, it's tracking but our expectation yeah on that the work that you have done prior to the launched in educating be affairs.
And the relationship that we have built is really coming to the bad I'd just point in time, so I would say stuck into the expectation.
Okay, great. Thank you and then just one more question little and kids six to 21.
I'll give any plans to disclose any additional follow up data I guess at some point, though.
Lets get lots or so.
Sure I'm trying to take that one Oh, we are will be it's anywhere muscles. The size and so maybe you can say if you're thinking about that.
Or lead have several abstracts, partly because they get more muscle.
In terms of the fixing 21 program.
I think that would be next point at which will be able to show that that publicly.
Great. Thank you.
Thank you.
Thank you.
So that moved her next question. This comes from search search boundary of Needham and company.
Hi, Good afternoon. This is channel for search such a question.
So the first one.
It's about rent so in terms of teacher vacation themselves.
How fast you expect them to go into them. So then they're sort of doctors and citizens and are you gonna be disclosing these numbers in the quarters in coming quarters and then the second question is the safety Japanese child, 'cause humans as any type of a milestone payments that are tied to the read out of that.
Trial for kids and any other regulatory milestones that the and the submission in Japan. Thank you.
She's take the first two questions maybe Mark you can take the question, but with once you back or up to that.
Yep.
Oh, sorry, Tony said, they patients enrolling into that I'm spoke about it depends on what type of fiction bad habits that idea if the patient tell somebody access program all the clinical trial.
I bet embedded rent is gonna be fairly smooth because they do not have to go to vehicle yeah down what we believe is that based on them that able to visit the ER physician they should be able to enrol maybe good seamlessly any via quickly.
One thing is we have these events God documents can be a million documents are available on the upside down I really believe that nobody though you can talk a little comfortable about devices you can electronically from them. So we have made it much easier or.
For the migration it takes almost the same time I think the only go a step dad was gonna be the naive patients. So we'll have to go through and I Cook office, So given out to do an echo and that takes as we sit idly everything they can either because into the whole weeks, depending on what our ability to find b y month.
You're going to be institute and depending on the public holdings to do it won't be it goes up and maybe or any other plays out but so far lucky have seen in the last Ah, let's say a became a half a dozen little them sort of going out of smoky as we had expected.
Mike.
Yes, so the.
So through our.
Oh collaboration with the punching after there a couple of payments that relate to a J Andy a submission for Jay as well as for Lgf injury is much more in the near term well loved worn near term then be obvious study I'm at least on the on the near term horizon. The the amounts.
Our tied to our submission and approved and then subsequently a price listing which comes in Japan right. After an approval. So I mean, it's in the neighborhood of the mid teen accommodates the boat goes in terms of milestone payments and then Elds, yes, which is ongoing as well it will come.
You know coming a little bit of time after drove a have those same type of milestone payments and those milestone payments or in the high 20 millions.
Combined [noise].
Got it thank you.
Yep. Thank you for your questions.
Thank you.
And when I moved to your next question from Tim Lugo of William Blair.
Hi, This is John on for Kevin. Thanks for the question just two from US. So first one just wondering how you guys are thinking about prioritizing getting additional sites around the certified are you more focus on specific regions get in like a local state of the endemic what are you more focus on other factors like silent until number of patients and second I'm not sure.
If I missed the in the prepared remarks or do you have any updates on the basket study of through Patla and if you had an update US is there anything you're looking for a feed before you start restarting it. Thanks.
Steve I'll take the first one of them go do it.
So that's it pretty intense stuff right John is going to throw out of transmission. That's yeah privatizing on these key stepping up the largest as I said in the bugs, but I don't fall under the 50 of the lapel are just idiotic what allows us to keep approximately 80% of the pace.
So we do reach into them for us and because of that I went out a few things focus is gonna be in the initial phase up the launch and the ones that is done then they're going to go over the next one.
But it's more but what I call. It a limitation from be geography, or because of the golden situation prominently because we've been able to connect it does offices if not impose some.
True telephone Cubism calls and we have made the m. tires and wheels on profit available online and most of the solutions have been little online it easily from different devices.
So hopefully that answered your question, but we'll go first would be type yes.
Does that keep up the largest and then she will be in Mexico.
Steve.
Yeah, Thanks, John with respect to the basket study or do you know, we put that on pools because of the curbing 19 situation and really a realization that was it was difficult in probably an appropriate too.
Machinery to a new clinical study at the time that so we have 30.
Oh, you're on what's going wrong or skin. So we had it approval in in Oh through troubling to vary we have started to see if there's opportunities to look to get this steady buck up and running well I don't have any timelines are not right now but are we are actively evaluating whether or not goes multitude of.
To to at least <unk>. Some of these cohorts of patients into the study as you just to sort through sort recalled for every one of.
This is this study will be bringing in several different epileptic inseparable suits or severe epilepsies under one protocol on they will be if you brought into various cohorts and we're looking to see if we can get somebody or some of these cohorts up and running that's a real or talked certainly motorparts dropped.
I'm, sorry, we got some more information.
Okay, great. Thanks, and congrats on the launch thank you.
Thank you very much.
And once again as a reminder, if you would like to ask the question. Please press star one, though that as star one for any further questions.
I mean not moved your next question. This comes from Michael Higgins of Ladenburg Thalmann.
[noise] except for.
Questions.
First of all Congrats awards and secure.
So far external well and she has the benefit of Bobby.
Characteristics. You've also mentioned soon after the health care providers are being signed up so far you just give us a little break out of that I still believe includes physicians and nurses. So how many sites are the 230 spread across all give any target goals for the back half so.
So when it's all eggs.
Thank you Michael if you care about breakdown for Michael.
Uh huh.
Because this time like I don't have the big done, but what I can tell you talked about she is that more than 95%, though these will be traditions, because we've been able to reach all of them.
I'm Lucky dealers that have that Ive few well to do some assistance yeah. Most stopped fish mills have signed up because they would've bought off the early access pulled that out on the clinical trial sites.
But do you can come back to you I give you that breakdown in terms of holiday traditions.
Yeah. That's done so if the data did go all that said earlier our goal is to get all these 450, keeping up the largest signed up.
It has already as possible and then more one GB met style that which is the happened at the largest who maybe keeping maybe one off to get their patients, but he want to make sure that each of them come under them into the hands. So that they can offer a pent up another that patients.
Okay. That's helpful. Thank you [noise].
Well just given so a helpful because invention.
On prior calls as well as just one of adult patient dose.
I assume that there.
But there's some sort of a protocol for handling those.
Most patients during that transition period.
How do you work that is that something that every month. There are some of them off supply to do that for several months time, how is that normally.
Yes.
Let me back your question so that I understood. It. So the question is regarding the transition how would it be how do the bill scan how much do we supply as he said during this transition Didier.
Right yes.
Yep.
Yes.
So at this point in time based and do follow the same guideline yeah. That's what you get from insurance companies.
That cash during the transition will be providing I'd give you had that applied yeah. We will continue to follow up based on how the coverage determination is made and then that based on that they can do either Phil I'd be talking as she brought up off switch to a commercially car connection last couple of product.
What is the typical transition period.
[noise] or at this time, it's really early to say because we just started this last week. So we didn't have that the metrics.
Hopefully future, but at the squandered data can be people much at the table membership.
Okay. Appreciate your feedback that starts.
Thank you.
[music].
Thank you. This time, we have no further questions. So I was on the call back to Dr. Stephen for.
Thank you operator, thank you all for joining us on our call today.
Very very plays extremely pleased to share a programs to becoming a commercial stage rare disease company, having a strong <unk> pipeline of very promising therapeutic candidates and those contracts out where they are showing tremendous after considering and and some devastating diseases or look forward sobriety mature that updates on our launch progress in clinical activity.
So thank you all again for joining us dollar coal today and enjoy the rest of either.
This concludes todays call. Thank you all for your participation you may now disconnect.
And.
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