Q2 2020 Chiasma Inc Earnings Call
Thank you for standing by this is the conference operator welcome to the key Osmose second quarter 2020, <unk> earnings Conference call I.
As a reminder, all participants are in listen only mode and the conference is being recorded [laughter]. After the presentation, there will be an obligation or due to ask questions. [laughter] joined the question cues can be a press star then one on your telephone keypad [laughter] should anyone need assistance during the conference calls.
No one operator by pressing star and deal [laughter] I would now like to turn the conference over to Glenn Guar monks Investor Relations. Please go ahead [laughter]. Thank you operator welcome to our conference call today, we issued our second quarter 2020, operating and financial results press release, a copy of which may be found on our website. During this call will be.
Making certain forward looking statements about events and circumstances, including but not limited to statements concerning our plans and expectations for the commercialization of mcwraps, including its reimbursement and market adoption much just isn't composition of the U.S. market for my job. So.
Commercial or therapeutic potential in the caps and anticipated market acceptance up much wraps up our expectations regarding the manufacturing supplement that we submitted to FDA for my caps at our plants to submit an additional manufacturing supplement and expectations regarding the availability of product supply.
The timing and success of a potential commercial launch of my job sit in the United States, our ability to convert endocrinologists and patients to my job. So from Octreotide, Atlanta real tight injections or plans concerning the number of customer facing employees and the timing of their hiring our expectations regarding financial results and the potential receipts of additional worthwhile.
Oh funds under our royalty agreement.
With healthcare royalty partners and the timing of topline results from the empowered trial and potential application for E U marketing approval.
These statements are based on current expectations and information available to US you should not place undue reliance on these statements. We may not achieve our goals carry out our plans or intentions or meet expectations actual results or events may differ materially due to numerous risks and uncertainties, including those detailed in the risk factor section of our.
Form 10-Q filed with the FCC for the quarter ended June Thirtyth 2020, as well as our subsequent filings with the FCC, we encourage everyone to read these documents.
Except as required by law Chiasma disclaims any obligation to update information contained in these forward looking statements, whether as a result of new information future events or otherwise.
Joining the call today as Raj, Kevin Chief Executive Officer, a non bird on executive Vice President and Chief Commercial Officer dual Ludlum Senior Vice President of clinical development, and medical Affairs, and Mark Fitzpatrick, President and principal financial Officer.
No I would like to turn the call over Twoq, Yasmin, Chief Executive Officer Raj Kinda Rush.
Thanks Glenn.
Thank you everyone for joining the call today.
We've been very productive during the second quarter booked preparing for the commercial launch of Mycapssa into U.S.
While in parallel continuing to advance our empowered beat three trials to support the potential approval of my cap so in the European Union.
I wanted to highlight three areas in my do you have to second quarter, all of which relate to my cap. So.
The first is the idea of Google and a broad indication we received.
The second is our a large preparedness.
And the third is our resources to support the plan robust commercial launch.
Words, DFT, a cool up my cap so the first and only oral so might affect analog on June 26, what's truly is significant and transformational achievement.
Talking aim vital come back for the company.
We delivered on a key 2020 goal in transforming key asthma into a commercial stage company with what we believe is the significant therapeutic advancement in the treatment of acromegaly.
We believe my Catholic would become the new standard a pharmacological care in a patient population that faces significant challenges.
Existing the matter that analog injectable.
Additionally.
This approval.
To date, our transient well Viewability enhancer Fourk TV.
Acknowledges the Liberty platform that we believe allows the.
The potentially develop additional oral therapies.
Designed to reduce the burden of chronic injections for people with the rare diseases.
Importantly, we believe the broad might capsule legal.
This would the opportunity to access all patients who responded to and tolerate it long term maintenance treatment with either Octreotide Orlando.
We estimate the approved label allows us to promote my caps, though.
Approximately 99% that that's a matter of fact analog injectable therapy market.
Which we estimate would be approximately 8000 patients in the U.S.
For whom other treatment options, including surgery to remove the pituitary tumor do not provide sufficient clinical benefit.
I'll bet, you Havent approved product with a broad indication.
Let me comment on our launch preparedness and my second topic to highlight.
As we indicated on June 26 on our approval called.
The U.S. accurate magli market is very concentrated.
Allowing us to market the innovative oral therapy ourselves with a small and targeted specialty sales force.
It is estimated that approximately 90% of patients with acromegaly, our managed by you wouldn't that a thousand medical accounts.
I've got to date, we've hired the first wave of our customer facing team, which is about one half of our planned full force of up to approximately 45 individuals.
In the they took kogut 19.
<unk> comping treated for allows us to be nimble and adapt quickly.
An initial remote launch.
Which leveraging tele health capability that are gaining acceptance by physician across the U.S.
Including endocrinologists.
We intend to expand this initial team depending on market conditions, including when and if the frequency of feet defeat the interaction increases to appropriate level or return to normal.
Non will provide a more detailed review of our commercial readiness activity in a moment.
In terms of our commercial supply Lady that we continue to work with our finished product packaging manufacturer. So really the initial commercial supplies of my capstone.
We expect this work to be completed and product to be made available to our specialty pharmacies by the end up this quarter.
On June 29, we submitted to the FDA eight C. D E 30 manufacturing supplement to our approved Andy.
Referencing our primary commercial octreotide acetate apiay manufacturer.
And we now await the FDA acceptance.
As of today and subject to finished packaging really.
We have reduced sufficient mycapssa capsules to meet our initial projected commercial demand.
As we announced in late July we were very pleased with the 48 week open label extension data.
Generated in patients.
He did with my cap. So following the 36 week he had my optimal trial.
Which demonstrated the durability of response on safety and efficacy with my cap so over the longer term.
Bill will walk you through additional detailed.
On this meaningful and relevant clinical data in a moment.
Lastly.
We believe we are well capitalized.
Our plan commercial launch and ongoing my cap that development activity.
We ended the second quarter.
$87.1 million of cash cash equivalents marketable security unrestricted cash excluding.
The approximately $75.5 million in net proceeds from the equity financing.
We completed last month.
And another $25 million, we just see through our revenue into its financing agreement with healthcare royalty partners in mid July.
Following the availability of commercial supply and the parts commercials. They look my caps in the U.S.
We expect to receive an additional.
$15 million from healthcare royalty partners under the terms of our agreement.
In summary, we have achieved every milestone plan to date this year.
And we remain on track, where the exciting commercial launch of mikasa in the fourth quarter.
And now I will turn the call over to build out of them.
Bill.
Thanks Raj.
Today's call I will review additional clinical data generated for my caps and our recently released 48 week open label extension results are the key asthma optimal trial and provide you with an update on the empowered trial.
Recall that 90% of patients who completed the 36 week key asthma optimal study on my crops are enrolled in the open label extension or Oh, well Lee, reflecting their strong preference to continue with an oral therapy to manage their condition.
I would like to provide additional insights we learn from that 48 week, Oh, well the data, which we recently announced notably.
The mean of the idea of one levels for the population of all 19 might cops are treated patients that completed the 36 week double blind placebo controlled or D. P C.
He asthma optimal trial and continued into the well we was maintained within normal limits at the end of the 48 week, Oh well the period.
90% or 18 of the 20 patients enrolled in the only who were treated with my caps. The during the DPC phase of the study completed the 48 week oily period.
All 14 patients who enrolled into the Oh, yes responders to my cap so meaning I do you have one within normal limits completed the 48 week, Oh, well, we period and 93% maintain their response within the normal limits at the end of this period.
Finally, the safety profile observed during early was generally consistent with the safety of my Thompson noted in the 36 week Yasmin optimal trial with no new patterns noted with the increased duration of exposure which are.
In summary, we believe the longer term data from the open label extension.
Demonstrated the durability of the safety and efficacy seen in the pivotal trial.
Importantly, it also confirmed the high levels of patients inherence to the drug regime over a longer term.
I will now turn to our ongoing empowered phase three clinical trial designed to support the potential regulatory approval of my cap. So.
In the E U.
As of today, a total of 92 patients randomized into the nine month double blind placebo controlled phase the trial as responders to my caps or per protocol.
85 have completed the trial and four patients remain active in the nine month randomized stays.
We continue to work with the clinical sites to ensure the safety of the patience and site personnel in light of the ongoing cobot 19 pandemic.
Notably the trial has already Matt you amaze required minimum of 80 patients randomized to the nine month randomized controlled phase of the trial.
The trials progressing as planned and we continue to expect to report topline data from this important trial in the fourth quarter of 2020.
The trial is positive we plan to complete our marketing authorization application for submission to the E Bay and the first half of next year.
Importantly, when the empowered trial is complete.
Mike Thompson will have been evaluated and more than 300 acromegaly patients globally across all three of our phase three studies.
This extensive clinical dataset should provide confidence to prescribing physicians, who are considering switching their patients from octreotide or landry a tight.
At this point I will turn the call over two and on for an update on our commercial activities.
John.
Thanks, Bill as Roger indicated we're continuing to advance toward the commercial launch of my CAFTA, which we expect will commence in the fourth quarter.
Our launch preparations are focused on three main priorities. The people, we now have onboard to execute the launch.
Promotional execution that can pivot with changing market conditions and market access and patient support to provide reimbursement and other support for patients transitioning to my caps.
On the people front, we have built our internal commercial team with top talent highly experienced in rare disease markets and competitive settings with numerous successful product launches to their credit.
We have now also hired and trained our first wave of sales inpatient services personnel and they're currently educating customers about my caps and our support surfaces.
Our CASM access and patient support or caps team is ready to provide personalized support to patients and providers to to obtain access arrange home delivery and assist with the transition process from Injectables.
And our account management team is engaging keep pairs to advance the process of obtaining broad access to my caps a four patients.
We're extremely pleased with the quality drive passion and track record of success of the team we've been able to attract a key asthma and with several members of our sales team having prior acromegaly SEC selling experience.
Our promotional execution builds on our efforts to raise awareness of the treatment burden endured by many patients on current injectable therapies.
This includes injection site pain injection site reactions and Miss workdays from having to visit a physician's office for a painful monthly injection.
As the first and only oral cemat OSAT and analog we believe my capsule will provide a much needed treatment option to help alleviate the challenges acromegaly patients have had to face with their current octreotide L.A., our Orlando Retied therapies.
Our multi faceted digital promotional program went into effect immediately after FDA approval and we had seen encouraging signs of both patient and HCP interest in learning more about the potential benefits of my capsule.
Our first wave of sales representatives again personal promotion to top tier endocrinology accounts at the end of July.
This team has been equipped with remote tools to engage customers or currently not open to face to face interactions due to covert 19 restrictions.
As a reminder, our current customer facing team is about one half the size of the total 45 members. We expect to ultimately have and we plan to scale up to that number as market conditions permit.
With a concentrated customer base with approximately 90% of patients treated at fewer than 1000 medical accounts, we anticipate that we can be effective with inefficiently size customer facing team.
With payers, we expect my capsule will be seen a significant innovation with important benefits to patients and we believe they will ultimately provide broad coverage at least on par with current treatments.
It is worth noting the payers already account for some aggrastat and analog injection treatments in their budgets. So my caps is not expected to represent an entirely new cost for that.
We believe our announced pricing of Mycapssa positions us competitively to existing injectable therapies, and we're working with payers to ensure the newly prescribed patients can obtain broad access to mycapssa through coverage policies implemented in the coming month.
We believe our go to market strategy is well adapted to succeed in the current covert 19 environment and we plan to continue to evolve our efforts based on changes to the marketplace and our own learning.
Notably the entire process of converting a patient from injectable therapy to my caps or can be accomplished with limited physical contact of desired from a tele health consultation with the clinician a prescription communicated over the phone or internet.
Mobile Phlebotomists for labs, and my capsid delivery and oral administration at home.
Overall, we're very excited by the opportunity to bring my cat set of patients.
Are ready to launch as soon as commercial product is available and are confident that we are well positioned to bring my capsid acromegaly patients in need of a new oral treatment option.
And now over to Mark.
Thanks, a lot has with summarized by rush at the outset of the call. We believe we are well capitalized for the planned commercial launch given our strong cash position at June Thirtyth.
And our more recent financing activity.
As we have emphasized in the past we will continue to prudently manage our cash resources to ensure that we are investing in the business to further stockholder value.
General and administrative expenses were $10.7 million for the second quarter ended June 32020, compared with $2.6 million for the same period of 29 team.
General and administrative expenses were $18.2 million for the six months ended June 30, 2020, compared with $5.1 million for the same period of 29 team.
The current year results include our continuing pre commercial activities, which were $5.6 million and $8.6 million for the three and six months ended June 32020, respectively.
An increase in compensation related expenses and increased other administrative costs as we prepare for the plans commercialization of my cap. So in the U.S. and the fourth quarter of this year.
Research and development expenses were $9.7 million for the second quarter ended June 32020, compared with $5.5 million for the same period of 29 team.
Research and development expenses were $17.8 million for the six months ended June 30, 2020, compared with $12 million for the same period of 29 team.
The increase in current year period results were primarily driven by the manufacturing of Octreotide capsules to support our plans commercial launch.
Costs associated with our disease State registry scientific literature publications and increased regulatory costs, which were offset by a decrease in clinical trial costs.
Going forward manufacturing costs related to the production of commercial supplies of Mikasa will no longer be captured in R&D expense, but we'll be capitalized to inventory.
For the quarter ended June 32020, net loss was $21.1 million or 50 cents per basic share compared with a net loss of $7.8 million or 25 cents per basic share for the same period of 29 team.
For the six months ended June 30, 2020, net loss was $36.5 million or 86 cents per basic share compared with a net loss of $16.6 million were 59 cents per basic share for the same period of 29 team.
Given the many variables associated with our commercial plans and the estimated timing of product availability. It would be premature to provide financial guidance for 2020 and 2021 at this time.
However, the following information may be helpful.
Our operating expenses in the first half of 2020 or $36 million.
These expenses included increasing pre commercial expenses as well as the costs of gradually expanding and readying our customer facing team.
We ended March 2020, with 49 employees and in July we completed the higher of approximately half of our plan to customer facing team, bringing our total full time employee head count to 68 at the end of July.
Also please bear in mind that our pre produce <unk> manufacturing costs to produce mikasa to support our plan commercial launch were significant in the first half of this year and are entirely contained in R&D expense.
These ongoing expenditures will now be capitalized to inventory going forward.
Immediately following my caps as approval, we began incurring promotional program costs that we expect will increase.
In addition, we have if we have positive empowered trial results.
We anticipate increased spending for yeah may submission in the first half of 2021.
Finally, we expect additional costs for potential pipeline product development, which are likely to be relatively low until we progressed further into the U.S. launch of my top so.
We will of course continue to refine our cost estimates as we evolve our commercial plans after which we will seek to provide more detailed guidance.
We ended the second quarter with $87.1 million of cash cash equivalents marketable securities unrestricted cash compared with $92.4 million as of December 31, 2019.
In April 2020, the company received a 25 million dollar payment less certain transaction expenses from healthcare royalty partners under the previously announced revenue interest financing agreement.
We received an additional $25 million from MCR in mid July triggered by the FDA approval of my cap. So.
In July we also raised approximately $75.5 million of net proceeds from an underwritten equity offering.
Upon completion of these financing activities in July we believe we have adequate capital to achieve our plans commercial and developmental milestones, including the commercial launch of my caps in the U.S. expected in the fourth quarter topline data from our phase three empowered trial also expected in the fourth quarter.
Yeah may regulatory submission planned for the first half of next year, if the empowered trial is positive.
And anticipated U.S. revenue growth and pipeline advancement utilizing RTP technology.
Now, let me turn things back over to Raj before we open the call Q in <unk>.
Thanks Mark.
We're excited for the planned U.S. commercial launch of Mycapssa to potentially transformed the lights that people with acromegaly in need of the new oral treatment option.
We've assembled a world class C and we look forward to executing on our robust commercial plans.
Operator would you. Please open the line for the Humanaone.
Certainly well now begin the question answer session.
He joined the question Q you May Press Star then one on your telephone keypad, you'll hear a tone acknowledging your request if you're using a speakerphone. Please pick up your handset because pricing anyway.
She withdraw your question. Please press Star then too.
Our first question is from Edward Tenthoff with Piper Sandler.
That's your Kindof your line is open.
Great. Thanks, very much because congrats on all of the success really exciting to here.
Are you getting southern Sawlogs in the fourth quarter.
One of them to get a sense for a little bit more what was the bus glue that factoring supplemental whether there's anything to kind of pay attention.
And then.
With respect to supply can you give us a little bit more characterization in terms of what you have and.
On him for the launch and does the manufacturing supplemental impact got so quiet all thanks, so much.
[noise] Hi, Ted This is Raj. Thanks for the question I'll make an overarching comment on the on the supply and the manufacturing supplement and I'll provide it tomorrow to add any additional comments as well on the mountain bikes and supplement as we stated before we had filed a CD.
30.
Which we are waiting the FDA decision to accept a b actual filing and then approve it.
We had mentioned that that there's a possibility.
If the ft approves that or accepts it on time, there's a possibility of in earlier than expected approval, but given the uncertainty around the manufacturing supplement in terms of when do you have to you will do view, except in a group. It we are maintaining our current guidance of pork you launch in terms of supply we.
As indicated in our prepared remarks that we have adequate commercial supply in hand to meet our initial projected demand. However that it's incumbent upon the FDA acceptance of our CD 30, which allows us to then put that commercial supply into the marketplace, Marc if I've missed some.
Being in that comment please feel free to weigh in.
Oh Raj said I think to capture to just fine.
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The next question is from Brandon So with Cantor Fitzgerald. Please go ahead.
<unk>.
Hi, Thanks, taking my questions and congratulations on one of the progress chain of caution and so just maybe following on from the prior question.
How quickly post an approval and of the top tenants would you be able to launch just in terms of getting inventory out the channel would you need a few weeks and then maybe secondly EM.
Since approval and based on your discussions with describe as it seems kind of travel do you think it any aspect of empowered anytime a bit more important well that had to describe as may play decided in the UK made right place a little bit more emphasis on wanting to see to further drive that adoption in the years. Thank you.
Hi, Brandon Thanks for those questions.
First and foremost on the supply availability I believe in our prepared remarks, we had said that we would be able to get a the commercial supply to our threepl or specialty pharmacies by the end of this quarter.
So I think that is still our expectation.
Whether we can do leave that commercial supply into the marketplace. As we said before depend on the FDA acceptance of the CD 30 manufacturing supplement. So that's that's it was a answer to the first question. The second question was on Mpower, obviously empowered as we know is a.
An important trial that will generate complementary data to optimal and so we expect a that physicians will pay attention to the.
Kind of data that you'd be able to generate which is one the relatives benefit versus injectables because that is in a head to head nodding Gardy Nannizzi already trial and importantly, there are many aspects with a with the quality of life information and these symptom mitigation.
Questionnaires that we would be able to address the hypothesis that whether a daily dose of my caps versus a monthly depot injection does contribute to a symptom mitigation for patients on Injectables hope that both answers your questions rent.
Hey, guys. Thank you very much.
The next question is from Douglas, though with H.C. Wainwright.
Just tell your line is up.
Hi, good afternoon, and thanks for taking the questions just.
Maybe a little bit of following up on Brandon's question just.
Curious in terms of the early days that you've been interacting with physicians post approval. Just you know what points around my caps or sort of point that feedback or you have you been getting.
You know from clinicians in terms of you know what their most excited about the types of patients their most interested and potentially switching I'm just any color would would be helpful. Thank you.
Hey, Doug Thanks for that question I will say that the Oh overarching respond to our introduction of my caps on approval has been very encouraging both from its cps patients and payers and especially in the corporate banking environment. A this is.
In particular quite an important option to consider for patients, but I'll, let on non weigh in war on the specific insights that we gathered from primary research as well as our field forces that are been engaging with our care well and our position since we put them on the ground.
And on.
Sure. Thanks Raj I appreciate it hi, Doug.
So Doug our the field sales organization has been in the just been out there now since the end of July since then a couple of weeks a the interaction. Since then I think it's pretty much tracked with our expectations around how the profile of my cap, so wouldn't be received and and what we've seen in prior market research and essentially.
What it is is that it's coming across as a viable option for those patients were on octreotide or Landry tied a who are eligible for an oral therapy in food for whom and all therapy would be would be quite strong and I think that that in that respect we've been pleased with that level of reception.
Of the into overall profile of the product and a and then for those that willingness for the specific patients that would be eligible for it.
The thing that we've been encouraged by is the interest level on the part of a cpms and patients that we saw before our sales organization was out in the field and I'm basing this on the traffic that we've seen to both our approach to our HCP as well as patient website and the engagement that the visitors have.
I had with the various aspects of it so they're not just sort of coming in and leaving their spending time, there are going through the brace modules that are downloading information and they're doing this from what weve away I gather from our agencies that at a at a rate that exceeds what are the benchmark. So have normally been all of that put together puts us in a and.
Optimistic mood and also one that says that a week or we think that the.
This product is coming through to the clinicians and for the patients that they think are eligible for it.
Okay, Great and then just one quick follow up in terms of empowered obviously.
Europe has had a much greater success in terms of controlling the virus. So at this point you know is there is the study really sort of executing the plan or and some of the modifications that you had anticipated or those not really or put into place you know those not having as big an effect or not as needed just given the situation there.
There <unk> you know that just be helpful that not understand as Weve of course that data. Thank you.
Yep.
So let me just provided a couple of things from build prepared remarks right. So bill had mentioned in his prepared remarks that we had 92 patients randomized.
As responders.
And then 85 of them have already completed and I want to remind folks.
Folks here that the EMA requirement the minimum requirement with randomization with 80 patients. So we are well about that particular, mark and we have four patients active and there's a global trial. So it's not just Europe alone, but we are on track built is there anything else that you would like to add to provide.
The sort of the confident that we have that empowered is on track.
No I mean, so as we would think saying all along.
We are using a time weighted.
Average analysis, which accounts for any missing data we have only four patients as Raj just mentioned I mentioned earlier that are still in the RCT everything is moving along very nicely exactly to plan.
I mean, I guess more just to clarify offline.
<unk>.
I was just 'cause they just in terms of any so obviously I know you know the time weighted average accounted for any missing data, but you know just given how quickly you know sort of X U.S. people are able to get control of the virus and you had you know has that been less of the factor then you potentially anticipated a rich you know several then several months ago.
Well, we haven't gotten into the specifics again. This this is an ongoing trial I can tell you that there has not been any.
Loss of patients do the coated 19 issues, we very proactively early on in the process began to create all kinds of safety measures. So we were able to follow up closely with patients provide drug so and working very very closely with the sites that are working closely with the patients. So we've been able to navigate.
Through this are really a very well and a as we said a patients are continuing to go through as planned and we only have for that are currently remaining.
Yeah, Okay Bollywood given phase we also remain on track to report the top line data that's still in fourth quarter and we remain excited about that particular milestone as well.
Absolutely okay great.
<unk>.
Your next question is from Kumar badge out when book line capital market.
Lodging your line is open.
Congratulations on all the progress and thanks for taking my question.
With regard to the might affect setting supplement how you hide any interactions with the F. B of calling the submission in June.
Do you have it Ben so at that site inspection would be required.
Yeah, Hi Kumar. Thanks for that question, obviously, there's ongoing a interactions with the FDA. We typically don't comment on however, with regard to the inspection remember we had mentioned this before that the given the reason inspection history of the.
A primary apiay supplier.
We did not believe this is going to the case, but however, we always caveat that as saying that the ft always reserves the right to conduct an inspection at any given point in time.
We that's why we're remaining conservative in our guidance and we continue to say that our launch is still scheduled to be in the fourth quarter and not necessarily jumping the gun and taking the best case and putting that out there right now.
And with regard with a goal based fans who did not from the part a week or open label extension.
Walked out of the fact, the side with the which they will not complete thing that any glad it they with regard to what type buying or they do.
The trial.
Well, how do you want to take on any.
Yes, we haven't given any further clarification other than what we've released in the press release and the the script today, we will be giving a very complete overview of the data we're very pleased with it.
And the and upcoming academic setting and we'll we'll publish it soon we have not gotten at this point into any further details 90% or completed the oil Lee that went and we thought that was very very positive very consistent with what we've been seeing a very nice maintenance on treatment good experience for clinicians and patients.
And haven't gotten any further granularity on that.
Yep, and <unk> and what I would also say Kumar is that I think we were very pleased with the durability of safety and efficacy that we saw over the longer terms. So there's only validate the response is maintained over a much longer period. So we hope that that will also be replicated in the real world and that is.
An important data point for commissions to be able to adopt and prescribed mycapssa.
And finally, one housekeeping question with regard to the supply for the specialty pharmacy.
Hi, if you feel good capital part the manufacturing supplement before Q3.
I think in last quarter, you said that a little bit recognizing.
Revenues ones or something like this by kind of get bought him as he thought.
You bet outflow comes through in Q3 little bit recognizing those revenues in Q3 I believe.
So there are other queued activity some of them spoke again, sorry, Mark go ahead.
I'm, sorry to interrupt you rush, yeah, So kumar Theres shipment to the specialty pharmacy in Q3, that's the revenue recognition event for the company.
Okay, great. Thanks.
This concludes the question and answer session I would like to turn the conference back are you guys kind on for closing remarks.
[noise]. Thank you for joining us on the call today, we always appreciate your continued support and we look forward to sharing our progress update and our continued progress periodically.
I have a wonderful day and a safe rest of the summer. Thanks again talk to you all to.
This concludes today's conference call you may disconnect. Your lines. Thank you for participating and how to present day [laughter] [noise].
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