Q3 2020 Chiasma Inc Earnings Call
Perhaps a bit.
Turn the call over to key customers Chief Executive Officer Raj candidate Raj.
Thank you Glen and.
And thank you to everyone for joining the call today.
I will start my comments today with an overview of our fighting Mycapssa us launch and provide an update regarding our planned phase three MPOWERED study data release.
He has more optimal trial result in acromegaly patient.
Of particular note the paper highlighted that might capture can be an effective maintenance therapy for those patients previously controlled with injectable sumatriptan analog.
For example for those patients treated with my capture in the study the mean of their idea one was maintained within normal limits.
Patients and physicians appear to have a positive experience with the oral octreotide capsules as 90% of Mycapssa treated patients opted to continue into the open label phase of the trial.
Quite the burden that clinical trials may place on patients and their families.
To us this suggests a strong preference for all treatment in patients previously controlled and successfully switched from occupied Orlando had injections.
Unmet need that we believe remain in this marketplace.
Shifting to our third phase three study empowered.
We're excited to announce that we expect to release top line results later this month.
<unk> sales team of 10 territory business managers and clinical nurse liaison.
This team engage customers for approximately a month before commercial product was available in.
In order to introduce key asthma begin educating on my cap Sir.
And our patient service offerings Bill.
Build relationships with new customers and prepare for the commercial launch.
We also learned valuable insights on the tactical mix that is most effective in this environment.
To share with you select relevant indicators of our early launch progress to date.
As is common in rare disease markets, each cps initiate mycapssa prescription by sending a consented patient enrollment form or PS into key as most dedicated in house patient services group, which we call key asthma access and patient services or caps.
We're pleased with the solid progress and receiving Tcfs for both patients who are to be initiated on my cap. So for the first time as well as for the conversion to commercial product of us might capture patients who were enrolled in the open label extension phase of both the optimal and empowered trials.
And the timeframe over which has happened is variable at this stage of the launch.
Are also encouraging.
Sure at the outset of the call. We believe we are now well capitalized for the US commercial launch of my cap. So.
Straight up costs to support the commercialization of my caps in the United States.
Research and development expenses were $4.5 million for the third quarter ended September 30th 2020, compared with $4.1 million for the same period of 2019.
As time.
However, the following information may be helpful.
Our operating expenses in the first nine months of 2020 were $53.6 million.
These expenses included increasing pre commercial expenses as well as the cost of gradually expanding training and deploying our customer facing team.
As of the end of October we currently have 85 full time employees.
Immediately following my caps as approval, we began incurring commercial related costs that we expect will continue to increase.
In addition, if we have positive and powered trial results. Later this month, we anticipate increased spending for M- m- submission in 2021.
Finally, we expect additional cost for potential pipeline product development to be relatively low until we progressed further into the us launch of my capstone.
We ended the third quarter with $177.1 million with cash cash equivalents marketable securities and restricted cash compared with $92.4 million as of December 31, 2019.
In April 2020, the company announced the revenue interest financing agreement with healthcare royalty partners for up to $75 million and since that time have received an aggregate of $65 million and financing under this arrangement.
When we expect a strong us launch trajectory to take shape as the business environment hopefully the open.
We look forward to releasing the empower data later this month, which is positive is expected to support an application for marketing approval for my cancer in the EU.
And potentially allows us to expand the benefits of mycapssa to patients outside the U.S, but.
Over the next few weeks, we are scheduled to present at various virtual cell site investor event.
In addition, we're hosting a key opinion leader Webinars on November Thirtyth.
And we encourage all of you to join.
We will provide additional details as the events near or on our website.
We will now open the call to take your questions.
We will now begin the question and answer session.
During the question here you May pursue star then one on your telephone keypad, you will share return acknowledging your request. If you are using a speakerphone. Please pick up your handset before pressing any keys to withdraw your question. Please press Star then too.
Well pause for a moment us callers join the queue.
Our first question comes from and 10 tough with Piper Sandler. Please go ahead.
Great. Thank you so listen congratulations on becoming a commercial company.
Thank you as you said.
One further is going to be a lot of questions on my car per car kind of skip ahead to really talk about sort of the pipe or in a little bit.
You bet.
From our competitors.
Point, and then secondly, given that we will get empowered later this month Uhm I envision a few questions you opportunity says could you maybe just talk about sort of the range of options that you were thinking about full commercialization there and then how 'bout market.
Holding you know I agree with some commentary about standards path and <unk> you. So just any color they would be great as well just as we speak could afford to how big that opportunity is gonna be relative to yes, which is obviously going to be the major off between two thank you.
Yep. So let me uhm see if I can sequentially address your questions brand and thank you for your questions Uhm first and foremost on the competitive datasets that was well the the other company was making a little a molecule in putting into development.
Let me make an overarching statement before I hand, it over to bill our internal medical experts and endocrinologist.
We hold to an industry standard in not comparing across trials <unk>.
Any conclusive statements unless it the head with study.
I would also say that we're pleased that there was another oral agent in development that validates the unmet needs in this patient populations.
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The actual data that we saw that was released recently I'll hand, it over to bill to provide this perspective on the data and is a clinical perspective on it bill.
Thanks Raj to your 0.1 should be really careful about making comparisons between trials H and optimal have two very different patient populations from a baseline.
F one standpoint, and a very different study duration.
The patient populations that are similar across the two agents my capsular and.
<unk> are the evolved an optimal studies as both studies enrolled well controlled patients on their injectables at baseline.
And the evolved study for the kinetics corporate deck and their recent street called transcript at eight weeks their time point of randomization only seven of 13 patients could be randomized with an IGF, one less than or equal to 1.0 times you up a little bit of normal in other words, 54%.
Pain IGF one in the normal range.
We have not previously recorded this but at the same eight week time point, an optimal 82% of my consultations were maintain in the normal range.
Is Raj mentioned yep.
Steve go ahead really sorry ethic, that's good maintenance.
Maintenance therapy for those patients previously controlled with injectable somatostatin analogues and I'll turn it back to you rush.
Yep, Thanks, Bill and I I would build on our Bill's comments again.
This was bored response to your question Brandon However.
I would not make any conclusion.
<unk> on these data points like.
Like I said I'm pleased that there was another option being made available in oral option being made available to patients in this particular marketplace.
In our in our estimate we are way ahead in terms of entrenching ourselves into the market and we look forward to the other molecules.
Generation of data in terms of proving their similarity to the current standard of care.
In regards to your next question in terms of Europe, and other markets, obviously, as we said what excited to.
Look forward to the date this month, when we released the empowered topline data results.
We hope to file in the E U some time in the middle of 2021, assuming the data or positive now.
Our our plans are to keep our options open for potentially commercializing my caps in Europe and in other markets, whether it directly or to one of our more potential collaboration arrangements.
In summary, I think at this point in time, we have no conclusions or no decisions made in choosing the option that makes the most sense.
Four key asthma, both on a strategic and financial basis.
Random did I have a third question Unempowered that if you could repeat that for me. Please.
No. It was just that with empowered coming this month, okay and I just got his money into asking about the European opportunity given that even though you have just launched and then you said that was very helpful. Thank you much and congrats again.
Thanks Brandon.
Once again, if you have a question. Please press Star then one.
The next question comes from Douglas.
<unk> with H T. Wang Wainwright. Please go ahead.
Been able to do you have given their limited numbers and reaching these key accounts.
Give you. Some examples we reached about three quarters of a pituitary care centers, which are the centres of excellence that treat acromegaly patients and that also represent a higher concentrations of acromegaly patients as well and we've done that both with personal sales calls either face to face or via video conference or via other <unk>.
Digital tools of engagement as well and then we've also branched into the larger group of higher volume endocrinologist that are not in to a charity care centers. We've reached nearly 40% of those accounts with either personal selling calls or with a digital engagement as well and we estimate that the.
<unk> the in those two categories of.
Of accounts that we targeted during this first wave that over half of the patients that are treated for acromegaly are represented in that in that population. So with what we learn from that first wave in with the limited numbers of that team had we decided to expand on that effort by more than doubling the size.
Of that selling team and that they are in the process as I mentioned in my prepared remarks of being hired and deployed and and then getting out in the field, but the the the positive learning. So we had from wave one really contributed to our decision to expand that effort and to capitalize on the learning. So we've had so far.
Thanks, and and the other question Chris that you had was the potential toward the empowered theda's positive.
For incorporation into the U S label, if that's correct.
So as you can call them power to the large space Yep, sorry, Chris.
Sorry, I was wondering not so much about the label I just wanted to see how that would affect the U S sales potentially.
I I would say that empowered.
I've been sort of a study skies and.
Potential to generate data from a comparative basis again alright.
Injectable unethical things safety symptoms are good quality of life they were.
High level of interest among kols in academics to understand how that at the theater that we generated an optimal. So this is something that I I know that we've heard anecdotally from our kols that they're looking forward to getting that data and it certainly is complementary to what we've already generated and I.
Add for a rat disease product. This is a typical type.
Type of the robust clinical database that we've already generated with three large studies that provides a degree of comfort for physicians to think about what patients would be appropriate for therapy as they think about it. It acromegaly does that answer your question Chris.
Yes. It does thank you for the details.
Thanks, Chris.
The next question.
Question comes from Kumar, Roger with Brookline Capital markets. Please go ahead.
Congratulations on the lawn and thanks for taking my question.
First with regard to the hundred million life sports actually that will be covered by the 830.
Yeah.
Sundays off Acromegalic patient contact income path.
And.
With regard to the macro registry.
Where are we with regard to the enrollment of pay hand, fine how respecting liberty once a month.
Yep. Thanks Kumar for those questions I think at this point in time, it would be difficult for us to parse out exactly how many patients would belong to those different plans because remember we are projecting this as to 100 million life that will.
Across the plan at work negotiating with currently.
<unk> formulary or a formal coverage policy in place. So we hope to update you maybe at our next earnings call. If the type of players that are provided formerly the coverage for my Cup, Sir in the fourth quarter or before the end of the year and we hope to be able to answer that question better when we have that data.
In terms of the macro registry.
So before before I go to the macro registry, let me ask the doctor or not.
If he wants to add any color to that statement anon.
Yes, Thanks, a lot Raj Kumar, it's good to speak to speak with you and you know regarding that 100 million lives. If you think about it but it's about 300 million lives that are under that.
That are covered by and they made major pairs, we anticipate that that acromegaly patients are going to be broadly distributed across the country and across payers just like anybody else. They don't aggregate in any particular space, they're not predominantly for example, Medicare or Medicaid patients. So they have a payer mix, which is broadly representative of the.
Population, so I think that that 100 million being about a third of the total covered lives would give you a sense of the proportion of the acromegaloid patients that would be contained in there as well.
Thanks, and on and on the macro Registry Kumar I would let me just make a statement I think we're very pleased with the progress. This is the first of its kind in terms of the interest that we've seen from physicians to enroll into this regulatory program in stock documenting the current state of <unk>.
Care, we hope to generate meaningful real world evidence through this registry, let me hand, it over to bill to add any color.
To our macro registry that we're excited about.
Bill.
Yeah. Thanks, Thanks Rush can work great. Thanks for the question Yeah. As Rush said, we're we're very excited about the the registry its capacity to Ah collect data on real world experience patient experience on variety of treatment options.
And it's progressing very well a lot of engagement with patience and various centers around the country. It's a U S. Only a registry and we'll look forward in the months ahead as we begin to do data cuts and and publishing that data and making it available to others.
Thanks commodity does that answer your question.
Yes. Thank you so much.
Yep.
This concludes the question and answer session I would like to turn the conference that covered at the present insurance for any closing remarks.
Thank you operator, I would like to close the session by recognizing acromegaly awareness day on November 1st where key asthma reiterated our support to the patients in patient advocacy organizations fighting the good fight having that many of the patients with acromegaly.
It is truly an honor to partner with them and making their lives better. Thank you all for participating in our last earnings call for 2020.
We look forward to speaking with you again, when we released the topline results from empowered later this month, thank you and speak with you all soon.
This concludes today's conference call. He may disconnect. Your lines. Thank you for participating and have a pleasant day.
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