Q1 2021 Axsome Therapeutics Inc Earnings Call
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Good morning, and spoken to the Axis Therapeutics conference call.
All participants are in a listen only mode. Later, there will be a question and answer session and instructions will follow at that time.
Today's conference call is being the quake.
I'd now like to turn the conference over to your host Mark Jacobson, Chief operating officer of Axis Therapeutics. Please go ahead.
Thank you operator.
Morning, and thank you all for joining us on today's conference call.
Our earnings press release, providing corporate update and details of the company's financial results for the first quarter 2021 cross the wire of short time ago kind of.
The available on our website at <unk> Dot com.
During today's call, we will be making certain forward looking statements. These statements may include statements regarding among other things the efficacy safety and intended utilization of our investigational agents for.
Clinical and non clinical plans from our plans to present or import conditional data interest.
The big conduct and source of future clinical trials regulatory plans future research and development plans commercial plans and possible in the use of cash and investment needs.
These forward looking statements are based on current information assumptions and expectations that are subject to change of involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward looking statements.
These and other risks are described in our periodic filings made with the six.
<unk> and Exchange Commission.
Including our quarterly and annual reports you are cautioned not to place undue reliance on these forward looking statements, which are only made as of today's date on the company disclaims any obligation to update such statements.
Joining me on the call today are Dr. Arie on two Butow, Chief Executive Officer, the PV, Chief Financial Officer, Lauren Inglebert Senior Vice President of commercial and business development for Amanda Jones Senior Vice President of clinical development, Dr. Cedric O'gorman Senior Vice President of Medical Affairs.
<unk> will first provide an overview of the company and then review recent developments and on.
What kind of milestones following the Oreo Marie will provide the commercial update and then Nick will review our financial results.
And then open the line for questions.
<unk> will be taken in the order they are received and with that I will turn the call over the area.
Thank you Mark good morning, everyone.
You all for joining acts on Therapeutics first quarter 2021 financial results and business update conference call. The timing of this call for five with the mental health month on axon is proud to observe the of mental health month by partnering with advocacy groups and helping to raise awareness and support for people living with the <unk>.
<unk> and other mental health conditions.
In the first quarter, we continued to make significant strides towards becoming a premier CNS for biopharmaceutical company focused on delivering potentially life changing medicines for people living with serious CNS conditions.
The dedicated work of the excellent team resulted in the submission of our NDA for <unk> for the treatment of major depressive disorder or MPD.
The NDA was granted priority review by the FDA and the FDA has set up of <unk> target action date for the NDA of August 22.
2021, the <unk>.
For our second lead product candidate, except for <unk> for the acute treatment of migraine is on track for submission to the FDA this quarter.
And we expect to announce the Fda's decision regarding its acceptance of the filing in the third quarter.
With two NDA filings of Purdue for target action date for ex that Sofia in late August axon is quickly approaching commercialization stage.
Lori will provide some details on our pre commercial activities to ensure launch readiness, assuming a successful NDA review.
For the rest of our differentiated late stage pipeline continues to advance.
Except for five is also being developed for the treatment of Alzheimers disease agitation and enrollment in the phase III of core trial is progressing.
Our next of 12 product candidate for narcolepsy is progressing towards initiation of the planned phase III trial early in the third quarter.
For our excess 14 product candidate for the treatment of fibromyalgia, we recently met with the FDA to discuss it further clinical development plan.
And we are awaiting written feedback from the meeting.
Our portfolio comprises for late stage product candidates under development for the.
Think of indications representing unmet medical needs that effect of large percentage of Americas.
We are energized by their potential to deliver significant benefit to patients and by our plan of the commercialization of approach.
I will now turn the call over to Laurie who will provide a commercial update.
Thank you area and good morning, everyone. This.
This is an exciting time of axiom as we continue to prepare for a successful launch of excess of five major depressive disorder.
Today, I will give you an update on our commercial activity as it relates to the launch readiness.
The prevalence of depression, Samsung and U S. Adult has been steadily on the rise for many years.
However.
Recent studies have shown that in 2020, almost one third of U S. Adult experience the credit has been.
Yeah.
That's a greater than four fold increase versus 2019.
As a result of the rapid increase in mental health conditions, and the associated personal and economic burden associated with them.
Undeniable urgent need to bring on awareness and support to those affected.
If approved in excess of five would be an important new treatment option for the many Americans living with depression.
We are committed to bringing this meaningful innovation to patients by commercializing the product in a timely manner.
We don't expect it to do the date of August 20.
We anticipate launch in the fourth quarter of this year.
Consistent with the actions culture, our commercial launch strategy with innovative and purposeful.
I have spoken previously about the plan for our digital centric commercialization, our DCC platform to the used at means to optimize engagement across all customer types.
Our commitment to and belief in the digital focus has only amplified over the past year as research continues to indicate a strong preference for and trend in this direction with our core customers.
Our foundational technology infrastructure is now fully implemented.
And we continue to build out of our digital capabilities.
Using sophisticated data and analytics streamline systems and digital enablement tools or.
Our DTC platform will allow for more effective efficient and meaningful engagement with physicians and consumers.
Along with building out our DTC platform over the past year, we've constructed the commercial team that combines breadth and depth of commercial experience.
With the desire to innovate.
I am extremely proud of our commercial team and I am impressed with our thought leadership and passion for helping those affected by CNS condition.
Functional thing of leadership across marketing market access commercial operations and sales are all in place.
Launch activities are focused on a potential queue for launch of excess of five <unk>.
True.
The preparations also include the launch readiness quite potential expense of seven months.
Our marketing team is focused on disease education and posts per day for a launch of promotional planning.
The market access team continues to engage in ongoing permitted discussions with payers and sharing of awareness of axiom and of access of five product profile.
Along with actively setting up a comprehensive patient support services.
The commercial operations team and ex partly working to implement and execute our D. C from vision.
And lastly, our sales team has determined the optimal size structure and design of our sales force and are now concentrating on sales force preparedness.
As hiring the field leadership and rack level has come true.
And finally on.
Side of commercial.
Medical Affairs group is focused on data presentations at upcoming Congresses, and continuing MSL engagement with Kols.
I will now turn it over to Nick who will review our financials.
Thank you Lori and good morning, everyone. Today, I will discuss our first quarter of 2021 results and provide some financial guidance.
We ended the first quarter with approximately $165 million in cash compared to roughly $184 million in cash at the end of the fourth quarter the.
Net decrease of approximately $19 million.
R&D expenses were $16 6 million for the quarter ending March 31, 2021 versus $27 5 million for the comparable period in 2020.
The decrease in R&D expense was driven by a one time charge of the prior period of $10 $2 million related to the Pfizer license agreement along with several of our clinical trials that were ongoing in the comparable period debt have subsequently been completed.
The current quarter include the $2 $9 million charge related to the Paducah application fee for the NDA submission for access of five.
Subsequent to the ended the quarter, we have received confirmation from the FDA that our small business way. The request has been accepted and we will be refunded the speaking for application fee.
G&A expenses were $11 2 million for the quarter, ending March 31, 2021, and $5 million for the comparable period in 2020.
The change was primarily due to the increase in pre commercial activities and stock compensation expense.
Net loss was $29 $3 million for 78 cents loss per share for the quarter ended March 31, 2021, compared to a net loss of $32 5 million or 88 loss per share for the comparable period in 2020.
As a reminder, we currently have a $225 million term loan facility of which $175 million in funding remains available. This.
Of this committed non dilutive capital gives us additional financial flexibility through both the anticipated potential commercial launches of the excess of five and excess of seven.
We believe our current cash position of $165 million, along with the remaining committed capital from our $225 million term loan facility is sufficient to fund our anticipated operations based on our current operating plans into at least 2024.
That concludes our first quarter 2021 financial review I will now turn the call back to Mark to lead the Q&A discussion.
Thank you Mike Operator May we please have our first question.
Thank you.
The migration at this time, if you would like to ask the question.
The press Star followed by the number one on your Touchtone phone to withdraw your question press, the pound or hash sign.
Your first question comes from the line of Charles Duncan from Cantor Fitzgerald. Please go ahead. Your line is now open.
And the loss.
Ariel and team congrats on really good progress in the quarter.
I had a quick question regarding the <unk>.
The upcoming could do for date for <unk>.
For Mbd would you anticipate an AD com in advance of debt.
FDA communicated anything or for even if the Hamlin.
Are you prepared to conduct an ad com.
Thanks for all for for the question.
Not gotten any communication from the FDA, indicating that there will be an outcome.
You know filing approval.
But what are your thoughts in interaction with payers on <unk> as well.
Hey, Matt.
The terms of coverage.
I know, it's kind of a lot on the call, but it is really too premature for us to really disclose that but its outside of the premature.
Those are ongoing.
And so we're thinking three of that in terms of of patient support services on offerings that we make sure of that patients are covered.
But we do anticipate that the product will be covered we have high confidence of the product well will be covered and.
And we do believe that payers are extremely interested in the product profile.
In terms of access of seven.
That those discussions.
We performed market research, but we have not discussed.
The access of seven with payers specifically outside of just an overall acts on portfolio introduction.
Okay very good thanks, and then maybe area in terms of next indications for <unk> five.
Can you talk a little bit about where you are and how it's out of the education phase. The program is progressing and then kind of next steps for <unk>.
Smoking cessation as well.
Sure.
Thanks, Matt for for those questions on <unk>.
Right.
I'm going to turn it over to Tom Enders Jones on too.
To provide color on those two programs.
Great. Thank you.
Hi.
So in regards to the Adi definition program that is progressing nicely and it's still a little bit early for us to give any formal guidance on it.
The.
The overall status just based on the nature of the study design, which involves the Nok. She is responding and then being randomized.
Two of relapse.
And then the second question was around smoking cessation.
Yes.
Yes, so we are planning to meet with the FDA in the third quarter.
And then based on our.
Interaction for example will provide an update on that program.
And then if I if I just may add two to tremendous comments regarding all of miners disease agitation.
In addition to the progress that's being made in the trial.
While it is still early.
On the metrics that we're seeing in currently.
<unk> our initial guidance.
On the data read out in the second half of 2022.
Yeah.
Okay. Thanks for the detail.
Your next question comes from the line of Myles Minter from William Blair. Please go ahead. Your line is now open.
Thanks for taking the questions.
Just one on the on the payer landscape and it's.
So there are for us, but it seems reasonable that the the pie is probably going to force.
For step through the 15th therapies and by the time of the clinicians down of prescribe this product of it's technically the playoff play out a population and so on.
I'm wondering have you got on any pushback from clinicians that stop on the missed the endpoint.
So we haven't necessarily seen control policy of day to day and I guess, if that's the case, what's your current message that you're educating those clinicians to get the models of the line to the swap based upon the potential launch.
Hey, Myles.
I'll start and the answer some of your questions, but I'd like to turn it over to Cedric and in terms of what the MSL for our hearing on that line.
Yes, and I would like to share of miles.
The nature of clinical trials people, who are actually enrolled in clinical trials for MTV tens of.
Typically in responding to.
<unk> treatment so in essence, the patients who are coming in for MTBE.
Already patients who are.
Of our somewhat resistant.
There hasnt been a great degree of pushback because of people realize that.
You treats coming out for the branded treatments tend to.
The market and I think that the data that we've generated to date on MTV with the versus the appropriate on the defense study versus placebo showed the differentiated clinical profile of both in terms of rapidity of onset of action, but also in the early improvements in quality of life of functioning so.
I think overall of the clinical profile of the differentiation of the access of five is an.
From what we're hearing in the field is a compelling argument as to.
But the use the drug if they see a difference from both on it yet.
Right and then if I may add to one on one of the things that debt.
Hearing.
From from Kols and from the <unk> in the field based upon our recent data presentation on the comments the studies for.
For example, what could be the outcome of subsidies in the.
<unk>.
Is that.
There is a very compelling profile that is emerging with a lot of evidence showing that the drug works actually just as well in those patients who had PRT sales multiple lines of treatment as in the patients.
Who are treated for frontline.
And then the other.
The other thing I think too that we are hearing.
From from experts.
In the field, who are familiar with the.
T O D and just depression in general.
Is that.
It is exiting rather impressive.
On that we've had now essentially.
For phase III trials.
All of which have been positive so even if you look at described one trial.
The <unk>.
The the growth clearly separated.
From an active control using a higher dose.
<unk>.
The.
The the.
The effect that we see.
With regards to depressive symptoms was evident at week, one and it lead to sort of just the.
It's important to remember that.
And in the <unk> trial physical significance was achieved at week, one and at week two in the in acuity.
Patient population and and not only that improvements in quality of life and also in the stability.
We are of much higher than has been seen with other agents. So why so it's overall, it's been it's been very positive and accurately.
On the NFL at the beginning of a lot of questions around stride because of its positivity.
Of.
Of course, with what happened to variability, which is expected in this patient population.
Hey, Myles I'll, just I'll just pile on here is there sort of comment perhaps on the comment on your question.
What was the stated by both standard and area.
Very consistent with what we're hearing with payers as well they are taking the entire.
The patient population in the study that we conducted in the population.
Accounts.
Yes, I think all of that along with product and Gary as well maybe just another quick one on now youre not commenting on the minutes because youre waiting for them.
But in the cash <unk>.
<unk>.
For bought it today does that actually include quotations for potential additional clinical Shaw for access for <unk>.
And for the object.
Yes.
So our our cash guidance certainly includes spend for excess of 14.
So as you know.
As we stated we are.
On sympathizing Epi this is the new chemical entity and.
And when do you want to make sure that we have a considerable supply ready.
Net would be necessary for registration for <unk>. So some of that spend is necessary for the potential next step with regards to.
With regards to two for the specifics of our clinical development plan.
We will be getting rid of feedback from the agency before making any pronouncements.
Fair enough thanks for the questions.
Your next question comes from the line of David Holmes from SMB <unk>. Please go ahead of your line is now open.
Alright, thanks for the update on taking my questions a lot of great questions asked already so I can have the.
Quick ones.
So first on an excess of five mbd.
How much of the target prescriber population would you say is primary care physician versus psychiatry.
And do you expect.
The there would be the.
A lot of prescribing from the primary care side of the.
Guidance for fiber base.
Yes, Hi, David Thanks, Thanks for the question, it's really really getting on.
So we tend to not look at it is at think versus PCP was looking at it.
On hydro <unk> and the.
The highest propensity prescribed on.
Either category.
Thanks of our PDP.
There are many PPP is out there to our mental health bucket.
And in our actually prescribed at the same level.
Some of the science of.
Of our targeting well on campus.
The drivers.
Along with the ones that we consider to be the most.
The benefit of other Tonight.
Got it. Thanks, that's really helpful. And then just in terms of both the nose. Kevin are there any plans for eventually commercialize those products out there.
On the U S and ex U S geographies, either on your own or through a partner.
So I can answer that question as of yet they're asking we publicly disclose that we aren't we are looking for partners outside of the U S.
Investments are ongoing.
Okay. Thanks, that's all from me.
Your next question comes from the line of Robert <unk> from BTG. Please go ahead, I mean, you kind of a thing.
Hi, This is Terry on the line for Bert Thanks for taking the question.
Just a brief question on the excess of five.
Alzheimer's disease agitation trial.
Should we expect an interim analysis at some point and if so.
What can we expect in terms of efficacy data at that point in any of any.
The color.
In terms of timing for the.
On a potential of the trend analysis.
Thanks.
Yes.
There are there currently is on.
There is not currently in the plan for an income analysis of this trial. However that the study is designed so that.
Based upon what we see in terms of.
Of that rates that one could be incorporated.
<unk> of growth studies are driven by the number of events and that is typically how they are powered.
So why.
Right now as we mentioned.
In the earlier remarks that it's too early to know what the cadence will be relapses.
<unk> has done a study like this before november's disease agitation, so while we're very much looking forward to seeing.
On how the study plays out but right now we are not.
We have not planned interim analysis.
Okay. Thanks, Thanks for that and then.
Just one more on excess of 12.
Could you could you just talk a bit about.
The potential.
Thoughts on endpoints in the trial, including <unk>.
Timing any any any color would be helpful.
So for excess 12 of the the primary endpoint of of the study will be the change in the frequency of cataplexy attacks.
So that is the state of that.
The spread of the supply.
The bill.
Completed phase <unk> trial.
The success.
Okay perfect. Thanks for thanks for taking the questions and congratulations on the progress.
Thank you.
And your last question here kind of from the line of from center on Shin from H C. Wainwright. Please go ahead. Your line is now open.
Yes.
Once again, Rob it sounds from <unk> from H C. Wainwright. Please go ahead and you for your question.
Okay.
Okay.
Okay.
The other question can the queue I will turn the call back over to management for closing comments.
Well. Thank you all again for joining our call. This morning, we are excited as we move potentially towards commercialization and as we advance the rest of our pipeline for the benefit of the many people living with serious CNS conditions. We look forward to keeping you updated on our progress in the months ahead.
And this concludes today's conference call. Thank you for participating you may now disconnect.
Okay.
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Good day.
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