Q3 2022 Amylyx Pharmaceuticals Inc Earnings Call
Including those set forth in our most recent filings with the SEC and any other future filings that we may make with the SEC.
You are cautioned not to place any undue reliance on these forward looking statements and analytics disclaims any obligation to update such statements now I will turn the call over to Justin.
Thank you Lindsay and thank you everyone for joining the call.
Our mission is to end the suffering caused by Neurodegenerative diseases.
And while much work remains.
Last few months have marked incredible progress, including the FDA approval and commercial launch of delivery for adults living with ALS in the United States.
This marks our second commercial launch following the approval of <unk> with conditions in Canada.
We know the ALS community is counting on us and we are working every day to help ensure that every eligible person who can benefit from <unk> and <unk> can gain access as quickly and efficiently as possible.
Given we are only a few weeks into the launch in the U S. It is too early to discuss specific expectations, but we are encouraged by the initial engagement with both physicians and with people living with ALS.
Margaret will share some further insight shortly.
Outside of North America, we are actively pursuing regulatory approval of Amex 35 for the treatment of ALS in the European Union.
Our marketing authorization application remains under review by the committee for medicinal products for human use or <unk> of.
The EMA.
We are now in possession of the rapid <unk> day, $1 50 Joint assessment report, which was provided to applicants as a reference as the <unk> comments to responses made to the day 120 list of questions.
While we have resolved several major objections from the day 120 list of questions. Some still remain and we will work to continue to try to address them as part of the MAA review process.
The next step in the process as the day 180 list of outstanding issues, which we will respond to accordingly.
The <unk> also intends to hold the scientific advisory group meeting as part of the regulatory review process.
The EMA process is still on track and we expect a decision in the first half of next year.
With that I will turn the call over to Margaret to share some insights into the early days of our launch in the United States and to provide an update on our Canadian launch.
Great. Thanks, Justin.
In the days and weeks following the Fda's approval of <unk> in September 2009, we immediately started receiving enrollments and prescription through the analytics care team and I've heard very positive feedback from physicians and the ALS community about the level of support we are providing.
Importantly on October 24, the first shipment of <unk> from one of our specialty pharmacies with them to a person living with ALS.
Earlier than we had originally anticipated.
In regard to interest in <unk>, we are seeing a solid initial bowl.
Including an encouraging number of product enrollment forms the prescriptions coming into the analytics care team.
This initial excitement has also been widespread across the country and not limited to one geography or group of physicians.
The field teams have engaged with clinicians throughout the country and the feedback from those serving the community has been positive.
We are initially focused on the lead in 186 ALS centers and the teams are already actively engaged with all of these centers since approval.
We're also dedicating time to smaller local centers and neurology practices to help ensure that every person living with a lab has access to and information on <unk>.
While we are pleased to see this level of initial excitement and have both the people and the product needed to fulfill it.
We cannot yet comment on how quickly this demand will translate into revenue given it can take 30% to 45 days.
But to get on treatment to the payer's medical exception process.
Which is standard brining, new launch, especially in orphan diseases.
As a result, we continue to expect a gradual commercial ramp up as outlined our approval call in September .
As it relates to working with insurers our conversations have been productive we are have robustness.
With the majority of major payers and pharmacy benefit managers and in general they have been supportive of delivery of <unk> clinical profile and have understood. The urgency to provide access to people living with ALS.
We are working hard to educate and encourage the broadest coverage possible, which we believe is appropriate given the data supporting the <unk> label.
Although it is early days, we are receiving generally good feedback at this point, we anticipate payers will begin to publish policy decisions in the first half of next year.
Now turning to our launch in Canada the.
The interest in Alberta to across the ALS community continues to be wide and national <unk>.
The number of prescribers continues to build month over month with interest brand across the country.
As it relates to accept as announced on our U S approval call in September .
We are in negotiations with our four largest private Canadian insurers, which represent approximately 80% of the private insured population.
To date, we have already closed one negotiation and expect the others to follow suit.
On the public side, we are currently in negotiations with the provinces and territories about the scope and breadth of coverage they will provide.
Our team knows that people living with ALS.
And their families.
No time to wait and we continue to be committed to reaching our goal of broad and equitable reimbursement criteria.
We continue to strongly believe that we're live real and <unk> has the potential to make a significant impact on the treatment of ALS.
Our commercial and medical affairs teams are in place to make this important treatment as accessible as top.
Each quarter, you will hear more from us as we progress through the launch and more experience and insights are gained.
To close I want to add that at every step our focus is on providing access and support to every appropriate person living with ALS, who can benefit from our product and we will continue to partner closely with the ALS community.
With that I will turn the call over to Jim to review our financials for the quarter.
Thanks, Margaret I'll now summarize our results from the third quarter, where we were particularly focused on launching in Canada. The reconvened Advisory Committee and our September 29th producer date.
For the quarter ended September 32022, net product revenues were <unk> $3 million and related to the sales of <unk> in Canada.
Although we have seen strong interest in Canada, thus far we do not expect this to translate to meaningful revenue in the near term given that the reimbursement process takes six to 12 months and there are only a small number of people covered by private insurers at this time.
Cost of sales were <unk> 2 million and represented the costs associated with our revenue in Canada This quarter.
This is elevated as a percentage of revenues since the majority of people who received <unk> received it for free and I Didnt, a dynamic that will continue into the fourth quarter.
Research and development expenses were $24 9 million for the quarter compared to $12 9 million for the same period in 2021.
The increase was mainly driven by higher product manufacturing and development expenses to support the global Phase III Phoenix trial.
And launch preparation activities for commercialization.
It was also driven by additional personnel related expenses due to new head count to support research and development efforts.
Selling and general administrative expenses or SG&A were $29 9 million for the quarter compared to $10 4 million for the same period in 2021.
The increase was primarily due to personnel related costs, which included hiring additional head count to support commercialization preparation initiatives and.
In other expenses for launch readiness activities and operations.
We expect some growth in SG&A expense going forward as we incur additional sales and marketing expenses as part of our U S launch.
Net loss for the quarter was $53 9 million.
Compared to a net loss of $23 1 million for the same period in 2021.
As for cash we are in a strong position cash and short term investments were $162 6 million at September 30.
Compared to $206 7 million at June 32022.
The third quarter balance does not reflect the net proceeds from the recent follow on stock offering we closed on October 11th of approximately $230 8 million in net proceeds.
So on a pro forma basis, we had roughly $390 million of.
Cash and short term investments at the start of Q4.
We are well positioned with sufficient capital and resources necessary to fund our ongoing commercial launches in the U S and Canada.
And our launch in Europe in 2023 to <unk> 35 is approved.
This is an exciting time for all of us at <unk> as we deliver delivery of the patients in the U S for the first time.
With that I'll turn the call over to Jeff for some closing remarks.
Thanks, Jim.
I wanted to provide.
Brief status update on our phase III Phoenix trial.
Phoenix is progressing well currently enrolling in Europe and on schedule. We continue to expect to recruit approximately 600 adults with AOS into the Phoenix trial with top line data planned for mid to late 2024, we are on track with Phoenix and continue to look forward to the results.
From this trial.
To close I want to take a moment to thank our team here at Amyris.
We are excited about the strong initial interest that we're seeing only a couple of weeks into launch. Our goal is that every eligible person who can benefit from <unk> will have access as quickly and efficiently as possible and our team is entirely dedicated to this.
We look forward to keep you all updated on our progress here in analytics, we are motivated by the community.
Every day looking for even greater opportunities to make a difference in the lives of people living with AOS.
You for joining us and for your support we welcome questions. Operator, Please open the call to Q&A.
We will now begin the question and answer session to ask a question you May Press Star then one on your telephone keypad, if youre using a speakerphone. Please pick up your handset before pressing the keys and to withdraw your question. Please press Star then two and at this time, we'll pause momentarily to assemble our roster.
And the first question will come from Corinne Jenkins with Goldman Sachs. Please go ahead.
Okay great.
Great Good afternoon, everyone.
Sorry, my headset seemed a little funky.
You just maybe provide any detail on the kinds of questions that are outstanding from the day 120 list of questions. You got from the EMA and then how confident are you that you'll be able to address those questions with your existing set of data.
Yeah, Great question Greg.
So as you probably know we generally don't provide granular details as we go through regulatory process on that.
Questions, we're receiving and everything like that and what I can say is we have a lot of confidence in the data and the studies that we've run we've already been through to regulatory approvals and processes, but of course every regulator has to review our package, which is only one study to support approval and income.
That decision I'd add to that we have an excellent team behind this some people may be aware <unk>, our global head of regulatory who has brought us through our first initial two approvals and we also have an excellent head of regulatory and Europe named beyond who is doing a fantastic job there as well.
So we're working through it I think it's much too early.
No.
The final decision will be but of course, we have a lot of confidence in our data and our ability to present the data.
Thanks, that's helpful and then with respect to the ongoing launch in the U S. How should we think about the cadence for that patient assistance program. I think you mentioned patients today are all getting free drug, but how should.
Do we expect that to normalize.
So.
I did not mention that patients today are getting free drug Duvernay Amex care team in the U S. We've just started to see our initial now that we have product and channel. We're starting to see a solid initial bolus of demand from physicians across the country.
And right now we're not giving any.
Data as to whether or not those are.
EAP patients versus clinical patients.
But I will say that there is very few.
IAP patients or <unk> patients going on right now.
Okay. Thank you.
The next question will come from <unk> <unk> with Evercore ISI. Please go ahead.
Hi, This is mighty jewelry in for Omar. Thanks, So much for taking my question and congrats on all the progress.
<unk>.
A couple for me.
One when will you start providing sales guidance <unk> patient number.
<unk>.
Without occur sooner rather than later.
And with respect to patients who are in the queue to receive <unk>. How many of them would you see are currently enrolled in commercial insurance versus enrolled in Medicare and Medicaid and does the split reflect the broader U S.
Market in general and I have one follow up.
Yeah, Hey, Mike It's Jim.
Thanks for the questions I'll start with that and maybe Margaret you can address the insurance coverage that we see so far but.
It's really we're 17 days from having drug in channel. So it's hard to give guidance at this stage right in a process thats going to take 30 to 45 days to get through on average to get through all the insurance coverage and insurance clarification. So.
Yes.
We'll know a lot more when we talk again after Q4.
The thing that we run will make sure of is any trends that we see and we start projecting our trends that we understand right. So.
And I have to get a little bit of experience under our belt before we start to give projections, but as.
You said I think as you heard from each of us on the call today, we're very happy where we sit today.
With the response and maybe just a follow up on your second question. So just as a reminder, in the U S. Our payer mix is roughly 50% commercial and 50% Medicare it's too early to know exactly which patients in the funnel are commercial versus Medicare, but I would expect that that national trend to actually be the.
The breakdown of what we see coming into the ammo scare team.
Great that's very helpful and last question.
Terms of the total addressable market in the U S. Do you foresee the roughly seven key patients that are currently taking <unk> every month as the total addressable market.
Or could you expand it by penetrating into the more of the untreated prevalence pool. Thank you.
Yes, so there's 29000 prevalent patients in the U S. We certainly feel like.
That's going to be that the number that we try to target and penetrate.
Definitely think that will be added on top of <unk> or standard of care as we were in the <unk> trial and physicians really do believe in combination therapy I am getting every one of these patients. It's all of our mission to give members shot on goal for treatment and we've heard from physicians that certainly their intent is to add delivery.
On top of whatever product, they're on and ultimately our strategy is to become foundational treatment and have all the products added onto embryo.
Great. Thanks, so much.
The next question will come from Marc Goodman with SBB. Please go ahead.
Yes, Hi, two questions first how long do you expect patients to stay on drug and your model like how long are you modeling that in and how long is it.
For some of these other products that are there and then second question is just around the Cabo obviously.
New launch with the oral just curious.
Hearing anything out there is there any way that the market has changed is that product doing well is there any impact on you with respect to your launch and the payers perfectly willing to pay for both I'm just kind of curious what youre hearing.
Yeah. Good question. So was it relates to time on therapy.
We haven't given specific guidance as to from time on therapy for our product, but I can say we've done some research on past products, probably mostly on <unk>, where we see in the ballpark of the year.
On average or median that being said one of our hopes with having a really robust education and patient support.
Function is that we'll be able to educate about the benefits of staying on therapy as well so that will certainly be one of our goals.
And as it relates to the oral available launch.
I think we're very confident in the data we have the relationships, we built and the education, we've done in the market.
I think we have a lot of confidence in where we set as Jim said, but I don't know if Margaret you want to add any other insights on that no again, what we've heard is that physicians want to add on to standard of care for most of their patients. They are excited about our data in our label and what it could offer to their patients living with ALS and <unk>.
And just in terms of public information that's out there from NT pharma I think they communicated that there's about 2000 patients currently on <unk>.
A lot of cava, roughly four or five months into the launch what we don't know is how many of those are naive patients versus switching from IV. So thats something we will continue to assess its lee.
Proceed through the launch.
And just to be clear I understand the physician for combo, the payers discussions that youre, having it's not going to be an issue with respect to combo.
It's not coming up we're really reviewing our clinical trial data, which was studied on top of.
Doyle and Orla Darvon NGL roughly over 70% of our patients were on.
Standard of care therapies that were added on there right now it's not and we're going to continue to keep an eye on that allocation as payers start to put together their public policy, but it's clearly a big part of our education now.
Thanks.
The next question will come from Neena <unk> Garg with Citi. Please go ahead.
Hey, guys, sorry about that.
Thanks for taking my question. So I just wanted to ask about the revenue number that was reported in Canada can you give us any more color on whether or not that was.
Just reflective of the number of patients that actually are on drug or whether that was mostly an inventory build.
Yes, Hey, Nina as Jim.
I think that you can fairly say thats reflective of the patients that are on broad but again.
Not all the patients that are getting the drug are getting paid for by the insurance in Canada, given the length of time that it takes the insurers to cover it up there.
But.
No so.
That reflects a revenue number of based on the number of patients.
And yes, and I would say Nina.
Hi.
Say as well we continue to believe that.
It will take six to 12 months.
From commercial availability to cat <unk>.
Broad reimbursement in Canada. Those are just sort of standard timelines and maybe the only other reminder, is just that we didn't.
Product and channel or launch in Canada.
But at the end of July start of August so.
That's an aspect in that revenue number as well.
Got it and then can you also talk a little bit about how long it took for the patients that are receiving reimbursed striking Canada was it like a similar timeline to what you're guiding.
<unk> in the U S for them to get reimbursement.
It's really too early to answer that question because the patients that are moving on to commercial.
As we secure the private pay insurers they are moving over so it's.
It's really a slow ramp up and how to get the additional private payers onboard we certainly hope to see more of that so it's a very different payer landscape in the U S and Canada.
Don't think thats really an analog that we can use for that.
It's also important to know Josh pointed out the drug was not available until the end of July .
The insurance contract that we signed didn't happen until the very end of the quarter as well.
It's really a I know people will want to look at the Canadian revenues and try and.
Use that as a crystal ball, but it's very unique and very also specific to the timing of launch.
Late in the quarter timing, where we've got actual reimbursement from a single insurer. So a lot more work to do in Canada.
And what.
What we will see that come to fruition kind of more early into next year, where the six to 12 months.
From the.
Late July launch comes into play.
Got it thank you.
Welcome.
The next question will come from Ananda Gosh with HC Wainwright. Please go ahead.
Hey, Hi, Thanks for taking my question Ananda on behalf of Andrew Fein.
Hi.
So that that was the reference of the campaign to and I was wondering how should we think about the future neuro degeneration focused pipeline.
More importantly, <unk> product right.
The mix indications.
Yeah, great great questions. So I think.
We were happy to share a couple of weeks ago at the annual Neil's conference. Some data on a campaign antisense oligonucleotide that we've developed in house and that data showed a potent knockdown as well as some other in vitro results. However, I think what's important is one this is very early stage product.
Just kind of started work on and our focus as a company is squarely in poorly.
Launch at this time, so we're continuing to evaluate and think about.
How we will continue to grow the pipeline, but I think that's all enabled by having an excellent launch and so that's where we have to have our our focus on our eyes.
Right now I'd say similar on the indication side, we do continue to believe that <unk> Amex 35 has potential and additional labor to generative diseases and we've been hard at work.
<unk>, which diseases.
Highest kind of clinical and scientific potential, but again I think the top priority right now for US is the launch and those are things that will be really exciting and enabled by a successful launch.
Alright. Thanks.
This concludes our question and answer session. At this time I would like to turn the conference back over to Mr. Justin <unk> for any closing remarks. Please go ahead.
Great and thank you everyone for joining us on the call today.
Just wanted to conclude by saying, while we're really proud of what our team has accomplished to date I think this is a really remarkable quarter for us much work remains and I think we all feel that working in the ALS community every day, our focus is on ensuring that every eligible person who can benefit from <unk> will have access as quicker.
<unk> and efficiently as possible, we know people with ALS and their families have no time delay. So thank you all for joining us and hope you have a good night.
Okay.
Conference has now concluded. Thank you for attending today's presentation you may now disconnect.
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