Q1 2020 Earnings Call
Good afternoon, and welcome to the Axia Therapeutics incorporated first quarter 2020 conference call.
<unk>, it's cold as being recorded Oh now taught turn the cold over two annual Enlo Akita's executive director of corporate Communications and Investor Relations Miss slow please began.
Thank you Jason.
Hello, everyone. Thank you for joining today's call.
Which make today are Damien mcdevitt, our chief Executive Officer.
<unk>, our chief commercial officer, and Alex powers are Chief operating officer.
As a reminder, this conference call includes forward looking statements.
Guarding the financial book outlook for Axia actually as businesses.
And the therapeutic on commercial potential of axes products and development.
Any statement, describing axiom goals expectation financial or other projection intentions once a week.
Including the commercial potential of Tech study <unk> and our pipeline medicine is the forward looking statements M.C.P. consider then I ask statement.
Statements are subject to a certain risks and uncertainty.
No it's related to be and it's hard to cope with that could have on our business, including but not limited to the impact on our commercial products at the medicines and I'll quite fun and particularly those inherent in the process of discovering developing and commercializing medicine, better safe and effective for use as human therapeutic.
And to me endeavor building a business around such medicine.
Axioms forward looking statements also involve assumptions that if they never materialized corrupt could cause it's results to defer material you from those expressed or implied by such forward looking statements.
Although axios forward looking statements reflect the good faith judgment of its management. These statements are based only on stocks and factors currently known by <unk>.
As a result, you are cautioned not to rely on these forward looking statements.
These and other risks concerning accuse programs are described additional detail and actually if most quarterly report on form 10 Q.
In the most recent annual report on foreign 10, K. on file with the S.P.C.
These are these another documents are available from the company.
In addition earlier today, we issued a press release and related to natural table, including reconciliation took out two are recorded nongaap financial measures that we will discuss today.
To read this really spend access the slides that accompanied today's call. Please visit the investor section of our website now I'll turn the call overcame.
Thank you Angela good afternoon, everyone. Thank you for joining today's cool.
We have a strong start here as we continue to advance our mission of delivering transformed treatments to people living with seriously word seasons. We ended the first quarter with $421 million cash in short term investment firm about cheese.
They're very strong position to execute on our strategic priorities in 2020 and beyond.
Strategy is to successfully excuse or to commercial launches.
The transformational programs that we currently housing developments, but also adding additional ranks these medicines to our pipeline both from my illness third parties.
Addition, we will Carter certain medicines actually treat broader disease indication.
In order to bring our medicines to more patients faster.
Let's see the old each reinvest a portion of the castle from abroad fees partnerships into our core <unk> business.
Choose the excuse on our strategy is critical but we have a strong key players in the first quarter. We continue to add two and build upon the stress of the leadership team and board of Directors. We welcome Doctor <unk> Board member and as you know in March.
Appointed Chief Executive Officer Fire Board of directors.
Since joining the company in from C.O. back in September I've seen firsthand the outstanding capabilities see a team is bouncing or development the commercialization strategy as well as our unsurpassable commitments to making a positive difference for patients affected quite serious.
I'm very honored to surf this organization pound with people and innovative therapies and look forward to continue so so I see a successes Oh see plan for many important pauses developments in the years ahead.
In the first quarter, we continue to make great progress who takes study.
<unk> commercially available of 12 countries. We live for a is approved in Europe and the commercially available in Germany and is now available Austria.
We are making excellent progress and expanding into new countries and expect these new countries to enable revenue.
Call, we'll talk more about the progress for making with text study.
Later on the call.
<unk> or X. was recently granted fast track designation by the U.S. to drug administration How's the potential treatments for people a significant risks for cardiovascular disease to to elevated levels like for protein Hey.
Artists continues to make great progress with this program.
And earlier in the quarter, we recorded calls the phase two results for both X.C.A. per c., three or X. and X.C.P.T.L. three hour X., which we've now which were now referring to.
<unk>.
With the completion all these two studies, we don't have data for more than a lot number patients treated in the clinical setting with like an medicines hundreds of which are from the F.C. at pipeline.
Oh, those 1100, a substantial number Haitian have been treated for one year.
As expected we are seen consistence positive results across the like a platform.
Are approved medicine are subcutaneous self injections that our ideal for treatments Uh huh.
This is one of our many as last year and we've seen magnified in the wake up the coast 19 pandemic.
Thankfully our patients that'd be nice say on therapy, while falling recommendations from W.H.M.M.C.D.C.
It is important to us that our patients who align our medicines. During this time captained them, we have several programs in place to make sure that happens quickly quickly and seamlessly.
At the present time, many businesses around the world dealing with adjusting to the recent called a virus fantastic.
<unk> immediate action to mitigate refers to our business we've quickly adjusted to the new normal although workforce continues to work remotely.
It's still relatively early in the situation remains fluid.
<unk> said, we've seen a little bit impacts to our business and we'll discuss that later on Nicole.
Looking ahead, we are excited about a number of upcoming milestones, we anticipate additional weight over it and take studied country launches throughout the year.
Oh wait <unk> U.S., we're on track to refiled with F.D.A. This here and we look forward to providing an update on this in the coming months.
Well the pipeline anticipate sharing a more detailed development plans for Axia April c., three or X. as we prepare to initiate the phase three study for F.C.S. later this year.
We will also be presenting the phase two data for both I see equals c., three or X. <unk>, a future medical conferences.
Furthermore, we continue to close to cooperate with idleness to identify touchy license a novel rare disease medicine from or hold your own pipeline.
To search for potential third party medicines accomplishments are rare diseases focus and capabilities.
<unk> turn the coal over to call she discuss or commercial efforts in more detail.
Thank you, Dan Yan and good afternoon, everyone.
We continue to make steady progress with our too commercial products text study and whatever and we are seeing positive results.
A little product revenue was $15 million first quarter and increase it 8% from the first fourth quarter of 2019, and a continuation of the sequential growth that we saw throughout 2019.
You're competing effectively in countries, where we have launched we are progressing with pricing and reimbursement negotiations an additional countries for both text that <unk>.
We have the foundation in place for both commercial products as we look ahead in 2020.
Right now a challenge at all companies space is called the 19 like most companies. We are working to determine the impact of crisis will have on our commercial business. The impacts that we have been experiencing have been anticipated and managed effectively by our team, including limited face to face H.C.P. engagements challenges for patients just either.
Oh care professional and delays and diagnosis.
To date covert 19 has not impacted our ability to fulfill patient demand for our products are industry, leading patients support program Axia connect has continued without interruption during the pandemic as nursed case managers have been conducting audio and video calls with patients for disease and drug education.
We continue to assess the impact of the crisis on our H.C.P. is our patients and our business and we will adjust our strategy an approach as the situation on false.
Regarding Tech study, we demonstrated continued growth from Q. 40, Q1, we consistently here from patients and doctors they prefer a solution for treatment at home and we believe that the ability of text study to provide an at home subcutaneous self injection continues to be the driver of text studies grow.
Let's now turning to our progress detect study in the U.S., where there is positive momentum.
The H.T.T.R. accomplish genetic testing program now has more than 1800 positions testing.
Total number of test continues to increase as well as the number of patients with a confirmed H.T.T.R. diagnosis.
These newly diagnosed H.T.T.T.R. patients are starting on text study.
Physicians with text study experience are choosing to put appropriate patients on therapy and physicians that have not use text study before are choosing to treat patients with text ready for the first time.
And Q1, we made progress with market access by securing another long term contract with a major pay or in the U.S.
Today, we have 94% of the total U.S. commercial life's covered and we have negotiated longterm coverage that secure 75 per cent of commercial lives through 2023.
These are positive signs of progress and demonstrate our ability to compete effectively in the U.S. market.
Outside of the U.S., we are expanding the total number of patients on commercial check study in those countries, where we have secured pricing at reimbursement.
Seeing our first countries launch in southern Europe, which isn't important region for us to enter because of its endemic patient population.
In Spain, we recently finalize pricing reimbursement and we were able to do so very quickly.
Took us just six months to finalize negotiations when typically it takes one to two years.
There are a couple of reasons for the fast turnaround.
First start team did a great job communicating the need for patients to be treated with tech study in this market.
And second the Ministry of Health of Spain recognize a tremendous value it takes steady brings to patients.
Early on the second quarter, we finalize pricing and reimbursement in Austria.
And in Canada, we have entered into a letter of intent with the Pan Canadian pharmaceutical alliance for P.C.P.A.
For Tech study and secured multiple agreements with private affairs.
In Brazil, P.T.C. is having ongoing discussions the Sci med, which we expect to be completed in Q. too.
Brazil is the single most important market for P.G.C. and has the highest prevalence of H.T.T.R.M. overdoses all into Robiskie worldwide.
Text that is the first and only self administered silence or approved in Brazil for the treatment of stage, one or two <unk> see an adult patients with H.T.T.R. to improve quality of life.
We are expanding access to H.T.T.T.R. patients across numerous geography is we are pleased with the ongoing progress the commercial team is making.
Overall with Tech study, we continue to be optimistic about the steady progress we are making and the momentum we are seeing in terms of new patients starts as well as the breadth and depth of prescribing physicians.
Starting to weigh liberal.
However is the only approved treatment, perhaps the s. patients in the U.
We livers commercially available in Germany and became commercially available in Austria. This past core.
And we continue to enroll patients in R.A.T.U. in France, which is a reimbursed early access program.
Our team is focused on building F.C.S. awareness with H.T.P.S. supporting patient advocacy groups identifying additional patients and securing market access as we followed the typical launched sequence in Europe.
We're seeing more F.C.S. patients initiating away liver therapy in countries, where we have commercial access.
In the U.K., we were in the early stages of our process to secure reimbursement with nice currently are we liver submission his paws due to cope with 19 pandemic.
We look forward to continuing discussions with nice when conditions improved.
In the U.S.R. discussions with the F.D.A. or ongoing and we are on track to refiled This year.
The P.T.C. team continues to work to provide access to wait liberated patients across Latin America and the goal is to file in Brazil, that'd be set and the second half 2020.
Our team is working diligently is we execute on both text chatting away rubber launches and we look forward to keep you updated on our progress.
Altering the call over to Alex to discuss our pipeline and our financials.
Thank you <unk>.
I'll start with yeah, Yeah T.T.R.L.R.X.
The cardio transport them in your Trans boom pastries studies are underway with both the registry and wild type forms of P.T. on the lower doses.
Just represents another important milestone in further demonstrating yeah, I'm bonuses commitment to bringing new treatment options to patients around the world sitting with P.T., a I'm a low doses H.T.T.
But to wildlife and hereditary forms of H.T.T.R. on diagnosed and faithful with limited treatment options available.
In regards to coded 19 patients who are currently Portugal on your transform and called you transform phase three studies have remained don't study.
Complexion identification and flat tax evasion remains ongoing.
In March we had temporally pools enrollment to assess the situation and determine the best course of action on the slide by slight basis.
Based on this assessment close consultation with investigators in sites and in accordance with local authorities. We've now lifted out temporary pools and enrollment in both studies has resumed.
Important maybe do not expect this brief pools to significantly impact the time lines of these studies.
Tending to do panels in which it upon to define so.
Any of this core to renounce positive top line results from interface to study in the population of patients with Hypertriglyceridemia type two diabetes and non alcoholic fatty liver disease or nestled.
We met the primary endpoint triglyceride lowering as well as significant reduction in additional lifted parameters and P.P.L. three.
Well, we did not see reductions in live without.
They won't see we all pleased with the evidence reduction in cardiovascular risk factors.
Grouping Olson generally how to favorable safety and told her belly profile.
You can present detailed results for the future Medical Congress.
Given the results of this study you see a lot of potential for beeping Olsen and treating cardiovascular disease and we are working with five to to design the best development off this medicine.
Next is an update on next yeah I play Lrx.
This medicine was granted fast track designation by the U.S. food and drug administration has the potential treatment for people, how significant risk of cardiovascular disease due to elevated levels of blood protein A.O.L.P. with like.
Plus track designation enables an expedited regulate ripoff medicine that addresses significant medical needs to patients with serious diseases.
<unk> the schools the significant value this medicine, they bring the millions of patients worldwide.
Established Opie little a good cardiovascular disease, who currently have no effective therapeutic options.
Yeah, Yeah, <unk>, a lrx State Street Horizons study is the 7005 them to patients <unk> outcomes trial on it's up and running with the boxes and says patients are on treatment.
The boss is is heavily invested in this program under success.
And last but certainly not least this brings us to x., yeah, a post c. three Alex.
<unk> also really excited about it.
January we announced positive top line results from the face to study.
A P.C. three lrx in the feeling of patience with hypertriglyceridemia or risk or up established cardiovascular disease.
We met the primary endpoint triglyceride lowering as well as multiple multiple secondary endpoints.
But the highest multidose, so more than 1% of patients reach quite it's probably levels below the recognized threshold for cardiovascular risk of 150 milligrams, but definitely tough.
Let's see a P.C. three lrx also had a favorable safety and told her brother to profile.
Importantly for <unk> for the broader like a bluff pool, there were no serious safety signals.
You plan to present, the more detailed data that the future Medical conference.
Real thrilled that we are able to retain the rights to actually I go see three lrx energized to drive the development and commercialization strategy for this medicine.
These data very encouraging when making excellent progressed the thought that they see study an F.B.S. later this yeah.
Station community and the market, we know very well.
[noise] [noise], we're committed to investing heavily in this medicine and we're also exploring the potential to use and other rather broad disease indications.
Now, let's review all financials.
Q1, we have the total revenue approximately 16 million and the operating loss of approximately 38 million on a non-GAAP basis.
Including non-GAAP operating expenses of 54 million.
[noise] Oh revenue includes approximately 50 million of product sales from text studying my Libra, which is called mentioned is approximately 8% growth cool to have a quota.
We look forward to continued growth as we launch both medicines and additional country. This yeah.
We ended the courtroom with approximately 421 million in cash and short term investing.
Strong balance sheet, well well positioned to execute on account strategic objectives about vision for the future.
Oh, no tend to cool Buck over today.
<unk> to wrap up we had a false start see here with loss look forward to on the horizon.
Quarter, we continue to make progress with our too commercial products takes studying will never we further if I'm wrong pipeline.
Oh, he threatens our management team directors, we have a set up my changing medicine.
Significant impacts on patients were currently under Sir.
We believe the public data, we have four X.P.A.P.L.C. Korea or.
No worse than earlier in the quarter demonstrate commercial potential of the like technology.
With launches an additional countries on the horizon for Texadian window.
The commitment from my own as to Tennessee license additional whereas the medicines are complementary to our pipeline capability.
See is very well positions and 2020.
I want to close by thanking all of our employees are patients caregivers and advocates for their share of dedication.
Emptiness Accordingly, you therapy he serious diseases.
I'm not open up the line for questions.
To ask a question you.
You may <unk> within one on your Touchtone phone if you use any speaker phone. Please pick up your handset before pressing the keys to withdraw your question. Please press store and too.
The first question comes from Chad mess or from need him. Please go ahead.
Great. Thank you could afternoon and thanks for taking my questions.
On the phase three trial for the April C. three like.
And even you can tell us about what that <unk> <unk> pretty much look like the F.B. approach study.
And and I know you've mentioned other rare disease indications potentially be including really high triglycerides and so there I was wondering if something akin to accomplish study would potentially be sufficient.
Hi, Todd standing here. Thank you for the question.
So we lost his clothes I need the details all the F.C.S.I.B.M. I mean this is this is a patient population you know very well.
We've run suddenly say three people study right Yep priests me. So you can you can make an assumption.
In terms of other indication.
See we're lucky other opportunities where significant practice.
Hey, she burst Murphy's indications of also.
Okay. So we're still working through what those indications.
We look forward to update you G. course.
Worked great. Thanks.
Then maybe just one <unk> the genetic testing program that you have going <unk>.
Can you tell us how many test you're running and what sort of the <unk> <unk> <unk> looks like there.
Yeah.
Wow.
Some information about how the study.
Hey, Chad good afternoon, and thanks for the question. So we're not disclosing all of the details around the campus program, but we are communicating obviously the 1800 positions currently utilizing the program.
We are seeing more positions testing quarter of a quarter, we are seeing more tests coming a quarter over a quarter and we're also seeing positive you know hereditary confirmation coming back from those tests, and then if and when appropriate and the position deems text studies the right therapy, they're moving those patients onto check study. So it's a program that is.
Operating effectively and doing exactly what it's designed to do at this point.
Okay, great. Thanks than the next week graphs on the quarter.
Thanks.
The next question comes from Doe Kim from B.M.O. capital. Please go ahead.
Hi, This is jane sent onto ago. Thanks for taking our questions and glad everyone is taken doing well so one from us on the way you <unk> you briefly mention the coping 19 impact how old the impact your launch trajectory and any additional details on timeline for reimbursement and the U.K. in France would be.
Thank you.
Thanks, <unk> Damien here I'll I'll start.
<unk>, yeah, well, it's a good start with we live right in Europe in terms to launch it's still it's still early but remember <unk>.
For S.P.S. patients in in Europe columns execute a little bit more information around.
<unk>.
Yeah, I'd be happy too so great question, we're progressing well so Germany. We currently are launched as well as Austria and then we have the A. to you that is ongoing and France. The slow down in the U.K., obviously is due to cope it as I communicated earlier, and we are still reaching back out.
The agency there to try to see when weekend Reengaging those discussions.
But typical launched sequence from there. So we'll look at Nordics, we'll look at a southern Europe, Yeah, we'll continue to navigate the price when reimbursement process as you would expect in those countries moving forward.
Perfect. Thanks for the extra details and again crap congrats on the quarter.
The next question comes from Jim Birch, you know from Wells Fargo. Please go ahead.
Jim is your line on mute.
Oh, sorry.
Sorry. The line was on me with this is the N. doubting before Jim Thanks for taking our questions to first just curious for the corporate 19 situation does it impact though.
If.
<unk> <unk>.
Oh. Thank you answer the question. This is danion. So let let me just take a step back and say no jurgen totally 19 were very focus obviously, all keeping our patients employees in health care professionals say some healthy jerks fine. That's that's very important for US. We we took the early in the media.
<unk> <unk> the business for the commercial business.
I'll give you some information around any impacts on commercial business, including monitoring.
Yeah, I'll speak to the actually connect program in the U.S. first you know that's our most robust program and the one that has fortunately been able to continue without any interruptions during the pandemic.
Our nurse case managers are able to be able excuse me are able to be able to coordinate with.
Patients in their home or they're doing audio and video calls with these patients they're talking about disease education and drug education, Our third party that handles or a mobile labs service is able to meet with these patients and do the draws in collections on a weekly basis and able to conduct the testing and we've had.
No interruption as it relates to the at home monitoring process, which was worked very effectively in the U.S. X.U.S. Similarly, we've been able to work effectively with the institutions and and the local agencies to make sure that those patients are able to be monitored per the label as well. So all is a is being handled I think approach.
Greatly and going well as it relates to monitoring program across the countries that we're in.
That's that's thanks for the color that's great too here and.
It's also great to hear that the subcutaneous the route of administration kind of stand out as as.
You indicated this current environment, just wondering going forward would there be any leading indicators for tech steady growth that we can get a already read.
Oh, well, let's talk about that.
Yeah. So you know when I look at the markets I think a first and foremost the subcutaneous and you know some few at home therapy is the most critical parts of this right. It's a key differentiator. We we know that text that is effective it knocking down the T.T.R. protein, we know that it's effective in terms of the tree.
<unk>, so that's really encouraging the leading indicators probably a number of positions testing as I indicated.
Is gonna be the the key parts of this so we've got a lot of physicians testing to the average attic testing program that tells us that positions are educated on the disease. They're looking for these types of patients in their actively engaged in a diagnosis and then treating those positions. The other indicator that I would bring up is our sequential launch X.U.S.
The European countries that we're continuing to move across southern Europe is a key area for us obviously with the endemic population of the success that we've had in Spain that I reference to my comments or the speed at which we were able to achieve that the interest by the agency based on the therapy and that the advantage is that it has and.
Being able to to treat the patient population there that needs treatment is very very encouraging to us. So I I think you know between the the testing that's occurring combined with the expansion that we're doing across Europe should should be pretty good indicators in terms of progress that we're making and we're optimistic about where we're headed.
<unk> wonderful last question from us any sauce on additional asset from Ionis or third party asset cooking license. Thank you.
Oh, Hi, I'm, staying and again, yeah, absolutely I mean, that's that's part of our strategy to grow pipeline [noise]. We're very focus on you know working socks as the with illness to find a new medicines life fit in with our capabilities on our expertise.
Levels and so they're of course, they're going to be rare to see some medicines and I'm quite familiar with the the eye on soil pipeline also we we continue to look for third party medicines. You know we're not looking for early face mask was looking for for me to lay face medicines closer closer to.
Approval, the better and you know that that program is still running on a course any medicines that we are to life.
Funny, well will fit in with our capabilities under expertise. So so no no specific yeah sort of news on <unk>.
Need to look actively and both of my oldest medicine from third already medicines.
Got it thanks for the color.
Again, if you every question. Please press Star then one the next question comes from Paul Mathias from Stiefel. Please go ahead.
Hey, guys. This is neat on for Paul that's taking the question.
First I just wanted to ask about the T.T.R. studies and co bid.
I know the pause was removed, but what percent of sites in the U.S.
Began reenrolling patients and then maybe I Miss this where they're actually any interruptions in goes thing.
So let me let me start with the the second part of that which was yeah. No. There was no interruptions devastating.
Patients who were on medicine remains on medicine, so that that's that part the second part.
I don't know Alex you have any sort of information about I don't think I've been any information about this is your first part of the question I like to you.
Oh, Yeah, we're we're sort of we're not getting a break down to the the resumption to the the sides, but yeah well. It can say is that you know the the pools has been lifted and yeah. We were the opinion that actually that will be a your normal impact from a time lunch is actually that's will study.
[noise], Alright, <unk> and then maybe of reading a little too much into this but I think you previously said their goal was to fly away liver. This year in the U.S. and now you're saying you plan on it did you hear did you have any conversations with yea yea that increase or coffins about your ability to file that and what were those.
It's so.
Oh Nice actually question you know so we we have they didn't discussions with the S.T.A.. We we have a fine now too refile and we're we're excited about that we we we believe it's it's a great medicine, but the the benefit significantly outweigh the risks and.
Yeah, we'll quite enough space on our progress over the coming months.
Right. Thanks, Thanks for answering the questions guys.
There are no more questions in the queue. This concludes or question Indian or session I would like to turn the conference back over to management for any closing remarks.
Okay. Thank you all for joining today, we look forward to keeping you updated on our progress as we continue to excuse on the text studying my number launches build upon the strong foundation is actually Oh, great afternoon.
Conferences now concluded. Thank you pretending today's presentation you may now disconnect.
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