Q2 2023 Xeris Biopharma Holdings Inc Earnings Call
Good morning, all I would like to welcome you, Okay, Danny Biopharma second quarter 2023 financial results call.
My name is pretty good and I would be even motivator for today's call.
All lines are on mute for the presentation portion of the school today, well does it tend to keep a question.
And if.
If you would like to ask a question. Please press Star then one on your telephone keypad.
I would now like to pass the conference a Virtualized Allison Wey Senior Vice President Investor Relations and corporate communications to begin so Allison. Please go ahead.
Thank you for your guys. Good morning, and welcome to Zurich, Biopharma second quarter financial results Conference call and webcast a press release with the company's financial results was issued earlier. This morning and can be found on our website. We are joined this morning by Paul It is chairman and CEO and Keith Piper.
Well provide opening remarks, Steve will provide details on our financial results. Then we will open the call for Q&A.
Before we begin I would like to remind you that this call will contain forward looking statements language.
We include but are not limited to statements concerning our business practices future expectations plans prospects clinical approvals commercialization corporate strategy and performance, which constitute forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by the forward looking statements made during this call as a result of various factors, including our financial position the need for financing, including to fund our product development programs or commercialization, whether our product will achieve or maintain market acceptance in a competitive business environment Our alliance.
Our third party suppliers, including Singapore required a reliance on third parties to conduct clinical trials the ability of our product candidates to compete successfully with existing and new drug adverse effect of macroeconomic conditions on our business operations and clinical activities and our and our collaborators collaborators ability to.
To protect our intellectual property and proprietary technology as well as the other risk factors set forth in our filings with the Securities and Exchange Commission.
The forward looking statements on this call represent our views only as of the date of this call. It should not be relied upon as representing our views as of any subsequent date.
Due to obligations are at school of law.
Any obligations to update such statements I'll now turn the call vertical.
Good morning, everyone and thank you for joining us today for the.
Several quarters I've started by reiterating what kind of company. We are building at <unk> I'm excited to once again say that the entire organization continues to execute performing at a high level and absolutely delivering on our vision.
I Hope you take away from today's call and our continued positive performance is that everyone. At <unk> remains intensely focused on delivering for patients by continuing to build a substantial patient centric commercially focused and self sustaining.
Enterprise.
I believe that all three pillars of our business multiple growing commercial products are highly targeted development pipeline and value added technology partnerships are contributing to our vision and will result in long term shareholder value.
I'll start with key highlights of another record quarterly performance.
We recorded total revenue of $38 million in the second quarter, a 50% increase from second quarter of 2022, and a 14% increase from first quarter of this year.
This is our third consecutive quarter of at least 50% revenue growth year over year. We ended the second quarter with over $80 million in cash cash equivalents and short term investments a very healthy cash position to support our continued growth.
Our performance year to date and our outlook for the rest of 2023, we have tightened our full year 2023 guidance as well.
Our revised guidance for 2023 is total net revenue of $145 million to $165 million.
Cash utilization of between 57% and $67 million and 2023 year end cash balance of between 55 and $65 million <unk>.
Importantly, we remain on track to hit our cash flow breakeven point by year end 2023, and we will continue to be a self sustaining company thereafter.
Steve will get into more of our financial performance in some detail later on.
Onto the first pillar of our business are growing commercial products all three products G. Both Tobias and require love showed strong growth collectively generating approximately $37 million of net product revenue in the second quarter, an impressive 46% increase over second quarter last year, and a 14% increase over first quarter 2020.
Three.
Let me break it down in one product at a time.
First <unk> <unk> had another record quarter of net revenue in prescriptions totaling $15 6 million in net revenue, a 30%, 36% increase compared to second quarter of 2022.
Total prescriptions for the second quarter were over 51000 growing 50% compared to the same period last year and a 12% increase from first quarter 2023.
Throughout the second quarter G book has averaged approximately 4000 prescriptions per week and has recently hit a new all time record of over 4500 prescriptions in the most recent weekly data.
Market growth for glucagon products is back to consistent double digits Gibeau continues to outpace all other products by driving the majority of the market growth.
We also continue to capture market share at the end of July G bulk market share of new and total prescriptions in the retail glucagon market excuse me grew to approximately 31% and 29% respectively.
The new ready to use glucagon products now represent 79% of new prescriptions and over 77% of total prescriptions.
We are in back to school season, now and with the latest weekly record high. We believe we are starting to see the bump in weekly prescriptions that recurs annually. During late July and August accompanied by an uptick in overall market growth.
To build on <unk> momentum later, this year and going into 2024 in the now double digit growing glucagon market. We are investing in another modest expansion of our inside sales force, we will be adding 20 inside sales reps in the fourth quarter of this year, bringing that forced to a total of 50. We've proven this group can be a highly productive.
Rather quickly and generating and generating G book awareness fueling market growth and gaining share.
Also you may have seen last week Jabil Jabil hit a major milestone over 1 million <unk> units have been shipped since its launch in late 2019.
We are extremely proud of this achievement. We are just however, we are just scratching the surface of this opportunity. There is a long way to go until the 15 million people with diabetes, who are at increased risk of a severe low blood sugar event are carrying a ready to use glucagon such as <unk>.
The key to a major change in this situation is the health care professionals, who manage these patients.
To address this critical situation and motivate health care professionals to do more the aviate the endocrine Society The association of clinical.
Clinical endocrinology and other professional societies have revised their guidelines or at our algorithms in some manner to advocate that the standard of care for all insulin. So fondly urea treated patients should be that they are also prescribed a ready to use glucagon. So they are protected against a potentially life threatening severe low blood sugar.
That.
Based on the latest available data there are over still over 240000 emergency Department visits 60000, hospitalizations and tens of thousands of deaths annually due to severe low blood sugar. These are avoidable with a new innovative ready to use glucagon products.
As are the associated health care costs.
On to record lows.
<unk> generated 77.
$7 2 million in net revenue for the second quarter, an increase of over 640% from the same period in 2022, which was its first full quarter since launch and an increase of 60% over first quarter of this year.
We're very pleased with the steady increase in carload revenue quarter over quarter patient referrals in average number of patients on.
Drug grew 37% and 33% respectively over the first quarter.
Even more impressive is that we are increasingly seeing the carload being prescribed as a patient's first drug therapy for a growing number of current referrals. This means that health care professionals are seeing some positive results from therapy, and using <unk> and increasing lead valuing the core lab as a first line treatment for Cushing syndrome.
<unk> post surgery.
Again building on our momentum with accelerating referral rates rising conversion rates.
And with the expected growth in the market, we will also be.
Further invest in expanding correlate salesforce to approximately 30 in the fourth quarter to take advantage of our momentum going into 2024.
Moving to <unk> <unk>.
<unk> had another great quarter in terms of revenue new referrals and patients on therapy. Despite the fact that there has been an approved generic since the end of last year second quarter revenue for <unk> was over $14 million, which represented an increase of 10% compared to the same periods in 2022.
Our excuse me our referral rates have also continued to grow approximately 8% to 10% compared to the second quarter of 2022, as we continue to identify new patients. The average number of patients on <unk> grew about 11% compared to the second quarter last year.
Date, we have seen our generics may impact the payer process and have taken measures to maintain and support our patients. We know it takes more than <unk> to treat patients with primary periodic paralysis.
There is a heightened focus on the value of our Zurich care connections team patient advocates and mentors to support our PPP patients and health care provider providers through screening reimbursement authorization initiation of therapy and the long process of titration to most effective dosage.
Onto the second pillar of our business pipeline development.
In the second quarter, we began enrolling patients in phase II study of our aerosol legal thyroxine they potentially once weekly subcutaneous section and that study is now about 25% enrolled as we've said previously the study will be rather slow to fully enroll the study design required subjects to be on a stable dose of oral lingual thyroxine for at least three months.
With normal thyroid laboratory tests, such as <unk>.
As expected, while we have screen many subjects, taking chronic oral levothyroxine a significant number of failed to meet the standard for stability over three months.
Further to the evidenced that the challenge associated with oral side right.
More replacement therapy.
Which speaks directly to the unmet need we aimed to address with our once weekly sub Q.
To enhance our pace of enrollment we are currently adding additional clinical research sites in order to maintain our goal of completing the study in the first half of next year.
Data from the Phase II study as we've said previously will help inform our proposal to the FDA for a pivotal phase III program.
We believe that our once weekly subcutaneous legal thyroxine if approved we will compete in a potential $2 billion to $3 billion market segment calculated at current brand prices.
Now onto the third pillar, our Zurich technology partnership business.
The three partnerships that we have with Merck horizon and Regeneron are all in various stages of development and continue to meet or exceed our partners expectations.
First for Merck, we have completed several rounds of <unk> formulation and formulation optimization, we have 100% of the agreed upon specifications and stability requirements for their molecule and have delivered all required data as defined by the joint development program.
Work plan, although our formulation work work exceeded their expectations Merck has chosen not to move this particular preclinical asset forward into clinical development given their other prepaid preclinical pipeline priorities, we have a great relationship with Merck that remain impressed with our team and technology and we continue to explore other potential opportunities.
<unk> to work together.
I would also note that even though this program is not progressing there was a huge side benefit to our <unk> program as a result of the Merck collaboration one of the deliverables that needs to be achieved was a detailed validated plan and timeline for potential manufacturing scale up.
As part of that plan development that team worked incredibly hard with very within a very short time window to successfully complete our first manufacturing scale up engineering batch using our own biologic materials.
Huge step forward in our <unk> program that can benefit all current and future collaborations.
For horizon.
Suitable progress has been made and work continues with formulation and optimization optimization of the sub Q version of <unk>. We're very confident we will meet the agreed upon target product profile and deliver three months of positive real time stability.
Once achieved we will receive a $6 million success payment from horizon we.
We expect horizon will soon thereafter also inform us as to whether they will execute the license option and whether they plan to proceed with further development and potential commercialization.
Since announcing the regeneron collaboration in late March Regeneron has already nominated the first two molecules in the platform program, we're well into formulation work on the first of the two molecules and expect to begin formulation work on the second very soon as we reported previously Regeneron also has the option to nominate additional molecules for formulation does.
<unk>.
Each of our technology partnerships highlight the unique value proposition of our proprietary <unk> formulation capabilities and their potential for long term value creation.
Hopefully as you've just heard we are we have.
You take away that we had another great quarter and first half of 2023 with each of the three pillars of our business continuing to perform.
Through continued revenue growth prudent allocation of resources and disciplined expense management, we expect to hit the cash flow breakeven point before year end. This milestone should demonstrate to our shareholders that we can be a growing self sustaining biopharmaceutical company without the need for additional equity capital to fund our operations.
I'll turn the call over to Steve for additional details on our second quarter financial performance.
Thanks, Paul and good morning, everyone. We had another great quarter, driven by the continued growth of all three products.
In net revenues and underlying market demand coupled with our disciplined cash management, we exited the second quarter with an extremely healthy cash position and are on track to hit cash flow breakeven in the fourth quarter.
For the second quarter total revenue was a record $38 million, representing a 50% increase over the same quarter last year.
It's worth highlighting that this is the third consecutive quarter of at least 50% revenue growth.
Strong underlying patient demand for all three products.
With revenue from our collaboration partnerships drove this growth in total revenue.
Let's start with <unk> as we are excited by the momentum we are generating with this product.
<unk> net revenue was $7 2 million for the second quarter and $11 6 million on a year to date basis.
Compared to Q1 'twenty three net revenue increased by $2 7 million. This growth is the result of an increase in the number of patients on therapy growing 38% quarter over quarter.
We expect these strong results to continue as we are generating high quality referrals and providing full service support to help patients start and stay on therapy.
<unk> net revenue for the quarter was a record $15 6 million, representing a 36% increase compared to the same period last year.
Year to date net revenue was $30 7 million, representing a 28% increase compared to last year.
In the quarter Chievo prescriptions top 51000 for the first time, a 50% increase compared to the same period in 2022.
In the second quarter, the total glucagon prescription market grew 1% compared to the first quarter, notably Chievo total prescriptions grew 12% in the same period ending the quarter with total retail market share of approximately 29%.
<unk> continues to significantly outpace the market.
Moving to convey as <unk> net revenue for the quarter was $14 1 million, representing a 10% increase compared to the same period last year.
Year to date net revenue was $26 8 million, representing a 21% increase compared to the same period last year. This.
This revenue growth was driven by an increase in the number of patients on <unk>.
This proves our strategy to continue to invest in <unk> has been successful to date and defending against generic competition. We will continue to invest in <unk> and <unk> care connections as they offer the best in class therapy and support for PPP patients.
Looking ahead for the full year 2023 based on our overall year to date results and confidence in our products and technology partnership collaborations we are raising the low end of our previously issued guidance, which as a reminder was $135 million, we are raising the low end to $145 million.
Which now takes our new total revenue guidance range from $145 million to $165 million.
Moving down the P&L cost of goods sold in the second quarter was $7 6 million, a 57% increase compared to the same quarter last year. This increase is mainly driven by higher sales.
Research and development expenses were $6 1 million for the quarter, a $2 4 million increase compared to the same quarter last year.
This increase is consistent with our comments from our guidance earlier. This year, we continue to expect a modest year over year increase in R&D expenses in order to fund our phase III Levo thyroxine clinical trial, the completion of our record level optic study and continued development work of our proprietary formulations.
Science.
Selling general and administrative expenses were $37 6 million for the quarter, a $4 7 million increase compared to the same quarter last year. This increase was driven by an increase in personnel costs from last year's fourth quarter sales force expansion.
Timing of marketing expenses and rent expenses related to the new lease that commenced in April .
On a year to date basis, SG&A increased slightly by 3% compared to last year, which is again consistent with our previous guidance that SG&A would be relatively flat for the year compared to 2022.
Given our strong commercial performance to date and our revised outlook as Paul previously mentioned, we are expanding our <unk> sales teams in the fourth quarter to build on our momentum it's worth noting that this expansion has been factored into our revised year end cash guidance.
We ended the quarter in a strong cash position as of June 30, we had total cash of approximately $81 million compared to 95 million at March 31 2023.
We are executing on our strategy and as we mentioned previously we expect cash utilization to moderate throughout the middle of 2023 until the fourth quarter, when we expect to achieve cash flow breakeven base.
Based on our strong year to date performance, we are increasing the low end of our previously issued yearend cash guidance, which as a reminder was $45 million. We are raising this to $55 million, which takes our new year end cash guidance.
255% to $65 million, which results in a revised and improved full year cash utilization of 57% to $67 million.
I'll now turn it over to the operator, please open the line for questions.
Thank you.
If you would like to ask a question. Please press star followed by one from Wellcare. Thank you Pat.
Is there any reason you would like to repeat that question. Please press star followed by <unk>.
To ask a question. Please press Star then one.
We have our first question on the sidelines from Orion <unk>.
Thanks, Mike.
You May proceed.
Thanks, I have a few.
Sure.
On <unk> to start.
We've seen it.
Flattening of the share I guess since mid May and.
I got the pattern, we've seen every year since launch in the summer and into early September some flattening or actually empires decline in share can you just remind us what the dynamics are there and.
How confident you are not just market growth going forward by a reacceleration in September and beyond marketshare.
Oren.
Sure.
What you see is that little bit of seasonality.
When we start to get into the back to school period.
Usually.
Mostly July and August .
<unk>.
Our share doesn't accelerate as fast as vaccines for example.
Back to school is really a peak endo, our pediatric endo business.
Lilly is or has been historically and still is extremely.
Strong in pediatric Endo. So our business continues to increase the sales of <unk> continue to increase with the share capture doesn't.
Flows a little bit.
Annual phenomenon you can see in every year for the last since launch.
And is there any difference with star promoting this product now versus <unk>.
Lilly and not just on their promotional or infrastructure side, but maybe on contracting and I noticed your prescriptions were up 12% that you highlighted quarter on quarter sales were a little flatter. So is there any underlying change there or is that just noise quarter to quarter in terms of question Thats our inventory buys.
It's noise quarter to quarter, and we have seen we haven't seen any.
<unk>.
Commercial activity to speak up at all on vaccine, we actually are hoping that <unk>.
As a as a strong commercial effort to continue to accelerate market growth.
Having both Lilly and Zurich in the game early on was really important and we hope that that continues.
But in no contracting activity at all.
Okay.
And I'll get in queue. After this one again, but.
<unk> you had a record sales and up 10% I think quarter over quarter. Despite I guess.
Some of our anxieties about a presence of a generic in the market.
How does that happen when you're fine with me.
Regards to any impact of a generic and are you still expecting potentially if I can answer it this year.
Yes.
I'll start with the second question first.
Our planning scenarios, we always expected from the get go a second entry we haven't seen one yet.
We'll cross that bridge when we come to it but our strategy has been the same as what we said we were going to do our care connections is extremely important to our physician customers.
And very very helpful to patients.
That's a big part of why we're able to continue to keep people.
On the branded product.
Physicians are willing to fight for brand patients are willing to fight for brand because they get tremendous support in terms of.
Negotiating reimbursement.
Our patient.
Assistant managers are constantly in touch with patients and helping them with whatever their needs are we have patient mentors, which are patients who've been on <unk> for a long time, helping patients who are new to <unk> through the titration period.
It's a very very white gloved hands on service.
And we think that's have a great deal to do with our ability to maintain the business. We're also continuing to add patients, we're growing referrals and we're growing patients quarter over quarter.
Obviously, if there are multiple generics in the future will pricing erode a little yes.
Might we lose the patients in the future, yes, but as we've said we're going to defend this business to continue to invest for as long as necessary.
And if I may just speaking of your.
White glove services per se on.
On the recall upfront.
How is that hub working versus expectations.
Not only getting patients on therapy from referral to paid therapy timeline wise and success rate wise, but also keeping them on I understand that a lot of youre still early in the launch but.
Some of these plans I understand require re certification a reauthorization quite frequently.
The drought.
How has your experience been on.
Getting patients on and keeping them on drugs.
It's been it's been excellent.
So once again these are our.
Rare disease products, and it's a negotiation patient one patient at a time, so youre not getting contracted.
Formulary.
Additions and things like that.
If you were to compare the <unk>.
Success rate that we have with getting patients approved for <unk> therapy.
It's as high as you would see if you were in a normal.
Therapeutic category trying to get formulary access.
Tremendous success getting great access.
Denials are relatively low and we apply the similar.
Care connections to record levels that we have for <unk> and.
And keeping people on drug.
It has been very successful.
As you know they have to titrate over time, and we kind of handhold them through that process.
There is a little bit of a correction in the first quarter of every year in terms of people getting reauthorization of there.
Insurance, but that has not been.
An obstacle at all.
Alright, Thanks I appreciate it.
That's on a good quarter.
Thank you. Thank you your next year. Thanks.
Your next question comes from David comes along the Pike.
Yes.
Hi, Thanks. This is Scott on for David.
Two questions here can you speak to the typical patient that is receiving or core lab or more broadly the patient mix, particularly in terms of prior exposure to receive a ketoconazole and in that vein. What is the payer landscape look like for those who want to use our core lab in the first line are you hearing that payers are requiring patients to step through a ketoconazole.
Yeah.
So the patient mix is not is not dominated by ketoconazole. It all we're getting patients from all over we're getting post surgical de novo patients. So the first line therapy doesn't require a step through that's what's really exciting about it is the fact that we're getting a lot of an increasing number of patients who are.
Sure.
Being referred to record level straight after surgery.
Is is unusual this early in the game.
And we're getting patients from all of the other branded products, including <unk> and.
Some are coming from Quito, but it's not an outsized number at all.
Got it that's helpful. Thank you.
Okay.
We now have Glenn Thank you Yang of Jefferies. You May proceed.
Oh, yes, thanks for taking my question I.
Just wanted to follow up on a couple of points that you discussed.
Obviously, a good quarter on record of living.
But I wanted to dig into G broke a little bit because <unk>.
It seem to suggest.
<unk> data seem to suggest that maybe.
Revenues would've been a little bit higher than what they were in which I guess is sort of just based on the script number and it kind of feels like a little bit of the same scenario from last quarter, where you're maybe making a little bit less money on a per script basis could you could you just unpack that.
The <unk>.
Revenues, a little bit and give us a better sense for what's happened on the script and pricing side.
Yes, Glenn that requires a little bit of math, which I will turn it over to Steve.
To answer yes, Glen good question. So yes, I think if you just did the math and assume that the IQ via data would extrapolate to net revenues that would suggest that our <unk> revenues would be about $1 million higher I think what we saw again in the second quarter.
Was a further tightening of wholesaler.
Channel inventory levels.
By about a half a week.
Not necessarily a bad thing that there's there's a tighter correlation I think between what's going on in the channel in terms of the inventory levels in the true demand that we see in the IQ via data so.
Again that that.
<unk> was a bit of a drag on net revenue.
If you look at kind of historical averages over the last three years.
It can go up.
Couple of weeks in terms of the inventory levels and down a couple of weeks and so the first half it's been a bit of a drag on net revenue, but I would say look the underlying demand the underlying patient demand is whats going to carry the day.
At the end of the day and if that continues to be really strong in that that the inventory levels in the channel should follow that.
Particularly perfect.
There is a back to school.
Yep Yep Yep perfect all right I appreciate that just two quick financial ones with respect to the horizon.
Contract them.
You mentioned the $6 million success payment that you are hopefully you're going to receive the FAA Ikea.
Or.
We are expecting to receive that and I'm kind of curious if any of that's embedded within this year's guidance.
Yes. So good question Glenn This is Steve I'll take that one so based on the work plan and our current progress we expect to complete that work plan.
In the fourth quarter. So yeah that is factored into our guidance both from a revenue and cash perspective.
Alright, and then last question on the on the cash flow Steve I mean, you mentioned a number of times, how do you expect to be cash flow breakeven by.
At the end of this year and I was just wanted to reconcile that based on the guidance that you're sort of putting out there right because you generated $71 million in revs in the first half which to hit the midpoint you need to generate $84 million in the second half, which is a nice step up but it also feels like your expenses are going up you.
Obviously with your revenues you also mentioned that Youre expanding the the <unk> sales force by 20 reps.
And you said youre expanding the record lift.
And the sales force to 30, I'm not sure how many incremental additions there are but just just looking at the.
The loss from operations this quarter, China forecast incremental revenues in the back half with an anticipated increase in expenses I'm just trying to reconcile all those data points to think about that path to cash flow breakeven by the end of this year and I'll stop there.
Yeah. Good question, so as Paul mentioned the expansion at least on the <unk> side is is very modest.
With it inside sales expansion.
Expansion so most of those folks.
It's not as costly as an expansion as a traditional field expansion.
We do have as I as I, just mentioned the $6 million from horizon, there our guidance as well in the fourth quarter that that certainly helps some other one timers I would say.
In general our SG&A should be relatively flat year over year. So.
We saw an increase in this quarter.
Some of that was just timing of marketing expenses, just preparing for the back to school push in the third quarter for <unk>, but on a year over year basis, it should be relatively flat.
So I think that that all kind of points to it and we feel again very confident about hitting cash flow breakeven in the fourth quarter very confident.
Okay. Thanks for the details.
Thank you.
We have a final question on the line Shang Ryan arrays.
You May proceed with your question.
Hi, everybody. Good morning. This is Nick <unk> on for ROE on earlier, thanks for taking our question maybe.
Maybe first.
Maybe a bigger picture question, what are some of the pushes and pulls but it's getting closer to the high end of your new guidance.
Yes.
Sure to your commercial products, you think are most likely to drive.
To driving towards the higher end of that range.
I have a quick follow up.
So good morning, Nick This is Steve I'll take that one so.
Don.
Think it's been a pretty resilient first half for <unk> in the face of generics. So that's that's given us increased confidence.
And I think where we saw record levels exiting Q2 also gave us.
Really.
Good confidence in terms of raising that low end so.
<unk> will continue to perform.
That's been our bag for nearly four years now so we have pretty good confidence in how that will perform particularly in the second half.
But I think what's happened with <unk> and how resilient. It has been in the first half of this year.
And in the growing momentum with <unk> getting those patients started and staying on therapy.
It gives us confidence to raise the low end of the revenue range.
Got it very helpful. And then just a quick follow up on <unk> could you talk a little bit about pricing.
Curious if you could share your outlook on gross to net dynamics in the back half of the year.
<unk>.
Generally stable or.
Naturally pick up or how should we think about.
Those dynamics for the back half.
Yeah, as I think even going back to the second half of last year, We said, we've said that.
Gross to nets have stabilized.
So we don't anticipate any uptick.
In the second half from.
From a gross to net perspective at all.
Got it very helpful and if I may one more question on record.
How should we think about.
Growth in new patient additions into next year.
And maybe I know you mentioned this earlier, but.
What are you hearing from physicians in the field on the dose titration process, how are patients doing on the drug overall.
Could you talk a bit more about that.
Hi, This is Paul I'll take that one patients are doing very well I think part of the reason the doctors are starting to get comfort starting.
Patients.
First line is because of the performance of the patients they have already put on the drug in terms of efficacy and.
Low and manageable side effects.
We expect patient.
Acquisition referrals and patients on drug to continue to grow at a similar pace.
Going into the fourth quarter or the second half of the year and towards the end of the year.
We're not going to really give any guidance for 2024, yet, but we expect continued momentum.
And we're seeing great response from physicians.
Very helpful. Thanks, Paul.
Thank you.
Even if a follow up question from Aman.
Please go ahead.
Thanks.
Follow up just two real quickly on <unk> is there any update on the patent front and on the Levo your guidance for data by first half next year.
Sounds I guess, a little faster than that.
Conservative expectations.
Gave us before about how hard it is to find patients and sort of reiterated the challenge there.
That 25% enrollment so far are you running ahead of schedule despite that.
The screen failures that you do and expect it to say it.
I think it's gone a little faster.
Thanks.
I wouldn't say things are going faster.
Screen failures are high as we anticipated because finding patients that are stable on levo for three months.
Is is proving to be what we anticipated as hard.
We didn't know what we didn't know going into the study in terms of timing. So I think being conservative in terms of enrollment when we first started out in terms of what we what we anticipated and what we conveyed to you.
Adding a couple more sites I think is going to help us to continue to push the.
The enrollment.
But I think the first half is still still achievable.
Yeah.
Correct.
Can I ask Scott and Frank.
Oh the patent.
We did have our as you know there are several layers of appeal in the patent process. As we've discussed you go through a direct appeal then you go to an Appeals board.
Have to get through all of that before you end up with the ability to potentially go to court as we anticipated that appeal to the patent trade Appeals panel.
They upheld the.
Examiners decision.
So the next step is federal Circuit Court, and that's where we're headed next.
Alright, thanks for the update.
Thank you.
I'd like to hand that team.
Thank you Dave for some closing remarks.
Thank you operator.
Thanks, again to everybody for joining us today, we're very proud of what we're building here at <unk> to service, our patients and our health care professional customers I'm, especially proud of our team's performance and all we've accomplished to date three consecutive quarters of at least 50% revenue growth is not something that a lot of companies can brag about today and I am excited.
For us to build on the first half of the year for the remainder of 2023.
I also want to thank our many loyal investors, who see the potential <unk> possesses and continue to support us as we build a special kind of company. Thanks again for joining our call.
Thank you for joining I can from time <unk> Biopharma has now completed.
Please have a lovely rest had you may now disconnect your line.
[music].