Good afternoon, ladies and gentlemen, and welcome to the Q2 2020 Evolus Conference Call. After the speakers’ presentation, there will be a question and answer session. [Operator Instructions] As a reminder, today's conference is being recorded. I would now like to introduce your host for today's conference, Mr.
Ashwin Agarwal, Vice President, Finance, Investor Relations and Treasury. Sir, please go ahead..
Thank you, operator, and welcome to everyone participating on today's call. This call is also being broadcast live over the internet at evolus.com, and a replay of the call will be available on the Company's website for 30 days.
With me on today’s call are, David Moatazedi, President and Chief Executive Officer; Lauren Silvernail, Chief Financial Officer and EVP, Corporate Development; Mike Jafar, Chief Marketing Officer; Rui Avelar, Chief Medical Officer and Head of R&D, and Jeff Plumer, Vice President of Legal.
In our remarks today, we will include statements that are considered forward-looking statements within the meaning of United States security laws. In addition, management may make additional forward-looking statements in response to your questions.
Forward-looking statements are based on management's current assumptions and expectations of future events and trends, which may affect the Company's business, strategy, operations or financial performance.
A detailed discussion of the risks and uncertainties that the Company faces is contained in its Annual Report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K. Actual results may differ materially from those expressed in, or implied by the forward-looking statements.
The Company undertakes no obligation to update or review any estimate, projection or forward-looking statement. Additionally, the discussion today will include non-GAAP financial measures. These non-GAAP measures should be considered in addition to, and not as a substitute for or in isolation from, our GAAP results.
A reconciliation of GAAP to non-GAAP results may be found in our earnings release, which was furnished with our Form 8-K filed today with the SEC and may also be found on our Investor Relations website at investors.evolus.com. And now let me hand the call over to David..
Thank you, Ashwin. It goes without saying that the second quarter was a challenging quarter for the entire aesthetic industry and Evolus was no exception. In the first half of the quarter, practices were largely shut down due to COVID-19 measures and spent that time rewiring their operations.
In speaking with customers most instituted measures focused on patient safety, and spacing appointments to minimize interaction between patients. Although patients’ throughput declined due to these measures, it was largely offset by extended office hours.
By June, the large majority of practices reopened and benefited from a strong surge in patient demand, reflecting the resilience of the toxin categories similar to what had been observed during the 2008 downturn.
Many customers commented that June was the strongest month of this year and acknowledge that pent-up demand was a key driver of the volume reinforcing our optimism about the continued underlying demand in the market. I am pleased by the progress we made in the second quarter.
During the first half of the quarter, we had an intense focus on rewiring Evolus to create a more efficient operating model, leaning further into our digital platform to support our customers. In addition, we introduced a stimulus program called Evolus 350 offering flat pricing to customers.
We also launched our consumer loyalty program, which offers greater savings for patients than competitive loyalty program and drove all of this activity through our proprietary digital platform. As a result of these strategic initiatives, we reduced our non-GAAP operating expenses by approximately 37% over the prior quarter.
Orders taken via our digital App platform nearly doubled versus prior quarters and we increased our purchasing account base to more than 4400. In the quarter, we delivered $7.8 million in net revenue with approximately 90% of that generated in the second half of the quarter.
In the second quarter we also celebrated the one year anniversary of the launch of Jeuveau. On reflection, the launch of Evolus and Jeuveau has been a success across all measures. We’ve rapidly established Jeuveau across the U.S.
occupying the number 3 market share position and gaining ground as we continue to increase our account base and reorder rates, while optimizing spend. We strategically positioned Jeuveau against a fast-growing younger demographic of consumers with a provocative branding effort. As a result, our patient base now over-indexes against millennials.
Lastly, we designed a unique business model with a highly specialized sales force and a proprietary digital platform designed to provide a frictionless customer experience. I could not be proud of the Evolus team for their excellence in execution and focus.
Now let me pass the call over to Mike who will provide more color around our second quarter performance and promotional programs. .
Thank you, David and good afternoon everyone. From a commercial perspective, I am very pleased with our team’s responsiveness and second quarter performance. Our first-to-market stimulus program called Evolus 350 was key to our success.
We extended payment terms up to 120 days, locked in our customers’ loyalty status for the year, and more importantly, leveraged our aesthetic only indication by offering the entire market one flat price of $350 through our App. The program has been a tremendous success as measured by the number of purchasing accounts, and revenue generated.
Stepping back from all of this, I would like to comment on our strategic differentiation and drivers of success. We launched Jeuveau with an aesthetic-only focus, a highly specialized sales force and a proprietary digital platform.
Our singularity and focus has been our competitive advantage and the second quarter was the first quarter where the entire Evolus value proposition was unveiled to the market.
The customer can now fully appreciate our unique patient acquisition strategy, our simple and highly effective consumer loyalty program, and lastly, the benefits of our technology platform. Allow me to elaborate. Evolus’ unique patient acquisition strategy is designed to answer two fundamental questions for consumers.
First one is, what options do I have to treat my front-lines and where can I go to get treated. Our co-branded media strategy hit the market in the second quarter. And as a reminder, any Platinum and above customer can qualify for co-branded ad featuring Jeuveau alongside of their practice.
Our co-branding media strategy generated over 5 million impressions through July and more importantly, driving leads directly to participating Jeuveau practices. Shifting gears to the launch of our consumer loyalty program called Evolus Rewards, I am pleased to share that the program has been adopted at a rate well beyond our internal expectation.
Within 30 days of launch, nearly 30% of customer base opted and over 16,000 patients enrolled into the program. The credit to the sales force and our product team who deployed a simple, easy to use and effective program. Lastly, our investment in technology continues to prove out our unique operating model.
During the second quarter, over 80% of our orders were generated through the Evolus Practice App, giving our sales representatives the flexibility, expanded reach and more importantly, efficiency.
In closing, I would like to thank the sales and marketing organization for their passion and commitment to making her beauty experience the likeful and achievable. I could not be more pleased with the continued momentum of our launch and success observed over the last four quarters.
I’ll now pass the call to Lauren for additional remarks and our second quarter financial performance.
Lauren?.
Thank you, Mike, and good afternoon, everyone. As we indicated on our Q1 call in May, our business climate changed dramatically in the middle of March as a result of COVID-19. Since that time, we have taken actions which have resulted in a stronger Evolus today.
In April, we rewired our business to conserve cash, significantly reduce our operating expense base and leverage our digital platform. These decisive actions resulted in a 37% reduction in our Q2 2020 non-GAAP operating expenses compared to the prior quarter. As a result, we expect to become profitable on a lower revenue base.
In July, we closed a $40 million financing on attractive terms which resulted in a strong June 30, 2020 pro forma cash position of $124.8 million. Today, we exceeded expectations by reporting second quarter net revenue of $7.8 million, we are pleased with the strength and the pace of the recovery of our business during the second quarter.
However, due to the ongoing COVID-19 crisis, we do not plan to provide U.S. revenue guidance at this time. As we previously stated, we do not expect to launch in Europe until 2021. Moving down the P&L, our second quarter gross margin percentage was strong at 75%. During the second quarter, we launched consumer loyalty and reduced coupon activity.
Going forward, our gross margin will depend on sales levels, promotional activity and other factors. Our non-GAAP operating expenses for Q2 2020 were $18.3 million, reduced by 44% from $32.9 million during the second quarter of last year when we launched Jeuveau.
Q2 2020 non-GAAP operating expenses include $3 million of cash severance and related expenses associated with our restructuring.
Non-GAAP operating expenses for the second quarter of 2020 excluded three non-cash items, $2.4 million for stock-based compensation, $1.7 million for depreciation and amortization and $2.4 million related to the reevaluation of the contingent loyalty obligation.
We continue to anticipate our non-GAAP operating expenses for the second half of 2020 will be less than $42 million. We believe we will incur higher non-GAAP operating expenses in the third and fourth quarters of 2020 as compared to the second quarter of this year as promotional and other activity increases.
Our non-GAAP net loss for the second quarter of 2020 was $12.4 million, reduced 26% from $22.9 million in the prior quarter. Our reduced operating expense footprint allows us to become profitable on a lower revenue base and assuming continued strong sales of Jeuveau, we believe we have a clear path to profitability.
Cash burn during the second quarter was cut in half to $15 million from $30 million during the prior quarter. During the second quarter of 2020, we made no cash payments for inventory. We do expect our cash burn rate will be higher in Q3 than Q2 2020, due to inventory purchases and other activities.
Our cash balance is expected to fund our operations for at least the next 12 months and potentially longer assuming an increasing revenue trajectory. I’d like to take a moment to thank the Evolus team for their tireless dedication and accomplishments during Q2.
We reported Q2 sales above expectation, have a highly efficient business model and are in a strong cash position. And with that, I’ll turn the call back to David. .
Thank you, Lauren. Before I close the call, I would like to provide an update on the International Trade Commission or ITC case. On July 6, we announced that the Administrative Law Judge or ALJ assigned to our case issued an initial determination.
This non-binding initial decision recommended to the ITC the imposition of an exclusion and a cease and desist order. We respectfully and strongly disagree with the ALJ’s initial view.
On July 20th, we issued our petition to the ITC to review the initial determination and set forth in our briefs a number of ground the ALJ had misapplied the law including issues related to an overreach on jurisdictions and trade secret law. We have also submitted a public interest statement to the ITC as has our partner Daewoong.
We remain confident in our case. We will continue our challenge and look forward to the Commission’s final determination which is scheduled for November 6. As we look ahead to the back half of 2020, several catalysts remain that will Evolus to drive meaningful shareholder value.
First, we look forward to a successful resolution of the ITC case by November 6. Second, our differentiated value proposition will drive the next phase of our growth, starting with consumer loyalty, Evolus 350, and our proprietary digital platform. Lastly, we remain optimistic that the U.S.
Toxin category will continue to recover in the back half of the year. The combination of these catalysts and our more efficient structure will enable Evolus to reach profitability on a lower revenue base. With that, I will turn the call over for Q&A.
Operator?.
[Operator Instructions] Your first question comes from the line of Marc Goodman from SVB Leerink. Your line is now open. .
Hi. I was wondering if you had a flavor for market share. Obviously, we know what – reported.
I was curious if you had any flavor for what the other two guys reported and how the market actually hit in the quarter? And your thoughts about how quickly the market kind of comes back in the fourth quarter, I mean, was it down 40-ish percent in the second quarter and you are expecting it to be less than that in the third and – or is it turning positive in the fourth quarter? Maybe just give us a sense of how you view the market for the rest of the year.
Thanks. .
Great. Thanks for the question, Marc. Well, let me start with our view on the market. Looking at the second quarter, you have now the second public company to report out on the volume returning back in the back half of the quarter.
And we do believe that the overall category in the second quarter was likely down roughly in that neighborhood of 50 or so percent on the full quarter largely driven by the fact that the front half of the quarter was shut down.
As we look to the back half of the year, we expect a gradual recovery into the third and fourth quarter, but we don’t expect that the markets will return back to 2019 levels in the back half of the year.
Now for our internal operating assumptions we coined it as a change to our recovery and part of that is because it’s going to vary state-by-state depending on what the public policy is and we are starting to see that now as we entered the third quarter and into the latter part of the year.
That being said, when you step in further back, the overall trend is still a favorable one.
And the penetration rates in this category is very low of consumers entering the market is roughly just a few percent of consumers interested that are getting treated and then younger demographic of millennials is predisposed to aesthetic procedures and we believe that that trend is favorable over time.
And as we’ve pointed out in the past, the price point of a neurotoxin procedure is also favorable in the 300 to 500 range. So, a combination of those things gives us a lot of confidence not only that the toxin market will be the fastest to recover in aesthetics. It’s already proving that, but also there is a long-term trends are intact.
And as it relates to market share, as you know, it’s challenging to triangulate shares especially such short window of time.
But what we do see for Jeuveau is that, our account base is expanding, reorder rates are growing and we hear from accounts that are purchasing products from us as they are increasing their utilization of Jeuveau in the practice in terms of the overall share.
And that in combination with new accounts is continuing to drive our penetration into the market. And as we get a better sense for how shares play out in the future, we’ll give you more color around that. .
So, your expectation just for the market overall is probably down year-over-year in the third quarter, still double-digits whatever it is and then, fourth quarter do you think it will be down as well or do you think you actually can – you will see the market trend positive year-over-year?.
Yes. We are expecting that relative to prior year the market will continue to be depressed. But it won’t get back to 2019 levels in the back half of this year. .
Thanks. .
Your next question comes from the line of Louise Chen from Cantor. Your line is now open. .
Hi. Thanks for taking my questions here. Congratulations on the quarter.
The first question I had for you is, basically, our initial determinations by the ITC ever reversed? And if so, under what circumstances? Second question, Lauren, you had talked about a clear path to profitability and I am just curious if that means that there is a potential to reach profitability without any more additional capital raises? And then, third one here is just are you thinking about adding any additional products to your portfolio in the near-term? And if so, what areas are you looking at? Thank you.
.
Great. Louise, I’ll take the first part of the question related to ITC and turn it over to Lauren on the second. First, as it relates to the overturn in cases, it’s not uncommon that the Commission will rule against the ALJ, the Administrative Law Judge on one or several issues.
This case in particular is unprecedented, because there is an extension of jurisdiction here by the ITC that makes this entirely unique and you see that’s represented in our petition to the ITC that is now been made public. Without going any further into the case, I’ll turn it over to Lauren to comment. .
Great. Thanks, David, and hi, Louise. On profitability, we introduced our operating expense base tremendously. As you saw from year-over-year, Q2-to-Q2, and also Q1-to-Q2 of this year. And so, we are able to go profitable on a much lower expenses base than we could before.
We’ve guided in the second half that we will have less than $42 million of non-GAAP operating expense. So, when you do the math that what’s historically for us except for first quarter has been a 70% plus gross margin, we really are at a start where we can go profitable much more quickly.
What we are fully dependent on is, is really the first question that David addressed which is how fast does the market come back. So we are waiting to see how that market develops. Obviously, we were thrilled with how May, June timeframe did.
It was really over our expectations and I think many folks, but it’s hard to tell the exact timing at this point. On business development, our focus continues to be aesthetics and adding either marketed aesthetic products or products for our pipeline that Rui Avelar can develop for us. .
Okay. Thank you. .
Your next question comes from the line of Annabel Samimy from Stifel. Your line is now open. .
Hi guys. Thanks for taking my question. Congrats on the resilience in the quarter. So I have a few. First, I want to ask about your – your couponing program or the consumer loyalty program. I think you mentioned it about, there was a 30% you said about $15 million – I am sorry, 16,000 find outs.
What do you expect for steady state and what you expect for net cost or compression of net price still pressuring that time. The second question I have is related to the ITC case. Also as you mentioned, you are disputing extension of their jurisdiction, but not necessarily disputing the underlying case.
So I was just curious when you got the $40 million from Daewoong, how should we read into that investment at this case and what they know and feel about their own case with Medytox in Korea? And then, finally, I wanted to your sense of, do you think anything will change in the new competitive landscape? Obviously, there is another player coming on the market with just a new filler right now, but again, eventually with a new toxin and with the fintech service platform.
So, do you think you might need to adapt in that environment? Thanks. .
Great, Annabel. Thanks for the questions. Why don’t we start with the consumer loyalty program, because that was such an important launch for us? As you know, we talked about that from the early launch of Jeuveau. And I am going to turn it over to Mike to give you a little bit more color around the launch of that program, how it’s been received now.
We think about the continued uptake there and let Lauren speak to the financial side of it and then, I’ll take the ITC question next. .
Hey, Annabel. How are you? I’d say the Evolus rewards program, for us it’s been a tremendous success. We spent nothing short of three quarters designing this thing to be a simple in its flaws of an execution endpoint, which is the reason why we are seeing these adoption rates as high as 30% and on its way north.
If you step back and look at most loyalty programs at any industry, you never get a 100% penetration into any programs and just never the case, and in the range of, call it, 30%, 40%, 50% would be on even higher end of most industry’s loyalty programs.
For us, the hard part of calling it steady state right now, is this really of our take our part, position in our launch. It’s so early in our launch phase and we are still adding a significant amount of accounts in any given year that will change the denominator.
But to be at 30% penetration, call it, six weeks into a loyalty launch, it’s something I haven’t seen before. And again, I’ll attribute it to the way that program is designed and how efficient it is.
So, if you gone closer to it as a consumer and I encourage also you to sign up, you will notice there is no need to download an App or remember a password or whatnot. That digital handshake is all tech base and it’s none at the office.
So, very pleased with the way it’s been rolling out and our customers are excited about the program, probably equally as much as we are. .
Okay. Great..
Hey, Annabel. This is Lauren. With regard to the financial impacts, coupons are a direct reduction of revenue in the current period when they are redeemed.
For us, on the loyalty program, it’s actually a deferral, and because you do have practice with meeting doctors and consumers need to opt in, the way it is playing through the financials for this year, we anticipate that we’ll have a higher gross to net conversion and a higher gross margins as compared to prior quarters.
And you actually see that with us at 75% versus most of last when we were couponing, we were in the low 70s. So, it’s playing out nicely for us. Could we coupon in the future? Sure. That’s why I mentioned in my remarks. It will vary quarter-to-quarter a little bit depending on what our promotions are.
But overall, the deferrals will be less on the loyalty program. Those are likely to result in a higher gross margin in the rest of this year than we seen in doing couponing. Let me turn it back to David on ITC. .
Thank you, Lauren. On the question around the $40 million investment from Daewoong, clearly, that signals Daewoong’s confidence and the strength of this case and our ability to overturn the decision due to Commission. And also speaks to the value they see in the long-term partnership with Evolus’ evidence by the conversion price of $13 a share.
So, we are very pleased to see our partner support us through this time period. And on the last question, regarding the role of technology as you mentioned, Revance made a move into fintech. I’d be first, just stepping back, there is no doubt that technology is playing a more important role across the industries and aesthetics is no exception.
As you heard earlier from Mike, greater than 80% of our orders are transacting to the digital platform. And our platform isn’t just there for the transactional value of orders. That same platform now powers our consumer platform, where consumers get immediate rewards and the accounts have immediate access to that level of information.
That same platform also powers our co-branding efforts. And as we continue to build on that platform, it becomes an extension between the company and the consumer. And we believe that we are the first aesthetic company with an injectable that has an entirely frictionless platform that powers the company digitally.
And that’s enabling our sales force to be more effective in front of the customer as was observed in our performance this quarter on a low revenue base, our reps can be far more efficient in the way that we operate.
And it continues to be an important part that we will invest in and I suspect the industry as a whole will continue to move in that direction. .
Okay. It’s great. Thank you. .
Your next question comes from the line of Gregg Gilbert from Truist Securities. Your line is now open. .
Thanks. Good afternoon. It's Gregg Gilbert from Truist. Just two, I'll ask them one at a time.
First, David, is your larger competitor doing anything to help consumers or practices in a way that's caused you to be more generous than you were planning to even if that's just adjusting terms or any other programs?.
So, Gregg. Nice to hear from you. Give me a minute there to recalibrate against the name Truist. So, congratulations on that move. Look, this landscape is always dynamic. We support small customers and the industry stayed as very close to these customers so that we can address their needs.
And when COVID-19 hit, I am very pleased by the quick response by our team. We believe we were the first to launch a stimulus measure for these accounts in order to help them weather through this period with no minimums required on their purchasing given that the procedural volume was unpredictable at the time.
That’s in combination with the loyalty program that we had planned on launching even prior to COVID obviously delivered some meaningful value to the customers.
Everything that we introduced over the quarter, we believe we led the way on and we continue to focus on our core value proposition, which is to improve profitability for the practice and to make this product more acceptable to the consumer.
That right there presents the challenge I think in this space, as you know for competitors that have both an aesthetic as well as a therapeutic form of their toxin. And we continue to lean into that in combination with our digital platform to drive value to our customers and we are seeing the results of that here in the back half of the quarter. .
Great. Sorry to confuse you on the name. It took a while for the merger name to kick in. My second question is about ITC from a different perspective.
David, I imagine a lot of investors that may be interested and really can't take their interest to the next level, if they think the company is hanging in the balance and heading into November's decision regardless of your confidence on the matter.
What can you tell us about your confidence in potentially resolving or having others resolve this issue before we get to November?.
Well, Gregg, look, it’s clearly in our best interest to get this case resolved sooner, rather than later, that became apparent following the July 6 decision. And it’s probably important when you step back from this case.
It’s realized that most cases, whether in the federal circuit and in the ITC, the majority of them ultimately settle before a final decision.
Now, I am not in a position to speak about settlement, but at the same time we look forward to bringing this to closure by November 6 and that’s ultimately a meaningful catalyst we recognize for shareholders and for our employees and we are very much focused on getting that done. .
Thanks a lot. .
Your next question comes from the line of Douglas Tsao from H.C. Wainwright. Your line is now open. .
Hi. Good afternoon. Thanks for taking the questions. Just in terms of the recovery seen in the market today, are there any particular sort of demographic groups that are over or under sort of indexing? Obviously, you’ve been targeting millennials.
Just trying to sort of think through some of the sort of economic impacts of the pandemic and - versus some groups might have sort of more stable economic situations which might let them engage in sort of aesthetic treatments, more so than others? Thank you. .
Hey, Doug. How are you? This is Mike. It’s a great question. So, coming into COVID, the first theory that was out there is that millennials are going to suffer from this disproportionately, because the unemployment rates and then the stimulus package and everybody want to jump on the unemployment bandwagon and start cashing out the stimulus check.
So, as you step back and look back to see if this demographic was negatively and disproportionately, the answer is no.
If anything, the mindset of that consumer going into this and going into any other year, that they spend more on their – more of their discretionary income into areas like skin and beauty, health and wellness and you see it all around with Peloton sales, you see it through skincare, especially online retail skincare.
But the shift of spend just went from brick and mortar into online. And not necessarily from one demographic to the other. So, we are not seeing a negative impact on the demographic and the focus.
If anything, we do believe this demographic will represent a larger portion of this category in the coming year and two and we are well positioned within that group. .
Okay. Great. That’s really helpful. .
Your next question comes from the line of Vamil Divan from Mizuho Securities. Your line is now open. .
Great. Thanks so much for taking my questions. Maybe one just following up on the millennials comment. Can you give us a sense of how much of your sales just maybe coming from the millennials demographic versus other I know you said it's more. I'm just trying and to guessing numbers behind that relative to other demographics.
And then the second question, someone asked earlier about Revance and they enter the market here soon with the filler and then obviously with their toxin.
I am just curious how that may impact your marketing efforts? You talked about the technology impact here, and how the – more of the role for technology, but just you would no longer be the newest toxin in the market.
I am just trying to get a sense of how – again how that might impact? How you think about promoting your product to both consumers and or I guess, patients and providers? Thanks. .
Vamil, great question. I’ll address both of them. From the millennial standpoint, as you know we book sales directly with customers, not consumers.
And so, the best tracker we have today is our awareness and we do overinvest in awareness where the market, by and large on an aided basis has about a 30% to 32% aided awareness of this product meaning Jeuveau and when you get closer to the millennial segment, it’s closer to 40%.
So, we have a good, call it, 10 basis point difference from an awareness and that’s obviously by design.
As consumer loyalty takes a deeper foothold in the marketplace, we will be able to segment the consumer transaction and back channel that into some data that you are looking for, which is – how do we over-index in ultimate sales, but since we sell to customers, it’d be hard to get that answer just as of today.
As far as Revance impact on their launch to us, there is a lot of unknown to make a statement right now about Revance. We don't know the label. We don’t know the price. We don’t know the final positioning and their go-to-market strategy. So, the one thing I will say though is, more noise around this category is preferred.
You are seeing that with our entrants, right? The focus on this category from both consumer and customers, as you step back and look at all of the players in this has only increased because of our launch and I suspect it will continue to increase with a fifth player to market.
And so, we welcome that, because more noise around this category is beneficial to all. But, like I said earlier in our call, our aesthetic-only indication keeps us very nimble and flexible and it’s a pivotal backdrop for the company. .
Okay. Thank you. .
Our last question comes from the line of Balaji Prasad from Barclays. Your line is now open. .
Hi. Good afternoon. Thanks taking my questions. Couple of questions from me to kind of spruce up everything else.
Firstly, do you have any recent update on Nuceiva? Or is this still the case that you are looking to launch this in Europe next year? Second, I also want to understand, David, how you are thinking about cash spend in light of ITC’s determination as it made you change the way you do business and think about spend and OpEx? And the last question is for Jeff, when you spoke last month, you spoke of the jurisdiction and how it is fundamentally an error.
And I think one of the things we discussed was also to see if there were any precedences where you had two non-U.S. companies backlit out in the ITC year and just draw an analogy to that, that will be helpful. Thanks. .
Great. Balaji, thank you for the questions. I am going to turn it over to Lauren here to answer the first two and then Jeff on your ITC question. Before we jump into the question that you had around cash in Nuceiva, I do want to make one comment here is that, we have a high degree of operating discipline in this company.
I could not be more impressed by our ability to focus on execution at a time where the markets largely are unstable and the noise around the ITC, of course, has increased. And the same applies to the discipline though that we have on our spend, as well. We have been very deliberate about the investments we’ve made thus far.
And I am very pleased by the work that Lauren and her team have done to create a more efficient operating model against what’s been a very successful launch as we enter this next phase enabling us to make strategic investments to help grow this business even further as we enter into the future.
So, I’ll let Lauren speak a little bit more into how we think about that. .
Great. Thank you. And hello, Balaji. Good to talk to you. On Nuceiva, we announced earlier this year that we would be launching in Europe next year that remains our plan, and that’s really unchanged.
When we spoke in April at restructuring the business, we really thought about where we could do the most impactful when this post-COVID – actually during the COVID time and we just have investing in the U.S. market rather than also investing and launching in Europe during COVID made the most sense. And there is no change to that strategy.
On the cash spend, at the same time, we also looked at what we should be spending in the U.S. this year to hit the numbers that we thought we hit. And it’s all worked out very well through the second quarter as you saw our financial results.
For the second half, we plan a burn rate – excuse me - non-GAAP operating expense of less than $42 million and that’s really also unchanged from the last quarter. We think that’s the best way to approach this pre-ITC time during COVID time. I am going to turn it back to David and Jeff off the ITC question. .
So, Balaji, on your question around jurisdiction, it does happen that the ITC will hear cases between two foreign companies. What’s unprecedented here is that normally one of those foreign companies also has a domestic industry here in the United States. Here Medytox has no domestic industry in the United States.
Instead, it’s relying on a separate domestic industry of BOTOX, which is completely unrelated then to the trade secrets which are added to in the case. And so, overall if the full Commission was to accept if they’d be taking a giant leap forward in an unprecedented manner in expanding their own jurisdiction. .
Thanks, Jeff. A final one from me.
Maybe, would there be any update before the final determination date from the ITC on this case?.
So, what we would expect the ITC to issue next is in September they would indicate which portions of the initial determination they plan to review.
Beyond that they have a lot of powers about whether they ask for additional briefings, whether they remand anything back to the Administrative Law Judge, but I think we are expecting just they will be processing toward November 6th decision after they give that interim look in September. .
That’s it. Thank you. .
I am showing no further questions. Ladies gentlemen, this concludes today’s conference. Thank you all for your participation and have a wonderful day. You may all disconnect..