Q1 2020 Earnings Call
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Ladies and gentlemen, today's conference is scheduled to begin shortly please continue to stand back. Thank you for your patience.
Unknown Executive: Ladies and gentlemen, today's conference is scheduled to begin shortly. Please continue to stand by. Thank you for your patience.
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To the reset therapeutics first quarter 2020 financial results in corporate update conference call.
Unknown Executive: Welcome to the Revance Therapeutics first quarter 2020 financial results and corporate update conference call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question at that time, please press a star followed by one on your touch-tone phone. If anyone has difficulty hearing the conference, please press star zero. An operator will come back on line to assist.
As Tom all participants listen only mode.
Following management's prepared remarks, we will hold acuity session to ask a question at that time. Please press star followed by one on your Touchtone phone.
Anyone has difficulty hearing the conference. Please press star Zero and operator, we'll come back on watch with history. As a reminder, this call is being recorded today may 720 20.
Unknown Executive: As a reminder, this call was recorded today, May 7, 2020. I would now like to turn the conference over to Jamie Herbert, Senior Director of Investor Relations and Corporate Communications at Reverence. Thank you, Stacy.
I would now like to turn the conference over to Jeanie Herbert Senior Director Investor Relations in corporate Communications I've referenced. Please go ahead.
Unknown Executive: Joining us on the call today from Revance is President and Chief Executive Officer, Mark Foley, Chief Financial Officer, Toby Schilke, Chief Operating Officer, and President of R&D and Product Operations, Dr. Abhay Joshi, and Chief Commercial Officer, Aesthetics and Therapeutics, Dustin Sjuts. Earlier today, Revance released financial results for the first quarter ended March 31, 2020. If you have not received this news release or you would like to be added to the company's distribution list to receive future releases, please go to the Investor Relations section of Revance's website, which can be found at www.revance.com. These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties. Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties.
Thank you Stacy Tony on the call today from romances, President and Chief Executive Officer, Mark Foley, Chief Financial Officer, Toby Schilsky, Chief operating officer, and President of R&D and product operations, Dr., API, Josee and Chief commercial officer, if that acetic from therapeutics Duston too.
Unknown Executive: Factors that could cause results to be different from these statements include factors the company describes in the section titled Risk Factors in our current report on Form 10-K, as filed with the SEC on February 26, 2020, and Form 10-Q, to be filed shortly on May 27, 2020 – May 7, 2020. Revance cautions you not to place undue reliance on forward-looking statements and undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events, or changes in its expectations.
Earlier today Revamps released financial results for the first quarter ended March 31st 2020, if you've not received this news release or you would likely be onto the company's distribution list to receive feature releases. Please go to the Investor Relations section there were dances website, which can be found at www dot revamps Dot com during this conference.
Called management will make forward looking statements, including statements related to her dances 2020 financial results and guidance the clinical development of our product candidates business strategy and planned operations.
Anticipated pre commercial launch plan financial estimates with respect to Tee Oxy distribution agreement and potential product candidates and technology. These forward looking statements are based on the company's current expectations and inherently involve significant risks and uncertainty or actual results and the timing of events could differ.
Materially from those anticipated in such forward looking statements as a result of these risks and uncertainties doctors that could cause results to be different from these statements include doctors. The company describes in the section titled Risk factors in our current report on form 10-K.
Filed with the FCC on February 26, 2020, and form 10-Q, two be filed shortly on May 27th 2000, 22000 May seven 2020 grams cautions you not to place undue reliance on forward looking statements and undertakes no duty or obligation to update any forward looking statements as result of new information.
Mark J. Foley: With that, I will now turn the call over to Mark Foley. Mark?
Future events or changes in its expectations.
I will now turn the call over to Mark Foley Mark.
You Jeanie good afternoon, everyone and thank you for joining our first quarter 2020 financial results Conference call.
Mark J. Foley: Thank you, Jeanne. Good afternoon, everyone, and thank you for joining our first quarter 2020 financial results conference call. I hope that you are all safe and well, and that you are successfully adapting to the evolving landscape. Before we begin, I would like to pay special tribute to the medical professionals, caregivers, first responders, and essential workers on the front lines of the COVID-19 crisis. In support of their efforts, we have contributed personal protective equipment to our local hospitals. I would also like to recognize and thank the entire Revance organization for their adaptability, flexibility, and resilience during these unprecedented times. Together, we are supporting others in need within our communities by providing weekly meals to a local soup kitchen and through a matching gift program to help fund three local and national charities providing critical support.
You are all safe and well and that Youre successfully adapting to the evolving landscape.
Before we begin I would like to pay special tribute to the medical professionals caregivers first responders and essential workers on the front line of the Cobot 19 crisis.
Supported their efforts, we have contributed personal protective equipment to our local hospitals.
I also want to recognize and thank the entire revamps organization further adaptability flexibility and resilient during these unprecedented times.
Together, we're supporting others in need within our communities by providing weekly meals to local soup kitchen and through a matching gift program to help on three local and national charities, providing critical support.
Like all companies across the U.S. and around the globe, we find ourselves adjusting to unforeseen circumstances caused by the cobot 19 pandemic and shelter cone directives.
Mark J. Foley: Like all companies across the US and around the globe, we find ourselves adjusting to unforeseen circumstances caused by the COVID-19 pandemic and shelter-at-home directives. To this end, we have implemented a detailed COVID-19 infectious disease preparedness and response plan that will govern our work environment and which will continue to evolve as more information and guidance becomes available. As we adapt to the new world shaped by the COVID-19 pandemic, Revance does so from a position of financial, operational, and product portfolio strength. We're very well-funded, with more than half a billion dollars in cash and investments as of March 31st.
To this end we've implemented a detailed cobot 19 infectious disease preparedness and response plan that will govern our work environment in which will continue to evolve as more information in guidance becomes available.
As we adopted the new world shaped by the Kogut 19 pandemic Revamps does so for this is from a position of financial operational and product portfolio strength.
We're very well funded with more than half a billion dollars in cash and investments as of March 31st we have an FDA approved RJ dermal fillers portfolio, we are ready for launch in the U.S. in the third quarter. Our PDUFA date for Daxibotulinumtoxina eight for injection remains on schedule for November 25th.
Mark J. Foley: We have an FDA-approved RHA dermal filler portfolio. We are ready for launch in the U.S. in the third quarter. Our PDUFA date for Daxibotulinum toxin A for injection remains on schedule for November 25th, and our key clinical development plans remain on track to deliver top-line results for multiple Phase 2 studies and a Phase 3 pivotal trial this year.
And our key clinical development plans remain on track to deliver topline results for multiple phase two studies and the phase three pivotal trial this year.
In short despite the challenging environment, we continued to be very well positioned and remain focused on delivering on our previously communicated strategy, while adjusting as necessary.
Mark J. Foley: In short, despite the challenging environment, we continue to be very well positioned and remain focused on delivering on our previously communicated strategy while adjusting as necessary. As previously announced on March 26, we shifted the hiring of our sales organization by one quarter to align with the new RHA dermal filler launch date in the third quarter. In light of that shift, we anticipate a modest impact on filler revenue for 2020, along with the reduction in Salesforce costs. Thus, we anticipate 2020 non-GAAP operating expense to come in at the lower end of our previously announced guidance.
As previously announced on March 26, we shifted the hiring of our sales organization by one quarter to align with the new Rhj dermal fillers launch date in the third quarter in light of that shift we anticipate we anticipate a modest impact on filler revenue for 2020, along with a reduction in sales force cost.
Thus, we anticipate 2020 non-GAAP non-GAAP operating expense to come in at the lower end of our previously announced guidance.
Despite the challenging cobot market landscape revamped still has a catalyst rich year with a number of important milestones occurring in the next six to seven months.
Mark J. Foley: Despite the challenging COVID market landscape, Revance still has a catalyst-rich year with a number of important milestones occurring in the next six to seven months. We continue to make very good progress towards the achievement of the remaining clinical, regulatory, and commercial catalysts for 2020. A couple of comments on our pending commercial launch. First, we feel very fortunate to approach the market with two truly novel and differentiated product lines that we believe will appeal to both physicians and consumers alike. And despite the current market disruption, our third quarter launch timing should coincide with a more stable or new normal environment, particularly as we plan for a targeted rollout strategy. With a very strong balance sheet, we are in a position to ensure a properly resourced launch, while also making sure that we have the right practice support tools to meet the needs of our aesthetic customers. During this shelter-in-place period, our team moved quickly to implement a virtual education and engagement program.
We continue to make very good progress towards the achievement of the remaining clinical regulatory and commercial catalyst for 2020.
A couple of comments on our pending commercial launch.
First we feel very fortunate to approach the market with to truly novel and differentiated product lines that we believe will appeal to both physicians and consumers alike and despite the current market disruption our third quarter launch timing should coincide with a more stable or new normal environment, particularly as we plan for targeted rollout strata.
Good.
With a very strong balance sheet, we earn a physician to ensure a properly resourced launch while also making sure that we have the right practice support tools to meet the needs of our instead of customers.
Turning to shelter in place period, our team moved quickly to implement a virtual education and engagement program.
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Called operation resilience. It was designed to support revamped the steering committee members investigators and key health care advisors.
Unknown Executive: Operation Resilience was designed to support Revance's steering committee members, investigators, and key healthcare advisors. Over multiple interactive webinars and events, we engaged a group of key physicians and outside experts to discuss market impact, return to work strategies, consumer engagement, social distancing, and other relevant topics. In these sessions, we heard that many practices are anticipating pent-up demand and are eager to open or are already in the process of reopening with certain safety procedures in place. Thus, we put together a working group on return to work best practices, which is focused on practical issues such as access to PPE, office protocols, and social distancing logistics.
Over multiple interactive Webinars and events, we engaged a group of key positions and outside experts to discuss market impact returned to work strategies consumer engagement, social distancing and other relevant topics. In these sessions, we heard that many practices are anticipating pent up demand and are eager to open or.
Already in the process of reopening with certain safety procedures in place.
Thus, we put together working group on return to work best practices, which is focused on practical issues such as access to PPD office protocols and social distancing logistics.
We received heartfelt. Thanks from this core health care group for the program content engagement and for creating a space for the professional community to connect with each other via video conferencing.
Unknown Executive: We received heartfelt thanks from this core healthcare group for the program content, engagement, and for creating a space for the professional community to connect with each other via video conference. As far as market dynamics and aesthetics are concerned, during the recession of 2008-2009, while plastic and elective surgeries were down 20-30%, facial injectable procedures were fairly resilient. The U.S. aesthetic neuromodulator market shrank 5% in 2009 and returned to growth rather quickly. Likewise, hyaluronic acid fillers were also resilient, with a U.S. dermal filler slowdown of 9% in 2009 and a quick rebound to growth in 2010. While it's difficult to predict the true impact of the COVID-19 virus on aesthetic practices and consumers, we've heard from many leading practices that they do expect pent-up demand from their regular facial injectable consumers.
As far as the market dynamics anesthetics during the recession of 2008 2009, while plastic an elective surgeries were down 20% to 30% facial injectable procedures were fairly resilient.
The U.S. aesthetic neuromodulator market shrank, 5% in 2009 and returned to growth rather quickly.
Likewise hyaluronic acid fillers were also resilient with the us dermal fillers slowdown of 9% in 2009, and a quick rebound to growth in 2010.
Well, it's difficult to predict a true impact of the cobot 19 virus on aesthetic practices and consumers. We've heard from many leading practices that they do expect pent up demand from their regular facial injectable consumers.
To account for this many of these leading practices are telling us they plan to work nights and weekends to accommodate consumer interest while taking into account the social distancing requirements and prevention strategies, which will impact the number of patients. They can see in a given day.
Unknown Executive: To account for this, many of these leading practices are telling us they plan to work nights and weekends to accommodate consumer interest while taking into account social distancing requirements and prevention strategies, which will impact the number of patients they can see in a given day. From our perspective, in the U.S., we anticipate that aesthetic procedures will experience a significant slowdown in the second quarter, followed by a modest recovery in Q3, and then a return to growth in Q4 off of a lower base. However, despite the economic impact, safety concerns, and social distancing logistics associated with the coronavirus, the underlying growth drivers remain strong and will continue to create demand going forward.
From our perspective in the US we anticipate that aesthetic procedures will experience a significant slowdown in the second quarter, followed by a modest recovery in Q3, and then a return to growth in Q4 off of a lower base.
However, despite the economic impact safety concerns and social distancing logistics associated with the Corona virus the underlying growth drivers remain strong and we'll continue to create demand going forward.
Fortunately for us and where we are in our product launch cycle Q3 for the RJ fillers in Q4 for our neuromodulator, we will be introducing our products into the market at a time when we expect that aesthetic practices and consumers will have settled into the new normal also when taking into account our targeted launch strategy.
Mark J. Foley: Fortunately, for us, and where we are in our product launch cycle, Q3 for the RHA fillers and Q4 for our neuromodulator, we will be introducing our products into the market at a time when we expect that aesthetic practices and consumers will have settled into the new normal. Also, taking into account our targeted launch strategy and phased rollout approach, we expect that we will be introducing our innovative products into a much more stable environment than we have today. And it will be at a time when we believe that new, novel products with a differentiated value proposition will be well received. In terms of our value drivers, our nearest commercial catalyst is the launch of our RHA 2, 3, and 4 dermal fillers.
Phased rollout approach, we expect that we'll be introducing our innovative products into a much more stable environment than we have today.
And it will be at a time, when we believe that new novel products with a differentiated value proposition will be well received.
In terms of our value drivers our nearest commercial catalyst is the launch of our Rhj two three and four dermal fillers a shared previously we shifted the launch of our Archie pillars by one quarter due to the cobot 19 situation, which caused a temporary closure.
Mark J. Foley: As shared previously, we shifted the launch of our RHA fillers by one quarter due to the COVID-19 situation, which was caused by the temporary closure of Teoxane Swiss manufacturing facilities. We are currently targeting a third quarter launch while being pragmatic about timing. We remain in close contact with Teoxane, who recently shared with us that they have reopened their manufacturing facility and that they plan to have sufficient product supply to support our third quarter launch. Now, I will hand the call over to Dustin to provide an update on our commercialization plans. Dustin?
Which was caused by the temporary closure of Chuxing switch manufacturing facility.
We're currently targeting a third quarter launch while being pragmatic about timing.
We remain in close contact with Ti boxing, who recently shared with us that they have reopened their manufacturing facility and that they plan to have sufficient product supply to support our third quarter launch now let me hand, the call over to duston to provide an update on our commercialization plans duston, thanks, Mark as Mark mentioned revanchist.
Dustin S. Sjuts: Thanks Mark. As Mark mentioned, Revance is fortunate to face this market situation with unique timing, products, and strategy. Our commercial team is in a robust launch planning phase with the right flexibility in our sales team on board. We are maximizing this time to engage virtually with key investigators and health care professionals to learn from and support them in this unusual situation. In addition to physician training and engagement, we are using this time prior to the launch of our RHA dermal fillers to progress and refine all aspects of our commercialization infrastructure and plan. We've completed the hiring of our regional sales managers, who have, in turn, been utilizing web-based interview tools to select top field sales talent. We are making prudent decisions on the timing for each field rep, while targeting a majority of the onboarding for mid-summer. Approximately 40% of our territories are filled, with remaining offers to be extended throughout the second quarter.
Fortunate to face this market situation with unique timing products and strategy. Our commercial team has done a robust launch planning phase with the right flexibility in our sales team Onboarding, we're maximizing maximizing its time to engage virtually with key investigators and healthcare professionals to learn from and to support them in this unusual situation in it.
Vision to physician training and engagement, we are using his time prior to the launch of our Rhj dermal fillers to progress and refine all aspects of our commercialization infrastructure and plan.
We've completed the hiring of a regional sales managers, who have been turn and utilizing web based interview tool to select top field sales talent, we are making prudent decisions on the timing for each field reps, while targeting a majority of the onboarding for mid summer approximately 40%. Other territories are filled with remaining offers to be extended throughout the second quarter.
The first shipments of our ha dermal fillers, just a few months away our regional managers are planning hands on training for select accounts and key opinion leaders. Our first step is to put samples of the products in the hands of key injectors to develop confidence in this new technology.
Dustin S. Sjuts: With the first shipment of the RHA dermal fillers just a few months away, our regional managers are planning hands-on training for select accounts and key opinion leaders. Our first step is to put samples of the products in the hands of key injectors to develop confidence in this new technology. This will be followed by a broader training and product sampling program scheduled to take place after our national sales meeting in the third quarter. Our marketing initiatives and infrastructure build-out continue to progress against our launch imperatives. Our marketing team has leveraged this time to commence virtual faculty education and engagement sessions with experts and trainers from Europe who bring knowledge and expertise to the RHA technology. Finally, we've begun implementing multiple infrastructure systems, integrated platforms to support commercial operations, including a CRM system, position training tools, and customer service technologies. These systems are either live or nearing finalization.
Will be followed by a broader training and product sampling program scheduled to take place after our national sales meeting in the third quarter.
Our marketing initiatives and infrastructure build out continues to progress against our launch imperatives, our marketing team have leverage this time to commence virtual faculty education and engagement sessions with experts and trainers from Europe, who bring knowledge and expertise on the Rhj technology.
Finally, we have begun implementing multiple infrastructure systems integrated platforms to support commercial operations, including a CRM system physician training tools and customer service technologies. These systems are either live or nearing finalization. Our customer service team is fully hired and training is nearly complete we've also welcome new members of lead.
Dustin S. Sjuts: Our customer service team is fully hired, and training is nearly complete. We've also welcomed new team members leading HCP education, sales training, and business analytics, as well as new commercial HR and legal partners to support our imminent launch plan. With the addition of these new hires and our existing team, our commercial foundation is in place and well prepared to execute. While COVID-19 continues to remain an evolving situation, some practices, depending on geographic location, began to schedule injectable appointments and elective surgeries starting May 1st, and 12 states are already open for elective procedures.
New new team members, leading HCP education sales training and business analytics as well as new commercial HR and legal partners to support our eminent launch plans with the addition of these new hires and our existing team our commercial foundation is in place and well prepared to execute.
Well covered 19 continues to remain evolving situation some practices, depending on geographic location began to schedule injectable pointman and elective surgeries, starting may Onest and 12 states are already open for elective procedures, we know that luxury spending as a surprisingly resilience during economic recoveries with the aesthetics no more modulator market.
Dustin S. Sjuts: We know that luxury spending is surprisingly resilient during economic recoveries, with the aesthetic neuromodulator market growing 35% from 2009 to 2013, while overall market growth was only 15%. As the market for injectables has grown, many consumers consider treatment a personal care necessity. The introduction of our Innovative Product Portfolio will be part of our creation of a new Prestige Category in Aesthetics. Our offerings in this category are compromised products and services that are expertly created to produce an exceptional experience available exclusively through select medical aesthetic practitioners. Ultimately, it will give dermatologists and plastic surgeons something truly new to offer their patients that delivers real value and transforms patient experience. Overall, our team is on track and focused on the anticipated launches of FDA-approved RHA 2, 3, and 4, the first and only dermal fillers indicated for the correction of dynamic wrinkles and folds, and Revance's next-generation neuromodulator, Daxibotulinum Toxin A, for injection. With that, I'll turn it back over to Mark.
Growing 35% from 2009 to 2013 or the overall market growth was only 15%.
As the market for Injectables has grown many consumers consider treatment a personal care necessity.
Introduction of our innovative product portfolio will be part of our creation of a new prestige category anesthetics our offerings in this category our compromised products.
Services that are expertly created to produce an exceptional experience available exclusively through select medical aesthetic practitioners ultimately it will give dermatologists and plastic surgeons something truly new to offer their patients that delivers real value and transforms patient experiences overall, our team is on track and focused.
On the anticipated launches of FDA approved RJ, two three and for the first and only dermal fillers indicated for the correction of dynamic rentals unfolds and advances next generation neuromodulator Daxibotulinumtoxina a for injection with that I'll turn it back over to Mark.
Thanks, Duston now let me cover Daxibotulinumtoxina for injection.
Mark J. Foley: Thanks, Dustin. Now, let me cover Dactybotulinum toxin A for injection. To date, we have not received any indication from the FDA that our PDUFA date will change, and our commercial launch is still planned for year end. Revance is a vertically integrated manufacturer of daxibotulinum toxin A for injection produced at our headquarters in California. As a result, we've been fortunate to avoid any supply chain or production issues related to the COVID-19 situation, and we continue to work with the FDA toward our November 25th fiduva date. Once we combine doxybotulinum toxin A for injection with our range of RHA dermal fillers, we'll have a synergistic portfolio of products that will establish a whole new prestige segment in the facial injectables market and that will provide both physicians and consumers with a truly differentiated alternative.
Today, we have not received any indication from the FDA that our PDUFA date will change and our commercial launch is still planned for year end.
Grievances, a vertically integrated manufacturer with doxey botulinum toxin day for injection produced at our headquarters in California.
As a result, we've been fortunate to avoid any supply chain or production issues related to the coated 19 situation and we continue to work with the FDA toward our November 25, 50 today.
Once we combine daxibotulinumtoxina for injection with a range of our ha dermal fillers, we'll have a synergistic portfolio of products that will establish a whole new prestige each segment in the facial injectables market and that will provide both physicians and consumers with a truly differentiated alternative.
As to our active clinical programs, we've been fortunate that most of our clinical trials have not been impacted by cobot 19.
Mark J. Foley: As to our active clinical programs, we have been fortunate that most of our clinical trials have not been impacted by COVID-19. Notably, the Aspen 1 Phase 3 cervical dystonia, Phase 2 plantar fasciitis, and two of the three Phase 2 trials in the upper phase studies were fully enrolled in dose before the U.S. outbreak of COVID-19. All subjects in those trials have passed through the primary endpoints and are completing the final assessment visits done either in person or remotely. The single exception is our Juniper Phase 2 Adult Upper Limb Spasticity Trial, in which enrollment has been paused due to challenges in subject assessments during a time of required social distancing.
Notably the Aspen, one phase III cervical dystonia phase two plantar fasciitis into the three phase two trials in the upper Phase studies were fully enrolled and dosed before the U.S. outbreak of Cobot 19.
All subjects in those trials have passed through the primary endpoints and are completing the final assessment visits done either in person or remotely.
The single exception as our Juniper phase two adult upper limb spasticity trial in which enrollment has been pause due to challenges in subject assessments during a time required social distancing.
We will provide a new date for expected full enrollment after the trial is reopened and an enrollment trajectory is established.
Mark J. Foley: We will provide a new date for expected full enrollment after the trial is reopened and an enrollment trajectory is established. We still expect to have top-line results for the Aspen 1 Phase 3 cervical dystonia and Phase 2 plantar fasciitis trials in the second half of 2020. I also want to note that the Aspen Open Label Safety Study has hit its target enrollment number, so the whole cervical dystonia program remains on track. As for the three Facial Aesthetics programs, we continue to expect we'll complete the forehead lines and crow's feet trials in the second quarter and the upper facial lines trial in the fourth quarter. We plan to present those results at upcoming medical conferences. A quick note on the Biosimilar asset
We still expect to have topline results for the Austin, one phase three cervical dystonia in phase two plantar fasciitis trials in the second half of 2020.
I also want to note at the Aspen Open label Safety study has hit its target enrollment number so the whole cervical dystonia program remains on track.
As to the three facial aesthetics programs. We continue to expect will complete the four headlines and crow's feet trials in the second quarter in the upper facial lines trial in the fourth quarter, we plan to present those results at upcoming medical conferences.
A quick note on the Biosimilar asset.
Mark J. Foley: As we noted in a brief press release on May 1st, we are still in discussions with Mylan regarding the Biosimilar to Botox program. Before making their decision as to whether or not they want to opt in, they asked for time to review the recently provided data with their team and the collective steering committee. We now expect a response by the end of May. With that overview of our first quarter and recent activities, let me turn the call over to Toby to summarize our financial results. Afterward, I'll have a few closing comments before we begin today's Q&A session. Toby? Thank you.
As we noted in a press release on May Onest, we're still in discussions with Mylan regarding the Biosimilar to Botox program before making their decision as to whether or not they want to opt in they asked for time to review. The recently provided data with their team in the collective steering Committee. We now expect a response by the end of May.
With that overview of our first quarter in recent activities, let me turn the call over to Toby to summarize our financial results. After world. Afterwards, I'll have a few closing comments before we begin today's Q and a session Toby.
Thank you Mark starting with our cash cash equivalents and short term investments balance we ended the first quarter with $511.3 million, which we believe is sufficient to fund the company into 2023.
Tobin C. Schilke: Thank you, Mark. Starting with our cash, cash equivalents, and short-term investments balance, we ended the first quarter with $511.3 million, which we believe is sufficient to fund the company into 2023. This balance includes proceeds from the $287.5 million convertible senior notes we issued in February. Revenue for First Border 2020 consisted of $58,000 recognized from the MyLand Collaboration. In the first quarter, our OPEX was $61 million. This included a one-time, non-cash purchase accounting charge of $11.2 million allocated to in-process research and development, reflecting the relative value of RHA-1 and other unapproved future advancements related to the Teoxane distribution arrangement. Excluding depreciation, amortization, stock-based compensation, and RHA-related in-process R&D, our OPEX was $42.6 million. The earnings release we issued today outlines our financial results in full, so I won't go through the details on this call.
This balance includes proceeds from the 287.5 million convertible senior notes we issued in February.
Revenue for the first quarter Twentytwenty consisted of $58000 recognized from the Milan collaboration.
In the first quarter, our Opex was $61 million. This included a onetime noncash purchase a key purchase accounting charge of $11.2 million allocated to in process research and development, reflecting the relative value of our ha one and.
Other unapproved future advancements related to the Trs same distribution arrangement.
Excluding depreciation amortization stock based compensation and the Rhj related in process R&D, our opex was $42.6 million.
The earnings release, we issued today outlines our financial results in full so I won't go through the details on this call.
As to our Twentytwenty guidance in February we issued Twentytwenty GAAP operating expense guidance of $270 million to $280 million and non-GAAP operating expense, which excludes depreciation amortization stock based compensation and the rhj related.
Tobin C. Schilke: As to our 2020 guidance, in February, we issued 2020 GAAP operating expense guidance of $270 to $280 million and non-GAAP operating expense, which excludes depreciation, amortization, stock-based compensation, and RHA-related in-process R&D of $220 to $230 million. Due to the shift in hiring of our field force, we expect both 2020 GAAP and non-GAAP OPEX to come in at the low end of Revance still expects 2020 non-GAP research and development expenses to be $95 to $100 million. In terms of future revenue, our policy remains to refrain from providing sales guidance until we can determine the launch trajectory of our RHA filler line. We will, however, provide updates on our progress as we approach the market. Finally, Revance's shares outstanding as of April 24, 2020, were approximately 57.1 million, with 62.4 million fully diluted shares, excluding the impact of the convertible debt.
In process R&D of $220 million to $230 million.
Due to the shift in hiring of our field force, we expect full twentytwenty GAAP and non-GAAP opex to come in at the low end of that range.
Revamped still expects Twentytwenty non-GAAP research and development expense would be $95 million to $100 million.
In terms of future revenue our policy remains to refrain from providing sales guidance until we can determine the launch trajectory of our AJ filler line. We will however provide updates on our progress as we approach the market.
Finally revamped the shares outstanding as of April 24, Twentytwenty were approximately 57.1 million with 62.4 million fully diluted shares excluding the impact of the convertible debt.
With that I'll turn the call back to Mark.
Mark J. Foley: With that, I'll turn the call back to Mark.
Thank you Toby.
Unknown Executive: Thank you, Toby. We believe Revance is very well positioned to manage through the COVID-19 situation with minimal disruption to our previously stated commercial and clinical development plans. And as we look ahead to the remainder of the year, we are very excited about the many meaningful milestones and catalysts that we have in front of us to build out our aesthetics and therapeutics franchises. The excitement is mounting as we prepare for two significant product launches this year, and I'm personally looking forward to providing you with updates along the way. With that, I will now open the call up for questions. Operator?
We believe Rebounce is very well positioned to manage through the cobot 19 situation with minimal disruption to our previously stated commercial and clinical development plans and as we look ahead to the remainder of the year. We're very excited about the many meaningful milestones in catalysts that we have in front of us to build out our aesthetics in therapeutic.
Six franchises.
The excitement is mounting as we prepare for two significant product launches this year and I'm personally looking forward to providing you with updates along the way with that I will now open the call up for questions operator.
As a reminder to ask your question you will need to press star one on your telephone.
Unknown Executive: As a reminder, to ask a question, you will need to press star 1 on your. Draw your question. Press the pound.
All your question Frank.
Please standby.
Jacob Hughes: Please stand by while we compile the Q&A and your first question. Jacob Hughes, Wells Fargo, Hey guys, good afternoon. Hey Jacob, how are you? Doing okay, doing okay. How are you? Good, thank you. Um, yeah, so I was wondering a couple questions. Just given coronavirus and all, can you give some additional color on where Teoxin is from a manufacturing standpoint, and when do you expect to get to the right inventory levels? And then secondly, just given the economic dynamics, how are you thinking about pricing for the filler launch and associated bundling with Teoxin?
Thank you and a roster.
And your first question comes from.
Take up Hughes Wells Fargo Securities.
Hey, guys good afternoon, Hey, Jacobs.
Okay. Okay Maria Thank you.
Yes, I was wondering couple of question.
Mark J. Foley: That's a great question. So first, on the Teoxane supply, I think, as we've mentioned in our prepared remarks, you know, they did shut down due to the virus. Similar to us here, they had a shelter in place, and so they couldn't manufacture. They've recently reopened their manufacturing facility, and we've been in routine communication with them. So they feel very good about their ability to provide us with products for our Q3 launch, so we feel very good about that current launch timing. In terms of, you know, pricing and bundling, you know, again, we'll share that when we get closer to the market. But, you know, right now, we don't think that, you know, there's going to be a necessity to sort of change our overall strategy.
Just given corrado buyers in all can you give some additional color.
Where t. octane is for manufacturing standpoint, and what do you get when do you expect gets the right inventory levels and then secondly.
Mark J. Foley: We're going to be very targeted in our approach. If you look at these practices today, they're seeing fewer patients, even though the demand is there, because of the social distancing requirements, and as a result, there's frankly not a huge incentive for them to try and discount as they have sort of fewer office visits coming through. We expect that that will ease over time. But, you know, our current thinking is that the pricing strategy that we had previously put in place still holds, and we'll provide more details on that once we're in the marketplace.
Jacob Hughes: Got it. Thanks a lot, guys. Appreciate it. Hi, this is Missy on behalf of Terence. Thanks for taking our question. Oh, sorry, one second.
Missy: How far along would you say that you are in your commercial prep work, and how much of the costs are fixed versus variable? And then, I'm kind of following up on that, what would you say the size of your target prescribing audience relative to your competitors? I know in the past I've mentioned that you're targeting kind of higher-end competitors. Customers for both.
Mark J. Foley: Mr. Mitzi, great question. So the first one on commercial preparations, you know, we were originally planning to launch in Q2. So we had made pretty good progress in terms of a lot of the infrastructure and everything that we needed to have in place from a launch logistics standpoint. We had started moving down the path of bringing in our regional sales managers. And frankly, we were working on a pretty aggressive and tight timeline, when it became apparent that with COVID-19, we weren't going to have product to shelter in place. We delayed the hiring of our entire field sales organization, so we largely had the regional managers in place, of which there are 12 of those. And then we held on to the others, but we made a lot of investments in, you know, the systems that were going to be needed to, you know, ship product and recognize revenue. And frankly, this extra time has given us a little bit more of an opportunity to make sure that we're fully ready on that side of it. So right now, we don't have any sales reps on board, so that's not a cost that we're currently incurring.
Unknown Executive: And we've been able to shift the onboarding of those reps to Q3, to coincide with the launch of the product. In terms of the size of the market, you know, we've given context and color that said we're going to start with kind of a 100-ish type of reps. And as a result, because of that size, there's obviously a limit to the number of accounts that reps can call on. And so because we're bringing sort of these premium or prestige products into the marketplace, we're going to be targeted in the, you know, the physician and injector accounts that we call on, and they're naturally going to be the busier or the higher-end practices. And so I don't know that we can necessarily give you a sense for exactly what portion of the market it is, but we feel very good that with those 100 reps, we'll have a good number of accounts for each of them to manage and handle, and that will allow us to enter the market from a position of strength.
Unknown Executive: Unknown Speaker Great, thanks so much. Unknown Speaker Great. Thank you.
Unknown Executive: Great, thank you.
Unknown Attendee: Hi, good afternoon. Thanks for taking the questions. A couple from me.
Unknown Attendee: Firstly, you're in a great position with more than half a billion dollars of cash and influence changing situations. Do you see the potential for any opportunistic business development activities as other businesses face cash flow issues? Do you think it's time to go shopping?
Mark J. Foley: Well, I think we're always going to be sort of disciplined buyers of assets that we think can add value to the company. So even though we've got a strong cash position, that's not going to necessarily change our strategy. It's certainly true that there might be some assets that are a little more attractively priced, but we really like where we're positioned today. In the injectable market, we think we've got two great assets where there's a ton of synergy and leverage with our field team and with our practices. And I think, you know, we're going to be very focused on, first and foremost, making sure that we can ensure a really good launch for those two products. But certainly, as we go forward, we recognize that there are a number of different factors that ultimately contribute to success in the marketplace.
And today in the injectable market, we think we've got two great assets, where there's a ton of synergy and leverage with our field a team and with the practices and so I think you know we're going to be very focused on you know first and foremost making sure that we can ensure really good launch from those two products, but certainly as we go for we we recognize that there are a number of different.
Factors that ultimately contribute to success in the marketplace and if we find things that make sense and that we think are at the right value than than absolutely. We're looking forward to building out you know kind of a world class aesthetics franchise and a.
Mark J. Foley: And if we find things that make sense, and that we think are at the right value, then absolutely, we're looking forward to building out, you know, kind of a world-class aesthetics franchise and a therapeutics franchise. And so we will continue to be opportunistic as we move forward, while also being very thoughtful and disciplined about making sure we've got our priorities in the right place.
<unk> franchise, and so we will continue to be opportunistic as we move forward, while also being very thoughtful on disciplined about making sure. We've got our priorities in the right place.
Great.
Unknown Attendee: Great, Mark. Secondly, on the RHA launch being moved to Q3, just wanted to understand if this was purely a question of change in timing, or is there a change in strategy? And also, on a related question, is there any impact on the RHA-1 launch in 2021?
<unk> I can't launch being moved to kill three just want <unk> timing or is that it changes strategy.
And those so and then related question is there any impact on the on a j. one launch for 2021.
Yeah, So I'll take a lot of one first the timing of the R.H.A. One we're still looking that as a 2021 approval. So we we continue to feel good about that on you know the overall strategy for R.R.A.J. launch really no change you know we've always talked in the past about starting with kind of sampling program to get experience into.
Mark J. Foley: Yeah, so I'll take the latter one first. The timing of RHA-1 is still looking at as a 2021 approval, so we continue to feel good about that. On, you know, the overall strategy for our RHA launch, really no change. You know, we've always talked in the past about starting with kind of a sampling program to get experience and to build sort of a good user base before we move into the next phase of the launch. I think that it's still very much intact.
Build sort of Ah you know a good user base before we move into the next phase of the launch I think that's still very much intact.
Again, we feel like with this extra time, we're able to put it sort of a few more materials and tools in place to ensure we've got to write launch but at this point no. No changes strategy of course will continue to be very mindful of the environment is we talked about in our prepared comments, we do like that you know, we're starting obviously see different states coming online people you know starting to see patients and.
Mark J. Foley: Again, we feel like with this extra time, we're able to put sort of a few more materials and tools in place to ensure we've got the right launch. But at this point, there is no change in strategy. Of course, we'll continue to be very mindful of the environment. As we talked about in our prepared comments, we do like that, you know, we're starting to see different states coming online, people, you know, starting to see patients and returning to, you know, what they do. So by the time we launch in September, we'll have had the benefit of a couple of months of things coming back to normal, and so we'll certainly be sensitive to those things. But right now, we're not anticipating any change in our strategy.
Returning to you know what they do so by the time, we we launch in September will have had the benefit of a couple of months of things coming back to normal and so will certainly be be sensitive to those things, but right now we're not anticipating any change in our strategy.
Great just one find one on bison about dogs I was under the impression that there was nothing to for you to provide in terms of them data said smiling and you mentioned you know prepaid amongst that you provided them. So much data at least complete what well into the boat and also any updates on.
Unknown Attendee: Great. Just one final one on Biospin or Botox. I was under the impression that there was nothing for you to provide in terms of data sets to Mylan, and you mentioned in your prepared remarks that you provided them with some data recently. What was it about? And also,
<unk> Oh, what's is my <unk>.
Yeah, well. So you know first off I think we continue to be very encouraged by this program I think that you know with where we started and having natural questions about whether or not there was a true 351, Kate bio similar pathway. We obviously got had encouraging dialogue with the agency and through some of the characterization work you know to continue to give us.
Mark J. Foley: Well, so, you know, first off, I think we continue to be very encouraged by this program. I think that, you know, with where we started and having natural questions about whether or not there was a true 351K biosimilar pathway, we obviously got, had encouraging dialogue with the agency, and through some of the characterization work, it's continued to give us a lot of confidence in this program. In terms of the delay in the opt-in decision by Mylan now being the end of May, no, I mean, we've been working really well together with them. This is obviously a big decision for both sides, and while the steering committees have been working really closely together, there was some additional information that we provided them recently that they just wanted to make sure that they had the appropriate time to review before giving us a final decision. So we think Mylan's been a great partner, and we look forward to getting their results, but we also have a lot of confidence in the program and feel that we've made a lot of progress with it.
Lot of confidence in this program in terms of the delay and the often decision by mile and now being the end of May no. I mean, we've been working really well together with this is obviously a big decision for both sides and while the steering Committee said been working really closely together there was some additional information that we provided them recently that they.
I just wanted to make sure that they they had the appropriate time to review before giving US a final decision. So we think my own spend a great partner and so we look forward to getting their results, but we also have a lot of confidence in the program in feel that that we've made a lot of progress with it.
Mark J. Foley: Thanks, Mark. Thank you.
<unk> Okay. Thank you.
Unknown Attendee: Thank you.
And your next question.
Mmm.
Oh.
Hi, Thanks for take my question somewhere I keep them pretty good staying in front of here k. wasn't engage them.
Annabel Eva Samimy: Hi, thanks for taking my question. So Mark, you've been pretty good staying in front of your KOLs and engaging them to assess their sort of mood and readiness.
They're sort of mood in readiness how.
We've talked about how long <unk> this position pent up demand how do you think that they're going to reconcile the demands that they have well appropriate social.
Annabel Eva Samimy: We've talked about how a lot of these patients, these physicians have pent-up demand. How do you think that they're going to reconcile the demand that they have with the appropriate social distancing that they need to not have tremendous flow through the office? And will they be able to accommodate the two, and can we potentially see a slower recovery because of that? I guess the other point I wanted to mention was that there's a lot of commentary around how toxins are the first product that these physicians will likely go to, so is the market ready for a new filler launch? When you think about that launch, will you potentially implement a longer sampling program to sort of wait for these practices to recover a little bit from that?
Thing that they need to not have a tremendous flow through the offsets and and well they be able to accommodate the the <unk>. The two and can we actually see it so recovery because of that.
I guess the other <unk>, but you know there's a lotta commentary around how toxins are the first product that.
Positions were likely go to so it's a market ready for a new set our lunch. When you think about that launch will you have to actually implement a longer sampling program to sort of wait for these practices to recover a little that from that thanks for great. Thanks had about great question. So you know maybe first off.
On the physician side, what are we hearing out there. So I think the first thing is that they're not all the same right. So it's easy to get a little bit myopic based on sort of the area that you live but you know each states different and you find that you know if you're obviously in New York or you know another area. That's been hit a little harder I think that you know.
Is back going to be a little bit different, but having said that I think it there you know pretty much universally across the board, they're all going through a fair bit of effort to ensure safe work environment, a safe environment for their patients and are taking steps to clean and and create more distancing for the patients and so what that means that a high level.
Mark J. Foley: the board, they are all going through a fair bit of effort to ensure a safe work environment, a safe environment for their patients, and are taking steps to clean and create more distance for the patients. And so, what that means at a high level is that they're not able to see as many patients as they were before in a given day. So, it's created a little bit of a bottleneck.
Mark J. Foley: I think to try and address this, some are going to have longer hours or more flexible hours, maybe even work some weekends. And so, right now, in this early phase, what we're hearing is that most have no shortage of patients. They just have a limit in terms of the number that they can move through their practice in a given day.
Is that they're not able to see as many patients as they were before any given day. So it's created a little bit of a bottleneck I think to to try and addressed at some are going to have longer hours or more flexible hours or maybe even work some weekends and so right now in this early face what we're hearing is that most have no shortage of patients. They just have a limit in terms of the number.
Mark J. Foley: And so, I think that's going to evolve over time. I think as this plays out and they get more comfortable, patients get more comfortable, I'm sure they will figure out a way to try and take care of what is, you know, probably a larger demand than what they can deal with today. And so, the fact that we won't be launching our filler until September and then our varimodulator not being approved until later this year, you know, we think that there is going to be an evolution and that by the time we hit the market, they will probably have figured out some ways to address a little bit more of the throughput. And your question on the filler, like, is, you know, is this a good time to be We've heard the same thing.
That they can move through their practice any given day and so I think that's going to evolve over time, I think as displays out and they get more comfortable patients get more comfortable I'm sure. They will figure out a way to try and take care of what is probably a larger demand the what they can deal with today.
And and so the fact that we won't be a launch of our filler until September and that are gonna modulator not being crude til. Later. This year. You know we think that there is going to be an evolution and that by the time, we hit the market you know they will probably have figured out some ways to address a little bit more of the throughput.
Mark J. Foley: There's no doubt that with regard to facial injectables, which I think across the whole aesthetic landscape are probably going to be the ones that recover first. Some have certainly expressed an interest in wanting to start with, you know, neuromodulators first and then fillers. Having said that, we know that filler procedures are going to take place, and patients are going to have an interest in them. Physicians will find a way to safely do this. And so, we think it's going to be there. So, you know, at a high level, we continue to feel good about our strategy; there's no change there. And hopefully, that gave you a little bit more color in terms of how we see the market right now.
Your question on the filler like is you know is this a good time to be launching pizza Miller and versus a neurotoxin. Yeah. We've heard the same thing there's no doubt that with regards to facial injectibles, which I think across the whole aesthetic landscape are probably going to be the ones that will recover first some it certainly expressed an interest in wanting to start with you know neuromodulators first.
And then fillers, having said that we know that solar procedures are going to take place agents are going to have an interest in it <unk>, we'll find out a way to safely do this and so we think it's going to be there and frankly, it aligns with our very targeted launch strategy, we're going to be working with these thought leaders were gonna be working with accounts that are very comfortable with pillars that hilfiger their way out around.
And you know our Neuromodulators is only a quarter behind it even though we're going to do a very sort of age launched with this you know, it's not going to be that far behind in in one thing that I would note you know we've we've long talked about what we believe us are really important value proposition with a longer acting or module later, but certainly in today's social.
Distancing environment.
And a limited number of patients that you can move sort of practice, we actually think that long duration profile is going to resonate even more with boat consumers and with positions that you know only have so much time in the day when it delivers much value, which they can so you know high level, we continue to feel good about our strategy no change their.
A bit more color in terms of how we see the market right now.
Yeah. Thank you.
Annabel Eva Samimy: Yes, thank you.
Sure that kind of.
Unknown Executive: Sheriff, thank you, Annabel.
Next question catching.
<unk>.
[noise]. Thank goodness you can't <unk>, just one for me I'm the Milan decision.
Dan Clark: Hi, thank you. This is Dan Clark from DFA. Just one question. On the MyLand decision, do you think there's a chance that they could come back to you asking for more data, or would you say at this point you've been pretty comprehensive in what you've given them?
Do you think there's a chance that they could come back to you asking for for more data or would you say at this point you you've been pretty comprehensive in what you'd you'd given them. Yeah. We feel very good with US you know I I think we both understand sort of the importance to get this right into our discussions with them. We expect a final decision by the end of May.
Mark J. Foley: Yeah, we feel very good about this. You know, I think we both understand sort of the importance of getting this right. And through our discussions with them, we expect a final decision by the end of May.
Oh, thank you.
Dan Clark: Thank you. Sure.
Unknown Executive: Sure, thanks.
<unk>.
Next question.
Yeah.
Oh, Thank you you're taking the question.
Unknown Attendee: Thank you for taking the question, and congratulations to the team as they're navigating this difficult environment. I assume, Mark, following up on Annabel's question about what you're hearing from physicians, training is going to be part of the federal launch in addition to sampling. When do you expect the market to kind of be amenable to training sessions and, you know, have to deploy as part of a launch? And, you know, I almost assume that when physician practices reach a new normal, that kind of maybe new therapy and training seminars aren't the initial focus for physicians. Can you just kind of walk me through that a bit?
Congratulations.
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I guess mark following up on.
Of course, she would only you're sharing positions.
I assume training is going to be part of its goal launch additional sample or when you expect the markets are trying to be amenable to training session and kind of leave the face to face marketing I couldn't figure out why they have to.
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Lunch and yeah, what is it yeah, almost <unk>, maybe new fair P. and training seminars.
Will focus for position you can walk you through.
Yeah, well I mean, I think like with everybody. We're we're having to sort of adapt and have to programs right winter in person into our remote training tools and so boat with for our own internal training and then for you know condition training on new products and so we believe that we can effectively accomplish whatever sort of the training requirements are gonna be.
Mark J. Foley: Yeah, well, I mean, I think, like everybody, we're having to sort of adapt and have two programs, right? One is in person, and two are remote training tools.
Either in person or remotely you know, there's no doubt that with any new product, there's going to be some subtleties that need to be incorporated in that people need to understand but you know this group that we're going to be targeting are pretty familiar with a filler injections and I think there's already a lot of excitement about getting their hands on this because it's a pretty well known.
Mark J. Foley: And so both for our own internal training and then for, you know, physician training on new products. And so we believe that we can effectively accomplish whatever sort of training requirements are going to be either in person or remotely. You know, there's no doubt that with any new product, there's going to be some subtleties that need to be incorporated and that people need to understand.
Mark J. Foley: But you know, this group that we're going to be targeting is pretty familiar with filler injections, and I think there's already a lot of excitement about getting their hands on this, because it's a pretty well-known product line in Europe, and many of them have talked to colleagues there. So this isn't going to require sort of a huge readjustment in terms of how they think about it.
Outline in Europe, and many of them I've talked to colleagues. There. So this isn't going to require sort of a huge re adjustment in terms of how they think about it and so we believe that for those positions that are really excited about the product line are excited about offering your consumer something new that we can provide the right sort of remote training program.
Mark J. Foley: And so we believe that for those physicians that are really excited about the product line or excited about offering their consumers something new, we can provide the right sort of remote training program to get them off to a good start if that's what's required. But we'll be ready to go either way, and we think we can be effective there. And then certainly with our neurotoxin, as we get there as well, there's obviously going to be three phase two studies around dosing and patterns. And we've obviously got phase three studies that are out there as well. And likewise, I think there's a tremendous amount of interest in people using this. Again, particularly as people look at, you know, if there's a way to have something last longer, and they don't have to go back into an office as soon afterwards, we think that that's going to create a lot of interest. So, you know, we're going to have to be creative there. But again, we feel really good that we'll have the tools to be able to navigate this environment.
To get them off to a good start it that's what's required will be ready to go either way and we think we can be we can be effective there and then certainly with our neurotoxin as we get there as well, there's obviously going to be three phase two studies around dosing and patterns. We've obviously got Youre phase three studies that are out there as well and and likewise I think there's a tremendous.
This amount of interest in people using this again, particularly as people look at you know if there's a way to have something last longer and they don't have to go back into an office is soon afterwards, we think that that's going to create a lot of interest. So you were going to have to be creative there, but again, we feel really good that we'll have the tools to be able to navigate this environment.
Okay that makes sense and maybe pivoting over to <unk> or simply because it's don't yeah, we'll pay top or expected in the second half will be here.
Unknown Attendee: Okay, that makes sense. And maybe pivoting over to the therapeutic side, for cervical dystonia, with the top line still expected in the second half of the year, have there been a number of patients that maybe have missed their protocol defined windows for twister assessments at all in the trial? And how do you plan on handling any data that may come if patients aren't able to, you know, execute on their affective powers or physicians can't execute on them given COVID?
A number of patients to maybe have missed their protocol.
Mm Oh How'd, you plan on handling any data that to make.
<unk> aren't able to yeah.
Execute on their sex manner position can execute on.
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Mark J. Foley: Yeah, no, I think, you know, as we mentioned, we're fully enrolled in the trials, even on the open label side. We're now kind of past the sort of minimum number that we need. You know, there were some patients that we still need to follow up on, but we think that, you know, through either remote or in person, we're going to be able to get all of the data that we need to wrap this up. So, fortunately, that has not been an issue for us.
No I think you know as we mentioned were were fully enrolled into trials even on the open label side. We're now kind of past sort of the minimum number that we need you know there were some patients that we still need to follow up but we think that you know through either remote or in person that you know, we're going to be able to get all of the data that we need to wrap this up so fortunately that that.
Has not been an issue for us.
Okay. Thank you phone calls.
Unknown Attendee: Okay, thank you for all the questions. Thank you.
Unknown Attendee: Thank you.
<unk>.
[noise] question.
Georgie Yordanova: The next question comes from Georgie Yordanova. Hi guys, thank you so much for taking my question. My first question is, if you could talk about your plans for DTC marketing, such as social media, and what would be your timing for it? And secondly, as we near the results for the forehead and cancel line programs, could you remind us of these two opportunities? And what should we be looking for in terms of results?
Hi, guys think you so much to take my question. My first question is if you could talk about your plans for D.D.C., Mark things, such as social media and what would be or timing for it and so it can only as me near the results for the poor head and candle line programs could do in mind is.
These two opportunities and what should we be looking for in terms of results.
Yeah.
Unknown Executive: Thanks for the question. On the DTC side, I think obviously, consumer demand definitely drives it.
Thanks, Thanks for the question on that she she side I think obviously consumer demand definitely drives this market. However, the first thing we've got to focus on is making sure that the outcomes are aligned with the physician's and those practices have experience with the technologies are focus when we first making sure that they are the physician's themselves have that that product they they've been trained they all.
unknown: Unknown Attendee, Chris Shibutani, Mikaela Franceschina, Douglas Tsao, Uy Ear, Dustin Schilke, Serge Belanger, Douglas Tsao, Uy Ear, Douglas Tsao, Unknown Attendee, Chris Shibutani, Mikaela Franceschina, Navann Dietschi, Jessica Serra, Stacy Ku, John Boyle, Charles Wang Unknown Attendee, Chris Shibutani, Mikaela Franceschina, Douglas Tsao, Uy Ear, Douglas
So are are focusing on the right outcomes and then at the right time will pull through some of the digital components around or did you see strategy. It consumer demand. We think we've got a compelling story with the combination of those two products, but those are in <unk> and well looked up to leverage.
<unk> of that product profile together. The second question. It's on the yeah. It was one of our head in in a lateral cancer lines. You know so that that we've got the forehead collateral cancel and pull up her face. So there's phase two trials, we'll all be completed a in data available by the time that we have our neuromodulator approved.
Mark J. Foley: Yeah, it was on the forehead and the lateral cancel lines, you know, so we've got the forehead, the lateral cancel, and the full upper face. So those phase two trials will all be completed and data available by the time that we have our neuromodulator approved. And so those are going to provide additional details and data around sort of injection patterns, dosing, and everything. So by the time that we go into the market, they'll not only have sort of the glabellar information from our Sakura studies, but they'll have additional information around, again, how these products are used in other areas. And again, these are largely focused on sort of the 30 day efficacy, because this is really more of an efficacy trial, making sure we've got the right dosing there. So we think the combination of all this will address, you know, most of the areas where physicians inject today.
And so those are going to provide additional details and data around sort of injection patterns dozing and everything so by the time that we go into the market that not only have sort of the glabellar information from Marcia career studies, but they'll have a additional information or around again. How these products are used you know other areas and again these are largely coke.
Based on sort of the a 30 day advocacy cause this is really more of a advocacy and making sure. We've got the right go thing there. So we think the combination of all this will address you know most of the areas where positions and Jack today.
Thank you so much disappear.
Georgie Yordanova: Thank you so much. This has been very helpful.
Great. Thank you.
Unknown Executive: Great, thank you.
I can't to ask a question.
<unk>.
That's good question.
The next question.
Yeah.
Oh, great. Thanks for the question. So I took a couple.
Seamus Christopher Fernandez: Great. Thanks for the question. So, just a couple.
You know Mark is you look at the environment as it stands today can you help with understand it seems to me like you have a real unique opportunity to maybe get even more aggressive with this launch.
And I'm just wondering if you or are you thought about considering you know whether it's through the the situation. It seems optimal for getting more aggressive with the launch because admissions are going to be working harder to satisfy their pay since he's got a longer acting treatment here. So I I don't know.
Seamus Christopher Fernandez: You know, Mark, as you look at the environment as it stands today, can you just help us understand? It seems to me like you have a really unique opportunity to maybe get even more aggressive with this launch. And I'm just wondering if you've, or you've thought about considering, whether it be through the situation that seems optimal for getting more aggressive with the launch. Because physicians are going to be working harder to satisfy their patients, you've got a longer acting treatment here. So I don't know if there are opportunities that you see in the midst of this crisis to actually drive more and potentially faster uptake. And then the second question is, just as we think about the global outlicing opportunities of GACCI, can you just help us understand, you know, how you're thinking about the pushes and pulls of outlicing versus, you know, maintaining control of the asset, you know, as it relates Thanks.
Opportunities that you see and and then there's this crisis to actually to drive more and and potentially faster up taking then the second question is just have we think about global out like thing opportunities.
<unk> can you just help us understand you know how you're thinking about the pushes and pulls up outline thing versus you know maintaining control the out but you know as it relates to no potential overall thoughts for for for revenge company. Thanks, Yeah, Seamus great great questions. Good to hear your voice.
Mark J. Foley: Yeah, Seamus, great, great questions. Good to hear your voice. So first, in terms of, you know, the launch strategy and ramp, if you go back and you sort of look at what we're trying to accomplish in this early phase of our launch, you know, we really feel strongly that with a new product, we need to make sure that we get it anchored on a really strong foundation with these physicians. And so that means, you know, getting some sampling programs, getting comfortable, if there's any tweak And so as a result, I don't think we want to necessarily take what could be an opportunity to accelerate the launch and skip over that, what we think is a really important position. You know, having said that, in this market today, certainly with a longer acting neuromodulator, there are some unintended and unexpected potential benefits there that obviously didn't exist before COVID-19.
So first in terms of you know the launch strategy Rampy could go back and you sort of look at what we're trying to accomplish in this early phase of our lawn you know, we we really feel strongly that with a new product we need to make sure that we get anchored on a really strong foundation with these positions and so that means you know getting some sampling programs getting comfortable if there's any.
Weeks or changes in technique that we give that opportunity for that to happen and so as a result, I don't think we want to necessarily take what could be an opportunity to you accelerate the launch and skip over that what we things are really important position you know having said that you know in this market today, certainly with a long racking neuromodulator, there's some and.
Mark J. Foley: Certainly, we always felt like a long acting profile was something that consumers wanted, and that would be well received. But we looked at it more in the context of overall, you know, classic market segment presentation. So in this market today, where, again, physicians can't see as many patients, they are trying to make sure that they get fairly compensated for the work that they're doing.
Tended in unexpected potential benefits there that obviously didn't exist before cobin 19, certainly we always felt like a long acting profile was something that consumers wanted and that would be well received that we looked at it more in the context of overall you know classic market segmentation. So in this market today were against positions can't.
Mark J. Foley: The only way that you tend to take price in these markets is if you have a product that has a very differentiated performance profile, and we think we can offer that. And certainly, on the consumer side, to the extent that they're trying to minimize the frequency of visits in a practice, certainly in this timeframe, we think that will resonate well. You know, the reality is this is going to continue to evolve and change, and so by the time we're on the market, we might be back to some new normal, and again, we really like the product profile. So right now, we don't necessarily see a change in our overall launch strategy or the pace of the uptake. You know, having said that, we'll continue to revisit it. Once we build this sort of anchor foundation, some of these poles will exist in the marketplace.
As many patients are trying to make sure that they get fairly compensated for the work that they're doing the only way that you tend to take price in these markets. As if you have a product that has a very differentiated performance profile and we think we can offer that and certainly on the consumer side to the extent that they're trying to minimize the frequency visits into practice certainly in this time frame.
We think that will resonate well you know the reality is this this is going to continue to evolve and change and so by the time, we're on the market we might be back to some new normal and and again, we we really like the product profile. So right now we don't necessarily see a change in over a launch strategy or the the pace of of the <unk> you know, having said that will continue to revisit it at once.
Mark J. Foley: We'll obviously toggle sort of our Salesforce coverage accordingly. The second question that you had in terms of the global strategy and how we think about outside the U.S., you know, we still like to control the rights to the product in the U.S., and that, you know, outside of the U.S., we will look to partner with it. There might be some markets that, you know, lend themselves to us managing them directly, but overall, we think that that's a winning strategy to find a good partner, partner with them outside of the U.S., both for the aesthetics and the therapeutics. You know, the aesthetics program was always sort of outpaced where we were on the therapeutic side, so we focused a lot more on the commercial side.
Build the sort of anchor foundation. Some of these pulls exist in the marketplace will obviously toggle sort of our sales force coverage a accordingly.
The second question that you had in terms of the global strategy and how we think about outside the U.S. Yeah. We still look at this is where we'd like to control the the rights to the product in the U.S. in that you know outside the U.S., we will have to partner it there might be some markets that you know lend themselves for US you know managing them directly but overall.
We we think that that's a winning strategy is to find a good partner Parker with them outside of the U.S. both for the aesthetics and the therapeutics you know if they're the effects program is always sort of outpaced where we were on the therapeutic side. So you know we focused a lot more on the commercial side, but as we now moving to the back half of the year and we have to really important data readouts for cervical this stone.
Mark J. Foley: But as we now move into the back half of the year and we have two really important data readouts for cervical dystonia and plantar fasciitis, we think that the read-through on the CD program in multiple movement disorders and the read-through on plantar fasciitis and pain disorders is going to bring our therapeutics program a lot more front and center, and so I think that's going to be the right time for us to dig in a little bit deeper on, you know, how do we think about the therapeutics program and opportunities, and so we're spending a lot of time on that, but I think that'll come into clarity a little bit more in the back half of the year.
And classroom plantar fasciitis, we think that the the read through on the C.D. program in most of movement disorders, and the read through on on plantar fasciitis and pain disorders is going to bring our therapeutic program a lot more front and center and so I think that's going to be the right time for us to dig in a little bit deeper on you know how do we think about the therapeutics program.
And opportunities and so we're spending a lot of time on that but I think that'll come into clarity a little bit more in the back half of the year.
Great. Thank you great. Thanks, so much.
The question.
Great. Thank.
Thank you operator in each travel constraints times, we are committed to using technology to keep in touch with our shareholder base. We plan to attend near term conferences versatile virtually including the Goldman Sachs healthcare and William Blair growth conferences in June and welcome your quest for calls over the next few months. Please reach out the Genie, if you'd like to touch base.
Seamus Christopher Fernandez: Great, thank you.
Unknown Executive: Great, thanks so much.
Unknown Executive: And There are no further questions.
Unknown Executive: Great. Thank you, operator. In these travel-constrained times, we are committed to using technology to keep in touch with our shareholder base. We plan to attend near-term conferences virtually, including the Goldman Sachs Healthcare and William Blair Growth Conferences in June, and welcome your requests for calls over the next few months. Please reach out to Jeanne if you'd like to touch base. With that, I would like to thank you all for participating in today's call, and please stay safe. Thank you.
With that I would like to thank you all for participating in today's call and please stay safe. Thank you.
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