Q1 2020 Earnings Call

Keith Kendall: This product received increasing market adoption in the first quarter of 2020, growing over 40% in March over December of 2019. Equestr's lead licensee product, Suboxone, continues to hold strong market share with strong production in the first quarter of 2020 and a strong order book for the second quarter. The Equestria team has begun the process to seek to monetize the anticipated royalties associated with APL 130277 apomorpha.

Keith Kendall: The monetization would occur only after Synovion receives approval from the FDA with an expected PDUFA goal date of May 21, 2020, and when we determine that the terms and conditions of a transaction at that time are appropriate for the company. The company expects that this monetization, if effected, along with our other capital resources and the careful management of our cash across our business, including any pre-approval and pre-launch spend associated with LibraVamp, would provide additional non-dilutive capital to fund the business well into 2021 and potentially beyond. Let's discuss in more detail each of these key areas of focus for the company.

Thank you operator, good morning, welcome today's call to review cost of Therapeutics results for the first quarter 2000.

20 and business highlights.

On today's call I am joined by Keith Kendall, President and Chief Executive Officer, and John Maxwells, Chief Financial Officer, what are going to provide an overview of the recent business development performance in the first quarter.

Additional members of our leadership team will be available for Q and.

In total we expect today's call collapsed approximately 60 minutes.

As a reminder.

Our remarks today correspond with the earnings release, we issued after market close yesterday. In addition, the recording of today's call will be made available on aggressive therapeutics website within the <unk> Investor Relations section surely following the conclusion of this call.

Keith Kendall: We expect to file the IND for request of 108 with the FDA in the second quarter of 2020, as promised. We continue to work toward and expect to initiate PK clinical trials before the end of the year, as expected. As a reminder, we had a very constructive pre-IND meeting with the agency in early February regarding epinephrine. The FDA confirmed two key points for epinephrine. First, the clinical development for epinephrine will be reviewed under the 505B2 Regulatory Approval Pathway, as proposed by Equestiv, and second, that no additional studies would be necessary prior to opening the proposed IND application. The FDA also gave us clear guidance about what they were looking for in our development program.

To remind you really discussing some non-GAAP financial measures. This morning as part of review over first quarter 2020 result.

It description of these measures along with a reconciliation to GAAP can be found in the earnings release, we issued yesterday, which is posted in the Investor Relations section of aggressive therapeutics website.

During the call the company will be making forward looking statements.

And you have the company's safe Harbor language as outlined in yesterdays release, as well as the risks and uncertainties affecting the company as described in the risk factors section, including the company's annual report on form 10-K filed with the FCC on merger 11, 2020 and their quarterly reports on form 10-Q.

Keith Kendall: The FDA also confirmed that it understands that there is a significant unmet medical need among patients who resist the standard of care use of subcutaneous and intramuscular injections in the treatment of anaphylaxis and that Questiv 108 may potentially address some of those unmet needs. We continue to believe that, based on the outcome of this meeting with the FDA, the development of epinephrine will be a less complex, less costly, and potentially faster path to filing than originally anticipated. Second, as we previously communicated, the NDA filing for LibriVant was accepted in January and assigned a PDUFA goal date of September 27, 2020. Over the past few weeks, we've received a number of information requests from the FDA related to our filing, and we continue to engage in the typical, normal course of business correspondence with the agency.

As with any pharmaceutical company with product candidates under development at products being commercialized.

Significant risks and uncertainties.

With respect to our business and the development regulatory approval and commercialization of our products.

And other matters related operations.

And Dr. Kogan 19 also cannot be predicted given these uncertainties you should not place undue reliance on these forward looking statements, which speak only as of the date made.

Actual results may differ materially from these statements.

All forward looking statements attributed to close at their third.

Or any person acting on our behalf are expressly qualified in their entirety by this cautionary statements and the cautionary statements contained in the earnings release issued yesterday.

The company assumes no obligation to update as forward looking statements. After the date of this conference call, whether as a result of new information future events or otherwise, except as required under applicable law with that I will turn off the line to Keith.

Thank you Stephanie and thank you to everyone on the call for joining us this morning.

Keith Kendall: We see no indication of delay and have no indication that, at this point, there is any reason to think we are not on track for September 27, 2020, PDUFA action as scheduled. Concurrently, we're continuing to advance the clinical development activities related to liver vans by advancing the ongoing studies that we touched on last December at Investor R&D Day. We've closed enrollment in the Pediatric Long-Term Safety Study and in the Pediatric Epilepsy Monitoring Unit, or EMU, study.

In our remarks, John and I will provide an update on our business for the first quarter during April 2020.

We'll be joined by additional members of the acquisitive leadership ship team during acuity session afterward.

Our key priorities as a company always store with the safety of our colleagues the people, we do business with the patients and caregivers, who interact with our product.

During this extraordinary period as leaders in managers of all of our business, we have a responsibility as well to ensure that through the best of that ability, while taking all steps to keep people say, we continue to advance the important work through the company.

Keith Kendall: We are collecting data from both studies and preparing the final analysis. We anticipate that the top-line findings from these studies will be available by the fourth quarter of 2020. With these two studies nearing completion, we anticipate that we may potentially be able to expand the label for Libervant to include pediatric patients between the ages of 6 and 12. I remind everyone that neither of these studies have any impact on the NDA currently under review. We've also closed enrollment in our Adult Long-Term Safety Study for Liberman.

A quick service carefully managed or business to be sure that its colleagues are safe and healthy that all key elements of its business continue including key R&D initiatives.

Review processes and product manufacturing.

The company's manufacturing facility continues to produce needed chronic use medicines for patients, including the company's proprietary product fits within the company's licensee products such as suboxone.

Keith Kendall: As a reminder, the NDA filing submitted last November included the interim analysis for this data. We're completing the data analysis and will provide the findings to the FDA to further support the NDA currently under review. We are seeking to demonstrate to the FDA that LibriVant, if approved for marketing in the U.S., would represent a major contribution to patient care within the meaning of FDA regulations and guidance as compared to the currently available device-dependent treatment options and would further expand patient choice as the first orally-administered product available for its proposed indication. As we have shared, the FDA provided us with the following criteria that it may consider when it evaluates clinical superiority for drugs demonstrating a major contribution to patient care, convenient treatment location, and duration of treatment.

The company has inventory and access to our supply chain for several months or production going forward in the event of an unforeseen shutdown of key suppliers, resulting from covert 19.

In early April we took an important step to keep our colleagues working through this crisis by partnering with the government and accessing funds available through the cares Act and the Paycheck protection plan, where PPP particular.

Towards disappointment, however, almost two weeks later the small business administration issued revised guidance that we viewed as establishing a strong presumption that no public company, regardless of need would be eligible for PPP loan.

Because of the implications of possibly not meeting ill defined in changing criteria for qualification. We made the decision to return or PPP loan under these new conditions.

Keith Kendall: Patient Comfort, reduce treatment burden. Advances in Ease and Comfort of Drug Administration, longer periods between doses, and the potential for self-administration. We believe that we can demonstrate to the FDA why LibriVant, as an orally delivered product for this indication, has one or more of these attributes quoted by the FDA to be considered a major contribution to patient care relative to the currently approved rectal and nasal products. Currently, we are also examining how nasal sprays can be used during bouts of seasonal allergies and or the common cold. A recently-approved nasal spray for seizures, in its pivotal study in a clinical setting, excluded patients with, quote, severe seasonal or non-seasonal allergies, nasal polyps, or any nasal passage abnormality that could interfere with nasal spray administration.

Regardless of the outcome of that program. The key areas of focus for the company include that we expect to file the I envy for quest of one or wait for their free as planned during the second quarter 2020.

The question of one away is it all sublingual film formulation delivering systemic up in there for and that is in development for the treatment of anaphylaxis.

We continue to progress toward the expected started PK trial later this year.

A quick continues to work with the FDA in seeking approval of liver van Diazepam buckle filled for the management of seizure clusters.

The company is engaging in normal course of business interactions, including responding to information request.

With the FDA related to our accepted in D.A. for liver van.

The FDA has assigned the prescription drug user fee Act PDUFA goal date of September 27, 2020 for liver van.

As we've said we are seeking to demonstrate to the FDA that live Revere will if approved for marketing in the U.S. represent a major contribution to patient care within the meaning of ft, a regulations in guidance.

Keith Kendall: We are also learning from our key opinion leaders about instances where nasal spray dosing could not occur due to seasonal allergies. According to the Asthma and Allergy Foundation of America, more than 50 million Americans have experienced various types of allergies in the last year. According to the Centers for Disease Control and Prevention, the average American adult has two to three colds per year, and children have even more. This is a sizable and meaningful portion of the population. LimbriVant, as you know, is administered orally and is not subject to the changing conditions of a patient's nasal passage.

As compared to currently available device based treatment options.

Liberating also will expand pacing choices the first orally deliberate diazepam based product available to manage seizure clusters in epilepsy patients, especially for patients who may not be able to effectively use nasal sprays due to nasal congestion irritation or seasonal.

Allergies.

Keith Kendall: Therefore, we believe that we could potentially show a plausible hypothesis that LibraVan provides a major contribution to patient care by avoiding issues associated with seasonal allergies and or the common cold. Over 1 million patients in the U.S. have active, uncontrolled epilepsy and a need for a rescue medication. However, less than 10% of these patients are successfully treating their seizures with the current standard of care, a rectal gel application of diazepam.

Concurrently a quest of is continuing to market. Sip is end quote was there an oral film for the treatment of seizures associated with Lennox Gastaut syndrome or old, yes to the same prescriber base for liberated.

At expanding its relationships with Payors and caregivers.

This product received increasing market adoption in the first quarter 2020 growing over 40% March over December of 29.

A quest as lead licensee products Suboxone continues to hold strong market share with strong production in the first quarter 2020, and a strong order book for the second quarter.

Keith Kendall: A medicine is only as good as its ability to be used by patients where they need it, when they need it, and in a form they accept. We have an accepted filing for a product with a very strong value proposition, and we believe that we can demonstrate to the FDA that LibraVant is clinically superior to the currently approved alternative. We will continue to be thoughtful and prudent about our choices, recognizing we may not successfully overcome the orphan drug exclusivity, and we therefore are appropriately managing our pre-launched spend on LibraVent and Symposan prior to having greater clarity on any approval. Subject to the FDA accepting our position, we are committed to launching LibriVant and have the foundational commercial capabilities to do that. Next, we remain focused on building our CNS franchise. We are advancing the commercialization of Simpozan, whose prescribers substantially overlap with potential prescribers of Liberman. Our aim is to raise the profile of our farm film technology as a commercial precursor and eventual complementary product in support of the LibraVan opportunity.

The question of team has begun that process to seek to monetize the anticipated royalties associated with a PEO one threeo to seven seven apomorphine.

The monetization or would occur only after sonobi in receives approval from the FDA within expected could do for goal date of May 21 2020.

And when we determined that the terms and conditions ever transaction at that time are appropriate for the company.

The company expects that this monetization if effective along with our other capital resources and the careful management of our cash across our business, including any pre approval and pre launch spend associated with Lipper van would provide additional non dilutive capital.

On the business well into 2021 and potentially beyond.

Let's discuss in more detail each of these key areas of focus for the company.

First we expect to file the I, Andy for quest of one or wait with the FDA in the second quarter 2020 as promised we continue to work toward and expect to initiate PK clinical trials before the end of year as expected.

Keith Kendall: Symposan continues to prove the build-out of our capabilities and processes in preparation for the commercial launch of LiberVan. All of our commercialization efforts relating to Simpazan provide an opportunity for direct conversations with healthcare practitioners, patients, caregivers, payers, advocacy groups, and others about the value of our farm film technology that would be the basis for LiveRVANT if approved. The acceptance of symposia by those groups is an important building block, providing a meaningful value proposition for caregivers of patients suffering from LGS, for Symposan to reach profitability as we expect in 2021, its third year in the market. Symposan's performance exceeded our internal expectations during the first quarter of 2020 as we continue to focus on growth for market penetration. Shipment volume on a monthly basis has grown over 400% year over year, and 40% of March over December of 2019. 25% quarter-over-quarter.

As a reminder, we had a very constructive pre I'd meeting with the agency in early February regarding if an effort.

The FDA confirmed to key points for effort effort first the clinical development for up at effort will be reviewed under the five or five be to regulatory approval pathway as proposed by collective.

And second that no additional studies would be necessary prior to opening the proposed I am the application.

The FDA also gave us cleared guidance about what they're looking for in our development program.

The FDA also confirm that understands that there is a significant unmet medical need among patients who resist the standard of care use of subcutaneous and intramuscular injections in the treatment of anaphylaxis and that a quest of one or wait may potentially address some of those unmet needs.

We continue to believe that based on the outcome from this meeting with the FDA the development of F and their front will be a less complex less costly and potentially faster path to filing that originally anticipated.

Keith Kendall: March represented the highest volume month for Symposan since its launch. The prescribing base also continues to grow, by over 25% since the end of 2019, with over 77% of those prescribers writing multiple scripts. We now have a penetration rate in our core focus group of prescribers of 22%. Symposan is strategically accomplishing what was intended when we launched the product last year. The work we do to continue to build the revenue stream and market penetration for Symposan will be an important foundation for a successful launch of LibraVan. We continue to focus all of our energy and available resources on advancing the key initiatives surrounding epinephrine and LibraVan. Additionally, we need to recognize and react to the declining revenue from our Suboxone business and adapt our business in the face of the COVID-19 pandemic. Our operations in Warren, New Jersey, and Portage, Indiana, are deemed to be essential by their resident states.

Second.

As we previously communicated the NDA filing for live prevent was accepted in January and assigned the PDUFA goal date of September 27 2020.

Over the past few weeks, we've received a number of information requests from the FDA related to our filing and continue to engage in a typical normal course of business correspondence with the agency.

We see no indication of delay and have no indication that at this point. There is any reason to think we're not on track for September 27, 2020 could do for action as scheduled.

Concurrently we are continuing to advance the clinical development activities related to live event by advancing the ongoing studies that we touched on last December at the investor or Indeed day.

We've closed enrollment in the pediatric long term safety study and into pediatric epilepsy monitoring unit or M use study.

We're collecting the data from both studies and preparing the final analysis.

Keith Kendall: As such, at this time, the R&D team has continued its operations at our headquarters in New Jersey, and our manufacturing facilities in Indiana continue to produce Suboxone and other therapeutics on farms. We're closely monitoring the number of reported COVID-19 cases in each of these geographies. The COVID-19 pandemic has created face-to-face access challenges with health care providers since mid-March for our field-based sales team. Virtually all of our target prescribers for Symposan have limited live access to their clinics until further notice.

We anticipate that the topline findings from these studies will be available by the fourth quarter of 2020.

With these two studies nearing completion, we anticipate that we may potentially be able to expand the label for liberated to include pediatric patients between the ages of six and 12.

I remind everyone that neither of these studies have any impact on the NVH currently under review.

We've also closed enrollment in our adult long term safety study for liver van.

As a reminder, the NDA filings submitted last November included the interim analysis for this data, we're completing that data analysis and will provide the findings to the FDA to further support the NVH currently under review.

John Maxwell: The Symposan team has rapidly adopted digital tools and continues to engage with health care providers and their staff remotely on a frequent basis. Some states have begun the discussion of reopening, and we expect prescribers to begin seeing new patients and resume checkup visits at different times in different areas of the country. At that point, it is expected that we will resume some face-to-face interaction. As such, we will continue to manage our costs and target our spending in 2020. Those plans are reflected in our guidance. We expect that our current cash resources will be sufficient through 2020 based on our internal plan and assumptions. We have begun to communicate with potential investors that would buy our royalty rights to Synovian's licensed apomorphine product, subject to approval by the FBA.

We are seeking to demonstrate to the FDA that labor bad if approved for marketing in the U.S. would represent a major contribution to patient care within the meaning of ft, a regulations and guidance as compared to the currently available device dependent treatment options and would further expand.

And patient choice as the first orally administered product available for its proposed indication.

As we have shared the FDA provided us the following criteria that it may consider when it evaluate clinical superiority for drugs, demonstrating a major contribution to patient care.

Convenient treatment location.

Duration of treatment.

Patient comfort.

Reduced treatment burden.

Advances in ease and comfort of drug administration.

John Maxwell: We will consider market conditions, COVID-related or otherwise, structure, and timing of any monetization to enable us to efficiently provide additional capital for the company. Such a potential monetization would be expected to further extend our capital horizon and provide additional capital to support our business well into 2021 and potentially beyond. We look forward to updating you at the time of the release of our second quarter financial results as we advance these initiatives throughout 2020. With that, I'd like to turn the floor over to John, who'll provide specifics on our financial performance and outlook. John?

Longer periods between doses and the potential for self administration.

We believe that we can demonstrate to the FDA why live event as an orally delivered product for this indication has one or more of these attributes quoted by the FDA to be considered a major contribution to patient care relative to the currently approved rectal nasal products.

Currently we are also examining how nasal sprays can be used during bouts of seasonal allergies and or common cold.

A recently approved nasal spray for seizures in its pivotal study and a clinical setting excluded patients with quote.

Severe seasonal or non seasonal allergies nasal polyps or any nasal passages abnormality that can interfere with nasal spray administration and quote.

John Maxwell: Thank you, Keith. Good morning, everyone.

John Maxwell: Last night we filed our 10-Q and issued our earnings release. We will tackle most of the discussion related to the first quarter 2020 results in the Q&A. In my comments this morning, I will highlight a few points from our results that are important in order to understand our reaffirmed 2020 financial guidance and our progress towards it. Before considering additional non-dilutive capital, we have worked hard to manage our capital horizon with our current cash resources, which we anticipate being sufficient to last into early 2021. This was done by focusing our investments on seeking liver van approval for U.S. marketing, continuing our development of AQST-108 epinephrine, and continuing to successfully expand Symposan's commercial footprint. Those initiatives are funded in our projections and expected to be on track.

We're also learning from our key opinion leaders about instances, where nasal spray dosing had not occurred due to seasonal allergies.

According to the Azimut Allergy Foundation of America more than 50 million Americans have experienced various types of allergies in the last year.

According to the centers for disease control and prevention. The average American adult has two to three calls per year and children have even more.

This is a sizable and meaningful portion of the population.

Libber Vamp as you know is administered orally and is not subject to changing conditions of a patients nasal passages.

Therefore, we believe that we could potentially show a plausible hypothesis that labor via provides a major contribution to patient care by avoiding issues associated with seasonal allergies and or the common cold.

John Maxwell: In terms of non-dilutive capital, we have begun investor meetings to start our process for a potential monetization of apomorphine after the May 21st PDUFA date. Our monetization is subject to FDA approval of apomorphine on that date, and we believe that the monetization could potentially generate non-dilutive capital of $50 to $100 million. The timing of any such transaction will be dictated by market conditions, which may be impacted by the COVID-19 pandemic. However, markets have begun to stabilize, and if this trend continues, we expect to see monetization of the asset as early as late Q2. However, we will select the timing and structure of any potential transaction that we believe would represent the best overall outcome for Equesta.

Over 1 million patients in the U.S. have active uncontrolled epilepsy and the need for rescue per a rescue medication.

Less than 10% of these patients are successfully treating their seizures with the current standard of care, a rectal gel application of day as Pam.

A medicine is only as good as its ability to be used by patients where they need it when they need it and in a form they accept.

We have an accepted filing for a product with a very strong value proposition and we believe that we can demonstrate to the FDA that liveramp is clinically superior to the currently approved alternatives.

John Maxwell: We expect that our conservative spending management and a potential apomorphine monetization would fund a quest for needs well into 2020 and possibly beyond. We will plan to update the market on our cash runway after such time as we complete any monetization transaction. Our first quarter revenue was in line with our own expectations. Suboxone production was over 40 million doses in the quarter, and we are seeing a similar rate of production in our Q2 order book.

We will continue to be thoughtful and prudent about our choices recognizing we may not successfully overcome the orphan drug exclusivity here.

And with therefore, our managing appropriately our prelaunch spend on liver van and simpler than prior to having greater clarity on any approval.

Subject to the FDA accepting our position we are committed to launching liver bet and have the foundational commercial capabilities to do that.

John Maxwell: We expect that Suboxone in the U.S. market, combined with non-U.S. markets, will continue to be a meaningful part of our revenue base, while our proprietary business continues to grow. As a result, our manufacturing and supply revenue in the first quarter of 2020 was approximately flat with the 2019 first quarter driven by lower volume but higher price suboxone revenue. Symposan reported net revenue grew sequentially over the fourth quarter by 70 percent.

Next we remain focused on building our CNS franchise.

We are advancing the commercialization of simple fan, whose prescribers substantially overlap with potential prescribers of liver man.

Our aim is to raise the profile of our Pharmfilm technology as a commercial precursor and eventual complementary product in support of the Liberty that opportunity.

John Maxwell: We expect that Symposan will continue to grow throughout 2020 as our prescription volume continues to grow. Our growth in recognized net revenue will be dependent on ordering of products by wholesalers, although going forward, we would expect that this will more closely align with prescription levels than we saw in the first year of launch. In addition to prescriptions filled, we continue to make solid inroads into prescribers and support teams, and this effort will help us significantly in the launch of liver van if approved for access to the U.S. market. We are very pleased with the commercial performance of Sempizan and its preparations for the potential launch of LibriVant in late 2020, if approved by the FDA. We are affirming our previously provided revenue guidance of $35 to $45 million. This guidance factors in lower year-over-year suboxone volumes with higher prices per unit, both of which we saw in the first quarter. Continued growth in the symposium

Simply think continues to prove the buildout of our capabilities and processes in preparation for the commercial launch of liver van.

All of our commercialization efforts relating to SIMPAS and provide an opportunity for direct conversations with health health care practitioners patients caregivers payors advocacy groups and others about the value of our Pharmfilm technology that would be the basis for liver.

Event if approved.

The acceptances symposium by those groups is an important building block.

Providing a meaningful value proposition forget caregivers of patients suffering from LG, yes.

Pause simpler than to reach profitability as we expect in 2021, its third year in the market.

Symposiums performance exceeded our internal expectations during the first quarter of 2020, as we continue to focus on growth and further market penetration.

John Maxwell: An expected $4 million milestone that would be payable for apomorphine six months after FDA approval, as well as co-development fees and modest licenses and royalties. Our guidance excludes any revenue for LibriVant and will not be included unless that product is approved. Our adjusted gross margin in the first quarter of 2020 was 66%, compared to our adjusted gross margin for the 2019 year. As our revenue base shifts towards our proprietary products, starting with Symposan and away from Suboxone, and we consider the impact of additional license fees and royalties later in the year. We expect our adjusted gross margin will rise to 70% plus, as we have guided. As outlined in the earnings release issued yesterday, our first quarter 2020 non-GAAP-adjusted EBITDA loss was $11.2 million and puts our performance on target to be within our guidance range for the year of a loss of $40 to $45 million.

Shipment volume on a monthly basis has grown over 400% year over year, 40% March over December of 2019, and 25% quarter over quarter.

March represented the highest volume month symptoms and since its launch.

The prescribing base also continues to grow over 25% since the end of 29 team with over 77% of those prescribers writing multiple scripts.

We now have a penetration in our core focus group of prescribers of 22%.

SIMPAS in is strategically accomplishing what was intended when we launched the product last year.

The work, we do to continue to build the revenue stream and market penetration for simple van will be an important foundation for successful launch of liver van.

John Maxwell: The first quarter non-GAAP-adjusted EBITDA reflects lower sequential expenses from the fourth quarter of 2019 to the first quarter of 2020, and we expect our level of spending to continue to moderate over the course of 2020. Obviously, while we have managed well to date in the face of the COVID-19 pandemic, the extent to which it may impact our ongoing and future operations and financial results and financial resources will depend on future developments, which we are obviously uncertain of and cannot be predicted with any clarity. We are focused on investing in seeking the approval of LibriVan at our PDUFA goal date in September, the continued development of AQST-108 after we open our IND, starting with PK clinical trials expected later this year, and the continued commercialization of Simpazan while focusing on seeking to drive this product to profitability in 2021. At the same time, we are focused on being as efficient as possible across the organization.

We continue to focus all of our energy and available resources on advancing the key initiatives surrounding FNF front and liver van. Additionally, we need to recognize the reacted a declining revenue from our suboxone business and adapt our business in the face of to cope with 19 pandemic.

Our operations in war in New Jersey, and Portage, Indiana are deemed to be essential by their residents states.

As such at this time the R&D team has continued its operations at our headquarters in New Jersey, and our manufacturing facilities in Indiana continue to produce suboxone and the other therapeutics on form film.

We're closely monitoring the number of reported Cobiz 19 cases in each of these geography.

The covert 19 pandemic has created face to face access challenges with health health care providers since mid March for our field based sales team.

Virtually all of our target prescribers for symptoms and have limited live access to their clinics until further notice.

John Maxwell: We continue to manage our variable cost structure at the plant to match the volume of production, focus on the efficiency of LibraVan investments in pre-launch marketing until we have clarity on any FDA approval, and carefully manage our support organizations to be aligned with the arc of the various focused initiatives of the company. Early in 2020, we rationalized our costs, improved our adjusted EBITDA guidance range, and improved our cash burn guidance by $20 million. We anticipate that this change in expenses, combined with our current cash position, should provide the capital necessary to get into early 2021 while maintaining the investments we need around the most important value-driving components of our business. Q1's performance is on track with our full year's expectations, and therefore, we have reaffirmed our earlier guidance.

The symposium team is rapidly adopted digital tools and continues to engage with health care providers and their staff remotely on a frequent basis.

Some states have become the begun the discussion of reopening and we expect prescribers to begin seeing new patients and resume checkup visits at different times in different areas of the country.

At that point it is expected that we will resume some face to face interactions.

As such we will continue to manage our costs and target our spending in 2020.

Those plans are reflected in our guidance.

We expect that our current cash resources are sufficient through 2020 based on our internal plan and assumptions.

We have begun to communicate with potential investors that would buy our royalty rights to Sanofi is licensed apomorphine product subject.

Two approval by the FDA.

We will considering what we will consider market condition, colgate related or otherwise structure and timing of any monetization to enable us to efficiently provide additional capital for the company.

John Maxwell: To further extend our capital, we will seek to monetize apomorphine after the May 21st PDUFA, although assuming approval by the FDA and acceptable market conditions. We anticipate that the combination of our prudent cost management and the additional non-dilutive capital we would expect to see from the potential monetization of apomorphine should take our capital runway well into 2021 and possibly beyond. After the time of essential monetization of apomorphine, we will plan to update the market on the timing of our capital runway. In summary, our reaffirmed guidance for 2020 reflects continued cash flow from our licensee and proprietary products revenue base, careful focus of our investments into the most value-driven aspects of our future, libervant and epinephrine, and continued focus on capital conservation so that cash is extended as far as possible. Operator, we will now open the line for questions.

Such a potential monetization would be expected to further extend our capital horizon and provide additional capital to support our business well into 2021 potentially beyond.

We look forward to updating you with time of the release of our second quarter financial results as we advance these initiatives throughout 2020.

With that I'd like to turn the floor over to John will provide specifics of our financial performance and outlook John.

Thank you Keith good morning, everyone.

Last night, we filed our 10-Q and issued earnings release, we will talk on most of the discussion related to the first quarter.

2020 results in the Q1.

My comments. This morning, I will highlight a few points from our results that are important in order to understand our reaffirms 2020 financial guidance and our progress towards it.

Operator: Thank you, sir. As a reminder, to ask a question, you will need to press Star 1 on your telephone, then type your question into the box provided.

Before considering additional non dilutive capital we have worked hard to manage our capital horizon with our current cash resources, which we anticipate being sufficient to last into early 2021.

Operator: Please stand by while we compile the Q&A roster. I show our first question comes from Gary Nachman from BMO Capital Markets. Please go ahead. Hi, good morning. It's Rafay on for Gary.

This was gone by focusing our investments on seeking lumberman's approval for U.S. marketing.

Continuing our development of a Qs T. One are you talking now from and continuing to successfully expand some presents commercial perhaps.

Operator: Hey Robbie, how are you?

Operator: So for apomorphine, can you provide a bit more color on the types of discussions you've had thus far and the level of market interest that you're seeing relative to your expectations? And have there been any changes to Synovian's potential launch plan due to COVID-19? And does that impact how you're viewing the monetization opportunity as well? So thank you, Rafael, for the question. Let me tackle it in reverse order.

Those initiatives are funded in our projections and expected to be on track.

In terms of non dilutive capital, we have begun investor meetings to start our process for a potential monetization of apomorphine. After the may 21st quarter for date.

Our monetization is subject to FDA approval of apomorphine on that date, and we believe that the monetization potentially generate non dilutive capital of $50 million to $100 million.

The timing of any such transaction will be dictated by market conditions, which may be impacted by the covert 19 pandemic.

Keith Kendall: Look, I don't think we're in a position to be able to comment on Synovion's specific launch plans. They publicly stated that they plan to launch late this year. And I believe, you know, until they tell us otherwise, that's fully their intention.

Markets have begun to stabilize and if this trend continues we expect to see to monetize viasat as early as late Q2.

However, we will select the timing and structure of any potential transaction and we believe would represent the best overall outcome for clusters.

Keith Kendall: I think with respect to COVID-19, it's very hard to know what the impact will be at this point, although hopefully things will be moving in the right direction. With respect to investor conversations, you know, we have the market well prepared for the fact that this asset is coming. The market is familiar with Synovion as a very strong commercializing organization.

We expect that our conservative spending management and a potential apomorphine monetization would fund to quest of speeds well into 2020, and possibly beyond we will plan to update the market on our cash runway after such time as we complete any monetization transaction.

Our first quarter revenue was in line with their own expectations Suboxone production was over 40 million doses in the quarter and we're seeing a similar rate of production in our Q2 order book.

Keith Kendall: And so what we're waiting to see is, one, we have got to get through the PDUFA date. And then once we're through the PDUFA date and the product is approved, we would then move from there to finalizing a transaction in terms of, you know, completing it if the markets are good. And, you know, look, COVID – the markets have stabilized, and they've gotten better. And we think that'll continue. And as long as that continues, we would expect to have a transaction hopefully in late Q2 or certainly sometime in Q3. Thanks.

We expect the suboxone on the U.S. market combined with non U.S. markets will continue to be a meaningful part of our revenue base, while our proprietary business continues to grow.

The result, our manufacturing and supply revenue in the first quarter of 2020 was approximately flat with the 2019 first quarter driven by lower volume, but higher price suboxone revenue.

Symposium reported net revenue grew sequentially over the fourth quarter by 70%, we expect the samples and we'll continue to grow throughout 2020 as our prescription volume continues to grow.

Daniel Barber: And then, regarding the NDA filing for LibriVine, can you describe the types of interactions you're having with the FDA and how much visibility do you expect to receive between now and the PDUFA on the potential to receive ODE? Good morning, Rafi. This is Dan Barber.

Our growth and recognized revenue will be dependent on ordering of products by wholesalers, although going forward. We would expect that this will more closely aligned with prescription levels than we saw in the first year of launch. In addition to prescriptions filled we continued to make solid inroads into the prescribers and support teams and this effort will.

Daniel Barber: It's nice to hear your voice. The interactions with the FDA are, as you would expect with any NDA filing, we are having regular back-and-forth on information requests across the different parts of the NDA, all questions that we would expect and that we are answering. In terms of any discussion with, you mentioned ODE, orphan drug, that would be up to us, and we will seek to have those discussions, as Keith has laid out in previous comments. Okay, thanks. And then, can you comment generally on how you're thinking about the market opportunity and peak sales for LibraVan at this point? And has your view changed at all based on the trends for Nasal Am since it launched around six months ago? Thank you.

Help us significantly in the launch of Lipper ramp if approved for access to the yours market.

We're very pleased with the commercial performance looks up exam and its preparations for the potential launch of liver vans in late 2020.

Yes.

We are affirming our previously provided revenue guidance of $35 million to $45 million. This guidance factors and lower year over year suboxone volumes with higher prices per unit, both of which we saw in the first quarter.

Renewed growth in symposium.

Unexpected 4 million dollar milestone that would be payable for apomorphine six months after after FDA approval.

As well as co development fees and modest licenses and royalties.

Our guidance excludes any revenue for live revamped and will not be included in unless that product is approved.

Keith Kendall: Sure. Thanks for the question, Rafi. This is Keith.

Keith Kendall: I think we continue to believe that there is a huge untapped and underserved patient population. This patient population has been underserved for a long time. This patient population is looking for choice. They're looking for medications or therapeutics that they can use when they need them and where they need them, and certainly in a form that fits their lives. We think Nasalam has demonstrated up to this point that that untapped population exists just because of the relative split between Nasalam and Diastat, the current rectal gel. But the uptake of Nasalam and the more recently approved nasal spray would demonstrate that the patient population is not necessarily enamored with a nasal option. We think we provide a choice, an oral choice that will be attractive to a good part of that population.

Our adjusted gross margin in 2021st quarter was 66% compared to our adjusted gross margin for 2019 year.

As our revenue base shifts towards our proprietary products, starting with symposiums and away from Suboxone.

And we consider the impact of additional license fees and royalties later in the year.

We expect our adjusted gross margin gross margin will rise to 70% plus as we have guided.

As outlined in the earnings release issued yesterday, our first quarter 2020, non-GAAP adjusted EBITDA loss was 11.2 million and puts our performance on target to be within our guidance range on a year of a loss of $40 million to $45 million.

First quarter non-GAAP adjusted EBITDA.

Flex lower sequential expenses from the fourth quarter of 2000 my team to the first quarter of 2020, and we expect our level of spending to continue to moderate over the course of 2020.

Obviously, while we have managed well to date in the face of to covert 19 pandemic.

The extent to which may impact, our ongoing and future operations and financial results and financial resources will depend on future developments, which are which we are obviously uncertain of and cannot be predicted with any clarity.

Keith Kendall: We continue to guide people to think this is a $300 million plus peak sales product for us, and we think right now the market size is there for that. The preference is being expressed around the nasal spray that we think will support an oral, and we continue to be incredibly bullish about the prospects of this product if it's approved and granted access to the market.

We are focused on investing in seeking the approval of liver van or produce a goal date of September the continued development of a Qs 21, I'll wait after we opened our R&D starting with Teekay clinical trials expected later this year and the continued commercialization of symposium.

Operator: Great, thank you so much. Thank you. Our next question comes from Randall Spanakey from RBC Capital Markets. Please go ahead. Great. I think, Keith, I want to go and ask a question.

While focusing just on seeking to drives this product to profitability in 2021.

Operator: on the liver ban. Has anything changed in your discussions with FDA? And I ask this because last quarter you said you don't think there's any scenario that keeps you out of the market?

The same time, we're focused on being as efficient as possible across the organization. We continue to manage our variable cost structure at the plant to match the volume of production.

Focus on the efficiency of Liberman investments and pre launch marketing until we have clarity on any after FDA approval.

Careful management of our support organizations to be aligned with the arc of the various focused initiatives on the company.

Operator: It sounds like you're looking at various options. So I just want to gauge your level of confidence so there's no confusion around the message of a quest for. Thank you for joining us this morning. Your outlook or expectation for approval. And then I have a follow-up after that.

Early in 2020, we rationalized our cost improved our adjusted EBITDA guidance range and improved our cash burn guidance by $20 million. We anticipate that this change in expenses combined with our current cash position should provide the capital necessary to get into early.

2021, while maintaining the investments we need around the most important value driving components of our business.

Keith Kendall: Sure, thanks Randall, it's good to talk to you again. I'm not sure; let me say it differently. We're not trying to communicate any change of thinking. We continue to believe that there is no way that LibraVent will be shut out of the market for the exclusivity period granted to the recently approved nasal spray. There are multiple paths that we can choose to go down to get to that access, some more expedient than others. And what we're doing is attacking this in what we think are the most expedient ways while preparing secondarily, as we always do, for an eventuality of a decision, perhaps, that we were not anticipating. So our level of confidence, our level of belief, and expectation has not changed. We believe strongly that this represents a major contribution to patient care.

Q1's performance is on track with our full year six expectations and therefore, we have reaffirmed or earlier guidance.

Further extend or capital, we will seek to monetize apomorphine after the may 21st producer.

Assuming approval by the FDA acceptance acceptable market conditions.

We anticipate the combination of our prudent cost management and the admission additional non dilutive capital we would expect to see from the potential monetization of apomorphine should take our capital runway well into 2021 and possibly beyond.

After the time of central monetization of Apomorphine, we will plan to update the market on the timing of our capital runway.

In summary, our reaffirmed guidance for 2020 reflects continued cash flow from our licensee and proprietary products revenue base careful focus of our investments into the most value driven aspects of our future. Let prevention happened upfront and continued focus on capital conservation. So that cash is extended as far as possible.

Keith Kendall: that it is clinically superior to the alternatives, and we're pursuing that with all the vigor that we can. Great. And John, can you help us? How much have you guys built in in terms of

John Maxwell: of spend for this year around the liver vat launch. So without getting into the specific dollars, Randall, the focus of our investments this year before the PDUFA date is focused on making sure that we have all the materials that we need to have put into the FDA process so that we're prepared. So think of that as just making sure that we gain market access. When we reduced our spending, one of the deferrals that we made was around the timing of when we would begin to launch. And so we pulled out any revenue associated with Libervant until we knew that we were in the market. And we pulled out most of the spending. Once we understand that we're approved, hopefully on September 27th, at that point, we would come in, and we would likely update you on what we think the revenue outlook is for the rest of this year, as well as any additional spending beyond where we are right now.

Operator, we will now open the line for questions.

Thank you Sir.

As a reminder to ask a question you would need to press star one on your telephone.

Your your question, Chris Mckenzie County.

Please standby, while we compile the kuni roster.

I sure first question comes from Gary Nachman from BMO capital markets. Please go ahead.

Hi, good morning, its rothsay on for Gary.

Hey, Rob.

Yes. Thank you.

So for Apomorphine can you provide a bit more color on the types of discussions you've had our level of market interest that you're seeing relative to your expectation.

And have there been any changes to the noveon potential launch plan due to cope with 19 and does not impact how you're viewing that monetization opportunity at all.

John Maxwell: We certainly do have some level of market presence in addition to just Symposan itself, and we are preparing the market for Libervant, but we're doing it in a prudent, careful way and not a huge amount of spend pre-launch. Great. And my last question is back to Keith.

So thank you refer to further question, let me tackle it in reverse order you look I don't think we're in a position to be able to comment on so noveon specific our launch plans. They publicly stated that they plan to launch late this year.

Keith Kendall: It's a bigger picture question. Is it a quest for a pipeline story, or is it a commercial story? And what I mean by that is, what's the, you know, as you talk to the board about the three to five year strategy and outlook, what's the strategy to grow the business? Is it blocking and tackling and pushing the pipeline forward? Or is it, you know, capitalizing on this commercial footprint that you're building and bringing in assets from the outside and leveraging that? And, you know, if it's the latter, how do you how do you do that, given the current capital structure and, and, you know, kind of opportunities to pursue business development?

And I believe.

Until they tell us otherwise thats fully their intention I think with respect to cope with my team. It's very hard to know what the impact will be at this point, although hopefully things will there will be moving into right direction.

With respect to Investor conversations we have the market as well prepared for the fact that this asset is coming off the market is familiar with Sanofi and as a very strong commercializing organization.

Keith Kendall: Sure, I think the answer to the question... Randall is this, we've worked very hard for a long period of time to ensure that we were not a binary risk story, that we were not a story built on one regulatory or commercial card being overturned, that we had a combination and a flow of commercial business, which we do, of opportunities in the pipeline at different stages of development, which we do, and the ability then to, on each of the individual performance platforms or segments of our business, whether it's value creation, the development of products, or the acquisition of products, value delivery, the ability to make and supply those products to the market, or value realization, a commercial platform that can extract value for therapeutics that we develop or acquire, we wanted to be able to put those pieces together. I think if you look at where we are right now, we're executing against that strategy.

And so what we're waiting to see as one we've got to get through the produced today.

And then once we're through the PDUFA date in the product is approved we would then move from there too.

Finalizing a.

Transaction in terms of.

Completing it if the markets are good and look to covert are the markets have stabilized they've gotten better and we think that will continue and as long as that continues we would expect to have a transaction hopefully late Q2 or certainly sometime in Q3.

Thanks, and then regarding the NDA filing for members.

Good morning, Rafi. This is Dan Barber nice to hear your voice the interactions with the FDA are as you would expect with any Andy a filing we are having regular back and forth on on information requests across the different parts of the N. da all.

Questions that we would expect and we are our answering.

In terms of the.

Any discussion with you mentioned OTI orphan drug.

That would be up to buys and we will seek to have those discussions as Keith has laid out in previous comments.

Okay and then.

Can you comment generally on how you're thinking about the market opportunity and peak sales would have been at this point and how do you have you changed at all based on the trends for nasal.

That launched around the guys. Thank you.

Sure. Thanks for the question Rafi. This is Keith I think we we continue to believe that there is a huge on tap and underserved patient population just pretty some population has been under served for a long time.

Keith Kendall: We have products in the market that generate revenue. We've got near and longer-term products in the pipeline that are of greater value than even the ones we've delivered up to this point, and we have a commercial platform as planned, with an introductory product and a larger, more valuable complementary product coming behind it. That's the strategy we're pursuing, and we're going to continue to do that. We understand that capital is an important element. We understand that our company has to react to what happens around us, whether it's the COVID pandemic and the impact that has on the capital markets, or it is an FDA decision about a potentially competitive product, and we react to that, but we're a company that has always had options for itself, and we've demonstrated that by extending the capital horizon with the cash we have right now and having the opportunity, at least the immediate opportunity, So we have capital options even in the face of sometimes difficult equity capital markets. That's the strategy that we're pursuing, and frankly, I think we've delivered on that up to this point. All right, great. Thanks, guys.

This patient population is looking for choice, they're looking for medications.

Our therapeutics that they can use when they needed and where they need it and certainly in a form that fits their life.

We think Maison Lam has demonstrated up to this point that that untapped population exist just because of the relative.

Split between nasal Lam and Diastat to read the current rectal gel.

But we the uptake of nasal Lam and the more recently approved nasal spray would demonstrate that.

Patient populations not necessarily enamored.

With the nasal option.

We think we provide a choice on oral choice.

That will be attractive to a good part of that population. We continue to guide people to we think this is.

Operator: Thank you, Randall.

Operator: Thank you. Our next question comes from Liana Nosatos from Wedbush Securities.

300 million dollar plus peak sales product for us.

Operator: Thank you for taking my questions. I have four about income from apomorphine. Is the $4 million milestone part of the $35 to $45 million revenue guidance, or will it be part of the monetization? And what sales presumptions underlie the $50 to $100 million expected monetization range? And the cash runway well into 2021, is that based on $50 million out of that? Yeah, so let me tackle those one at a time.

And we think right now the market size is there for that the preference is being expressed around nasal spray that we think we will support an oral.

And we continue to be incredibly bullish about the prospects it is product.

If it's approved and grant that access to the market.

Great. Thank you very much.

Thank you. Our next question comes from Randall Stanicky from RBC capital markets. Please go ahead.

John Maxwell: The $4 million milestone is in our Q4 numbers, so it is part of the 35 to 45 estimate. It'll happen. That payment will occur either six months after approval or when they launch the product, whichever is earlier. The net sales that we used to predict the value of the asset were determined in a few different ways, but primarily with a study that we did with L.E.K. That looked extensively and deeply at the market, the competition, the physician's environment, and really a complete bottom-up view of that potential market size. We then measured that analysis against what Synovion or its parent company, DSP, is saying, which I believe they're in the $500 million peak revenue range, somewhere like that. You could look that up.

Great. Thanks, Keith I want to going out the prior question differently on LIBOR Ben has anything changed in your discussions with FDA and I ask because last quarter. You said, you don't think theres any scenario the kitchen of the market and.

Now it it it sounds like you're looking at various options. So I just want to gauge your level of confidence. So there's no confusion around the message out of a collective.

Morning on your outlook or expectation for approval and then I have a follow up after that.

Sure. Thanks, Randall it's good too good to talk to you again.

I'm not sure let me say it differently, we're not trying to communicate any change your thinking we continue to believe that there is.

There's no way that labor advantage will be shut out of the market for the exclusivity period granted to the recently approved nasal spray there are multiple paths that we can choose to go down.

John Maxwell: And then there are analysts that go up to a billion dollars, although we're not assuming in our own thought process that. So we've taken what we think is a reasonable view and a very thorough and thought-out view of the market, and that's how we came up with the royalties that we would be paid. And then you discount that. That's how we get to our number.

To get to that access some are more expedience than others.

And what we're doing is attacking this in what we think are the most expedient ways.

While preparing secondarily as we always do for an adventure Whalley of a decision perhaps that we were not.

John Maxwell: How much money we take out of that, the $50 to $100, is really going to be dependent upon the structure and how we do the deal. So it may not be that we sell the entire asset. We may only sell part of the asset. And is Cash Runway based on $50 million or another number? No.

Anticipating so our our level of confidence so our level of belief and expectation has not changed we believe strongly that this represents a major contribution to patient care that it is clinically superior to the alternatives.

John Maxwell: The Cash Runway, when you think about the Cash Runway to 2020, that does not depend upon apomorphine at all. So, in other words, What about well into, yeah, well into 2021? Yeah, well into 2021 or possibly beyond, includes a moderate view. So sort of think of it as a haircut view of what we think the potential value of the asset is and how much we would take out. So we've not assumed that we take the entire asset out of our thought process that gets us to that number. Okay, so closer to 50 million. Yeah, I won't give you a specific number, and we will update the market once we have a view of what kind of structure of a deal that we want to do. We're going to do a deal in the market that we think represents the best economics for an inquirer. That could be a partial sale, it could be a pharma bond, it also could be an outright complete sale. It really depends on discount rates and the overall view of the market in terms of what we think it would do.

And were pursuing that with all the figure that we can.

Great and John can you help but how would you guys built in in terms of spend for this year around the liver revamp launch.

So the without getting into the specific dollars, our randall, but the focus of our investments.

This year before PDUFA date are focused on making sure that we have all the materials that we need to have put into the FDA process. So that we are prepared so think about as just making sure that we gained market access.

When we reduced our spending one of the one of the deferrals that we made was around the timing of when we would begin to launch and so we pulled out any revenue associated with live revamped until we know that were in the market and we pulled up most of the spending once we understand that were approved hopefully on September 27 at that point.

We would come in and we would update likely with what we think the revenue outlook is for the rest of this year as well as any additional spending beyond where we are right now we certainly do have some level of.

Market presence in addition to just separately in itself.

And we are preparing the market for labor math, but we're doing it in a prudent careful way.

And not a huge amount of spend our pre launch.

Keith Kendall: Liana, this is Keith. Just amplifying John's comment because you keep pushing around the quantum. We took the range of values that was given to us by the folks who were working with us around this, plus the independent view that the L.E.K. study represented. We cut that and looked at that number as the starting point for our comments around being able to get well into 2021 or into 2022, potentially.

Great and my last question is back to keep the bigger picture question is the question of pipeline three or commercial story and what I mean by that is what.

You talked to the board another three to five year strategy outlook.

Keith Kendall: Okay, thank you very much.

What's the strategy to grow the business it blocking and tackling it pushed in the pipeline forward or is it.

Operator: Thank you. Our next question comes from Jason Butler from JMP Securities. Please go ahead.

Capitalizing on the commercial footprint that you're building and bringing in assets from the outside and leveraging that and if it's no matter. How do you do you do that you've now the current capital structure and.

Operator: Hi, thanks for taking the questions.

Operator: That's a couple for me.

Operator: First on Lieberwenn

Operator: In your dialogue with FDA, have you had any discussion around a pre-approval manufacturing inspection and how FDA is thinking about that in light of COVID? And then the second one, just in terms of the virtual educational market.

And.

Kind of.

Opportunities to too.

To pursue business development.

Operator: [inaudible] Good morning, Jason. This is Dan again. Nice to hear your voice.

Sure I think the answer to the question.

Daniel Barber: On the FDA side, we have not had a specific interaction with the FDA discussing a PAI or a pre-approval inspection. However, the FDA has given guidance to industry, and that guidance does talk about your inspection history and how they will handle audits both internationally and in the U.S. So we are confident, based on our audit history and our existing commercial products, that we do not require a PAI during the COVID-19 era prior to launching our product, and we also do not believe that we have any international risk from any of our suppliers based on who we've used for the product in the past.

Randall is this we've worked very hard.

For a long period of time to ensure that we were not a binary risk story that we were not a story built on one regulatory or commercial card being overturn that we had a combination and a flow of commercial business, which we view.

Of opportunities in the pipeline at different stages of development, which we do.

And the ability then to on on each of the individual performance platforms or segments of our business, whether its value creation the development of products or the acquisition of products value delivery, the ability to make and supply those products to the market or value real.

Keith Kendall: Yeah, Jason, I'm sorry. I wanted to make sure you weren't going to follow up with Dan before I jumped in on the other part.

Keith Kendall: So, look, we're all learning how, well, I think every one of us is learning how to use technology in a way we hadn't two months ago. We've all had our share of dogs being introduced into conference calls and kids pulling the plugs out while a video call is going on. We have, the truth of the matter for us is that different parts of the country are behaving very differently.

Jason to commercial platform that can extract value for therapeutics that we develop or acquire we wanted to be able to put those pieces together I think if you look at where we are right now.

We're executing against that strategy, we have products in the market that.

Generate revenue, we've got near and longer term products in the pipeline.

Keith Kendall: We still have a small number of our sales force that are able to make face-to-face visits. And as people start, as parts of the country start reopening, doctors are seeing new patients and doing well-care visits, we expect more of our sales force to be able to resume face-to-face conversations. Be that as it may, we have discovered that some of the tools available to us technologically are very useful, and it is causing us to think about what sales deployment might look like and how we might be able to use a combination of those tools and our face-to-face opportunity to not only drive sales for Simpazan but to help accelerate the curve, the slope of the curve, on the launch of LibraVan. What those are specifically, we've not yet laid out, but we'll certainly talk about them as we go.

Our of greater value than even the ones. We've delivered up to this point and we have a commercial platform.

As planned with a.

Introductory product and a larger more valuable complementary product coming behind it.

That's what that's the strategy, we're pursuing and we're going to continue to do that we understand that capital is an important element.

We understand that.

Things with that our company has to react to what happens around us.

Whether it's the covert pandemic and the impact that has on the capital markets or it is an FDA decision about potentially competitive product and we reacted against that.

But we're a company that has always had options for itself and we've demonstrated that by extending the capital horizon with the cash we have right now and having the opportunity.

At least the immediate opportunity of monetizing a substantial royalty stream. If you look into our portfolio. There's another potential royalty stream growing behind that in our relationship with Kempharm.

Operator: Great, that's helpful. Thanks for taking the time to ask the question.

Operator: Thanks, Jason. Thank you. Our next question comes from Thomas Flaten from Lake Street Capital. Please go ahead.

So we have capital options, even in the face of sometimes difficult.

Keith Kendall: Good morning, thanks for taking the questions. Just to follow up on the field question, in advance of the Libervant launch, do you expect any significant field force changes, territory realignments, anything like that, an upsizing of the field force, or are you happy with the current deployment to support the initial launch of the product?

Equity capital markets. That's the strategy that we're pursuing and frankly I think we've delivered on that up to this point.

Alright, great. Thanks.

Thank you rental.

Thank you.

Next question comes from Liana Moussatos from Wedbush Securities.

Keith Kendall: Well, we are going to absolutely grow the field sales force substantially for the launch of LiberVant. I think we'll determine how far in advance; we'll make a determination based on our confidence in the outcome of September 27th, when to start that build. The prudent thing to do is wait until after we have absolute confirmation that the market is available to us, and we'll build the sales force very quickly after that. If we're confident going into that based on the interactions we're able to have, if we're able to have interactions with the agency, then we'll build in advance of that. LiberVant as a launched product will represent a significantly larger sales force than we have now. I would assume based on that, yes, there will be a realignment of territories and a redistribution of regions and a distribution of accountabilities around LiberVant and Simpazan revenue targets.

Thank you for taking my questions I have four about income from acre morphine.

4 million milestone part of the 35 to 45 million revenue guidance or will it be part of the.

Monetization and what sales presumptions underlie the 50 to 100 million expected monetization range and the cash runway well into 2021 is that based on 50 million out of that.

Yes, So let me let me talk a little is one of the time before million dollar milestone is in our Q4 number. So it is part of the 35 to 45.

Yes.

That will happen that payment will occur either six months after approval or when they launch the product whichever is earlier.

The the sales or the net sales that we use to predict.

While you have the asset we are determined.

In a few different ways for primarily with the study that we did with Elie K that.

Look extensively and deeply aftermarket.

Competition, the physicians environment really a complete bottoms up view about potential market size.

Operator: Regarding switching over to epinephrine, could you provide any additional color around what you anticipate that PK study will look like and any additional studies beyond that that you've preliminarily discussed with FDA?

We then measured that analysis against what Sanofi and or the slogan parent company DSP, saying.

Which I believe there in the 500 million dollar revenue range somewhere like that.

Operator: Sure, so as we

Operator: Thank you, Thomas. This is Dan again.

You could look better off but I.

And then there are analysts that go up to a $1 billion, although we're not assuming at our thought process around so we've taken what we think is a reasonable view in a very thorough and brought out view of the market and Thats. How we came up with the royalties that we would be paid and then you discount that that's how we shipped to our number.

Daniel Barber: We will be in the clinic again in the fall for a fairly standard PK study where we will compare our product against approved epinephrine products, and the PK data we'll collect will be the typical CMAX, AUC, TMAX, as well as we will also have some blood pressure data, things like that. Once we have completed that initial PK study, we will look to ramp up to what would be typically called a true pivotal PK study, where the time gap between this first study and the second study will be fairly tight, we believe. In between those studies, we will most likely go back to the FDA and have a conversation and ensure we are on course for the expectations we believe we heard in the pre-IND study.

How much money, we take out of that the 50 to 100 is really going to be dependent upon the structure and how we do have the deal. So we may not be that we sell the entire I certainly would you may only so part of the asset.

Cash runway is based on 50 million or.

The cash runway when you think about cash runway.

Two 2020 that does not dependent on that does not depend upon apomorphine at all so.

Well.

Yes, well in any one yes, well into 2021 or possibly beyond includes a moderate view so sort of think of it as a haircut view of what we think the potential value of the asset is.

Daniel Barber: And then just one final one, regarding, you've had a, obviously you have a fair bit of experience with Simpazan in the market, could you share anything qualitatively around the patient experience, you know, average time on treatment, you know, treatment success with the first few doses, and anything like that? I'm just curious to hear what you guys are hearing from prescribing doctors.

And how much we would take out so we've not assumed that we take the entire srl.

Process that gets us to that market.

Let's say so closer to 50 million.

Yeah, I won't give you a specific number and we will update the market. Once we have a view of what kind of structure of a deal that we want to do we're going to do a deal in the market that we think represents the best economics for questar.

Kenneth W. Marshall: Sure, this may be a technological feat, but let's try it anyway. Ken, are you there? Yeah, I'm here. Do you want to take this?

That could be a partial sale it could be a pharma bond. It also could be an outright complete sale.

Really depends on discount rates.

Kenneth W. Marshall: Yes, sure, absolutely. Yeah, we've actually had very positive feedback from physicians, and as Keith noted in his remarks, we've seen a substantial growth in our prescriber base. To date, we have just crossed over around 550. And if you look at those positions, about 77% of them have been written multiple times. It's a little challenging to define the absolute number of prescriptions for patients since these are scheduled meds and a lot of times they have to repeatedly come through as NRXs, but the qualitative feedback is very strong. If you look at historic analogs where you can dig into patient data, you'd expect maybe 8 to 10 months on a patient. We have every reason to believe we're getting at least that with Simcha Zahn, and then qualitatively, the value proposition holds up. The ability to deliver a consistent, full dose seems to be ringing true with a lot of physicians. That's great. Thanks for taking the questions.

The overall view what the market.

So what were you thinking with the.

Liana. This is Keith just just amplifying John's comment.

You guys you keep pushing around.

The quantum.

We took the range of value that was given to us by the folks who are working with us around this plus the.

Independent view that BLE case study represented we hair cut that.

And and looked at that number as.

The starting point for our comments around being able to get well into 2021 or into 2022 potentially.

Okay. Thank you very much.

Thank you.

Our next question comes from Jason Butler from JMP Securities. Please go ahead.

Hi, Thanks for taking the questions that couple from me first on LIBOR Van your dialogue with that you have you had any discussion around.

Operator: Thank you. As a reminder, to ask a question, please press star 1 on your telephone. To withdraw your question, press the pound key.

A pre approval manufacturing section and how you're thinking about that in light of that and then the second one.

Operator: I assure you our next question comes from Raghuram Selvaraju, from H.C. Wainwright.

Just in terms of the.

The virtual education of marketing strategy, you're thinking about presented them right. Now how are you thinking longer term about how those who could could remain useful I do think forward to the LIBOR event launch. Thanks.

Keith Kendall: Hi, this is Blair Cohen on behalf of Rob. Just a couple questions for you. First, what has been your worst challenge to cope with the COVID-19 pandemic, and how quickly do you anticipate getting back up to speed?

Good morning, Jason This is Dan again nice to hear your voice.

On the FDIC side, we have not had a specific.

Keith Kendall: This is Keith. I think the worst challenge for a lot of old people is figuring out how to deal with so much technology so fast in order to be able to continue to communicate. The serious answer is this is a company built on collaboration. It's a company built on interaction, and not being able to see each other, sit in a room together, has been a challenge, but we have used the technology available to us to be able to continue to do that. We were a very planful and thoughtful company about very quickly making sure we protected the essential parts of our business, the R&D work to support the products in development, and the manufacturing facilities to support production.

Interaction with the FDA disgusting.

Hi, or pre approval inspection however, the FDA has.

Given guidance to industry in that guidance does talk about your inspection history and.

How they will handle.

Audits, both internationally and in the U.S. So we are confident based on our audit history and our existing commercial products that.

We do not require a P.A. I during the cobot 19 era.

Prior to launching our product and we also.

Do not believe that we have any international risk from any of our suppliers based on.

But what will be who we've used for the product in the final.

Great. Thanks.

Yes, Jason I'm, sorry that I wanted to make sure you weren't going to follow up with Dan before I jump in on the other part of the question. So ill look we're all learning.

Keith Kendall: We've approached all of this from the number one principle that it is absolutely imperative that we protect our colleagues, their families, the people they interact with, and the people who interact with our therapeutic products. So making sure that we took those steps early and we took those steps decisively has allowed us to continue to operate as well as we possibly can up to this point. At this point in time, virtually all of our sales people are... Interacting with prescribers virtually, no one is working in our offices other than the lab folks here in New Jersey and the manufacturing folks in Indiana so that we are protecting everybody in the organization.

I think every one of US is learning how to use technology in a way we hadn't.

Two months ago, we've all had our share of.

Dogs being introduced into conference calls in kids pulling the plugs out while a video call is going on.

We have a the truth of the matter for US is that different parts of the country are behaving very differently. We still have some small number of our salesforce that are able to make face to face visits and as as people start as parts of the country.

Reopening.

Doctors are seeing new patients and doing well care visits we expect more of our.

Salesforce to be able to resume face to face.

Keith Kendall: Okay, great. And do you think the demand for Suboxone has been affected by COVID-19?

Be that as it may we have discovered that some of the tools available to us technologically are very useful and it is causing us to think about what sales deployment might look like and how we might be able to use a combination of those tools that are face to face opportunity.

Keith Kendall: Suboxone volume is doing pretty well, I think, at this point in time. Whether or not the inability for doctors to see new potential patients for sublocade, as Endivior has spoken about, has an impact on the volume of suboxone, I think, remains to be seen. It's a little early to understand that, but suboxone, at least according to our projections for the year, is performing at the level we expect in the first quarter, and we've got a good order book for the second quarter, as John said. Okay, and just last...

To not only drive sales for SIMPAS and but to help.

Accelerate the curve the law the slope of the curves on the launch of Liberman. What those are specifically, we have not yet laid out, but we'll certainly talk about them as we do.

Great. That's helpful. Thanks for taking my questions.

Thanks, Jason.

Thank you next question comes from Thomas Flatten from Lake Street Capital. Please go ahead.

Good morning, Thanks for taking the questions just a follow up on the field question in.

Keith Kendall: Lastly, and forgive me if you've already answered this, but do you still expect on-time approval for sublingual apomorphine?

In advance of the Liberal Grant launch do you expect any significant field force changes territory realignments anything like that upsizing of the field force or are you.

Keith Kendall: We still expect apomorphine and synovium to get an approval in May. I forget what the exact date is. May 21st. Thank you, John. We still expect that, and as we've said repeatedly in the comments today and leading up to today, we've begun the process of monetizing that royalty stream, and once it's approved,

Are you happy with the current deployment to support the initial launch in the product.

Well.

We are going to absolutely.

Grow the field sales force substantially for the launch of liver Vance I think will determine how far in advance, we'll we'll make a determination based on our confidence on the outcome of September 27th when to start that build.

Operator: Okay, and that's it for me. Thank you.

If the prudent thing to do is wait until after we have absolute confirmation that the market is available to us we build the salesforce very quickly after that.

Operator: Thank you. Thank you. I have no further questions in the queue.

Keith Kendall: At this time, I'd like to turn the call over to Keith Campbell, President and CEO, for closing remarks. Well, thank you everyone for your continued interest in Equestiv. Thank you for taking the time to join us this morning. Thank you for your questions, and we look forward to keeping you up to date on the progress on the key value drivers for the company. Have a great day, and we look forward to talking to you again soon.

We are confident going into that based on the.

Interactions, we're able to have if we're able to have the interactions with the agency.

Then we'll build in advance of that LIBOR van Theres, a launched product will represent a significantly larger salesforce than we have now.

I would assume based on that yes, there will be a realignment of territories into redistribution of regions and distribution of Accountabilities around live revamping SIMPAS in revenue targets.

Operator: Ladies and gentlemen, this concludes today's conference call.

Operator: Thank you for participating. You may now disconnect.

Operator: You may now disconnect. BF-WATCH TV 2021

Switching over to FNF front can you provide any additional color around what you anticipate that PK study looked like in any additional studies beyond that that Youve preliminarily discussed with you.

Sure so.

As we.

Discussed before and thank you Thomas this is Dan again.

We will be in the clinic again in the fall and in a a fairly standard PK study, where we will compare our product against approved FNF run our products.

And the end the PK data will collect will be.

The typical cmax or you see.

The Max as well as we also will have some blood pressure data things like that.

Once we have completed that initial PK study, we will look to ramp up to what would be typically called a true pivotal PK study, which we the time gap between this first starting the second study.

We will be fairly tight we believe.

In between those studies, we will most likely go back to the FDA and have a conversation and ensure we are on course for the expectations. We believe we heard and appreciate indeed meeting.

Great and then just one final one.

Regarding you've had obviously have a fair big time of the experience of SIMPAS then in the market could you share anything qualitatively around round the patient experience average time on treatment treatment success with the first few doses and and anything like I'm just curious to hear what you guys are hearing from from prescribing dock.

Sure. This may be a technological fee, but lets try in any way Kenny you there.

Yeah I'm here.

You want to you want to take that.

Yes sure absolutely.

Yeah, we have had actually very positive feedback from physicians and keep noted in his remarks, we've seen a substantial growth in our prescriber base.

To date, we just crossed over around 550.

And if you look at those physicians about 77% to then have written multiple times.

It's a little challenging to define the absolute number of.

Prescriptions.

Patients since these are scheduled meds and a lot of times they have to repeatedly come through as in our axis.

But the qualitative feedback is very strong.

If you look at historic analog where you can dig into patient data you'd expect maybe eight to 10 months on a patient.

We have every reason to believe we're getting at least that.

All right with since then and then qualitatively and the value the value proposition proposition holds up.

The ability to deliver a consistent pull those seems to be ringing true with a lot of the position.

That's great. Thanks for taking the questions.

Thank you.

As a reminder to ask a question. Please press star one on your telephone to withdraw your question press the pound cake.

I show on next question comes from rock around Celgar are gone from H.C. Wainwright. Please go ahead.

Hi, This is blair calling on for Rob.

Just a couple of questions for you.

First what it's been your worst challenge to cope with over 90 pandemic and how quickly you thinking back up to speed.

Hi.

This is Keith I think the worst challenges for a lot of old people to figure out how to deal with so much technology. So fast in order to be able to continue to communicate.

The serious and series. This is a company built on collaboration it's a company built on interaction and not being able to see each other sit in a room together.

Has been a challenge, but we have used the technology available to us.

To be able to continue to do that.

We were very Planful and thoughtful company about very quickly, making sure we protected the essential parts of our business the R&D work to support.

Two it too.

Support the products in development.

And the manufacturing facilities to support to production we've approached all of this from the number one principle that is absolutely imperative that we protect our colleagues their families. The people they interact with.

And the people who interact with our.

Therapeutic products right, so making sure that we took those steps early and we took those steps decisively I think has allowed us to continue to operate.

As well as we possibly can up to this point at this point in time virtually all of our salespeople are.

Interacting with prescribers.

Virtually.

No one is working in our offices other than the lab folks here in New Jersey, and the manufacturing folks in Indiana. So that we're protecting everybody in the organization.

Okay, great and.

You think the demand for suboxone, it's been affected by carbon Nike.

Hey, Suboxone Suboxone volume is doing pretty well.

I think at this point in time, whether or not the inability for doctors to see new potential patients for sub blockade.

As in DVR has spoken about has an impact on the suboxone volume I think remains these remains to be seen so little early to understand that but.

Suboxone at least according to our.

Our projections for the year is performing at the level we expect.

In the first quarter and we've got a good order book for the second quarter as John said.

Okay, and just lastly in forgive me if you've already answer that but you still expect on high approval for sibling all marketing.

Yes, we still expect apomorphine, and Sanofi and to get an approval in May I forget what exact David may 21st Thank you John.

We still expect that and as we've said repeatedly in the.

The comments today and leading up to today, we've begun the process of monetizing that royalty stream and once its approved will.

In a transaction or series of transactions based on the market conditions structure in timing monetize those royalties.

Okay and that's it for me thank you.

Thank you for Blair.

Thank you I shouldn't further questions in the queue at this time I like to turn the call over to keep candle president and CEO for closing remarks.

Well. Thank you everyone for your continued interest in a quest Steve. Thank you for taking the time to join US. This morning. Thank you for your questions and we look forward to keeping you up to date on to progress on the key value drivers for the company.

Have a great day and.

We look forward to talking to you again soon.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.

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