Q4 2023 Evoke Pharma Inc Earnings Call

March 14, 2024

Following management's prepared remarks, the call will be opened up for questions. If you would like to ask a question at that time. Please press star one on your telephone keypad, if you need to remove yourself from the queue Press star two.

Anytime if you should need operator assistance press Star Zero. Please be advised that today's call is being recorded I will now turn the call over to Daniel Concho. Boeing. Please go ahead Sir.

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[music].

Good afternoon, and thank you for participating and invoke farmers conference call and webcast today with me today are Dave on your Ebooks, Chief Executive Officer, Chris question, Barry Genuity, Chief commercial officer from ever Sona, and Matt <unk>, President and Chief operating Officer.

By now you should have a copy of the press release, we issued earlier if not it is available on the Investor Relations page of our website at evoke pharma dot com.

We encourage everyone to read today's press release as well as evokes annual report on Form 10-K, which has now filed with the SEC.

The company's Form 10-K and earnings release are also available on evokes website.

Please note that certain information discussed on the call today is covered under the Safe Harbor provisions of the private Securities Litigation Reform Act.

We caution listeners that during this call management will be making forward looking statements.

Actual results could differ materially from those stated or implied by these forward looking statements due to risks and uncertainties associated with the company's business.

Good afternoon, and welcome to the evoke pharma fourth quarter and full year 2023 earnings Conference call. Currently all colors have been placed in a listen only mode and following management's prepared remarks, the call will be opened up for questions. If you would like to ask a.

These forward looking statements are qualified by the cautionary statements contained in evokes press releases and SEC filings, including its annual report on Form 10-K and subsequent filings.

Question at that time, Please press star one on your telephone keypad, if you need to remove yourself from the queue Press star two.

This conference call contains time sensitive information that is accurate only as of the date of this live broadcast.

Anytime if you should need operator assistance.

Star Zero. Please be advised that today's call is being recorded I will now turn the call over to Daniel Concho.

<unk> undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this conference call and webcast.

Please go ahead Sir.

Good afternoon, and thank you for participating.

With that I would now like to turn the call over to David gone here Dave.

This conference call and webcast today with me today are Dave Gonyer Ebooks, Chief Executive Officer, Chris question, Barry <unk>, Chief commercial officer from episodic and Matt year, Nokia Ebooks, President and Chief operating officer by now you should have a copy of the press release issued earlier.

Thank you Danielle and thanks, everyone for joining the call. This afternoon.

As was described in today's press release 2023 marked a milestone in evokes journey not just commercially but also fulfilling our core mission.

Which is ensuring <unk> Modi is within reach for every patient who needs it.

It is available on the Investor Relations page of our website at evoke pharma dot com.

Let me tell you why this core mission is so important.

Courage, everyone to read today's press release as well as evokes annual report on Form 10-K, which is now filed with the SEC.

Because it's about the patient and their experiences that can and will fuel the progress.

Help us fuel the progress as an organization.

The company's Form 10-K and earnings release are also available on <unk> website.

A testament to our efforts comes from the countless positive stories, we've been told from health care providers patients and our own sales Representatives, who hear Intel has some amazing patient success stories on a daily basis.

Please note that certain information discussed on the call today is covered under the Safe Harbor provisions of the private Securities Litigation Reform Act, we caution listeners that during the call management will be making forward looking statements.

While gastroparesis impacts predominantly women today I'd like to share just a brief very inspiring story that was this share to us. This week about a 30 year old male who battled both type one diabetes.

Actual results could differ materially from those stated or implied by these forward looking statements due to risks and uncertainties associated with the company's business.

And severe gastroparesis.

This man.

These forward looking statements are qualified by the cautionary statements contained in evokes press releases and SEC filings, including its annual report on Form 10-K and subsequent filings.

Who was in and out of the hospital just about every month because it was gastroparesis shared with this healthcare provider that since starting on <unk>. He hasnt had a single hospital visit not one.

This conference call contains time sensitive information that is accurate only as of the date of this wide broadcasts.

And to his admission.

Been life changing for him.

<unk> undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this conference call and webcast.

The stories like these that will push payers providers.

And that gets to fight for patients who suffer from this insidious disease.

Can receive the best care possible.

With that I would now like to turn the call over to David gone here Dave.

Now this is just one of many affirmation we have heard that continues to energize our commitment.

Thank you Danielle and thanks, everyone for joining the call. This afternoon.

Now while we are humbled to receive these stories of success. We also want to encourage providers to do more to diagnose and treat these patients with gastroparesis.

As was described in today's press release 2023 marked a milestone in evokes journey not just commercially but also fulfilling our core mission.

But unfortunately.

Nor for patients is two eight years before the diagnosed and then often told theres not much. They can do can be done for them.

Which is ensuring <unk> Modi is within reach for every patient who needs it.

Let me tell you why this core mission is so important.

When treatment is prescribed all too often payers are pushing the cost to the patient for.

Because it's about the patient and their experiences that Ken will fuel the progress.

Or outright denying coverage.

Help us fuel the progress as an organization.

Players can do better and patients deserve better treatment.

A testament to our efforts comes from the countless positive stories, we've been told from healthcare providers patients and our own sales Representatives, who hear Intel has some amazing patient success stories on a daily basis.

The compelling.

Evidence for GMO goes beyond anecdotes with scientific groundwork the publication of our phase III clinical data in the peer reviewed in plenary presentations of a real world Health resource utilization studies at leading Gastroenterology Congresses, demonstrating a reduction in emergency room and.

While gastroparesis impacts predominantly women today I'd like to share just a brief very inspiring story that was just share to us. This week about a 30 year old male who battled both type one diabetes and severe gastroparesis.

Hospital visits and a significant total health care cost savings compared to oral medical Mike.

This man.

Who was in and out of the hospital just about every month because of this gastroparesis shared with this healthcare provider that since starting on gymboree. He hasnt had a single hospital visit not one.

Underscores the value of <unk> versus the current gold standard.

Our story is really simple and straightforward and it's shaping up to be very compelling as well.

<unk> achieved rapid and direct absorption in the bloodstream.

And to his admission.

Been life changing for him.

Promoted provides documented symptomatic relief as early as one week.

The stories like these that will push payers providers.

And now Jim motive shows improved outcomes versus oral metoclopramide.

And that gets despite for patients who suffer from this insidious disease.

The drug.

Can receive the best care possible.

Livery through the nose avoid the problem of the disease, which is an inability to predictably deliver pills into the small intestine to be absorbed.

Now this is just one of many affirmation we have heard that continues to energize our commitment.

Now while we are humbled to see these stories of success. We also want to encourage providers to do more to diagnose and treat these patients with gastroparesis.

So importantly, many patients previously on oral medical from mines in the <unk> study or the health risk.

Resource utilization study, who were switched to <unk> Modi likely because they were not doing well experienced the same reduction in ER visits and hospitalization, while taking demoted confirming its place as a transformed formative medicine and gastroparesis treatment.

But unfortunately.

Nor for patients is two eight years before the diagnosed.

And then often told theres not much they can do can be done for them.

When treatment is prescribed all too often payers are pushing the cost to the patient for.

Or outright denying coverage.

Now, let me switch gears a bit in terms of some highlights for 2023.

Payers can do better and patients deserve better treatment.

I'm happy to report that we doubled our net revenue for <unk> over the last year.

The compelling evidence for Jim already goes beyond anecdotes scientific groundwork the publication of our phase III clinical data in the peer reviewed in plenary presentations of a real world Health resource utilization studies at leading Gastroenterology Congresses, demonstrating a reduction in <unk>.

Number of new prescriptions grew by notable 86%.

Total prescriptions dispensed increased by 101% year over year.

Clearly demonstrating the growing demand for <unk>.

We also augmented our prescriber base by 72%, while amplifying the depth of their prescribing by 36%.

Regency room, and hospital visits and the significant total health care cost savings compared to oral medical Mike.

Our commercial teams relentless focus propels, our targeting and outreach to health care providers, driving our financial achievements above our expectations.

Underscores the value of <unk> versus the current gold standard.

Our story is really simple and straightforward and it's shaping up to be very compelling as well.

An important gastroenterology gatherings, such as digestive disease week, and the American College of guests around gastro neurology conferences, our data was selected by the respective governing boards preliminary presentations at both meetings.

<unk> achieved rapid and direct absorption in the bloodstream.

<unk> provides documented symptomatic relief as early as one week.

And now <unk> Modi shows improved outcomes versus oral metoclopramide.

This is a testament to the strength and importance of the health resource utilization study we performed.

The drug delivery through the nose avoid the problem of the disease, which is an inability to predictably deliver pills into the small intestine to be absorbed.

Data highlighted <unk> role and significantly reducing ER visits and hospitalization outperforming oral metoclopramide in delivering care at a reduced price.

So importantly, many patients previously on oral metoclopramide in the <unk> study or the health.

This evidence not only resonated with Gi professionals, but also underscores our commitment to patient care and economic efficiency for payers.

Resource utilization study, who were switched modi likely because they were not doing well experienced the same reduction in ER visits and hospitalization, while taking demoted confirming its place as a transformed formative medicine and gastroparesis treatment.

Further in our strategic initiatives, we transitioned our pharmacy services to Aspen.

Our strategic alignment with <unk> robust platform positions us to better meet our distribution needs enhanced patient access and streamline our services and Chris will elaborate a little bit more on this in a moment.

Now, let me switch gears a bit in terms of some highlights for 2023.

I'm happy to report that we doubled our net revenue grew remotely over the last year.

The number of new prescriptions grew by notable 86%.

Looking back on a year of dynamic growth, our strategic investments have paid dividends.

Total prescriptions dispensed increased by 101% year over year.

We have not only strengthened my belief in <unk>, but doubled the patient count on therapy.

Clearly demonstrating the growing demand for <unk>.

As we lean into 2024, we're aiming high with a projected net revenue of approximately $14 million nearly tripling our 2023 performance.

We also augmented our prescriber base by 72%, while amplifying the depth of their prescribing by 36%.

Our commercial teams relentless focus propels, our targeting and outreach to health care providers, driving our financial achievements above our expectations.

And with that let me turn it over to Chris to talk about our current commercialization activities and plans moving forward for this year.

As important gastroenterology gatherings, such as digestive disease week, and the American College of guests around gastro neurology conferences, our data was selected by the respective governing boards preliminary presentations at both meetings.

Thanks, Tim.

To confirm the uptake and acceptance that Dave just spoke about and re validate last year's commercial strategy.

We also take a look at providers consecutively prescribing generic after their initial script.

The notes that close to 30% of our cumulative prescribers, which totaled <unk> hundred 48 positions.

This is a testament to the strength and the importance of the health resource utilization study we performed.

Prescribed Germany, five or more times.

This data highlighted <unk> role and significantly reducing ER visits and hospitalization outperforming oral metoclopramide in delivering care at a reduced price.

The writers that have written prescriptions continue to write more and more over time.

Our standpoint, this is highly encouraging and a strong testaments to the drugs efficacy and prescriber and user friendly profile.

This evidence not only resonated with Gi professionals, but also underscores our commitment to patient care and economic efficiency for payers.

The unabated, adding a new prescribers are so called breadth of prescribing in 2023, while simultaneously continuing to grow the depth of prescribing.

Further in our strategic initiatives, we transitioned our pharmacy services to Aspen.

It is difficult to do and is also an indication that there is still significant potential for growth for Jimmy.

Strategic alignment with <unk> robust platform positions us to better meet our distribution needs enhance patient access and streamline our services and Chris will elaborate a little bit more on this in a moment.

We have not reached any ceiling on views for generic.

Quite the opposite is true.

While not shown on this slide our market share of metoclopramide.

A medical.

Market's showing similar gains throughout 2023.

Looking back on a year of dynamic growth, our strategic investments that pay dividends.

Encouragingly as you look across important prescriber Audi.

Not only strengthens our belief in <unk>, but it doubled the patient count on therapy.

The share of Germany, compared to oral metoclopramide grew throughout 2023, and it's from aggressively stronger as you move from all potential prescribers of Giovanni to those that are in our call plan target list.

As we lean into 2024, we're aiming high with a projected net revenue of approximately $14 million nearly tripling our 2023 performance.

Further improves as you look specifically at <unk> targeted to Gastroenterologists.

And with that let me turn it over to Chris to talk about our current commercialization activities and plans moving forward for this year.

Importantly, our highest share for genuity as with nurse practitioners and physician assistance and provide a significant portion of the medical care for patients with Gastroparesis as many gastroenterologists spend less time in clinic.

Thanks, Tim.

To confirm the uptake any patents that Dave just spoke about and re validate last year's commercial strategy.

Deciding instead to perform procedures or scopes.

We also take a look at providers consecutively prescribing generic after their initial script.

As mentioned our objective is to nearly triple our performance in 2023.

The slides and note that close to 30% of our cumulative prescribers, which totaled <unk> hundred 48 positions.

Excuse me in 2024.

In 2023, we built a solid foundation and believe we have earned the right to challenge our provider and payer colleagues to offer commodity to a broader base of patients with diabetic gastroparesis.

Hi, Jim 95 or more times.

The writers that have written prescriptions continue to write more and more over time.

From our standpoint, this is highly encouraging and a strong testaments to drugs efficacy and prescriber and user friendly profile.

Throughout 2024 and beyond our focus remains steadfast.

Reinforces the belief in Germany amongst providers.

The unabated, adding a new prescribers are so called breadth of prescribing in 2023.

Importantly, we will make clear that oral metoclopramide did not have the same healthcare resource utilization productions that you might be provided and underscore that the named Robert administration matters.

Simultaneously continuing to grow the depth of prescribing.

It is difficult to do and is also an indication that there is still significant potential for growth Virginia.

For appropriate patients, we will ask providers to switch to Germany.

We have not reached any ceiling on views for generic.

Thereby broadening and deepening prescribing.

Quite the opposite is true.

We've addressed improving the fill rate for Genuity and we'll continue this imperative throughout 2024.

While not shown on this slide our market share.

The medical.

Market share <unk> gained throughout 2023.

We earned a significant amount of prescribing community in 2023.

Encouragingly as you look across important prescriber audience.

And much of it was unable to be filled because providers prescription to a local retail pharmacy.

This year, maybe compared to oral metoclopramide grew throughout 2023, and it's from aggressively stronger as you move from all potential prescribers of Giovanni to those that are in our call plan target list.

We will use tools and partners to mitigate this and guidance Chris too.

Our pharmacy and our network to capture scripts appropriately.

Further improves as you look specifically at <unk> targeted to Gastroenterologists.

Lastly, we will increase our communication and education for tardive dyskinesia.

And leverage latent concerns to clarify risks and encourage appropriate benefit risk discussions.

Importantly, our highest year for genuity as with nurse practitioners and physician assistants, who will provide a significant portion of the medical care for patients with Gastroparesis as many gastroenterologists spend less time in clinic.

Here again, there is tremendous untapped potential.

Clarify appropriate use.

We will be clear about who is inappropriate for humanity and request those who are appropriate to be offered to them.

Deciding that perform procedures or scopes.

As mentioned our objective is to nearly triple our performance in 2023.

Tactically, here's how we plan to build on these initiatives.

Excuse me in 2024.

We will continue to promote and advocate for humanity at the optimal choice for Gastroparesis treatment due to its optimized nasal administration.

In 2023, we built a solid foundation and believe we have earned the right to challenge our provider and payer colleagues to offered committee to a broader base of patients with diabetic gastroparesis.

We will support this isn't a quantitative and qualitative healthcare utilization data.

Throughout 2024 and beyond our focus remains steadfast.

Currently we are partnering with pharmacy organizations to leverage their systems and services to mitigate prescriptions that fall outside our distribution lines and never reach patients.

Reinforces the belief in Germany amongst providers.

Additionally, with asking pharmacy, joining our network, we will gain access to their extensive pharmacy distribution network, including specialty drug pharmacies.

<unk>, improving generic fill rates and ensuring our patients receive the treatment they need without delay.

For appropriate patients, we will ask providers to switch to <unk>.

Thereby broadening and deepening prescribers.

Through appropriate channels will also persist to demystify the risks associated with tardive dyskinesia RTD.

We've addressed improving nozomi for Genuity and we'll continue this imperative throughout 2024.

Vacation and transparency.

We earned a significant non prescribing community in 2023 and much of it was unable to be filled because providers prescription to a local retail pharmacy.

For background, tardive dyskinesia, and the side effects of medications.

Commonly seen with older anti psychotic medications that causes intolerant involuntary and maintenance to one's face and body control.

We will use tools and partners to mitigate this and guidance too.

The recent ACG guidelines indicate the risk of this side effect due to exposure to metoclopramide is lower than previously thought.

Our pharmacy and our network to capture scripts appropriately.

Lastly, we will increase our communication and education for tardive dyskinesia.

Fact is likely less than 1%.

And leverage lightened concerns to clarify and risk and encourage appropriate debt benefit risk discussions.

And our own claims analysis presented at <unk> in 2022 confirmed Acg's conclusion.

Here again, there is tremendous untapped potential.

By presenting clear data, including the low incidence, which.

Clarify appropriate use.

We will be clear about who is inappropriate for humanity and request those who are appropriate to be offered to them.

And which at risk patients to avoid we.

We are shifting the narrative from fear to inform prescribing and monitoring.

Believe this will reshape perceptions and encourage physicians to prescribe <unk> to appropriate patients with confidence.

Tactically, here's how we plan to build on these initiatives.

We will continue to promote and advocate for humanity at the optimal choice for Gastroparesis treatment due to its optimized nasal administration.

Perhaps by a comprehensive understanding of its safety profile.

As we build demand.

Utilization automotive, we've taken deliberate strides to enhance accessibility to Germany by evolving our distribution and pharmacy capabilities.

So important discipline, a quantitative and qualitative healthcare utilization data.

Concurrently we are partnering with pharmacy organizations to leverage their systems and services to mitigate prescriptions that fall outside our distribution lines.

Our journey began with the focuses around pharmacy, which allowed us to implement the system swiftly.

Relied on manual processes and had longer fulfillment times.

To reach patients.

Just wondering with asking pharmacy, joining our network, we will gain access to their extensive pharmacy distribution networks, including specialty drug pharmacies improved and premium to ammonia fill rates and ensuring our patients receive the treatment they need without delay.

As we progress the binary care, we significantly upgraded our capabilities integrating seamlessly with medical workflows, enabling electronic prescribing.

Facilitating automatic refills.

Using the automated retail expedite drilling.

Through appropriate channels will also persist to demystify the risks associated with tardive, dyskinesia, RTD and education and transparency.

Drilling process.

Now.

We've taken our distribution to the next level building.

Building on our previous advancements Sandia offers real time patient communications via text.

For background Tardive dyskinesia.

Medications more commonly seen with older anti psychotic medication.

<unk> end to end automation, including prior authorizations and transparent prescription Spanish.

Causes intolerant and voluntary maintenance, one face and body control.

Testable portals to physicians and patients is.

The recent ACG guidelines indicate the risk of this side effect due to exposure to metoclopramide is lower than previously thought in fact, it's likely less than 1%.

This not only streamlines the prescription process for health care providers, but also ensures that patients can receive their medication promptly.

Importantly, SMB is robust infrastructure and expansive pharmacy network position us to further scale, our reach and positively impact patient outcomes.

And our own claims analysis presented at <unk> in 2022 confirmed Acg's conclusion.

I am presenting clear data, including the low incidence, which and which at risk patients to avoid.

These strategic enhancements and body, our commitment optimizing multi asset.

<unk> and signify our unwavering dedication to patient care.

We are shifting the narrative from fear to inform prescribing and monitoring.

Although we've only just initiated a partnership with the syndrome.

Also known as asked in pharmacies in November of 2023, it's clear we've identified a critical lever for enhancing our coatings.

We will refine strategies and communication and process optimization within the admin Aspen platform.

<unk> seen a tangible uptake on our conversion rates.

Typically there has been a 2% overall increase in the number of new prescriptions filled.

Even more impressive when we exclude and process prescription and improvement jumps to 22%.

Moreover, we are seeing a significant shift towards greater efficiency with a 6% increase in sales that are reimbursed without the need for our patient affordability programs.

Estimate to streamline process and.

And inherent value proposition on <unk>.

Additionally, asking focus on rapidly and transparent patient communication is yielding results with.

With Aspen, there has been a 12% reduction in patient initiated abandonment prescriptions.

Underscoring our commitment to ensuring that patients not only start.

We continue their treatment with <unk> as appropriate.

These metrics are not just numbers they represent real improvements in patient access and adherence which are vital to our mission of providing you might need to all who can benefit from it. These.

These benefits.

Also fall to the bottom line.

As we fortify our commitment to ensuring dmitry reaches those in need.

<unk> technology remains a headwind.

By actively reminding healthcare professionals to write prescriptions directly to ask them.

Pharmacies at the point of prescriptions within the electronic Medical records, we are addressing retail leakage effectively.

Using this approach we successfully made headway and intercepting scripts.

Initially intended to be prescribed to a retail pharmacy and successfully redirected our 1500 event to our pharmacy, including asthma.

We believe this strategic communication effort with prescribers pharmacists and patients alike is critical cementing <unk> presence in the market and improving patient outcomes.

Based on the success, we have recently expanded our coverage in partnership with other EMR partners or <unk>.

Messaging has now enabled nearly half of all electronic health record systems.

And we have added new partners and Dr first and connected by reps at the beginning of this month.

Ensuring that humidity prescriptions pathway is even more clear and direct.

Now last year, we unveiled to real world evidence studies that demonstrated the qualitative and quantitative valued genuity and addressing healthcare resource utilization of patients with diabetic gastroparesis.

Image on the left hand side of the slide shows the inpatient hospitalizations were reduced by 68%.

Patients using chimbote compared to oral metoclopramide and it also shows emergency department visits were similarly reduced significantly by 60%.

And those taking humidity versus Earl medical Mike.

The 257 patients taking javadi experienced 34, fewer hospitalizations and aiming for fewer ER visits over a six month period.

That is a significant win for patients who can spend more time at home with their families are doing simple things that we all take for granted.

The redemptions will also be a significant win for patients.

Amazingly looking to the right hand side of the slide despite numerically larger prescription costs merger Mooney arm total health care costs, which is the sum of all medical costs and pharmacy cost encounters were significantly lower in fact over $15000 lower for patients taking Jim noted.

And those taking.

Generic oral metoclopramide over six month period of time.

These datasets reinforced the Moody's clinical benefits and illustrates the profound potential economic impact.

Substantial reductions in hospitalization and emergency Department visits speaks volumes about its role in enhancing Hansen patient daily life.

Are you seeing the burden on our health care system.

Moreover, the significant cost savings highlight <unk> value proposition.

Marketing not only as a superior treatment option.

Inside of the slide shows the inpatient hospitalizations were reduced by 68%.

I also financially responsible choice for health care providers and patients Payors.

I would argue that this is more than a win win with a new standard treatment gastroparesis setting a precedent for how we evaluate treatments.

Patients using <unk> compared to oral metoclopramide.

And it also shows emergency Department visits were similarly reduced significantly by 60% in.

Efficacy and cost effectiveness for patients with this debilitating disease and progressive disease.

And those taking humidity versus Earl metoclopramide.

The 257 patients taking javadi experienced 34, fewer hospitalizations and aiming for fewer ER visits over a six month period.

No other agent in fact, no other modality use for Gastroparesis.

These type of breakthrough data demonstrating outcomes.

That is a significant win for patients who can spend more time at home with their families are doing simple things that we all take for granted.

And so we're going to test these data with payers back we're doing that right now ensures pbms and IBM Blake.

Market research and asking them, how the data might impact coverage decisions.

The reductions will also be a significant win for patients.

We are in the midst of wrapping up this research, but what we are hearing from payers is that our healthcare resource utilization data is enough provocative elements to potentially impact the coverage decisions for genuity based on the same data interchange on the previous slide.

Looking to the right hand side of the slide.

Spite numerically larger prescription costs merger multi arm total health care costs, which is the sum of all medical costs and pharmacy cost and counters.

Were significantly lower in fact over $15000 lower for patients taking chimbote than those taking.

A significant portion of the payers who are not currently covering chimbote indicated the data presented would make them reconsider coverage decision.

Generic oral metoclopramide over six month period of time.

With 40% of them are affirming outright and another 40% expressing willingness to reconsider with additional evidence of cost savings.

These datasets reinforce some of its clinical benefits and illustrates the profound potential economic impact.

Additionally, other payers, who currently do provide coverage for Germany nearly half of it will further ease the process documentation requirements for obtaining genuity.

A substantial reductions in hospitalization and emergency department visits speaks volumes about its role in enhancing enhancing patient daily life.

Reducing the burden on our health care.

This preliminary preliminary feedback bolsters, our conviction that providing robust evidence can shift.

Hmm.

Moreover, the significant cost savings highlight <unk> value proposition.

Perspectives.

Marketing not only as a superior treatment option.

Payers are looking for more detailed analysis of cost saving drivers in peer review data to underpin credibility.

But also financially responsible choice for health care providers and patients Payors.

We recognized this need for continued evidence generation focusing on key factors such as reduced hospitalizations links Rio.

I would argue that this is more than a win win with a new standard in the treatment of gastroparesis setting a precedent for how we evaluate treatments.

Readmission rates and the overall reduction of the prescription burdens.

Efficacy and cost effectiveness.

Additionally, the reduction of the burden of illness, the avoidance of unnecessary medical procedures and assurance of safety.

<unk> with this debilitating disease and progressive disease.

No other agent in fact, no other modality use for Gastroparesis.

Pivotal components that would enhance the value story and humility.

Has these type of breakthrough data demonstrating outcomes.

Now one of the main reasons for hesitancy among providers to prescribe the money is the package multi carries a box warning for tardive dyskinesia.

And so we're going to test these data with payers back we're doing that right now with insurers pbms and IBM delight through market research and asking them, how these data might impact coverage decisions.

To what oral medical might had in their label.

TD as a movement disorder that causes involuntary and even to the face or body.

In the midst of wrapping up this research, but what we are hearing from payers is that our healthcare resource utilization data has enough provocative elements to potentially impact the coverage decisions for <unk> based on the same data that I showed you on the previous slide.

Certainly it can occur with medical Mike, but TV is more commonly associated with anti psychotic medicines.

We've come to appreciate that TD is a mystery for gas neurologists, we don't deal with it on a regular basis and there is a significant gap in our understanding of TD and how often occurs.

A significant portion of payers, who are not currently covering chimbote indicated the data presented would make them reconsider coverage decision.

The apprehension is leading many to avoid use them in a closed mind for reserve it for the more refractory patients.

With 40% of them affirming outright and another 40% expressing willingness to reconsider with additional evidence of cost savings.

We need to shift this narrative from being afraid and avoiding to one of educated and monitor.

Additionally, other payers, who currently do provide coverage for Germany nearly half of it will further ease the process documentation requirements for obtaining genuity.

We'll leverage our label and the excellent information within it to help providers to use the box warning is the roadmap and the legal information on protocols to help a provider avoid perspective patients at risk and thereby develop a clear understanding of the many appropriate patients who can.

This preliminary preliminary feedback bolsters, our conviction that providing robust evidence can shift.

Perspectives.

Payers are looking for more detailed analysis of cost saving drivers in peer review data to underpin credibility.

Can benefit from generic.

We will update hcp's with the most recent data and guidance around the rest of the TD with medical combined which again is likely less than 1%, we will educate on which patients to avoid and we will clarify that to date no TV had been reported in the clinical development program.

We recognized this need for continued evidence generation focusing on key factors such as reduced hospitalization links lower readmission rates and the overall reduction of the prescription Burton.

Additionally, the reduction of the burden of illness, the avoidance of unnecessary medical procedures and assurance of safety.

Or since the launch of <unk> in October of 2012.

Pivotal components that would enhance the value story of generic.

We will intensify our education efforts moving forward to ensure that providers can make informed benefit risk assessments when considering your money for their patients.

Now one of the main reasons for hesitancy among providers to prescribed by the fact, it's multi carries a box warning for tardive dyskinesia.

Our multi pronged approach includes educating our sales team latest insights on tardive dyskinesia during motility specials through symposia at providing and providing sales force targeted resources and lastly, engaging patients through their providers with education. So they can make informed choices.

To what oral medical might have in their label.

TD as a movement disorder that causes involuntary and even to the face or body.

Certainly it can occur with medical Mike, but TV is more commonly associated with anti psychotic medicines.

We continue to engage kols with and gastroenterology, but importantly are expanded to educate and inform ourselves with kols within psychiatry and neurology specialties.

We've come to appreciate that TD is a mystery for gas neurologists, we don't deal with it on a regular basis and there is a significant gap in our understanding of TD and how often in the curves.

Peter Mcallister of new of the New England Institute Neurology and headache.

The apprehension is leading many to avoid use them in a closed mind for reserve it for the more refractory patients.

And this is to inform our own education efforts.

We need to shift this narrative from being afraid and avoiding to one of educated and monitor.

Our commitment is to ensure that every stakeholder from health care providers to patients is fully informed basmati, thereby supporting its appropriate use and reinforcing our dedication to patient safety and wellbeing.

We'll leverage our label and the excellent information within it to help providers to use the box warning as a roadmap and the legal information our guardrails health a provider avoid perspective patients at risk and thereby develop a clear understanding of the many appropriate patients who can.

That I will turn the call over to Matt to review the financials and closing remarks.

Thanks, Chris.

Once again, thanks again for everyone joining today I'll get right into <unk> financials for the fourth quarter and full year and 2020 results.

Can benefit from generic.

We will update you with the most recent data and guidance around the rest of the TV with medical combined which again is likely less than 1%, we will educate on which patients to avoid and we will clarify that to date no television has been reported in the clinical development program.

And as Dave mentioned for the fourth quarter net product sales were approximately $1 7 million compared with 796000 during the fourth quarter of 2022, and the net loss was approximately 2 million or <unk> 59 per share compared with $1 8 million or <unk> 54 per share for the fourth quarter of 2022 for the year ended December 31 2002.

Or since the launch of <unk> in October of 2012.

We will intensify our educational efforts moving forward to ensure that providers can make informed benefit risk assessments when considering giovanni for their patients.

23, net product sales of approximately $5 2 million compared with approximately $2 5 million for the year ended December 31, 2022, and the net loss was approximately $7 8 million or $2 33 per share compared with a net loss of $8 2 million or $2 62 per share for the year ended December 31 2022.

Our multi pronged approach includes educating our sales team latest insights on tardive dyskinesia during motility specials through symposia at providing and providing our sales force with targeted resources and lastly, engaging patients through their providers with education. So they can make informed choices.

Hi.

Year over year increase in revenue was due to higher net product sales in 2023, resulting from prescription sales through pharmacy service partnerships with Aspen pharmacy, as Dave and Chris elaborated earlier recapture prescription sent to retail pharmacies that previously didn't have the ability to order product.

We continue to engage kols with and gastroenterology.

But importantly are expanded to educate and inform.

And sharing with providers and the GI community the exceptional head to head real world data comparing <unk> to oral metoclopramide shown improvements in fewer hospitalizations and ER visits with genuity compared to oral.

And this is to inform our own education efforts.

Our commitment is to ensure that every stakeholder from health care providers to patients was fully informed of optionality, thereby supporting its appropriate use and reinforcing our dedication to patient safety and wellbeing.

Research and development expenses totaled 23000 for the fourth quarter of 2022 compared to 27000 for the fourth quarter of 2023.

With that I'll turn the call over to Matt to review, the financial and closing remarks.

Full year 2022 research and development expenses were approximately <unk> two.

$2 million compared with approximately $3 million for the prior year.

Thanks, Chris.

Once again, thanks again for everyone joining today I'll get right into <unk> financials for the fourth quarter and full year and 2020 results.

For the fourth quarter 2023, selling general and administrative expenses were approximately $3 5 million compared with $2 3 million for the fourth quarter of 2022 for the year ended December 31, 2023, selling general administrative expenses were approximately $12 2 million versus approximately $9 6 million for the year ended December 31 2000.

Dave mentioned for the fourth quarter net product sales were approximately $1 7 million compared with 796000 during the fourth quarter of 2022, and the net loss was approximately 2 million or <unk> 59 per share compared with $1 8 million or <unk> 54 per share for the fourth quarter of 2022.

22 <unk>.

The increase in SG&A costs or year over year resulted primarily from higher marketing loyalty and Arizona profit sharing costs, we expect that selling general and administrative expenses will increase in the future as we continue to progress with the commercialization of <unk> and we reimburse at restaurants and the net profit attained from the sales of Genuity.

For the year ended December 31, 2023, net product sales of approximately $5 2 million compared with approximately $2 5 million for the year ended December 31, 2022, and the net loss was approximately $7 8 million or $2 33 per share compared with a net loss of $8 2 million or $2 62 per share for the year ended.

Total operating expenses for the fourth quarter of 2023 were approximately $3 6 million compared with $2 3 million for the same period of 2022 and three year ended December 31, 2023 total operating expenses were approximately $12 6 million compared with approximately $10 3 million for the full year of 2022.

At December 31, 2020 to the.

The year over year increase in revenue was due to higher net product sales in 2023, resulting from prescription sales through pharmacy service partnerships with ASP in pharmacy, as Dave and Chris elaborated earlier recapture prescription sent to retail pharmacies that previously didn't have the ability to order product.

As of December 31, 2023, cash and cash equivalents were approximately $4 7 million. We believe based on our current operating plan with the existing cash cash equivalents, including the proceeds from the recent public offering that we executed in February of 2024, as well as future future cash flows from net product sales of promoting that will be sufficient.

And sharing with providers in the GI community the exceptional head to head real world data comparing <unk> to oral metoclopramide shown improvements in fewer hospitalizations and ER visits with promoting compared to oral.

Research and development centers totaled 23000 for the fourth quarter of 2022 compared to <unk> 27 for the fourth quarter of 2023.

To fund our operations into the fourth quarter of 2024.

While we are seeing new prescription trends increasing through February beginning of the year typically has higher co pay expenses for the company to cover and other discounting because of the changing coverage for patients and patients needing to meet their deductibles and the renewals of prior authorizations recently, we've also been watching the situation with change healthcare closer.

Full year 2022 research and development expenses were approximately <unk> two.

$2 million compared with approximately $3 million for the prior year.

<unk>.

See what impact this may have on our business it is clear that.

All health care entities were impacted by this not just pharmaceutical companies or revoke although evoke in Arizona, we're able to put a solution in place within a week of the change healthcare outage. We are hearing from our partners and other industry experts that providers inability to check patient eligibility benefits or submit claims has started.

22 <unk>.

The impact of new prescribing across the brands based support.

And.

Lastly.

Total operating expenses for the fourth quarter of 2023 were approximately $3 6 million compared with $2 3 million for the same period of 2022 and for the year ended December 31, 2023 total operating expenses were approximately $12 6 million compared with approximately $10 3 million for the full year of 2022.

A new opportunity that has gained some attention over the last several months with the ongoing interest in <unk>, one agonists glucagon like peptide one agonist.

Currently on the market and the association with Gastroenterology side effects attributed to those products, particularly gastroparesis.

We believe the increased use of <unk>, one agonist could increase the number of people suffering from Gastroparesis.

<unk> one receptor agonist affects glucose control for several mechanisms, including enhancement of glucose dependent insulin secretion.

<unk> gastric emptying and reduction of postprandial glucose and food intake.

Hello, gastric emptying may potentially lead to symptoms similar to gastroparesis, although definitive evidenced attributing <unk> one agonist, specifically, causing Gastroparesis is limited a recent study published in the journal of American Medical Association found that the use of <unk> for weight loss compared with the use of <unk>.

To fund our operations into the fourth quarter of 2024.

And patients needing to meet their deductibles and the renewals of prior authorizations reasonably we've also been watching the situation with change healthcare closely.

The appropriate naltrexone was associated with increased risk of pancreatitis bowel obstruction and gastroparesis.

See what impact this may have on our business it is clear that.

While these adverse events from <unk>.

All health care entities were impacted by this not just pharmaceutical companies or revoke.

Have been relatively rare, even a 1% incidence rate could have an impact on the gastroparesis market considering the gigantic population very large population expected to be treated with <unk> in the future.

Although evoke in Arizona, we're able to put a solution in place within a week of the change healthcare outage. We are hearing from our partners and other industry experts that providers inability to check patient eligibility benefits or submit claims has started to impact new prescribing across the brand based support.

And with that operator, we've completed our formal remarks, I will turn it over for questions.

Thank you Sir at this time, if you wish to ask a question. Please press star one on your telephone keypad, you may remove yourself from the queue by pressing star two.

And.

Lastly.

A new opportunity that has gained some attention over the last several months with the ongoing interest in <unk>, one agonists, while glucagon like peptide one agonists.

We do have a question from.

Currently on the market and the association with Gastroenterology side effects attributed to those products, particularly gastroparesis we.

Again, Jim from Laidlaw and company.

Good afternoon, and thanks for taking the question and congrats on the performance.

We believe the increased use of <unk>, one agonist could increase the number of people suffering from Gastroparesis.

Sure.

Is that towards the short question here.

First one is you mentioned about the Aspen pharmacy service.

<unk>, one receptor agonist affects glucose control through several mechanisms, including enhancement of glucose dependent insulin accretion.

Has.

Improved.

Load gastric emptying and reduction of postprandial glucose and food intake.

Distribution.

You have elaborate some but could you.

Hello, gastric emptying may potentially lead to symptoms similar to gastroparesis, although definitive evidence attributing <unk>, one agonist, specifically, causing Gastroparesis is limited a recent study published in the journal of American Medical Association found that they use the guilty one or weight loss compared with the use of <unk>.

There's a little bit more color.

How that will impact.

2024 versus 2023.

Based on your estimates.

Chris you want to take that.

Sure and thanks for the question so.

The appropriate naltrexone was associated with increased risk of pancreatitis bowel obstruction and gastroparesis.

Aspen delivers a couple of different.

Aspects of their platform that can help us one is.

While these adverse events from <unk>.

Through efficient communication with patients they get more patients to return phone calls and result in fewer abandonment of prescriptions.

Have been relatively rare, even a 1% incidence rate could have an impact on the gastroparesis market considering the gigantic populating very large population expected to be treated with <unk> in the future.

So that is a key to in fact, that's the largest reason for.

And with that operator, we've completed our formal remarks, I will turn it over for questions.

Leakage in our in our prescription funnel those patients not calling us back so they will significantly reduce that the second thing is is that they had strong relationships with payers and are integrated into those payer systems. So the efficiency.

Thank you Sir at this time, if you wish to ask a question. Please press star one on your telephone keypad, you may remove yourself from the queue by pressing star two.

And processing prescriptions and electronic prior authorizations is yielding a higher percentage of prescriptions.

We do have a question from.

Jim from Laidlaw and company.

<unk> approval for those prior authorizations and again there is approval in prior authorizations mean increased reimbursed scripts, which certainly will help us from a revenue perspective.

Good afternoon, and thanks for taking the question and congrats on the performance.

Yes.

But.

The fuel question.

And the last piece.

First one is you mentioned about the Aspen pharmacy service.

And one that we're excited about too is the fact that we are going to be adding pharmacies to our network through the Aspen network of pharmacies, which will give us access to pharmacies that has.

Has.

Improved.

Distribution.

You have elaborated some but could you.

There's a little bit more color.

Strong contract with payers, including Medicaid.

How that will impact.

And Medicaid.

Plenty plenty for Paul versus 'twenty three.

<unk> is an important aspect for our growth in 2024.

Based on your estimates.

And maybe just tack on this.

Chris you want to take that.

Here in terms of the pharmacy.

Sure and thanks for the question.

What kind of the distributions geographic.

<unk>.

Aspen delivers a couple of different.

<unk> is the United States more local regional or more internationally.

Aspects of their platform that can help us one is.

Our current pharmacies have coverage in all.

Through efficient communication with patients they get more patients to return phone calls and result in fewer abandoned prescriptions.

Figures 50 states. So we have.

And good coverage from that perspective.

So that is a key to in fact, that's the largest reason for leakage.

As you can imagine some states.

In terms of Medicaid require you to have a local pharmacy in order to distribute the product. So that's why adding pharmacies are going to be important to us and certainty of those states we can't.

<unk> in our in our prescription bundled those patients not calling us back so they will significantly reduce that the second thing is that they have strong relationships with payers and are integrated into those payer systems. So the efficiency.

Deliver a prescription even though we might have approval to do so so we're strategically adding pharmacies that will augment our coverage, especially in Medicare and Medicare and Medicaid.

And processing prescriptions and electronic prior authorizations.

Yielding a higher percentage of prescriptions.

Okay, Great and then maybe the last question here.

Again approval for those prior authorization and again there is approval in prior authorizations mean increased reimbursed scripts, which certainly will help us from a revenue perspective.

In terms of 14 related sales.

Guidance for 2024 should we consider that a little bit conservative or how should we overall think about this guidance.

And the last piece.

One that we're excited about too is the fact that we are going to be adding pharmacies to our network.

<unk>.

Yes, yes. This is Matt.

I guess, we're not going to comment further on.

Through the Aspen network of pharmacies, which will give us access to <unk>.

For the guidance, we're putting that out there in terms of what we believe is doable, what we've seen in terms of growth in the past.

Pharmacies that have.

Strong contracts with payers, including Medicaid.

We believe that there is as Chris said earlier unlimited opportunity at this point, we haven't seen any curtailing of physician's interests.

And Medicaid.

<unk> is an important aspect for our growth in 2024.

We are in no way, reaching some sort of significant market share yet with any of the targets that were currently meeting with so.

And maybe just back on the cost will be.

In terms of the pharmacy.

What kind of a distribution geographic distribution in the United States more local regional or more internationally.

We think this is appropriate and very doable network, providing guidance at this time.

Okay, maybe just kind of a lot more question here.

At <unk> one.

Our current pharmacies have coverage in all.

Got that.

Gastroparesis is a one off expected.

This 50 states so we have.

Sorry effects, just curious up to now have you ever treat a patient that actually.

And good coverage from that perspective.

As you can imagine some states.

Also taking a prescription.

In terms of Medicaid require you to have a local pharmacy in order to distribute the product.

<unk>, along with it that would be appeal or a drug effect.

So that's why adding pharmacies youre going to be important to us and certain of those states we can't.

Yes, so yes.

Question I really appreciate your opening this up.

I think it's really important for people to understand that <unk> is one of the key mechanisms of action.

Deliver a prescription even though we might have approval to do so so we're strategically adding pharmacies that will augment our average, especially in Medicare and Medicare and Medicaid.

Several different things related to the Thai curtailing sort of that the cravings other thing, but it does also clearly slow down the Gi track and by definition delayed gastric emptying that is what gastroparesis is so.

Yes.

Okay, Great and then maybe the last question here in terms of sales.

Our.

Guidance for 2024.

Whether or not patients who are mostly diabetic and thats. What the original indication was floor had gastroparesis beforehand very mild perhaps in this.

That's a little bit conservative or how should we overall think about deciding.

Yeah, Yeah, Matt, Yes, I guess, we're not going to comment further on.

Additionally, the guilty one sort of unmask or exacerbated those issues, we're not certain exactly.

Any further guidance, we're putting that out there in terms of what we believe is doable, what we've seen in terms of growth in the past.

And then in or it would be completely de novo new patients coming on with US we have read stories online of some persons, claiming that it's totally de novo they had no problems beforehand.

We believe that there is as Chris said earlier unlimited opportunity at this point, we haven't seen any curtailing of physician interest.

I still think it's just early days around that and then in terms of whether or not.

We're in no way, reaching some sort of significant market share yet.

<unk> has been used with any of these patients.

With any of the targets that were currently meeting with so.

Of course, we're not promoting or anything of that nature, we do receive prescriptions from physicians and will pursue authorization for whatever reason they so choose to write it for.

We think this is appropriate and very doable for us.

Finding guidance at the time.

Okay. Maybe just has a lot more question here as you mentioned about the GOP one.

I myself happened too.

The nurse practitioner, who did have significant symptoms associated with our own treatment of herself will go away.

Drop that guests are pleased to see for one of expected.

Sorry.

Just curious <unk> now have you ever treat a patient that activity.

And use <unk> to treat herself and her symptoms with that.

So taking a prescription of <unk>.

That was her decision we found out after the fact, so and we also are hearing from physicians at the conferences, they're asking questions about utilizing promoting to help patients with these problems because they do either do have gastroparesis or mimics it very very.

<unk> along with it that would be a few or no.

Thanks.

Yeah, so great.

Great question I really appreciate your opening this up.

I think it's really important that people understand that <unk> is one of the key mechanisms of action.

Keenly so.

Are things related to the tidy curtailing sort of the cravings other things, but it does also clearly slow down the Gi track and by definition delayed gastric emptying that is what gastroparesis is so.

And I think physicians are starting to find their own ways to deal with these problems, which may impact again be gastroparesis.

Yes. This is Dave just one thing I pointed out. So this was not in our forecast assumptions for 2024.

Whether or not patients who are mostly diabetic and thats. What the original indication was floor had gastroparesis beforehand very mild perhaps in this.

Or does it just be upside so I want to make sure that's clear as well.

Okay, that's great and again congrats on.

Additionally, the guilty one sort of unmask or exacerbated those issues, we're not certain exactly.

But.

A nice portfolio so far.

Thank you. Thank you.

And then in or that would be completed de novo new patients coming on with US we have read stories online of some persons, claiming that they're it's totally de novo they had no problems beforehand.

This concludes the Q&A portion of today's call I would now like to turn the call back over to Matt Donofrio for any additional or closing remarks.

I still think it's just early days around that and then in terms of whether or not <unk>.

Yes, Thank you well building on the momentum from 2023, our guidance for net revenue again is that $14 million target for 2024 and.

<unk> has been used with any of these patients.

Of course, we're not promoting or anything of that nature.

And that represents nearly a three fold increase from last year. This forecast is supported by our.

Do we see prescriptions from physicians and will pursue authorization for whatever reason they so choose to write it for.

Our strategy the investments and has been central to strengthening health care provider belief in the value of promoting.

I myself happen too.

Again, we continue to strive for improved execution, and the breadth and depth of prescription rates, while continuing to invest in the evidence that supports two mortgages outstanding brand.

Earth practitioner, who did have significant symptoms associated with our own treatment of herself will go away.

We look forward to sharing our progress over the course of the year and really appreciate you all for your continued support.

And use <unk> to treat herself and her symptoms with that.

That was her decision we found out after the fact, so and we also are hearing from physicians at the conferences. They are asking questions about utilizing promoting to help patients with these problems because they do either do have gastroparesis, where it mimics it very very.

Thank you very much and we'll close this time operator.

Thank you Sir this concludes the Q I'm sorry. This concludes today's evoke pharma fourth quarter and full year 23 earnings call and webcast. You may disconnect. Your lines at this time and have a wonderful day.

Keenly so.

I think physicians are starting to find their own way to deal with these problems, which may impact again be gastroparesis.

Yes. This is Dave just one thing I pointed out. So this was not in our forecast assumptions for 2024.

Those would just be upside, but we want to make sure that's clear as well.

Okay.

Great and again congrats on.

But.

And now for closing remarks.

Thank you. Thank you.

This concludes the Q&A portion of today's call I would now like to turn the call back over to Matt Donofrio plenty of additional or closing remarks.

Yes, Thank you well building on the momentum from 2023, our guidance for net revenue again is that $14 million target for 2024.

That represents nearly a three fold increase from last year. This forecast is supported by our our strategy the investments and that's been central and.

Strengthening health care provider belief in the value of promoting again, we continue to strive for improved execution on the breadth and depth of prescription rates, while continuing to invest in the evidence that supports two mortgages outstanding brand.

We look forward to sharing our progress over the course of the year and really appreciate you all for your continued support.

Thank you very much and will cause the same operator.

Okay.

Thank you Sir this concludes the Q I'm sorry. This concludes today's evoke pharma fourth quarter and full year 'twenty three three earnings call and webcast. You may disconnect. Your lines at this time and have a wonderful day.

[music].

Uh huh.

[music].

Yes.

Q4 2023 Evoke Pharma Inc Earnings Call

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