Q4 2021 Evoke Pharma Inc Earnings Call
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This is the operator today's call is scheduled to begin momentarily.
That time realize they can be placed on music hold thank you for your patience.
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Good day, ladies and gentlemen, and welcome to evoke Parma incorporate.
Fourth quarter and fiscal year 2021 earnings conference call. My name is Jenny and it wont be a conflict Jaffrey X date.
I think what I'd like now like to turn the presentation ever changed your hedge book.
Daniel Hangzhou watching Investor Relations for Evo. Please proceed sir.
Good afternoon, and thank you for participating in evoke pharma conference call today with me today are Dave Gardner evokes Chief Executive Officer, Chris question buried your Moody's Chief Commercial officer for members Sona and Matt Donofrio evokes Chief business 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 10-K report and press release are also available on evokes website.
In addition, this conference call is being webcast through the Companys website and will be archived for 30 days.
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Yeah.
Thank you <unk> Italia welcome to Radians fourth quarter 2021 earnings.
Good day, ladies and gentlemen, and welcome to evoke pharma incorporate.
Fourth quarter and fiscal year 2021 earnings conference call. My name is Jenny and it won't be a conflict Jacquie X date is costing quoted I'd like now like to turn the presentation over to you that you're hedged for Daniel.
Daniel Hi, Joe watching Investor Relations for <unk>. Please proceed sir.
Good afternoon, and thank you for participating in evoke pharma conference call today with me today are Dave Gardner evokes Chief Executive Officer, Chris question, Barry <unk>, Chief commercial officer from ever Sona, and Matt DNR Krio evokes chief business 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 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 10-K report and press release are also available on evokes website and.
In addition, this conference call is being webcast through the company's website and will be archived for 30 days.
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Yeah.
Yes.
Yeah.
Yeah.
Okay.
Okay.
Ladies and gentlemen, todays conference will resume momentarily please hold.
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And we now have today's management on the call. Please go ahead.
Good afternoon, and thank you for participating any books farmers conference call today with me today are Dave gone year evokes Chief Executive Officer, Chris question, Barry You, Moody's Chief commercial officer from ever Sona and Matt Donofrio.
Evokes chief business 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 dotcom we.
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 Companys 10-K report and press release are also available on evokes website.
In addition, this conference call is being webcast through the company's website and will be archived for 30 days. Please.
Please note that certain information discussed on the call today is covered under the Safe Harbor provisions of the 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.
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 in previous filings.
This conference call contains time sensitive information that is accurate only as of the date of this live broadcast.
<unk> undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this conference call with that I would now like to turn the call over to Dean Garden here Dave.
Thank you Danielle.
Sorry for the delay with the telephone Teleconferencing company, we apologize, but we do welcome you to evoke <unk> fourth quarter and fiscal year 2021 financial results conference call and I am happy to report that by several key metrics. We showed very good progress in creating important value catalysts during 2021.
Especially in the fourth quarter and thus far in 2000 22022.
Thankfully the recent easing of Covid restrictions and societies early attempts to return to normalcy played a major role in fueling these value enhancing indicators.
Let's start with the concrete results that give us confidence or not prescription sales increased by 46% to approximately $360000 in the fourth quarter of 2021 from 247000.
<unk> dollars in the third quarter.
Net prescription sales exclude sales to third parties for research purposes.
In addition, the number of <unk> cumulative prescribers increased by 23% from September 30 to December 31, 2021 to 425, new health care providers or Hcp's for short.
It's more at the end of February of this year that number has reached 499 cumulative prescribers.
We're also seeing a positive trend in future indicators that point to potentially stronger sales results in 2022.
These include <unk>.
Higher number of in person meetings with health care.
Professionals and many areas of the U S. We expect these vital encounters with HCP to increase throughout 2022, assuming COVID-19 becomes endemic and Omicron variant continues to recede. We believe the more face time with Hcp's equals higher net prescription sales.
Now any new Covid variance in the future could reverse this trend, but with what we know now we're very optimistic.
Another future indicators, the judicious increase in <unk> samples distributed to health care providers.
Converting to higher prescription sales.
<unk> are most effective in allowing for patients and physicians to experience the experience when sales professionals can remind hep's of its availability face to face.
This has been seen with higher prescriptions per physician with samples over those without a sample and this was confirmed at our second national sales meeting held last month, which provided us with valuable insights on the positive trends, we're seeing in the field.
On today's call will highlight the progress we've seen in making gymboree more widely accessible to patients and physicians through new and updated initiatives as well as the corporate initiatives, we are executing to support our commercial business through 2022.
Recently, we reached key validation milestones in both the awareness and adoption of <unk>. In addition to mapping out the company's long term strategic goals specifically the extension of our strategic collaboration with <unk> to commercialize and distribute <unk> within the U S.
Moreover, other key accomplishments in activity over the past year include the <unk> follow on offering we completed in January 2021, and the strength and the strengthening of our intellectual property estate.
A clear affirmation of <unk> potential and the Gastroparesis market was the extension of our commercialization partnership with ever Sada, which we announced last month.
Under the extended agreement evoke an ever side, we will continue to collaborate on the commercialization and distribution of <unk> in the U S to the end of 2026.
As a review of the original agreement signed in January 2020 specified that evoke would retain ownership of the <unk>, new drug application as well as legal regulatory and manufacturing responsibilities.
The agreement calls for ever sounded to utilize its internal sales organization and other commercial functions from market access marketing distribution and other patient support services.
We record sales for chimbote, and evoke retains more than 80% of the net product profits once each party's costs are reimbursed.
The amended agreement extension increase as a percentage of the net profit retained by evoke and accelerates the reimbursement of commercialization cost ever signed after the product breaks even on a monthly basis.
The initial term provided in the original agreement was five years following FDA approval, which would have been June 2025.
This amendment will extend the term of the agreement by more than 18 months through December 31 2026.
This amendment was sought after by ever Sona and we interpret is showing continued belief in the opportunity for <unk> and our partnership.
Regarding the market opportunity for <unk>.
The independent market research data claims that potential diabetic gastroparesis or BGP patient pool in the U S is approximately $12 million to $16 million adults with about $2 6 million with diagnosed DGB.
A significant significant portion of those seeking treatment are prescribed medical provide administered orally or by IV.
Currently we estimate approximately 3 million prescriptions the medical from mice are dispensed annually in the U S, which makes up only a portion of the total addressable market.
We firmly believe that the non oral delivery is a critical differentiator in treating patients with the disease that can block or make absorption of oral medications unpredictable.
We are confident that this.
We are confident that this extended partnership with ever Sona will ensure that chimbote will reach patients more efficiently and ultimately revolutionize the gastroparesis treatment landscape.
Our confidence in the value and life changing benefits chimbote shared by a prominent gastroenterologists and founding member of Carolina digestive Health Associates in Charlotte North Carolina.
Dr. Fred Fowler recently said that DCP can be difficult to treat because of the disease itself can limit the effectiveness of oral treatments.
Orally administered medications can be blocked by the faulty stomach or vomited due to the symptoms often experienced by these patients.
Having a non oral alternative like <unk> allows rapid delivery of a medication that bypasses the stomach to lessen the symptoms such as abdominal pain nausea and vomiting.
Also new market research makes the case for broader acceptance of <unk> among hcp's most.
Most importantly patients described remarkable benefits after initiating the <unk> therapy.
Our conclusion from this data we believe in the long term opportunity for <unk> and are excited to continue leveraging the expertise of ever signed is ever growing 7500 person corporate organization forged motive.
Especially given their financial strength and commercialization knowhow with lifestyle science products like <unk>.
Another piece of good news that came recently was our success rate with government program access initiatives, specifically expanded Medicaid coverage.
<unk> was recently added to the New York State Medicaid program.
And as New York is a bellwether for state Medicaid programs. We are encouraged by their decision to coverage of Modi and is a testimony to our account teams who are working hard to educate payers on the burden of BGP and wide treatments, especially.
One is like <unk> are needed.
We and our ever sign up partners.
Our continuing to introduce the benefits of <unk> to various public and private insurance.
<unk> with the belief that more positive coverage decisions will be forthcoming.
With the increased access to <unk>, it's important to call out our supplementary patient support and savings programs <unk>.
Once enrolled the evoke assist program connect patients with the team of professionals, including nurses to verify insurance coverage through the proper channels confirm pharmacy orders and provide co pay assistance based upon eligibility.
There's one thing we know for sure there is an imminent need for an alternative and effective solution to gastroparesis treatment and we will exhaust all viable options to make sure Jim Modi reaches eligible patients.
Another very notable aspect of our business is the important intellectual property protection, we've built around <unk>.
Last June we announced that another patent covering methods of use for nasal delivery of metoclopramide for the treatment of Gastroparesis was listed in the Fda's Orange book publication and carry the patent turned to at least 2029.
Patents listed in the Orange book cover drugs that FDA has approved and deemed both safe and effective.
Also inclusion into the books list of patents can make it easier for us to monitor new generic drugs that can potentially arrive in the U S market and infringe on our patents.
This news was exciting for us as we continue to protect our technology for <unk> unique method of use it.
It also enhances our mission to improve the quality of life for patients suffering from DCP.
Turning now to marketing initiatives.
In June 2021, we announced the launch of the first wave of social media campaign to reach patients directly with education about BGP.
This initial wave began with two Facebook pages.
<unk> multi branded page in a diabetic gastroparesis page called PGP and me diabetic Gastroparesis support.
DTP and me as a community dedicated offerings support education and advice to millions in the U S who suffer from the symptoms of Gastroparesis the.
<unk> Facebook page allows community members to connect and find more information about managing PGP.
The <unk> Facebook page supports increasing awareness of <unk> as a persuasive nasal delivery option for patients seeking relief of their acute and recurrent diabetic gastroparesis symptoms.
Especially in cases, where oral therapies may not be effective.
Happily we have received numerous encouraging testimonials from patients and their families expressing their gratitude for life changing solutions like <unk>.
We've heard about the symptomatic relief patients are experiencing by taking demoted which is enabling patients to resume normal daily activities that each of us likely take for granted such as simply just eating a solid meal.
These heartfelt messages inspire team and their daily efforts to ensure we do our part to help ease the pain of patients and their families burdened by this disease.
Patients suffer symptoms an average of five years before they have a confirmatory diagnosis of gastroparesis.
During this time, they seek answers to the cause of their symptoms even.
Even post diagnosis patients can receive very little education support educational support from the medical community about the disease and available treatments in the strategies to manage their symptoms.
People suffering from GGP, often resort to searching online for answers and evoke intends to play a role in helping bring more information and assistance to these patients in need with our digital campaigns I described earlier.
And the process, we hope to help raise awareness of the disease and its burden on patients as well as our novel nasal delivery treatment option that may offer a benefit in cases, where oral medications are ineffective.
Her physician experience program through sampling has been a vital opportunity to provide chimbote directly to physicians, who haven't prescribed promoting.
It's also increases trial among patients with DCP, who seek an alternative approach to traditional oral medications.
Gastroenterologists frequently tell us they have moderate to high level of concern about their patients' ability to absorb oral medications and estimate that 21% to 60% of their patients with BGP may experienced this difficulty and.
And in addition about two thirds of these patients have some difficulty ingesting oral medications.
We believe that our experienced program will widen the network of physicians and patients familiar with promoting and help ensure those who suffer from GGP have access to our novel treatment.
We have worked diligently on our strategic messaging for <unk> and Excitingly last September evoke an ever sought us engage which is emphasizes marketing team.
Where core Silver award winners for automotive sales eight due to the influence influential publication P. M 360.
<unk> hundred 60, as the Premier publication from marketing decision makers, and the pharmaceutical biotech and medical device industries and our team took the podium to accept this award.
The award cited our spray to spray away campaign and was in recognition for the creative execution of the overall campaign and clarity of our message emphasizing the novel spray component of <unk> unique <unk> treatment.
This campaign reflects the insights gained from market research in patients post on social media and details symptom.
BGP and chronicle the difficulties in taking oral medications.
We look forward to continue the promotional growth of <unk> through our valued partnership with ever Sona and their talented engaged team.
And keeping our stakeholders and broader financial community abreast with our commercial progress we added supplementary investor communications events, starting with our fireside chat with key opinion leaders.
On the treatment of Gastroparesis last April and hosted in conjunction with one of our covering analysts.
We are joined by Dr. Richard Mccallum at the Division of Gastroenterology Center for Neuro, Gastroenterology, and GI motility at Texas, Texas Tech University Health Science Center.
Event included an investor Q&A session with Dr. Mccallum.
We have a similar events slated for next week on March 16th with another one of our key opinion leaders.
On the competitive landscape front, there continues to be nothing new coming to the market in the near term and leaves the gastroparesis marketplace wide open for <unk>.
Recently, Vanda pharmaceuticals announced that their investigational gasser, gastroparesis product, which was targeting to treat nausea, only failed to meet statistical significance in a phase III trial.
While not a good day for patients as they need options. It underscores the difficulty in high hurdle hurdle to bring a new gastroparesis therapy to market.
And ultimately it reinforces the achievement of <unk> and represents a preserved near and longer term value for the brand.
And lastly, we also made important changes to our board of directors in 2021.
In May we announced the appointment of Vickie Reed to the board and retirement of Ann Rhoads, who ably served on our board for more than eight years.
With her breath of extensive financial experience, Missouri shares our board Audit Committee.
Vickie Reed also.
<unk> already has also contributed significantly to our board and offered valuable insights to management.
We believe her wealth of leadership experience and financial knowledge in the biotechnology industry will help evoked maximize corporate financial performance in 2022 and beyond.
And with that I'd like to turn the call over to Chris <unk> Chris.
Sure.
Thanks, Dave.
Before I delve into the progress we made in commercializing <unk> during the fourth quarter and last fiscal year as a strategic partner I want to offer my numbers on his view on the promise, we see in <unk> and <unk> business objectives in 2022 and beyond that Dave just outlined.
<unk> see tremendous value and potential that Jim O'dea can provide for patients who suffer from diabetic gastroparesis, there's a significant unmet need for improved symptomatic relief for these patients and plainly speaking <unk> works.
We are gaining increased experience and feedback from physicians on how <unk> is a welcome addition to their treatment armamentarium.
And their patients are providing testimonials to the impact treatment with Jim <unk> is having on them.
<unk> alongside evoke remains committed to our vision that <unk> become the preferred treatment to improve symptoms of patients struggling with diabetic gastroparesis.
Intern through the commercialization of <unk> to offer these patients some hope.
And help them regain control over this disease, which as Rob them and their families of so much.
We have made steady commercial progress despite headwinds over the past 16 months and I would say we are poised to make significant progress in 2022.
In order to realize our vision for patients, which is tied to our commercial success of <unk>. We are focused on four strategic imperatives.
We must first raise awareness of <unk> and motivate patients to advocate for better diabetic gastroparesis treatment.
Positioning <unk> to health care practitioners as the best option to treat diabetic gastroparesis due to its unique nasal delivery and continue to have them gain trial and adoption.
We need to educate patient payors about gastroparesis and <unk> and help them realize that it's in everyone's interest to simplify the approval process.
And we need to improve conversion and in the fulfillment process for patients and the care team.
During today's call I will share with the advances we are making in each of these areas and then turn my focus to what is currently in the works and when you can expect from US this year.
Overall awareness of <unk> among patients is increasing and still there is significant opportunity to improve.
As Dave mentioned, we have a robust online paid search and social digital presence.
Since launch we have at <unk>.
Garnered over 22 million impressions, which are drive driving significant click through rates.
And these are at rates more than double the industry average.
Those click through rates represent engagement and interest in the brand.
In addition, our engagement level is showing great improvement over the year, specifically paid search which again in the fourth quarter was more than double the industry average.
We expect to sustain and improve on this with increasing the number of patient testimonials and making our websites even more transactional than they are today.
One such video testimonials that we have added is from an actual patient named Tammy who is a former nurse and a patient with diabetic Gastroparesis Sheila.
<unk> accounts for experienced on Genuity and how the spring worked and how they were able to do something that they hadn't been able to do in a while go out to dinner.
It down and eat.
I encourage you to watch this video and others on our <unk> homepage by visiting Www Dot <unk> or <unk> dot com.
Our ultimate goal is to see more organic mentions of genuity by providers and patients online and patients requesting Jim Modi from their hcp's.
With that our promotion to ACP is also paying dividends.
We have achieved a cumulative reach of nearly 70% of our target Acp's. Despite continued challenges to access.
When we have the opportunity to discuss <unk> mody with physicians it takes fewer than five details to prompt them to prescribe <unk> for the first time.
Cumulatively through December 2021, 746, Hep's prescribed chimbote at least once and nearly half of our prescriptions overall came from Hcp's, who had written five or more prescriptions for <unk>.
Through the end of February the number of cumulative prescribers is 941.
These actual results mirror, our market research with targeted and non targeted health care providers, which shows high and increasing awareness of <unk> among.
More than 80%.
Additionally, 88% of the 135 providers surveyed indicated that they intend to prescribe in the future.
As you might expect targeted customers have a higher intent to prescribe as evidenced by 92% of the targeted Gi has said they would prescribe.
92% of non target Gi so they would prescribe it and 80% of <unk> and 89% of nurse practitioners and physician assistance indicated they would prescribe.
When we dive deeper into the prescribing hamer behavior, we see an increase in prescribing across all lines of therapy the majority of.
Utilization of our chimbote among these physicians as in the third line position likely after an anti emetic and oral metoclopramide.
Since we since the last wave of research, we have seen an increase in utilization by 33% in the third line position.
<unk> in the third line is consistent with what we expected at launch is the majority of patients have tried multiple therapies since being diagnosed what we're pleased to see is the incremental improvements in second and even first line utilization.
<unk> target Gis their state of utilization of <unk> is six percentage as first line, 19% in second line and 33% as third line.
<unk> improvements over prior waves of research.
In practice, we see this too with Dr. Dib loves to knotty from Montgomery, Alabama, indicating that <unk> is becoming his first line agent for diabetic gastroparesis.
When we ask Hep's, which formulation of metoclopramide was most effective.
All ATP group stated that oral was the least affected and placed the nasal route of administration on par with IV medical over mine.
With this impression of efficacy the stated awareness and.
And intent to prescribe and only 14% of our current targets, having prescribed we see tremendous upside potential and intend to capitalize on this.
Beyond the numbers, we are pleased to see the increasing preference for <unk>.
Not excuse me novel nasal route of administration compared with traditional oral treatments.
We continue to hear from patients and Ecp's about the benefits of <unk> and we are using this feedback to strengthen our marketing efforts and adding to our testimonials.
Sure.
In the fourth quarter, we launched our national account team to engage insurers and payers throughout 2021, we gained significant clarity around how payers we're viewing dramatically.
Our primary goal with payers in the near term is to educate them on gastroparesis and <unk> and help them realize it's in everyone's interest to simplify the approval process for <unk> pay.
Patients with diabetic gastroparesis desperately need it.
Players are causing ER visits and hospitalizations, resulting in consuming an inordinate amount of health care resources and dollars and providers lack FDA approved options to provide moderate to severe patients really.
Payers have not had conversations about gastroparesis in decades and are open to having these discussions.
That said there are obvious focus is on prescription drug spend in spite of this our nabs are having hundreds of engagements across payers and across each of their value chains with pharmacy and medical teams with our commercial teams and others.
These conversations are beginning to uncover the gap.
And understanding among payers and also what they might need to support reducing restrictions and prior authorizations, we expected payers to make a step through oral metoclopramide before approving gene movie. We are finding a number of payers are currently requesting additional requirements.
Clinical notes to affirm need to.
Two the approval process our goal is for the payers to ease the approval.
Two simple alignment with our label indication.
This would ease access for patients and reduce workload for providers, we are seeing and gateway engagement finance starting to bear fruit. Two recent examples over the last two quarters was the decision by two state Medicaid programs, Michigan, and New York to cover Genuity.
Not only is this consistent with our goal.
But with new European a bellwether state and it encourages us that we can replicate this outcome with other payors, including government programs.
Currently we have had at least 88 plans approve at least one prescription for <unk>.
I should add that is without a single contract in place.
Of course those prescriptions.
<unk>.
Prescriptions filled nearly 80% of our prescriptions are covered by insurance with the remaining being supported by our cash pay savings program or patient assistance program.
I am encouraged that our net realized price continues to improve from quarter to quarter.
In fact fourth quarter net realized price was nearly 5% improvement over full year.
There are a couple of positive trends to see here one we have more cover prescriptions too we're improving our approval rates for prior authorizations as well as winning higher percentage of our appeals and three our refill rates are improving.
As indicated before refill rates are an important indicator for us.
A leading indicator of efficacy and persistency on therapy.
Refill rates in the fourth quarter were 71% overall versus 63% in the third quarter with improvements seen in most refills from the second fill to the sixth refill compared to full year rates.
Overall, we made steady progress commercially in 2021 with each quarter, improving in leading and lagging performance metrics versus the last.
We are gaining momentum and looking towards a strong.
2022.
Some top line initiatives you can expect from a vote in support of <unk> in 2022 include <unk>.
Piloting a new electronic medical record distribution program that is more automated and within the workflow of Hcp's. We have initiated this pilot at the end of January .
In six of our most productive territories initial signs are very encouraging with a meaningful uptick in prescriptions higher percent of prior authorization approvals and therefore more patients receiving dispense product.
This pilot is planned to run through April and if we hit our metrics, we will expand to all geographies.
Physician reception has been very favorable also on the program to date.
We intend to increase our peer to peer speaker programs.
We're expanding this program based on the success, we had in the fourth quarter a.
A significant subset of Hcp's learn from their peers and our content and actual paste patient cases that we presented through our speakers are proving to be compelling.
We will likely ramp up our speaker programs towards the end of this quarter and being full deployment in the second.
Key opinion leader engagement and Congress activities will increase significantly also with more exhibiting planned programming and scientific discourse.
In fourth quarter <unk> participated in the ACG, which was a significant success in one of our first and likely most important congresses.
Of the year.
This year, our most important Congress will be at digestive disease week in May.
This program will be in San Diego, and we plan to have a significant presence.
Data generation will also be a key activity for us. This year, we will prioritize publication of past clinical studies and look to generate new evidence to support Genuity using closed claim database studies or physician experience to provide insight into how Germany may offset healthcare utilization and improved disease.
<unk>.
We will also focus on supporting the safety position of metoclopramide and <unk> for appropriate patients.
We have uncovered there is still significant hesitancy with metoclopramide use.
Leveraging the <unk> health markets can database, we were able to examine the association between tardive dyskinesia and the risk factors such as age sex underlying medical diagnosis and exposure derives including medical open mind.
These data were submitted to digestive disease week, or <unk>, CDW and accepted as a poster with distinction and award provided to only the top 10% of submissions. We look forward to updating the medical literature on the risk of tardive dyskinesia and educating providers.
Important risk factors to avoid when utilizing Jim movie.
We also have plans to expand our digital presence and effectiveness. Although we are proud of our initial progress. We believe there is untapped potential to reach and activate patients.
With the recent $1 billion acquisition of Intouch Agency <unk>, we look forward to accessing their insights and capabilities to further our goal.
In addition, we will continue our sampling program as Dave mentioned is increasing patient trial for <unk>.
In addition, we are seeing increased access in detail activities to those hcp's that we have detailed and sampled versus those that we have only detailed.
Data also indicate that Acp's, who have been provided a sample are nine times more likely to prescribe <unk>.
We will continue to refine our messaging and creative campaign to account for the insight we are learning.
Just two weeks ago, we had a very successful national sales meeting, where we debuted new more focused message on <unk> differentiation from oral <unk> efficacy and safety for <unk>. The field is trained highly.
<unk> and currently leveraging the training with customers to strong effect.
Lastly, we are exploring alternate channels to reach patients and provide them with access to consider whether <unk> is appropriate for them.
So many patients are dissatisfied with their current treatments and therapies.
They are searching for answers and solutions, including looking online and we believe these patients are ready to make a change and could benefit from a product like <unk>.
We have already initiated the planning and starting acted on started acting on some of these initiatives I'm very pleased to report that this last month February was our strongest month for both prescriptions.
And dispenses by over 25% versus January .
Our last best month.
With that I will end by restating, we continue to be encouraged by our progress. We are excited about our plans and focus for 2022 and believe they will lead to accelerated adoption of patients on <unk> and commercial success.
Now I'll turn the call over to Matt for the financials and other updates.
Thanks, Chris I once again, thank you all for joining this afternoon.
I'll jump straight to the financials for the fourth quarter and full year end 2021 results as Dave mentioned for the fourth quarter of 2021 net sales of approximately 361000 and the net loss was approximately $2 1 million or <unk> <unk> per share compared with 23000, and a net loss of approximately $2 3 million or <unk> <unk> per share for 2000.
25th.
For fiscal year ended December 31, 2021, net sales were approximately $1 6 million of which approximately 718000 consistent energy module sales to third parties for research purposes.
The net loss was approximately $8 5 million or <unk> 27 per share compared with a net loss of approximately $13 2 million or 50.
Two cents per share in year prior.
Research and development expenses totaled 36000 for the fourth quarter of 2021, compared with <unk> 1 million for the fourth quarter of 2020.
Full year 2021, R&D expenses were approximately <unk> 6 million compared with $6 6 million for the prior year.
Since the FDA approval and promoting June of 2020 research and development costs have decreased and shifted to commercialization and selling costs.
For the fourth quarter 2021, selling general and administrative expenses were approximately $1 7 million compared with 2 million fourth quarter of 2020.
For the year ended December 31, 2020, SG&A expenses were approximately $8 9 million compared with $6 4 million for the full year 2020.
Selling general and administrative expenses consisted primarily of salaries and related benefits, including stock based compensation, we expect that SG&A expenses will increase in the future as we continue to progress with the commercialization of <unk> and reimburse Arizona from the net profit attained from the sales locomotive.
Total operating expenses for the fourth quarter of 2021 were approximately $1 9 million compared with $2 2 million for the same period of 2020 for.
For the year ended December 31, 2021, total operating expenses were approximately $9 8 million compared with $13 1 million for the full year of 2020.
As of December 31, 2021, the company's cash and cash equivalents were approximately $9 1 million. We believe based on our current operating plan that our existing cash and cash equivalents as well as future cash flows from net sales of <unk> will be sufficient to fund our operations into the first quarter of 2023.
And with that we'll now open up for <unk>.
Hope the call for questions operator.
Your first question is from.
And with Laidlaw.
Thanks for.
Taking the questions and congrats on.
The progress so far.
My first question.
<unk>.
Simply it seems to be effective.
First of all.
What level of expansion will continue going forward.
Secondly, what's the metrics key gauging.
Yes.
Simply it is.
Paul.
Hey, Thanks, Joe Im going to turn the call over the Chris It's a good one we appreciate that so Chris.
Yes, I mean, I think we kind of need to see growing up prescriptions that will help us to understand what we're looking at a number of different metrics that position uptake line expansion.
Of HCP prescribing.
So we're looking at those numbers now we're doing it.
Analysis, and we know where we would look to expand.
So the opportunity arise.
Initially we targeted physicians, who have not prescribed promoted also we didn't want to flood the marketplace.
Overall with samples.
But as Chris said, we filed with the physicians that had been samples versus those who have not we've definitely seen an increase in prescribing from those positions.
Okay.
And secondly, the housekeeping questions.
Fourth quarter G&A.
G&A numbers seems lower than the previous quarter.
Should we consider that to be a trend.
2022, or one five.
Situations.
Yes. This is Matt good question.
No I just think in general we've.
<unk> been very frugal.
Much as we possibly can wherever we can over the course of the lifeblood of the company.
We did have a little bit lighter last quarter, but we would consider.
Not being continuous shall we say I think.
Somewhere in that prior range is probably more appropriate.
Okay.
Maybe the last question I'll get back in queue, which is that.
Linda.
Hey al.
Unfortunately, the overall, what do you see the current sort of the competitive landscape, particularly in terms of.
Hey, Bob.
Right.
And how.
How much.
Yes.
Leeway you guys may have.
If some of those.
I'll take fruition.
Thanks.
Yeah.
Unfortunately for patients there is.
There is nothing in the near term that we're aware of.
The failed vanda.
Trial was when they were looking just at nausea relief for Gastroparesis and they were still not able to reach that.
Milestone of a statistical significance and.
And so that was the most near term product.
Everything else that seems to be in development.
Hasnt, even started phase III trials, yet so we're looking at a pretty wide open path going forward without competition.
It's bad for patients it would have a nice to have more people talking about the product as well get some more.
Discussions on Gastroparesis is out there.
I said earlier it does help our runway going forward with no competition. So.
Like I said unfortunately for patients but.
It's.
Nothing is really coming.
And maybe just a couple more comments to that.
For our trials are definitely efficacy trials, there were a couple of years or longer each.
And it's not because theres not a lot of patients out there just because theres, so frail and on so many different medications, it's difficult to find patients that want to offer to go off of their current medications get sick and then go on to either active or placebo. So.
It's just very unfortunate.
That you are trying to help.
Okay, Great that's very very helpful.
Get back to the queue right now.
Thanks, Joe.
Your next question is from Mitchell Kapoor of Wainwright.
Hi, there thanks for taking the questions.
First one is I was wondering if you could talk about the retail rates.
Quarter the trend in the number of refills, the average patient might be having and how that matches up with your expectations.
So thank you mentioned this is Chris I. Appreciate the question, we're actually looking at that pretty closely.
And the average number of fills that a patient is having is increasing as well so.
In prior quarters, we were at two five or around two and a half.
A therapy per patient and we're now just over three.
Over the course of the subsequent quarter. So we see this increasing.
By increasing the number of months on therapy Thats, an indicator that the product the patients are staying on product and the product is working for them.
Right now we expect over the course of this year to continue to see.
That months on therapy expand.
We have a lot of patients that have recently come on so they only have their initial course of therapy and we have many patients that are on two and three months, but there's a long tail. So theres a lot of patients that have been on 456 after 12 months of therapy on <unk>.
So as we continue to gain experience as patients tend to continue.
Continue to drive the money, we expect this number to increase.
Okay, Great and then.
I was wondering if you could elaborate on what you think.
The locations of the DW presentation on rethinking tardive dyskinesia might be and then if you could just talk about how this message.
Will ultimately get to the physician.
Yes, that's a great question, we're excited about the data that ever side of the team was able to.
Obtained through some significant analysis and then to be accepted by GW is a poster of distinction as a nice honor as well.
Tardive dyskinesia is always been associated and discussed with medical providers and it prevents some physicians from prescribing the product. They are taught in medical school may be cautious of medical from HUD code because a part of.
And the literature has stated in the past that anywhere between 10% of patients may experience target, but what the real world data is shown here is far less.
So we think a message of continue.
Continuing to show the safety of the product and how the safety of the product as such.
<unk> piece of it.
For physicians and for patients we think it will bring very loudly.
With prescribing physicians and patients.
So once those data are published through the initial poster at GW and we expect that this likely will be a presentation. There as well. We also are currently developing a manuscript that we're going to be submitting two prominent gastroenterology journal.
And so we have four of our gastro neurology key opinion leaders that are working on this with us.
From very noted institutions across the U S and luminaries within Gastroparesis as well as a prominent neurology neurologist, who has a movement disorder specialists and so we believe that the data being published at DW being published and.
In a journal as well as leveraging the Kols will allow us to <unk>.
First to get the information out into.
And to the public and into the medical literature to update the team and given the fact that there is not much discussion around.
Our new around Gastroparesis. This is definitely going to be new information and I expect that gastroenterologist themselves will be picking this up and incorporating their own presentations.
Depending upon how this goes we also have an opportunity to potentially promote these data.
Assuming that.
We can kind of work through our internal processes to do so so it gives us a great opportunity to update the medical literature.
And in addition, and this is just just providing context on the true rates of tardive dyskinesia and the largest such database in the us it.
It gives us an opportunity to help providers to understand which patients to avoid so where not only are we going to be updating the medical literature, but we're actually going to be doing good by helping providers to understand which patients in which situations. They shouldnt be prescribing metoclopramide too and I think that will actually.
<unk>.
Tremendous value for us as a company and our brand.
Great. Thank you very much for the detailed answer.
Okay.
Your next question is a follow up from Yale Jen of Laidlaw.
Okay. Thanks, a lot appreciate it ticked up on off just two quick ones. The first one is that.
Do you have both the Michigan and new.
New York date got the Medicaid.
Or just.
New York State.
So it's both.
Michigan State, Michigan, and New York are there are other states also are improving prescriptions for <unk>. So those are just two recent ones. So we have.
Prescription that have gone through Connecticut, New York, New Jersey, we have gone somewhat gone through Florida, and even in California. So those are just two of the more recent ones.
But the approval in those two states are important for us.
Okay, and maybe just two quick follow ups one is that.
In terms of the Medicare.
What type of effort at this point you will have to pursue.
To that end.
<unk>.
Yes, so Medicare obviously is an important patient.
Patient population for us what I would say is about 25%.
Of our prescriptions that are currently.
Covered or through Medicare. So we are seeing prescriptions that.
That are going through and being covered by Medicare So thats again.
First point, that's without any supplemental rebates or contracts.
Due to this.
Insurers that have those Medicare plans. The second thing is our national account team is having conversations with the.
The insurers and payers that do provide Medicare part D insurance to patients and so those discussions are ongoing and hopefully what we'll do is replicate what we're seeing in Medicaid.
<unk> like New York and Michigan.
And just just a quick point on that the kind of coverage in New York as an example.
It is actually with very limited restrictions.
And to our label indication, which is kind of what our stated goal is so again, what we're doing is hopeful that our education of Payors and underscoring the pipe that these patients have and bringing to life.
Cost that these patients represent to these plans will help them to see that this is unnecessarily treatment.
Okay, great and thanks for taking the question and congrats.
Yeah.
There are no further questions I will turn the call back over to Mr. Gardner for closing remarks.
Alright, thank you.
Just wanted to reiterate what I said at the start of the call. We believe we are beginning to see tangible value enhancing benefits of our business strategy overall, and specifically the value of <unk> for those who suffer from gastroparesis.
Although these are early indicators, it's gratifying to report what we see as numerous data points and market conditions that could signal a lower longer term success for evoke and our shareholders and so we look forward to continuing to provide updates with overall progress in what we are observing in the.
Thank you very much.
That does conclude today's conference you may now disconnect.
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