Please stand by. Your program is about to begin. [Operator Instructions] Good afternoon and welcome to the Evoke Pharma First Quarter 2022 Earnings Conference Call. Currently all callers have been placed in listen-only mode and following management's prepared remarks, the call will be open up for questions.
[Operator Instructions] Please be advised that today's call is being recorded. I would like to turn the call over to Daniel Kontoh-Boateng. Thank you. You may begin..
Good afternoon and thank you for participating in Evoke Pharma's conference call today. With me today are David Gonyer, Evoke's Chief Executive Officer, Chris Quesenberry, Gimoti’s Chief Commercial Officer from EVERSANA, and Matthew D’Onofrio, Evoke's 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 evokepharma.com. We encourage everyone to read today's press release as well as Evoke's quarterly report on Form 10-Q new, which is now filed with the SEC. The company's 10-Q report and press release are also available on Evoke's website.
In addition, this conference call is being webcast through the company's website will be archived for 30 days. Please note that certain information discussed on the call today is covered under The Safe Harbor provisions of the Private Securities Litigations 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 Evoke's press releases and SEC filings, including its annual report on Form 10-K and subsequent filings. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast.
Evoke 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 David Gonyer.
Dave?.
Thank you, Daniel. Welcome to Evoke Pharma 's first quarter 2022 financial results conference call. I'll be updating everyone on key developments that occurred during the quarter ended March 31st and thus far in Q2. I will then review some first quarter numbers and other metrics before turning the call over to Chris.
First and very important, on April 27th, we announced that Evoke was granted new drug product exclusivity by FDA for Gimoti. This provides exclusivity for Gimoti marketing rights for three years from the original date of the approval under the Hatch-Waxman Act and protects Gimoti from generic competition.
These FDA marketing exclusivity rights further established our proprietary concept of delivering an effective medication through the nasal pathway for the treatment of symptoms associated with diabetic gastroparesis.
Gimoti's marketing exclusivity along with other factors I'll discuss in a moment, will enable us to continue our mission of getting Gimoti to more patients who may benefit from our novel solution. I want to also add that in addition to the FDA granted market exclusivity, Evoke maintains a strong intellectual property estate.
We currently have two Orange Book-listed patents under the title ''Nasal Formulation of Metoclopramide '' that expire in 2029 and 2030. Evoke has been granted patents in the EU, Japan, and Mexico, with coverage until 2032. And furthermore, we have other pending applications with individual exploration dates and if approved of 2032, 2037, and 2038.
As a commercial stage company with a novel and clinically proven product, we proactively and aggressively protect our intellectual property.
Concurrent to our efforts to fortify Gimoti's intellectual property estate, a critical element to growing our patient population, we're also expanding patient access with new channel sales partnerships through our strategic collaboration with EVERSANA.
Just as a reminder, the extension of our agreement with EVERSANA that we discussed last quarter, allows for them to utilize their internal sales organization and other commercial functions for market access, marketing, sales, distribution, and other patient support services.
And through EVERSANA, we're piloting a new distribution model with Vidacare patient services, which was recently acquired by GoodRX. They provide an electronic prescription service that delivers an effective, quick, and convenient way for patients to receive medications.
And we're excited about some of the preliminary results and look forward to providing more information on this program as it develops further. Staying on the theme of our efforts to increase patient access of Gimoti, last month we announced that Gimoti was added to the Texas Medicaid -preferred drug list.
This decision supports reimbursement for Gimoti on the Texas Medicaid formulary and associated program that provides healthcare to an estimated five million people. Notably, Gimoti was also previously added to the New York State Medicaid program, another significant coverage area with a large patient population.
I should add that during the first quarter, government programs including Medicaid and Medicare made up approximately 51% of the filled prescriptions for Gimoti.
With EVERSANA 's robust patient support and reimbursement team, we've been able to allow for reimbursement submission of Gimoti for patients seeking treatment, and Chris will talk a bit more about that in a moment. I'll now review the key value-adding metrics I discussed last quarter.
Our net prescription sales have increased every quarter since launch. Net revenue increased by 16% to approximately $418,000 in the first quarter of 2022 compared to last quarter.
In addition, the number of Gimoti new cumulative prescribers increased by 41%, from 425 on December 31st, to 538 new healthcare providers or HCPs for short on March 31st of this year. Two other key data points I'd like to share are one, patient enrollments for new prescription increased by 18% in the first quarter to 474 from 388 in Q4.
And two, billed prescriptions increased by 28% in Q1 compared to the fourth quarter of last year. We're also seeing continuing positive trends and future indicators. These include continued higher numbers of in-person meetings with healthcare providers in many areas of the U.S.
We've heard directly from sales representatives that some of our key target offices are just now opening from COVID shutdown protocols. As mentioned last quarter, when a presentation of Gimoti's benefits as delivered, we've frequently see prescriptions soon after. We continue to see that more face time with HCPs equals higher net prescription sales.
The other positive indicator is that we're able to put into place into key offices a significant number of trial product or samples for patients.
These trials samples will allow patients to experience the benefits of Gimoti while waiting coverage completion from insurances, and allows patients to start treatment even if they currently do not qualify for insurance reimbursement.
Before I turn the call over to Chris, I would like to touch on two important events, one that took place in the first quarter and another that will occur later this month. On March 16th, together with the research team at H.C. Wainwright, we hosted a virtual key opinion leader, fireside chat with Dr.
Viplove Senadhi, who is the CEO and Medical Director of Greater Montgomery Patient Centered Gastroenterology and Hepatology, and a Gimoti prescribing physician. Dr. Senadhi discussed how diabetic gastroparesis affects his patients as well as his utilization of Gimoti as a treatment option.
His case studies of patients who've benefited from Gimoti we're very encouraging, but also very heartening as we heard how patients lives have been changed for the better. In addition, Dr. Senadhi also touched on a retrospective analysis of U.S.
administrative claims data that examines the association between tardive dyskinesia or TD, which is a possible side effect of using metoclopramide and potential risk factors. New real-world data allows the medical community to better determine how marketed drugs perform in large patient populations.
Leveraging the 80 million patient Truven markets scan database, a team of key opinion leaders led by Dr. Richard McCallum of Texas Tech University Health Sciences examined the association between TD and risk factors such as age, sex, underlying medical diagnosis, and exposure to drugs, including metoclopramide.
Current literature on the subject is comprised of smaller, decades old studies that may not represent today's standard of care. As a result, TD incidents in metoclopramide-treated patients may have been overestimated and risk factors, comorbidities, and co-medications in those cases were poorly understood.
We believe this information will prove invaluable to healthcare providers in the treatment of their patients with diabetic gastroparesis.
A retrospective analysis of these data that examine the association between TD and potential risk factors has been selected as a poster of distinction at the Adjusted Disease Week meeting taking place from May 21st through the 24th of this month in San Diego.
Our poster titled "Revisiting the Risk of Tardive Dyskinesia with Metoclopramide " is a real-world data driven epidemiology study from 2011 to 2021 will be presented on Saturday May 21st by Dr. Macallan. With that, I'd like to now turn the call over to Chris..
Thank you, Dave, and good afternoon, everyone. During our last call, I outlined four strategic areas to accelerate our Gimoti commercialization. In that call, we said we needed to raise awareness of Gimoti among patients and motivate them to advocate for better treatment.
Position Gimoti as optimal therapy for patients with diabetic gastroparesis and the only intranasal treatment. We needed to educate payers about gastroparesis and Gimoti and simplify the approval process. And finally, we needed to improve the conversion of fulfillment process.
I'd like to walk you through the progress we've made in each of these areas and then speak to additional insights and actions that will impact commercialization. First, awareness. HCP awareness continues to increase with 86% of target GIs and 75% of nurse practitioners and physician assistance being aware of Gimoti.
Strong awareness of Gimoti, which is a score of four or five out of five, is that 48% for all HCPs. Intention to prescribe Gimoti is also very high with 92% of targeted gastroenterologist declaring their intention to prescribe compared to 79% previously. Among all other HCP survey, 89% of all respondents intend to prescribe Gimoti.
When we look at patient awareness, that also continues to grow. In a newly completed market research study among patients, 19% of patients indicated familiarity with Gimoti compared to 8% last fall. We plan to continue to invest in education and awareness among patients and help them to advocate for improved treatments.
Moving to positioning for Gimoti, our second priority, we continue to position Gimoti as the optimal treatment for appropriate patients with diabetic gastroparesis and continue to ask our customers why are we still prescribing orals to patients with a dysfunctional gut.
We're gaining traction and the feedback from our sales organization continues to be positive with regard to messaging for Gimoti. HCPs overwhelmingly admit a nasal route of administration makes sense for patients with diabetic gastroparesis.
Although fewer makes a connection that not absorbing an oral tablet may likely lead to an inadequate response to oral therapy. We are updating our advertising and messaging to make a stronger connection for both providers and patients about the differences between nasal and an oral route of administration.
In the recent testing of these ads, we received very strong feedback on both campaigns. For patients in particular, when they saw the profile for Gimoti and our new campaign, they indicated an overwhelmingly strong interest in learning more about Gimoti, scoring it on a scale of five, a score of 4.9, which is an unprecedented score.
Related to positioning, we updated our target list in January and improved our target potential. Despite the call plan introducing 39% new targeted HCP to our sales organization, which many of them were nurse practitioners and PAs, our sales team has already reached 57% of them.
About 50% of Gimoti is precribed and generated by gastroenterologist, and nurse practitioners and PAs are starting to increase their prescribing and represent the next largest specialty in prescribing.
When we look to our third priority of market access and educating payers, we continue to make progress on the access of Gimoti among insurance companies and pharmacy benefit managers. Without contracting, Gimoti is covered or reimbursed for 45% of the lives in the U.S., improving since the end of last year at 42%.
We continue to have productive discussions with payers through our capable national account team, and as Dave mentioned, two states have recently added Gimoti to their preferred drug list, New York and Texas. And, at least 94 plans have approved at least one prescription of Gimoti since launch.
While the majority of prescriptions required a prior authorization, we are improving our ability to gain these approvals across commercial, Medicare, and Medicaid payers. It's important to note that when a prior authorization is approved, it's generally approved for an an entire year.
We expect to gain additional positive decisions and improved access from payers over time.
As they see demand grow, experience how patients respond to Gimoti clinically, and are educated on the needs of this patient population and the differences between oral and the nasal route of administration, we believe they will understand the value proposition of Gimoti.
Lastly, our fourth priority to improve the conversion and the fulfillment process, we have observed steadily improving conversion of prescriptions to dispenses. In January, we launched a pilot program with our partner, vitaCare prescription services to test an alternate distribution process that is automated and more in line with office workflows.
This pilot deployed by six out of our 27 representatives demonstrated improvements in HCP acceptance and ultimately generated increased prescribing among existing and importantly, new prescribers. Additionally, vitaCare increased conversions and TA approvals over our current program.
As we move from our priorities to look at prescribers in more detail, through the end of March we have increased our cumulative new prescribers by 26% in the first quarter, as compared to the new prescribers [Indiscernible] launched to-date through the end of fourth quarter.
That increase was fueled by 43% increase in new prescribers in 1Q versus 4Q and a 52% increase in total prescribers in the first quarter compared to those that prescribe in the fourth quarter.
As we're seeing an increase in the breadth of physicians prescribing, we are also seeing those physicians who initially prescribed Gimoti increase the depth of their prescribing, which means they are seeing the benefits of Gimoti. 55% of our prescriptions overall came from HCPs who've written more than five prescriptions for Gimoti.
In monitoring how HCPs are using Gimoti through our ATU study, we see that while the majority of prescriptions are switches to Gimoti for an existing gastroparesis patient, an increasing number of HCPs are considering Gimoti for newly diagnosed patients.
Looking at our target gastroenterologists, they're increasing their prescribing across all lines up there, both first-line, second-line, and third line. Many of them are positioning Gimoti's second-line after oral metoclopramide, which is either tablet or solution.
Target GI starting oral tablet metoclopramide then using Gimoti account for 45% of their use, moving from 31% last quarter. They also prescribed Gimoti first-line 9% of the time, up from 5% last quarter.
We see this trend of increased utilization of Gimoti and positioning Gimoti earlier in the treatment paradigm among non-targeted GIs, primary care physicians, and importantly, advanced practice providers, those nurse practitioners and physician assistants that are so important to us. Severity of sentence is a driver for Gimoti utilization.
Each of our HCP groups are more likely to prescribe Gimoti in the second or first-line if the patient has moderate or severe symptoms. Anecdotally, feedback from HCPs continues to be strong and HCPs are continuing to share positive feedback from patients.
We held an advisory board with nurse practitioners and to physician assistant leaders two weeks ago where they shared the feedback and experiences with Gimoti and we discussed ways in which we could help them improve patient care.
Feedback from the group about Gimoti was very strong, with many of them having positive examples of symptom improvements with their patients. One of the most revealing discussions was regarding particular success in prescribing Gimoti for patients who had previously had an inadequate response to oral metoclopramide, or a failure.
These discussions cemented the value of nasal administration and the limitations of oral. At the end of the meeting, each of the four advisors subgroups indicated the ideal position for Gimoti was first-line. Finally, as we continue to support increase adoption of Gimoti, there are a few other noteworthy strategic developments.
As Dave mentioned, we completed an analysis of the risk of tardive dyskinesia or TD in the U.S. based population, using the largest healthcare claims database in the U.S.
The results of the incidence of TD and the overall patient population compared to other relevant subgroups will be shared on Saturday, may 21st at 1:30 at Digestive Disease Week being held in San Diego.
We look forward to the scientific discourse that results from updating the current literature of the published incidence of TD, which has limited many HCPs from prescribing metoclopramide. We are exploring also a telehealth option for patients with diabetic gastroparesis. Telehealth is increasingly accepted and utilized by HCPs and patients alike.
Many institutions offer telehealth and this has only expanded since COVID. A significant subset of patients are currently dissatisfied and frustrated with current treatment and are seeking other options. So this telehealth option could be an important delivery of care model to provide patients for Gimoti.
We plan to expand also our sample program and evaluating our program and increase the number of patients who were able to try out Gimoti. Additionally, we observed that many HCPs who were hesitant to prescribe Gimoti without a sample to provide patients were willing to prescribe Gimoti after seeing a positive respond to a sample.
In fact, HCPs receiving a sample were five times more likely to prescribe than those who have not received a sample. In summary, we're confident in the continued progress we see with Gimoti and the increased adoption of Gimoti by providers and patients.
Our first quarter was our strongest quarter since launch, and we anticipate continued and increased performance in the months to come. I'll now turn over the call to Matt for financials and other updates..
Thanks, Chris. I'll get ready to do our financial performance for the first quarter of 2022. As Dave mentioned for the first quarter of 2022, net sales were approximately $418,000 compared with approximately $90,000 in the first quarter of 2021.
Net loss was approximately $2.2 million or $0.07 per share in the first quarter of 2022, compared with approximately $2.6 million or $0.08 per share for the same period in 2021. Research and development expenses for the three months ended March 31st, 2022, compared to the three months ended March 31st, 2021 decreased to just $42,000.
During 2022 and 2021, we incurred expenses for ongoing stability testing of batches of Gimoti, our manufacturing has received a FDA approval of Gimoti NDA in June of 2020. For the first quarter of 2022, selling general administrative expenses increased by approximately $67,000 compared with the first quarter of 2021.
Total operating expenses for the first quarter of 2022 were approximately $2.4 million compared with $2.7 million for the same period of 2021. As of March 31st, 2022, the company's cash and cash equivalents were approximately $7.7 million.
In addition, we also received net proceeds of approximately $7.1 million from sales under our ATM program after March 31, 2022. 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 Gimoti will be sufficient to fund our operations into the second quarter of 2023.
And with that, we'll now open the call for questions.
Operator?.
[Operator Instructions] We'll take our first question from Yale Jen from Laidlaw and Company..
Good afternoon and thanks for taking the questions.
My first question here is that given the Gimoti on the market is rapidly short as well, less than two years, is there any seasonality in terms of the sales, particularly for the first quarter, can only potentially be lower than rest of the quarters of the year or this is another patent to be seen in here?.
Thanks for the question, Yale. No, there's no real seasonality with the disease. We know that flares do occur more often during holidays when patients are eating more and have more activities and more stress, things like that, but nothing that would say its seasonality..
Okay.
Maybe another question here is that, what's the total spread written for the first quarter '22 and how will that compare to the fourth quarter of last year?.
We haven't described a number of prescriptions that have been dispensed. We talk about enrollments, but not specifically the dispense prescriptions..
Okay.
Was there any price differences per unit or revenue income difference of per revenue -- per unit between last quarter and -- the fourth quarter of last year versus the first quarter of this year?.
This is Matt. We haven't also divulged the average net realized price as that's a direct factor associated with any contracting related topics and obviously, understanding our WAC price at $1750, and then the patient programs we have in place down to $20 per prescription.
You can understand there's an averaging across the two in terms of where the actual end net realized price comes out. It's remained relatively stable over the course of the last year or so. We wouldn't expect it to change dramatically..
Okay. And then the last question here is that, based on the call of first quarter of '22, that seems to be substantially lower than prior quarters, at least most of the prior quarters.
Should we anticipate this COGS could be something persistent for remaining of the year? Or how should we see the COGS for modeling purposes?.
It's a really good question. We had prior research and other expenses winding through and a lot of that has worked its way out. At this point we're completely focused on commercialization, and as you know, all of the costs associated with that are directly related to revenue and come strictly out of revenue.
So it'll really just be in proportion to revenue growth. Depending upon that, otherwise the expenses that we have here internally, we keep as de minimis is actually possible..
Okay. Great. Thanks a lot. I'll get back to the queue..
Our next question comes from Mitchell Kapoor from H.C. Wainwright..
Hi, thanks for taking our questions. Just wondering if you could talk about the payer strategy near-term and what the roadmap for expecting expansion looks like in the coming quarters..
Mitch, it's Matt. In terms of contracting, our approach initially has been primarily to not contract, at least for pricing purposes. As we've discussed in the past, when you have a marketplace that has multiple products that are substitutable, oftentimes you'll find a lot of contracting going on in that situation.
We have a situation where is really almost no treatments that are approved for this patient type. Therefore, the contracting doesn't necessarily improve the likelihood of patients will actually get access. That being said, we're still continuing to look for opportunities to get coverage through things like the Medicaid process as another approval.
We still have a team out in the field that is actively engaging with these teams for insurance purposes to help them understand the benefits of Gimoti to at least allow for access. And with that, maybe I'll turn it over to Chris and see if you want to add anything further into that..
I think the primary thing that we need to do is just educate the payers and engage in those conversations. That's what we're doing primarily right now. We have our national account team working with national and regional payers, as well as with the states.
So what we're seeing is those conversations are productive and they're starting to yield some results, and so we expect further improvement over the course of the year..
Okay. Great. Thank you.
And just along those lines, Medicaid and Medicare made up 51% of scripts in the first quarter, is there any kind of color on how you expect this to trend or how that could settle out longer-term?.
I expect that trend to be relatively constant over time and we're seeing an improving conversion rate overall, and that rate of conversion is improving for both commercial Medicare and Medicaid. So I expect that as the volume grows, that will settle in roughly to the same percentages..
Great. Thank you very much..
This does conclude the Q&A portion of today's call. I would now like to turn the call back over to David Gonyer and for any additional or closing remarks..
Sure. Thank you.
I'll just conclude by saying that we're all optimistic about the progresses that we are making in generating higher net prescription sales, inking new partnerships and collaborations to provide additional sales channels for Gimoti as Chris just described, strengthening our IP protection for the product, bringing up board additional Gimoti HCP prescribers, gaining additional Medicaid coverage territories, increasing patient enrollments for new Gimoti prescriptions, and growing the number of filled Gimoti prescriptions.
While we're encouraged by all of these incremental improvements in Gimoti sales and prescriptions and continue to receive very positive feedback from both patients and healthcare providers, there's clearly continued room for improvement.
By working closely with our strategic commercial partner, EVERSANA, we'll continue to implement and execute strategies in the quarters ahead.
We believe we are putting the right pieces in place to show tangible improvements in some of the metrics I just mentioned, and we'll continue to update the market with our overall progress and what we and EVERSANA are doing to enhance shareholder value. Thank you very much..
This does conclude today's Evoke Pharma First Quarter 2022 Quarterly Earnings Call and webcast. You may disconnect your line at this time and have a wonderful day..