Q4 2023 Phathom Pharmaceuticals Inc Earnings Call
Operator: Hello, and welcome to the Phathom Pharmaceuticals fourth quarter and full year 2023 earnings conference. At this time, all participants are in a listen-only mode.
Hello, and welcome to the Fathom Pharmaceuticals fourth quarter and full year 2023 earnings conference call. At this time all participants are in a listen only mode. After the presentation. There will be a question and answer session to ask a question. During the session you will need to press star one on your telephone.
Operator: After the presentation, there will be a question-and-answer session. To ask a question during this session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising you that your hand is raised.
And here an automated message if I didn't hear your hand is raised.
Operator: To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. With that, I would like to turn the conference over to Eric Sciorilli, Phathom's Head of Investor Relations. Please go ahead.
Your question. Please press Star one again, please be advised today's conference is being recorded with that I would like to turn the conference over to Eric Shirley Evans head of Investor Relations. Please go ahead.
Eric Sciorilli: Thank you, operator. Hello, everyone, and thank you for joining us this morning to discuss Phathom's fourth quarter and full year 2023 results. This morning's presentation will include remarks from Terrie Curran, our President and CEO, Martin Gilligan, our Chief Commercial Officer, and Molly Henderson, our Chief Financial Officer. Azmi Nabulsi, our Chief Operating Officer, will also be joining the team during the Q&A portion of today's call. Just a couple of logistical items before we get started. Earlier this morning, we issued a press release detailing the results we will be discussing during the call. A copy of that press release can be found in the news releases section of our corporate website. In addition, the recording of today's webcast can be found in the events and presentations section of our corporate website.
Thank you operator, Hello, everyone and thank you for joining us this morning to discuss fathoms fourth quarter and full year 2023 results.
This morning's presentation will include remarks from Terrie Curran, our president and CEO Martin go again, our Chief commercial officer, and Molly Henderson, Our Chief Financial Officer, <unk>, Our Chief operating Officer will also be joining the team during the Q&A portion of today's call.
Just a couple of logistical items before we get started.
Earlier. This morning, we issued a press release detailing the results we will be discussing during the call.
A copy of that press release can be found under the news releases section of our corporate website.
Further the recording of today's webcast can be found under the events and presentations section of our corporate website.
Eric Sciorilli: Before we begin, let me remind you that we will be making a number of forward-looking statements throughout today's presentation. These forward-looking statements involve risks and uncertainties, many of which are beyond Phathom's control. Actual results can materially differ from the forward-looking statements, and any such risk can materially adversely affect the business, the results of operations, and trading prices for Phathom's common stock.
Before we begin let me remind you that we will be making a number of forward looking statements throughout todays presentation. These forward looking statements involve risks and uncertainties many of which are beyond <unk> control.
Actual results could materially differ from the forward looking statements and any such risks can materially adversely affect the business the results of operations and trading prices for <unk> common stock.
Eric Sciorilli: A discussion of these statements and risk factors is available on the current Safe Harbor slide, as well as in the risk factors section of our most recent Form 10-K and subsequent SEC filing. All forward-looking statements made on this call are based on the beliefs of Phathom as of this date, and Phathom disclaims any obligation to update these statements. Also included today are non-GAAP financial measures, which should be considered only as supplemental to, and not a substitute for, or superior to, GAAP measures.
<unk> of these statements and risk factors is available on the current safe Harbor side as well as in the risk factors section of our most recent Form 10-K and subsequent SEC filings.
All forward looking statements made on this call are based on the beliefs of fathom as of this date and <unk> disclaims any obligation to update these statements.
Also included today are non-GAAP financial measures, which should be considered only as supplemental to and not a substitute for or superior to GAAP measures to the extent applicable. Please refer to the tables at the end of this mornings press release for reconciliations of these non-GAAP measures to the most directly comparable GAAP measures.
Eric Sciorilli: To the extent applicable, please refer to the tables at the end of this morning's press release for reconciliations of these non-GAAP measures to the most directly comparable GAAP measures. With that, I will now turn the call over to Terrie Curran, Phathom's President and CEO, to kick us off.
With that I will now turn the call over to Terrie, Curran, Darden's, President and CEO to kick us off.
<unk>.
Terrie J. Curran: Thank you, Eric, and thank you to all those joining us on today's call. This is our first earnings call as a commercial company, and I'm excited to report on the progress we've made during both the fourth quarter of 2023 and the start of the calendar year 2024. In that short period, we've achieved many regulatory, manufacturing, financial, and commercial milestones, demonstrating the significant experience and dedication of our team. In November, we set out with three initial goals for the early stages of launch: communicate Quesna's clinical superiority versus the PPI, drive awareness with physicians, and build access to commercial patients. Today I'm proud to share that we're delivering on those goals. Prescribers have quickly recognized Quesna's differentiated and novel mechanism of action.
Thank you Eric and thank you to all those joining us on today's call. This is our first earnings call as a commercial company.
Cited to report on the progress we've made during both the fourth quarter 2023, and the start of the calendar year 2024 in that short period, we have achieved many regulatory manufacturing financial and commercial milestones demonstrating the significant experience and dedication of our teams.
We set out with three initial goals for the early stages of launch.
Communicates equation is clinical superiority versus the PPI.
<unk> awareness with physicians and build access to commercial patients.
I am proud to share that we are delivering on those calls prescribers have quickly recognized the quest is differentiated and novel mechanism of action, our reps or even sharing stories of physicians echoing equation is rapid Tyson and <unk> acid suppression profile excitement is translating into demand with <unk>.
Terrie J. Curran: Our reps are even sharing stories of physicians echoing the Quesna's rapid, potent, and durable acid suppression profile. Excitement is translating into demand, with thousands of scripts being written since the product became available. After over 30 years since the first PPI was approved, there is strong demand for something new. Further, the number of patients who have used the Quesna is growing daily.
The scripts being written since product became available.
After over 30 years since the first PPI was approved there is strong demand for something new.
The number of patients have used the questioner is growing daily.
Terrie J. Curran: For me, this is one of the most rewarding elements of our launch. Through our reps, employees, and sometimes even friends and family, I'm hearing stories of long-suffering patients who are experiencing noticeable improvement with the Quesna. We're working hard to ensure as many patients as possible can access Quesna and share that experience. In fact, with our recent Express Scripts win, we're well on our way to securing widespread coverage for commercial patients. These early indicators, along with Benoprezen's massive commercial success in Japan, have reinforced my belief in BeQuesna's bright future here in the U.S. With an erosive GERD market of approximately 7 million U.S. adults, positive feedback from physicians and patients, and anticipated label expansions, we remain confident in our belief that Quesna has the potential to reach annual peak revenue of greater than $3 billion. As for For clarity, this includes scripts captured by Acuvia, as well as those that were filled through BlinkRx.
This is one of the most rewarding element to that launch.
Reps employee and sometimes even the friends and family I'm hearing stories of long suffering patients.
We are experiencing noticeable improvement with sequester.
Working hard to ensure as many patients as possible can access the question up and share that experience in fact with our recent express scripts when we're well on our way to securing widespread coverage the commercial patients.
These early indicators along with Bill presents massive commercial success in Japan have reinforced my belief in the <unk> bright future here in the U S.
Within our rice at good market of approximately 7 million U S. Adults positive feedback from physicians and patients and anticipated label expansions. We remain confident in our belief that <unk> has the potential to reach annual peak revenues of greater than $3 billion.
As for our early launch data I'm happy to report that I have a 3800 prescriptions have been filled for the equation of products.
For clarity. This include scripts captured by <unk> as well as those that were filled through link Rx.
Terrie J. Curran: We specify filled because we have simultaneously been monitoring an estimate of total demand, which we believe paints a comprehensive picture of the early and growing position interest in writing the Quesna product. We estimate upwards of 14,000 total prescriptions have been written-launched to date. We're pleased with this magnitude of total demand and see it as an indicator of what's on the horizon for the Quesna as we continue pursuing broad payer companies. Last month, the Quesno was added to Express Scripts national formularies for commercial patients. In line with our goal, we secured placement with a single step edit through a generic PPI. As a result, the Quesna bottle's access expanded to an estimated 60 million commercially covered lives.
We specify field because we have simultaneously be monitoring an estimate of total demand.
Which we believe paints a comprehensive picture of the early and growing position interest in riding the question of products.
We estimate upwards of 14000 total prescriptions have been written launch to date. We're pleased with this magnitude of total demand and see it as an indicator of what's on the horizon is the question as we continue pursuing broad payer coverage.
Last month, the Quiznos added to express scripts national Formularies, the commercial patient.
In line with our goal, we secured placement with a single step edit sure generic PPI.
As a result, the questioner bottles access expanded to an estimated $16 million commercially covered lives.
Terrie J. Curran: We believe our ability to obtain commercial formulary placement with one of the nation's largest PBMs so quickly after approval indicates that our pricing and access strategy is responding well with payers. We remain actively engaged with other major PBMs and health plans, and we expect further expansion of commercial coverage throughout 2024. Ultimately, as this coverage comes online, we anticipate the gap between total demand and field scripts will narrow significantly. As we continue to execute on the launch, our R&D team remains focused on advancing pipeline opportunities for the not-present. In December, we announced that the FDA had accepted our non-erosive GERD daily dosing NDA and assigned the PDUFA target action date of July 19, 2024. We are now only four months away from that decision date. Non-erosive GERD represents the largest subcategory of GERD, with an estimated 15 million U.S. adults diagnosed and treated for the disease annually.
We believe our ability to obtain commercial formulary placement was one of the nation's largest pbms. So quickly after approval indicates that our pricing and access strategy is resonating well with payers.
We remain actively engaged with other major Pbms and health plans and we expect further expansion of commercial coverage throughout 2024.
Ultimately as this coverage comes online we anticipate the gap between total demand and field scripts will narrow significantly.
As we continue to execute on the launch.
R&D team remains focused on advancing pipeline opportunities because we're not present.
In December we announced that the FDA had accepted our non erosive good daily dosing NDA and assigned a <unk> target action date of July 19 2024.
We are now on a four month away from that decision date.
Non or I said good represents the largest subcategory of good with an estimated 50 million U S. Adults diagnosed and treated for the disease annually.
Terrie J. Curran: If approved, this indication will significantly broaden Quesna's addressable population and we believe it will further accelerate uptake. The review of our application is proceeding as expected, and we continue to plan for a July launch in this sizable indication. As for further development, we anticipate initiating a Phase 3 trial for as-needed non-erosive goods and a Phase 2 trial for eosinophilic esophagitis later this year. We believe that Noprazan's unique MOA bodes well for success in these two trials.
If approved this indication will significantly broaden the quiznos addressable population and we believe further accelerate uptake.
The review of the application is proceeding as expected and we continue to plan for July launch and a sizable indication.
As for further development, we anticipate initiating a phase III trial fascinated nonhierarchic.
In our phase two trial for Ace going to feel like a sofa Jive. It's later this year.
We believe the not presents unique MLA bodes well for success in these two trials.
Terrie J. Curran: If approved, these additional label extensions will further differentiate Monoprazan relative to PPIs and continue to expand the total addressable market for the Quezna products. We're excited about these programs and anticipate sharing more information about our progress in the future. Later in the call, Molly will further detail our fourth quarter and full year 2023 financials, for which we reported revenues of $682,000 and ended the year with $381 million in cash.
Approved these additional label extensions will further differentiate and offer them relative to <unk> and continue to expand the total addressable market for the equivalent products.
We're excited about these programs and anticipate sharing more information about our progress in the future.
Later in the call Molly will further detail, our fourth quarter and full year 2023 financials for which we.
Reported revenues of 692000 and ended the year with $381 million in cash.
Terrie J. Curran: Overall, we believe our strong balance sheet will enable us to continue delivering on our launch and development strategy. I've previously stressed several foundational dynamics that are necessary for a potential blockbuster drug. These included a significant addressable market, clear unmet need among patients, demonstrated superiority, and positioned malice. The qualitative feedback from these early months of launch has bolstered our belief that these elements are present in the GERD market. It now comes down to us executing on our strategy, and this team is poised to deliver.
Overall, we believe our strong balance sheet will enable us to continue delivering on our launch and development strategies.
I've previously stressed several foundational dynamics that are necessary for a potential blockbuster drug.
These included a significant addressable market.
Clear unmet need among patients.
Constraining superiority and physician demand.
Qualitative feedback from these early months of launch has bolstered our belief that these elements are present in the market.
Now comes down to us executing on our strategy and this team is poised to deliver.
Martin J. Gilligan: These are exciting times for Phathom as we continue to make progress on both the commercial and development fronts. This year is sure to be filled with new milestones and will set the foundation for the future of the Questionnaire. Our pursuit of becoming the number one prescribed acid suppressant in the U.S. is off to a strong start, and we remain steadfast in delivering on our strategy of driving blockbuster potential through continued market expansion. I will now turn the call over to Martin to dive deeper into our launch progress. Martin
These are exciting times as we continue to make progress on both the commercial and development fronts.
This year is sure to be filled with new milestones.
We'll set the foundation for the future of the question.
Our pursuit of becoming the number one prescribed.
The person in the U S is off to a strong start and we remain steadfast in delivering on our strategy of driving blockbuster potential.
<unk> market extension.
I'll now turn the call over to Martin to dive deeper into our launch progress Martin.
Martin J. Gilligan: Thanks, Terrie. And hello, everyone. I'd like to first echo Terrie's comments that we're very happy with how the launch of Aquesna has started. It is progressing as anticipated, and our pre-launch research is being validated by the feedback we're hearing from physicians and patients. During today's call, I'll touch on both quantitative and qualitative elements from our launch. But I know many of you on this call are most keen to hear about our script data, so let's start there. Today, we're reporting script data as of February 23rd from both Acuvia and BlinkRx, which represents our latest available information. With the second half of our sales force entering the field in early January, this reflects about seven weeks of our full promotional effort.
Thanks, Terry and Hello, everyone I would like to first Echo Terry's comments that we're very happy with how the launch of a question of has started we're progressing as anticipated and our prelaunch research is being validated by the feedback we're hearing from physicians and patients.
During today's call I'll touch on both quantitative and qualitative elements from our launch.
But I know many of you on this call are most keen to hear about our script data so let's start there.
Today, we're reporting script data as of February 23rd from both Cuba, and Blink Rx, which represents our latest available information.
With the second half of our sales force entering the field in early January this reflects about seven weeks of our full promotional efforts.
Martin J. Gilligan: This has translated to achieving over 3,800 filled prescriptions, which have reached patients' hands. As our reps continue to promote to positions and garner the backing of strengthened commercial coverage, we expect positive script momentum to continue. Additionally, our KPIs indicate that over 1,200 unique prescribers have written a bequest of scripts that have ultimately been filled. Among those writers, we are already seeing repeat prescribing, which builds our confidence that physicians recognize Quesna's value for patients. We are encouraged by the initial breadth of this prescriber base and anticipate it will grow as we further engage with high-volume targets. Another important metric that Terrie mentioned was total demand. We estimate that upwards of 14,000 prescriptions have been written since the start of launch. We believe this significant amount of demand to be indicative of the high level of unmet need in the market.
This has translated to achieving over 3800 filled prescriptions, which have reached patients' hands.
As our reps continue to promote to physicians and garner the backing of strengthened commercial coverage, we expect positive script momentum to continue.
Additionally, our kpis indicate that over 1200 unique prescribers have written to the question of scripts that has ultimately been filled.
Among those writers we are already seeing repeat prescribing, which builds our confidence that physicians recognize with business value for patients.
We're encouraged by the initial breath of this prescriber base and anticipate it will grow as we further engage with high volume targets.
Another important metric that Terry mentioned was total demand.
We estimate that upwards of 14000 prescriptions have been written since the startup launch we.
We believe the significant amount of demand to be indicative of the high level of unmet need in the market.
It demonstrates that patients are interested in trying something new and physicians are willing to rate request now.
Martin J. Gilligan: It demonstrates that patients are interested in trying something new, and physicians are willing to write requests. As you've heard us say historically, providing access to patients is key to meeting demand. As with all new products, negotiating coverage with payers is an essential step in achieving a successful launch, and this process often takes time. In anticipation, we established a patient support program through BlinkRx, which has meaningfully expanded patient access, resulting in an increased number of filled scripts. Early data shows the use of BlinkRx growing consistently and being accompanied by positive feedback. However, there are still physicians sending scripts to their patients' long-established retail pharmacies.
As you've heard us say historically, providing access to patients is key to converting demand.
As with all new products negotiating coverage with payers is an essential step in achieving a successful launch and this process often takes time.
In anticipation, we establish a patient support program <unk>, which has meaningfully expanded patient access resulting in an increased number of build scripts.
Early data shows the use of <unk> growing consistently accompanied by positive feedback.
However, there are still physicians, sending scripts to their patients long established retail pharmacies.
Although this has led to proportion of early request the prescriptions not being filled we believe we are well positioned to get more of these scripts overtime.
In the near term our Salesforce continues to emphasize the availability of link our extra physicians as it often represents the best option for getting the questioner into patients' hands in.
Martin J. Gilligan: Although this has led to a proportion of early requested prescriptions not being filled, we believe we are well positioned to convert more of these scripts over time. In the near term, our sales force continues to emphasize the availability of BlinkRx to physicians, as it often represents the best option for getting Boquesna into patients' hands. And ultimately, future contracting with PVMs and health plans will increase payer access and narrow the gap between total demand and filled scripts. In fact, we have a question now in formulary at the first of the three major PBMs; we are already making progress on that front. The first major PBM contracting win was with Express Scripts, often referred to as ESI.
And ultimately future contracting with Pbms and health plans will increase payer access and narrow the gap between total demand unfilled scripts and.
In fact, we have a question now on formulary at the first of the three major Pbms, we are already making progress on that front.
The first major PVM contracting win was with express scripts, often referred to as ESI about.
About three weeks ago, we announced the positioning of a question on ESI National Formulary. This was a key accomplishment for fathom expanding the questions availability to roughly $23 million additional commercial lives.
Our team was able to secure non preferred brand status with a single step edit exactly as intended.
The single step is with respect to use of generic PPI prescriptions within the last 130 days.
These criteria will be evaluated at the pharmacy counter electronically avoiding any administrative burden for physician or office staff.
Internally, if a patient use over the counter <unk> instead of prescriptions during that time period. They could also satisfy the single step by means of a prior authorization with Esso station by their Doctor.
Martin J. Gilligan: About three weeks ago, we announced the positioning of Bequesna on ESI's national formulary. This was a key accomplishment for Phathom, expanding Bequesna's availability to roughly 23 million additional commercial lines. Our team was able to secure non-preferred brand status with a single step edit exactly as intended.
This latter Avenue for access is a significant development as it means ESI patients could potentially access for quest as a first line treatment as.
As intended this formulary position provides physicians a straightforward path to accessing book Cuesta for the broadest patient population.
Martin J. Gilligan: The single step is with respect to the use of generic PPI prescriptions within the last 130 days. These criteria will be evaluated at the pharmacy counter electronically, avoiding any administrative burden for physicians or office staff. Alternatively, if a patient used over-the-counter PPIs instead of prescriptions during that time period, they could also satisfy the single step by means of prior authorization with attestation by their doctor. This latter avenue for access is a significant development, as it means ASI patients could potentially access Quesna as a first-line treatment. As intended, this formulary position provides physicians a straightforward path to accessing Boquesna for the broadest patient population, but Quesna's total commercial coverage now reflects an estimated 60 million commercially covered lives.
For questions total commercial coverage now reflects an estimated 60 million commercial covered lives.
Achieving this level of commercial access less than three months into product availability is fantastic, but we know there is still work to be done.
We believe our progress so far bodes well for our other ongoing negotiations, where we remained focused on securing for quest to coverage with similar formulary position.
We are confident in our strategy and believe it will continue to yield expanded coverage, resulting in an uptick in filled prescriptions throughout the remainder of 2024.
Shifting to our promotional efforts the sales reps continue to report back that the question is generating enthusiasm with prescribers.
Physicians are articulating patients' unmet need and recognizing <unk> value as a treatment option.
Our reps are focused on their reach and frequency among our full call panel of approximately 52000 targets.
In parallel we are working diligently to reach patient suffering from the conditions for which the president is approved.
In these early days, we are happy to see that we appear to be making an impact.
Martin J. Gilligan: Achieving this level of commercial access less than three months into product availability is fantastic, but we know there is still work to be done. We believe our progress so far bodes well for our other ongoing negotiations where we remain focused on securing Bequesna coverage with similar formulary positions. We are confident in our strategy and believe it will continue to yield expanded coverage, resulting in an uptick in filled prescriptions throughout the remainder of 2024. Shifting to our promotional efforts, sales reps continue to report back that Bequesta is generating enthusiasm among prescribers. Physicians are articulating patients' unmet need and recognizing Boquesna's value as a treatment option. The refs are focused on their reach and frequency among our full call panel of approximately 52,000 targets.
To date, we've had over 185000 visits to our consumer website and we're hearing from physicians offices that patients are asking about sequester.
Patient requests are a key component of our demand strategy and market research conducted with 200 of our target physicians almost 80% stated they would grant request upon request for their erosive GERD patients.
With this in mind, we plan to initiate a new branded consumer campaign, which has been met with positive and motivating feedback from test audiences.
This campaign speaks directly to erosive GERD patients and their symptoms.
Most notably this will include TV commercials on popular streaming services.
If you suffer from erosive GERD keep an eye out for requests to ads on your devices. Starting later this month.
In closing I am extremely happy with the commentary, we're hearing from prescribers and how it translates into demand.
We are successfully executing our launch strategy with continued promotion of physicians, a broadened consumer campaign and expanded commercial coverage, we anticipate significant growth in filled prescriptions over the course of 2024 are.
Martin J. Gilligan: In parallel, we are working diligently to reach patients suffering from the conditions for which Bequesna is approved. In these early days, we are happy to see that we appear to be making an impact. To date, we've had over 185,000 visits to our consumer website, and we're hearing from physicians' offices that patients are asking about ProQuestna. Patient requests are a key component of our demand strategy, and market research conducted with 200 of our target physicians, almost 80% stated they would grant a bequest upon request for their erosive GERD patients. With this in mind, we plan to initiate a new branded consumer campaign, which has been met with positive and motivating feedback from test audiences. This campaign speaks directly to a group of GERD patients and their symptoms.
Our teams are energized and committed to our belief in the blockbuster potential for Brickworks now.
I'll now pass it off to Molly to walk through our financial results Molly.
Thank you Martin and Hello to everyone on the call I'm happy to share our fourth quarter and full year 2023 financial results with you today.
This is a momentous earnings call for Fathom as it is the first time, we are reporting net revenues for our <unk> products.
Other revenues reflect about a month of launch activity. We are pleased with the initial results.
I'd like to note two items before going into the numbers first during this call we will not be providing financial guidance regarding projected annual revenues spend or earnings as we are still early months of launch. Additionally, I will be commenting on both GAAP and non-GAAP financial measures.
Supporting schedules with detailed reconciliations between non-GAAP measures and their most directly comparable GAAP measures will be discussed later in my section and can be found in this morning's press release.
Martin J. Gilligan: Most notably, this will include TV commercials on popular streaming services. So if you suffer from erosive GERD, keep an eye out for the ads on your devices starting later this month. In closing, I'm extremely happy with the commentary we're hearing from prescribers and how it translates into demand. We are successfully executing our launch strategy. With continued promotion to physicians, a broadened consumer campaign, and expanded commercial coverage, we anticipate significant growth in filled prescriptions over the course of 2024. Our teams are energized and committed to our belief in the blockbuster potential for Bequesna. I'll now pass it off to Molly to walk through our financial results. Molly.
Now turning to the numbers for the fourth quarter 2023, we reported net revenues of 682000, driven by the initial stocking of wholesalers in December Fitch.
This reflects a partial quarter sales given that the question of bottles became commercially available as of November 28, and request <unk> as of mid December.
<unk>, we reported gross profit of 515000 for the fourth quarter 2023.
<unk> gross margin of approximately 76%.
The cost of revenues includes royalties out at Takeda and exclude certain inventory costs, which were expense prior to receiving FDA approval.
Note that the royalties owed as part of our revenue interest financing agreement are not captured in cost of revenues, but rather in other interest expense.
Molly Henderson: Thank you, Martin, and hello to everyone on the call. I'm happy to share our fourth quarter and full year 2023 financial results with you today. This is a momentous earnings call for Phathom, as it is the first time we are reporting net revenues for our Requisna product. Although revenues reflect about a month of launch activity, we are pleased with the initial results. I'd like to note two things before going into the numbers.
Moving down the P&L to our spend we reported non-GAAP R&D expenses of $6 1 million for the fourth quarter 2023, compared to $14 3 million for the same period in 2022.
As for SG&A, we reported non-GAAP expenses of $39 7 million for the fourth quarter 2023, compared to $25 7 million for the fourth quarter 2022.
Molly Henderson: First, during this call, we will not be providing financial guidance regarding projected annual revenues, spend, or earnings as we are still in the early months of launch. Additionally, I will be commenting on both GAAP and non-GAAP financial measures. Supporting schedules with detailed reconciliations between non-GAAP measures and their most directly comparable GAAP measures will be discussed later in my section and can be found in this morning's press release. Now, turning to the numbers. For the fourth quarter of 2023, we reported net revenues of $682,000, driven by the initial stocking of wholesalers in December. This reflects a partial quarter of sales given that Vaquesna bottles became commercially available as of November 28th and Vaquesna packs as of mid-December. Additionally, we reported gross profit of $515,000 for the fourth quarter of 2023, which equates to a gross margin of approximately 76%. The cost of revenues includes royalties owed to Takeda and excludes certain inventory costs which were expensed prior to receiving FDA approval. Note that the royalties owed as part of our Revenue Interest Financing Agreement are not captured in the cost of revenues but rather in other interest expenses.
On a full year basis, we reported non-GAAP R&D expenses of $37 6 million for 2023 compared to $65 9 million for 2022.
And for SG&A, our non-GAAP expense was $85 2 million for 2023 compared to $82 4 million for 2022.
On a full year and quarterly basis. The decrease in R&D expenses was primarily related to lower clinical trial costs. As we concluded our phase III non erosive GERD daily dosing trial during 2023.
Regarding SG&A our increase in spend was driven by the buildout of our commercial infrastructure and initiation of marketing activities in support of the commercial launch of our questionnaire.
Additionally, the most significant reconciling items between GAAP and non-GAAP opex expenses for the periods with noncash stock based compensation largely associated with divesting of performance shares upon the approval of erosive GERD. Other non-GAAP reconciling items include noncash interest on a revenue interest financing liability and noncash inter.
Expense related to the amortization of debt discount.
Turning to EPS, we reported GAAP net loss for the fourth quarter 2023 of $79 6 million or $1 39 loss per share compared to $55 million or $1 33.
Loss per share for the fourth quarter 2022.
non-GAAP adjusted net loss for the fourth quarter for 2023 with $46 million or <unk>.
Loss per share compared to $42 2 million or $1 <unk> loss per share for the same period in 2022.
Molly Henderson: Moving down the P&L to our spend, we reported non-GAAP R&D expenses of $6.1 million for the fourth quarter 2023, compared to $14.3 million for the same period in 2022. As for ST&A, we reported non-GAAP expenses of $39.7 million for the fourth quarter 2023, compared to $25.7 million for the fourth quarter 2022. On a full year basis, we reported non-GAAP R&D expenses of $37.6 million for 2023, compared to $65.9 million for 2022. And for SG&A, our non-GAAP expense was $85.2 million for 2023, compared to $82.4 million for 2022.
As of December 31, 2023, cash and cash equivalents were $381 million. This includes 175 million received during the fourth quarter of 2023 from a revenue interest financing agreement upon the approval of erosive GERD.
Also during the fourth quarter, we announced the expansion of our existing term loan facility with Hercules capital.
The amendment provides access to more favorable terms and an additional $100 million in non dilutive capital subject to achievement of certain revenue milestones.
With this amendment, we now have a total of $160 million available via our debt facility.
We believe we are in a solid financial position and reaffirm our expectation that we have cash runway through the end of 2026 based on our current operating plan expected product revenues and funds available under our term loan.
Lastly, as we shared previously we expect nominal revenue. During these first couple of quarters of launch while payer coverage is materializing and.
Additionally, I mentioned, our fourth quarter 2023 revenues, mostly represented inventory stocking by wholesalers.
We expect to sell through of restocking to take place during the first quarter of 2024, reinforcing our previous comments regarding nominal revenues. During these first couple of quarters of launch.
Molly Henderson: On a full year and quarterly basis, the decrease in R&D expenses was primarily related to lower clinical trial costs as we concluded our Phase 3 non-erosive GERD daily dosing trial in 2023. Regarding SG&A, our increase in spend was driven by the buildout of our commercial infrastructure and the initiation of marketing activities in support of the commercial launch of Equestria. Additionally, the most significant reconciling item between GAAP and non-GAAP OPEX expenses for the period was non-cash stock-based compensation, largely associated with the vesting of performance shares upon the approval of a higher level of GERD. Other non-GAAP reconciling items include non-cash interest on a revenue interest financing liability and non-cash interest expense related to the amortization of debt discounts. Turning to EPS, we reported a gap net loss for the fourth quarter 2023 of $79.6 million or $1.39 loss per share compared to $55 million or $1.33 loss per share for the fourth quarter 2022. Non-GAAP adjusted net loss for the fourth quarter 2023 was $0.46 million or $0.80 loss per share compared to $42.2 million or $1.02 loss per share for the same period in 2022. As of December 31st, 2023, cash and cash equivalents were $381 million.
With that I'll now turn the call back over to Terry for closing comments Terry.
Thank you Mollie and thank you again to everyone joining us on today's call.
The accomplishments in 2023 with nothing short of amazing and I'm extremely proud of this team.
As we round out Q1 at approach Q2, our primary focus has been on securing formulary placement with payers we've.
We've made great progress on that front, so far and anticipate expanded commercial coverage throughout the week.
As for the back half of 2024, we believe the planned launch of non erosive. Good daily dosing in July pending FDA approval will serve as another key catalyst for driving adoption.
We believe equation and represents a blockbuster opportunity and this launch is off to an exciting start.
Enthusiasm here at Fathom is tremendous and there is much to look forward to in 2020 full. Thank you again for joining US today. We appreciate your continued interest and support.
Now turn it over to the operator to facilitate a 10 minute question and answer session operator.
Thank you as a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, one moment, while we compile our Q&A roster.
And our first question comes from the line of Yadkin <unk> with Guggenheim. Your line is open. Please go ahead.
Hey, guys. Thank you for thank you for taking my question.
A couple a couple from me could you just talk about the reason for not filling the script other than the coverage and how long does it takes four blank.
IDEXX to get based on X patients to get the coverage.
Molly Henderson: This includes $175 million received during the fourth quarter of 2023 from our Revenue Interest Financing Agreement upon the approval of Rosa Garten. Also, during the fourth quarter, we announced the expansion of our existing term loan facility with Hercules Capital. The amendment provides access to more favorable terms and an additional $100 million in non-dilutive capital subject to achievement of certain revenue milestones.
Yes. So yes. This is Martin I'll take that question. So in terms of the coverage I'll just reiterate how happy we are with the express scripts win.
As we've talked about in the past.
Objective was to get one step through our PPI, which.
Which opens up the broadest market and I think the additional thing here that we walked away with is that if a patient has only been on OTC. The physician can do it at a station in the nation have access to the plasma. So we anticipate that since it was just announced and just became available we will start to see an increase in the number of scripts that are getting <unk>.
Molly Henderson: With this amendment, we now have a total of $160 million available via our debt facility. We believe we are in a solid financial position and reaffirm our expectation that we will have cash runway through the end of 2026, based on our current operating plan, expected product revenues, and funds available under our term. Lastly, as we shared previously, we expect nominal revenues during the first couple quarters of launch while payer coverage is materialized. Additionally, I mentioned our fourth quarter 2023 revenues mostly represented inventory stocking by cold. We expect the sell through of the stocking to take place during the first quarter of 2024, reinforcing our previous comments regarding nominal revenues during these first couple quarters of launch. With that, I'll now turn the call back over to Terrie for closing comments. Terry.
Through the system and then we would also envision that given this win and it seems to fit with our strategy, we're very far along in negotiations with other major payers. So we would start to see that coming on board.
Probably during as we enter into Q2, and then going into the rest of the year.
The other thing I will just say is what we've actually been able to do is in terms of supporting that as with Blink Rx I think you heard you mentioned that a couple of times. Our goal there was really to make sure that first of all customers had a good experience. We wanted to address the lack of coverage early on.
We also wanted to make sure that commercial patients on <unk>.
They got another question that is a position incentive and then the other thing that was really important to US was that the program that we set up that the refills were realized at once a patient converted from patient support over to commercial coverage that went through normal channels.
Terrie J. Curran: Thank you, Molly. And thank you again to everyone joining us on today's call. Phathom's accomplishments in 2023 were nothing short of amazing, and I'm extremely proud of this team.
Got it and then just maybe a follow up really quick one I understand you are.
And in the early phase of our launch of not providing.
Guidance, but could you just talk about your comfort with the consensus out there, which is around $40 million to $45 million and then also if you can talk about the GTS dynamics, where we are and how do you think it's going to evolve and where do you expect to end up in 2024. Thank you.
Terrie J. Curran: As we round out Q1 and approach Q2, our primary focus is set on securing formal replacement with payers. We've made great progress on that front so far and anticipate expanded commercial coverage throughout the year. As for the back half of 2024, we believe the planned launch of non-erosive GERD daily dosing in July, pending FDA approval, will serve as another key catalyst for driving adoption. We believe Aquenda represents a blockbuster opportunity, and this launch is off to an exciting start. The enthusiasm here at Phathom is tremendous, and there is much to look forward to in 2024. Thank you again for joining us today.
Sure.
I'll take that it's Molly so.
So overall as you said, we're not providing specific guidance as it relates to our revenues other than reinforcing our previous commentary that we expect very nominal revenues for the first couple of quarters of launch as we are building payer coverage and working through the stocking that we.
That I alluded to in Q4 as it relates to GCN.
Not commenting necessarily on where we are based upon the discussions we have ongoing with the payers.
We have said previously and we will continue to provide some framework guidance around is the run rate and what we've said is that we expect between 50 and 65% on a.
Operator: We appreciate your continued interest and support. I'll now turn it over to the operator to facilitate a 10 minute question and answer session. Operator.
Operator: Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again.
Normalized basis from a steady state so those mailing pieces that we're providing guidance at this point.
As we're still early in the launch.
Thank you and one moment as we move on to our next question.
Operator: One moment while we compile our Q&A roster. And our first question comes from the line of Yatin Suneja with Guggenheim. Your line is open. Please go ahead. Hey, guys, thank you for taking my question. A couple of questions for me.
And our next question is going to come from the line of Joseph <unk>, Joseph Stringer with Needham <unk> Company. Your line is open. Please go ahead.
Hi, good morning, Thanks for taking our questions gave some very helpful. Info on the contribution to film scripts from Blink Rx since launch, but just curious if you can comment on the relative proportion so that <unk> split was it higher or lower in <unk> 'twenty.
Yatin Suneja: Could you just talk about the reason for not filling the script other than the coverage? And how long does it take for blank Rx patients to get the coverage? Yeah, so Yatin, this is Martin, and I'll take that question.
He then what.
It is.
In the first quarter of this year to date.
And.
Maybe as a follow up to that can you provide any qualitative guidance on how you see that relative split trending as the launch goes on and of course more coverages carrier would you expect that to trend down and reached a steady state level at some point.
Martin J. Gilligan: So in terms of the coverage, you know, I'll just reiterate how happy we are with the Express Scripps win. As we've talked about in the past, our objective was to get one step ahead through a PPI, which opens up the broadest market. And I think the additional thing here that we walked away with is that if a patient has only been on an OTC, the physician can do an attestation, and then they should have access to QuestNut.
Yes, good morning.
Joey.
I'll take the first part of your question I think there were two parts there yes.
Yes, so what we see is that the utilization of Blink Rx is growing over time, which is exactly what we intended and we communicated to you all in a strongly communicating to physicians that it's the best opportunity.
Martin J. Gilligan: So we anticipate that, since this was just announced and just became available, we'll start to see an increase in the number of Scripps that are getting through the system. And then we would also imagine that, given this win, and it seems to fit with our strategy, we're very far along in negotiations with other major payers. So we would start to see that coming on board probably during, as we enter into Q2, and then going into the rest of the year. The other thing I'll just say is what we've actually been able to do in terms of supporting that with BlinkRx. I think you heard me mention that a couple times.
For ensure patients get access to bow questioner. So you would you would assume that since the launch that continues both in 2023 up until this point that the utilization of Blink Rx grows.
Just wanted to clarify for you an important point in terms of the filled scripts. So as you take a look and.
When you think about the scripts that you're seeing in the <unk> those were actually filled at retail.
Anything else that we're seeing above and beyond that was actually part of the fills out took place uplink Rx. So we would envision to the second part of your question is.
Martin J. Gilligan: Our goal there was really to make sure that, first of all, customers had a good experience. We wanted to address the lack of coverage early on. We also wanted to make sure that commercial patients got Bequesna as the position intended. And then the other thing that was really important to us was that the program that we set up for the refills so that once a patient converted from patient support over to commercial coverage, that went through normal channels. Sorry, just maybe a follow-up and a really quick one. I understand you're in the early phase of a launch and not providing any sort of guidance, but could you just talk about your comfort with the consensus out there, which is around 40-45 million? And also, could you talk about the GTN dynamics, where we are and how you think it's going to evolve, and where do you expect it to end up in 2024?
<unk> split will remain consistent and then we will start to change and shift Moreover to retail as we get more wins in.
Great. Thanks, so much for the color.
Thank you and one moment as we move on to our next question.
And our next question is going to come from the line of Paul Choi with Goldman Sachs. Your line is open. Please go ahead.
Okay.
Great. Thank you and good morning, everyone I just wanted to maybe follow up a little bit on the previous question with regard to the pace of conversion between blank and <unk>.
Filled scripts and so forth.
I guess as you think about that ratio over the course of the next 12 to 18 months.
Do you expect it to evolve more more linearly or do you sort of see step function changes as coverage is.
Added here, including wins such as the recent.
With that and then I had a pipeline question.
Yes so.
Paul.
I'll take that question again, so I think you'll see that change over time based upon access so early on in the very early weeks of launch obviously, we had no access so what went into blink.
Yatin Suneja: Thank you. Sure. Hi Yatin. I'll take that. It's Molly.
Was clearly filled from a patient they received the prescription and they use our patient support program.
Molly Henderson: So overall, as you said, we're not providing specific guidance as it relates to our revenues, other than reinforcing our previous commentary that we expect very nominal revenues for the first couple quarters of launch, as we're building payer coverage and working through the stocking that I alluded to in Q4. As it relates to GTN, we are not necessarily commenting necessarily on where we are based upon the discussions we have ongoing with the payers. But what we have said previously, and we'll continue to provide some framework of guidance around is the run rate. And what we have said is that we expect between 50 and 65% on a normalized basis from a steady state. So those are the only pieces that we're providing guidance on at this point, as we're so early in the launch. Thank you. And one moment as we move on to our next question, and our next question is going to come from the line of Joseph Stringer with Needham and Company. Your line is open. Please go ahead.
Going forward as we have more access and theres more win wins with Payors with no scripts come in there'll be immediately identified as having commercial coverage and will be sold at retail.
Okay got it.
And then a pipeline question.
The program is really interesting.
I noticed in the press release, you guys referenced.
PPI as off label or unapproved treatment, but im just curious how youre thinking about the study population.
Clearly in the recent light of.
<unk> being approved for that population as well as two Pixar and so I'm. Just curious are you thinking about this study as a treatment naive population or a post steroid post biologic population as your initial study study population maybe subsequent studies in other populations down the road. Thank you very much.
Joseph Robert Stringer: Hi, good morning. Thanks for taking our questions. Gave some very helpful info on the contribution to filled scripts from BlinkRx since launch. But just curious if you can comment on the relative proportion of that Blink IQVIA split. Was it higher or lower in 4Q23 than what it was in the first quarter of this year to date?
<unk>.
Hey, Paul Thanks for the question I'll I'll kick it off and then I'll pass over to Anthony.
So we're finalizing the protocol for the <unk> phase two we are really excited about that.
And as you know PPI utilize this line, but another period.
<unk> positioning in the treatment paradigm would be pre biologic first line.
And so that's what we're pursuing there and we intend to initiate that phase III by year end, but maybe as maybe do you have any other comments.
Martin J. Gilligan: And maybe as a follow-up to that, can you provide any qualitative guidance on how you see that relative split trending as the launch goes on? And, of course, more coverage is secured. Would you expect that to trend down and reach a steady state level at some point? Yeah, good morning. Good morning, Joey. So I'll take the first part of your question. I think there were two parts there.
Yes.
We're definitely targeting first line, we're looking at broader population because remember this is a phase II. So we need to understand the performance in different population.
Segments.
But the intent is to be first line pre biologic patient.
Patients will start with a similar treatment that hopefully we'll be able to show it's effective.
Thank you.
Thank you and one moment as we move on to our next question.
And our next question is going to come from the line of Nomura asset with Evercore. Your line is open. Please go ahead.
Martin J. Gilligan: Yeah, so what we see is that the utilization of BlinkRx is growing over time, which is exactly what we intended. And, you know, we communicated to you all and are strongly communicating to physicians that it's the best opportunity to ensure patients get access to VoQuesna. So you would assume that since the launch that continues both in 2023 up until this point, the utilization of BlinkRx grows. I do just want to clarify, though, for you an important point in terms of the filled scripts. So, as you take a look and think about the scripts that you're seeing in Acuvia, those were actually filled at retail. Anything else that we're saying above and beyond that was actually part of the deals that took place at BlinkRx. So we would imagine that the second part of your question is that that split will remain consistent, and then we'll start to change and shift more over to retail as we get more wins. Great, thank you so much for the color.
Hi, guys. Thanks for taking my question I have a couple here if I may 1st could.
Could you remind us there is some confusion on whether the.
<unk> taken IMS, especially what was observed in January.
Was that a function of IMS, just doing a better job capturing blink or was that completely exclusive maybe a different way of answering that is.
The significant sort of acceleration we saw almost tripling in <unk> heading into January February was that also seen in the prescriptions to date you guys saw and I have a couple of follow ups.
Yes. Good morning number so I think what your question was specifically asking about the <unk> data and any anything uptick or anything else in January.
What that is any script that has gone through a retail channel is being picked up by <unk>. So that's all scripts realized through normal retail channels.
It's all scripts, but I guess just to clarify.
Acceleration seen in prescription pickup which is over a doubling of <unk> was that something also observed in the prescription fill rate you guys were seeing as well the overall prescriptions.
Paul Choi: Thank you. And one moment as we move on to our next question. And our next question is going to come from the line of Paul Choi with Goldman Sachs. Your line is open. Please go ahead.
Yes, yes, we're seeing that we're seeing the same patterns.
Martin J. Gilligan: Great, thank you. And good morning, everyone. I just want to maybe follow up a little bit on the previous question with regard to the pace of conversion between Blink and filled scripts and so forth. And just, I guess, as you think about that, that ratio over the course of the next 12 to 18 months, do you all expect it to evolve more, more linearly? Or do you sort of see step function changes as coverage is added here, including when, such as the recent Express Scripts ad, and then add a pipeline question? Yeah, so, Paul, I'll take that question again. So I think that you'll see that change over time based upon access. So early on, in the very early weeks of launch, obviously, we had no access.
<unk>, Blink and anything thats filled by Blink and anything thats filled by the <unk>, but what you are seeing on a weekly basis through <unk> are all scripts that are filled through retail means.
Okay got it that's great now the next one is really around some of the stuff. The data points you guys shared so we know by <unk>.
Total prescriptions reported so far are just under 2000 or so.
You guys implied 3800 have been failed so is it reasonable to assume that the IQ via to Blink ratio is about one to one right now is that reasonable.
Yes, I think I think it's a pretty pretty good assumption tumor.
Got it and I guess the last one would be how do you think about.
How do you think about the prescriptions being filled up is that because of some payment issue because presumably through blinked people are able to pay for.
50, or $75 and get it so why would there be 10000, or so prescriptions not picked up.
Paul Choi: So what went into Blink was clearly filled from a patient, they received the prescription, and they used our patient support program. Going forward, as we have more access, and there are more wins with payers, when those scripts come in, they'll be immediately identified as having commercial coverage and will be filled at retail. Okay.
Yes so.
Physicians have obviously when they are writing a prescription.
Ability to send it anywhere and Thats, a really important point that fill questions available at all retail pharmacies Blink.
Blink overall as a new service that we are creating change at the same time, what we're seeing is utilization growing a blank we're seeing.
Weekly demand growing at blank, meaning theres, new physicians coming in and there is repeat physicians coming in so we would expect over time as more physicians start to use blink.
Terrie J. Curran: And then a pipeline question. The EOE program is really interesting. I noticed in the press release, you guys reference PPI as an off-label or unapproved treatment. But I'm just curious, you know, how you think about the study population, particularly in the light of Budesonide being approved for that population, as well as Dupixent. And so I'm just curious, are you thinking about this study as a treatment naive population or a post-steroid, post-biologic population as your initial study population and maybe, you know, subsequent studies in other populations down the road? Thank you very much. Hey Paul, thanks for your question. I'll kick it off, and then I'll pass it over to Azmi.
See that gap start to narrow simultaneously as we have more wins. The gap is also going to narrow. So there is we're an early weeks of the launch humor. So theres a lot of variation that we're seeing in the midst of a launch and then in a very positive side, we will see more variation in things such as this going forward.
Okay excellent. Thank you very much.
Youre welcome.
Thank you and one moment as we move onto our next question.
And our next question is going to come from the line of Matthew Coffield with H C. Wainwright. Your line is open. Please go ahead.
Great Hi, good morning, guys and congrats on the launch progress.
Based on the current erosive labeling do you have a sense of whether any non erosive patients or patients that are possibly unconfirmed if their diseases erosive or non erosive are included in the current script launch numbers either.
Azmi Nabulsi: So we're finalizing the protocol for the ischemic ehrlichiosophagitis Phase 2. We're really excited about that. And as you know, PPIs are used first line but are not approved. And so our positioning in the treatment paradigm would be pre-biologic first line. And so that's what we're pursuing there, and we intend to initiate that Phase 2 by year end. But maybe Azmi, do you have any other
<unk> sorry, the <unk> numbers.
Yes, thanks for the question.
Right now, it's not even right now we're not tracking by.
By indication, but I guess, what I should make really clear is we're also not promoting for non erosive.
So at the same time, we're not measuring any non erosive utilization.
Azmi Nabulsi: Yeah, I mean, we're definitely targeting first. We're looking at a broader population because, remember, this is phase two, so we need to understand the performance in different population segments. But the intent is to be first in line pre-bio, as patients will start with a similar treatment that, hopefully, we'll be able to show. Thank you. Thank you, and one moment as we move on to our next question. And our next question is going to come from the line of Umer Raffat with Evercore. Your line is open. Please go ahead. Hi guys, thanks for taking my question. I have a couple here, if I may.
Okay.
That's helpful. And then just one quick follow up so with the range of the <unk> scripts written to date and the 3800 plus that were filled.
Is that spread at least at this stage in line with what you would've expected for this part of launch.
Yes, just to clarify did you say nationwide.
Yes.
Yes, yes, no we're seeing we're seeing.
<unk> similar uptake similar across the U S. We're not seeing differences by area of the country regions.
And so we have the representatives are calling on 52000 physicians.
And they're all getting very similar positive feedback receptivity that we're seeing uptake across all of the <unk>.
Umer Raffat: First, could you remind us, there was some confusion on whether the uptake in IMS, especially what was observed in January, was that a function of IMS just doing a better job capturing blink, or was that completely exclusive? Maybe a different way of answering that. The significant sort of acceleration we saw, almost tripling TRX heading into January and February. Was that also seen in the prescriptions to date that you guys saw? And I have a couple of follow-ups. Yeah, good morning, Umer.
All of the different targets that we're calling on and we're really pleased with the demand we see 14000 scripts and as I mentioned earlier or I should say written scripts.
I mentioned earlier that we only had our full sales force in place only seven weeks ago. It really shows that the unmet need is there. We're hearing feedback from physicians that they're seeing patients already who were quickly within hours healing healing results that happened in a very short period of time.
Martin J. Gilligan: So I think what your question was specifically asking about the IQVIA data and any uptick or anything else in January. What that is, is any script that has gone through a retail channel is being picked up by IQVIA. So that's all scripts realized through normal retail channels; thank you all for listening. Yeah, yeah, we're seeing this, we're seeing the same patterns between Blink and anything that's filled by Blink and anything that's filled by QVIA. But what you're seeing on a weekly basis through QVIA are all scripts that are filled through RetailMe. Okay, I got it.
Okay, great. Thank you and congrats on the progress.
Thank you and one moment for our next question.
And our next question is going to come from the line of Chase Knickerbocker with Craig Hallum. Your line is open. Please go ahead.
Good morning, everyone.
Obviously, great to see with the ESI win.
I guess Martin what's your confidence level in kind of recreate the structure, there, particularly around how they're structured.
Pretty simple process, if it's simple.
Umer Raffat: That's great. Now, the next one is really around some of the stuff the data points you guys shared. So we know from IQVIA that the total prescriptions reported so far are just under 2000 or so, and you guys implied that 3800 have been filled. So is it reasonable to assume that the IQVIA to blink ratio is about one to one right now? Is that reasonable?
Animated Paul if they were on our <unk> in the last six months or so and then a simple attestation on the OTC PPS is that something that you think you can recreate kind of broadly in all your contracts.
Yes, so the chase.
I would say that the confidence that Scripps will go through for express scripts National formulary as we're absolutely confident about.
What I'll also say is and I believe Terry mentioned this in our opening remarks.
Umer Raffat: Yeah, I think that I think it's a pretty, pretty good assumption, Umer. Got it. And I guess the last point would be, how do you think about, um, how do you think about the prescriptions being filled? Is that because of some payment issue?
We have really progressed with the large payers.
In terms of getting access peripheral questioner and all of those discussions are centered around the same strategy as one step through PPI and I think as we've always spoke about before is that is the largest segment given that the majority of patients are already on the PPI and Theres a lot of switching from.
Unknown Executive: Because, presumably, through Blink, people are able to pay. Transcription by CastingWords: Yeah, so, you know, physicians have, obviously, when they're writing a prescription, the ability to send it anywhere. And that's a really important point that PhilQuest is available at all retail pharmacies. Blink, overall, is a new service that we are creating change at the same time.
<unk> PPI to another there is a lot of OTC add ons. So we see that this is.
We really were successful in getting the broadest population possible.
But then particularly around that kind of.
The structure of the PPA, there and how it functions. That's something that you think you can recreate the other large formularies and then also I just wanted to dig in a little bit on the characteristics of the early riders so far they largely Gi docs should we think of them as higher volume. Obviously is just a couple of scripts filled purpose prescriber today just.
Martin J. Gilligan: What we're seeing is utilization growing for Blink. We're seeing weekly demand growing for Blink, meaning there are new physicians coming in, and there are repeat physicians coming in. So we would expect over time, as more physicians start to use Blink, you might see that gap start to narrow. Simultaneously, as we have more wins, the gap is also going to narrow.
Some color there would be helpful.
Yes, so I'll take the first part of the question in terms of the OTC.
Martin J. Gilligan: So there's, you know, we're in the early weeks of the launch, Umer, so there's a lot of variation that we're seeing in the midst of a launch. And then, on the very positive side, we'll see more variation in things such as this going forward. Okay, excellent. Thank you very much. Welcome. Thank you, and one moment as we move on to our next question. And our next question is going to come from the line of Matthew Caufield with H. C. Wainwright.
Associated with that so listen this is clearly something thats on the table for discussion.
Our best case was and will always be one step through our PPI I would take that addition of a PPA for an OTC patient is beyond the best case, So I feel really confident about our best case and very hopeful that we can also get that additional ta.
In terms of in terms of utilization, thus far our sales force has been very focused on calling on the highest volume physicians in the category and as you can imagine when you play all that out the majority of them who have spent in the highest volume of Gastroenterologists. So as a result of what we're seeing out of the gate is our larger.
Matthew Coleman Caufield: Your line is open. Please go ahead. Great. Hi. Good morning, guys. And congrats on the launch progress. So based on the current erosive labeling, do you have a sense of whether any non-erosive patients or patients that are possibly unconfirmed whether their disease is erosive or non-erosive are included in the current script launch numbers, either uqvia or the BlinkRx numbers? Yeah, thanks for the question.
Group of prescribers or Gis, However, I'll say, what's really nice and there is they've got.
Martin J. Gilligan: You know, right now, well, not even right now, we're not tracking by indication. But I guess what I should make really clear is we're also not promoting non-erosive. So at the same time, we're not measuring any non-erosive utilization.
A real a real strong base in those offices of nurse practitioners or physician assistance, we're seeing uptake among them. They are actually often the both the first line prescriber as well as those who are accountable for switches and then we're just starting to see prescriptions among primary care as we start reaching out to that group.
Martin J. Gilligan: Okay, that's helpful. And then just one quick follow up. So with the range of the 14 case scripts written to date and the 3800 plus that were filled, is that spread, at least at this stage, in line with what you would have expected for this part of the launch? Yeah, just to clarify, do you say nationwide? Yeah. Yes, yeah, no. We're seeing similar uptake across the US. We're not seeing differences by area, or by country regions.
Got it that makes sense and then lastly, just one for Molly.
But quite a bit of stock based comp in the quarter is that kind of one time, new employee stock comp and then that's it from me. Thank you.
Yes, hi, Jason Yes, so that related to the psus associated with the approval of erosive GERD.
$19 three of that was I would characterize as a onetime event.
Martin J. Gilligan: And so, you know, we have representatives calling on 52,000 physicians. And they're all getting very similar, positive feedback and receptivity, and we're seeing uptake across all of the different targets that we're calling on. We're really pleased with the demand when we see 14,000 scripts. And as I mentioned earlier, or I should say written scripts, and as I mentioned earlier, that we only had our full salesforce in place only seven weeks ago, it really shows that the unmet need is there. We're hearing feedback from physicians that they're seeing patients already who it worked quickly within hours, healing, and healing results that happened in a very short period of time. Okay, great.
Great. Thanks, a lot.
Thank you and one moment for our next question.
And our last question is going to come from the line of <unk> with Guggenheim. Your line is open. Please go ahead.
Thank you just one follow up which is around the spend rate obviously with DTC campaign. Just curious if you can articulate how should we model to spend in 2024. Thank you.
Yes, so we're not providing any additional commentary as it relates to guidance on spend yet, but what we can say with confidence is that the spend that we're anticipating for DTC is well within our guidance for the cash runway and we feel comfortable that we still have runway through <unk>.
Matthew Coleman Caufield: Thank you and congratulations on the progress. Thank you and one moment for our next question. And our next question is going to come from the line of Chase Knickerbocker with Craig Hallam. Your line is open. Please go ahead. Good morning, everyone. You know, obviously, great to see with the ESI win.
That's very good thank you.
Thank you. This does close today's question and answer session, Ladies and gentlemen. This also does conclude today's conference call. Thank you for participating and you may now disconnect everyone have a great day.
Chase Richard Knickerbocker: I guess, Martin, what's your confidence level, you know, in kind of recreating the structure there, particularly around, you know, how the PA is structured? You know, pretty simple PA process if it's a simple, you know, automated poll if they were on RX PPIs in the last six months or so, and then, you know, a simple attestation on the OTC PPIs. Is that something that you think you can recreate kind of broadly in all your contracts?
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Martin J. Gilligan: Yeah, so the Chase, I would say that the confidence that Scripps will go through for Express Scripps National Formulary is that we're absolutely confident of that. What I'll also say is, and I believe Terrie mentioned this in her opening remarks, we've really progressed with the large payers in terms of getting access for Vaquesna. And all of those discussions are centered around the same strategy as one step through a PPI. And I think, as we've always spoken about before, that is the largest segment, given that the majority of patients are already on a PPI, and there's a lot of switching from one PPI to another. There's a lot of OTC add-ons.
Martin J. Gilligan: So we see that this is, we really were successful in getting the broadest population possible. But then, particularly around that kind of the structure of the PA there and how it functions, that's something that you think you can recreate on the other large formularies. And then also, I just want to dig in a little bit on the characteristics of the early writers so far.
Martin J. Gilligan: They are largely GI docs; we think of them as higher volume. Obviously, it's just a couple scripts filled per prescriber today. Just some color there would be helpful.
Martin J. Gilligan: Yeah, so I'll take the first part of the question in terms of the OTC, you know, the PA associated with that. So listen, this is clearly something that's on the table for discussion. And you know, our best case was and will always be one step through a PPI. I would take that adding a PA for an OTC patient is beyond the best case. So I feel really confident about our best case and very hopeful that we can also get that additional PA. In terms of utilization, thus far, our sales force has been very focused on calling on the highest volume physicians in the category. And as you can imagine, when you lay all that out, the majority of them who fit in the highest volume are gastroenterologists.
Martin J. Gilligan: So as a result, what we're seeing out of the gate is our largest group of prescribers are GIs. However, I'll say what's really nice about them is they've got a real, really strong base in those offices of nurse practitioners or physician assistants. We're seeing uptake among them. They're actually often both the first line prescriber, as well as those who are accountable for switches. And then we're just starting to see prescriptions amongst primary care as we start reaching out to that group.
Chase Richard Knickerbocker: That makes sense. And then lastly, just one for Molly. Quite a bit of stock-based comp in the quarter. Is that, you know, a one-time, new employee sort of stock comp? And then, you know, that's it for me.
Molly Henderson: Thank you. Yep. Hi, Chase.
Molly Henderson: Yeah, so that related to the PSUs associated with the approval of erosive GERD. So 19.3 of that was, I'd characterize as, a one-time event. Great. Thanks, Molly. Thank you, and one moment for our next question. And our last question is going to come from the line of Yatin Suneja with Guggenheim. Your line is open, please go ahead.
Yatin Suneja: Thank you. Just one follow-up, which is around the spend rate, obviously, with the DTC campaign. Just curious if you can articulate how we should model the spend.
Molly Henderson: Yeah, so we're not providing any additional commentary as it relates to guidance on SPEN, Yatin, but what we can say with confidence is that the SPEN that we're anticipating for DPC is well within our guidance for the cash runway, and we feel comfortable that we still have runway through 2026. Very good. Thank you. Thank you. This does close today's question and answer session. Ladies and gentlemen, this also does conclude today's conference call. Thank you for participating and you may now disconnect. Everyone have a great day. ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? Hello and welcome to the Phathom Pharmaceuticals fourth quarter and full year 2023 earnings conference. At this time, all participants are in a listen-only mode.
Operator: After the presentation, there will be a question-and-answer session. To ask a question during this session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising you that your hand is raised.
Operator: To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. With that, I would like to turn the conference over to Eric Sciorilli, Phathom's Head of Investor Relations. Please go ahead.
[music].
Eric Sciorilli: Thank you, operator. Hello, everyone, and thank you for joining us this morning to discuss Phathom's fourth quarter and full year 2023 results. This morning's presentation will include remarks from Terrie Curran, our President and CEO, Martin Gilligan, our Chief Commercial Officer, and Molly Henderson, our Chief Financial Officer. Azmi Nabulsi, our Chief Operating Officer, will also be joining the team during the Q&A portion of today's call. Just a couple of logistical items before we get started. Earlier this morning, we issued a press release detailing the results we will be discussing during the call. A copy of that press release can be found in the news releases section of our corporate website. In addition, the recording of today's webcast can be found in the events and presentations section of our corporate website.
Eric Sciorilli: Before we begin, let me remind you that we will be making a number of forward-looking statements throughout today's presentation. These forward-looking statements involve risks and uncertainties, many of which are beyond Phathom's control. Actual results can materially differ from the forward-looking statements, and any such risk can materially adversely affect the business, the results of operations, and trading prices for Phathom's common stock.
Eric Sciorilli: A discussion of these statements and risk factors is available on the current Safe Harbor slide, as well as in the risk factor section of our most recent Form 10-K and subsequent SEC filing. All forward-looking statements made on this call are based on the beliefs of Phathom as of this date, and Phathom disclaims any obligation to update these statements. Also included today are non-GAAP financial measures, which should be considered only as supplemental to, and not a substitute for, or superior to, GAAP measures.
Eric Sciorilli: To the extent applicable, please refer to the tables at the end of this morning's press release for reconciliations of these non-GAAP measures to the most directly comparable GAAP measures. With that, I will now turn the call over to Terrie Curran, Phathom's President and CEO, to kick us off.
Terrie J. Curran: Thank you, Eric, and thank you to all those joining us on today's call. This is our first earnings call as a commercial company, and I'm excited to report on the progress we've made during both the fourth quarter of 2023 and the start of the calendar year 2024. In that short period, we've achieved many regulatory, manufacturing, financial, and commercial milestones, demonstrating the significant experience and dedication of our team. In November, we set out with three initial goals for the early stages of launch: communicate Quesna's clinical superiority versus the PPI, drive awareness with physicians, and build access to commercial patients. Today I'm proud to share that we're delivering on those goals. Prescribers have quickly recognized Quesna's differentiated and novel mechanism of action.
Hello, and welcome to the Fathom Pharmaceuticals fourth quarter and full year 2023 earnings conference call. At this time all participants are in a listen only mode. After the presentation. There will be a question and answer session to ask a question. During the session you will need to press star one on your telephone you will then hear an automated message. So if I didn't hear you.
Terrie J. Curran: Our reps are even sharing stories of physicians echoing the Quesna's rapid, potent, and durable acid suppression profile. Excitement is translating into demand, with thousands of scripts being written since the product became available. After over 30 years since the first PPI was approved, there is strong demand for something new. Further, the number of patients who have used the Quesna is growing daily.
Your hand is raised.
Your question. Please press Star one again, please be advised today's conference is being recorded with that I would like to turn the conference over to Eric Shirley Southern's head of Investor Relations. Please go ahead.
Thank you operator, Hello, everyone and thank you for joining us this morning to discuss fathoms fourth quarter and full year 2023 results.
Terrie J. Curran: For me, this is one of the most rewarding elements of our launch. Through our reps, employees, and sometimes even friends and family, I'm hearing stories of long-suffering patients who are experiencing noticeable improvement with the Quesna. We're working hard to ensure as many patients as possible can access Quesna and share that experience. In fact, with our recent Express Scripts win, we're well on our way to securing widespread coverage for commercial patients. These early indicators, along with Benoprezen's massive commercial success in Japan, have reinforced my belief in Bequesna's bright future here in the U.S. With an erosive GERD market of approximately 7 million U.S. adults, positive feedback from physicians and patients, and anticipated label expansions, we remain confident in our belief that Quesna has the potential to reach annual peak revenue of greater than $3 billion. As for our early For clarity, this includes scripts captured by Acuvia, as well as those that were filled through BlinkRx.
This morning's presentation will include remarks from Terrie Curran, our president and CEO Martin go again, our Chief commercial officer, and Molly Henderson, Our Chief Financial Officer.
<unk>, our chief operating officer will also be joining the team during the Q&A portion of today's call.
Just a couple of logistical items before we get started.
Earlier. This morning, we issued a press release detailing the results we will be discussing during the call a.
A copy of that press release can be found under the news releases section of our corporate website.
Further the recording of today's webcast can be found under the events and presentations section of our corporate website.
Before we begin let me remind you that we will be making a number of forward looking statements throughout todays presentation. These forward looking statements involve risks and uncertainties many of which are beyond fathoms control actual results could materially differ from the forward looking statements and any such risks can materially adversely affect the business the results of.
<unk> and trading prices for <unk> common stock and a discussion of these statements and risk factors is available on the current safe Harbor side as well as in the risk factors section of our most recent Form 10-K and subsequent SEC filings.
Terrie J. Curran: We specify filled because we have simultaneously been monitoring an estimate of total demand, which we believe paints a comprehensive picture of the early and growing position interest in writing the Quesna product. We estimate upwards of 14,000 total prescriptions have been written-launched to date. We're pleased with this magnitude of total demand and see it as an indicator of what's on the horizon for the Quesna as we continue pursuing broad payer culture. Last month, the Quesna was added to Express Scripts national formularies for commercial patients. In line with our goal, we secured placement with a single step edit through a generic PPI. As a result, the Quesna bottle's access expanded to an estimated 60 million commercially covered lives.
All forward looking statements made on this call are based on the beliefs of fathom as of this date and fathom disclaims any obligation to update these statements.
Also included today are non-GAAP financial measures, which should be considered only as supplemental to and not a substitute for or superior to GAAP measures to the extent applicable. Please refer to the tables at the end of this mornings press release for reconciliations of these non-GAAP measures to the most directly comparable GAAP measures.
With that I will now turn the call over to Terrie, Curran Darden's, President and CEO to kick us off Barry.
Thank you Eric and thank you so all of those joining us on today's call. This is our first earnings call as a commercial company I'm excited to report on the progress we've made during both the fourth quarter 2023, and the start of the calendar year 2024 in that short period, we have achieved many regulatory manufacturing.
Terrie J. Curran: We believe our ability to obtain commercial formulary placement with one of the nation's largest PBMs so quickly after approval indicates that our pricing and access strategy is responding well with payers. We remain actively engaged with other major PBMs and health plans, and we expect further expansion of commercial coverage throughout 2024. Ultimately, as this coverage comes online, we anticipate the gap between total demand and field scripts will narrow significantly. As we continue to execute on the launch, our R&D team remains focused on advancing pipeline opportunities for the not-present. In December, we announced that the FDA had accepted our non-erosive GERD daily dosing NDA and assigned the PDUFA target action date of July 19, 2024. We are now only four months away from that decision date. Non-erosive GERD represents the largest subcategory of GERD, with an estimated 15 million U.S. adults diagnosed and treated for the disease annually.
During financial and commercial milestone demonstrating the significant experience and dedication of our teams.
In November we set out with three initial goals.
Early stages of launch.
Indicate the equation is clinical superiority versus the PPI drive awareness with physicians and build access to commercial patients did I am proud to share that we are delivering on those calls prescribers have quickly recognize the credit is differentiated and novel mechanism of action, our reps or even.
Sharing stories of physicians echoing the equation is rapid Tyson and <unk> acid suppression profile.
Excitement is translating into demand with thousands of scripts being written since product became available.
After over 30 years since the first PPI was approved there is strong demand for something new.
Terrie J. Curran: If approved, this indication will significantly broaden Quesna's addressable population and we believe it will further accelerate uptake. The review of our application is proceeding as expected, and we continue to plan for a July launch in this sizable indication. As for further development, we anticipate initiating a Phase 3 trial for as-needed non-erosive goods and a Phase 2 trial for eosinophilic esophagitis later this year. We believe Noprexan's unique MOA bodes well for success in these two trials.
The number of patients have used the questioner is growing daily.
This is one of the nice rewarding elements that launch turnaround reps in place and sometimes even the friends and family I'm hearing stories of long suffering patients.
Experiencing noticeable improvement with sequester.
We're working hard to ensure as many patients as possible can access and share that experience in fact with our recent express scripts when we're well on our way to securing widespread coverage the commercial patients.
These early indicators along with Bill presents massive commercial success in Japan.
Reinforced my belief in the equation is bright future here in the U S.
Terrie J. Curran: If approved, these additional label expansions will further differentiate Monoprazan relative to PPIs and continue to expand the total addressable market for the Quezna products. We're excited about these programs and anticipate sharing more information about our progress in the future. Later in the call, Molly will further detail our fourth quarter and full year 2023 financials, for which we reported revenues of $682,000 and ended the year with $381 million in cash.
With an eraser good market of approximately 7 million U S. Adults positive feedback from physicians and patients and anticipated label expansions. We remain confident in our belief that <unk> has the potential to reach annual peak revenues of greater than $3 billion.
As for our early launch data I'm happy to report that I have a 3800 prescriptions have been filled for the equation of products.
For clarity. This includes scripts captured by <unk> as well as those that were filled through Blink Rx.
We specify field because we have simultaneously be monitoring an estimate of total demand.
Terrie J. Curran: Overall, we believe our strong balance sheet will enable us to continue delivering on our launch and development strategy. I've previously stressed several foundational dynamics that are necessary for a potential blockbuster drug. These included a significant addressable market, clear unmet need among patients, demonstrated superiority, and positioned malice. The qualitative feedback from these early months of launch has bolstered our belief that these elements are present in the GERD market. It now comes down to us executing on our strategy, and this team is poised to deliver.
Which we believe paints a comprehensive picture.
Ali and growing position interest in riding the questioner products.
We estimate upwards of 14000 total prescriptions have been written launch to date. We're pleased with this magnitude of total demand and see it as an indicator of what's on the horizon.
As we continue pursuing broad payer coverage.
Last month <unk> was added to express scripts national Formularies, the commercial patient.
Last month <unk> was added to express scripts national Formularies, the commercial patient.
In line with our goal, we secured placement with a single step edit sure generic PPI.
Terrie J. Curran: These are exciting times for Fathom as we continue to make progress on both the commercial and development fronts. This year is sure to be filled with new milestones and will set the foundation for the future of the Questionnaire. Our pursuit of becoming the number one prescribed acid suppressant in the U.S. is off to a strong start, and we remain steadfast in delivering on our strategy of driving blockbuster potential through continued market expansion. I will now turn the call over to Martin to dive deeper into our launch progress. Martin
As a result, the questioner bottles access expanded to an estimated $60 million commercially covered lives.
We believe our ability to obtain commercial formulary placement was one of the nation's largest pbms. So quickly after approval indicates that our pricing and access strategy is resonating well with payers.
We remain actively engaged with other major Pbms and health plans and we expect further expansion of commercial coverage throughout 2024.
Ultimately as this coverage comes online we anticipate the gap between total demand and field scripts will narrow significantly.
Martin J. Gilligan: Thanks, Terrie. And hello, everyone. I'd like to first echo Terrie's comments that we're very happy with how the launch of Aquesna has started. It is progressing as anticipated, and our pre-launch research is being validated by the feedback we're hearing from physicians and patients. During today's call, I'll touch on both quantitative and qualitative elements from our launch. But I know many of you on this call are most keen to hear about our script data, so let's start there. Today, we're reporting script data as of February 23rd from both Acuvia and BlinkRx, which represents our latest available information.
As we continue to execute on the launch our R&D team remains focused on advancing pipeline opportunities and I'll present.
In December we announced that the FDA had accepted our non erosive.
Daily dosing NDA and assigned a <unk> target action date of July 19, 2024.
We are now in a format so away from that decision date.
Non or I said good represents the largest subcategory of good with an estimated 50 million U S. Adults diagnosed and treated for the disease annually.
If approved this indication will significantly broaden the quiznos addressable population and we believe further accelerate uptake.
Martin J. Gilligan: With the second half of our sales force entering the field in early January, this reflects about seven weeks of our full promotional effort. This has translated into achieving over 3,800 filled prescriptions that have reached patients' hands. As our reps continue to promote to positions and garner the backing of strengthened commercial coverage, we expect positive script momentum to continue. Additionally, our KPIs indicate that over 1,200 unique prescribers have written a bequest of scripts that have ultimately been filled. Among those writers, we are already seeing repeat prescribing, which builds our confidence that physicians recognize Quesno's value for patients. We are encouraged by the initial breadth of this prescriber base and anticipate it will grow as we further engage with high-volume targets. Another important metric that Terrie mentioned was total demand. We estimate that upwards of 14,000 prescriptions have been written since the start of launch. We believe the significant amount of demand to be indicative of the high level of unmet need in the market.
The review of the application is proceeding as expected and we continue to plan for July launch in this sizable indication.
As for further development, we anticipate initiating a phase III trial to as Natus non or I think.
In our phase III trial for Ace and affiliate Gustaf Agile. That's later this year.
We believe the not presents unique MLA bodes well for success in these two trials afib.
If approved these additional label extensions will further differentiate <unk>.
Then relative to PPI and continue to expand the total addressable market for the equivalent products.
We're excited about these programs and anticipate sharing more information about our progress in the future.
Later in the call Molly will further detail, our fourth quarter and full year 2023 financials.
For which we reported revenues of 692000 and ended the year with $381 million in cash.
Overall, we believe our strong balance sheet will enable us to continue delivering on our launch and development strategies.
I've previously stressed several foundational dynamics that are necessary for a potential blockbuster drug <unk>.
These included a significant addressable market clear unmet need among patients.
Martin J. Gilligan: It demonstrates that patients are interested in trying something new, and physicians are willing to write requests. As you've heard us say historically, providing access to patients is key to meeting demand. As with all new products, negotiating coverage with payers is an essential step in achieving a successful launch, and this process often takes time. In anticipation, we established a patient support program through BlinkRx, which has meaningfully expanded patient access, resulting in an increased number of filled scripts. Early data shows the use of BlinkRx growing consistently and being accompanied by positive feedback. However, there are still physicians sending scripts to their patients' long-established retail pharmacies.
Constraining superiority and physician demand.
Qualitative feedback from these early months of launch has bolstered our belief that these elements are present in the good market.
Now comes down to us executing on our strategy and this team is poised to deliver.
These are exciting times with Adam as we continue to make progress on both the commercial and development fronts.
This year is sure to be filled with new milestone.
We'll set the foundation for the future of the Quesnel.
Our pursuit of becoming the number one prescribed.
<unk> in the U S is off to a strong start and.
And we remain steadfast in delivering on our strategy of driving blockbuster potential through continued market expansion.
Ill now turn the call over to Martin to dive deeper into our launch progress Martin.
Martin J. Gilligan: Although this has led to a proportion of early requested prescriptions not being filled, we believe we are well positioned to convert more of these scripts over time. In the near term, our sales force continues to emphasize the availability of BlinkRx to physicians, as it often represents the best option for getting Boquesna into patients' hands. And ultimately, future contracting with PBMs and health plans will increase payer access and narrow the gap between total demand and filled scripts. In fact, we have a question now in formulary at the first of the three major PBMs; we are already making progress on that front. The first major PBM contracting win was with Express Scripts, often referred to as ESI.
Thanks, Terry and Hello, everyone I'd like to first Echo Terry's comments that we're very happy with how the launch of a question of has started we're progressing as anticipated and our prelaunch research is being validated by the feedback we're hearing from physicians and patients.
During today's call I'll touch on both quantitative and qualitative elements from our launch.
But I know many of you on this call are most keen to hear about our script data so let's start there.
Today, we're reporting script data as of February 23rd from both Cuba, and Blink Rx, which represents our latest available information.
With the second half of our sales force entering the field in early January this reflects about seven weeks of our full promotional efforts.
This has translated to achieving over 3800 filled prescriptions, which have reached patients' hands.
Martin J. Gilligan: About three weeks ago, we announced the positioning of Bequesna on ESI's national formulary. This was a key accomplishment for Phathom, expanding Bequesna's availability to roughly 23 million additional commercial lines. Our team was able to secure non-preferred brand status with a single step edit exactly as intended. The single step is with respect to the use of generic PPI prescriptions within the last 130 days. These criteria will be evaluated at the pharmacy counter electronically, avoiding any administrative burden for physicians or office staff.
As our reps continue to promote to physicians and garner the backing of strengthened commercial coverage, we expect positive script momentum to continue.
Additionally, our kpis indicate that over 1200 unique prescribers have written to the question of scripts that has ultimately been filled.
Among those writers we are already seeing repeat prescribing, which builds our confidence that physicians recognize for Christmas value for patients.
We are encouraged by the initial breath of this prescriber base and anticipate it will grow as we further engage with high volume targets.
Martin J. Gilligan: Alternatively, if a patient used over-the-counter PPIs instead of prescriptions during that time period, they could also satisfy the single step by means of prior authorization with attestation by their doctor. This latter avenue for access is a significant development as it means ASI patients could potentially access Quesna as a first-line treatment. As intended, this formulary position provides physicians a straightforward path to accessing Boquesna for the broadest patient population. Bequest's total commercial coverage now reflects an estimated 60 million commercially covered lives.
Another important metric that Terry mentioned was total demand we estimate that upwards of 14000 prescriptions have been written since the startup launch.
We believe the significant amount of demand to be indicative of the high level of unmet need in the market.
It demonstrates that patients are interested in trying something new and physicians are willing to wait for questions.
As you've heard us say historically, providing access to patients is key to converting demand.
As with all new products negotiating coverage with payers is an essential step in achieving a successful launch and this process often takes time.
In anticipation, we establish a patient support program uplink Rx, which has meaningfully expanded patient access resulting in an increased number of field scripts.
Martin J. Gilligan: Achieving this level of commercial access less than three months into product availability is fantastic, but we know there is still work to be done. We believe our progress so far bodes well for our other ongoing negotiations where we remain focused on securing Quesna coverage with similar formulary positions. We are confident in our strategy and believe it will continue to yield expanded coverage, resulting in an uptick in filled prescriptions throughout the remainder of 2024. Shifting to our promotional efforts, sales reps continue to report back that Bequesta is generating enthusiasm among prescribers. Physicians are articulating patients' unmet need and recognizing Boquesna's value as a treatment option. The refs are focused on their reach and frequency among our full call panel of approximately 52,000 targets.
Early data shows that use of Blink Rx growing consistently accompanied by positive feedback.
However, there are still physicians, sending scripts to their patients long established retail pharmacies.
Although this has led to proportion of early for questions prescriptions not being filled we believe we are well positioned to convert more of these scripts overtime.
In the near term our Salesforce continues to emphasize the availability of link our extra positions as it often represents the best option for getting the questioner into patients' hands in.
And ultimately future contracting with Pbms and health plans will increase payer access and narrow the gap between total demand unfilled scripts.
In fact, the requested now on formulary at the first of the three major Pbms, we are already making progress on that front.
Martin J. Gilligan: In parallel, we are working diligently to reach patients suffering from the conditions for which Bequesna is approved. In these early days, we are happy to see that we appear to be making an impact. Today, we've had over 185,000 visits to our consumer website, and we're hearing from physicians' offices that patients are asking about ProQuestna. Patient requests are a key component of our demand strategy, and market research conducted with 200 of our target physicians, almost 80% stated they would grant bequest upon request for their erosive GERD patients. With this in mind, we plan to initiate a new branded consumer campaign, which has been met with positive and motivating feedback from test audiences. This campaign speaks directly to a group of GERD patients and their symptoms.
The first major PVM contracting win was with express scripts, often referred to as ESI about.
About three weeks ago, we announced the positioning of a question on ESI National Formulary. This was a key accomplishment for fathom expanding the questions availability to roughly $23 million additional commercial lives.
Our team was able to secure non preferred brand status with a single step edit exactly as intended.
The single step is with respect to use of generic PPI prescriptions within the last 130 days.
These criteria will be evaluated at the pharmacy counter electronically avoiding any administrative burden for physicians our office staff.
Alternatively, if a patient use over the counter <unk> instead of prescriptions during that time period. They could also satisfy the single step by means of a prior authorization with asset station by their Doctor.
Martin J. Gilligan: Most notably, this will include TV commercials on popular streaming services. So if you suffer from erosive GERD, keep an eye out for the ads on your devices starting later this month. In closing, I'm extremely happy with the commentary we're hearing from prescribers and how it translates into demand. We are successfully executing our launch strategy. With continued promotion to physicians, a broadened consumer campaign, and expanded commercial coverage, we anticipate significant growth in filled prescriptions over the course of 2024. Our teams are energized and committed to our belief in the blockbuster potential for Verquezna. I'll now pass it off to Molly to walk through our financial results. Molly.
This latter Avenue for access is a significant development as it means ESI patients could potentially access for quest as a first line treatment.
As intended this formulary position provides physicians a straightforward path to accessing bow cuesta for the broadest patient population.
For questions total commercial coverage now reflects an estimated 60 million commercial covered lives.
Achieving this level of commercial access less than three months Endo product availability is fantastic, but we know there is still work to be done.
We believe our progress so far bodes well for our other ongoing negotiations, where we remained focused on securing for quest to coverage with similar formulary position.
We are confident in our strategy and believe it will continue to yield expanded coverage, resulting in an uptick in filled prescriptions throughout the remainder of 2024.
Shifting to our promotional efforts the sales reps continue to report back that the question is generating enthusiasm with prescribers.
Molly Henderson: Thank you, Martin, and hello to everyone on the call. I'm happy to share our fourth quarter and full year 2023 financial results with you today. This is a momentous earnings call for Phathom, as it is the first time we are reporting net revenues for our Requisna product. Although revenues reflect about a month of launch activity, we are pleased with the initial results. I'd like to note two things before going into the numbers.
Physicians are articulating patients' unmet need and recognizing <unk> value as a treatment option.
Our reps are focused on their reach and frequency among our full call panel of approximately 52000 targets.
In parallel we are working diligently to reach patient suffering from the conditions for which the president is approved.
In these early days, we are happy to see that we appear to be making an impact.
To date, we've had over 185000 visits to our consumer website and we're hearing from physicians offices that patients are asking about sequester.
Molly Henderson: First, during this call, we will not be providing financial guidance regarding projected annual revenues, spend, or earnings as we are still in the early months of launch. Additionally, I will be commenting on both GAAP and non-GAAP financial measures. Supporting schedules with detailed reconciliations between non-GAAP measures and their most directly comparable GAAP measures will be discussed later in my section and can be found in this morning's press release. Now, turning to the numbers. For the fourth quarter of 2023, we reported net revenues of $682,000, driven by the initial stocking of wholesalers in December. This reflects a partial quarter of sales given that Vaquesna bottles became commercially available as of November 28th and Vaquesna packs as of mid-December. Additionally, we reported gross profit of $515,000 for the fourth quarter of 2023, which equates to a gross margin of approximately 76%. The cost of revenues includes royalties owed to Takeda and excludes certain inventory costs which were expensed prior to receiving FDA approval. Note that the royalties owed as part of our revenue interest financing agreement are not captured in the cost of revenues but rather in other interest expenses.
Patient requests are a key component of our demand strategy and market research conducted with 200 of our target physicians almost 80% stated they would wrap up president upon request for their erosive GERD patients.
With this in mind, we plan to initiate a new branded consumer campaign, which has been met with positive and motivating feedback from test audiences.
This campaign speaks directly to erosive GERD patients and their symptoms.
Most notably this will include TV commercials on popular streaming services.
If you suffer from erosive GERD keep an eye out for requests the ads on your devices. Starting later this month.
In closing I am extremely happy with the commentary, we're hearing from prescribers and how it translates into demand.
We are successfully executing our launch strategy with continued promotion of physicians, a broadened consumer campaign and expanded commercial coverage, we anticipate significant growth in filled prescriptions over the course of 2024 or.
Our teams are energized and committed to our belief in the blockbuster potential for request now.
I'll now pass it off to Mali to walk through our financial results Molly.
Thank you Martin and Hello to everyone on the call I'm happy to share our fourth quarter and full year 2023 financial results with you today.
This is a momentous earnings call for Fathom as it is the first time, we are reporting net revenues for our requests new products.
Other revenues reflect about one month of launch activity. We are pleased with the initial results.
I'd like to note two items before going into the numbers. During this call we will not be providing financial guidance regarding projected annual revenues spend or earnings as we are still early months of launch. Additionally, I will be commenting on both GAAP and non-GAAP financial measures.
Molly Henderson: Moving down the P&L to our spend, we reported non-GAAP R&D expenses of $6.1 million for the fourth quarter 2023, compared to $14.3 million for the same period in 2022. As for ST&A, we reported non-GAAP expenses of $39.7 million for the fourth quarter 2023, compared to $25.7 million for the fourth quarter 2022. On a full year basis, we reported non-GAAP R&D expenses of $37.6 million for 2023, compared to $65.9 million for 2022. And for SG&A, our non-GAAP expense was $85.2 million for 2023, compared to $82.4 million for 2022.
Supporting schedules with detailed reconciliations between non-GAAP measures and their most directly comparable GAAP measures will be discussed later in my section and can be found in this morning's press release.
Now turning to the numbers for the fourth quarter 2023, we reported net revenues of 682000, driven by the initial stocking of wholesalers in December.
This reflects a partial quarter sales given that book question of bottles became commercially available as of November 28th and requesting the packs as of mid December.
<unk>, we reported gross profit of 515000 for the fourth quarter, 2023, which equates to a gross margin of approximately 76%.
The cost of revenues includes royalties owed to Takeda and exclude certain inventory costs, which were expense prior to receiving FDA approval.
Note that the royalties owed as part of our revenue interest financing agreement are not captured in cost of revenues, but rather in other interest expense.
Molly Henderson: On a full year and quarterly basis, the decrease in R&D expenses was primarily related to lower clinical trial costs as we concluded our Phase 3 non-erosive GERD daily dosing trial in 2023. Regarding SG&A, our increase in spend was driven by the buildout of our commercial infrastructure and initiation of marketing activities in support of the commercial launch of Bequest. Additionally, the most significant reconciling item between GAAP and non-GAAP OPEX expenses for the period was non-cash stock-based compensation, largely associated with the vesting of performance shares upon the approval of Erosive GERD.
Moving down the P&L to our spend we reported non-GAAP R&D expenses of $6 1 million for the fourth quarter 2023, compared to $14 3 million for the same period in 2022.
As for SG&A, we reported non-GAAP expenses of $39 7 million for the fourth quarter 2023, compared to $25 7 million for the fourth quarter 2022.
On a full year basis, we reported non-GAAP R&D expenses of $37 6 million for 2023 compared to $65 9 million for 2022.
And for SG&A, our non-GAAP expense was $85 2 million for 2023 compared to $82 4 million for 2022.
Molly Henderson: Other non-GAAP reconciling items include non-cash interest on a revenue interest financing liability and non-cash interest expense related to the amortization of debt discount. Turning to EPS, we reported a gap net loss for the fourth quarter 2023 of $79.6 million or $1.39 loss per share compared to $55 million or $1.33 loss per share for the fourth quarter 2022. Non-gap adjusted net loss for the fourth quarter 2023 was 46 million or 80 cents loss per share compared to 42.2 million or $1.02 loss per share for the same period in 2022. As of December 31st, 2023, cash and cash equivalents were $381 million.
On a full year on a quarterly basis. The decrease in R&D expenses was primarily related to lower clinical trial costs. As we concluded our phase III non erosive GERD daily dosing trial during 2023.
Regarding SG&A our increase in spend was driven by the buildout of our commercial infrastructure and initiation of marketing activities in support of the commercial launch of our questionnaire.
Additionally, the most significant reconciling items between GAAP and non-GAAP Opex expenses for the period was noncash stock based compensation largely associated with the vesting of performance shares upon the approval of erosive GERD.
Other non-GAAP reconciling items include noncash interest on a revenue interest financing liability and noncash interest expense related to the amortization of debt discount.
Turning to EPS, we reported GAAP net loss for the fourth quarter 2023 of $79 6 million or $1 39 loss per share compared to $55 million or $1 33.
Molly Henderson: This includes $175 million received during the fourth quarter of 2023 from our Revenue Interest Financing Agreement upon the approval of Rose of Girton. Also, during the fourth quarter, we announced the expansion of our existing term loan facility with Hercules Capital. The amendment provides access to more favorable terms and an additional $100 million in non-dilutive capital subject to achievement of certain revenue milestones.
Loss per share for the fourth quarter 2022.
non-GAAP adjusted net loss for the fourth quarter for 2023 with $46 million or <unk> <unk>.
<unk> per share compared to $42 2 million or $1 <unk> loss per share for the same period in 2022.
As of December 31, 2023, cash and cash equivalents were 381 million. This includes $175 million received during the fourth quarter of 2023 from a revenue interest financing agreement upon the approval of rest of garden.
Also during the fourth quarter, we announced the expansion of our existing term loan facility with Hercules capital.
Molly Henderson: With this amendment, we now have a total of $160 million available via our debt facility. We believe we are in a solid financial position and reaffirm our expectation that we will have cash runway through the end of 2026, based on our current operating plan, expected product revenues, and funds available under our terms. Lastly, as we shared previously, we expect nominal revenues during these first couple quarters of launch while payer coverage is materialized. Additionally, I mentioned our fourth quarter 2023 revenues, which mostly represented inventory stocking by hold. We expect a sell-through of the stock to take place during the first quarter of 2024, reinforcing our previous comments regarding nominal revenues during these first couple quarters of launch. With that, I'll now turn the call back over to Terrie for closing comments. Terry.
The amendment provides access to more favorable terms and an additional $100 million in non dilutive capital subject to achievement of certain revenue milestones.
With this amendment, we now have a total of $160 million available via our debt facility.
We believe we are in a solid financial position and reaffirm our expectation that we have cash runway through the end of 2026 based on our current operating plan expected product revenues and funds available under our term loan.
Lastly, as we shared previously we expect nominal revenue. During these first couple of quarters of launch while payer coverage is materializing.
Additionally, I mentioned in our fourth quarter 2023 revenues, mostly represented inventory stocking by wholesalers, we expect to sell through of the stocking to take place during the first quarter of 2024, reinforcing our previous comments regarding nominal revenue. During these first couple of quarters of launch.
With that I'll now turn the call back over to Terry for closing comments.
Terrie J. Curran: Thank you, Molly. And thank you again to everyone joining us on today's call. Phathom's accomplishments in 2023 were nothing short of amazing, and I'm extremely proud of this team.
Terry.
Thank you Mollie and thank you again to everyone joining us on today's call fathoms accomplishments in 2023 with nothing short of amazing and I'm extremely proud of this team.
Terrie J. Curran: As we round out Q1 and approach Q2, our primary focus is set on securing formal replacement with Payette. We've made great progress on that front so far and anticipate expanded commercial coverage throughout the year. As for the back half of 2024, we believe the planned launch of non-erosive GERD daily dosing in July, pending FDA approval, will serve as another key catalyst for driving adoption. We believe Aquenda represents a blockbuster opportunity, and this launch is off to an exciting start. The enthusiasm here at Phathom is tremendous, and there is much to look forward to in 2024. Thank you again for joining us today.
As we round out Q1 and approach Q2, our primary focus has been on securing formulary placement with payors.
Great progress on that front, so far and anticipate expanded commercial coverage throughout the year.
As for the back half of 2024, we believe the planned launch of non erosive. Good daily dosing in July pending FDA approval will serve as another key catalyst to driving adoption.
We believe the equation and represents a blockbuster opportunity and this launch is off to an exciting start.
Susie Hasnt here at Fathom is tremendous and there is much to look forward to in 2024.
You again for joining us today. We appreciate your continued interest and support I'll now turn it over to the operator to facilitate a 10 minute question and answer session operator.
Operator: We appreciate your continued interest and support. I'll now turn it over to the operator to facilitate a 10 minute question and answer session. Operator.
Operator: Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again.
Thank you as a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, one moment, while we compile our Q&A roster.
Operator: One moment while we compile our Q&A, and our first question comes from the line of Yatin Suneja with Guggenheim. Your line is open. Please go ahead. Hey, guys, thank you for taking my question. A couple of questions for me.
And our first question comes from the line of Yadkin <unk> with Guggenheim. Your line is open. Please go ahead.
Hey, guys. Thank you for thank you for taking my question a couple a couple from me could you just talk about the reason for not filling the scrip other than the coverage and how long does it takes four blank.
Yatin Suneja: Could you just talk about the reason for not filling the script other than the coverage? And how long does it take for blank Rx patients to get the coverage? Yeah, so Yatin, this is Martin, and I'll take that question. So in terms of the coverage, you know, I'll just reiterate how happy we are with the Express Scripps win. As we've talked about in the past, our objective was to get one step through the PPI, which opens up the broadest market. And I think the additional thing here that we walked away with is that if a patient has only been on an OTC, the physician can do an attestation, and then they should have access to BequestNet.
On X to get a blank on X patients to get the coverage.
Yeah. So yeah. This is Martin I'll take that question. So in terms of the coverage I will just reiterate how happy we are with the express scripts win.
As we've talked about in the past our objective was to get one step through our PPI.
Opens up the broadest market and I think the additional thing here that we walked away with is that if a patient has only been on an OTC. The physician can do it attestation and then they should have access to the plasma. So we anticipate that since it was just announced and just became available we will start to see an increase in the number of scripts that are getting through.
Martin J. Gilligan: So we anticipate that, since this was just announced and just became available, we'll start to see an increase in the number of Scripps that are getting through the system. And then we would also imagine that, given this win, and it seems to fit with our strategy, we're very far along in negotiations with other major payers. So we would start to see that coming on board probably during, as we enter into Q2, and then going into the rest of the year. The other thing I'll just say is what we've actually been able to do in terms of supporting that with BlinkRx. I think you heard me mention that a couple of times.
The system and then we would also envision that given this win and it seems to fit with our strategy, we're very far along in negotiations with other major payers. So we would start to see that coming on board.
During as we enter into Q2, and then going into the rest of the year.
The other thing I'll, just say is what we've actually been able to do is in terms of supporting that as with Blink Rx I think you heard you mentioned that a couple of times. Our goal there was really to make sure that first of all customers had a good experience. We wanted to address the lack of coverage early on.
Martin J. Gilligan: Our goal there was really to make sure that, first of all, customers had a good experience. We wanted to address the lack of coverage early on. We also wanted to make sure that commercial patients got Bequesna as the position intended. And then the other thing that was really important to us was that the program that we set up for refills so that once a patient converted from patient support over to commercial coverage, that went through normal channels. Sorry, just maybe a follow-up and a really quick one. I understand you're in the early phase of a launch and not providing any sort of guidance, but could you just talk about your comfort with the consensus out there, which is around 40-45 million?
Also wanted to make sure that commercial patients on <unk>.
<unk> got another question that is a position incentive and then the other thing that was really important to US was that the program that we set up that the refills will realize that once a patient converted from patient support over to commercial coverage that went through normal channels.
Got it and then just maybe a follow up in a really quick one I understand you on an early phase of our launch of not providing sort of guidance, but could you just talk about your comfort with the consensus out there which is around 40 to 45 <unk> and then also if you can talk about the.
Yatin Suneja: And then also, if you could talk about the GTN dynamics, where we are and how you think it's going to evolve, and where you expect to end up in 2024? Thank you. Sure. Hi Yatin. I'll take that. It's Molly.
GTS dynamics, where we are and how do you think it's going to evolve and where do you expect to end up in 2024. Thank you.
Sure.
I'll take that it's Molly.
Molly Henderson: So overall, as you said, we're not providing specific guidance as it relates to our revenues, other than reinforcing our previous commentary that we expect very nominal revenues for the first couple quarters of launch, as we're building payer coverage and working through the stocking that I alluded to in Q4. As it relates to GTN, we are not necessarily commenting necessarily on where we stand; we are based upon the discussions we have ongoing with the payers. But what we have said previously, and we'll continue to provide some framework of guidance around is the run rate. And what we've said is that we expect between 50 and 65% on a normalized basis from a steady state. So those are the only pieces that we're providing guidance on at this point, as we're so early in the launch. Thank you, and please take a moment as we move on to our next question. And our next question is going to come from the line of Joseph Stringer with Needham and Company. Your line is open. Please go ahead. Hi, good morning.
So overall as you said, we're not providing specific guidance as it relates to our revenues other than reinforcing our previous commentary that we expect very nominal revenues for the first couple of quarters of launch as we are building payer coverage and working through the stocking that we.
That I alluded to in Q4 as it relates to GCN.
Not commenting necessarily on where we were.
Based upon the discussions we have ongoing with the payers, but we have said previously and we'll continue to provide some framework guidance around is the run rate and what we've said is that we expect between 50 and 65%.
On normalized basis.
A steady state. So those are the only pieces that we're providing guidance at this point.
As we're still early in the launch.
Thank you and one moment as we move on to our next question.
And our next question is going to come from the line of Joseph <unk>, Joseph Stringer with Needham <unk> Company. Your line is open. Please go ahead.
Hi, good morning, Thanks for taking our questions gave some very helpful. Info on the contribution to field scripts from Blink Rx since launch, but just curious if you can comment on the relative proportion so that <unk> split was it higher or lower in <unk> 'twenty.
Joseph Robert Stringer: Thanks for taking our questions. Gave some very helpful info on the contribution to field scripts from BlinkRx since launch. But just curious if you can comment on the relative proportion of that Blink IQVIA split. Was it higher or lower in 4Q23 than what it was in the first quarter of this year to date?
Three then what.
It is.
In the first quarter of this year to date and.
Martin J. Gilligan: And maybe as a follow-up to that, can you provide any qualitative guidance on how you see that relative split trending as the launch goes on? And, of course, more coverage is secured. Would you expect that to trend down and reach a steady state level at some point? Yeah, good morning. Good morning, Joey.
Maybe as a follow up to that can you provide any qualitative guidance on how you see that relative split trending as the launch goes on and of course more coverages carrier would you expect that to trend down and reached a steady state level at some point.
Yes, good morning.
Joey.
Martin J. Gilligan: So I'll take the first part of your question. I think there were two parts there. Yeah, so what we see is that the utilization of BlinkRx is growing over time, which is exactly what we intended. And, you know, we communicated to you all and are strongly communicating to physicians that it's the best opportunity to ensure patients get access to VoQuesna. So you would assume that since the launch that continues both in 2023 up until this point, the utilization of BlinkRx grows. I do just want to clarify, though, for you an important point in terms of the filled scripts. So as you take a look and think about the scripts that you're seeing in Acuvia, those were actually filled at retail.
So I'll take the first part of your question I think there were two parts there yes.
Yes, so what we see is that the utilization of Blink Rx is growing over time, which is exactly what we intended and we communicated to you all in a strongly communicating to physicians that it's the best opportunity.
For ensure patient gets access to bow questioner.
You would you would assume that since the launch that continues both in 2023 up until this point that the utilization of link Rx grows.
Just wanted to clarify Joe for you an important point in terms of the film scripts. So as you take a look and.
When you think about the scripts that you're seeing in <unk> those were actually filled at retail.
Martin J. Gilligan: Anything else that we're saying above and beyond that was actually part of the bills that took place at BlinkRx. So we would imagine the second part of your question is that that split will remain consistent, and then we'll start to change and shift more over to retail as we get more wins. Great, thank you so much for the color.
Anything else that we're seeing above and beyond that was actually part of the build out took place uplink Rx. So we would envision to the second part of your question is.
<unk> split will remain consistent and then we will start to change and shift Moreover to retail as we get more Windsor.
Great. Thank you so much for the color.
Paul Choi: Thank you. And one moment as we move on to our next question. And our next question is going to come from the line of Paul Choi with Goldman Sachs. Your line is open. Please go ahead. Great. Thank you. And good morning, everyone.
Thank you and one moment as we move on to our next question.
And our next question is going to come from the line of Paul Choi with Goldman Sachs. Your line is open. Please go ahead.
Okay.
Great. Thank you and good morning, everyone I just wanted to maybe follow up a little bit on the previous question with regard to the pace of conversion between blank and.
Martin J. Gilligan: I just want to maybe follow up a little bit on the previous question with regard to the pace of conversion between Blink and filled scripts and so forth. And just, I guess, as you think about that, that ratio over the course of the next 12 to 18 months, do you all expect it to evolve more, more linearly? Or do you sort of see step function changes as coverage is added here, including when, such as the recent Express Scripts ad?
<unk> scripts and so forth.
I guess as you think about that ratio over the course of the next 12 to 18 months.
Do you expect it to evolve more more linearly or do you sort of see step function changes as coverage.
Added here, including wins such as the recent.
Paul Choi: And then I had a pipeline question. Yeah, so, Paul, I'll take that question again. So I think that you'll see that change over time based upon access. So early on in the very early weeks of launch, obviously, we had no access.
With that and then I had a pipeline question.
Yes so.
Paul.
I'll take that question again, so I think you'll see that change over time based upon access so early on in the very early weeks of launch obviously, we had no access so what went into blink.
Martin J. Gilligan: So what went into Blink was clearly filled from a patient, they received the prescription, and they used our patient support program. Going forward, as we have more access, and there are more wins with payers, when those scripts come in, they'll be immediately identified as having commercial coverage and will be filled at retail. Okay, got it. And then a pipeline question. The EOE program is really interesting.
Was clearly filled from a patient they received the prescription and they use our patient support program.
Going forward as we have more access and theres more win wins with Payors with those scripts come in there'll be immediately identified as having commercial coverage and will be filled at retail.
Okay got it.
And then a pipeline question.
<unk> program is really interesting.
Paul Choi: I noticed in the press release, you guys reference PPI as an off-label or unapproved treatment. But I'm just curious, you know, how you think about the study population, particularly in the light of Budesonide being approved for that population, as well as Dupixent. And so I'm just curious, are you thinking about this study as a treatment naive population or a post-steroid, post-biologic population as your initial study population and maybe, you know, subsequent studies in other populations down the road? Thank you very much. Hey Paul, thanks for your question.
I noticed in the press release.
You guys referenced.
PPI is off.
Off label or unapproved treatment, but I'm, just curious how youre thinking about the study population.
Clearly in the recent light of.
<unk> being approved for that population as well as <unk>.
And so I'm just curious are you thinking about this study as a treatment naive population or a post steroid post biologic population as your initial study study population that maybe.
Studies in other populations down the road. Thank you very much.
Hey, Paul Thanks for the question I'll I'll kick it off and then I'll pass over to Anthony.
Terrie J. Curran: I'll kick it off, and then I'll pass it over to Azmi. So we're finalizing the protocol for ischemic ehrlichisophagitis phase 2. We're really excited about that.
So we're finalizing the protocol for the <unk> phase two we're really excited about that.
Azmi Nabulsi: And as you know, PPIs are used first line but are not approved. And so our positioning in the treatment paradigm would be prebiologic first line. And so that's what we're pursuing there, and we intend to initiate that Phase 2 by year end. But maybe Azmi, do you have any other comments? Yeah, I mean, we're definitely targeting first. We're looking at a broader population because, remember, this is phase two, so we need to understand the performance in different population segments. But the intent is to be first in line pre-bio, as patients will start with a similar treatment that, hopefully, we'll be able to show. Thank you. Thank you, and one moment as we move on to our next question. And our next question is going to come from the line of Umer Raffat with Evercore. Your line is open.
And as you know <unk> utilize this line, but another approved and positioning in the treatment paradigm would be pre biologic post line.
And so that's what we're pursuing there and we intend to initiate that phase III by year end, but maybe do you have any other comments.
Yes.
We're definitely targeting first line, we're looking at broader population because remember this is a phase II. So we need to understand the performance in different population.
Segments.
But the intent is to be first line pre biologic patient.
Patients will start with assemblers treatment that hopefully, we'll be able to show it's effective.
Thank you.
Thank you and one moment as we move on to our next question.
And our next question is going to come from the line of whom Mcgrath with Evercore. Your line is open.