Q4 2024 ARS Pharmaceuticals Inc Earnings Call
Thank you.
Speaker Change: Good day and welcome to ARS Pharmaceuticals' fourth quarter on full year 2024 financial results conference call. At this time all participants are on a listen only mode. After the speaker's presentation there will be a question and an intercession. Instructions will be provided at that time.
Speaker Change: As a reminder, this call is being recorded. I would like to turn the call over to Justin Chakma, Chief Business Officer. Please go ahead.
Speaker Change: Good morning, with me today, Richard Lowenthal, co-founder, president, and CEO of ARS Pharma, Eric Karas, our Chief Commercial Officer, and Kathy Scott, our CFO .
Richard Lowenthal: Our call today will proceed as follows. Rich will provide an overview of our corporate progress and key development insights into the nephew launch. Eric will discuss nephew's ongoing and plant commercialization efforts in the US and a market strategy. Kathy will then provide a financial overview after which we will open the call for questions.
Richard Lowenthal: Before we begin, please note that today's discussion includes forward-looking statements based on our current expectation.
Richard Lowenthal: These statements are subject to risks and uncertainties that may cause actual results to differ materially. Please refer to our earnings and release issue today for further details on the discussion of risks.
With that, I'll turn the call over to Rich.
Rich: Thank you, Justin, and thank you to everyone dialing in today.
The past six months have been extremely productive for ARS.
Rich: Since September , we have successfully launched Nephi 2 milligrams in the United States and secured FDA approval for the 1 milligram Nephi dose for patients weighing 15 kilograms to less than 30 kilograms. The population of children at this lower weight range that will use Nephi 1 milligram represents 23% of the current auto-injector market.
ARS has also made significant strides in payer coverage.
Rich: With over 51% commercially ensured able to get Neffi without a prior authorization as of April 1st and we anticipate over 80% without prior authorization by early this summer with the addition of Neffi to the care mark formulary.
Rich: Our commercial execution has established a strong foundation of healthcare provider awareness for NFE as a compelling alternative to traditional epinephrine autoinjectors, providing patients with a needle-free, portable, and highly effective option for severe allergic reactions, including antiflexus.
Rich: The U.S. epinephrine market represents a $3 billion in the annual net sales near-term addressable opportunity among 6.5 million patients prescribed epinephrine in the last three years, with an additional expansion opportunity among untreated patients of over $7 billion in annual net sales covering an estimated 20 million patients that have been diagnosed with severe allergic reactions based on claims data.
Rich: However, only 3.2 million patients consistently fill their auto-injector prescriptions, leaving a vast population without protection. Nephi directly addresses this gap by eliminating barriers such as the needle anxiety and portability
Rich: Just a few weeks ago at the 2025 American Academy of allergy asthma, and immunology annual scientific meeting, we showcase nine presentations on the continuously growing body of clinical evidence demonstrating the therapeutic value of Murphy to health care providers.
Rich: Notably among the presentations at the Quad AI meeting Ah study in Japanese patients experienced anaphylaxis symptoms. After oral food challenge found that patients receiving lasting experienced low symptom scores within 10 minutes compared to traditional intramuscular injection.
Rich: A separate set of clinical studies in China reinforced the bracketed pharmacokinetics and Pharmacodynamic profile of Murphy and persons with pure Chinese ethnicity, demonstrating its efficacy and safety under a variety of conditions, including self administration allergic rhinitis infectious rhinitis.
Rich: Allergy challenges and repeat dosing.
Rich: And additional analysis confirmed that Murphy is safe and achieved an effective exposures of epinephrine for patients four years of age and older and weighing 15 kilograms to less than 30 kilograms.
Rich: I'm proud of these data we presented at the quality of our meeting as it showcases nephew.
Rich: Extensive and rigorous clinical development program.
Rich: Nephew remains the only approved product to have generated anaphylaxis efficacy data in our clinical studies to have met the bracketing criteria established by FDA for approval of all key pharmacokinetic parameters to ensure safety and efficacy and to have that data demonstrating that it is well tolerated in children down to 15 Kelly.
Rich: <unk> body weight to account for almost half of the patients prescribed epinephrine.
Rich: This and other extensive clinical data we have previously presented on nephews profile has now been supported by the growing real world data of treating anaphylactic reactions from our nephew experience program.
Rich: The data from the naphthalene experienced program to date.
Rich: Is numerically better than that historically reported with the epinephrine injections, we plan to share additional details of the survey of our depth of experience program. Once we have completed the survey and plan to repeat this several times during the program as it progresses with over 2500 clinicians having Murphy.
Rich: For oral food challenges in immunotherapy treatments.
Rich: At quite a high one hundreds of physicians shared with US many of their positive success stories of treating patients with raffi, including cases, where patients had been rescued by Murphy from even having very severe anaphylactic reactions and being unconscious.
Rich: Physicians are clearly and enthusiastically communicating to us that they believe that nothing is definitely represent a new standard of care.
Rich: We have established a strong initial commercial trajectory in the U S to ultimately deliver on this expectation and establish <unk> as a new standard of care.
Rich: Since the initial launch in September 2020 for Murphy generated $7 3 million in net product revenue in the United States, reflecting our strong early adoption since it became available in the fourth quarter and strong breadth of early prescribing with thousands of health care providers prescribing Murphy.
Rich: <unk> allergy community's confidence in Murphy as an alternative treatment.
Rich: That said as you can see in the IQ via prescription data we are still on the early part of the S curve of what we anticipate to grow into a multi billion dollar blockbuster peak sales trajectory, we anticipate a significant inflection in both the depth as well as the breadth of health care provider.
Rich: <unk> prescribing later this year as the <unk>.
Rich: Headwinds from the need for prior authorization requests diminish.
Rich: Health care providers consistently tell us that the current levels of nephew prescribing represent only a fraction of their intended use of the product in the future.
Rich: In fact, one meeting allergist stated that he intends to switch all of those 4000 patients, but our data shows that this doctors only prescribed to about 1% of their patients to date given the need for these prior authorizations to get approval.
Rich: Our key learning that we launch is the unique administrative barrier that prior authorization is posed for nafie due to the large volume of epinephrine eligible patients as well as the acute nature of this disease.
Rich: This resulted in the need for a very large number of prior authorizations to get a significant revenue given each prior authorization translates to an average of one three prescriptions per patient to date.
Rich: As a result healthcare providers only have bandwidth to prescribed very selectively due to the cumulative time required to prepare prior authorizations, even with simply tide forums and arris facilitation through blank Rx.
Rich: Based on this feedback from hundreds of prescribers, including most.
Rich: Most recently at the Quad AI meeting, we expect to see a tipping point and the nephew trajectory as we obtain our payer coverage goals early this summer and make prescribing more seamless for physicians.
Rich: Our payer engagement strategy has already yielded multiple favorable coverage decisions, including the fed the group purchasing organization for express scripts, one of the three largest pharmacy benefit managers in the United States, who put <unk> on formulary within 10 weeks of launch.
Rich: In the last month, we also had signed contracts and provided patients with unrestricted access telephony with two other group purchasing organizations MSR and zinc at terms that preserve our greater than 50% gross to net yield.
Rich: MSR signing agreement in February, adding nephew to their formulary, which now gives patients who have optimized access without any restrictions.
Rich: As of April 1st United Health Care will also add <unk> to their formulary with unrestricted coverage under the MSR agreement.
Rich: Just the past few days, we also obtained agreement and coverage with zinc, which provides access to the largest payer in the United States Cvs Caremark as well as anthem Aetna and several other insurers, we anticipate being on formulary for Cvs Caremark, Aetna and others by July.
First in time for the summer peak prescribing season for children.
Rich: Therefore, we remain on track for 80% unrestricted commercial coverage by the summer of this year.
Rich: We have also made progress on Medicaid with bellwether states, such as Texas, Alabama, and Montana, adding Murphy to their formularies without prior authorization and other states are expected to follow suit in the coming months, leading into the summer prescribing season for children.
Rich: By this summer, we anticipate physicians to freely start writing Murphy for their patients without being deterred by the administrative workload of prior authorizations. This will be in time for back to school season, driven by the pediatric population.
Rich: We will also be supported by the fact that we will have one milligram Murphy in the marketplace by May 2025, which represents 23% of all prescriptions as mentioned earlier.
Rich: And having ended this year with over $314 million in cash or cash equivalents. We are in a strong financial position to accelerated adaptation and awareness during the back to school season, including an extensive direct to consumer campaign, we anticipate launching in may of 2025.
Rich: In parallel we are also on track to have a global commercialization footprint with Daffy within one year from now.
Speaker Change: As a reminder, your nafie the equivalent of Murphy in Europe is approved in the European Union.
Speaker Change: Our U K regulatory submission is under review with a decision expected by May 2025, and our partner <unk> Belo is preparing for commercial launches in Germany and UK by this summer.
Speaker Change: Regulatory submissions are also completed and Canada, China, Japan, and Australia with decisions in Canada, China, and Japan anticipated by year end of 2025.
Speaker Change: As we look ahead to physicians and patients demand is clear for nothing.
Speaker Change: We are also getting favorable payer formulary coverage, which is now just a function of time with the three major GPO signing agreements that are favorable and give us a 50% gross to net or better.
Speaker Change: We are also accelerating our marketing and investments in direct to consumer advertising prior to the back to school peak prescribing season.
Speaker Change: We expect to see significantly broader and deeper adaptation that thing across the board.
Speaker Change: Through conversion of the existing epinephrine users reactivation of patients who previously avoided treatment due to their fear of injection and bringing Murphy to those who didn't have a prescription or diagnosis in the past.
Speaker Change: Let me turn the call over to Eric to walk through our commercial highlights and plans for increasing adoption and use of Murphy in 2025.
Eric Karas: Good morning, and thank you rich as we've laid out previously our commercial strategy is focused on three core areas physician education and engagement to drive <unk> adoption and market share per.
Eric Karas: Payer coverage to ensure affordability and access to nappy and patient awareness and education to encourage adoption and <unk>.
Eric Karas: <unk> patients to ask their health care provider for Nike.
Eric Karas: Our team is executing very well against all three of these.
Eric Karas: To date, our sales team is directly engaged with approximately 9000 health care providers.
Eric Karas: Additionally, more than 4000 health care providers have submitted 90 prescriptions through Blink Rx by Nafie connect.
Eric Karas: Importantly, approximately 81% of these prescriptions were submitted by physicians in our highest decile of allergists.
Eric Karas: Our physicians, who represent the highest volume prescriptions in the U S.
Eric Karas: At the recent <unk> meeting, we met with over 1000 physicians and the feedback across the spectrum of stakeholders continues to reinforce the enthusiasm for a needle free epinephrine treatment and the growing demand for Nancy.
Eric Karas: Among the physicians that the team engage at the conference the feedback regarding the product was overwhelmingly positive.
Eric Karas: Many hcp's, who have used <unk> in a clinical setting as part of the experience program shared their experiences.
Eric Karas: One particular influential physician, who is a thought leader amongst its peers had its first experience with nappy just two weeks before the conference.
Eric Karas: He was so impressed with the response, which appeared with in a minute that he shared his experience with his colleagues and nursing team.
Eric Karas: I would just have reported.
Eric Karas: Right, where world success with response rates similar to or even better than those historically recorded with epinephrine injection products.
Eric Karas: As of today, approximately 2500, allergists have enrolled or nephew experienced program and as shared it allows for hands on clinical use and we're well validation of the product. This participation represents over 80% of the health care professionals conducting allergy challenge studies, reflecting a strong interest in <unk>.
Eric Karas: Our commercial team is actively sharing this information with both net the experienced participants and health care professionals, more broadly, which reinforces their confidence in <unk> clinical profile backed by real World response data.
Eric Karas: We have observed strong adoption by payers with positive coverage decisions from major organizations, such as express scripts, Cigna, Optum novelist health and Tri care.
Eric Karas: The coverage enhances access to Napa for millions of commercially insured patients across the nation.
Eric Karas: Are there more starting April one Unitedhealthcare will include Murphy is a covered treatments without a prior authorization.
Eric Karas: In addition, all three group purchasing organizations have signed contracts with us.
Eric Karas: Ascent in late Q4 of last year and zinc in MSR in the last few weeks and we expect downstream payers of these GPO is to adopt the negotiated terms and add nafie to the formularies with unrestricted access.
Eric Karas: Payers recognize the added value that <unk> offers by lowering barriers to prompt epinephrine use leading to better outcomes for patients and reduce health care costs.
Our goal is for <unk> to achieve more than 60% commercial coverage by the end of the first quarter given our current position we are confident in our ability to reach this target. We are actively engaging in discussions in contract negotiations with additional key payers and expect to achieve 80% commercial coverage by the early part of the third quarter.
Eric Karas: As commercial coverage increases the product acquisition process is streamlined, allowing doctors to more easily send prescriptions directly to retail pharmacies, such as Cvs and Walgreens.
Eric Karas: For patients with commercial insurance, our co pay assistance program has made net be more affordable most commercial patients only pay $25 for each prescription which is lower than the average co pay of $40 for generic auto injector.
Eric Karas: Our copay support is automatically applied at the point of sale, ensuring that net is accessible to more patients.
Eric Karas: Switching gears. We are also proud of our nephew schools program, which provides K through 12 schools with two cartons or for single use doses of <unk> at no cost. This initiative aims to promote widespread adoption of the product in schools nationwide.
Eric Karas: To date more than 5000 nurses have participated in our educational sessions and are now advocates for NSE. We greatly appreciate the collaboration with school nurses, who play a crucial role in safeguarding children by administering this easy to use needle free epinephrine device in emergencies.
Eric Karas: As we look ahead, we are planning a large scale direct to consumer advertising campaign. Starting in May. This is time for the peak prescribing season. During the summer. This campaign will include connected TV platforms, such as Hulu, Netflix and prime as well as linear television focused on news and sports channels. In addition.
Eric Karas: We'll utilize print and social media, incorporating influencer partnerships with a combination of broad and targeting advertising strategies.
Eric Karas: This initiative is crucial because our market research indicates that when a patient requests nafie physicians will prescribe. It provided there are no market access barriers. We also recognize that the epinephrine market has been highly responsive to promotional efforts in the past and we have seen no meaningful promotion in the last decade.
Eric Karas: We are planning additional near term commercial initiatives, specifically aimed at the pediatric population targeting both healthcare providers and caregivers, we plan to share more details about these initiatives in the coming weeks.
Eric Karas: The pediatric population significantly contributes to the summer peak and prescriptions observed in the market as schools prepare to reopen we believe we are well positioned to take advantage of this seasonal trend, especially since early adopters of Murphy, our parents with children who were affected the.
Eric Karas: The recent approval of the one milligram dose will allow us to access the entire school age population.
Eric Karas: We also plan to continue collaborating with advocacy partners running PSA campaigns as well as other institutional partners to create a total surround sound environment for naphtha.
Eric Karas: Finally, as the year progresses, we will evaluate further expansion of our sales team by early 2026 to maximize health care provider engagement and drive market share.
Eric Karas: After spending several months on the front lines with our sales team and meeting with hundreds of prescribers. It has become clear that <unk> has a compelling clinical profile that resonates with both physicians and patients. This has been further validated by the successful treatment of patients with allergic reactions as demonstrated in our net he experienced program.
Eric Karas: All indications show that physicians are eager to prescribe <unk> more frequently and we understand the steps needed to remove the obstacles. They face we're excited to unlock the demand for <unk> in the coming months by ensuring a more seamless insurance experience in driving patient demand through our comprehensive DTC campaign, and our sales and marketing efforts.
Eric Karas: Let me now pass the call over to Kathy to talk through our financials.
Kathy Scott: Thanks, Eric we reported our Q4 and full year 2020 financial results press release, this morning, and I'll walk through some of the highlights in terms of sales. We're proud to have recorded $6 7 million in net sales for the fourth quarter of 2024, and $7 3 million for the full year 2024.
Eric Karas: Since our launch in late September.
Eric Karas: These revenues are slightly higher than the preliminary numbers that we announced in mid January.
Eric Karas: Before turning to our revenue I'll take a minute to explain how we're treating the cash proceeds from our <unk> licensing agreement that was signed in November 2024.
Eric Karas: As a reminder, we received a nonrefundable upfront cash payment of $145 million from Alk <unk>.
Eric Karas: In Q4, only $73 5 million of that payment was included in our revenues the remaining $71 $5 million is treated as a liability on the balance sheet due to GAAP accounting treatment spitz.
Eric Karas: Specifically $69 $4 million is treated as a financing liability and $2 1 million is treated as a contract liability for future performance obligations.
This GAAP accounting treatment is because of a specific term license agreement that we built around two main strategic optionality for the future.
Eric Karas: The agreement ensures that AOS has the option to repurchase rights or certain regions.
Eric Karas: Partnered out to Alk, which resulted in our not being able to account for a portion of the cash proceeds as revenue.
Eric Karas: So while the business and economic Okay is that of a licensing agreement due to be opened and the flexibility of the re acquisition run rate GAAP cash flows from these certain territories at the final agreement that shows up on our balance sheet impacting our reported revenue figures.
Eric Karas: To reiterate there is no.
Eric Karas: No impact on the amount of the nonrefundable cash proceeds received and we have full discretion and currently are used.
Eric Karas: Going forward, none of the financing liability from the LTA agreement that appears on the balance sheet as of December 31, 2024 will be included in the revenue until the expiration of the Alk agreement.
Eric Karas: We expect to receive $5 million in cash proceeds from milestones under the alk agreements in each of Q2, our Q4 2025.
Eric Karas: Approximately half of its $5 million payment.
Eric Karas: Will be recognized as GAAP revenue.
Eric Karas: Yes.
Eric Karas: I would not be recognized as GAAP revenue that will be added to the financing liability on the balance sheet.
Future royalty payments from Alk would be recognized as GAAP revenue. If they are related to the territories that are not subject to the repurchase rate royalty.
Eric Karas: Royalty payments related to territories that are subject to the repurchase rate would be capitalized and added to the financing liability on the balance sheet.
Eric Karas: To summarize our 2020 for revenue.
Eric Karas: Total revenue for the fourth quarter of 2024 with $86 6 million.
Eric Karas: Which included $6 7 million in net product revenue from sales in the United States.
Eric Karas: $73 5 million in collaboration revenue from Alk.
Eric Karas: $6 million in collaboration revenue from our licensing partner in Japan.
Eric Karas: $4 million in revenue and supply agreements.
Eric Karas: Full year 2024 revenue totaled $89 1 million.
Eric Karas: $7 3 million in net new sales in the U S.
Eric Karas: $81 $5 million in collaboration revenue.
$4 million of supply agreements.
Eric Karas: The Q4 and full year 2024 revenues do not include the $71 5 million cash proceeds received from alk that are required by GAAP to be recorded as a liability on the balance sheet.
Eric Karas: Turning to our expenses.
Eric Karas: R&D expenses for the fourth quarter and full year, 2024 were 3 million and $19 6 million respectively.
Eric Karas: These costs were primarily associated with the manufacturing to support our U S commercial launch along with certain other product development costs.
Eric Karas: And personnel related expenses.
Eric Karas: Our SG&A expenses for the fourth quarter, and full year, 2024, or $35 5 million.
Eric Karas: The $1 7 million respectively.
Eric Karas: This primarily reflect marketing expenses and personnel related costs associated with the commercial launch of Etsy ads.
Eric Karas: Well, our general operating expenses.
Eric Karas: We had net income of $49 9 million or <unk> 51 per share basic and <unk> 48 per share diluted for the fourth quarter.
Eric Karas: Net income was 8 million or <unk> <unk> per share basic and diluted for the full year 2024.
Eric Karas: In terms of our balance sheet and cash run rate, we ended the year with $314 million cash cash equivalents and short term investments.
Eric Karas: At the time of FDA approval of <unk> two milligram in August 24, we guided to an operating runway at least three years, which budgeted an upfront fee of about $50 million or ex U S partnership.
Eric Karas: Okay licensing agreements provide us with a significantly greater cash infusion of $145 million upfront and an additional $10 million in near term regulatory and launch milestones expected to be in mid to late 2025.
Eric Karas: As such the combination of the capital from our Alk deal along with our earlier than anticipated success in that.
Eric Karas: Favorable coverage decisions from U S payers has given us a lot.
Eric Karas: Our flexibility to further invest in the commercialization of Mackie, while maintaining a strong balance sheet.
Eric Karas: Looking ahead as Eric noted, we plan to accelerate our DTC investment in May in order to take advantage of the back to school seasonality.
Eric Karas: We are projecting a DTC campaign.
Speaker Change: Between 40 and $50 million in 2025.
Speaker Change: In parallel we are working to ensure availability of the one milligram dose for children for years, our order starting to play with.
Speaker Change: With this in mind, we anticipate operating expenses excluding.
Speaker Change: Cost of goods sold and stock based compensation will be approximately $200 million to $210 million full year 2025.
With this forecast, we still expect to maintain a run rate of at least three years based on our current operating plan.
Rich: I'll hand, the call over to rich now to finish up.
Speaker Change: 2024 has set up 2025 to be a pivotal year of commercial execution for Nancy.
Rich: Our primary focus is accelerating adoption of Murphy and expanding global market access and advancing our intranasal epinephrine technology with the plan to start phase two in order to carrier as well as our allergy Challenge Clinic Registry study in the next few weeks.
Rich: The early enthusiasm from physicians payers and patients reinforces our confidence in <unk> potential to become a new standard of care and emergency allergy treatment.
Rich: I'd like to thank the entire era team for their dedication in making this launch a success we.
Rich: We look forward to continued momentum in 2025 and beyond with that let's open up the call for questions.
Rich: Thank you we will now begin the question and answer session, ladies and gentlemen, if you have a question or comment at this time. Please press star one on your telephone. If your question has been answered or you wish to move yourself from the queue. Please press star one again, we will pause for a moment, while we compile the Q&A roster.
Speaker Change: Our first question comes from Ryan <unk> with Raymond James Your line is open.
Ryan: Hi, good morning, Thanks for the question.
Speaker Change: Congrats on the progress.
Speaker Change: I think you mentioned that.
Speaker Change: Nephew, one milligram will be available starting in may.
Speaker Change: A lot of Kols, we've spoken to the big source of demand even currently.
Speaker Change: How are you looking at the ramp for this format relative to what we've seen with the to make product and then I have a follow up.
Speaker Change: Yes, we believe it's additive.
Speaker Change: It's about 23% of the market. However, it's probably more than that for the impact on the sales ramp of <unk> as we discuss the the adoption. We're seeing right now is heavily weighted towards children.
Speaker Change: So obviously, adding.
Speaker Change: The younger children, which obviously parents have more of an issue with injecting.
Speaker Change: It's actually should be very beneficial and as we said we expect it to be weighted.
Speaker Change: And in 2024, it was 23% of the prescriptions for epinephrine injection. So we think that 'twenty three we will have a significant impact on our sales ramp.
Speaker Change: Sorry, the one milligram, assuming a 23% will have a significant impact.
Speaker Change: Got it.
Speaker Change: And then.
Speaker Change: Just one more I was wondering if you could give us any more detail on the progress towards the 80% access goal.
Speaker Change: I think was more towards the end of the third quarter. It sounds like it's evolving.
Speaker Change: And what proportion of <unk> sales do you expect to come from public programs like Medicaid. Thank you.
Speaker Change: And I'll speak a little bit to that and then Eric if there's anything I Miss you can add in.
Speaker Change: So at this point, we're at about as of April one so United Healthcare.
Speaker Change: Came to agreement with Us and we'll put it on unrestricted access on April one so as of April one will be at about 51% of commercial patients will have access without prior authorization now its little over 60% of total.
Speaker Change: But we actually focus on the ones that don't need the prior authorization because that's the.
Speaker Change: What we're realizing is the major barrier to prescribing messy for a lot of physicians, even those that are very favorable.
Speaker Change: They honestly tell us they only have so many hours in a day and weekends to right. Prior authorization. So so it is a big headwind.
Speaker Change: With that also said, we just signed an agreement.
Speaker Change: Really just within the last week with zinc.
Speaker Change: Zinc represents caremark Aetna anthem in a number of other.
Speaker Change: Insurers, which is more than 25% of the commercially insured market.
Speaker Change: Unfortunately, our.
Speaker Change: For whatever reason I can't tell you, but caremark typically only puts things on formulary either January one and July one so.
Speaker Change: So we do currently expect them to put <unk> on formulary by July one they do make exceptions. It could go sooner, but we don't know that yet.
Speaker Change: It's caremark goes on formulary July one we also expect that non anthem to be on formulary and by formulary unrestricted access right. So no prior authorization required because they are already improving prior authorizations.
Speaker Change: Fairly readily.
Speaker Change: But we do expect them to have unrestricted access by July one or sooner.
Speaker Change: So that would bring us very close to that 80% Mark certainly if you count all coverage, but but even just counting unrestricted access I think we'd be close to the 80% Mark by July one.
Speaker Change: And we think thats very encouraging going into the summer season on top of our DTC campaign and other information, we'll be putting out to make doctors more and more comfortable with the use of Murphy. We think it will all come together for this summer period.
Speaker Change: And really hopefully drive sales over the summer.
Speaker Change: Thanks for the color appreciate it.
Speaker Change: One moment for our next question.
Our next question comes from Alexia <unk> with Cantor Fitzgerald. Your line is open.
Speaker Change: Good morning, everyone. This is electric humour on for Josh Shimmer and congrats to the Arris team on another great year.
Speaker Change: Wanted to ask what percentage of the epinephrine market is direct to patients in comparison to the broader entities like airlines and schools.
Speaker Change: Okay Kara.
Speaker Change: Italy, very little is being sold.
Speaker Change: Outside of the retail market, so almost all of our sales or retail.
Speaker Change: We are working with the two largest tip manufacturers for airlines, who do want to replace other epinephrine products into kits.
Speaker Change: Obviously, the airlines have to opt in.
Speaker Change: But theres a lot of advantages to nafie between the ease of use the lack of the needle which reduces liability for the airlines as well as the temperature excursion data high temperature data, which is important in an airplane.
Speaker Change: But very very little and Eric you can chime in here I don't think much if any of our revenue is coming from outside of retail.
Speaker Change: We expect that to grow over time.
Speaker Change: But initially it takes time for that to happen and for example, the kit manufacturers did not want to put nothing the kits until the one milligram was available so they are waiting.
Speaker Change: Because they want they need both doses.
So at that point, we expect that to start to pick up over time.
Again, not immediately because they are not going to throw away all their kits to replace all their epinephrine in the kits theyre going to do it over time as it expires.
Eric Karas: Eric do you want to add anything into that.
Richard Lowenthal: Rich I'll just add that when we look at our forecasting it's really focused on the retail market.
Richard Lowenthal: As rich mentioned kind of it's public interest market of Airlines, you can think about hotels restaurants.
Richard Lowenthal: Law enforcement emergency rescue that's not included but as time goes on in terms of education and awareness and then getting funding we do have an opportunity in that channel.
Speaker Change: And then just one point back to Ryans question to people may be thinking that the one milligram is also included in all of our payer contracts. So again once that's available theres no issues with the Doctor writing to one milligram.
Richard Lowenthal: And to the three milligram.
Speaker Change: And I would just add one more point to that because.
Richard Lowenthal: One of the things you need in the retail market is.
Speaker Change: Find a way to make or.
Richard Lowenthal: Or to make it easier for.
Richard Lowenthal: Some of these organizations such as restaurants to purchase naphtha right. So you can imagine a very well off restaurant can easily afford to buy a couple of boxes of Murphy.
Speaker Change: Most restaurants, Brian on fairly tightened margins, so buying murphy to have in the restaurant.
Richard Lowenthal: Perhaps a hurdle.
Speaker Change: One of our largest advocacy groups.
Speaker Change: He came up with a great idea and is working on this independently of us because they want to see Murphy in the restaurants and they believe that without the needle at the liability again becomes much better so that the.
Speaker Change: Good Samaritan using nappy can't hurt themselves versus auto injectors.
Speaker Change: Theyre actually negotiating with several of the largest insurance companies as I've mentioned is to a few analysts already.
Speaker Change: To give a discount on their insurance if they have an FTE in the restaurant or epinephrine in general.
Speaker Change: And we think Thats a brilliant idea actually.
Speaker Change: Does that would potentially pay for the fee or the restaurant by giving a discount on their insurance if they actually have the epinephrine in the restaurants. So those kind of things are all happening.
Speaker Change: But again, we will take some time before we start to realize significant revenue from those type of opportunities.
Speaker Change: Awesome, Thank you and congrats again.
Speaker Change: One moment for our next question.
Speaker Change: Our next question comes from Louise Chen with Scotiabank. Your line is open.
Louise Chen: Hi, congratulations on all the progress this quarter and thank you for taking my questions I had a few for you. So.
Louise Chen: So first question I wanted to ask you is how long is prior authorization for those payers that require you to do it usually lasts where does it have to be renewed.
Second question I had was do you have any data that talks about that upside expansion opportunity for you and how many of those patients are actually picking up from there are those that are untreated or previously diagnosed and then last question is I saw some headlines and the potential for epinephrine to go over the counter I don't know, Steve any thoughts on if that were to ever happen what that would need for ya.
Louise Chen: Thank you.
Louise Chen: Okay. So.
Louise Chen: Could you just repeat the question is what are the time first question sorry, just to make sure.
Sure.
Louise Chen: So I wanted to ask you with respect to prior authorization.
Louise Chen: For the payers that require you to do it how long does it usually lack or does it does it have to be renewed at some point.
Eric Karas: Yeah, I think Eric.
Speaker Change: Eric you can you.
Speaker Change: You can add into this but I believe that they need a prior authorization.
Speaker Change: I mean again the nature of this is a little unusual you might only get one or two or three prescriptions a year right.
Speaker Change: So they're going to get a prior authorization for that prescription some of them are for one some too we've seen three prescriptions go through our three boxes in one prescription I should say.
Speaker Change: <unk> units.
Speaker Change: Pretty pretty readily.
But I believe they would probably need that prior authorization each time.
Speaker Change: So that's a huge burden and if you think about the revenue on.
Speaker Change: On average right now we're seeing one three.
Speaker Change: Units per prescription now we believe that will go up significantly because a lot of those are cash pays where theyre just buying one now and they'll get more what's it's an unrestricted coverage once their insurance company is covering it.
Speaker Change: But.
The if you think about it it's only a little more than $500 in revenue to us net revenue. So each prior authorization accounts for a very small net revenue and Thats why we believe.
Speaker Change: In this category, it's a major hurdle for the doctors do you want to add anything to that or yes, I would just say, it's a mix it depends on the insurers as rich mentioned some will require at every single time, others, maybe a little bit longer but I also think it's important as we mentioned in our presentation that we are on track to hit that 80.
Speaker Change: Percent of coverage in commercial and when we say that that's covered with no PPA.
Speaker Change: All of our contracts that we're putting in place with the GPO as with Pbms again, we're not paying any rebates. If there is any type of step edit or prior authorization. So we're really confident that.
Speaker Change: Again, we're lowering the barriers in time here for physicians to write this product without appear.
Speaker Change: Okay, and if you could just repeat your second question again.
Speaker Change: Yes sure. Okay. So wanted to ask you for patients that were previously diagnosed untreated with traditional epinephrine.
Speaker Change: Many of them has chosen to take your product just trying to assess the expansion opportunity and how that's progressing for you.
Kathy Scott: Eric do you have that information.
Kathy Scott: We haven't broken out and done any claims analysis, we have plans to do that.
Kathy Scott: In the middle parts of the year here, but from a opportunity perspective as we've shared there is 3.2 million patients that have current treatment and then you are looking at another $16 five that are diagnosed without treatment within that group. We know over the last couple of years, there's $3 3 million patients that have been prescribed <unk>.
Kathy Scott: About a third of them have filled but they haven't refilled. So there is opportunity a significant opportunity there to reengage those patients when we talk to physicians when we talk to patients in that group. The major reasons why they didn't resale or Phil initially is because of the needle size portability and afford afford.
Kathy Scott: Ability as well so when you look at our programs in commercial again, if they're covered $25 for the prescription even if they get more than one carton, we only charge one co pay but we're able to again get reimbursed on two cartons were three cartons. The average co pay for a needle injector is about $40. So I think were real.
Kathy Scott: Moving a lot of the challenges in terms of our needle free easy to use portable option and we do see a very significant opportunity to reengage. This population whether its through the physician or our DTC efforts that will launch in may.
Kathy Scott: And does that help.
Kathy Scott: Yes. It does can I ask one more quick question.
Thank you.
Speaker Change: With the opportunity for epinephrine to go over the counter what would that mean for you.
Speaker Change: Yes, it's been brought up to us multiple times, including by Big Pharma companies.
Speaker Change: Of course, we know the inhaled epinephrine is over the counter but it's not systemic and it's for.
Speaker Change: Asthma.
Speaker Change: The two criteria for over the counter obviously your first safety.
Speaker Change: We believe Murphy is very safe, especially with only two doses you can overdose on epinephrine, so that as a big risk and FDA has raised significant concerns about levels above the data observed with to epipen. So that's been a big significant discussion for years and years and years that they just don't know that.
Speaker Change: Safety in real World patients.
Speaker Change: With levels above that so people might take more than two doses and nothing would be a concern to FDA.
Speaker Change: The other criteria self diagnosis, you got to be able to self diagnose that you have.
Speaker Change: The disease.
Speaker Change: And Theres a lot of causes of symptoms similar to food allergies that may or may not be an actual food or venom allergy.
Speaker Change: So FDA would also have to get over that barrier of the ability of people to self diagnose so well, it's a discussion and would be interesting.
Speaker Change: I think it's a it's a difficult hurdle for this type of product just the profile.
Speaker Change: For FDA, so I would not.
Speaker Change: <unk> it to go OTC certainly in the near future I would not expect that to happen.
Speaker Change: Thank you.
Speaker Change: One moment for our next question.
Speaker Change: Our next question comes from <unk> <unk> with Leerink partners. Your line is open.
Speaker Change: Hey, good morning, everyone. So I was curious what are you hoping to learn from the challenge Clinic Registry study for Duffy that starting in April and the ground, how long will that run for.
Speaker Change: As you gather the data would you presented and sort of a rolling basis this year at medical meetings or publications.
Speaker Change: Yes. So so first of all this is going to be the largest randomized controlled study ever done with epinephrine period.
Speaker Change: There's never been a study like this done but now that we're approved.
Speaker Change: 402 hundred on <unk>.
Speaker Change: Im injection.
Speaker Change: And again, it will be randomized and partially blinded by partial I mean, its blinded up to the time the physician decides to give a dose of epinephrine.
Speaker Change: They won't know what the treatment is up to that point.
Speaker Change: Second dose would not be blinded because of course, they know what they gave us the first time.
Speaker Change: We'd have to be the same product the second time, if they need a second dose.
Speaker Change: So this is this is going to be.
Barry Cigna: Barry Cigna.
Speaker Change: Significant study FDA as primary interest in safety again as I mentioned.
Speaker Change: All of our clinical trials are in healthy people in their clinic.
Barry Cigna: Not having a reaction.
Barry Cigna: So FDA is very interested in seeing real world data.
Barry Cigna: All comers basically this study will be anyone theyre going to give oral food challenge to us eligible to enroll.
Barry Cigna: That would normally get epinephrine, if they have a reaction.
Barry Cigna: And so.
Barry Cigna: It's a really real world study, where youre going to get patients with asthma with all sorts of other concomitant meds.
Barry Cigna: Nothing is barred in this study so we will get a really good sense of the safety of Murphy and also of injection. So even even prime injection I don't think we have.
Barry Cigna: A super good sense of of that in a clinical environment like this where you're really recording things.
Barry Cigna: That are not just spontaneously reported.
Barry Cigna: So that's the nature of the study it's going to be really it's going to be an amazing study. We will do an interim analysis I don't think it will do multiple rolling ones because thats just not normally done, but we probably will do an interim analysis so that.
Barry Cigna: At least preliminary data will be presented probably at the next quality our meeting.
Barry Cigna: And then and then we'll present the full data and we will be looking at clinical outcomes as well, but those are secondaries because FDA did.
Barry Cigna: Really focus on safety that they wanted to understand the safety of of Murphy.
Barry Cigna: They have better data on the safety of nephew, we understand it.
Barry Cigna: Side effects are very mild and very infrequent but.
Barry Cigna: But nonetheless, they want to see in patients that actually have a reaction on.
Barry Cigna: Older concomitant measure of all their other concomitant conditions.
Barry Cigna: That you typically see in this population. So that's really the main focus of the study.
Barry Cigna: And we will probably do an interim analysis for on those so that's that's helpful as well.
Barry Cigna: Yes got it interesting and then I wanted to follow up I thought your Kols feedback that you mentioned earlier was really interesting in terms of physicians that want to switch all of their patients to duffy or possibly majority yes.
Barry Cigna: The proportion of physicians out there that you're detailing that have this interest.
Barry Cigna: I think it's mixed I think.
Barry Cigna: Some we talked to a quad AI, which are really the top tier physicians to be very honest because they're the ones that are going because of meetings.
Educating themselves.
Barry Cigna: I've had a number of conversations myself with a lot of these in.
Barry Cigna: One major one told me that he just doesn't have.
Barry Cigna: You can't spend all.
Good evening and weekend, writing <unk>. So prior authorization. So he is kind of limited he's picking and choosing that he would switch almost everybody anything so almost all of those patients would prefer an iffy.
Barry Cigna: And you also noted that he in his region. He is a major advisor to pediatricians and general practitioners.
Barry Cigna: So he had thrown out that he advisors about 100 pediatricians that a couple of hundred general practitioners that have patients.
Barry Cigna: The contact him with questions.
Barry Cigna: And he said none of them were right. So I just wanted to it so allergists are more flexible right. These prior authorizations.
Speaker Change: We're pediatricians, just probably have less time I don't know if theyre not as equipped in there and their clinics to write prior authorization that manage it.
Speaker Change: So you said, they just won't do it until that that barrier clears.
Speaker Change: But even there contacting him about Murphy and wanting to prescribed especially again to the children.
Speaker Change: Our primary focus of a lot of these doctors right now but.
Speaker Change: But we think it's pretty prevalent there are still a few that are waiting to see some real world data and were.
Speaker Change: Collecting real world data from a nephew experience it looks spectacular right now and once we get to a large enough and.
Speaker Change: Right now we can talk about it a little bit if you want but we're at about 758 patients treated that had been reported from 470 <unk> doctors.
Speaker Change: And the data is coming in really like it's working at least as well as injection, possibly even even better but nonetheless.
Speaker Change: Once we get to maybe a couple of thousand we might do a publication of.
Speaker Change: Basically a letter to the editor of one of the major publications to two.
Speaker Change: To give some data.
Speaker Change: And I think Thats, what there are a lot of them are waiting for it they are waiting to see.
Speaker Change: Especially the <unk>.
Speaker Change: Less less.
Speaker Change: Let's let's say academic scientific doctors that understand the data well the other ones that are like well, Okay. Let me, let me see it.
Speaker Change: Used in a bunch of patients in it.
Speaker Change: Working well and they are now.
Speaker Change: Our prescribed but then they.
Speaker Change: They all agree this is a much better profile much better product and injection for their patients but.
Speaker Change: A lot of them still have that hesitation. So that's another one of the other two or three things we're focused on is really.
Speaker Change: That that access unrestricted access making.
Speaker Change: Making the doctors comfortable and getting real world data for them that it's really working equal to injection.
Speaker Change: And then the third is make is raising awareness among the patients and caregivers that <unk> available and they can go get it unrestricted without.
Speaker Change: Complications or high fees.
Speaker Change: That's going to be a big initiative as well and that's why we're aligning our DTC campaign with that access occurring in.
Speaker Change: Some people will say north of 50% is already good enough to start driving patients into the doctor's we're actually going to start that process. When we're we're hopefully closer to the 80% Mark so that people will get it very easily and without high co pays.
Speaker Change: Makes sense, thanks, a lot.
Speaker Change: Well remember for our next question.
Speaker Change: Our next question comes from lesson Hanbury Brown with William Blair. Your line is open.
Speaker Change: Hey, guys. Thanks for taking the questions I guess first on.
Speaker Change: Just.
Speaker Change: Can you talk about the system that you have to go back to.
Speaker Change: Doctors or patients who were written a script Molson approved once you get.
Speaker Change: Average with the insurer.
Speaker Change: Sort of the.
Speaker Change: Our system you haven't.
Speaker Change: Maybe what you're seeing from that so far as you've won.
Speaker Change: Yes.
Speaker Change: Yes, so Gary.
Speaker Change: Two different things I would separate if it's through Blink Rx our online pharmacy, then <unk> is obviously keeping records of all.
Speaker Change: Patients who are denied prior authorization or who even filed a prior authorization. So we have all that data.
Speaker Change: And their contact information because they went through <unk>.
Speaker Change: So as as insurers are added to.
Speaker Change: Coverage.
Speaker Change: And when you get unrestricted coverage with new insurers. They can go back and inform the patient as well as the doctor.
Speaker Change: That that patient is now covered.
Speaker Change: You can go back and get Murphy without.
Speaker Change: Prior authorization. So that's one thing I think Eric's team is doing quite effectively the other is a little harder to deal with if it was a script written through a pharmacy.
Speaker Change: And of course.
Speaker Change: Even if we have the cash pay in place or patient goes in that.
Speaker Change: Don't have that co pay assistance.
Speaker Change: You could have a lot of people walk away from the script that we don't want to we want them to go to the pharmacy and how that 25 dollar copay.
Speaker Change: So.
Speaker Change: In that regard we're doing a couple of things. The sales force is really tasked with informing the doctors that their patients are now covered for let's say United as of April one right. So another couple of weeks, if your unitedhealth patient, which is about 8% of the United States commercial insurance.
Speaker Change: You can now go back and get that script again or if the script is still valid just go back to the pharmacy and get messy.
Speaker Change: And not have to have the prior authorization.
Speaker Change: On top of that we also don't want patients to walk away from a co pay so they have a.
Speaker Change: With United if they have $80 copay, just throwing out a number just as an example, but do you have an $80 co pay for Nafie with United.
Speaker Change: You don't want to pay 80, but you would easily pay 25, you have to have our coupon from our website from your smartphone to give to the pharmacist.
Speaker Change: We are now working very hard with both Cvs and really help to sign agreements too.
Speaker Change: To preload their cards, so when patients and caregivers go to the pharmacy will be automatic that they won't they won't have to have the coupons and if they forgot to coupons and surprisingly even somebody I know is used nephew multiple times already.
She has a lot of different allergies, and she's a very smart person very.
Speaker Change: She actually paid 200 for Duffy and she had authorizations you had prior authorization approved third insurance coverage and I was shocked at ICR.
Speaker Change: Didn't you use the coupons.
So we don't want that because she obviously you could afford to achieving think anything of $200, but.
Speaker Change: A lot of people $200 as a barrier and we will walk away from the script. So were trying to get that done as well to make sure that it is seamless meaning you get your script from the Doctor you go to the local pharmacy you had in the script to the pharmacy or sent electronically of course. These days. So you don't actually have a physical script, but.
Speaker Change: You go into the pharmacy, and they just say co pays $25 any walkaway happy and Thats really what were trying to get to make that as seamless as possible for the vast majority of the population as quickly as possible and especially going into this summer.
Speaker Change: Okay. Thanks.
Speaker Change: Can you comment on.
Speaker Change: So that covers that you'd want so far have you seen.
Speaker Change: Many of those groups for example, the ones through Blink Rx go back you've got filled all those patients maybe when the initial script is denied today you just get a script for an auto injector.
Eric Karas: So I'll refer to Eric.
Speaker Change: Eric.
Speaker Change: Eric do you have.
Speaker Change: Do you have any information on that as to vertical <unk> goes back after coverage I don't know lessened.
Speaker Change: We are seeing.
As a percentage of those patients convert.
Richard Lowenthal: We have a protocol in place as rich mentioned once we get coverage and we've been doing this over the last couple of weeks, we're re engaging those patients.
Richard Lowenthal: A portion of those patients opted to go to the cash prescription.
Richard Lowenthal: But the other ones, we're getting a nice amount of them kind of coming back and saying, Okay, Hey, great number that my insurance is covering this is affordable they are moving from kind of a submitted prescription thats waiting.
Speaker Change: Two obviously, a dispense prescription so they have so we're not only doing that as rich said with blink, but our field team is also trained to engage the doctors on all of these updates really working closely with the staff because they are carrying that workload to.
Speaker Change: Working with patients and going through that process. So the field team has data based on each position of what payers their patient base represents and their messaging accordingly, so we're pulling that through and driving that.
Speaker Change: All of those wins that we're seeing.
Speaker Change: Okay, great. Thanks.
Speaker Change: Follow up.
Speaker Change: Got it.
Speaker Change: No no.
Speaker Change: Add that again, a lot of people are telling us that they're just getting if theyre not covered they are getting one now, but they want more than one prescription. So theyre getting one now at the cash pay price of $199 and theyre waiting for coverage to.
Speaker Change: For their insurer to cover <unk>. So they can go back and get more because that seems to be a.
Speaker Change: Common strategy common theme, we're hearing from patients and caregivers that they just want the one initially.
Speaker Change: And I know, we just spoke to somebody like advocacy person in Utah.
Speaker Change: State advocacy person that's working on the legislation in Utah.
Speaker Change: Our kids both have this disease and she hasnt FAA into us.
Speaker Change: Just waiting for her cases everything she wants her kids the carry ratio once she just loves nephew, because their kids could actually carriers. So she went out and got it.
Speaker Change: And I'm sure you'll get more prescriptions. He just wanted to get one for each of the kids. Initially so that they have in their hands walking around with it and they're really thrilled about it. So that's the kind of feedback we get all the time.
Speaker Change: And heard from a lot of people are already in that and that kind of mode of all pay for the one at the 199, but then I'll wait for insurance for more.
Speaker Change: Okay, Great that's great context, as a follow up you talked about how to access and getting the payer coverages.
Speaker Change: Two driving prescription because of that prior authorization burden can you talk about the.
Speaker Change: Maybe lag that you see there I mean, how quickly when you sign a new contract so far when you sign new contracts, we got on formulary.
Speaker Change: Are you able to see an uptick in prescribing early the following week. So a couple of months or like how should we think about what that sort of delay.
Speaker Change: It's a great question because I just asked that question yesterday of the market.
Speaker Change: And I think they're still collecting the data I don't know Eric if you have it I haven't seen it yet but.
Speaker Change: The example is kind of like the express scripts, which started now.
Speaker Change: A couple of months ago, it really kind of hit with express scripts. So Howard.
Speaker Change: How are the.
Speaker Change: Sales going now of patients under express scripts versus other insurance companies, which may have only recently added that piece. So it's not the data won't be as impactful, but I don't know Eric do we have any sense of that yet.
Speaker Change: We are looking at individual cohorts of patients based on an insurance I can tell you that the last couple of weeks, especially with like express scripts were seeing inclined there in terms of share relative to what we see in the overall average that's what we expect to see and for each of those plans that we're winning we're driving that through messaging, whether it's non personal promotion.
Speaker Change: Through marketing.
Speaker Change: Most importantly through our direct efforts with our field team interacting with doctors interacting with staff I would say also that it takes time when the patient comes in right certain patients see their doctor every six months others, maybe every year, but when they come in now the doctor knows that if that patient has expressed.
Speaker Change: Starting April one United.
Speaker Change: This is going to be covered without a prior authorization. So we are encouraged by what we're seeing in terms of the increases here and it does really create a nice opportunity for us over the next couple of weeks and.
Speaker Change: And especially going into the back to school season, with a lot of patients coming in to really drive this.
Speaker Change: Yes, and just add one more thing to that.
Speaker Change: We're actually going a little overtime, a little bit, but we just are now.
Speaker Change: Working with advocacy and on our website posting a scorecard. If you wanted to wait until we cross that 50% Mark.
Speaker Change: The United gets us there, but we're putting a scorecard and the advocacy groups posted on their web sites as well another nafie.
Speaker Change: <unk>.
Speaker Change: Where it's going to show who is covering.
Speaker Change: Without without any restrictions without any prior authorization.
Speaker Change: Who's covering but is still requiring prior authorization again I don't differentiate between the insurer thats covering with prior authorization and one that's not covering at all and then who is not covering at all and there's two purposes of this one is that.
Speaker Change: I want I want the patients to know their cover and the caregivers right.
Speaker Change: And the doctors so the scorecard is also being shared by our sales force with the doctors.
Speaker Change: But I also want them to know who's not covered because if your insurers not covering.
Speaker Change: And you see this whole list of insurers that are.
Speaker Change: And you go and call up your insurer and say Hey, why are you guys not covering this in all of these other insurers are covering it.
Speaker Change: We think that puts a lot of pressure on insurance companies to cover more quickly.
Speaker Change: So thats another strategy, we have to try to facilitate that bye bye now starting to make it very public.
Speaker Change: Who is who is covering without prior authorization requirement, Ed who is not and we are hoping that that will also start to have some impact over time.
Speaker Change: Alright. Thanks.
One moment for our next question.
Speaker Change: Our next question comes from Julian Harrison with <unk>. Your line is open.
Speaker Change: Hi, Good morning, Thank you for taking my questions and congrats on all the recent progress on the CSU phase two B trial, you expect to initiate in the next few weeks I'm wondering if you could remind us of the competitive positioning here and any early feedback you have on preference for episodic relief versus chronic therapies CSU.
Speaker Change: Yes, Chris.
Speaker Change: They're very independent okay. Because these people are on chronic therapy right. So you could be on chronic antihistamine hydro centers being therapy or high dose.
Speaker Change: So there are and you still have flares.
Speaker Change: What what there is no current therapy for as those flares, meaning youre on Xolair in your stable, but every couple of months you have a big episode, where you've got a couple of days to two days of severe symptoms all of a sudden and it's very very upsetting to these people and a lot of times they get not only that.
Speaker Change: And painful but they also sometimes get.
Speaker Change: Angioedema facial engine demos, so that lip swells up their cheeks wells up.
Speaker Change: They don't want to go to work they don't want to go out.
Speaker Change: While that's happening.
Speaker Change: So.
Speaker Change: The difference is you're on your chronic therapy and.
Speaker Change: Then you have a flare.
Speaker Change: And now you can have an immediate treatment to treat that flare.
Speaker Change: And resolve it within minutes.
Speaker Change: And then go back and just go about your daily lives go to work go wherever you want to go.
Speaker Change: Versus go to the hospital and get the other current ways. They deal with this flare either just tolerate it.
Speaker Change: And the hope or wait for it to go away because it will go away.
Speaker Change: And you or you go to the hospital and get IV and this means that have very high doses tends to be effective in a lot of cases.
Speaker Change: And then the other is to take a steroid which takes hours to take effect. Okay. So.
Speaker Change: So so nephew would provide a unique.
Speaker Change: Advantage of treating that acute event.
Speaker Change: While they're on chronic therapy. So it's synergistic with chronic therapy I just want to make sure. It's clear that we are not intending to replace chronic urticaria therapy. At all this is this is a supplemental treatment to treat that exacerbation that occurs and if you go back to the Xolair phase III studies that were published.
Speaker Change: People on Xolair, even will have three to six of these events a year.
Speaker Change: And then well they actually more than three to six events I should take that back. It was they went to the emergency room three to six times a year to treat this type of event.
Speaker Change: No.
Speaker Change: So it's a pretty significant issue even on chronic therapies like Xolair now there are a portion of people that are just stable on xolair antihistamine, even that never have these events, but there is a large proportion of people that have these events. So it is an unmet medical need we're not we're not proposing to replace chronic.
Speaker Change: Or the carrier therapies, we're looking at supplementing them.
Speaker Change: Does that help.
Speaker Change: That's very helpful. Thank you and congrats again.
Speaker Change: Okay. Thank you great.
Richard Lowenthal: And I'm not showing any further questions at this time I'd like to turn the call back over to Richard.
Richard Lowenthal: Okay, well I really appreciate everybody joining the call and.
Richard Lowenthal: Look forward to the next conference call when we get closer to that summer period.
Richard Lowenthal: Obviously, we think at that point.
Richard Lowenthal: We're hoping to see a significant uptick in scripts and then going into the summer with our DTC campaign starts in May.
Richard Lowenthal: We really start raising that awareness and we think you'll really enjoy our DTC campaign, where we've been.
Richard Lowenthal: Working very hard and we think it will be.
Richard Lowenthal: Very very positive.
Richard Lowenthal: Shifting shifting to thinking shifting the paradigm towards.
Richard Lowenthal: Net fees easy easy to carry easy to use and.
Richard Lowenthal: Not threatening and treat the symptoms immediately and don't wait for severe asthma Arctic disease. So we think that that will.
Richard Lowenthal: Really shift the paradigm towards earlier and earlier use of epinephrine in order to stop the symptoms immediately whenever reaction occurs and thats really how doctors want to see epinephrine used.
Richard Lowenthal: So with that I'll close the call.
Richard Lowenthal: Thank you ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.
Richard Lowenthal: Okay.