Q4 2023 Zevra Therapeutics Inc Earnings Call
unknown: for a few moments. Again, we appreciate your patience and ask that you please continue to stand by, and Unknown. Unknown. Unknown.
I appreciate your patience and ask that you. Please continue to standby.
[music].
unknown: Unknown Executive, Tamara Favorito, Zevra, [inaudible] Bye! [inaudible] McFarlane, Louise Chen, Sumant Kulkarni, Oren Livnat, Nichol Ochsner, Jonathan Aschoff, Nichol Ochsner, Oren Livnat, Jonathan Aschoff, Nichol Ochsner, Unknown Executive, Tamara Favorito, Ze Today's program is delaying for a moment or two. Again, we appreciate your patience and ask that you please continue to stand by. [inaudible] Please stand by; your program is about to begin. Good afternoon, everyone.
unknown: Thank you for joining the Zevra Therapeutics Q4 2023 Corporate Updates and Financial Results Call. Today's call is being recorded and will be made available on the company's website following the conclusion of the call. With that, I will now turn the call over to Nichol Ochsner, Vice President of Investor Relations and Corporate Communications for Zevra Therapeutics. Good afternoon, and thank you for joining us today to review Zevra Therapeutics' progress in the fourth quarter and full year of 2023. Outlining our Clinical Advancements, Operational Achievements, and Financial Results. Before we get started, let me take a moment to provide some important information.
Do you all sites on whole. We appreciate your patience today's program is delayed for a moment or two again, we appreciate your patience and ask that you. Please continue to standby.
[music].
Please standby your program is about to begin.
Nichol L. Ochsner: I encourage you to access the news release, which was just published and is available in the investor relations section of Zevra's website. As we proceed with this call, it's important to highlight that today's discussion will include forward-looking statements. Forward-looking statements are not promises or guarantees and are inherently subject to risks, uncertainties, and other significant factors that may lead to actual results differing materially from the projections made.
None: Good afternoon, everyone. Thank you for joining these separate therapeutics Q4, 2023, corporate updates and financial results call. Today's call is being recorded and will be made available on the company's web site. Following the conclusion of the call.
None: I will now turn the call over to Nicole Oceaneering, Vice President of Investor Relations and corporate communications for Zephyr Therapeutics.
Nichol L. Ochsner: Please refer to the risk factors section in our most recent quarterly report on Form 10-Q and our other filings with the SEC in our annual report on Form 10-K. I'm pleased to welcome Zevra's management team members participating in today's call. I'm joined by Neal McFarlane, President and Chief Executive Officer, LaDwayne Clifton, our Chief Financial Officer, Joshua Schafer, our Chief Commercial Officer and EVP of Business Development, Neal McFarlane, Louise Chen, Sumant Kulkarni, Oren Livnat, Jonathan Aschoff, Nichol Ochsner, Christal Mickle, our Chief Development Officer, and Adrian Quartel, Now, I'll turn the call over to you.
Nicole Oceaneering: Good afternoon, and thank you for joining us today to review Zebra Therapeutics progress in the fourth quarter and full year of 2023.
Nicole Oceaneering: Outlining our clinical advances operational achievements and financial results.
Nicole Oceaneering: Before we get started let me take a moment to provide some important information.
Nicole Oceaneering: I encourage you to access the news release, which was just published and available in the Investor Relations section of <unk> website. As we proceed with this call. It is important to highlight that todays discussion will include forward looking statements.
Neil F. McFarlane: Thank you, Nichol, and thank you all for making the time to join us today. During the fourth quarter and into 2024, we made solid progress towards transforming Zevra into a commercial stage company. On our last call, we announced that we were focused on three key priorities. First, to close the ACER acquisition and deliver value to patients by commercializing Olprova. Second, to resubmit the Aramoftamol NDA. Third, to complete the Phase 2 trial in idiopathic hypersomnia and prepare to advance KP1077 into Phase 3. I'm happy to report that we have executed on all of these objectives.
Nicole Oceaneering: Forward looking statements are not promises or guarantees and are inherently subject to risks.
Nicole Oceaneering: Steve and other significant factors that may lead to actual results differ materially from the projections made please refer to the risk factors section in our most recent quarterly report on Form 10-Q, and our other filings with the SEC.
Nicole Oceaneering: I will report on Form 10-K.
I'm pleased to welcome beverage management team members participating in today's call I'm joined by Neil Mcfarlane, President and Chief Executive Officer.
None: Duane Clifton, our Chief Financial Officer, Joshua Schaefer, Chief commercial officer, and EVP of business development Kris.
Neil F. McFarlane: And I would like to take the opportunity to recognize the extraordinary effort from our entire team to deliver for people living with rare diseases. Before discussing our results, it's important to note that our financial statements for fiscal year 22, including all interim periods and the interim periods of 2023, will be restated due to a change in our warrant accounting. Ledoine will provide more details later in the call, but we believe the restatement will have no impact on the company's cash or ability to execute on our strategic priorities.
Neil F. McFarlane: Crystal Nicole our Chief Development Officer, and Adrian portal, our Chief Medical Officer, now I'll turn the call over to me.
Neil F. McFarlane: Thank you Nicole and thank you all for making the time to join us today.
Neil F. McFarlane: During the fourth quarter and into 2024, we made solid progress towards transforming zebra into a commercial stage company.
Neil F. McFarlane: On our last call, we announced that we were focused on three key priorities first to close the <unk> acquisition and deliver value to patients by commercializing on approval.
Neil F. McFarlane: Turning to the fourth quarter corporate highlights, let me start with the completion of the ACER acquisition, which propelled us into becoming a commercial stage company, diversifying our revenue potential, and providing scale. The acquisition was a natural fit with Zevra's mission, bolstering the talent on our team, and bringing complementary rare disease assets, including commercially available Olprova. OPRU is indicated for the treatment of certain urea cycle disorders or UCDs, which are a group of rare genetic disorders that can cause harmful levels of ammonia to build up in the blood, potentially resulting in neurocognitive impairments, brain damage, and in some cases, coma or death. We estimate that there are approximately 2,000 people in the U.S. with UCDs, of which roughly half are diagnosed and treated.
Neil F. McFarlane: Second to resubmit, the Aramark the mall NDA.
Neil F. McFarlane: To complete the phase II trial in idiopathic hypersomnia and prepare to advance <unk> 277 into phase III.
Neil F. McFarlane: I'm happy to report that we executed on all of these objectives.
Neil F. McFarlane: I would like to take the opportunity to recognize the extraordinary effort from our entire team to deliver for people living with rare disease.
Neil F. McFarlane: Before discussing our results it's important to note that our financial statements for fiscal year, 'twenty, two including all interim periods and the interim periods of 2023 will be restated due to a change in our warrant accounting.
Neil F. McFarlane: Duane will provide more details later on the call, but we believe the restatement will have no impact on the company's cash or ability to execute on our strategic priorities.
Neil F. McFarlane: Turning to the fourth quarter corporate highlights, let me start with the completion of the <unk> acquisition.
Neil F. McFarlane: Which propelled us into becoming a commercial stage company diversifying our revenue potential in providing scale.
Neil F. McFarlane: The UCD market in the U.S. is estimated at approximately $350 million annually. Despite the available therapies, unmet needs for people living with UCD persist. We believe that OPRUBA is well suited to address these needs as it provides personalized dosage for each patient's requirements. It's portable and easy for a patient to take. And most importantly, it is palatable, as it was formulated to overcome the challenging taste and smell that are associated with other formulations of sodium phenylbutyrate.
Neil F. McFarlane: The acquisition was a natural fit with zebras mission bolstering the talent on our team and bringing complementary rare disease assets, including commercially available or approval.
Neil F. McFarlane: <unk> is indicated for the treatment of certain urea cycle disorders or ucd's.
Neil F. McFarlane: There are a group of rare genetic disorders that can cause harmful levels of ammonia to build up in the blood potentially.
Neil F. McFarlane: Potentially resulting in neurocognitive impairments brain damage and in some cases coma or death.
Neil F. McFarlane: We estimate that there are approximately 2000 people in the U S with Ucd's.
Neil F. McFarlane: Of which roughly half are diagnosed and treated.
Neil F. McFarlane: The UCD market in the U S is estimated at approximately $350 million annually.
Neil F. McFarlane: Our commercial launch strategy is comprised of two major components. One, establishing a customer-facing team, and two, building awareness. Since the completion of the ACER acquisition in mid-November, we have made significant progress towards executing on these priorities, ensuring that people who suffer from UCDs have access to, and are aware of, the benefits of OPROVA. As of the end of January, we have a customer-facing team with decades of rare disease experience to support the launch of Olprova. This team was built to be targeted and able to meet the needs of our customers and partners, most of whom are located in approximately 40 centers of excellence across the country.
Neil F. McFarlane: Despite the available therapies unmet needs for people living with UCD persists.
Neil F. McFarlane: We believe that will improve as well suited to address these needs as it provides personalized dosage for each patient's requirements.
Neil F. McFarlane: It's affordable and easy for patients to take and most importantly, it as powerful as it was formulated to overcome the challenging taste and smell that is associated with other formulations of sodium phenol beautifully.
Neil F. McFarlane: Our commercial launch strategy is comprised of two major components one.
Neil F. McFarlane: Establishing a customer facing team and to building awareness since the completion of the <unk> acquisition in mid November we have made significant progress towards executing on these priorities ensuring that people who suffer from ucd's have access to and are aware of the benefits of approval.
Neil F. McFarlane: In addition to the sales specialists, we have marketers, patient services, and market access professionals, as well as medical science liaisons and patient advocates to engage with key customers. While initially built to support the launch of OPRUVA, this same group of professionals will launch Aramakamal if approved. We've initiated several strategies that are being utilized to build awareness for OPRUBA, which is currently quite low.
Neil F. McFarlane: As of the end of January we have a customer facing team with decades of rare disease experience to support the launch of approval.
Neil F. McFarlane: This team was built to be targeted and able to reach the needs of our customers and partners. Most of whom are located in approximately 40 centers of excellence across the country.
Neil F. McFarlane: In addition to the sales specialists, we have marketers patient services and market access professionals as well as medical science liaison and patient advocates for engaging with key customers.
Neil F. McFarlane: For example, we have established QuickStart, which is a 30-day free trial to allow patients and physicians to gain experience with Alprova. We're working with patient advocacy groups, the patient community, and UCD Centers of Excellence to drive brand recognition. We're also working with payers to ensure broad market access for patients. We've seen meaningful growth in reimbursement coverage, which was approximately 55% at the time of acquisition to now more than 70% of covered lines.
Neil F. McFarlane: While initially built to support the launch of approval. This same group of professionals will launch a remarkable if approved.
Neil F. McFarlane: We've initiated several strategies that are being utilized to build awareness for all approval, which is currently quite low.
For example, we have established quick start which is a 30 day free trial to allow patients and physicians to gain experience without approval.
Neil F. McFarlane: We're working with patient advocacy groups the patient community and you see these centers of excellence to drive brand recognition.
Neil F. McFarlane: We're also working with payers to ensure broad market access for patients, we've seen a meaningful growth and reimbursement coverage, which was approximately 55% at the time of acquisition to now more than 70% of covered lives.
Neil F. McFarlane: While it's too early in the launch to provide data on today's call, we're monitoring key launch performance indicators, including new patient enrollments, number of covered lives, and net revenue. As previously mentioned, the commercial footprint we established provides a high strategic fit for Aramakamal as the majority of prescribers for both products work within the same centers of excellence. If our mock-a-mole is approved, we believe this close proximity and overlap in patient care will allow us to realize synergies and scale with the infrastructure that we've built. As a reminder, Aromathomol is our drug candidate in development for the treatment of Niemann-Pick Disease Type C, or NPC. NPC is a rare genetic, progressive, and potentially fatal neurologic disease.
Neil F. McFarlane: While it's too early in the launch to provide data on today's call. We're monitoring key launch performance indicators, including new patient enrollments number of covered lives and net revenue.
Neil F. McFarlane: As previously mentioned the commercial footprint, we established provides a high strategic fit for our remarkable as the majority of prescribers for both products work within the same centers of excellence.
Neil F. McFarlane: If our mothballed is approved we believe this close proximity and overlap in patient care will allow us to realize synergies and scale with the infrastructure that we've built.
Neil F. McFarlane: As a reminder, our multiple mall is our drug candidate in development for the treatment of Niemann pick disease type C or MPC.
Neil F. McFarlane: MPC is a rare genetic progressive and potentially stable neurologic disease.
Neil F. McFarlane: Earlier this month, the FDA assigned a new PDUFA date of September 21, 2024, and reaffirmed its intent to present the resubmission for discussion at an advisory committee meeting. If approved, we intend to utilize our clinical data, as well as real-world evidence, and the data from our Expanded Access Program, to support market access, reimbursement, and treatment decisions to establish Arimothamol as the foundation of treatment for people with NPC. We will continue to work closely with key opinion leaders to educate them on Aramalka Mall's clinical profile and raise awareness of the heterogeneous presentation of NPC, which may include neurological and psychiatric symptoms, all of which make NPC difficult to identify and diagnose. Because of this, the time to diagnosis remains a significant unmet need in the NPC community.
Neil F. McFarlane: Earlier this month the FDA assigned a new producer date of September 21, 2024, and reaffirmed its intent to present the resubmission for discussion at the Advisory Committee meeting.
Neil F. McFarlane: If approved we intend to utilize our clinical data as well as real world evidence and the data from our expanded access program to support market access reimbursement and treatment decisions to establish our mothball as the foundation of treatment for people with MPC.
Neil F. McFarlane: We will continue to work closely with key opinion leaders to educate on aramark amongst clinical profile and raise awareness of the heterogeneous presentation of MPC, which may include neurological and psychiatric symptoms all of which make MPC difficult to identify and diagnose.
Because of this the time to diagnosis remains a significant unmet need in the MPC community. Therefore.
Neil F. McFarlane: Therefore, we're working with patient advocates to drive early diagnosis and support efforts for MPC to be included in newborn screening. Together with an approved indication, these initiatives will help drive the evolution of treatment guidelines and accelerate the time to diagnosis and treatment initiation. We will continue to work with all stakeholders to develop patient services that will provide access and a positive experience. We applaud the NPC patient advocacy community who united and submitted a compelling response through an informal petition to the FDA in support of Aramath Amal's approval. They received nearly 1,000 signatures from 47 states expressing their support.
Neil F. McFarlane: Therefore, we are working with patient advocates to drive early diagnosis and supporting efforts for MPC to include to be included in newborn screening.
Together with an approved indication these initiatives will help drive the evolution of treatment guidelines and accelerate the time to diagnose diagnosis and treatment initiation.
Neil F. McFarlane: We will continue to work with all stakeholders to develop patient services that will provide access and a positive experience.
Neil F. McFarlane: We applaud the MPC patient advocacy community, who United and submitted a compelling response through an informal petition to the FDA in support of Ara Mothballs approval.
Neil F. McFarlane: They received nearly 1000 signatures from 47 states so voicing their support.
Neil F. McFarlane: As the FDA review continues, Zevra will maintain our Expanded Access Program for Arimaukamal and continue working tirelessly to bring this potential therapy to patients as soon as possible. Now, I'd like to turn your attention to KP1077, our clinical candidate being developed as a treatment for idiopathic hypersomnia, or IH. IH is a rare chronic sleep disorder characterized by excessive daytime sleepiness, an uncontrollable need for sleep, and difficulty waking up from sleep in most instances despite average or longer amounts of nocturnal sleep.
Neil F. McFarlane: As the FDA review continues as ever we'll maintain our expanded access program for our remarkable and continue working tirelessly to bring this potential therapy to patients as soon as possible.
Neil F. McFarlane: Now I'd like to turn your attention to <unk> 77, a clinical candidate being developed as a treatment for idiopathic hypersomnia or IH.
Neil F. McFarlane: <unk> is a rare chronic sleep disorder characterized by excessive daytime sleepiness and uncontrollable need to sleep and difficulty waking up from sleep in most instances.
Neil F. McFarlane: Despite average or longer amounts of not total asleep.
Neil F. McFarlane: As you may recall, KP 1077. Sertex methylphenidate, or SDX, was designed to steadily release d-methylphenidate, its active ingredient. This unique pharmacokinetic profile allows for flexible dosing to overcome these primary IH symptoms. The design also ensures that patients receive the highest drug concentration when they need it most. FDX is designated as a Schedule IV controlled substance by the U.S. Drug Enforcement Administration
Neil F. McFarlane: As you May recall K P $10 77.
Neil F. McFarlane: <unk> X methylphenidate or SPX was designed to steadily release D. Methylphenidate, it's active ingredient.
Neil F. McFarlane: This unique pharmacokinetic profile allows for flexible dosing to overcome these primary IH symptoms.
Neil F. McFarlane: The design also ensures that patients receive the highest drug concentration when they need it most.
Neil F. McFarlane: SPX is designated as a schedule for controlled substance by the U S drug enforcement administration.
Neil F. McFarlane: Earlier this week, we announced positive top-line data from our placebo-controlled, double-blind, proof-of-concept phase 2 study, evaluating the safety and tolerability of KP1077 in patients with IH. Consistent with the interim data that we previously reported in Q4, KP1077 was well tolerated at all dose levels evaluated in the study, including the highest dose of 320 milligrams daily and at dosing The most common adverse events were insomnia, headache, anxiety, nausea, and decreased appetite.
Neil F. McFarlane: Earlier this week, we announced positive topline data from our placebo controlled double blind proof of concept phase II study evaluating the safety and Tolerability of <unk> 77 in patients with IH.
Neil F. McFarlane: Consistent with the interim data that we've previously reported in Q4, <unk> 77 was well tolerated at all dose levels evaluated in the study.
Neil F. McFarlane: Including the highest dose of 320 milligrams daily.
And dosing regimens of either once or twice daily.
Neil F. McFarlane: The most common adverse events were insomnia, headache, anxiety nausea and decreased appetite.
Neil F. McFarlane: Due to KP1077's unique pharmacokinetic profile, adverse events were mostly mild in severity despite higher overall exposure levels. These data support the study's primary endpoint of safety and tolerability. Top-line results from the Phase 2 study also show that KP1077 produced clinically meaningful improvement in excessive daytime sleepiness, or EDS, as assessed by change from baseline in the EPWRF sleepiness scale during the five-week open-label titration period, which was maintained throughout the two-week double-blind withdrawal period for both dose resonances. Additionally, patients administered KP1077 showed benefit in change from baseline at the end of the The study successfully fulfilled its objectives by providing key information for the design of a potentially pivotal efficacy trial, and the results of the secondary efficacy endpoints are supportive of initiating a Phase III trial of KP1077.
Neil F. McFarlane: <unk> hundred 77 unique pharmacokinetic profile adverse events were mostly mild in severity despite higher overall exposure levels.
These data support the study's primary endpoint of safety and Tolerability.
Topline results from the Phase II study also showed that <unk> 10 to 77 produced clinically meaningful improvement in excessive daytime sleepiness or eds as assessed by change from baseline in the Epworth sleepiness scale. During the five week open label Titration period, which was maintained throughout the two.
Neil F. McFarlane: Week double blind withdrawal period for both dose regiments.
Neil F. McFarlane: Additionally, patients administered K P. 10, 77 showed benefit in change from baseline at the end of the open label titration.
Neil F. McFarlane: And at the end of the double blind withdrawal period for the IH severity scale, the sleep inertia visual analog scale and brain fog severity scale.
Neil F. McFarlane: The study is successful the study successfully fulfill the objectives by providing key information for the design of a potentially pivotal efficacy trial and the results of the secondary efficacy endpoints are supportive of initiating a phase III trial of <unk> $10 77.
Neil F. McFarlane: We plan to request an end of Phase 2 meeting with the FDA to seek guidance on the design of the Phase 3 clinical trial. We are pleased with the top-line data and believe that KP1077 could provide a significant benefit to the estimated 37,000 people in the U.S. who are currently diagnosed with IH. With only one FDA-approved treatment for IH, there remains an unmet need for therapies with different mechanisms of action to address symptoms, including sleep inertia, excessive daytime sleepiness, and cognitive dysfunction.
Neil F. McFarlane: We plan to request an end of phase II meeting with the FDA to seek guidance on the phase III clinical trial design.
Neil F. McFarlane: We are pleased with the top line data and believe that <unk> 77 could provide a significant benefit to the estimated 37000 people in the U S. We're currently diagnosed with IH.
Neil F. McFarlane: With only one FDA approved treatment for IH, there remains an unmet need for therapies with different mechanisms of action to address symptoms, including sleep inertia excessive daytime sleepiness and cognitive dysfunction.
Neil F. McFarlane: We look forward to presenting the results from our Phase 2 study at the upcoming SLEAP 2024 conference this summer. And, in summary, we're pleased with our progress in the fourth quarter. As we enter 2024, we have three areas of focus. First, to successfully launch Alprova and ensure access for patients. Second, to prepare for the potential launch of Aramakalon. And third, to advance KP1077.
Neil F. McFarlane: We look forward to presenting the results from our phase II study at the upcoming sleep 2024 conference. This summer.
And in summary, we're pleased with our progress in the fourth quarter as we enter 2024, we have three areas of focus first to successfully launch our approval and ensure access for patients second to prepare for the potential launch of Aramark alone and third to advanced <unk> $10 77.
Neil F. McFarlane: And sleep disorders.
LeDuane: We believe that we are well positioned to continue to execute and deliver on these key strategic objectives. Now, I'll hand the call over to LeDuane, who will provide an update on our financial results and outlook. Thank you, and good afternoon.
We believe that we are all we believe that we are well positioned to continue to execute and deliver on these key strategic objectives.
Neil F. McFarlane: I hand, the call over to Ludwig who will provide an update on our financial results and outlook.
Ludwig: Thank you and good afternoon.
LeDuane: 2023 was a time of incredible progress as we seek to make therapies available to people living with rare diseases. Our financial results for the quarter and full year reflect our continued investments in advancing our development programs and building out our commercial capabilities. As Neil pointed out at the beginning of the call, we are restating our previously issued financial statements for the fiscal year end of 2022, including all interim periods, and the interim period in 2023 due to a change in the accounting for warrants with certain cash settlement features. Warrants from 2021 have been classified as equity and are now accounted for as a liability, resulting in non-cash fair value adjustments that will be recognized at the end of each reporting
Ludwig: 2023, with a time of incredible progress as we seek to make therapies available to people living with rare diseases.
Ludwig: Our financial results for the quarter and full year reflect our continued investments in advancing our development programs and building out our commercial capabilities.
Ludwig: As Neil pointed out at the beginning of the call. We are restating our fuse we issued financial statements for the fiscal year ended 2022, including all interim period and the interim period in 2023.
Ludwig: Due to a change in the accounting for warrants with certain cash settlement features war.
Ludwig: Orange from 2021 had been classified as equity and are now accounted for as a liability, resulting in noncash fair value adjustments that will be recognized at the end of each reporting period.
LeDuane: This change and the related non-cash adjustments are expected to have no direct impact on the company's cash, cash equivalents, and investments, our forecasted runway, or our business operations. Now focusing on our financial results for Q4 2023, we reported net revenue of $13.2 million.
Ludwig: This change and the related noncash adjustments are expected to have no direct impact on the company's cash cash equivalents and investments are forecasted runway or our business operations.
Ludwig: Now focusing on our financial results for Q4 2023.
Ludwig: We reported net revenue of $13 $2 million.
LeDuane: This was a solid quarter in which we earned a net sales milestone of $10 million under the Astoris License Agreement as annual net sales for that product surpassed $50 million for the year. Revenue also included royalties under the license, which rose to $1.3 million for the period, compared to $900,000 in Q3 2023. Net reimbursements from the French Expanded Access Program for Aramontimal were $1.8 million, and there was recognition of some initial sales of approval. R&D expenses for the quarter were $11.4 million, which was primarily driven by the Phase 2 study in KP 1077 that has since been completed, along with the work to prepare the Aramakuma NDA for resubmission. General and administrative expenses were $14.7 million.
Ludwig: This was a solid quarter in which we have garnered the net sales milestone of $10 million under the <unk> license agreement as annual net sales for that product surpassed $50 million for the year.
Ludwig: Revenue also included royalties under the license, which rose to $1 $3 million for the period comparing to 900000 in Q3 2023.
Ludwig: Net reimbursements from the French expanded access program for Aramark Mall was one $8 million and there was recognition of some initial sales of approval.
Ludwig: R&D expenses for the quarter were $11 $4 million, which was primarily driven by the phase III study in KC 10, 77 that has since been completed along with the work to prepare the aramark more NDA for Resubmission.
Ludwig: General and administrative expenses were $14 7 million.
LeDuane: The period-over-period increase was primarily related to personnel costs and professional fees associated with our investments and our commercial infrastructure, as well as our business development activities, which included the closing of the ACER acquisition. The net loss for Q4 2023 was $19.6 million, or $0.51 per basic and diluted share. Our full year 2023 results included net revenue of $27.5 million, which was primarily driven by the $15 million in total net sales milestones earned under the Astaris License Agreement, royalties of $3.8 million, and net reimbursements from the French Early Access Program for Aramakamal totaling $8.6 million for the year. With total R&D expenses of $39.8 million, and G&A expenses of $34.3 million, we reported a net loss of $ As of year end, total cash, cash equivalents, and securities were $67.7 million, which was a decrease of $15.7 million compared to September 30, 2023. Total shares of Common Stock outstanding were $41.5 million, and Fully Diluted Shares Outstanding were $58.2 million, which includes approximately 5.6 million shares issuable upon the exercise of the warrant.
Ludwig: The period over period increase was primarily related to personnel costs and professional fees associated with our investments in our commercial infrastructure.
Ludwig: As well as our business development activities, which included the closing of the <unk> acquisition.
Ludwig: Net loss for Q4, 2023 was $19 $6 million or <unk> 51 per basic and diluted share.
Ludwig: Our full year 2023 results included a net revenue of $27 $5 million, which was primarily driven by the $15 million in total net sales milestones earned under the <unk> license agreement.
Ludwig: Royalties of $3 $8 million and net reimbursements from the France early access program for Aramark, immel totaling $8 $6 million for the year.
Ludwig: With total R&D expenses of $39 8 million and G&A expenses of $34 $3 million, we reported a net loss of $46 million or $1 30 per basic and diluted share for 2023, which includes the noncash impact of the change in fair value adjustment.
Ludwig: The warrant liability or <unk>.
Ludwig: One $4 million or <unk> <unk> per basic and diluted share.
Ludwig: As of year end total cash cash equivalents and securities were $67 $967 $7 million, which was a decrease of $15 7 million compared to September 32023.
Ludwig: Total shares of common stock outstanding were $41 5 million and.
Ludwig: And fully diluted shares outstanding was $58 2 million, which includes approximately $5 6 million shares issuable upon exercise of warrants.
Operator: Looking ahead, our available resources are expected to support our forecasted operating cash runway into 2026, and we intend to evaluate the optimization of our debt structure. Our forecast includes commercial revenue from sales of Okruva and ongoing reimbursements from the French EAP for Aramakamal, but it does not include commercial revenue from sales of Aramakamal or the sale of the Priority Review Voucher, which would follow potential FDA approval. We remain optimistic about the opportunities we have in store during 2024, and our focus is on creating long-term value for shareholders by consistently executing against our plan in support of our mission to become a leading rare disease company. Now, our colleagues Josh, Christal, and Adrian will join us for our Q&A session. Operator, please open the line for questions. At this time, if you'd like to ask a question, please press the star and one on your telephone keypad. Keep in mind; you may remove yourself from the question queue by pressing star and two.
Ludwig: Looking ahead our.
Ludwig: Our available resources are expected to support our forecasted operating cash runway into 2026, and we intend to evaluate optimization of our debt structure.
Ludwig: Our forecast includes commercial revenue from sales of approval and ongoing reimbursements from the French EAP, where aramark them all but it does not include commercial revenue from sales of Aramark mall or the sale of the priority review voucher, which would follow a potential FDA approval.
Ludwig: We remain optimistic about the opportunities we have in store during 2024.
Ludwig: And our focus is on creating long term value for shareholders by consistently executing against our plan in support of our mission to becoming a leading rare disease company.
None: Now our colleagues, Josh Crystal and Adrian will join us for our Q&A session.
None: Operator, please open the line for questions.
None: At this time, if you'd like to ask a question. Please press the star and one on your telephone keypad keep in mind you may have moved yourself from the question queue by pressing star and <unk>.
Oren Gabriel Livnat: We'll take our first question from Oren Livnat with HC Wainwright. Please go ahead, your line is open. Oh, thanks. That was helpful. I'm just really curious about this old Pruva launch.
None: We'll take our first question from Oren <unk> with H C. Wainwright. Please go ahead. Your line is open.
Oren: Thanks Thats helpful. I'm, just really curious about this whole approval launch.
Joshua M. Schafer: Sounds like you've got your infrastructure in place and, you know, maybe are just now trying to build awareness. You know, I know you're not giving guidance and certainly not on a product-specific basis, but should we expect material revenue growth for that product this year? Or is this more about just like a sampling and awareness building year and just getting all the patient support processes worked out, especially ahead of Aromaclomol? And on Aromaclomol, can you just talk about what it is? If anything, you can say about your expectations for an adcom as far as what areas of focus you are most preparing for where you think the agency might be most interested, whether it be, you know, the connection between real world data and your clinical data or validation and statistical issues, you know, anything you can provide on that would be really helpful. Hey, it's Josh.
Oren: You've got your infrastructure in place in.
Oren: Maybe arent just now trying to build awareness.
Oren: I know, you're not giving guidance certainly not on a product specific basis, but should we expect material revenue growth for that product. This year or is this more about just like a sampling.
Oren: And awareness building year.
Oren: And just getting all of the.
Oren: Patient support processes worked out, especially ahead of Aramark limo and an Aramark Limbaugh could you just talk about what.
Oren: If anything you can say about your expectations around an AD com as far as what areas of focus.
Oren: You are most preparing for where you think the agency might be most interested whether it would be.
Oren: The connection between where all data and your clinical data or validation and statistical issues anything you can provide on that front would be really helpful.
Joshua M. Schafer: Thanks for the question. With regard to the Alprova performance, as you noted, we are in full launch. As Neil just mentioned, effective the end of January, we had an entire commercial and medical team out engaging with our customers. We knew at the beginning of all this that awareness for Alprova and Zevra was quite low, but Alprova in particular, if you'll recall, it was approved through a 505B2 pathway, which meant that it had very little clinical experience.
Oren: Hey, Brian its Josh Thanks for the question with regards to the all proof of performance.
Joshua M. Schafer: As you noted we are in full launch.
Joshua M. Schafer: Neil just mentioned.
Joshua M. Schafer: Effective at the end of January we had an entire commercial and medical team out engaging with our customers.
Joshua M. Schafer: We knew at the beginning of all of this at awareness for all <unk> and Zimbra was quite low, but all prudent in particular.
You'll recall it was approved through a 505 <unk> pathway, which meant that it had very little clinical experience and so our priorities have really been around driving awareness and ensuring that patients have access to all prove out and to do that our team is working with physicians to identify the appropriate patients.
Joshua M. Schafer: And so our priorities have really been around driving awareness and ensuring that patients have access to Alpruva. And to do that, you know, our team is working with physicians to identify the appropriate patients. We have a quick start program in place to make sure that patients can experience the benefits of Alpruva.
Joshua M. Schafer: We have a quick start program in place to make sure that patients can experience the benefits of all prove up and and our reimbursement is increasing from 55% or 70.
Adrian: And our reimbursement is increasing from 55% to over. So, it is too early for us to give any guidance on performance and revenue. We will be watching new patient enrollments, covered lives, and net sales as we go, and we'll be providing updates on a quarterly basis. [inaudible] I was going to ask Adrian to comment a little bit on the agency and the potential focus of the ADCOM. Yeah, so the FDA has currently not confirmed the ADCOM, so there's an intention to hold an ADCOM, and no date has been set. We're obviously clearly preparing for the ADCOM.
Joshua M. Schafer: It is too early for us to give any guidance on.
Joshua M. Schafer: Performance in revenue, we will be watching new patient enrollments covered lives in net sales as we go and we'll be providing updates on that.
Joshua M. Schafer: On a quarterly basis.
Joshua M. Schafer: Alright.
Joshua M. Schafer: What I was going to ask Adrian to comment a little bit on the agency and the potential.
Adrian Portal: The focus of.
Adrian Portal: The AD com so.
Adrian Portal: So the FDA has currently knocked confirmed the <unk>. So there is an intention to hold an ethical and no date has been set.
Adrian Portal: We obviously clearly preparing for Ya com.
Adrian: As part of the original submission and the CRL, we kind of know what the questions were that the agency was looking for, and we're focusing on addressing those. Most important, though, is that we're really focusing on telling the story that the clinical data clearly shows, which is a significant benefit for patients. Some additional information that we got during the two type B meetings prior to our resubmission will also be included. But we're really mostly looking forward to having a healthy debate about what we consider clear efficacy in these patients and a clear benefit-risk profile. All right, thanks. I appreciate it. I'll jump back into queue.
Adrian Portal: As part of the.
Adrian Portal: The original submission and the Seawell, we kind of know what the question is whether the agency. We're looking for we're focusing on addressing those most important as always we are really focusing on.
Adrian Portal: Telling the story.
Nickel data clearly shows.
Adrian Portal: Benefit for patients.
Adrian Portal: Additional information that we got during the two tybee meetings.
Adrian Portal: Prior to our Resubmission will also be included.
None: Yeah, mostly looking forward how are you.
None: Healthy debates about what we consider core.
None: Clear efficacy in these spaces.
None: Benefit risk profile.
None: Okay.
None: Yes.
None: Alright, Thanks I appreciate it.
None: I'll jump back in the queue.
Jonathan Matthew Aschoff: We'll take our next question from Jonathan Aschoff with Roth MKM. Please go ahead, your line is open. Thank you very much, guys. I haven't had a chance to read the press release yet. It came out a little late, and there's a whole bunch of calls, but can you help us better understand the magnitude of benefit in IEH and thus your optimism for an end of phase 2 meeting that will go well and inform Phase 3 design? Absolutely.
None: Okay.
None: We'll take our next question from Jonathan Aschoff with Roth.
Jonathan Matthew Aschoff: Please go ahead your line is open.
Jonathan Matthew Aschoff: Thank you very much guys I haven't had a chance to read the press release that came out a little rate and there's a whole bunch of calls, but can you help us better understand the magnitude of benefit and IH and thus your optimism for an end of phase two meeting that will go well.
Jonathan Matthew Aschoff: Inform phase III design.
Jonathan Matthew Aschoff: Absolutely.
Christal M. M. Mickle: First, we need to really focus on what that Phase 2 trial was trying to achieve. This was a trial that was designed to demonstrate safety and tolerability and inform us about what the data would say about how to design a development program at NIH. Part of the secondary endpoints was looking at daytime sleepiness and the idiopathic hypersomnia scoring scale.
Jonathan Matthew Aschoff: Firstly to just really focus on what that phase II trial was trying to achieve this is a trial that was designed to demonstrate safety and tolerability and inform us for what what's.
Jonathan Matthew Aschoff: What's the data say into how to design it.
Jonathan Matthew Aschoff: Development program in the <unk>.
Jonathan Matthew Aschoff: NIH.
Jonathan Matthew Aschoff: Part of the secondary endpoints was looking at.
The daytime sleepiness and idiopathic hypersomnia scored scale we saw clear.
Christal M. M. Mickle: We saw clinically meaningful improvements, not only in the titration phase, but also in the double-blind phase. As I said, this trial was not designed to show statistical significance. We are planning to present this data at the Sleep24 meeting, and because of that, we're on data embargo, so we will discuss the data there with the sleep experts that will attend that meeting.
Jonathan Matthew Aschoff: Any meaningful improvements not only the titration phase, but also in the double blind phase.
Jonathan Matthew Aschoff: This trial was not designed to show statistical significance.
Jonathan Matthew Aschoff: Or are planning to present these data at <unk> 24 meters.
Jonathan Matthew Aschoff: Meeting and because of that were on beta embargo. So we will discuss the data that with the sleep expert steps that will attend that meeting.
Christal M. M. Mickle: Okay, so when you did this trial, you optimized these people to, you know, any one of the four different doses. So it's a complete random smattering, like it's not 16 patients per dose. It's, you know, whatever was their optimum dose. That's where they landed.
None: Okay. So when you did this trial you optimize these people.
None: Any one of the four different doses.
None: It's a complete random smattering like it's not 16 patients per dose.
None: It's whatever it was their optimum dose that's where they land is that there is no balance among those four groups that is client we've run it as okay. So after seeing that you know that the phase two press release are you still contemplating in narcolepsy trial, because the word narcolepsy is not in that press release on Tuesday, I was just curious.
Neil F. McFarlane: There's no balance among those four groups. That is correct. Okay. So after seeing the, you know, the phase two press release, are you still contemplating a narcolepsy trial? Because the word narcolepsy was not in that press release on Tuesday. I was just curious why that was.
Neil F. McFarlane: Thanks, Jonathan. It's Neil. You know, we're taking this data that we've got now on our Phase 2 to inform a Phase 3 in IH, but we're also understanding our Phase 1 data, some of our Phase 1 data, and other data to understand how to unlock the value of the broader sleep disorder opportunity. So we're evaluating that, but we have no further comment today on whether we're going to move forward into narcolepsy. Okay, and just a yes or no, I'll prove that MSUD is going to wait until you see how you track with the first indication, correct? Or do you have development plans for MSUD such that you could even give us a time? So you are correct.
None: Why that was.
Yeah. Thanks, Jonathan It's Neal we're taking this data that we've got now on our phase II to inform our phase III NIH, but we're also understanding our phase one data some of our phase one data and other data to understand how to unlock the value of the broader sleep disorder opportunity. So we're evaluating that.
None: We have no further comment today on it if we're going to move forward into narcolepsy.
None: Okay, and just a yes or no I'll prove inside.
None: I'm, sorry, just going to wait until you see how you track with the first indication correct.
None: Or do you have development plans for <unk>, such that you could even give us a timeline.
None: So you are correct, where we're waiting to do a full evaluation of our.
Neil F. McFarlane: We're waiting to do a full evaluation of our portfolio and strategic plan before we make any decisions on maple syrup uranes. Okay. And lastly, when it comes to your adcom, do companies typically have any sort of back and forth with patient advocates and, you know, strategize in any way? And if so, do you intend to do anything like that? Or is it, you know, just everyone goes?
None: Portfolio and strategic plan before we make any decisions on maple syrup urine disease.
None: Hey.
None: Lastly, when it comes to your AD com two companies typically have any sort of back and forth with the patient advocates and strategize in any way and if so do you intend to do anything like that or is it just everyone shows up.
Christal M. M. Mickle: This is Christal. Yes, it is very common for companies to engage with patient advocacy groups, and we are doing that. You know, one of the ways was the patient petitions that came through. That was something that we were very happy to see. And so we will continue to engage and make sure that the voices of the patients are being heard at the adcom in their own way. I mean, I think that'll be an important part of an adcom.
Christal M. M. Mickle: This is crystal.
Christal M. M. Mickle: Yes.
Christal M. M. Mickle: It is very common for companies to engage with the patient advocacy groups and that we are doing that.
Christal M. M. Mickle: You know one of the way.
Christal M. M. Mickle: What you.
Christal M. M. Mickle: The patient.
Christal M. M. Mickle: A petition that that came through.
Christal M. M. Mickle: Certainly that was something that we are very happy to see.
Christal M. M. Mickle: And so we will continue to engage and make sure that.
Christal M. M. Mickle: The voice is in the patients that are being incurred.
Christal M. M. Mickle: Hum and their own way.
None: I mean, I think that will be an important part of the AD com. So that's good to hear thank you very much.
Sumant Satchidanand Kulkarni: So that's good to hear. Thank you very much. Thank you, Jonathan. We'll take our next question from Sumant Kulkarni with Conocord. Please go ahead. Your line is open. Good afternoon, thanks for taking our questions. I have two.
None: Thank you Jonathan.
None: We will take our next question from <unk> Kulkarni with Canaccord. Please go ahead. Your line is open.
Kulkarni: Afternoon, Thanks for taking my questions I have.
Kulkarni: Two.
Adrian: The first one is, have you had any interactions with the FDA on the pending Aromaclomol filing since you announced the three-month pushout of the action date, and how have those discussions gone? Thank you, Sumant. Maybe I'll take that one.
Kulkarni: First one is have you had any interactions with the FDA on the pending Adam optimal filing since you announced the three month push out of the action date and how those discussions gone.
None: Thank you so maybe I'll take that one.
Neil F. McFarlane: We get, as part of the NDA resubmission information requests from the agency, which we've been able to satisfy and return in a timely way. One of those requests, as we've announced previously, was to satisfy the requirement of becoming a major amendment, which then caused the delay of three months and our September 21st PDUFA. So we are having those discussions, information requests are coming in, and we're able to satisfy those information requests in a timely fashion. And then on the recent phase 2 data for 1077 in IH, we are yet to see any quantitative details because of the sleep meeting-related embargo, but qualitatively, would you say there was anything counterintuitive either in a positive or negative way in the data relative to your original expectations? I think the most important lesson from this study was about the primary endpoint. So we dosed patients up to 320 mg, which is a pretty high dose, higher than we've dosed before in patients. And we saw no increase in the safety profile or safety risk.
None: We get as part of the NDA Resubmission information requests from the agency, which we've been able to.
None: Satisfy and return in a timely way.
None: One of those requests as we've announced previously was a satisfy the requirement of becoming a major amendment, which then caused a delay of three months and our September 21.
None: So we are having those discussions information requests are coming in and we're able to satisfy those information request in a timely fashion.
None: Got it and then on the recent phase II data for <unk> 10, 77, NIH, we're yet to see any quantitative details because at the sleep meeting related embargo, but qualitatively would you say there was anything content either in a positive or negative in the data relative to your original expectations.
None: I think the most important message from this study was on the primary endpoint. So we dose patients up to 320 milligrams, which is a pretty high dose higher than we've done dose before in patients and we saw no increase in the safety profile and safety risk more importantly, the cardiovascular safety profile is exactly as we had expected.
Adrian: More importantly, the cardiovascular safety profile is exactly as we had expected, and there were no changes in the cardiovascular safety profile, showing that we, you know, in principle, have a compound that can be safely administered to patients with idiopathic hypersomnia. Thank you. We'll take our next question from Louise Chen with Kantor. Please go ahead, your line is open. Hi, good afternoon. Harvey, R.W.
And there's no changes in the cardiovascular safety profile shown that.
None: This will have a compound that can be safely administered to patients we see in your better copper somewhere.
Thank you.
None: We will take our next question from Louise Chen with Cantor. Please go ahead. Your line is open.
None: Hi, good afternoon.
Louise Alesandra Chen: Harvey answer reviews, and Cantor Congrats Peter and thank you for taking my question.
Louise Alesandra Chen: Newsom-Kanner, congratulations on the data and thank you for taking our questions. Our first question is on KP1077. Post-positive phase 2 results, what are its closest competitors in IH? What differentiates KP1077?
Louise Alesandra Chen: First question.
Louise Alesandra Chen: AEP 10, 77 post positive phase III results one of its closest competitors in I H, what differentiates KC 10, 77, and our second question is on Air Mocha mill, the rare pediatric disease PR program.
Neil F. McFarlane: Our second question is on Aramakamo. The rare pediatric disease PRV program is expected to end this year. If Aramakamo gets approved and the program does become terminated, how might that impact the value of Aramakamo's PRV? Thank you so much. You were a little challenging to hear.
Louise Alesandra Chen: This year.
None: <unk> gets approved and a program does become terminated how might that impact the value of our market.
Thank you so much.
None: You were a little challenging to here I understood the question to be.
Neil F. McFarlane: I understood the question to be if we were going to get a PRV with the approval of the Aramatha law. Is that correct? And then the other 1077 program in regards to the differentiation from competitors? Yes, that's correct. Thank you. Okay, so yes, we have a PRV that will be issued upon approval with our Immoka Mall's NDA approval. So that does...
None: If we were going to get at priv with the approval of Ara mothball.
None: Is that correct and then the other 10 77 program in regards to the differentiation.
None: Competitors.
None: Yes, that's correct. Thank you okay.
Okay. So so yes.
None: We have a <unk> that will be issued upon approval.
None: With Ara Mako malls.
None: NDA approval so.
None: That does.
Neil F. McFarlane: I would add, Neil, and Carby, I think what you said is, what is the likelihood or what do we think the value change would be if the program governing that was ending this year? And I think the analysis we've seen or the information we've heard from a variety of sources says there is a potential that if that program ends, the value could go up. So I think we're going to assess that and look at that, but that's our current thinking on that point. Adrian, okay, Adrian here with regard to the competition in the idiopathic hypersomnia space.
None: I would add Neil that <unk> I think what you said is what is the likelihood or what do we think the value change would be if the program governing that would be ending this year and I think the analysis, we've seen or the information we've heard from variety of sources says, it's the potential if that Kroger.
None: Mens the value could go up so I think we're going to assess that and look at that but that's our current thinking on on that point.
None: Okay, Adrian here with regards to our to the competition.
Adrian: So KP1077 has a differentiated profile, a significantly different pharmacokinetic profile than other products on the market, and also a specific mode of action being a stimulant. There's only a Schedule IV program, and as I said previously, cardiovascular safety really, you know, jumps out when you look at the benefit of this program compared to other drugs currently on the market. Great. Thank you so much. And as a reminder, if you'd like to ask a question today, please press the star and one keys on your telephone keypad. We'll take our next question from Tim Lugo with William Blair. Please go ahead; your line is open.
None: The idiopathic hypersomnia space. So <unk> 77 has a differentiated profile.
Second different pharmacokinetic profile than other products in the market and also a specific motive action being stupid.
Adrian Portal: It is only scheduled for program in essence previously the cardiovascular safety really.
Adrian Portal: Jumps out when you look at the benefit of this program compared to other drugs currently on the market.
None: Great. Thank you so much.
None: And as a reminder, if you'd like to ask a question today. Please press the star and one keys on your telephone keypad.
None: Will take our next question from Tim Lugo with William Blair.
Tim Lugo: Please go ahead your line is open.
Tim Lugo: Hey guys, this is Lachlan. I'm for Tim. Thanks for taking the questions. I guess the first one is just on the approval launch. It sounds like obviously with low awareness.
Tim Lugo: Hey, guys. This is lachlan on for Tim Thanks for taking the questions.
Lachlan: First one is just on the operator launch it sounds like.
Lachlan: Low awareness.
Joshua M. Schafer: You maybe don't have a ton of experience, but can you maybe talk about the feedback that you've gotten thus far from those who do have experience? And then second, you know, I understand Revicti is meant to lose exclusivity at some point in the next year or two. So can you just sort of talk about your expectations for that and, you know, what it might mean for the market and for Allprover and maybe what the sort of scenarios there are? Sure, thanks for the question.
Lachlan: Maybe you don't have a ton of experience, but can you maybe talk about the feedback that you've gotten thus far have experience and then second I understand.
Lachlan: Mental lose exclusivity at some point in the next year or two so can you just sort of talk.
Lachlan: Talk about your expectations for that.
What it might mean for the market and for all preferreds and maybe what the sort of scenario thereof.
None: Sure. Thanks for the question.
Joshua M. Schafer: Yes, so awareness has been low for the reasons that I stated, and our primary objective now is to really build that awareness, working with physicians to identify those appropriate patients and to put in place programs so that patients can gain that experience with Alproova. The initial feedback that we're getting is that those patients who have had experience with Alproova are continuing on with it. We have a number of patients who are continuing to get refills of Alproova, and that really bodes well for future uptake. In terms of Revicti and their patent expiration, or I guess it's really the entrance of authorized generics, we are aware that later next year it's likely that an authorized generic, the first authorized generic for Revicti, will come into the market, and potentially a second thereafter.
Yes. So so awareness has been low for the reasons that I that I stated in our primary objective now is to really build that awareness working with physicians to identify those appropriate patients and to.
None: To put in place programs, so that patients can gain that experience with all through the.
None: The initial feedback that we're getting is those patients who have had experience with our crews are continuing on that we have a number of patients who are continuing to get refills of all prove up.
None: And that really bodes well for future in future uptake in terms of <unk>.
None: Their patent exploration or I guess, it's really the entrance of authorized generics. We are aware that later next year, it's likely that an authorized generic the first authorized generic for predicting will come into the market and potentially a second thereafter, we view that really as entrants into the higher end of the market specifically.
Joshua M. Schafer: We view that really as entrance into the higher end of the market, specifically products competing with Revicti in the same formulation. I'll prove it is very much clinically differentiated from Revicti and any authorized generic that comes into the market. And we believe that we've got a great clinical benefit, and we're well priced to be able to compete in this market. Thanks. And next, we have a follow-up question from Oren Livnat with H.C. Wainwright. Please go ahead. Thank you. Just to follow up on old Peruvia.
None: A.
None: Products competing with <unk> and the same formulation.
None: <unk> is very much clinically differentiated from <unk> and any authorized generic that comes into the market and we believe that we've got a great clinical benefit and we're well priced to be able to compete in this market.
None: Yes.
None: Okay.
Alright. Thanks.
None: Yeah.
None: And next we have a follow up question from Oren <unk> with H C. Wainwright. Please go ahead.
Oren: Thank you just a follow up again it will prove out.
Joshua M. Schafer: You know, I know it's quite early, but as you get more patients, hopefully, into the funnel, into the referral network, and then as you try to get them through adjudication to paid therapy, are you finding that, you know, you're being held to the hurdle of being compared to generic buprenorphine from a cost perspective, or is the bar, most likely, lower, and that you're essentially being benchmarked And regarding the patients you know you're going after, are you assuming current Revicti patients are low-hanging fruit, given you've got a presumably much superior product here from the patient perspective, or conversely, are they maybe the stable business and not your target patient? Yeah, thanks. So all branded products in this space are required to have some form of step edit. And so it's not unique for Alpruva to have a step edit where generic buprenol is required first.
Oren: I know, it's quite early but as you get more patient hopefully into the funnel to the referral.
Oren: Network and then as they tried to get them to adjudication to paid therapy.
Oren: Are you finding that you are being.
Oren: You're being held to the hurdle.
None: Thank you Pak generic do you for now from a cost perspective or is the bar are most more likely lower and that youre essentially being benchmarked against our market leading <unk>.
None: And regarding the patients youre going after or are you assuming current victory patients are low hanging fruit given you've got a presumably much superior product here from the patient perspective.
None: Or Conversely are they may be the stable business and not youre targeting patient.
None: Yeah. Thanks.
None: So all products all branded products in this space are required to have some form of step edit.
None: And so it's not unique for for all prove out to have a step edit.
None: Generic <unk>.
None: <unk> is required first but we're seeing patients stepping through that very very quickly and physicians and patients who are making a decision as to what's the next best.
Joshua M. Schafer: But we're seeing patients step through that very, very quickly, and then physicians and patients are making the decision as to what's the next best clinical opportunity for patients. Many of the physicians that we've been speaking with, and albeit it's been just a few short weeks since we had that exposure, really find Alprova to have the most clinically differentiated and beneficial profile for these patients. So it's a little too early to give you the definitive answers to that, Oren, but the early signals are that, again, the profile of our crew is really lending itself towards patients switching both from, Oren, and One additional comment to that is that I think that that's an important perspective. As Josh mentioned, you know, the approach to getting patients on therapy is fairly consistent.
None: The opportunity for patients.
None: Many of the physicians that we've been speaking with them, albeit it's been just a few short weeks that we've had that exposure really find all proven to have the most clinically differentiated and beneficial profile for the for these patients. So it's a little too early to give you any definitive answers to that orange.
None: Early signals are that the again the profile of <unk> is really lending itself towards patient switching both from.
None: Submarine and <unk> improvement.
None: Or I might add one additional comment to that one additional comment to that I think that's an important perspective as as Josh mentioned.
None: The approach to getting patients on therapy is fairly consistent or improvement of the reimbursement of covered lives from 55% up to 70% really puts us close to par also.
Joshua M. Schafer: Our improvement in the reimbursement of covered lives from 55% up to 70% really puts us close to par also in that area, which then, you know, we can drive that awareness and clinical differentiation from the other products in the market. And the quick start program and other awareness campaigns that we're moving forward with will allow us to be able to give patients an option and physicians an option. Thanks. Good luck!
None: In that area, which then we then can drive that awareness and clinical differentiation from the other products in the market.
And with the.
None: Quick start program and other awareness campaigns that we're moving forward with will allow us to be able to to give patients.
None: <unk> option and physicians an option.
Thanks.
None: Yes.
Operator: Thank you. And this does conclude the Q&A portion of today's call. I'd now like to turn the call back over to Neil McFarlane for any closing remarks. Thank you, Operator. The fourth quarter of 2023 was a period of tremendous transformation for Zevra. We made solid progress toward achieving our mission of building a leading patient-focused rare disease company. As we look to 2024, our key strategic priorities are clear, and we look forward to updating you in the future.
None: Good luck.
None: <unk>.
None: Thank you.
None: And this does conclude the Q&A portion for today's call I'd now like to turn the call back over to Neil Mcfarlane for any closing remarks.
Neil F. McFarlane: Thank you operator, the fourth quarter 2023 was a pretty a period of tremendous transformation for zebra.
Neil F. McFarlane: We made solid progress towards achieving our mission of building a leading patient focus rare disease company as we look to 2020 for our key strategic priorities are clear and we look forward to updating you in the future. Thanks for joining us today.
None: This does conclude today's program. Thank you for your participation and you may disconnect at anytime.
None: Hum.
None: Hum.
None: Hum.
None: [music].
None: Hum.
None: Hum.
None: [music].
Neil F. McFarlane: Thanks for joining us today. This does conclude today's program. Thank you for your participation, and you may disconnect at any time.
None: Okay.
None: [music].
None: Okay.
None: [music].
None: Mhm.