Q4 2023 Deciphera Pharmaceuticals Inc Earnings Call

February 6, 2024

Operator: For more UN videos, visit www.un.org Good morning, everyone, and welcome to Decipher Pharmaceuticals' fourth quarter and full year 2023 financial results conference. Today's call is being recorded. At this time, I would like to turn the call over to Jen Larson, Senior Vice President of Finance and Investor Relations. Gen.

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Good morning, everyone and welcome to decipher Pharmaceuticals fourth quarter and full year 2023 financial results Conference call. Today's call is being recorded at this time I would like to turn the call over to Jenn Larson Senior Vice President.

Jessica Fye: <unk> finance and Investor Relations.

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Jen Larson: Thank you, Operator. Welcome, and thank you for joining us today to discuss Decipher's fourth quarter and full year 2023 financial results. I'm Jen Larson, Senior Vice President of Finance and Investor Relations. With me this morning to discuss the financial results and provide a general corporate update are Steve Herter, President and Chief Executive Officer, Matt Sherman, Chief Medical Officer, Dan Martin, Chief Commercial Officer, Marguerita Duarte, Head of International, and Tucker Kelly, Chief Financial Officer. Before we begin, I would like to remind you that any statements we make on this call that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Examples include our expectations for our preclinical and clinical programs, our commercialization of Kinloch, and guidance.

Jessica Fye: Thank you operator, welcome and thank you for joining us today to discuss <unk> fourth quarter and full year 2023 financial results I'm, Jim Martin Senior Vice President of Finance and Investor Relations with me. This morning to discuss the financial results and provide a general corporate update are Steve heard our president.

Steve Heard: And Chief Executive Officer, Matt Sherman, Chief Medical Officer, Dan Martin Chief Commercial Officer, Margherita Duarte head of International and Tucker Kelly Chief Financial Officer.

Steve Heard: Before we begin I would like to remind you that any statements. We make on this call that are not historical facts are forward looking statements made pursuant to the safe Harbor provisions of the private Securities Litigation Reform Act of 1995.

Steve Heard: Examples include our expectations for our preclinical and clinical programs, our commercialization of Kinloch and guidance forward looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward looking statements.

Jen Larson: Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statement, and we cannot assure you that our expectations will be achieved. Such risks and uncertainties include those set forth in our most recent annual report on Form 10-K, as well as in our other SEC filings. We assume no obligation to update or revise any forward-looking statements.

Steve Heard: We cannot assure you that our expectations will be achieved such risks and uncertainties include those set forth in our most recent annual report on Form 10-K, as well as our other SEC filings, we assume no obligation to update or revise any forward looking statements. Following this call a replay will be available on the company's website www.

Steve Herter: Following this call, a replay will be available on the company's website, www.deciphera.com. With that said, I will now turn the call over to Steve Herter, President and Chief Executive Officer of Deciphera. Thank you, Jen. Good morning, everyone, and thank you for joining us today as we provide an update on the fourth quarter and full year 2023, review our financial results, and discuss our strategic outlook and planned corporate milestones for 2024. 2023 was a year of significant progress toward our goal of becoming a self-sustaining company with multiple approved medicines. Continued strong Kinloch growth in the U.S. and internationally drove record annual revenue, demonstrating the global capabilities of our commercial organization. With a highly successful phase three study in TGCT, we expect Dimseltonit to be our second approved medicine. We believe that at peak, Kenlock and Dimseltonit will be able to generate over $1 billion in global revenue.

Steve Heard: Dot decipher a dot com with that I will now turn the call over to Steve <unk>, President and Chief Executive Officer, I'll Decipher Steve.

Steve Heard: Thank you John and good morning, everyone and thank you for joining US today as we provide an update from the fourth quarter and full year 2023 review, our financial results and discuss our strategic outlook and planned corporate milestones for 2024.

Steve Heard: 2023 was a year of significant progress toward our goal of becoming a self sustaining company with multiple approved medicines continued strong <unk> growth in the U S and internationally drove record annual revenue demonstrating the global capabilities of our commercial organization.

Steve Heard: With a highly successful phase III study in <unk>, we expect <unk> to be our second approved medicine. We believe that at peak can walk into results and Ed will be able to generate over $1 billion in global revenue with a long runway for both products. We are actively pursuing label expansion opportunities to create further value for <unk>.

Steve Herter: With a long IP runway for both products, we are actively pursuing label expansion opportunities to create further value for patients and for our shareholders. Beyond these late-stage programs, we continue to strategically invest in key earlier-stage programs to help build a sustainable pipeline of potential new medicines to improve the lives of people with cancer. Last month, we outlined our key strategic priorities for 2024.

Steve Heard: Patients and for our shareholders.

Steve Heard: Beyond these late stage programs, we continue to strategically invest in key earlier stage programs to help build a sustainable pipeline of potential new medicines to improve the lives of people with cancer.

Steve Heard: Last month, we outlined our key strategic priorities for 2024, we expect 2020 for it to be a year of continued growth in kinloch sales driven by strong demand both in the U S and internationally. Meanwhile, our clinical team is working towards our goal of expanding <unk> label based on the ongoing phase III <unk> study.

Steve Herter: We expect 2024 to be a year of continued growth in Kenloch sales, driven by strong demand both in the U.S. and internationally. Meanwhile, our clinical team is working towards our goal of expanding Kenloch's label based on the ongoing Phase 3 Insights study in second-line GIST patients with mutations in KIT Exon 11 and 17 or 18, which has the potential to double peak sales. A few weeks ago, we were thrilled to announce the publication in Nature Medicine of the exceptional results from the ctDNA analysis from the INTRIGUE study in second-line patients with mutations in KIT exon 11 and 17 or 18, showing that Kenlock provided significant progression-free and overall survival benefit compared to the current standard of care, SUNIT-B. Publication in one of the world's leading medical journals highlights the clinical importance of this compelling data and serves as strong validation for the ongoing insight study.

Steve Heard: In second line Gist patients with mutations in kit exon 11 in 17, or 18, which has the potential to double peak sales.

Steve Heard: A few weeks ago, we were thrilled to announce the publication in nature medicine of the exceptional results from the Cte DNA analysis from the intrigue study in second line patients with mutations in kit exon 11 in 17 or 18, showing that Ken lock provided significant progression free and overall survival benefit compared to the current standard.

Steve Heard: <unk> care Sunitinib.

Steve Heard: Publication in one of the world's leading medical journals highlights the clinical importance of this compelling data and serve as a strong validation for the ongoing insight study.

Steve Herter: In addition to the Nature Medicine publication, we recently presented the final overall survival results from the Intrigue Study at the ASCO GI Symposium, which showed that the overall survival rate was similar for both Kenlock and Sunitinib and that treatment with Kenlock continued to show a favorable safety profile compared to treatment with Sunitinib. We believe that these results demonstrate the strong clinical activity of Kenlock in the second-line just patient population studied in Intrigue.

Steve Heard: In addition to the nature Medicine publication. We also recently presented the final overall survival results from the intrigue study at the <unk> Gi Symposium, which showed that the overall survival rate was similar for both <unk> and Sunitinib and the treatment with <unk> continued to show a favorable safety profile compared to <unk>.

Steve Heard: We believe that these results demonstrate the strong clinical activity of catalog in the second line just patient population studied in intrigue.

Steve Herter: For Vimseltenib, building upon the exciting positive results of the Motion Phase III study in patients with tenosynovial giant cell tumors, we remain on track to submit the NDA to the FDA in the second quarter of this year and an MAA to the EMA in the third quarter of this year. With the potential approval of Vimseltenib in sight, we are also exploring potential indication expansion opportunities, including our plan to initiate a Phase II proof-of-concept study of Vimseltenib for the treatment of chronic graft-versus-host disease, or CGVHD, in the fourth quarter of 2024. In addition, we're making focused investments in our earlier stage pipeline, which we expect will fuel our future growth.

Steve Heard: For himself and Ed building upon the exciting positive results of the motion Phase III study in patients with tennis and OBL giant cell tumor we remain on track to submit the NDA to the FDA in the second quarter of this year and an MAA to the EMA in the third quarter of this year with the potential approval of themselves.

Steve Heard: Insight, we are also exploring potential indication expansion opportunities, including our plan to initiate a phase II proof of concept study of themselves. So net for the treatment of chronic graft versus host disease or gvhd and the fourth quarter of 2024.

Steve Heard: In addition, we're making focused investments in our earlier stage pipeline, which we expect will fuel our future growth.

Steve Herter: For our ULK inhibitor, DCC3116, our goal is to select a recommended phase 2 dose later this year and move to our first expansion cohort. For DCC3084, our pan-RAF inhibitor, we expect to initiate a phase 1 study in the first half of this year. Finally, for DCC3009, our new pan-KIT inhibitor, we expect to submit an IND with the FDA in the first half of this year and initiate a phase 1 study in the second half of 2024. We remain well capitalized with $352 million in cash at the end of the year and a cash runway into the second half of 2026.

Steve Heard: For our <unk> inhibitor DCC 31, 16, our goal is to select a recommended phase II dose later this year and move to our first expansion cohort for <unk> 384, our Pan RAF inhibitor, we expect to initiate a phase one study in the first half of this year finally for DCC 3009 hour.

Steve Heard: New Pan Kit inhibitor, we expect to submit an IND with the FDA in the first half of this year and initiate a phase one study in the second half of 2024.

Steve Heard: We remain well capitalized with $362 million in cash at the end of the year and our cash runway into the second half of 2026.

Matthew L. Sherman: I'll now pass the call to Matt Sherman, our Chief Medical Officer, who will provide more detail on our development pipeline. Dan Martin, our Chief Commercial Officer, will then share insights on our U.S. commercial performance and outlook for the year ahead. Margarita Duarte, our Head of International, will provide an update on the progress of the ongoing Kinloch launch in Europe for Forthline GIST and its continued strong momentum. We'll end with Tucker Kelly, our Chief Financial Officer, who will review highlights from the fourth quarter and full year 2023 financial results. Thanks, Steve.

Steve Heard: I will now pass the call to Matt Sherman, our Chief Medical Officer, who will provide more detail on our development pipeline, Dan Martin Our Chief Commercial Officer will then share insights on the U S commercial performance and outlook for the year ahead, Margarita Duarte, our head of international who will provide an update on the progress of the ongoing <unk> launch in Europe for fourth line Gist and it's.

Matthew L. Sherman: <unk> strong momentum will end with Tucker Kelly, our Chief Financial Officer, who will review highlights from the fourth quarter and full year 2023 financial results Matt.

Matthew L. Sherman: Together with our commercial success, we continue to make great strides with our development pipeline, which we believe will provide continued growth for Deciphera over the coming years. First, I'd like to start with our recent Kinloch update. As Steve mentioned, in January, we presented the final overall survival results from an intriguing Phase III study at the ASCO GI Conference. As you may recall, in the INTREAD trial, 453 patients with second-line GIFs were randomized one-to-one to receive Kinloch or Subitinib. The final analysis included 18 months of additional follow-up based on the data cut in March 2023.

Matthew L. Sherman: Thanks, Steve.

Matthew L. Sherman: Together with our commercial success, we continue to make great strides with our development pipeline that we believe will provide continued growth for <unk> over the coming years.

Tyler Van Buren: First I'd like to start with our recent kinloch updates.

Tyler Van Buren: As Steve mentioned in January we presented the final overall survival results from the new treat phase III study at the <unk> Gi conference as.

Tyler Van Buren: As you may recall in intrigue trial 453 patients with second line Gist, where randomized one to one to receive kinloch or sunitinib.

Tyler Van Buren: The final analysis included 18 months of additional follow up based on the data cut in March 2023.

Matthew L. Sherman: Median overall survival in the intensive treatment population was very similar, with Kinloch at 35.5 months versus Sunitinib at 31.5 months, resulting in a hazard ratio of 0.86. The long-term safety profile was consistent with the primary analysis showing fewer patients with grade 3-4 TEAEs and a lower rate of treatment discontinuations due to TEAEs with Kinloch versus Sumitnick. We also looked at whether treatment in the second line with Kinloch versus Smith had any differential impact on clinical outcomes after third-line treatment. Irrespective of treatment with Kinloch in the second line, the results show that patient outcomes in the third line were similar.

Tyler Van Buren: Median overall survival in the intent to treat population was very similar with Kinloch at 35, five months versus Sunitinib at 31, five months, resulting in the hazard ratio of <unk> 86 for.

Tyler Van Buren: The long term safety profile was consistent with the primary analysis showing fewer patients with grade three four <unk> and a lower rate of treatment discontinuation is due to to ease with kinloch versus sunitinib.

Tyler Van Buren: We also looked at where the treatment in the second line with Tim rock versus submit had any differential impact on clinical outcomes. After third line treatment.

Tyler Van Buren: Irrespective of treatment with <unk> in the second line the results show that the patient outcomes in the third line with similar.

Matthew L. Sherman: The median PFS on the next line of therapy was 7.7 months for Kinloch versus 7.4 months for Suvitinib. These final results for intrigue demonstrate that Kinloch offers similar efficacy versus subitinib in the second line GIST population studied in intrigue. The Nature Medicine publication last month was another major achievement for Deciphera, showcasing the potentially practice-changing results from an exploratory ctDNA analysis from Intrigue and one of the world's leading medical journals. In second-line GIST patients with KITX11 and 1718 mutations, treatment with Kinloch resulted in a 78% reduction in the risk of disease progression and a 66% reduction in the risk of death compared to some of these.

Tyler Van Buren: Median PFS on the next line of therapy was seven seven months for Ken lock versus seven four months for Sunitinib.

Tyler Van Buren: These final results were intrigued demonstrate the Kimberly Clark for similar efficacy versus Sunitinib in the second one just population studied inventory.

Tyler Van Buren: The nature Medicine publication last month was another major achievement towards the safer showcasing the potentially practice changing results from an exploratory Cte DNA analysis from intrigue and one of the world's leading medical journals.

Tyler Van Buren: And second line Gist patients with kit exon 11, and 70 to 80 mutations treatment with <unk> resulted in the 78% reduction in the risk of disease progression and.

Tyler Van Buren: And a 66% reduction in the risk of death compared to this amendment.

Matthew L. Sherman: Median PFS was 14.2 months for the Kinloch patients, compared to only 1.5 months for the Sunitinib patients. Median overall survival for Kinloch was not reached versus 17.5 months for a submit. Kinloch showed an objective response rate of 44% compared to 0% for submittance.

Tyler Van Buren: Median PFS was $14 two months for the <unk> patients compared to only one five months for the Sunitinib patients.

Tyler Van Buren: Median overall survival for Kinloch was not reached versus $17 five months for Sunitinib.

Tyler Van Buren: <unk> showed an objective response rate of 44% compared to zero percent for Sunitinib.

Matthew L. Sherman: Together, the data represents a striking clinical benefit to these second-line GIST patients when treated with Kymlock. We're excited that our Insight Pivotal Phase III study in the same patient population is now actively enrolling patients. If positive, we believe the results of the INSIGHT study will support an expanded label for Kinloch and significantly improve clinical outcomes for patients based on the precise understanding of their GIST tumors.

Tyler Van Buren: Together the data represents a striking clinical benefit for these second line gist patients when treated with <unk>.

Tyler Van Buren: We're excited at our insight pivotal phase III study in the same patient population is now actively enrolling patients.

Tyler Van Buren: If positive we believe the results of the insight study will support an expanded label for Kim Locke and significantly improve clinical outcomes for patients based on the precise understanding of their just tumors.

Tyler Van Buren: We are also working hard to get our second potential approved medicine to patients as quickly as possible.

We remain on track to submit an NDA for themselves and for patients with <unk> in the second quarter of 2024, and an MAA with third quarter 2024.

Matthew L. Sherman: We are also working hard to get our second potential approved medicine to patients as quickly as possible. We remain on track to submit an NDA for it for themselves and for patients with TGCT in the second quarter of 2024 and an MAA in the third quarter of 2024. These filings are supported by the outstanding success of the Phase III Motion Study, which achieved its primary endpoint of ORR at Week 25, as well as all six key secondary endpoints. In a disease such as TGCT, the secondary endpoints are critical measures of clinical benefit. These outcomes of how patients feel and function play an incredibly important role in treatment decisions, as well as for patients' interest in starting and staying on drug therapy. DGCT can be a difficult chronic condition associated with severe pain, swelling, stiffness, and loss of mobility.

These filings are supported by the outstanding success of the Phase III <unk> study, which achieved its primary endpoint of our and we 25 as well as all six key secondary endpoints.

Tyler Van Buren: And the disease, such as <unk>. The secondary endpoints are critical measures of clinical benefit.

Tyler Van Buren: Outcomes of how patients beyond function play are incredibly important role in treatment decisions as well as for patients' interest in starting and staying on drug therapy.

Tyler Van Buren: <unk> can be a difficult chronic condition associated with severe pain swelling stiffness and loss of mobility.

Tyler Van Buren: All of these can severely limit patients' daily activities and quality of life, including their ability to continue to work a function independently.

Tyler Van Buren: Without an effective treatment of TGT diagnosis can have a profound impact on their ability to lead a normal active and healthy life and we look forward to making this important new medicine available to these patients as quickly as possible.

Matthew L. Sherman: All of these can severely limit patients' daily activities and quality of life, including their ability to continue to work or function independently. Without effective treatment, a TGCT diagnosis can have a profound impact on their ability to lead a normal, active, and healthy life. And we look forward to making this important new medicine available to these patients as quickly as possible. We plan to present results from the EMOTION study at a major medical meeting in the second quarter of 2024, as well as updated results from the ongoing Phase I-II study in the second half of this year. Decipher remains committed to ensuring that the full therapeutic potential of medicine and product candidates is explored. To that end, we plan to initiate a Phase II proof-of-concept study of vimseltinib and chronic GVHD based on its potential as a best-in-class CSF1 receptor inhibitor.

Tyler Van Buren: We plan to present results from the motion study at a major medical meeting in the second quarter of 2024 as well as updated results from the ongoing phase <unk> study in the second half of this year.

Tyler Van Buren: The sofa remains committed to ensuring that the whole therapeutic potential of our medicine and product candidates are explored.

Tyler Van Buren: To that end, we plan to initiate a phase II proof of concept study of <unk> in chronic gvhd based on its potential as a best in class CSF one receptor inhibitor.

Tyler Van Buren: Chronic gvhd effects, 30% to 50% of allogeneic hematopoietic stem cell transplant recipients with an estimated 14000 prevalent patients in the U S.

Tyler Van Buren: There is a significant unmet medical need in this setting with 50% of patients being refractory to treatment with steroids and overall desire to move towards combination therapy.

Tyler Van Buren: Inhibiting CSF, one receptor expressing pro inflammatory and pro fibrotic macrophages has been clinically validated for patients with Gvhd based on a recent pivotal study with an antibody targeting the CSF one receptor.

Matthew L. Sherman: Chronic GVHD affects 30 to 50% of allogeneic hematopoietic stem cell transplant recipients, with an estimated 14,000 prevalent patients in the U.S. There is a significant unmet medical need in this setting, with 50% of patients being refractory to treatment with steroids and an overall desire to move towards combination therapy. Inhibiting CSF1 receptor-expressing pro-inflammatory and pro-fibrotic macrophages has been clinically validated for patients with GVHD based on a recent pivotal study with an antibody targeting the CSF1 receptor.

Tyler Van Buren: As an oral agent <unk> may offer a best in class CSF, one receptor option as a single agent or in combination with other oral therapies.

Tyler Van Buren: We expect to initiate a proof of concept study by the end of this year, putting us on a path to potentially expand the utility of <unk> for patients in the future.

Tyler Van Buren: Beyond <unk>, we remain very excited about the potential for our clinical and research pipeline to fuel to ciphers growth.

Tyler Van Buren: As Steve mentioned earlier, we expect to select a recommended phase II dose for DCC 3116 in 2024 to move into our first expansion cohort.

Matthew L. Sherman: As an oral agent, Denisultanib may offer a best-in-class CSF1 receptor option as a single agent or in combination with other oral therapies. We expect to initiate a proof of concept study by the end of this year, putting us on a path to potentially expand the utility of Insultin for patients in the future. Beyond Kinloch and Vinfeldtavid, we remain very excited about the potential for our clinical and research pipeline to fuel Decipher's growth. As Steve mentioned earlier, we expect to select a recommended phase 2 dose for DCC 3116 in 2024 to move into our first expansion cohort.

Tyler Van Buren: We also expect to initiate a phase one study for DCC 30, 84 in the first half of 2020 for.

Tyler Van Buren: Finally, we expect to submit an IND for DCC three series or a nine with the FDA in the first half of 2024 and initiate a phase one study in the second half of 2024.

Tyler Van Buren: I will now turn the call over to Dan Martin to discuss our U S commercial updates.

Tyler Van Buren: Dan.

Dan Martin: Thanks, Mac 2023 was a very successful year for Kim market in the U S with net product revenue growing to 121 5 million.

Dan Martin: A 25% increase over 2022 in the fourth quarter U S. Net product revenue was $35 3, million% to 38% increase over Q4 2022. These.

Dan Martin: We also expect to initiate a Phase I study for DCC 3084 in the first half of 2024. Finally, we expect to submit an IMD for DCC 3009 with the FDA in the first half of 2024 and initiate a Phase I study in the second half of 2024. I will now turn the call over to Dan Martin to discuss our U.S. commercial update. Dan?

Dan Martin: These record results were driven by strong demand in our core Portland business, increasing average duration of therapy and contribution from uninformed noted earlier line use in.

Dan Martin: In Q4, the percentage of total demand that was fulfilled through our patient assistance program or cap was at the high end of our 20% to 30% expected range and gross to net was between 15 and 20%.

Dan Martin: Thanks, Matt. 2023 was a very successful year for Kinloch in the U.S., with net product revenue growing to $121.5 million, a 25% increase over 2022. In the fourth quarter, US net product revenue was $35.3 million, a 38% increase over Q4 2022. These record results were driven by strong demand in our core Portland business.

Dan Martin: Looking at 2023 as a whole consistent with prior years, Pat was between 20% and 30% and we expect the percentage to be similar in 2020 for gross to net in 2023 was between 15 and 20% and we expect it to be in a similar range in 2024 as a result of the Medicare.

Dan Martin: Increasing Average Duration of Therapy and Contribution from Unpromoted Earlier Line Use. In Q4, the percentage of total demand that was fulfilled through our Patient Assistance Program, or PAP, was at the high end of our 20 to 30 percent expected range, and gross net was between 15 and 20 percent. Looking at 2023 as a whole, consistent with prior years, PAP was between 20 and 30 percent, and we expect the PAP percentage to be similar in 2024. Rose-Tenet in 2023 was between 15 and 20 percent.

Dan Martin: Inflation rebates required by the inflation reduction.

Dan Martin: We expect continued cannot revenue growth in 2024, driven by its position as the standard of care in fourth line Gist potential promoted off label use in earlier lines of therapy based on physician decision as well as increasing average duration therapy.

Dan Martin: Further we expect quarterly revenues this year to follow a similar pattern to what we've seen in prior years, including Q1 seasonality consistent with the industry dynamics we remain.

Dan Martin: Confident in the strength of our business and the potential for another record year for <unk> in 2024.

Dan Martin: Now I will turn to the exciting opportunity, we see in <unk> within Sultan our potential second approved medicine.

Dan Martin: And we expect it to be in a similar range in 2024 as a result of the Medicare inflation rebates required by the Inflation Reduction Act. We expect continued Kinloch revenue growth in 2024, driven by its position as the standard of care in Fort Lyon JIT. Potential unpromoted off-label use in earlier lines of therapy based on physician decision, as well as increasing average duration of therapy. Further, we expect quarterly revenues this year to follow a similar pattern to what we have seen in prior years, including Q1 seasonality consistent with industry dynamics.

Dan Martin: Based on our analysis of U S claims data, we believe the total addressable market for <unk> in the U S is approximately $700 million.

Dan Martin: Based on the estimated 1400 treatment in patients who are diagnosed receive systemic therapy and have recently engaged with an oncologist. This U S opportunity does not include the estimated 9000 feet.

Dan Martin: Prevalent patients seen by oncologists or the estimated 1300 treatment incident patients seen by surgeons we.

Dan Martin: We believe there is a comparable number of patients in the five largest European markets, where there are no approved treatments.

Dan Martin: We remain confident in the strength of our business and the potential for another record year for Kinloch in 2024. Now, I will turn to the exciting opportunity we see in TGCT with Insultanant, our potential second approved medicine. Based on our analysis of U.S. claims data, we believe the total addressable market for TGCT in the U.S. is approximately $700 million based on the estimated 1,400 treatment incident patients who are diagnosed, receive systemic therapy, and have recently engaged with an oncologist. This U.S. opportunity does not include the estimated 9,000 prevalent patients seen by oncologists or the estimated 1,300 treatment incident patients seen by surgeons.

Dan Martin: We recently provided additional insight into the treatment landscape for these 1400 treatment incident patients in the U S that has increased our confidence in the market opportunity and then our commercial team's ability to reach these patients given our deep experience in gist.

Dan Martin: Based on our claims analysis, we believe there is a 70% to 80% overlap in the prescriber base for <unk> and <unk> and that we are uniquely positioned to drive awareness and used in both the academic and community settings.

Dan Martin: We have captured a blinded product profile of <unk> versus <unk>, which is approved in the U S, but not in Europe and versus amendment, which is commonly used off label managed patients with TCT.

Dan Martin: We believe there are a comparable number of patients in the five largest European markets where there are no accrued treatments. We recently provided additional insight into the treatment landscape for these 1,400 treatment incident patients in the U.S., which has increased our confidence in the market opportunity and in our commercial team's ability to reach these patients given our deep experience in JIF. Based on our claims analysis, we believe there is a 70% to 80% overlap in the prescriber base for GIFT and TGCT and that we are uniquely positioned to drive awareness and use in both academic and community settings. We have tested a blinded product profile of insulpinib versus pexidartanib, which is approved in the U.S. but not in Europe, and versus imatinib, which is commonly used off-label to manage patients with TGCT.

Dan Martin: The results from the qualitative market research showed that consultant and its rated the highest across the key measures of efficacy and tolerability that physicians tell us debut as most important when selecting the PKI to treat <unk> patients.

Dan Martin: In the same market research study, 100% of physicians surveyed selected the <unk> profile as their preferred agent for managing patients with TCT.

Dan Martin: We are working diligently on prelaunch activities as we prepare to leverage our strong commercial capabilities to launch consultant and rapidly upon approval.

Dan Martin: I will now turn the call over to Marguerite or Duarte, our head of international to discuss the progress of the cannot launch in Europe Margarita.

Marguerite: Thanks, Dan we are very enthusiastic about the notable achievements, we made in 2023 and our international business.

Marguerite: Bring strong results that accounted for more than 25% of total revenue, while laying the foundation for future growth.

Dan Martin: The results from the qualitative market research show that benzaltamide is rated the highest across the key measures of efficacy and tolerability that physicians tell us they view as most important when selecting a TKI to treat their TGCT patient. In the same market research study, 100% of physicians surveyed selected the Vimseltenit profile as their preferred agent for managing patients with TGCT. We are working diligently on pre-launch activities as we prepare to leverage our strong commercial capabilities to launch Vimseltenit rapidly upon approval. I will now turn the call over to Margarita Duarte, our Head of International, to discuss the progress of the Kinloch launch in Europe. Margarita?

Marguerite: In 2023, Kinloch generated $37 million in international net product revenue.

Marguerite: 33% from 2022.

Well and $4 3 million in collaboration revenue from our partners XI lab in greater China.

Marguerite: For the fourth quarter of 2023 International net product revenue increased 56% from the fourth quarter of last year to 11 4 million in collaboration revenue with an additional $1 6 million.

Marguerite: Last year was a milestone year for Europe with growth across entire Jeff Good evening.

Margarita Duarte: Thanks, Dan. We are very enthusiastic about the notable achievements we made in 2023 in our international business, delivering strong results that accounted for more than 25% of Decipher's total lab revenue while laying the foundation for future growth. In 2023, Kinloch generated $37.5 million in international net product revenue, up 33% from 2022, as well as $4.3 million in collaboration revenue from our partner Zylab in Greater China. For the fourth quarter of 2023, international net product revenue increased 56% from the fourth quarter of last year to $11.4 million, and collaboration revenue was an additional $1.6 million.

Marguerite: Strong price outcome.

Marguerite: Excellent progress in market access in multiple countries and the launch in Italy, which is off to an excellent start.

Marguerite: The initial results we are seeing in Italy are a testament to the high unmet medical need the exceptional Taylor with Barclays.

Marguerite: Remarkable fully relation writing glenda to kinloch by detailing authority.

Marguerite: For our non QM, UBB, which have significantly accelerated the launch and the many Italian regions.

Marguerite: Louise and answer any color. If there is an example of the type of opportunity that remains to be unlocked in Europe.

Marguerite: This core theme park with geographic expansion to overall growth in the business.

Marguerite: Last month, we announced a new distribution agreement with Genesis pharma for central and Eastern Europe.

Marguerite: And the geographic reach of Kinloch to 14 European Union countries with a combined population of 118 million people.

Margarita Duarte: Last year was a milestone year for Europe, with growth across the entirety of the Disney brand, Strong Price Outcomes, Significant Progress in Market Access in Multiple Countries, and the launch in Italy, which is off to an excellent start. The initial strong results we are seeing in Italy are a testament to the high and met medical needs, the exceptional KOL advocacy, and the remarkable Food Innovation Ratings granted to Kinloch by the Italian Authority, the highest for a non-curetive disease, which has significantly accelerated the launch in many Italian countries. Our recent entry into Italy is a good example of the type of opportunity that remains to be unlocked in Europe and underscores the importance of geographic expansion to overall growth in the region.

Marguerite: Ken will has already received regulatory approval in all of these countries under the EMI umbrella.

Marguerite: Will significantly accelerate the time to commercialization for central and Eastern Europe.

Marguerite: We're also excited to announce that we have with Macy's.

Marguerite: <unk> is reimbursement in the Netherlands, and continued with best price negotiation in Spain, France and Switzerland.

Marguerite: Our cable Wi Fi Barclays. Paul include a continued focus on geographic expansion and open new markets to drive successful launches.

Marguerite: We are very pleased by the strength of our execution and we expect our international revenue to continue to grow as reimbursement agreements and approvals are achieved alongside the growth from our initial launch market, where they think you walk to reach more patients around the world.

Marguerite: Touching on themselves.

Marguerite: Comparable excitement in Europe surrounding the outstanding Phase III motion data, where we believe the number of patients is comparable to the U S and the five largest European markets and then we have made is higher.

In our statements.

Speaker Change: Yeah, working hard towards our first initial engagements with HCA agencies earlier this year and I look forward to the MAA submission in the third quarter and preparing for the commercial launch.

Margarita Duarte: Last month, we announced a new distribution agreement with Genesis Pharma for Central and Eastern Europe to expand the geographic reach of Kinloch to 14 European Union countries with a combined population of 118 million people. Kinloch has already received regulatory approval in all of these countries under the EMA umbrella, which will significantly accelerate the time to commercialization for Kinloch in these countries. We are also excited to announce that we have submitted for pricing and reimbursement in the Netherlands and continue to advance price negotiations in Spain, France, and Switzerland. Our key growth drivers for 2024 include a continued focus on geographic expansion and opening new markets to drive successful, We are very pleased by the strength of our execution, and we expect our international revenues to continue to grow as reimbursement agreements and approvals are achieved alongside the growth from our initial launch. Positioning team logs to reach more patients around the world.

Speaker Change: I will now turn the call over to Tucker Kelly, Our Chief Financial Officer will review, the fourth quarter and full year financial results.

Speaker Change: Sure.

Tyler Van Buren: Thanks Margarita.

Tyler Van Buren: Revenue for the fourth quarter was $48 3 million, which included $46 7 million in net product revenue Kinloch and $1 6 million in collaboration revenue for the full year total revenue grew 22% to $163 4 million, including net product sales of $159 1 million in collaboration revenue of $4 3 million.

Tyler Van Buren: Cost of sales in the fourth quarter was $1 8 million, which includes 900000 in cost of product sales compared to cost of product sales of 700000 for the fourth quarter of 2022 for.

Tyler Van Buren: For the full year cost of sales were $3 $7 million, including 2 million and cost of product sales compared to cost of sales of $8 7 million and 22, including cost of product sales of $2 7 million.

Tyler Van Buren: As a reminder, the third quarter of 2022, we completed the sales of zero cost inventories of Kinloch that had been expensed as R&D prior to FDA approval in 2020.

Tyler Van Buren: Research and development expenses for the fourth quarter of 2023 were $58 6 million compared to $48 1 million for the fourth quarter of 2022, and $234 1 million for the full year compared to $187 8 million in 2022.

Tyler Van Buren: Touching on Jim Seltzner, there is palpable excitement in Europe surrounding the outstanding phase 3 motion data, where we believe the number of patients is comparable to the U.S. in the five largest European markets, and GenRevNeed is higher as there are no approved treatments. We are working hard towards our first initial engagement with HTA agencies early this year, and I look forward to the NIA submission in the third quarter and preparing for the commercial launch. I will now turn the call over to Tucker Kelly, our Chief Financial Officer, to review our fourth quarter and full year financial report. DECCA? Thanks, Margarita. Total revenue for the fourth quarter was $48.3 million, which included $46.7 million in net product revenue from Kinloch and $1.6 million in collaboration revenue. For the full year, total revenue grew 22% to $163.4 million, including net product sales of $159.1 million and collaboration revenue of $4.3 million. Cost of sales in the fourth quarter was $1.8 million, which included $900,000 in cost of product sales, compared to cost of product sales of $700,000 for the fourth quarter of 2022.

Tyler Van Buren: Selling general and administrative expenses, the fourth quarter were $39 1 million compared to $32 2 million in the fourth quarter of 2022.

Tyler Van Buren: For the full year SG&A was $136 5 billion compared to $122 million in 2022.

Tyler Van Buren: <unk> ended the year with cash cash equivalents in marketable securities of approximately $352 9 million.

Tyler Van Buren: In January we announced that we had extended our cash runway guidance into the second half of 2026, which remains unchanged.

Tyler Van Buren: With that I'll now turn the call back over to Steve.

Steve Heard: Thanks Tucker, we're very excited for 2024 as we continue to drive commercial growth that Ken lock seek regulatory approval for <unk>, and <unk> and advance our clinical pipeline, including our plans to develop themselves and Gvhd building off our momentum in 2023, we're pleased by our late stage clinical execution and <unk>.

Speaker Change: Global commercial excellence as we continue our evolution into a self sustaining company with multiple approved medicines with that operator, I'd now like to open the call for Q&A.

Speaker Change: Thank you as a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, one moment for questions.

Speaker Change: Our first question comes from Jessica Fye with Jpmorgan you May proceed.

Jessica Fye: Hey, guys. Good morning, Thanks for taking my questions.

Jessica Fye: Two from me.

Jessica Fye: First what's the latest you're hearing about when doctors are turning to Kinloch for second line Gist.

Tyler Van Buren: For the full year, cost of sales was $3.7 million, including $2 million in cost of product sales, compared to cost of sales of $8.7 million in 2022, including cost of product sales of $2.7 million. As a reminder, in the third quarter of 2022, we completed the sale of zero-cost inventories of Kinloch that had been expensed as R&D prior to FDA approval in 2020. Research and development expenses for the fourth quarter of 2023 were $58.6 million, compared to $48.1 million for the fourth quarter of 2022, and $234.1 million for the full year, compared to $187.8 million in 2022. Selling general and administrative expenses for the fourth quarter were $39.1 million, compared to $32.2 million in the fourth quarter of 2022. For the full year, SG&A was $136.5 million, compared to $120.2 million in 2022. We ended the year with cash, cash equivalents, and marketable securities of approximately $352.9 million.

Jessica Fye: <unk> real world use.

Jessica Fye: Mainly with Kinloch experienced treaters, who are otherwise using its report line or are you seeing any pick up of new prescribers as a result of that type of use.

Jessica Fye: Second I appreciate the.

Jessica Fye: Details on.

Jessica Fye: Can you just frame a little bit more how you think about the shape of that launch ramp. Thank you.

Jessica Fye: Hey, Josh Good morning, it's Steve Thanks for the two questions I'll ask Stan to take both of those questions. One with respect to on promoted off label use of can lock in the second line based on physician decision and then the expected ramp for a potential themselves that launch here in the U S. Yes. Thank you Jeff.

Stan: <unk> for the questions and good morning.

Stan: So as it relates to your question about Kinloch as we've noted it is challenging to.

Stan: Measure exactly.

Stan: What and where we are seeing in terms of the contribution of earlier line use the data sources for us to be able to do that just aren't great.

Stan: Do believe that it's been a mix of existing and new prescribers. So we really think that it's something that reflects.

Stan: Rod appreciation for the role of refreshing them for patients.

Stan: Lines of therapy in jest of course, I always want to underscore that that's an unfamiliar to us. So of course, we're not out there promoting that.

Steve Herter: In January, we announced that we had extended our cash runway guidance into the second half of 2026, which remains unchanged. With that, I'll now turn the call back over to Tucker. We're very excited for 2024 as we continue to drive commercial growth at Kenloch, seek regulatory approval for Vimseltenib in TGCT, and advance our clinical pipeline, including our plans to develop Vimseltenib in GVHD. Building off our momentum in 2023, we're pleased by our late-stage clinical execution and global commercial excellence as we continue our evolution into a self-sustaining company with multiple approved medicines. With that, operator, I'd now like to open the call for Q&A. Thank you. As a reminder, to ask a question, please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 118.

Stan: It needs to happen spontaneously based on physician decision.

Stan: With respect to your second question on.

Stan: The launch ramp the shape of the ramp we'll have the opportunity to get into more details about launch strategy and expectations as we draw closer to a potential approval but.

Stan: What we're focused on right now is a significant unmet need that we know.

Stan: Exists in this space for patients who are suffering from the <unk>.

Stan: Significant morbidity of TCT, and what physicians keep telling us that theres, a real opportunity to improve upon the existing therapies. So we look forward to continuing to work really hard to be ready to launch consulting nib as rapidly as possible.

Stan: Pending approval.

Speaker Change: Thank you.

Speaker Change: One moment for questions.

Speaker Change: Our next question comes from Tyler Van Buren with TD Cowen You May proceed.

Speaker Change: Hey, guys. Good morning, Congrats on the progress during the quarter can you guys discuss what else needs to be done to have the themselves filing ready for submission next quarter.

Operator: One moment for a question. Our first question comes from Jessica Fye with J.P. Morgan. Hey guys!

Steve Herter: What's the latest you're hearing about? Dr. Promoted, Real World. What's happening mainly with Kinloch experienced treaters who are, you know, otherwise using it for fourth line? Or are you seeing any pickup? For more information, please frame a little bit more how you think about that. Hey, Jess.

Speaker Change: And related to that.

Speaker Change: What's your confidence that you will not see a rems program or black box warning upon approval.

Speaker Change: Hey, Tyler its Steve Good morning. Thanks for the question. So first we remain very much on track for the filing of the NDA for consultant here in quarter, two coming up and then the MAA to the EMA in Q3.

Steve Herter: Good morning. It's Steve. Thanks for the two questions. I'll ask Dan to take both of those questions, the one with respect to unpromoted off-label use of Kinloch in the second line based on physician decision, and then the expected ramp for a potential themselves-led launch here in the US. Dan?

Steve Heard: So it's really just the usual and customary activities as we prepare for that filing that we are engaged in.

Steve Heard: We remain very confident in the profile of themselves and then based on the motion data as you know.

Steve Heard: <unk> achieved the primary endpoint in all six key secondary endpoints and also demonstrated that the drug is well tolerated and the patient population. So we believe we have a very clean and well characterized safety profile with the drug and continue to have the expectation that we would there's no reason to expect.

Dan Martin: Yeah, thank you, Jess, for the questions and good morning. As for your question about Kinloch, as we've noted, it is challenging to measure exactly what and where we're seeing in terms of the contribution of earlier line use. The data sources for us to be able to do that just aren't great.

Steve Heard: A rems program or a black black box warning for that potentially fatal hepatic toxicity that is seen with <unk> and is believed to be an off target effect. So we remain on track for the filings and we're excited to bring our potential next approved medicines forward to patients.

Dan Martin: We do believe that it's been a mix of existing and new prescribers. So we really think that it's something that reflects, you know, a broad appreciation for the role of repretinib for patients across lines of therapy. And just, of course, I always want to underscore that that's an unpromoted use.

Steve Heard: Okay.

Speaker Change: Thank you.

Speaker Change: One moment for questions.

Speaker Change: Our next question comes from Union with Jefferies. You May proceed.

Dan Martin: So, of course, we're not out there promoting that. And it needs to happen spontaneously based on physician decision. With respect to your second question on the launch ramp, the shape of the ramp, you know, we'll have the opportunity to get into more details about launch strategy and expectations as we draw closer to a potential approval. But what we're focused on right now is the significant unmet need that we know exists in the space with patients who are suffering from the significant morbidity of DGCT and what physicians keep telling us, that there's a real opportunity to improve upon the existing therapies. So we look forward to continuing to work really hard to be ready to launch from Sultanib as rapidly as possible, pending approval. Thank you. One moment for questions. Our next question comes from Tyler Van Buren with T.E. Cowan

Speaker Change: Yeah.

Union: Sure Kimberly <unk> with second line off label use.

Is that.

Union: You said largely driven by.

Union: Patients, who are intolerant to Ken or patients, who leads exon 11, 17 H mutation.

Union: Hi, Good morning. This is Steve I'll ask Dan to take the question on the off label use that we're seeing in earlier lines based on physician decision.

Dan Martin: Yes, Hi, Hugh and good morning, Thanks for the question so.

Dan Martin: We believe that.

Steve Heard: Two significant events that occurred last year.

Dan Martin: Or what's behind the contribution that we've seen from earlier line use on promoted earlier line use so there was the <unk>.

Steve Herter: You may. Hey, guys. Good morning. Congratulations on the progress during the quarter. Can you guys discuss what else needs to be done to have the VIMS-CELTA NIB filing ready for submission next quarter? And related to that, what is your confidence that you will not see a REMS program or a black box warning upon approval?

Dan Martin: As you noted the NCC and listing for patients who are intolerant of student in the second line.

As well as the really exceptional data that was presented and now recently published in nature Medicine.

Steve Herter: It's Steve. Good morning. Thanks for the question. So first, we remain very much on track for the filing of the NDA for Vimseltonid here in quarter two coming up, and then the MAA to the EMA in Q3. So it's really just the usual and customary activities as we prepare for that filing that we are engaged in. We remain very confident in the profile of Vimseltonid based on the motion

Dan Martin: Showing the dramatic treatment benefit that <unk> can offer patients with the <unk>.

Dan Martin: On 11, 17, 18 mutation, we think that both of those certainly have increased the noise level.

Dan Martin: Again I always score this is something we don't promote but.

Steve Herter: As you know, the study achieved the primary endpoint and all six key secondary endpoints and also demonstrated that the drug was well tolerated in the patient population. So we believe we have a very clean and well-characterized safety profile with the drug and continue to have the expectation that there is no reason to expect a REMS program or a black box warning for the potentially fatal hepatiotoxicity that is seen with pexidartanib and is believed to be an off-target effect. So we remain on track for the filings, and we're excited to bring our potential next approved medicine forward to patients. Thank you. One moment for questions. Our next question comes from Eun Yang with Jeffries. You may, Thank you.

Dan Martin: Through the natural disc.

Dan Martin: Dissemination of this information and the presentation and publication certainly have raised the noise levels. So it's hard to discern.

Dan Martin: Which which patient which bottle is being driven by which of those factors, but we think that.

Dan Martin: Both are reflective of real interest in opportunities to use for prep nib and.

Dan Martin: In patients with <unk> and of course.

Dan Martin: We think that it's important to note the level of energy that we see around the insight study and the excitement that we have for a potential.

Dan Martin: Proved indication.

Dan Martin: Pending a positive study.

Speaker Change: Thank you and I have one question for Tucker.

Speaker Change: So opex for Q sequentially R&D is down slightly better SG&A job. So could you could you give us some guidance of how opex level would there be in 2024 as it related to collaboration revenue line. Thank you.

Steve Herter: Thank you. Thank you. So, Kinloch's second line of labor use, is that, you know, is that largely driven by patients who are intolerant to SUTAN or patients with exon 11, 17, 18 mutations? Hi, Euan. Good morning. This is Steve. I'll ask Dan to take the question on the off-label use that we're seeing in earlier lines based on physician decision. Dan?

Tyler Van Buren: Sure. So on the Opex side, it was a little higher sequentially as you mentioned in SG&A. There is some one off items in end of year items that we think are more exceptional. So we wouldn't expect that necessarily to have that be the run rate going or where SG&A. We will have some in the second half of the year expenses as we prepare for.

Dan Martin: Yes. Hi Eun. Good morning. Thanks for the question. So, you know, we believe that the two significant events that occurred last year are what's behind the contribution that we've seen from earlier line use and promoted earlier line use. So, there was, as you noted, the NCCN listing for patients who are intolerant of student in the second line, as well as the really exceptional data that was presented and recently published in Nature Medicine showing the dramatic treatment benefit that repretinib can offer patients with the exon 11, 17, We think that both of those certainly have increased the noise level.

Tyler Van Buren: The launch of itself and it as well.

Tyler Van Buren: And in terms of collaboration revenue as we've always said that <unk> really have a couple of components. One is the royalty revenue that we get from our collaborations XI and then secondly that often the supply revenue. The supply revenue is much more episodic sits on quarters, we havent in some quarters, we don't.

Tyler Van Buren: There was some supply revenues, you'll see cost of goods line for the collaboration revenue this quarter and thats difficult to predict so I think we always try and guide people to focus on the <unk>.

Dan Martin: Again, I always score, this is something we don't promote, but just through the natural dissemination of this information, the presentation, and the publication, you know, certainly have raised the noise level. So it's hard to discern, you know, which patient, which bottle is being driven by which of those factors, but we think that both are reflective of real interest in opportunities to use repretinib in patients with GIST. And, of course, we think that it's important to note the level of energy that we see around the INSIGHT study and the excitement that we have for a potential approved indication pending a positive study. Thank you. And I have one question for Tucker.

Tyler Van Buren: Expectations for the royalty revenue.

Tyler Van Buren: But the upside in quarters, where we do have supply revenue covenant.

Speaker Change: Thank you.

Speaker Change: One moment for questions.

Speaker Change: Our next question comes from Michael Schmidt with Guggenheim Securities You May proceed.

Michael Schmidt: Hey, guys. Good morning, Thanks for taking my questions.

I had one on the nacelle to never be a plans in gvhd.

Michael Schmidt: How do you think about potential differentiation of south and advent gvhd from some of the antibodies like ex Italian map and can you comment about possibly sign of your planned phase III study.

Tyler Van Buren: So OPEX in 4Q sequentially, R&D is down slightly, but SG&A is up. So could you give us some guidance on what the OPEX level would be in 2024 as well as the collaboration revenue line? Thank you. Sure, so on the OPEX side, it was a little higher sequentially, as you mentioned, in SG&A. There are some one-off items and end-of-year items that we think are more exceptional, so we wouldn't necessarily expect to have that bit of a run rate going forward for SG&A.

Michael Schmidt: Will that.

Michael Schmidt: Hey, Matt naive patients where you include pretreated patients how do you think about that space.

Speaker Change: Yeah, Hi, Michael Good morning, I'm happy to take the question. So first we're excited about the potential to expand themselves and its utility beyond <unk> and intuit, a new potential indication in chronic gvhd and certainly one of the factors that enables us to do that in addition to the strong data we have now in <unk>.

Tyler Van Buren: We will have some second-half-of-the-year expenses as we prepare for the launch itself, and in terms of collaboration revenue, as we've always said, that's composed really of a couple of components. One is the royalty revenue that we get from our collaboration with ZEI, and then secondly, there's often supply revenue.

Speaker Change: <unk> is the very long IP runway that we have for themselves with a composition of matter patents that take.

Speaker Change: US to 2034, plus pte, which we believe takes us to the end of the decade and that doesn't include secondary patents for themselves.

Tyler Van Buren: The supply revenue is much more episodic, so some quarters we have it, and some quarters we don't. There was some supply revenue, as you'll see, in the cost of goods line for the collaboration revenue this quarter, and that's difficult to predict, so I think we always try and guide people to focus on the expectation for the royalty revenue and then the upside in quarters when we do have supply revenue coming. Thank you. One moment for questions. Our next question comes from Michael Schmidt with Guggenheim Securities; he may... Hey guys, good morning. Thanks for taking my questions. I had one of the results of your plans in GBHD, and how do you think about... Potential differentiation of mesalatinib and GVHD from some of the antibodies like oxytocin map?

Speaker Change: So ample opportunity for us to make additional investments in them to take it into additional indications we will have the opportunity to benefit patients. So in terms of the landscape of Gvhd and how we see differentiation at this early stage first I would just comment that certainly the target CSF. One receptor is now clinically validated in this disease.

<unk>, which is which is very important so it's a derisked mechanism in gvhd, we believe the data that we've generated in Tennessee, <unk> giant cell tumor demonstrates that we have a very potent and selective inhibitor against the target and in a disease, where the current backbone of treatment is all oral regimens, we believe that an oral.

Steve Herter: Any comment about the possible design of your....... will back and access to my naive patients. Hi, Michael. Good morning. It's Steve.

Speaker Change: Asia like themselves and I have an oral CSF one receptor inhibitor could play an important role as an add on therapy. In addition to a mono therapy and later lines, but as an add on therapy to current standard of care, whether that be a JAK inhibitor or whether that be a.

Steve Herter: I'm happy to take the question. First, we're excited about the potential to expand Vimseltenib and its utility beyond TGCT and into a new potential indication, chronic GVHD. And certainly one of the factors that enables us to do that, in addition to the strong data we have now in TGCT, is the very long IP runway that we have for Vimseltenib with a Composition of Matter patent that takes us to 2034 plus PTE, which we believe takes us to the end of the decade. And that doesn't include secondary patents for Vimseltenib.

Speaker Change: A drug like <unk> as an example, so we haven't yet disclosed full details of our clinical development strategy in Gvhd I am sure. We will have incremental additional disclosures over time, particularly once we get the phase II study stood up at the end of this year, but we're excited about the potential now to expand.

Speaker Change: The places where <unk> can benefit patients.

Speaker Change: Thank you.

Speaker Change: One moment for questions.

Speaker Change: Our next question comes from Christopher Raymond with Piper Sandler You May proceed.

Steve Herter: So, there is ample opportunity for us to make additional investments in Vim to take it into additional indications where we'll have the opportunity to benefit patients. So, in terms of the landscape of GVHD and how we see differentiation at this early stage, first, I would just comment that certainly the target CSF1 receptor is now clinically validated in this disease, which is very important. So, it's a de-risked mechanism in GVHD. We believe the data that we've generated in tenosynovial giant cell tumor demonstrates that we have a very potent and selective inhibitor against the target.

Speaker Change: Hey, thanks.

Christopher Joseph Raymond: Another question I guess on themselves.

Christopher Joseph Raymond: And this is on the adjuvant opportunity I know this has come up in the past but.

Christopher Joseph Raymond: What do you guys see as sort of a go no go points to running a study in the adjuvant setting.

Christopher Joseph Raymond: As you guys. Even noted in your market landscape slide Thats, a pretty sizable opportunity.

Just any sort of plan there that you guys can articulate.

Christopher Joseph Raymond: And then maybe a second part of that question is is there an opportunity or a chance that you get a broad label.

Steve Herter: And in a disease where the current backbone of treatment is all oral regimens, we believe that an oral agent like Vimseltenib, an oral CSF1 receptor inhibitor, could play an important role as an add-on therapy, in addition to monotherapy in later lines, but as an add-on therapy to current standard of care, whether that be a JAK inhibitor or whether that be a drug like Resiroc, as an example. So, we haven't yet disclosed full details of our clinical development strategy for GVHD. I'm sure we'll have incremental additional disclosures over time, particularly once we get the Phase II study standing up at the end of this year, but we're excited about the potential now to expand the places where Vim can benefit patients.

Christopher Joseph Raymond: Potentially inclusive of the adjuvant setting.

Christopher Joseph Raymond: Yeah, Hi, Chris It's Steve Thanks for the two questions really good questions. So of course excited about the data for motion, which will give us. This initial label and Tennessee, <unk> giant cell tumor as you'll remember the patient population that we treated in the motion study as patients who are not amenable to surgery. So materially for me to comment on what.

Christopher Joseph Raymond: Timidly FDA will decide as the indication statement or the label for themselves.

Christopher Joseph Raymond: But we too have heard also from investigators interest in exploring a role of an inhibitor like themselves.

Christopher Joseph Raymond: <unk> and other lines or earlier lines of treatment for tennis Ferrovial giant cell tumor. So recall this is a disease that.

Christopher Joseph Raymond: Particularly in the localized form of the diseases, often curable through surgery alone. So we'd probably be speaking about a patient population that would not be amenable to surgery, but potentially could be made amenable to surgery with adjuvant neo adjuvant treatment.

Steve Herter: One moment for questions. Our next question comes from Christopher Raymond with Piper Sandler. Hey, thanks. Just another question, I guess, on Vimseltenib, and this is about the adjuvant opportunity. I know this has come up in the past, but what do you guys see as sort of the go, sort of no-go points to running a study in the adjuvant setting?

Christopher Joseph Raymond: Again too early for us to comment on any specific plans, but certainly with the.

Christopher Joseph Raymond: The evidence that we have now in the patient population that we've studied it is very clear we have strong activity in this disease with <unk> and there may be opportunity for us to pursue whether label, enabling studies or a non label, enabling studies to further characterize the potential of themselves and have to benefit patients here.

Steve Herter: As you guys even noted in your market landscape slide, that's a pretty sizable opportunity. Any sort of plan there that you guys can articulate, and then maybe a second part of that question is, is there an opportunity or a chance to get a broad label that is inclusive of the adjuvant setting? Yeah, hi, Chris, it's Steve.

Speaker Change: Great. Thank you so much.

Speaker Change: Thank you.

Speaker Change: One moment for questions.

Speaker Change: Our next question comes from Andrew Berens with Leerink Partners you May proceed.

Andrew Scott Berens: Alright. This is came on for Andy Thanks for taking the question.

Andrew Scott Berens: So you guys I think has been saying that the average duration for <unk> in the fourth line setting that's starting to come quickly.

Andrew Scott Berens: About seven months now increasingly potentially up to eight half I'm wondering do you have any color on the penetration in the fourth line.

Steve Herter: Thanks for the two questions; really good questions. So, you know, we're excited about the data from Motion, which will give us this initial label for Tenosynovial Giant Cell Tumor. As you'll remember, the patient population that we treated in the Motion study were patients who were not amenable to surgery.

Speaker Change: Where that could be right about now.

Speaker Change: Thanks.

Speaker Change: Yes. Thanks for the question Dan would you like to take that sure absolutely. So yes, you had mentioned about the average duration of therapy. In fact, we think thats a really important dynamic to our continued growth as we think about 2024.

Steve Herter: So it's too early for me to comment on what ultimately FDA will decide as the indication statement or the label for themselves in PCPT. But we, too, have heard from investigators' interest in exploring a role of an inhibitor like Themseltinib in other lines or earlier lines of treatment for Tenosynovial Giant Cell Tumor. So, recall, this is a disease that, particularly in the localized form of the disease, is often curable through surgery alone.

Speaker Change: We look to the continued strength in our fourth line opportunity, we look to a continuing increasing average duration of therapy and as we've noted in.

Dan Martin: Earlier questions contribution from on promoted earlier line use so as we think about.

Dan Martin: The opportunity for.

Dan Martin: 2024, we're looking forward to another potential record year in the U S for for Kinloch as it relates to penetration in the fourth line setting.

Steve Herter: So we'd probably be speaking about a patient population that would not be amenable to surgery but potentially could be made amenable to surgery with adjuvant or neoadjuvant treatment. So, again, too early for us to comment on any specific plans, but certainly, with the evidence that we have now in the patient population that we've studied, it's very clear we have strong activity in this disease with Themseltinib, and there may be opportunity for us to pursue whether label-enabling studies or non-label-enabling studies to further characterize the potential of Themseltinib to benefit patients in Great Thank you so much.

Dan Martin: As we've said.

Dan Martin: In the past.

Dan Martin: We feel as though we've done a really good job penetrating that opportunity.

Dan Martin: And that.

Dan Martin: It's pretty highly penetrated opportunity as a result of not only a.

Really strong drug on high unmet need and our ability to execute over the last number of years.

Speaker Change: Thank you.

Speaker Change: One moment for questions.

Speaker Change: Our next question comes from Brad <unk> with Stifel. You May proceed.

Steve Herter: Thank you. One moment for questions. Our next question comes from Andrew Berens with Leering Partners. Hi, this is Kanon for AMD. Thanks for taking the question. So you guys, I think, have been saying that the average duration for Quinloch in the fourth We're wondering, do you have any color on the penetration in the fourth line? where that could be right about now.

Brad: Good morning, and thank you.

Brad: Another question for me on <unk> wondering how many doses do you think you plan to use in the proof of concept study in chronic gvhd and I'm asking in light of the inverse dose response noted for the antibody and the working hypothesis there around allowing for some degree of macrophage function recovery. Thank you.

Speaker Change: Yeah. Thanks for the question, Brad Matt would you like to take that on an.

Dan Martin: Yeah, thanks for the question. Dan, would you like to take that? Sure, absolutely. So, yes, you had mentioned the average duration of therapy. In fact, we think that's a really important dynamic to our continued growth as we think about 2024. We look to the continued strength in our fourth-line opportunity.

<unk>.

Speaker Change: Sure.

Speaker Change: Good morning, Brad the emphasis Matt so yes, so what you are referring to.

Matthew L. Sherman: The pivotal <unk> study with <unk> in Gvhd, where they testing three dose levels and different schedules as well as here in what they did demonstrate reimburse dose response, where some of the lower doses.

Matthew L. Sherman: Much like the higher doses.

Matthew L. Sherman: It'd be more unique to antibiotics.

Matthew L. Sherman: <unk> antibody.

Matthew L. Sherman: Inhibition of the CSF one receptor has led to much more prolong prolong on target effect and it's been difficult in other indications to develop those antibodies clinically so as Steve said earlier.

Dan Martin: We look to a continuing, increasing average duration of therapy, and, as we've noted in earlier questions, contribution from unpromoted earlier-line use. So, as we think about..., the opportunity for 2024, we're looking forward to another potential record year in the U.S. for Kinloch.

Matthew L. Sherman: I'm excited about moving forward with our proof of concept study in the second half of this year in Gvhd, we haven't yet given the details of the of the study, but as we are closer to the initiation of that study will be to be.

Dan Martin: As it relates to penetration in the fourth line setting, as we've said in the past, we feel as though we've done a really good job penetrating that opportunity and that, you know, it's a pretty highly penetrated opportunity as a result of not only a really strong drug at high unmet need but also our ability to execute over the last number of years. Thank you. One moment for questions. Our next question comes from Brad Canino with Stifel. You may... Good morning, and thank you. Another question for me: I'm Vince Elton.

Matthew L. Sherman: We decided that study and what we expect to achieve.

Speaker Change: Thank you.

Speaker Change: One moment for questions.

Speaker Change: Our next question comes from Reni Benjamin with citizens JMP you May proceed.

Reni Benjamin: Hey, good morning, guys. Thanks for taking the questions and congratulations on the progress.

Reni Benjamin: Maybe just to start off Steve can you give us any sort of color on on the inside study and how that's progressing have you have you kind of hit all the trial sites are they all kind of open or are you still ramping that up any sort of color as to how that's progressing because that seems to be key in terms of unlocking the second.

Brad: I want to know how many doses you think you plan to use in the proof of concept study in chronic GVHD. And I'm asking in light of the inverse dose response noted for the antibody and the working hypothesis there around allowing for some degree of macrophage function. Thank you. Yeah, thanks for the question, Brad. Matt, would you like to take that on in GVH?

Reni Benjamin: Lyne just opportunity and then just as a follow up with <unk>.

Reni Benjamin: We're filing the NDA and MAA any chance that we could get some sort of a priority review or is the base case scenario a standard review.

Reni Benjamin: Both in the U S as well as Europe.

Matthew L. Sherman: Sure. Good morning, Brad. Yeah, this is Matt.

Reni Benjamin: How long does it take in Europe.

Matthew L. Sherman: So yeah, so what you're referring to is the pivotal study that was done with Taxopilumab and GVHD, where they tested three dose levels in different scriptures as well, and what they did demonstrate was an inverse dose response, where some of the lower doses had more efficacy. So, as you know, antibody inhibition of the CSLN receptor has led to a much more prolonged on-target effect, and it has been difficult in other indications to develop those antibodies clinically.

Reni Benjamin: Just to get the decision.

Reni Benjamin: Yeah, Hi, Ryan its Steve Good morning, Thanks for the great questions. So first support insight.

Steve Heard: As you are aware I should first note that we published the results from the analysis of intrigue in nature Medicine last month, so really exciting to see the data and such a top tier journal.

Steve Heard: The noise that that analysis has generated both with the presentations at <unk> and now with the publication in nature Medicine has been a real tailwind in terms of building enthusiasm for the ongoing insight study. So we continue to make.

Matthew L. Sherman: So, as Steve said earlier, you know, I'm excited about moving forward with our proof-of-concept study in the second half of this year for GVHD. We haven't yet given the details of the study, but as we get closer to the initiation of that study, we certainly will. Since it was designed for that study, it won't be expected to achieve...

Steve Heard: Really good progress in getting sites opened actively screening and enrolling patients in that study and the enthusiasm from investigators is really palpable I think theyre really excited not only about the data that's been <unk>.

Steve Heard: <unk> presented so far from the analysis of intrigue, but just also the potential to be part of advancing our second line just is treated.

Steve Herter: Thank you. One moment for questions. Our next question comes from Rennie Benjamin with Citizens JMP. You may say, Hey, good morning, guys. Thanks for taking the questions and congratulations on the progress. Um, maybe just to start off, you know, Steve, can you give us any sort of color on the insight study and how that's progressing? Have you kind of hit all the, you know, trial sites? Are they all kind of open?

Steve Heard: Based on insights into a patient's tumor using circulating tumor DNA, so drawing a simple tube of blood in order to understand our secondary mutation status that is up and aim our goal I think that the field and thought leaders in the field are really excited about and their participation in the insight study, we believe will help us.

Steve Heard: To achieve that goal of demonstrating prospectively. This outsized benefit of Ken lock versus Sunitinib in the selected patient population. So we continue to be moving forward are very much on schedule and on track with the insight study and we'll have further updates I'm sure over the coming quarters on our progress with that specific.

Steve Herter: Are you still ramping that up? Any sort of color as to how that's progressing? Because that seems to be key in terms of unlocking the second line, you know, just, And then, just as a follow-up with Tim Seltzner, you know, you're following the NDA and MAA, any chance that we could get some sort of a priority review? Or is the base case scenario a standard review, you know, both in the U.S. as well as Europe? And, you know, how long does it take in Europe, you know, just to get the... Yeah, hi, Ren. It's Steve.

Steve Heard: Study in second line Gist patients.

Speaker Change: Second question was related to <unk> and what our expectations are in terms of regulatory review and timing and your specific question was with respect to whether we may enjoy priority review with the application. So it's too soon for us to comment on that and it's certainly the FDA will make that determination as to whether or not.

Steve Herter: Good morning. Thanks for the great question. So first, for insight, you know, as you're aware, I should first note that we published the results from the analysis of Intrigue in Nature Medicine last month. It was really exciting to see the data in such a top-tier journal. And the noise that that analysis has generated both with the presentations at ASCO and now with the publication in Nature Medicine has been a real tailwind in terms of building enthusiasm for the ongoing insight study. So we continue to make really good progress in getting sites open, actively screening, and enrolling patients in that study. And the enthusiasm from investigators is really palpable. I think they're really excited, not only about the data that's been published and presented so far from the analysis of Intrigue but also about the potential to be part of advancing how second-line GIST is treated, based on insights into a patient's tumor using circulating tumor DNA. So drawing a simple tube of blood in order to understand the secondary mutation status.

Speaker Change: The application qualifies for priority review as you May remember the enliven study on the applications with exit art Nib was reviewed by FDA with priority review status. So that certainly is the precedent. If you will in this disease. So we're looking forward to our ongoing and continued productive dialogue with the FDA as we prepare to file.

Speaker Change: Here in the second quarter and will of course make appropriate disclosures at the right time in terms of whether that is a priority review or a regular review.

Speaker Change: The Fda's discretion and then in terms of the European review process that as you May remember is a lengthier process. So we would expect that that will take potentially longer than the FDA review, but as we get into our further dialogue with the EMA, we may be able to better cast a timeline as to when we might.

Steve Herter: That is an aim or a goal, I think, that the field and thought leaders in the field are really excited about, and their participation in the insight study, we believe, will help us to achieve that goal of demonstrating prospectively this outsized benefit of Kenlock versus Sunitinib in this selected patient population. So, we continue to be moving forward very much on schedule and on track with the Insights Study, and we'll have further updates, I'm sure, over the coming quarters on our progress with that specific study in second-line gestation. Your second question was related to Vimseltenib and what our expectations are in terms of regulatory review and timing, and your specific question was with respect to whether we may enjoy priority review with the application.

Speaker Change: Expect action on the application once it gets filed but we remain super excited about the profile of the drug the motion data are very clear and compelling and we're looking forward to delivering our second potential appeared medicine to patients.

Speaker Change: Great and then if I could just have a follow up regarding insulting.

Speaker Change: And what could ultimately.

Speaker Change: <unk> be involved in prelaunch activities.

Speaker Change: Is this something that we should just be just given the overlap I think Dan mentioned in the call is this something that could just be as easy as kind of dropping it into the bag of sales and they are sort of off and running or are there significant prelaunch activities that need to be.

Steve Herter: So it's too soon for us to comment on that, and certainly the FDA will make that determination as to whether or not the application qualifies for priority review. As you may remember, the ENLIVEN study and the application for pexidartanib were reviewed by FDA with priority review status, so that certainly is the precedent, if you will, in this disease. So we're looking forward to our ongoing and continued productive dialogue with the FDA as we prepare to file here in the second quarter, and we'll, of course, make appropriate disclosures at the right time in terms of whether that is a priority review or a regular review at the FDA's discretion. And then in terms of the European review process, that, as you may remember, is a lengthier process, so we would expect that that will take potentially longer than the FDA review, but as we get into our further dialogue with the EMA, we may be able to better cast a timeline as to when we might expect action on the application once it gets filed.

Speaker Change: Inducted.

Speaker Change: Given given this market.

Speaker Change: Yes, I'll ask Dan to comment on the prelaunch activities, but you are right Ryan.

Dan Martin: We believe there is 70% to 80% overlap in terms of the prescriber base, so a really meaningful opportunity both in the U S as well as in Europe for meaningful synergy with our existing commercial organization Daniel I'll comment further on the prelaunch activities, yes, absolutely. Thanks Ram for the question.

Daniel: So we think that investment in market development or pre prelaunch activities is really important.

Daniel: Our focus will be on disease education, largely to make sure that all potential treaters of <unk> or <unk>.

Daniel: Fairly educated on it.

Steve Herter: But we remain super excited about the profile of the drug. The motion data are very clear and compelling, and we're looking forward to delivering our second potential approved medicine to patients. And then, if I could just have a follow-up regarding Vimseltenib and what, you know, could ultimately be involved in pre-launch activities. You know, is this something that we should just be doing, you know, just given the overlap? This is a question from a colleague who asked, is this something that could just be as easy as dropping it into the bag of sales, and they're sort of off and running?

Daniel: How common TCT is and the burden that these patients deal with this is a really debilitating disease.

Daniel: Something that isn't a lethal disease of course, but it is.

Daniel: One that can be very locally aggressive and really have a significant impact on how patients feel and function and we want to really paint that patient picture bring that to light raise that awareness.

Daniel: So certainly that coupled with our Med Affairs organization.

Daniel: And data from.

Steve Herter: Or are there significant pre-launch activities that need to be conducted? Yeah, I'll ask Dan to comment on the pre-launch activities. But you're right, Ren, we believe there's 70% to 80% overlap in terms of the prescriber base, so a really meaningful opportunity, both in the U.S. as well as in Europe, for meaningful synergy with our existing commercial organization. Dan, do you want to comment further on the pre-launch activities? Absolutely. Thanks, Ren, for the question. We think that investment in market development or pre-launch activities is really important. Our focus will be on disease education, largely to make sure that all potential treaters of TGCT are thoroughly educated on how common TGCT is and the burden that these patients deal with. This is a really debilitating disease.

Daniel: Our studies all of this will be part of making sure that in prior to launch and physicians appropriately. So no the information that they need.

Daniel: And then as Steve mentioned at launch Yes, we think there is tremendous synergy we think were really uniquely positioned to take advantage of both the opportunity and just with Ken Mark and the opportunity in <unk> with himself.

Speaker Change: Terrific. Thanks for taking the questions guys. Good luck.

Speaker Change: Thank you and as a reminder to ask a question. Please press star one on your telephone.

Speaker Change: One moment for questions.

Speaker Change: Our next.

Speaker Change: <unk> comes from Peter Lawson with Barclays. You May proceed.

Peter Lawson: Great. Thank you so much thanks for taking my questions.

Peter Lawson: Just two firstly just on the seasonality and how we should think about that for the U S versus ex U S.

Peter Lawson: We have invested most of our 2020 revenues and then just moving to Gvhd, just your thoughts on differentiation as well around safety and potentially efficacy versus an antibody and the ability to combine with other regimens that gvhd space. Thank you.

Dan Martin: It's something that isn't a lethal disease, of course, but it is one that can be very locally aggressive and really have a significant impact on how patients feel and function. And we want to really paint that patient picture, bring that to light, raise that awareness. So certainly that, coupled with our Med Affairs organization and, you know, data from our studies, all of this will be part of making sure that, prior to launch, physicians appropriately know the information that they need. And then, as Steve mentioned, at launch, yes, we think there's tremendous synergy. We think we're really uniquely positioned to take advantage of both the opportunity in GIST with Kinloch and the opportunity in TGCT with consultants.

Speaker Change: Yes, hi, Peter Thanks for the two questions. So I'll ask Dan and Margarita to comment on expectations for the year broadly in 2024, and our expectation of the usual seasonality patterns and.

Speaker Change: And then I'll ask Matt to take your second question with respect to themselves and <unk> in Gvhd, Dan you want <unk> sure absolutely Hi, Peter Good morning, Thanks for the question.

Dan Martin: So as we noted on the call we feel really excited and pleased with the progress that we've made.

Speaker Change: I'll speak to the U S. Specifically in the fourth quarter, delivering $35 3 million.

Matthew L. Sherman: Dollars and revenue net product revenue, which was a <unk>.

Dan Martin: Perfect. Thanks for taking the questions, guys. Good luck. Thank you, and as a reminder, to ask a question, please press star 1 1 on your telephone. One moment.

Matthew L. Sherman: <unk>, 38% year over year increase for the full year 2023.

Matthew L. Sherman: $121 5 million, which is a 25% year over year increase so we feel really pleased with that and as we look to 2024, we think some of the core drivers of our recent.

Operator: Our next question comes from Peter Lawson with Barclays Humane. Great. Thank you so much. Thanks for taking the questions. I guess, too, firstly, just on seasonality and how we should think about that for the U.S. versus ex-U.S. and their investment model for 2024 revenues. And then just moving into GVHD, just your thoughts on differentiation as well, around safety and potential risks. This is an antibody and, combined with other registries. Hi Peter.

Matthew L. Sherman: Success will continue to be the core drivers of what we expect to be another record year for kinlaw specifically.

Matthew L. Sherman: Specifically strengthen our core business.

Matthew L. Sherman: Increasing average duration of therapy, and then as as noted earlier contribution from on promoted earlier line use so when we take a step back and look at the year as a whole.

Matthew L. Sherman: Those are sort of the themes and the reason for our excitement as we think about just the quarter to quarter pattern.

Speaker Change: We wanted to note.

Peter Lawson: Thanks for the two questions. So, I'll ask Dan and Margarita to comment on expectations for the year broadly in 2024 and our expectation of the usual seasonality patterns, and then I'll ask Matt to take your second question with respect to bimfeltenab and GBHD. Dan, do you want to go first?

Matthew L. Sherman: But we would expect.

Matthew L. Sherman: Similar to past years, which reflect some seasonality dynamics, specifically as it relates to Q.

Matthew L. Sherman: Q1.

Matthew L. Sherman: Very common in the industry to see a strong quarterly buying pattern at the end of.

Matthew L. Sherman: The year Ken.

Matthew L. Sherman: Ken potentially impact Q1, as well as some.

Dan Martin: Sure, absolutely. Hi Peter. Good morning. Thanks for the question. So, as we noted on the call, we feel really excited and pleased with the progress that we've made. I'll speak to the U.S. specifically, in the fourth quarter, delivering $35.3 million in net product revenue, which was a 38% year-over-year increase for the full year 2023.

Matthew L. Sherman: Early in the year sort of post holiday demand seasonality of demand softness of course, the other factor that we've noted in the past and would expect this year to also.

Matthew L. Sherman: Play out true to form is the pop dynamic, which we typically see a lower <unk> percentage in the early part of the year with a gradual increase throughout the year. So those are some of the moving parts that we that we wanted to note Margarita.

Dan Martin: So, we feel really pleased with that, and as we look to 2024, we think some of the core drivers of our recent success will continue to be the core drivers of what we expect to be another record year for Kinloch, specifically, strength in our core business, increasing average duration of therapy, and then, as noted earlier, contribution from unpromoted earlier-line use. So, when we take a step back and look at the year as a whole, those are sort of the themes and the reason for our excitement. As we think about just the quarter-to-quarter pattern, we wanted to note that we would expect a pattern similar to past years, which reflects some seasonality dynamics, specifically as it relates to Q1. It is common in the industry to see a strong quarterly buying pattern at the end of the year that can potentially impact Q1, as well as some early-in-the-year sort of post-holiday demand seasonality or demand softness.

Matthew L. Sherman: Sure.

Margarita Duarte: Regarding ex U S. I mean, let me start by saying that we are delighted with the launch how he's got Alex going on the strong revenue growth from last quarter, which was driven by strong performance in existing markets, but also the contribution from the launch in Italy.

I would say that as we continue to successfully advance our price has been basement and launching new markets. We expect can look to continue to grow in international it is always difficult to predict when new market will open given the different reimbursement processes and different timelines in each market, but assuming we get there I expect this to happen.

Margarita Duarte: March was the second part of 2024.

Margarita Duarte: So another thing to note is that while we expect future growth, we cannot exclude quarter over quarter variability. So we have seen these in the past and we may see this again in the future.

Margarita Duarte: I'd say all in all geographic expansion is a key focus for us in 2024, chemo is well positioned for growth and the recent deal with Genesis for Central and Eastern Europe is also a good example of the type of transactions that you can expect from us in the future.

Dan Martin: Of course, the other factor that we've noted in the past and would expect this year to also play out true to form is the PAP dynamic, where we typically see a lower PAP percentage in the early part of the year, with a gradual increase throughout the year. So, those are some of the moving parts that we wanted to note.

Margarita Duarte: Alright, Thanks, Margaret Matt you want to take those insulting a question yes.

Matthew L. Sherman: Yes, So hi, Peter Yes. So in regards to your question about consultant and <unk> I'm, sorry in preferences as disease, and our ability to be able to differentiate us and we do remain very excited of our plan to initiate our <unk>.

Margarita Duarte: Sure. So regarding XQS, I mean, let me start by saying that we are delighted with the launch, how it's going, and the strong revenue growth from last quarter, which was driven by strong performance in existing markets, but also the contribution from the launch in. So I would say that as we continue to successfully advance our price and reimbursement and launch in new markets, we expect Kinloch to continue to grow in international markets. It is always difficult to predict when new markets will open, given the different reimbursement processes and different timelines in each market, but assuming we get there, I expect this to happen more toward the second part of 2024.

Matthew L. Sherman: Proven concept study in the second half of this year.

Matthew L. Sherman: So we have a very large database of safety based on consultant and <unk> are both from the motion phase III study as well as from the phase one two study.

Matthew L. Sherman: Gvhd is a chronic disease, and particularly with the skin and joint involvement there can be severe limitations of patients.

Matthew L. Sherman: <unk> and antibody therapy would have to be given intravenously every two weeks and for chronic disease such as gvhd.

Matthew L. Sherman: Pretty significant a burden on patients. So one of the major features using themselves and that is an oral agent will be to combine with other oral therapies. As you noticed in the secured now consists primarily of oral agents, whether it's objected kinase inhibitor or <unk>.

Margarita Duarte: So, another thing to note is that while we expect future growth, we cannot exclude quarter over quarter variability. We have seen this in the past, and we may see this again. So, I would say, all in all, geographic expansion is a key focus for us in 2024. Kinloch is well positioned for growth. And the recent deal with Genesis for Central and Eastern Europe is also a good example of this.

Matthew L. Sherman: <unk> two inhibitor.

Matthew L. Sherman: In the background steroids, as well too and so our ability to differentiate from an antibody.

Matthew L. Sherman: Pretty significant with consultants.

Matthew L. Sherman: These two studies.

Matthew L. Sherman: Okay.

Speaker Change: Thank you is there any way from preclinical data there.

Margarita Duarte: Thanks so much. Great, thanks Margarita. Matt, do you want to take those insults in the question?

Speaker Change: See any differentiation.

Speaker Change: An oral drug versus a.

Speaker Change: An antibody.

Matthew L. Sherman: Yes. So, hi Peter. Yes. So, in regards to your question about dimsulfonib and TGCT, I'm sorry, and Bradford's disease and our ability to be able to differentiate it, we do remain very excited about our plan to initiate our proof of concept study in the second half of this year. And also, we have a very large database of safety based on dimsulfonib and TGCT, both from the motion phase 3 study as well as from the phase 1, 2 study. TPHD is a chronic disease, and particularly with the skin and joint involvement, there can be severe limitations of patients' mobility.

Speaker Change: You think that could drive differences in efficacy durability and safety.

Speaker Change: Yes, I think most of the preclinical data just speaks to the role of the macrophage in the pro fibrotic manifestations of the disease and that's particularly important in several organs as I mentioned, particularly the skin because these patients are pretty severe sclerotic skin lesions and even joined contractions and also particularly in the lungs as well too in Congress.

Speaker Change: Okay.

Speaker Change: Linda there.

Speaker Change: And in Egypt.

Speaker Change: Jeremy.

Speaker Change: Current treatments.

Speaker Change: Regiments.

Speaker Change: Tore gvhd, so the role of the macro <unk> macrophages and those particular areas.

Matthew L. Sherman: And the antibody therapy would have to be given intravenously every two weeks, so for a chronic disease such as GVHD, now that's a pretty significant burden on patients. So one of the major features of using Insultinib as an oral agent will be to combine it with other oral therapies. As you know, the standard of care now consists primarily of oral agents, whether it's a JAK2 kinase inhibitor or the ROCK2 inhibitor, and on the backbone of steroids as well, too. And so our ability to differentiate from an antibody is pretty significant with Insultinib.

Speaker Change: Could really be a benefit.

Speaker Change: <unk> himself in the businesses.

Speaker Change: Great. Thanks, so much.

Speaker Change: Yeah.

Thank you I would now like to turn the call back over to Steve Barker for any closing remarks.

Steve Barker: Yes. Thank you for joining us on today's call and thanks for your support we look forward to keeping you updated on our continued progress here at the site for during the course of the year, but we have a great day.

Speaker Change: Thank you for your participation you may now disconnect.

Okay.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: [music].

Matthew L. Sherman: ... Thank you. Is there any way from, I guess, preclinical data?

Speaker Change:

Speaker Change: Okay.

Matthew L. Sherman: I don't see any differentiation between an oral drug and everybody, and Zach Kudrow, and many others. Thank you. I think most of the preclinical data just speaks to the role of the macrophage in the pro-fibrotic manifestations of the disease, and that's particularly important in several organs, as I mentioned, particularly the skin, because these patients can have pretty severe sclerotic skin lesions and even joint contractions, and also particularly in the lungs as well. Thank you. Thank you, current arrangements for GDHD. So, the role of macrophages in those particular patients could really be a benefit for them in this disease.

Speaker Change: Okay.

[music].

Speaker Change: Yes.

Matthew L. Sherman: Great. Thanks so much. Thank you. I would now like to turn the call back over to Steve Horter for any closing remarks. Yeah, thank you for joining us on today's call and thanks for your support. We look forward to keeping you updated on our continued progress here at Deciphera during the course of the year. Hope you have a great day. Thank you for your participation. You may now disconnect. Thank you for watching!

Speaker Change: [music].

Speaker Change:

Speaker Change: Yeah.

Speaker Change: [music].

Speaker Change: Okay.

Q4 2023 Deciphera Pharmaceuticals Inc Earnings Call

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