NASDAQ:CALT Calliditas Therapeutics AB (publ) Q2 2024 Earnings Report $40.00 0.00 (0.00%) As of 04/28/2025 Earnings HistoryForecast Calliditas Therapeutics AB (publ) EPS ResultsActual EPS-$0.16Consensus EPS -$0.25Beat/MissBeat by +$0.09One Year Ago EPS-$0.33Calliditas Therapeutics AB (publ) Revenue ResultsActual Revenue$52.36 millionExpected Revenue$42.89 millionBeat/MissBeat by +$9.47 millionYoY Revenue GrowthN/ACalliditas Therapeutics AB (publ) Announcement DetailsQuarterQ2 2024Date8/13/2024TimeBefore Market OpensConference Call DateTuesday, August 13, 2024Conference Call Time8:30AM ETConference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckInterim ReportEarnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Calliditas Therapeutics AB (publ) Q2 2024 Earnings Call TranscriptProvided by QuartrAugust 13, 2024 ShareLink copied to clipboard.There are 5 speakers on the call. Operator00:00:00Welcome to Calidya's Q2 2024 Report. The participants will be in listen only mode, and there will be no Q and A session after the presentation. Now I will hand the conference over to the speakers. Please go ahead. Speaker 100:00:15Thank you very much. Welcome to our Q2 2024 report. My name is Rene Aguiar Lukander, CEO of Kalida Taz. And I'm joined today by Richard Phillipson, Chief Medical Officer Frederick Johansen, our Chief Financial Officer and Maria Thornsen, President of North America. Next page, please. Speaker 100:00:42I'd like to draw your attention to the disclaimer notice, which covers forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended. And I refer to our public filings, including those containing risk factors. Next page, please. So I'd like to review some of the key events in Q2, which included the conclusion of our Phase 3 study in Effigard, with a readout of the open label extension from which we reported 9 months efficacy and safety data similar to that observed in the active arm of the Phase III trial for those patients who were retreated with nephicon after 15 months of observation. In April, we reported our positive top line data from our Phase II proof of concept study in head and neck cancer with a lead product candidate from our novel and unique NOx inhibitor platform, setonaxit. Speaker 100:01:35This shows statistically significant impact on both progression free survival as well as overall survival. We also were granted a new patent by the USPTO for the treatment with setonaxent in cancer with expiry in 2,039. In May, our partner, Everest Medicines, launched neficon in China, and EMA issued a positive opinion for full approval of Kympaygo in Europe. We also participated in several important conferences where we present additional data, which Rachel will cover a bit later in the call. Next page, please. Speaker 100:02:11In the quarter, there was an offer announced by Sahikasai. So on May 28, Sahikasai announced a public cash offer for all shares in Kalinitas for SEK 208 per share, valuing the company at approximately SEK 1,200,000,000. The tender is presently ongoing with the last day announced to be August 30, subject to any potential extensions. The offer is recommended by the Board and around 45 percent of shareholders have entered into undertakings to accept the offer subject to customary conditions. Next page. Speaker 100:02:45So with regards to commercial highlights of Q2. So from a commercial perspective, this quarter was a record quarter in terms of revenues, with $46,300,000 of net TR PAYO revenues, representing 90% growth over the same quarter last year. In addition, we saw record enrollments with 750 new enrollments and continued strong growth in new prescribers. The strong demand we're seeing is very encouraging and we continue to see demand in the market for TROPEO with summer seasonality seemingly being less pronounced this year in comparison to last year. The team has during the quarter undertaken a very substantial number of P and T committee meetings and the vast majority of major plants have now updated their rules to align with the new label. Speaker 100:03:31We are expecting the full approval and this kind of reduced market access friction to continue to drive TRYPEA revenue growth for the year. Revenues from partners in the quarter amounted to SEK 49,000,000, representing growth of close to 300% compared to last quarter as Netfecom was launched in China also in May. Operating profitability for the underlying business, excluding those costs related to the offer by Asahi Kasai, for the quarter came in at SEK 70,000,000, enabling us to reach our target of achieving operating profitability in the quarter. This excludes costs related to advisory services and provisions for incentive plans in connection with the Tsai Kasai offer amounting to approximately SEK 102,000,000 taking us to an overall operating loss for the quarter of SEK 31,500,000. Achieving operating level profitability is a goal we were hoping to achieve and targeting in Q3, and we're obviously delighted that we reached this target already in Q2. Speaker 100:04:36With regards to cash, we were almost cash neutral for the quarter with cash burn amounting to approximately SEK 700,000 or SEK 7,000,000. We believe that we'll be continued to be profitable on operating level for the remainder of the year, excluding any deal related costs based on continued revenue growth from Terpeo and the Nephicom franchise as Speaker 200:04:58a whole. Next page, please. Speaker 100:05:03Following the quarter, so in July, we reported our positive data from our Phase IIb trial in PBC primary biliary cholangitis with both the 12 1600 milligram dose is achieving statistical significance in terms of the primary endpoint. This was a heavily pretreated population, making this outcome even more rewarding. Richard will cover this in more Richard will cover this in more detail shortly. Also in July, Kinpega was granted full approval for the treatment of primary IgA in adults by the European Commission, which also triggered a €10,000,000 milestone payment, which will be recognized in Q3. With that, I'd like to hand over to Richard, who will take us through the PBC data to discuss. Speaker 300:05:49Thanks very much. Renee, next slide please. And the next slide. So I'd like to start by giving you a summary of the recently announced results of the TRANSFORM study of setonaxib in primary biliary cholangitis or PBC. As a reminder, this was a Phase 2b study evaluating patients aged 18 years older with a confirmed diagnosis of PBC, a serum alkaline phosphatase level of 1.67 times the upper limit of normal or higher and the liver stiffness of 8 kilopascals or higher as measured by FibroScan. Speaker 300:06:29In this double blind placebo controlled study, patients were randomized to 1 of 2 doses of setonaxib or placebo. Patients randomized to setonaxib received either a 1200 milligram daily dose administered as 800 milligrams in the morning and 400 milligrams in the evening or a 16 100 milligram daily dose administered as 800 milligrams twice daily. Treatment was administered for 24 weeks and the primary endpoint was change in alkaline phosphatase at week 24 compared to baseline. Next slide. We screened the 178 patients, of whom 77 patients were randomized. Speaker 300:07:10The demography and baseline characteristics of the trial population were representative of the target patient population and the treatment arms were generally well balanced. It is worth noting, as Rene has already said, that this was a heavily pretreated population at baseline. 43.4% of patients were receiving dual therapy, that is UDCA plus a coliva or UDCA plus a fibrate, and 13.2% of patients were receiving triple therapy of UDCA plus or coliva plus a fibrate. Next slide. With respect to the primary endpoint change from baseline in the ratio of alkaline phosphatase at week 24, there was a statistically significant difference for both dose comparisons versus placebo. Speaker 300:08:03The 1600 milligram dose group, there was a 19% difference compared to placebo. And for the 1200 milligram dose group, there's a 14% difference compared to placebo. Again, it's worth noting that although week 24 was the time point for the primary comparison, significant changes were observed from week 8 onwards. Next slide. We also observed favorable This is encouraging as clinically relevant changes in liver stiffness are typically detectable by FibroScan over a minimum of a 52 week observation period. Speaker 300:08:47Next slide. So in terms of safety, treatment emergent adverse events were balanced across the treatment groups overall. 76% of Setanaxa patients and 85% of placebo patients experienced at least one treatment emergent adverse event, but most of these were considered unrelated to treatment. Serious treatment emergent adverse events occurred approximately at similar rates in the cetanaxypin placebo treated patient groups with 12% of cesenaxyp patients and 11.5% of placebo patients experiencing serious treatment emergent adverse events. And events leading to study treatment discontinuation occurred in 14% of Sesamax of patients and 7.7% placebo patients. Speaker 300:09:43When we look at the adverse events occurring at a frequency of 10% or higher in the overall study population, then it's noteworthy that nausea, headache and pruritus actually occurred at a higher frequency in placebo treated patients. Afralgia and fatigue both occurred at similar frequencies in the combined Sesanaxit treatment group and placebo treated patients. And nasopharyngitis occurred at a higher frequency in the combined setanaxit treatment group compared to placebo. So in conclusion, the primary endpoint for the study was met, Statistically significant reductions in alkaline phosphatase was observed in both sezonaxit arms versus placebo from week 8 onwards and actually from week 4 onwards when we looked at the 2 active doses combined. We saw favorable improvements in liver stiffness at 24 weeks in patients treated with cetinaxib compared to placebo, and cetinaxit was generally well tolerated. Speaker 300:10:53So now I'd like to move on and provide a brief update on the company's activities at ERA EDTA this year. So next slide. So at ERA EDTA in May, which was held in Stockholm, Caligitas gave an oral presentation on the real world challenges associated with the use of systemic glucocorticoids in a U. S. IgA nephropathy cohort. Speaker 300:11:16And we also presented a poster describing the outcomes of a matching adjusted indirect comparison of EGFR in patients with IgA nephropathy treated with Nethicon or sparsentan. And we also sponsored a symposium entitled Clinical Markets in IgA nephropathy is all proteinuria the same and this was chaired by Professor Jonathan Barrett. In the latter poster presentation, we used patient level data from our NEFICARD Phase 3 trial and trial level data from the sparsentan PROTECT trial in IgA nephropathy to estimate the relative effect of Neficon with optimized RAS inhibition compared with sparsentan on the absolute eGFR change from baseline at 9, 12 24 months with common comparators of optimized resin inhibition for nephigard and irbesartan for the PROTECT study. The results from the anchored comparison showed statistically significant favorable effects of nefikon with optimized RAS inhibition versus varsentan on EGFR for all time points analyzed as shown in the figure in the slide on the right. These results suggest that neficon with optimized RAS inhibition may preserve kidney function to a greater extent than sparsentan and provide support for nephicon as a disease modifying therapy in IgA nephropathy. Speaker 300:12:40So I'd now like to hand over to my colleague, Maria Twonze. Speaker 200:12:46Thank you very much, Richard. Next slide, please. As you recall, in Q1 2024, we had our strongest quarter since launch with 705 enrollment forms. In the Q2 of 2024, we continue to see a very strong demand for Tarpeo with 750 enrollment forms received by our patient services hub, Tarpeo Touchpoints, another record quarter. During the Q2, we also had 343 new prescribers, and we now have over 2,300 health care providers who have prescribed Tarpeo. Speaker 200:13:27We believe the strong demand we are seeing is a result of our full approval, our new label with the removal of the UPCR criteria and physicians recognizing Tarpeo as a disease modifying agent that treats the disease at the source, reducing the pathogenic IgA. As mentioned, our total sales for Tarpeo in Q2 was $46,000,000 another record quarter. Year to date net sales for Tarpeo is $73,000,000 And as a result of the strong performance, we are raising our full year guidance to $165,000,000 to $185,000,000 for the NetEcon franchise. Next slide, please. In the Q2, we launched our new promotional campaign, highlighting the full approval and shining a light on Tarpeo's EGFR data. Speaker 200:14:22As you know, Tarpeo is the 1st and only FDA approved product to reduce the loss of kidney function. As mentioned last quarter, we've been spending time educating U. S. Payers on the new label, and I'm pleased to report that we now have seen significant changes on key commercial plans. Over 80% of U. Speaker 200:14:42S. Lives covered by commercial plans now have policies aligned with our new label and removed UPCR completely or reduced to seraphone date. In Q2, our medical teams also participated in multiple scientific congresses where they presented scientific data and engaged with key opinion leaders, including the National Kidney Foundation and the 61st ERA Congress, which was held in Stockholm, Sweden in May. Next slide. We are very excited at the opportunity ahead of us. Speaker 200:15:18We've already seen the positive reaction to the full approval of TRPEO. We will continue to educate U. S. Health care professionals on TRPEO's position as a disease modifying cornerstone treatment of IgAN. In October, we will participate in the ASN Congress, and we also look forward to the rollout of the CDU guidelines in the fall. Speaker 200:15:41We expect the guidelines will include Herpail and also broaden the definition of the at risk population. And as mentioned earlier, we've seen a significant impact on payer policies in Q2, and we will continue to educate U. S. Payers to ensure more plans reflect the new TRPAIO label and secure broad access for patients. Next slide, please. Speaker 200:16:07Finally, the IGEN treatment paradigm is evolving and addressing the source of the disease is crucial. TRYPEA does that by targeting the production of pathogenic IgA. As shown in the diagram, there are no other approved treatments that work in the same way. Majority of health care providers view TARPEO as a disease modifying agent that treats the disease at the source, reducing the pathogenic IgA. In market research, health care providers further state that the primary reasons they choose Tarpeo are for its efficacy in reducing UPCR, significant eGFR data, favorable tolerability profile and because Torpeo is treating the underlying cause of IGAS. Speaker 200:16:57And as you've seen from our strong results reported today, Torpeo is becoming a cornerstone treatment for IGAP. With that, I will hand it over to our CFO, Fredrik Johansen, to discuss our financial results. Fredrik? Speaker 400:17:13Thank you, Maria. I will now present to you the financial overview for the Q2. And as always, all numbers presented to you are SEK 1,000,000 unless otherwise stated. To start with, we report SEK559,800,000 in net revenues for the quarter. For the same quarter last year, we reported net revenues of $269,400,000 Tarpeo net product sales for the quarter amounted to $493,400,000 or $46,300,000 which is a reported increase of 90% from the same quarter previous year. Speaker 400:17:47The remaining $66,400,000 in revenues in the quarter are related to our partnerships, primarily from royalties from Southern Everest and shipment of products to Everest. For the same quarter last year, we have partnership revenues of $10,100,000 Our total operating expenses for the quarter amounted to 530 $7,800,000 compared to $330,300,000 for the same quarter last year. Included in the operating expenses for the quarter are expenses related to the SAICASA offer and expenses related to provisions for Social Security contributions for incentive programs due to the increase in our share price, this totaling SEK101,700,000 These costs are distributed over R and D, sales and marketing and G and A. The cost for research and development increased by $31,700,000 in the quarter to $120,700,000 compared to $89,000,000 for the same quarter previous year. Besides the previous mentioned provisions for incentive programs, the change in the period primarily relates to increased costs for Nefcon manufacturing scale up. Speaker 400:18:53The cost for sales and marketing increased by CAD61.5 million in the quarter to CAD253 1,000,000 compared to CAD191.5 million for the same quarter previous year. The increase is primarily related to scale up of the sales and marketing of Terpeo in the U. S. Following the full approval and also the mentioned provisions for the incentive programs. The cost for G and A increased by €89,600,000 in the quarter to 100 and €166,800,000 compared to €77,200,000 for the same quarter previous year. Speaker 400:19:28The increased cost for G and A primarily relates to the mentioned provisions for incentive programs and advisory fees related to the public offering from Assai Cafe. We made an operating loss in the quarter of $31,500,000 compared to an operating loss of $75,200,000 for the same quarter last year. As mentioned by Ronnier, excluding the expenses relating to the Asai Kase offer and expenses related to provisions for Social Security contributions for the incentive programs due to an increase in the share price. We report an adjusted operating profit of $70,200,000 in the second quarter. The cash flow used in operating activities in the quarter was $7,000,000 compared to $163,000,000 for the same quarter previous year, And this leaves us with a net decrease in cash in the first in the second quarter of $11,200,000 and we continue to have a healthy cash position of $797,300,000 at the end of the quarter. Speaker 400:20:27That was all for me. Thank you. And back to you, Renee. Speaker 100:20:32Thank you very much. Next slide, please. Thank you. So obviously, as we reported, Q2 was financially strong with positive progress of our pipeline. But some of the key takeaways, obviously, we had a record quarter in terms of net product revenues from Tarpeo, terms of posting $46,300,000 for the quarter as well as for the Nephicom franchise achieving approximately $53,000,000 for the quarter. Speaker 100:20:58We also achieved our target of operational profitability excluding the advisory costs and incentive program provisions as stated. We also was our partner, Stata, was granted full approval of Comtego in Europe by the European Commission. And also saw a new patent issued by the USPTO covering cetronaxib in terms of treatment of cancer with expiry of 2,039. As Frederic has said, we have a strong cash position and obviously saw an almost neutral impact on cash for the quarter. And we are expecting continued strong demand for Torpejo for all the reasons that Maria described. Speaker 100:21:39And as mentioned, in terms of our revenue guidance for 20 24, we're updating that, reflecting these growth expectations. And so the revenue guidance for 2024 is updated to be $165,000,000 to $185,000,000 And with that, this concludes our Q2 2024 presentation. Thank you very much to all for listening in.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallCalliditas Therapeutics AB (publ) Q2 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsSlide DeckInterim report Calliditas Therapeutics AB (publ) Earnings HeadlinesCalliditas Therapeutics to Present Four Abstracts at American Society of Nephrology (ASN) Kidney Week 2024October 17, 2024 | tmcnet.comCalliditas Therapeutics (NASDAQ:CALT) Stock Quotes, Forecast and News SummaryOctober 4, 2024 | benzinga.comElon Reveals Why There Soon Won’t Be Any Money For Social SecurityElon Musk's Near-Death Experience Sparks Dire Warning for Americans After cheating death twice—once in a terrifying supercar crash with billionaire Peter Thiel, then from a deadly strain of malaria—Elon Musk emerged with a stark warning for Americans about looming financial dangers. Discover the little-known Trump IRS loophole that thousands are now using to safeguard their retirement from inflation and market turmoil—before it's too late.May 2, 2025 | Colonial Metals (Ad)Delisting of Calliditas Therapeutics AB (publ) from Nasdaq StockholmSeptember 16, 2024 | prnewswire.comNotice of extraordinary meeting of Calliditas Therapeutics AB (publ)September 3, 2024 | prnewswire.comCalliditas Therapeutics takes certain corporate actions following announcement by Asahi KaseiSeptember 3, 2024 | prnewswire.comSee More Calliditas Therapeutics AB (publ) Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Calliditas Therapeutics AB (publ)? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Calliditas Therapeutics AB (publ) and other key companies, straight to your email. Email Address About Calliditas Therapeutics AB (publ)Calliditas Therapeutics AB (publ) (NASDAQ:CALT), a commercial-stage bio-pharmaceutical company, focused on identifying, developing, and commercializing novel treatments in orphan indications with an initial focus on renal and hepatic diseases with significant unmet medical needs in the United States, Europe, and Asia. It offers Nefecon (TARPEYO/Kinpeygo), an oral formulation of budesonide to reduce the loss of kidney function in adults with immunoglobulin A nephropathy. The company's lead compound is Setanaxib, a NOX inhibitor that is in Phase 2b clinical trial for the treatment of primary biliary cholangitis; and in Phase 2 clinical trial for the treatment of squamous cell carcinoma of the head and neck cancer and idiopathic pulmonary fibrosis, as well as for solid tumors and Alport Syndrome. Calliditas Therapeutics AB (publ) was incorporated in 2004 and is headquartered in Stockholm, Sweden.View Calliditas Therapeutics AB (publ) ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Palantir Earnings: 1 Bullish Signal and 1 Area of ConcernMicrosoft Crushes Earnings, What’s Next for MSFT Stock?Qualcomm's Earnings: 2 Reasons to Buy, 1 to Stay AwayAMD Stock Signals Strong Buy Ahead of EarningsAmazon's Earnings Will Make or Break the Stock's Comeback CrowdStrike Stock Nears Record High, Dip Ahead of Earnings?Alphabet Rebounds After Strong Earnings and Buyback Announcement Upcoming Earnings Palantir Technologies (5/5/2025)Vertex Pharmaceuticals (5/5/2025)Realty Income (5/5/2025)Williams Companies (5/5/2025)CRH (5/5/2025)Advanced Micro Devices (5/6/2025)American Electric Power (5/6/2025)Constellation Energy (5/6/2025)Marriott International (5/6/2025)Energy Transfer (5/6/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 5 speakers on the call. Operator00:00:00Welcome to Calidya's Q2 2024 Report. The participants will be in listen only mode, and there will be no Q and A session after the presentation. Now I will hand the conference over to the speakers. Please go ahead. Speaker 100:00:15Thank you very much. Welcome to our Q2 2024 report. My name is Rene Aguiar Lukander, CEO of Kalida Taz. And I'm joined today by Richard Phillipson, Chief Medical Officer Frederick Johansen, our Chief Financial Officer and Maria Thornsen, President of North America. Next page, please. Speaker 100:00:42I'd like to draw your attention to the disclaimer notice, which covers forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended. And I refer to our public filings, including those containing risk factors. Next page, please. So I'd like to review some of the key events in Q2, which included the conclusion of our Phase 3 study in Effigard, with a readout of the open label extension from which we reported 9 months efficacy and safety data similar to that observed in the active arm of the Phase III trial for those patients who were retreated with nephicon after 15 months of observation. In April, we reported our positive top line data from our Phase II proof of concept study in head and neck cancer with a lead product candidate from our novel and unique NOx inhibitor platform, setonaxit. Speaker 100:01:35This shows statistically significant impact on both progression free survival as well as overall survival. We also were granted a new patent by the USPTO for the treatment with setonaxent in cancer with expiry in 2,039. In May, our partner, Everest Medicines, launched neficon in China, and EMA issued a positive opinion for full approval of Kympaygo in Europe. We also participated in several important conferences where we present additional data, which Rachel will cover a bit later in the call. Next page, please. Speaker 100:02:11In the quarter, there was an offer announced by Sahikasai. So on May 28, Sahikasai announced a public cash offer for all shares in Kalinitas for SEK 208 per share, valuing the company at approximately SEK 1,200,000,000. The tender is presently ongoing with the last day announced to be August 30, subject to any potential extensions. The offer is recommended by the Board and around 45 percent of shareholders have entered into undertakings to accept the offer subject to customary conditions. Next page. Speaker 100:02:45So with regards to commercial highlights of Q2. So from a commercial perspective, this quarter was a record quarter in terms of revenues, with $46,300,000 of net TR PAYO revenues, representing 90% growth over the same quarter last year. In addition, we saw record enrollments with 750 new enrollments and continued strong growth in new prescribers. The strong demand we're seeing is very encouraging and we continue to see demand in the market for TROPEO with summer seasonality seemingly being less pronounced this year in comparison to last year. The team has during the quarter undertaken a very substantial number of P and T committee meetings and the vast majority of major plants have now updated their rules to align with the new label. Speaker 100:03:31We are expecting the full approval and this kind of reduced market access friction to continue to drive TRYPEA revenue growth for the year. Revenues from partners in the quarter amounted to SEK 49,000,000, representing growth of close to 300% compared to last quarter as Netfecom was launched in China also in May. Operating profitability for the underlying business, excluding those costs related to the offer by Asahi Kasai, for the quarter came in at SEK 70,000,000, enabling us to reach our target of achieving operating profitability in the quarter. This excludes costs related to advisory services and provisions for incentive plans in connection with the Tsai Kasai offer amounting to approximately SEK 102,000,000 taking us to an overall operating loss for the quarter of SEK 31,500,000. Achieving operating level profitability is a goal we were hoping to achieve and targeting in Q3, and we're obviously delighted that we reached this target already in Q2. Speaker 100:04:36With regards to cash, we were almost cash neutral for the quarter with cash burn amounting to approximately SEK 700,000 or SEK 7,000,000. We believe that we'll be continued to be profitable on operating level for the remainder of the year, excluding any deal related costs based on continued revenue growth from Terpeo and the Nephicom franchise as Speaker 200:04:58a whole. Next page, please. Speaker 100:05:03Following the quarter, so in July, we reported our positive data from our Phase IIb trial in PBC primary biliary cholangitis with both the 12 1600 milligram dose is achieving statistical significance in terms of the primary endpoint. This was a heavily pretreated population, making this outcome even more rewarding. Richard will cover this in more Richard will cover this in more detail shortly. Also in July, Kinpega was granted full approval for the treatment of primary IgA in adults by the European Commission, which also triggered a €10,000,000 milestone payment, which will be recognized in Q3. With that, I'd like to hand over to Richard, who will take us through the PBC data to discuss. Speaker 300:05:49Thanks very much. Renee, next slide please. And the next slide. So I'd like to start by giving you a summary of the recently announced results of the TRANSFORM study of setonaxib in primary biliary cholangitis or PBC. As a reminder, this was a Phase 2b study evaluating patients aged 18 years older with a confirmed diagnosis of PBC, a serum alkaline phosphatase level of 1.67 times the upper limit of normal or higher and the liver stiffness of 8 kilopascals or higher as measured by FibroScan. Speaker 300:06:29In this double blind placebo controlled study, patients were randomized to 1 of 2 doses of setonaxib or placebo. Patients randomized to setonaxib received either a 1200 milligram daily dose administered as 800 milligrams in the morning and 400 milligrams in the evening or a 16 100 milligram daily dose administered as 800 milligrams twice daily. Treatment was administered for 24 weeks and the primary endpoint was change in alkaline phosphatase at week 24 compared to baseline. Next slide. We screened the 178 patients, of whom 77 patients were randomized. Speaker 300:07:10The demography and baseline characteristics of the trial population were representative of the target patient population and the treatment arms were generally well balanced. It is worth noting, as Rene has already said, that this was a heavily pretreated population at baseline. 43.4% of patients were receiving dual therapy, that is UDCA plus a coliva or UDCA plus a fibrate, and 13.2% of patients were receiving triple therapy of UDCA plus or coliva plus a fibrate. Next slide. With respect to the primary endpoint change from baseline in the ratio of alkaline phosphatase at week 24, there was a statistically significant difference for both dose comparisons versus placebo. Speaker 300:08:03The 1600 milligram dose group, there was a 19% difference compared to placebo. And for the 1200 milligram dose group, there's a 14% difference compared to placebo. Again, it's worth noting that although week 24 was the time point for the primary comparison, significant changes were observed from week 8 onwards. Next slide. We also observed favorable This is encouraging as clinically relevant changes in liver stiffness are typically detectable by FibroScan over a minimum of a 52 week observation period. Speaker 300:08:47Next slide. So in terms of safety, treatment emergent adverse events were balanced across the treatment groups overall. 76% of Setanaxa patients and 85% of placebo patients experienced at least one treatment emergent adverse event, but most of these were considered unrelated to treatment. Serious treatment emergent adverse events occurred approximately at similar rates in the cetanaxypin placebo treated patient groups with 12% of cesenaxyp patients and 11.5% of placebo patients experiencing serious treatment emergent adverse events. And events leading to study treatment discontinuation occurred in 14% of Sesamax of patients and 7.7% placebo patients. Speaker 300:09:43When we look at the adverse events occurring at a frequency of 10% or higher in the overall study population, then it's noteworthy that nausea, headache and pruritus actually occurred at a higher frequency in placebo treated patients. Afralgia and fatigue both occurred at similar frequencies in the combined Sesanaxit treatment group and placebo treated patients. And nasopharyngitis occurred at a higher frequency in the combined setanaxit treatment group compared to placebo. So in conclusion, the primary endpoint for the study was met, Statistically significant reductions in alkaline phosphatase was observed in both sezonaxit arms versus placebo from week 8 onwards and actually from week 4 onwards when we looked at the 2 active doses combined. We saw favorable improvements in liver stiffness at 24 weeks in patients treated with cetinaxib compared to placebo, and cetinaxit was generally well tolerated. Speaker 300:10:53So now I'd like to move on and provide a brief update on the company's activities at ERA EDTA this year. So next slide. So at ERA EDTA in May, which was held in Stockholm, Caligitas gave an oral presentation on the real world challenges associated with the use of systemic glucocorticoids in a U. S. IgA nephropathy cohort. Speaker 300:11:16And we also presented a poster describing the outcomes of a matching adjusted indirect comparison of EGFR in patients with IgA nephropathy treated with Nethicon or sparsentan. And we also sponsored a symposium entitled Clinical Markets in IgA nephropathy is all proteinuria the same and this was chaired by Professor Jonathan Barrett. In the latter poster presentation, we used patient level data from our NEFICARD Phase 3 trial and trial level data from the sparsentan PROTECT trial in IgA nephropathy to estimate the relative effect of Neficon with optimized RAS inhibition compared with sparsentan on the absolute eGFR change from baseline at 9, 12 24 months with common comparators of optimized resin inhibition for nephigard and irbesartan for the PROTECT study. The results from the anchored comparison showed statistically significant favorable effects of nefikon with optimized RAS inhibition versus varsentan on EGFR for all time points analyzed as shown in the figure in the slide on the right. These results suggest that neficon with optimized RAS inhibition may preserve kidney function to a greater extent than sparsentan and provide support for nephicon as a disease modifying therapy in IgA nephropathy. Speaker 300:12:40So I'd now like to hand over to my colleague, Maria Twonze. Speaker 200:12:46Thank you very much, Richard. Next slide, please. As you recall, in Q1 2024, we had our strongest quarter since launch with 705 enrollment forms. In the Q2 of 2024, we continue to see a very strong demand for Tarpeo with 750 enrollment forms received by our patient services hub, Tarpeo Touchpoints, another record quarter. During the Q2, we also had 343 new prescribers, and we now have over 2,300 health care providers who have prescribed Tarpeo. Speaker 200:13:27We believe the strong demand we are seeing is a result of our full approval, our new label with the removal of the UPCR criteria and physicians recognizing Tarpeo as a disease modifying agent that treats the disease at the source, reducing the pathogenic IgA. As mentioned, our total sales for Tarpeo in Q2 was $46,000,000 another record quarter. Year to date net sales for Tarpeo is $73,000,000 And as a result of the strong performance, we are raising our full year guidance to $165,000,000 to $185,000,000 for the NetEcon franchise. Next slide, please. In the Q2, we launched our new promotional campaign, highlighting the full approval and shining a light on Tarpeo's EGFR data. Speaker 200:14:22As you know, Tarpeo is the 1st and only FDA approved product to reduce the loss of kidney function. As mentioned last quarter, we've been spending time educating U. S. Payers on the new label, and I'm pleased to report that we now have seen significant changes on key commercial plans. Over 80% of U. Speaker 200:14:42S. Lives covered by commercial plans now have policies aligned with our new label and removed UPCR completely or reduced to seraphone date. In Q2, our medical teams also participated in multiple scientific congresses where they presented scientific data and engaged with key opinion leaders, including the National Kidney Foundation and the 61st ERA Congress, which was held in Stockholm, Sweden in May. Next slide. We are very excited at the opportunity ahead of us. Speaker 200:15:18We've already seen the positive reaction to the full approval of TRPEO. We will continue to educate U. S. Health care professionals on TRPEO's position as a disease modifying cornerstone treatment of IgAN. In October, we will participate in the ASN Congress, and we also look forward to the rollout of the CDU guidelines in the fall. Speaker 200:15:41We expect the guidelines will include Herpail and also broaden the definition of the at risk population. And as mentioned earlier, we've seen a significant impact on payer policies in Q2, and we will continue to educate U. S. Payers to ensure more plans reflect the new TRPAIO label and secure broad access for patients. Next slide, please. Speaker 200:16:07Finally, the IGEN treatment paradigm is evolving and addressing the source of the disease is crucial. TRYPEA does that by targeting the production of pathogenic IgA. As shown in the diagram, there are no other approved treatments that work in the same way. Majority of health care providers view TARPEO as a disease modifying agent that treats the disease at the source, reducing the pathogenic IgA. In market research, health care providers further state that the primary reasons they choose Tarpeo are for its efficacy in reducing UPCR, significant eGFR data, favorable tolerability profile and because Torpeo is treating the underlying cause of IGAS. Speaker 200:16:57And as you've seen from our strong results reported today, Torpeo is becoming a cornerstone treatment for IGAP. With that, I will hand it over to our CFO, Fredrik Johansen, to discuss our financial results. Fredrik? Speaker 400:17:13Thank you, Maria. I will now present to you the financial overview for the Q2. And as always, all numbers presented to you are SEK 1,000,000 unless otherwise stated. To start with, we report SEK559,800,000 in net revenues for the quarter. For the same quarter last year, we reported net revenues of $269,400,000 Tarpeo net product sales for the quarter amounted to $493,400,000 or $46,300,000 which is a reported increase of 90% from the same quarter previous year. Speaker 400:17:47The remaining $66,400,000 in revenues in the quarter are related to our partnerships, primarily from royalties from Southern Everest and shipment of products to Everest. For the same quarter last year, we have partnership revenues of $10,100,000 Our total operating expenses for the quarter amounted to 530 $7,800,000 compared to $330,300,000 for the same quarter last year. Included in the operating expenses for the quarter are expenses related to the SAICASA offer and expenses related to provisions for Social Security contributions for incentive programs due to the increase in our share price, this totaling SEK101,700,000 These costs are distributed over R and D, sales and marketing and G and A. The cost for research and development increased by $31,700,000 in the quarter to $120,700,000 compared to $89,000,000 for the same quarter previous year. Besides the previous mentioned provisions for incentive programs, the change in the period primarily relates to increased costs for Nefcon manufacturing scale up. Speaker 400:18:53The cost for sales and marketing increased by CAD61.5 million in the quarter to CAD253 1,000,000 compared to CAD191.5 million for the same quarter previous year. The increase is primarily related to scale up of the sales and marketing of Terpeo in the U. S. Following the full approval and also the mentioned provisions for the incentive programs. The cost for G and A increased by €89,600,000 in the quarter to 100 and €166,800,000 compared to €77,200,000 for the same quarter previous year. Speaker 400:19:28The increased cost for G and A primarily relates to the mentioned provisions for incentive programs and advisory fees related to the public offering from Assai Cafe. We made an operating loss in the quarter of $31,500,000 compared to an operating loss of $75,200,000 for the same quarter last year. As mentioned by Ronnier, excluding the expenses relating to the Asai Kase offer and expenses related to provisions for Social Security contributions for the incentive programs due to an increase in the share price. We report an adjusted operating profit of $70,200,000 in the second quarter. The cash flow used in operating activities in the quarter was $7,000,000 compared to $163,000,000 for the same quarter previous year, And this leaves us with a net decrease in cash in the first in the second quarter of $11,200,000 and we continue to have a healthy cash position of $797,300,000 at the end of the quarter. Speaker 400:20:27That was all for me. Thank you. And back to you, Renee. Speaker 100:20:32Thank you very much. Next slide, please. Thank you. So obviously, as we reported, Q2 was financially strong with positive progress of our pipeline. But some of the key takeaways, obviously, we had a record quarter in terms of net product revenues from Tarpeo, terms of posting $46,300,000 for the quarter as well as for the Nephicom franchise achieving approximately $53,000,000 for the quarter. Speaker 100:20:58We also achieved our target of operational profitability excluding the advisory costs and incentive program provisions as stated. We also was our partner, Stata, was granted full approval of Comtego in Europe by the European Commission. And also saw a new patent issued by the USPTO covering cetronaxib in terms of treatment of cancer with expiry of 2,039. As Frederic has said, we have a strong cash position and obviously saw an almost neutral impact on cash for the quarter. And we are expecting continued strong demand for Torpejo for all the reasons that Maria described. Speaker 100:21:39And as mentioned, in terms of our revenue guidance for 20 24, we're updating that, reflecting these growth expectations. And so the revenue guidance for 2024 is updated to be $165,000,000 to $185,000,000 And with that, this concludes our Q2 2024 presentation. Thank you very much to all for listening in.Read morePowered by