Q2 2024 Calliditas Therapeutics AB (publ) Earnings Call
Speaker Change: Thank you. Thank you.
Speaker Change: Thank you very much for coming.
Speaker Change: [inaudible]
Operator: Welcome to Calliditas' Q2 2024 report. The participants will be in listen-only mode, and there will be no Q&A session after the presentation.
Speaker Change: And I'm going to be talking about the the the the the the the the the the the the the the
Speaker Change: Welcome to Calidia's Q2 2024 report. The participants will be in listen-only mode and there will be no Q&A session after the presentations. Now we'll hand the conference over to the speakers. Please go ahead.
Renee Aguiar-Lukander: Now we'll hand the conference over to the speaker. Please go ahead. Thank you very much. Welcome to our Q2 2024 report. My name is Renee Aguiar-Lukander, CEO of Calliditas, and I am joined today by Richard Philipson, Chief Medical Officer, Fredrik Johansson, our Chief Financial Officer, and Maria Tornsen, President of North America. Next, Fee, I'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 And I refer to our public filings, including those containing risk.
Renee Aguiar-Lukander: So I'd like to review some of the key events in Q2, which included the inclusion of our Phase 3 study nephagorase, with the readout of the Open Label extension, from which we reported nine months of efficacy and safety data, similar to that observed in the active arm of the Phase 3 trial, for those patients who were retreated with nephacon after 15 months of observation. This is the end of the Phase 3 trial, which is the end of the Phase 3 trial for those patients who were retreated with nephacon after 15 months. In April, we reported 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, Cetonexid.
Renee Aguiar-Lucander: Thank you very much. Welcome to our Q2 2024 report. My name is Renee Aguiar-Lucander, CEO of Kalita Taz, and I am joined today by Richard Philipson, Chief Medical Officer
Renee Aguiar-Lukander: This shows a 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 seton acid in cancer with expiry in 2039. In May, our partner Everest Medicines launched Nefacon in China, and EMA issued a positive opinion for full approval of Kimpego in Europe. We also participate in several important conferences where we present additional data, which Richard will cover a bit later in the call.
Speaker Change: our Chief Financial Officer, and Maria Tornsen, President of North America.
Speaker Change: Next page, please.
Speaker Change: I'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.
Renee Aguiar-Lukander: In the quarter, there was an offer announced by Sahe Qasai. On May 28, Sahe Qasai announced a public cash offer for all shares in Calliditas at 208 Swedish crowns per share, valuing the company at approximately 1.2 billion Swedish crowns.
Speaker Change: Next page, please.
Speaker Change: So I'd like to review some of the key events in Q2.
Speaker Change: which included the conclusion of our phase 3 study Nefigard with the readout of the open label extension from which we reported nine months efficacy and safety data similar to that observed in the active arm of the phase 3 trial for those patients who were retreated with Neficon after 15 months of observation.
Speaker Change: 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, Cetamaxib.
Speaker Change: This showed 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 seton acid in cancer with expiry in 2039.
Speaker Change: In May, our partner, Average Medicines, launched Nefacon in China, and EMA issued a positive opinion for full approval of Kimpego in Europe. We also participate in several important conferences where we present additional data, which Richard will cover a bit later in the call.
Speaker Change: In the quarter, there was an offer announced by Asahi Kasai, so on May 28th, Asahi Kasai announced a public cash offer for all shares in Kalinitas for 208 Swedish crowns per share, valuing the company at approximately 1.2 billion Swedish crowns.
Renee Aguiar-Lukander: The tender is presently ongoing, with the last day announced to be August 30, subject to 28 potential extensions. The offer is recommended by the board, and around 45% of shareholders have entered into undertakings to accept the offer, subject to customary conditions. So with regard to commercial highlights of Q2, from a commercial perspective, this quarter was a record quarter in terms of revenues, with $46.3 million of net TARPAYA revenues representing 90% growth over the same quarter last year.
Speaker Change: The tender is presently ongoing, with the last day announced to be August 30th, subject to any potential extensions. The offer is recommended by the Board, and around 45% of shareholders have entered into undertakings to accept the offer, subject to customary conditions.
Speaker Change: Next page.
Speaker Change: So, with regards to commercial highlights of Q2, so from a commercial perspective, this quarter was a record quarter in terms of revenues, with $46.3 million of net TARPAYA revenues representing 90% growth over the same quarter last year.
Renee Aguiar-Lukander: 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 Torpedo with summer seasonality seemingly being less pronounced this year in comparison to last year.
Speaker Change: In addition, we saw record enrollments with 750 new enrollments and continued strong growth in new prescribers.
Speaker Change: The strong demand we're seeing is very encouraging, and we continue to see demand in the market for tapio with summer seasonality seemingly being less pronounced this year in comparison to last year.
Renee Aguiar-Lukander: The team has during the quarter undertaken a very substantial number of P&T committee meetings, and the vast majority of major plans have now updated their rules to align with the new label. We are expecting full approval and this kind of reduced market access friction to continue to drive Trapeo revenue growth for the year. Revenues from partners in the quarter amounted to 49 million Swedish crowns, representing growth of close to 300 percent compared to last quarter, as Neficon was launched in China also in May.
Speaker Change: The team has during the quarter undertaken a very substantial number of P&T committee meetings, and the vast majority of major plans have now updated their rules to align with a new label. We are expecting the full approval and this kind of reduced market access friction to continue to drive TARPAYA revenue growth for the year.
Speaker Change: Revenues from partners in the quarter amounted to 49 million Swedish crowns representing growth of close to 300% compared to last quarter as Neficon was launched in China also in May.
Renee Aguiar-Lukander: Operating profitability for the underlying business, excluding those costs related to the offer by Asahi Kasai, for the quarter came in at 70 million Swedish crowns, enabling us to reach our target of achieving operating profitability in the quarter.
Speaker Change: Operating profitability for the underlying business, excluding those costs related to the offer by Asahi Kasai for the quarter, came in at 70 million Swedish crowns, enabling us to reach our target of achieving operating profitability in the quarter.
Renee Aguiar-Lukander: These exclude costs related to advisory services and provisions for incentive plans in connection with the psych as I offer, amounting to approximately 102 million Swedish crowns, taking us to an overall operating loss for the quarter of 31.5 million Swedish crowns. 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 Q3. With regard to cash, we were almost cash neutral for the quarter, with the cash burden mounting through approximately $700,000 or $7 million.
Speaker Change: These exclude costs related to advisory services and provisions for incentive plans in connection with the psychos I offer, amounting to approximately 102 million Swedish crowns, taking us to an overall operating loss for the quarter of 31.5 million Swedish crowns.
Speaker Change: 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 Change: With regards to cash, we were almost cash neutral for the quarter, with cash burden amounting to approximately $700,000 or 7 million crowns.
Renee Aguiar-Lukander: We believe that we'll continue to be profitable on the operating level for the remainder of the year, excluding any deal-related costs, based on continued revenue growth from Tarpaio and the Nefacon franchise as a whole. Following the Quarters, in July, we report positive data from our face-to-face trial in PBC, primary billionaire at Callan Gitis, with both the 1,200 and 1,600 milligram doses achieving This was a heavily pre-treated population, making this outcome even more rewarding. Richard will cover these details in more detail. Richard will cover this in more detail in a short time.
Speaker Change: We believe that we'll continue to be profitable on the operating level for the remainder of the year, excluding any deal-related costs, based on continued revenue growth from Tarpayee and the Nefacon franchise as a whole.
Speaker Change: Next page, please.
Speaker Change: Following the quarters, in July we reported our positive data from our Phase 2b trial in PBC, primary biliary cholangitis, with both the 1200 and 1600 milligram doses achieving statistical significance in terms of the primary endpoint.
Speaker Change: This was a heavily pre-treated population, making this outcome even more rewarding. Richard will cover this in more detail shortly.
Renee Aguiar-Lukander: [inaudible] Also in July, Kinpeka was granted full approval for the treatment of primary eye gain in adults by the European Commission, which also triggered a 10 million euro milestone payment which will be recognized in Q3. With that, I'd like to hand over to Richard, who will take us through the PVT data. Thank you very much.
Richard Philipson: Also in July, Kinpeka was granted full approval for the treatment of primary eye gain in adults by the European Commission, which also triggered a €10 million milestone payment, which will be recognised in Q3.
Richard Philipson: With that I'd like to hand over to Richard who will take us through the PVP data.
Richard Philipson: Renee, next slide please. So, I'd like to start by giving you a summary of the recently announced results of the TRANSFORM study of Cessna in Primary Billory Co-Langiritas. As a reminder, this was a Phase 2B study evaluating patients aged 18 years and older with a confirmed diagnosis of PPC. Serum Alkaline Phosphatase level of 1.67 times the upper limit of normal or higher and liver stiffness of 8 kilopascals or higher as measured by fibroscope.
Richard Philipson: Thanks very much. Renee, next slide please.
Richard Philipson: 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 cetamaxib in primary biliary cholangitis or PBC.
Speaker Change: As a reminder, this was a Phase 2b study evaluating patients aged 18 years and older with a confirmed diagnosis of PPC.
Speaker Change: a serum alkaline phosphatase level of 1.67 times the upper limit of normal or higher and a liver stiffness of 8 kilopascals or higher as measured by FibroScan.
Richard Philipson: In this double-blind placebo-controlled study, patients were randomized to one of two doses of Cessnax-support placebo. Patients randomized to setonaxib received either a 1,200 milligram daily dose administered as 800 milligrams in the morning and 400 milligrams in the evening, or a 1,600 milligram daily dose administered as 800 milligrams twice.
Speaker Change: In this double-blind placebo-controlled study, patients were randomized to one of two doses of Cessnax-support placebo.
Speaker Change: Patients randomized to set an axis received either a 1200 milligram daily dose administered as 800 milligrams in the morning and 400 milligrams in the evening or a 1600 milligram daily dose administered as 800 milligrams twice daily
Richard Philipson: Treatment was administered for 24 weeks, and the primary endpoint was changed in alkaline phosphatase. Therefore, we screened 178 patients, of whom 77 patients were random. The 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 Renee has already said, that this was a heavily pre-treated population at base. 43.4% of patients were receiving dual therapy, UDCA plus or coliva or UDCA plus a fibrate, and 13.2% of patients were receiving triple therapy of UDCA plus or coliva plus. With respect to the primary end point, change from baseline and the ratio of alkaline phosphatase at week 24, there Again, it's worth noting that although week 24 was the time point for the primary comparison, significant changes were observed from week eight onward.
Speaker Change: Treatment was administered for 24 weeks and the primary endpoint was change in alkaline phosphatase at week 24 compared to baseline.
Richard Philipson: Next slide. We also observed favorable improvements in liver stiffness at week 24 in patients treated with Cetimaxib compared to placebo. This is encouraging as clinically relevant changes in liver stiffness are typically detectable by FibroScan over a minimum of a 52-week period. So, in terms of safety,
Speaker Change: Next slide.
Speaker Change: So we screened 178 patients, of whom 77 patients were randomised.
Speaker Change: The demography and baseline characteristics of the trial population were representative of the target patient population and the treatment arms were generally well balanced.
Speaker Change: It is worth noting, as Renee has already said, that this was a heavily pre-treated population at baseline.
Renee Aguiar-Lucander: 43.4% of patients was receiving dual therapy.
Renee Aguiar-Lucander: That is UDCA plus a coliva or UDCA plus a fibrate
Speaker Change: And 13.2% of patients were receiving triple therapy of UGCA plus Ocoliva plus a fibrate.
Speaker Change: Next slide.
Speaker Change: With respect to the primary endpoint change from baseline and the ratio of alkaline phosphatase at week 24 there was a statistically significant difference for both dose comparisons versus placebo.
Speaker Change: The 1600 milligram dose group there was a 19% difference compared to placebo and for the 1200 milligram dose group there was a 14% difference compared to placebo.
Speaker Change: 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.
Speaker Change: We also observed favorable improvements in liver stiffness at week 24 in patients treated with setonaxib compared to placebo.
Speaker Change: This is encouraging as clinically relevant changes in liver stiffness are typically detectable by FibroScan over a minimum of a 52 week observation period.
Richard Philipson: Treatment Emergent Adverse Events with Balanced Across the Treatment Groups Overall, 76% of Seth Naxe's patients and 85% of placebo patients experienced at least one treatment emergent adverse event, but most of these were considered unrelated to treatment. Sirius, treatment immersion, adverse events occurred approximately... Similar rates in the Cessna accident.
Speaker Change: Next slide.
Speaker Change: So in terms of safety treatment emergent adverse events were balanced across the treatment groups overall
Speaker Change: 76% of Cessnaxia patients and 85% of placebo patients experienced at least one treatment emergent adverse event but most of these were considered unrelated to treatment.
Speaker Change: Serious treatment emergent adverse events occurred approximately at similar rates in the Cessna accident.
Richard Philipson: Seybal Trichet, patient group. 12% of Cessnaxia patients and 11.5% of placebo patients experienced the disease. Serious treatment of merchant adversaries and events leading to study treatment discontinuation occurred in 14% of session exit patients. 7.7% When we look at the adverse events occurring at a frequency of 10% or higher in the overall study population, it's noteworthy that nausea, headache, and pruritus actually occurred at a higher frequency in placebo-treated patients. Fralgia and fatigue both occurred at similar frequencies in the combined Cessnaxic treatment group.
Speaker Change: placebo-treated patient groups with 12% of Cessnaxib patients and 11.5% of placebo patients experiencing serious treatment emergent adverse events.
Speaker Change: and events leading to study treatment discontinuation occurred in 14% of SES and EXIT patients and 7.7% of SEPA patients.
Speaker Change: When we look at the adverse events occurring at a frequency of 10% or higher in the overall study population,
Speaker Change: then it's noteworthy that nausea, headache and pruritis actually occurred at a higher frequency in placebo-treated patients. Arthralgia and fatigue both occurred at similar frequencies in the combined sesanoxic treatment group and placebo-treated patients.
Richard Philipson: CBOE-Treated Patients And nasopharyngeitis occurred as a higher frequency in the combined cessinaxe of treatment group compote and as a higher frequency in the combined cessinaxe of treatment group compote of treatment group compote of treatment group compote. So, in conclusion, the primary endpoint for the study was met, statistically significant reductions in alkaline phosphatase were observed in both Se We saw favorable improvements in liver stiffness at 24 weeks in patients treated with setonaxib compared to placebo, and setonaxib was generally well tolerated.
Speaker Change: and nasopharyngitis occurred at a higher frequency in the combined sesanoxic treatment group compared to placebo.
Speaker Change: So in conclusion...
Speaker Change: The primary endpoint for the study was met. Statistically significant reductions in alkaline phosphatase.
Speaker Change: was observed in both seton acid arms versus placebo from week eight onwards and actually from week four onwards when we looked at the two active doses combined.
Speaker Change: We saw favourable improvements in liver stiffness at 24 weeks in patients treated with sesamaxib compared to placebo and sesamaxib was generally well tolerated.
Richard Philipson: So now I'd like to move on and provide a brief update on the company's activities at ERA EDTA this year. Next slide. So at ERA EDTA in May, which was held in Stockholm, Calliditas gave an oral presentation on the real world challenges associated with the use of systemic glucocorticoids in a US IgA nephropathy cohort, and we also presented a poster describing the outcomes of a matching adjusted indirect comparison of EGFR in patients with IgA nephropathy treated for nephricon
Speaker Change: So now I'd like to move on and provide a brief update on the company's activities at ERA EDTA this year.
Speaker Change: So next slide. So at ERA EDTA in May, which was held in Stockholm, Kalliditas gave an oral presentation on the real world challenges associated with the use of systemic glucocorticoids in a US IgA nephropathy cohort.
Speaker Change: and we also presented a poster describing the outcomes of a matching, adjusted, indirect comparison of EGFR in patients with IgA nephropathy treated with Neficon or SpasMTAN.
Richard Philipson: And we also sponsored a symposium entitled Clinical Markers in IgA Neuropathy: Is All Proteinuria the Same?, and this was chaired by Professor Jonathan Barratt. In the last part of the presentation, we used patient-level data from our Neffigard Phase 3 trial and trial-level data from the sparsentan protect trial in IJ nephropathy to estimate the relative effect of nephicon with optimized Ras inhibition compared with sparsentan on the absolute EGFR change from baseline at 9, 12 and 24 months with common comparisons of optimized Ras inhibition for nephigard and herbicartan.
Speaker Change: And we also sponsored a symposium entitled Clinical Markers in IgA Nephropathy, Is All Proteinuria the Same? And this was chaired by Professor Jonathan Barratt.
Speaker Change: In the latter poster presentation, we used patient-level data from our Nefigard Phase III trial.
Speaker Change: and trial-level data from the Spast-Centan-Protect trial in IgA nephropathy to estimate the relative effect of nephicon with optimized Ras inhibition.
Speaker Change: compared with Balsentan on the absolute EGFR change from baseline at 9, 12 and 24 months with common comparisons of optimized Ras inhibition for Nefigard and Erbisartan for the PROTECT study.
Richard Philipson: The results from the anchored comparison showed statistically significant favourable effects of Neficon with optimized RAS inhibition versus Barcentan on EGFR for all time points analysed, as shown in the figure on the right. These results suggest that Neficon with optimized RAS inhibition may preserve kidney function to a greater extent than Spartenz and provides support for Leficon as a disease-modifying therapy.
Speaker Change: The results from the anchored comparison showed statistically significant favorable effects of nephekon with optimized Ras inhibition versus barcentan on EGFR for all time points analyzed as shown in the figure in the slide on the right.
Speaker Change: These results suggest that Neficon with optimised RAS inhibition may preserve kidney function to a greater extent than Sparcenta and provide support for Neficon as a disease modifying therapy in IgA nephropathy.
Richard Philipson: [inaudible] and I.G.A. Macroft. So I'd now like to hand over to my colleague, Maria Tornsen. Thank you very much, Richard.
Speaker Change: So I'd now like to hand over to my colleague, Maria Tornsen.
Maria Tornsen: Next slide, please. As you recall, in Q1 2024, we had our strongest quarter since launch with 705 enrolments. In the second quarter of 2024, we continue to see a very strong demand for TARPAYO with 750 enrolment forms received by our patient services hub, TARPAYO Touchpoints. Another record quarter.
Maria Tornsen: Thank you very much Richard. Next slide please.
Maria Tornsen: As you recall, in Q1 2024, we had our strongest quarter since launch, with 705 enrolment forms.
Speaker Change: In the second quarter of 2024, we continue to see a very strong demand for TARPEO with 750 enrolment forms received by our patient services hub, TARPEO Touchpoints. Another record quarter.
Maria Tornsen: During the second quarter, we also had 343 new prescribers, and we now have over 2,300 health care providers who have prescribed Tarpaio. We believe the strong demand we are seeing is the result of our full approval, our new label with the removal of the UPCR criteria, and physicians recognizing Tarpaio as a disease-modifying agent that treats the disease as a source, reducing the pathogenic IgA. As mentioned, our total sales for Tarpaio in Q2 were $46 million, another record quarter.
Speaker Change: During the second quarter, we also had 343 new prescribers, and we now have over 2,300 healthcare providers who have prescribed Tarpaio.
Speaker Change: We 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 Tarpaio as a disease-modifying agent that treats the disease as a source, reducing the pathogenic IgA.
Maria Tornsen: Year-to-date net sales for Tarpaio are $73 million, and as a result of the strong performance, we are raising our full year guidance to $165 to $185 million for the NET-A-CON franchise. Next slide. In the second quarter, we launched our new promotional campaign, highlighting the full approval and shining a light on Tarpaio's EGFR data. As you know, Torpeo is the first and only FDA-approved product to reduce the loss of kidney fungus.
Speaker Change: As mentioned, our total sales for Tarpaio in Q2 was $46 million, another record quarter. Year-to-date net sales for Tarpaio is $73 million.
Speaker Change: And as a result of the strong performance, we are raising our full year guidance to $165-185 million for the NET-A-CON franchise.
Speaker Change: Next slide, please.
Speaker Change: In the second quarter, we launched our new promotional campaign highlighting the full approval and shining a light on Tarpaio's EGFR data. As you know, Tarpaio is the first and only FDA approved product to reduce the loss of kidney function.
Maria Tornsen: 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.S. lives covered by commercial plans now have policies aligned with our new label and remove UPCR completely or reduce it to CERA funding. 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. We've already seen the positive reaction to the full approval of TARPAO.
Speaker Change: 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.
Speaker Change: Over 80% of U.S. lives covered by commercial plans now have policies aligned with our new label and removed UPCR completely or reduced to 0.8.
Speaker Change: 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.
Speaker Change: Next slide.
Speaker Change: We are very excited at the opportunity ahead of us. We've already seen the positive reaction to the full approval of TARPEO. We will continue to educate U.S. healthcare professionals on TARPEO's position as a disease-modifying cornerstone treatment of IgAN.
Maria Tornsen: We will continue to educate U.S. health care professionals on Tarpehio's position as a disease-modifying cornerstone treatment for eye gas. In October, we will participate in the ASN Congress, and we also look forward to the rollout of the CADIU guidelines in the fall. We expect the guidelines will include TARPAIL and also broaden the definition of the at-risk population.
Speaker Change: In October, we will participate in the ASN Congress, and we also look forward to the rollout of the CADIU guidelines in the fall.
Speaker Change: We expect the guidelines will include TARPAIL and also broaden the definition of the at-risk population.
Maria Tornsen: And as I 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 tarpeo label and secure broad access for patients. Next slide. Finally, the eigentreatment paradigm is evolving, and addressing the source of the disease is crucial. Torpeo does that by targeting the production of pathogenic IgA. As shown in the diagrams, there are no other approved treatments that work in the same way.
Speaker Change: And as mentioned earlier, we've seen a significant impact on payer policies in Q2, and we will continue to educate US payers to ensure more plans reflect the new TARPAYO label and secure broad access for patients.
Speaker Change: Next slide, please.
Speaker Change: Finally, the eigen-treatment paradigm is evolving and addressing the source of the disease is crucial.
Speaker Change: Torpeo does that by targeting the production of pathogenic IgA.
Speaker Change: As shown in the diagram, there are no other approved treatments that work in the same way.
Maria Tornsen: The majority of health care providers view Tarpaio as a disease-modifying agent that treats the disease at the source, reducing the pathogenic IgA. In market research, healthcare providers further state that the primary reasons they choose to pay for Tarpaio are for its efficacy in reducing UPCR. Significant EGF4 data, favorable tolerability profile, and the cost for payout are treating the underlying cost of Aga. And as you've seen from our strong results reported today, Torpeo is becoming a cornerstone treatment for eye cancer. With that, I will hand it over to our CFO Fredrik Johansson to discuss our financial results. Fredrik.
Speaker Change: Majority of health care providers view Tarpaio as a disease-modifying agent that treats the disease at the source, reducing the pathogenic IgA.
Speaker Change: In market research, health care providers further state that the primary reasons they choose Tarpaio are for its efficacy in reducing UPCR,
Speaker Change: significant EGFR data, favorable tolerability profile, and because Torpeo is treating the underlying cause of eye gas.
Speaker Change: And, as you've seen from our strong results reported today, Torpeo is becoming a cornerstone treatment for eye gap.
Fredrik Johansson: With that, I will hand it over to our CFO, Fredrik Johansson, to discuss our financial results. Fredrik?
Fredrik Johansson: Thank you, Maria. I will now present to you a differential overview for the second quarter, and as always, all numbers presented to you are a million sick unless otherwise specified. To start with, we reported $559.8 million in net revenues for the quarter. For the same quarter last year, we reported net revenues of $269.4 million. Tarpaio net product sales for the quarter amounted to $493.4 million or $46.3 million, which is a reported increase of 90% from the same quarter last year.
Fredrik Johansson: Thank you, Maria.
Fredrik Johansson: I will now present to you the financial overview for the second quarter and as always all numbers presented to you are a million SEC unless otherwise stated.
Fredrik Johansson: The remaining 6.4 million in revenues in the quarter are related to our partnerships, primarily royalties from Staden Everest and shipment of products to Everest. For the same quarter last year, we had potential revenues of 10.1. Our total operating expenses for the quarter amounted to $537.8 million, compared to $330.3 for the same quarter last year. Included in the operating expenses for the quarter are expenses related to the Asai Kasei offer and expenses related to provisions for social security contributions for incentive programs due to the increase in our share price.
Fredrik Johansson: To start with, we report $559.8 million in net revenues for the quarter. For the same quarter last year, we reported net revenues of $269.4 million.
Fredrik Johansson: Tarpaio Net private sales for the quarter amounted to $493.4 million or $46.3 million, which is a reported increase of 90% from the same quarter previous year.
Fredrik Johansson: The remaining 6.4 million in revenues in the quarter are related to our partnerships, primarily from royalties from Staden Everest and shipment of products to Everest.
Fredrik Johansson: For the same quarter last year, we have partnership revenues of 10.1 million.
Fredrik Johansson: Our total operating expenses for the quarter amounted to $537.8 million compared to $330.3 for the same quarter last year.
Fredrik Johansson: Included in their operating expenses for the quarter are expenses related to the Assaic-Casse offer and expenses related to provisions for Social Security contributions for incentive programs due to the increase in our share price.
Fredrik Johansson: Totaling $101.7 million, these costs are distributed over R&D, sales and marketing, and GM. The cost for research and development increased by 31.7 million in the quarter to 120.7 million, compared to 8.9 million 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 an ethical manufacturing scale-up. The cost for sales and marketing increased by 61.5 million in the quarter to 253 million compared to 191.5 million for the same quarter previous year.
Fredrik Johansson: These totaling $101.7 million.
Fredrik Johansson: These costs are distributed over R&D, sales and marketing, and DNA.
Fredrik Johansson: The cost for research and development increased by $31.7 million in the quarter to $120.7 million compared to $89 million for the same quarter previous year.
Fredrik Johansson: Besides the previous mentioned provisions for incentive programs, the change in the period primarily relates to increased costs for Nefcon Manufacturing Scala.
Fredrik Johansson: The cost for sales and marketing increased by 61.5 million in the quarter to 253 million compared to 191.5 million for the same quarter previous year.
Fredrik Johansson: The increase is primarily related to the scale-up of the sales and marketing of Tapio in the U.S. following full approval, and also the mentioned provisions for the incentive program. The cost per GNA increased by 89.6 million in the quarter to 166.8 million compared to 77.2 million for the same quarter last year. The increased cost for GNA primarily relates to the mentioned provisions for incentive programs and advisor fees related to the public offer from AFAI CAFE.
Fredrik Johansson: The increase is primarily related to scale-up of the sales and marketing of Tarpeio in the U.S. Following the full approval,
Fredrik Johansson: and also the mentioned provisions for the incentive programs.
Fredrik Johansson: The cost for G&A increased by 89.6 million in the quarter to 166.8 million compared to 77.2 million for the same quarter previous year The increased cost for G&A primarily relates to the mentioned provisions for incentive programs and advisor fees related to the public offer from Acai Cafe
Fredrik Johansson: We made an operating loss in the quarter of 31.5 million compared to an operating loss of 75.2 million for the same quarter last year, as mentioned by Renee, excluding the expenses relating to the SICASE 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 70.2 million in the second quarter. The cash flow used in operating activities in the quarter was 7 million compared to 163 million for the same quarter last year. And this leaves us with a net decrease in cash in the second quarter of $11.2 million. And we continue to have a healthy cash position of 797.3 million at the end of the year. That was all for me.
Fredrik Johansson: We made an operating loss in the quarter of 31.5 million compared to an operating loss of 75.2 million for the same quarter last year. As mentioned by Renee, excluding the expenses relating to the SICASA offer and expenses related to provisions for social security contributions for the incentive programs.
Renee Aguiar-Lucander: due to an increase in the share price.
Speaker Change: We report an adjusted operating profit of $70.2 million in the second quarter.
Speaker Change: The cash flow used in operating activities in the quarter was 7 million compared to 163 million for the same quarter previous year.
Speaker Change: And this leaves us with a net decrease in cash in the second quarter of 11.2 million and we continue to have a healthy cash position of 797.3 million at the end of the quarter.
Renee Aguiar-Lukander: Thank you and back to you, Renee. Thank you very much. Next slide, please. Thank you.
Speaker Change: That was all for me. Thank you and back to you Renee.
Renee Aguiar-Lukander: So, obviously, as we reported, Q2 was financially strong with positive progress in our pipeline. Some of the key takeaways Obviously, we had a record quarter in terms of net product revenues from Tarpeo in terms of posting $46.3 million for the quarter, as well as for the Neficon franchise, achieving approximately $53 million for the quarter. We also achieved our target of operational profitability, excluding the advisory costs and incentive program provisions, as stated.
Renee Aguiar-Lucander: Thank you very much. Next slide, please. Thank you. So, obviously, as we've 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 Tarpaio.
Renee Aguiar-Lucander: in terms of posting $46.3 million for the quarter, as well as for the Nethercom franchise, achieving approximately $53 million for the quarter.
Renee Aguiar-Lukander: We also were a partner start; I was granted full approval of Campega in Europe by the European Commission. And I also saw a new patent issued by the US PTO covering sets an accident in terms of the treatment of cancer with an expiry of 2030. As Fredrik has said, we are going to 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 Tarpeo for all the reasons that Maria described.
Renee Aguiar-Lucander: We also achieved our target of operational profitability, excluding the advisory costs and incentive program provisions as stated. Our partner, Stata, was granted full approval of Contego in Europe by the European Commission.
Renee Aguiar-Lucander: and also saw a new patent issued by the USPTO covering setonaxib in terms of treatment of cancer with expiry of 2039.
Fredrik Johansson: As Fredrik 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 Tarpeo for all the reasons that Maria described.
Speaker Change: And as mentioned, in terms of our revenue guidance for 2024, we're updating that, reflecting these growth expectations. And so the revenue guidance for 2024 is updated to be $165 million to $185 million.
Speaker Change: And with that, this concludes our Q2 2024 presentation. Thank you very much to all for listening in.
Speaker Change: Call recording is off. Thank you for watching.
Renee Aguiar-Lukander: [inaudible] And as mentioned in terms of our revenue guidance for 2024, we're updating that, reflecting these growth expectations, and so the revenue guidance for 2024 is updated to be 165 to 185 million US dollars. And with that, this concludes our Q2 2024 presentation. Thank you very much to all for listening in. Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music, Welcome to the Calliditas Therapeutics Q2 2023 report.
Speaker Change: Welcome to the Caliditas Therapeutics Q2 2023 report
Renee Aguiar-Lukander: For the first part of the conference call, the participants will be in listen only mode. [inaudible] During the questions and answer session, participants are able to ask questions by dialing, star five on their telephone keypad. Now I will hand the conference over to the speaker to CEO Renee Aguiar, Lucanda, and CFO, Fredrik Johansson. Please go ahead. Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music, Dr. Paret Johansson, Dr. Paret Johansson, Rami Katkhuda [inaudible] Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music, Dr. Paret, Dr. Paret, Dr. Paret [inaudible] Dr. Paret, Dr. Paret, Dr. Paret, Dr. Paret, Dr. Paret, [inaudible] Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music, Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music, Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Dr. Paret Johansson, Dr. Paret Johansson, Rami Katkhuda [inaudible] Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Dr. Paret, Dr. Paret, Rami Katkhuda Dr. Paret, Rami Katkhuda, Rami Katkhuda, Rami Katkhuda, Dr. Paret, Rami Katkhuda, Rami Katkhuda, Rami Katkhuda, Rami Katkhuda, Rami Katkhuda, [inaudible] Music Music Music Music Music Music Music Conference will automatically end in 30 seconds.
Speaker Change: For the first part of the conference call, the participants will be in listen-only mode.
Speaker Change: During the questions and answer session, participants are able to ask questions by dialing star 5 on their telephone keypad. Now I will hand the conference over to the Speaker CEO Renee Aguiar-Lucanda and CFO Fredrik Johansson. Please go ahead.
Speaker Change: [inaudible]
Unknown Executive: Welcome to Callidias Q22024 Report. The participants will be in listen only mode and there will be no Q&A session after the presentations.
Unknown Executive: Now we'll hand a conference over to the speakers. Please go ahead. Thank you very much.
Renee Aguiar-Lukander: Welcome to our Q22024 Report.
Renee Aguiar-Lukander: My name is Renee Aguiar-Lukander, CEO of Calliditas and I'm joined today by Richard Philipson. Chief Medical Officer, Fredrik Johansson, our Chief Financial Officer, and Maria Tornsen, President of North America.
Renee Aguiar-Lukander: Next page, please. I'd like to draw your attention to disclaimer notice, which covers forward looking statements within the meeting of the private security litigation reform act of 1995 as amended. And I refer to our public filings, including those containing risk factors.
Renee Aguiar-Lukander: Next page, please. So I'd like to review some of the key events in Q2, which included the inclusion of our phase three study in the regard with the readout of the open label extension, from which we reported nine months efficacy and safety data similar to that observed in the active arm of the phase three trial for those patients who are retreated with nephicon after 15 months of observation. In April, we reported our positive top line data from our phase two proof of concept study and had a net cancer with the lead product candidate from our novel and unique NOx inhaler platform set on accident.
Renee Aguiar-Lukander: This showed statistically significant impact on both progression free survival as well as as well as overall survival. We also regretted a new patent by the US PTO for the treatment with second acts of in cancer with expiring in 2039. In May, our partner average medicine launched nephicon in China and IMA issued a positive opinion for full approval of Kempago in Europe. We also participated in several important conferences where we present additional data, which ritual will cover a bit later in fall.
Speaker Change: Question 2 Question 3 Question 4 Question 5 Question 6 Question 7 Question 8 Question 9 Question 10 Question 11 Question 12 Question 13 Question 14 Question 15 Question 16
Renee Aguiar-Lukander: In the quarter, there was an offer announced by Sahikasai, so on May 28, Sahikasai announced a public cash offer for all shares in Caleditas for 208 Swedish crowns per share, valuing the company approximately 1.2 billion Swedish crowns. The tender is presently ongoing with the last day announced to be August 30, February 28, potential extensions, the offer is recommended by the board and around 45% of shareholders have entered into undertaking to accept the offer subject to customary conditions.
Renee Aguiar-Lukander: Next page. So with regards to commercial highlights of Q2, so from a commercial perspective, this quarter was a record quarter in terms of revenues with $46.3 million of net torpedo 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 Tapio with summer seasonality seemingly being less pronounced this year in comparison to last year.
Renee Aguiar-Lukander: The team is during the quarter and it's taken a very substantial number of P&T committee meetings and the vast majority of major plans have not updated their rules to align with a new label. We are expecting the full approval and this kind of reduced market access friction to continue to drive to our pay or revenue growth for the year. Operating profitability for the underlying business excluding those cross related to the offer by Asahi Kasai for the quarter came in at 70 million Swedish crowns enabling us to reach our target of achieving operating profitability in the quarter.
Renee Aguiar-Lukander: These excludes cost related to advisory services and provisions for incentive plans in connection with Asahi Kasai offer and mounting to approximately 102 million Swedish crowns taking us to an overall operating loss for the quarter of 31 and a half million Swedish crowns. 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. With regards to cash we were almost cash neutral for the court for the quarter with cash burden mounting through approximately $700,000 or $7 million crowns.
Speaker Change: Jon Enders, Al lebenskatten, Olivia Perrimont, Stafford Smith, Sophie Heaton, Jon Enders, Al lebenskatten, Sophie Heaton, Jon Enders, Al lebenskatten, Sophie Heaton,
Renee Aguiar-Lukander: We believe that will be continued to be profitable on an operating level for the remainder of the year excluding any deal related costs based on continued revenue growth from Tarpeo and the network on franchise as a whole.
Renee Aguiar-Lukander: Next page please. Following the quarter so in July we reported positive data from our face to be trial in PBC primary billionaire Colin Gytus. With both the 1216 hundred milligram doses achieving statistical significance in terms of the primary endpoint. This was a heavily pre-treated population making this outcome even more rewarding.
Renee Aguiar-Lukander: Richard will cover this in more details shortly. Also in July can pay it was granted full approval for the treatment of primary eye again in adults by the European Commission which also triggered a 10 million euro milestone payment which will be recognized in Q3.
Richard Philipson: With that I'd like to hand over to Richard who will take us through the PVP data discussed. Thanks very much. Renee, next slide please. And the next slide.
Richard Philipson: So I'd like to start by giving you a summary of the recently announced results of the 10th form study of set an active in primary billionaire Colin Gytus or PBC. As a reminder this was a phase 2 B study evaluating patients age 18 years and older with a confirmed diagnosis of PBC. A serial malculine 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.
Richard Philipson: In this double blind placebo controlled study patients were randomized to one of two doses of Cessnaxable placebo. Patients randomized to set an exit received either a 1200 milligram daily dose administered as 800 milligrams in the morning and 400 milligrams in the evening or a 1600 milligram daily dose administered as 800 milligrams twice.
Richard Philipson: Staley. Treatment was administered for 24 weeks and the primary endpoint was changed in alkaline phosphatase at week 24 compared to baseline.
Richard Philipson: Next slide. So we screened the 178 patients of whom 77 patients were randomised. The 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 Renee has already said, that this was a heavily pre-treated population of baseline. 43.4% of patients were receiving dual therapy, that is, UDCA plusical livery or UDCA plus a fibrate. In 13.2% of patients were receiving triple therapy of UDCA plusical livery plus a fibrate.
Richard Philipson: Next slide. With respect to the primary end point of change from baseline in the ratio of alkaline phosphatase at week 24, there was a statistically significant difference for both dose comparisons versus placebo. For the 1600 milligram dose group, there was a 19% difference compared to placebo. For the 1200 milligram dose group, there was 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.
Richard Philipson: Next slide. We also observed favorable improvements in liver stiffness at week 24 in patients treated with sesimaxid compared to placebo. 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 Change: [inaudible]
Richard Philipson: Next slide. In terms of safety, treatment emergent adverse events were balanced across the treatment groups overall. 76% of sesimaxid 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 sesimaxid and placebo treated patient groups with 12% of sesimaxid patients and 11.5% of placebo patients experiencing serious treatment emergent adverse events and events leading to study just treatment discontinuation occurred in 14% of sesimaxid patients and 7.7% of placebo patients.
Richard Philipson: When 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 pruritis actually occurred at a higher frequency in placebo treated patients. Aphralgia and fatigue both occurred at similar frequencies in the combined sesimaxid treatment group and placebo treated patients and nasopharyngeitis occurred as a higher frequency in the combined sesimaxid treatment group Pasebo.
Richard Philipson: So in conclusion, the primary endpoint for the study was met, statistically significant reductions in alkaline phosphatitease was observed in both Seth Maxxib arms versus Pasebo from weak ape onwards, and actually from weak forearm words when we looked at the two active doses combined. We saw favorable improvements in liver stiffness at 24 weeks in patient street of Seth Maxxib compared to Pasebo, and Seth Maxxib was generally well tolerated.
Richard Philipson: So I'd like to move on and provide a brief update on the company's activities at ERAEDTA this year. So next slide. So at ERAEDTA in May, which was held in Stockholm, Calliditas gave an oral presentation on the real-world challenges associated with the use of systemic glucocorticoids in a U.S. I.J. Nephropathy cohort, and we also presented a poster describing the outcomes of a matching adjusted indirect comparison of E.G.FR in patients with I.J.
Richard Philipson: Nephropathy treated from Nephicon also by Centan. And we also sponsored a symposium entitled Clinical Markers in I.J. Nephropathy is all protein-eury of the same, and this was chaired by Professor Jonathan Barrett. In the last opposed to presentation, we used patient-level data from our Neficart Phase 3 trial, and trial-level data from the Sparcentan Protect trial in I.J. Nephropathy to estimate the relative effect of Neficon with optimized RAS inhibition compared with Sparcentan on the absolute E.G.FR change from baseline at 9, 12, and 24 months, with common comparisons of optimized RAS inhibition for Neficart and Erbasartan for the Protect study.
Richard Philipson: The results from the anchored comparison show statistically significant favorable effects of Neficon with optimized RAS inhibition versus Sparcentan on E.G.FR for all time points analysed, 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 Sparcentan and provide support for Neficon as a disease-modifying therapy in I.J. Nephropathy.
Maria Tornsen: So I'd now like to hand over to my colleague, Maria Thompson. Thank 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 second quarter of 2024, we continue to see a very strong demand for tarpeo with 750 enrollment forms received by our patient services help tarpeo touch points. Another record quarter. During the second quarter, we also had 343 new prescribers and we now have over 2,300 healthcare providers who have prescribed tarpeo.
Maria Tornsen: We believe the strong demand we are seeing is the result of our full approval, our new label with the removal of the UPCR criteria and physicians recognising tarpeo as a disease-modifying agent that treats the disease at the source, reducing the pathogenic ideate. As mentioned, our total sales for tarpeo in Q2 was $46 million, another record quarter. Here today's next sales for tarpeo is $73 million.
Maria Tornsen: And as a result of the strong performance, we are raising our full year guidance to $165 to $185 million for the net income franchise. Next slide please. In the second quarter, we've launched our new promotional campaign highlighting the full approval and shining a light on tarpeo's EDFR data. As you know, tarpeo is the first and only FDA approved product to reduce the loss of kidney functions. As mentioned last quarter, we've been spending time educating US payers on the new label.
Maria Tornsen: And I'm pleased to report that we now have seen significant changes on key commercial plans. Over 80% of US lives covered by commercial plans now have policies aligned with our new label and removed UPCR completely or reduced to CERF on 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 and May.
Maria Tornsen: Next slide. We are very excited as the opportunity ahead of us. We've already seen the positive reaction to the full approval of tarpeo. We will continue to educate US healthcare professionals on tarpeo's position as a disease modifying cornerstone treatment of IGA. In October, we will participate in the ASN Congress, and we also look forward to the rollout of the Canadian guidelines in the fall. We expect the guidelines will include tarpeo and also broaden the definition of the at risk nation.
Maria Tornsen: And as mentioned earlier, we've seen a significant impact on payer policies in Q2, and we will continue to educate US payers to ensure more plans reflect the new tarpeo label and secure broad access for patients. Next slide.
Maria Tornsen: Finally, the eigen treatment paradigm is evolving and addressing the source of the disease is crucial. Tarpeo 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 healthcare providers view tarpeo as a disease modifying agent that treats the disease of the source reducing the pathogenic IGA. In market research, healthcare providers further state that the primary reasons they choose tarpeo are for its efficacy in reducing UPCR, significant EGFR data, favorable tolerability profiles, and because tarpeo is treating the underlying cause of IGA. And as you've seen from our strong results reported today, tarpeo is becoming a cornerstone treatment for IGA.
Fredrik Johansson: With that, I will hand it over to our CEO, Fredrick Johansson, to discuss our financial results. Fredrick? Thank you, Maria.
Fredrik Johansson: I will now present to you the financial overview for the second quarter and as always all numbers presented to you are a million sec unless otherwise stated. To start with, we report 558 million in net revenues for the quarter. For the same portal last year, we report the net revenues of 269.4 million. The pay on net product sales for the quarter amounted to 493.4 million or 46.3 million dollar which is a reported increase of 9% from the same quarter previous year.
Speaker Change: Niki Hulme, Richard Philipson, Andrew Udell, Fredrik Johansson, Renee Aguiar, Fredrik Johansson, Andrew Udell, Fredrik Johansson, Niki Hulme, Richard Philipson, Andrew Udell, Fredrik Johansson, Niki Hulme, Richard Philipson, Andrew Udell, Fredrik Johansson, Niki Hulme, Richard Philipson,
Fredrik Johansson: The remaining 6.4 million in revenues in the quarter are related to our partnerships, primarily from royalties from start and average and sheep and the products to average. For the same quarter last year, we have partnership revenues of 10.1 million or total operating expenses for the quarter amounted to 537.8 million compared to 330.3 for the same quarter last year. Included in the operating expenses for the quarter are expenses related to the site as I offer and expenses related to provisions for social security contributions for incentive programs due to the increase in our share price.
Speaker Change: [inaudible]
Fredrik Johansson: This totaling 100 and 1.7 million. This cost that is viewed over R&D sales and marketing and DNA. The cost for research and development increased by 31.7 million in a quarter to 120.7 million compared to 89 million for the same quarter previous year. Besides the previous mentioned provisions for incentive programs, the change in the period primarily relates to increased cost for net manufacturing scale up. The cost for sales and marketing increased by 61.5 million in a quarter to 253 million compared to 191.5 million for the same quarter previous year.
Speaker Change: Thank you for watching si repeat
Fredrik Johansson: Increase is primarily related to scale up of the sales and marketing of tapio in the US following the full approval and also the mentioned provisions for the incentive programs. The cost for DNA increased by 9.6 million in a quarter to 166.8 million compared to 77.2 million for the same quarter previous year. The increased cost for DNA primarily relates to the mentioned provisions for incentive programs and advice of fees related to the public offer from a high cafe.
Fredrik Johansson: We made an operating loss in the quarter of 31.5 million compared to an operating loss of 75.2 million for the same quarter last year. As mentioned by Rene, excluding expenses related to the SICASA offer and expenses related to provisions for social security contributions for the incentive programs due to increase in the share price. We report an adjusted operating profit of 70.2 million in the second quarter. The cash flow used in operating activities in the quarter was 7 million compared to 163 million for the same quarter previous year. This leaves us with a net decrease in cash in the second quarter of 11.2 million and we continue to have a health cash position of 7.3 million at the end of the quarter.
Fredrik Johansson: That was all for me. Thank you. Thank you very much.
Renee Aguiar-Lukander: So obviously as we reported Q2 was financially strong with positive progress of our pipeline. Some of the key takeaways, obviously we had a record quarter in terms of net product revenues from Tarpeo in terms of posting $46.3 million for the quarter as well as for the net income franchise achieving approximately $53 million for the quarter. We also achieved our target of operational profitability, excluding the advisory costs and incentive program provisions as stated.
Renee Aguiar-Lukander: We also was, our partner thought I was granted full approval of Compega in Europe by the European Commission, and also saw a new patent issued by the US PTO covering sets an accident in terms of treatment of cancer with expiry of 2039. As Fredrik has said, we are going to 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 tarpeo for all the reasons that Maria described. And as mentioned in terms of our revenue guidance for 2024, we're updating that, reflecting these growth expectations, and so the revenue guidance for 2024 is updated to be 165 to 185 million US dollars.
Speaker Change: [inaudible]
Renee Aguiar-Lukander: And with that, this concludes our Q2 2024 presentation. Thank you very much to all for listening in.
Unknown Executive: Welcome to the Caliditas Thera Putics Q2 2023 report. For the first part of the conference call, the participants will be in listen only mode. During the questions and answer session, participants are able to ask questions by dialing star 5 on their telephone keypad.
Unknown Executive: Now I will hand the conference over to the speaker CEO Renee Aguiar-Lukanda and CFO Fredrik Johansson. Please go ahead.
Speaker Change: [inaudible]
Unknown Executive: [inaudible] Thank you, thank you, thank you,[inaudible] thank you, thank you, thank you,[inaudible][inaudible] thank you, thank you, thank you, thank you,[inaudible][inaudible][inaudible] to talk to you about this. And I'm going to talk to you about this. Conference will automatically end in 10 minutes.
Speaker Change: I say to the world, don't punish the people who do it. Don't implement things such as poverty, preaching law. Foreign nations are controlling
Unknown Executive: Annabel Samimy, Ashiq Mubarack, Annabel Samimy, Ashiq Mubarack,[inaudible][inaudible]