Calliditas Therapeutics AB (CALT) 2023 Q4 法說會逐字稿

Thank you very much, and welcome to the Q4 2023 presentation.

非常感謝，歡迎來到 2023 年第四季的演示。

I'd like to draw your attention, first of all, to the disclaimer notice as usual, which covers forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended.

首先，我想提請您注意免責聲明，其中涵蓋了 1995 年《私人證券訴訟改革法案》修訂版含義內的前瞻性陳述。

And I refer you to public filings, including those containing risk factors.

我建議您參閱公開文件，包括那些包含風險因素的文件。

Next page, please.

請下一頁。

So with regards to Q4, and to start just with some highlights, so obviously the key event for this quarter was December 20, the FDA granted us full approval of TARPEYO based on the submission of the full Phase 3 data set, which we filed in June 2023.

因此，關於第四季度，首先從一些亮點開始，顯然本季的關鍵事件是12 月20 日，FDA 根據我們提交的完整3 期數據集授予了我們TARPEYO 的完全批准，該數據集是我們在2019年提交的。2023 年 6 月。

The Phase 3 trial showed a highly statistically significant outcome on the primary endpoint of eGFR with a p-value of less than 0.0001. Additional supportive data obviously is being presented on conferences and in other place in terms of slope analysis, three mils per minute per year in favor of TARPEYO versus placebo, a statistically significant impact on microhematuria and biomarkers such as IgA1.

3 期試驗顯示 eGFR 主要終點具有高度統計顯著性，p 值小於 0.0001。顯然，在會議和其他地方的斜率分析方面，正在提供額外的支持性數據，每年每分鐘3 密耳，有利於TARPEYO 與安慰劑相比，對微量血尿和IgA1 等生物標誌物具有統計上的顯著影響。

The new indication that we have received reflects reduction of loss of kidney function and is now also indicated for the entire IgAN population at risk of disease progression.

我們收到的新適應症反映了腎功能喪失的減少，現在也適用於處於疾病進展風險的整個 IgAN 族群。

Other things that occurred in the quarter was obviously, we also received conditional approval of Nefecon in China, which was granted in November.

本季發生的其他事情很明顯，我們還獲得了 Nefecon 在中國的有條件批准，該批准於 11 月獲得。

And this approval, we believe, provides access to a very large market opportunity as IgAN is not a rare disease in China, but actually fairly common with estimates of up to 5 million patients.

我們相信，這項批准提供了一個非常大的市場機會，因為 IgAN 在中國並不是一種罕見疾病，但實際上相當常見，估計患者人數高達 500 萬人。

And we're very excited about being able to for a partner for medicines to launch commercially at this year.

我們非常高興能夠在今年找到藥品商業化的合作夥伴。

In the quarter, there was also initiation of a Phase 2 trial in Alport syndrome, and this is being done with setanaxib.

本季度，也啟動了 Alport 症候群的 2 期試驗，該試驗是用 setanaxib 進行的。

This is the lead compound from our pipeline platform consisting of NOX inhibitors, a novel platform with setanaxib being the first ever candidate in clinical trials.

這是我們的 NOX 抑制劑組成的管道平台的先導化合物，這是一個新穎的平台，setanaxib 是臨床試驗中的第一個候選藥物。

So Alport syndrome is a rare kidney disease, and today, there are no approved medications.

因此，奧爾波特症候群是一種罕見的腎臟疾病，目前還沒有批准的藥物。

And so we're very excited about being able to hopefully repeat our success in the IgAN space of being the first company to hopefully bring an approved medication to those patients suffering from this rare disease.

因此，我們非常高興能夠在 IgAN 領域重複我們的成功，成為第一家為患有這種罕見疾病的患者提供核准藥物的公司。

Also in the quarter, the USPTO issued a Notice of Allowance for a new patent covering TARPEYO in the US and that provides a run rate until 2043.

同樣在本季度，美國專利商標局 (USPTO) 在美國發布了一項涵蓋 TARPEYO 的新專利授權通知，並提供了 2043 年之前的運作率。

And this was issued in December of last year.

這是去年12月發售的。

We also, towards the end of the year, we financed an existing credit line that we had with Athyrium Capital.

我們也在年底時為 Athyrium Capital 的現有信貸額度提供了資金。

And we added a small amount of additional capital to our balance sheet in terms of just under $20 million.

我們在資產負債表上增加了少量額外資本，金額略低於 2,000 萬美元。

And actually, this allowed us to continue to have a interest rate only -- interest payment only kind of period for another several years.

實際上，這使我們能夠在接下來的幾年裡繼續只採用利率——只支付利息。

So if we can turn the page, please.

所以，請讓我們翻過這一頁。

So talking a little bit more about the commercial highlights.

因此，請多談論商業亮點。

And this obviously on the commercial side, we saw a very strong quarter from TARPEYO, reflected by strong growth, both in terms of enrollments and new prescribers.

顯然在商業方面，我們看到 TARPEYO 的季度表現非常強勁，這反映在註冊人數和新處方者方面的強勁增長。

So actually, we saw a 51% increase in enrollments over Q3 and new prescribers also grew by over 50%.

事實上，我們看到註冊人數比第三季增加了 51%，新開處方者也增加了 50% 以上。

And we believe that this is reflecting of the growing familiarity with the Phase 3 data, especially the convincing eGFR data as well as good results and positive patient experiences from nephrologists using the product in real life.

我們相信，這反映了人們對 3 期數據的日益熟悉，尤其是令人信服的 eGFR 數據，以及腎臟科醫生在現實生活中使用該產品的良好結果和積極的患者體驗。

Q4 saw total revenues of $42.4 million or SEK452 million, out of which TARPEYO represented $32.6 million, which is at 22% growth over Q3 and more than 100% growth over Q4 2022.

第四季總營收為 4,240 萬美元，即 4.52 億瑞典克朗，其中 TARPEYO 營收為 3,260 萬美元，比第三季成長 22%，比 2022 年第四季成長超過 100%。

We also achieved positive cash flow from operations in Q4, and this was a target we had set for ourselves earlier in the year, and we are indeed very excited to have successfully achieved that in the year of 2023.

我們在第四季度也實現了營運現金流為正，這是我們今年稍早為自己設定的目標，我們確實非常高興能夠在 2023 年成功實現這一目標。

So looking forward a little bit into the first half of 2024, we do expect that there might be some initial disconnect between the new label language and the existing payer rules, which obviously are based on the old label.

因此，展望 2024 年上半年，我們確實預期新標籤語言和現有付款人規則之間可能會出現一些最初的脫節，而現有付款人規則顯然是基於舊標籤的。

As I'm sure you understand, this is a new labe, this would have to go through the same kind of process in a P&T committees as when we originally launched the product a couple of years ago.

我相信您明白，這是一個新標籤，必須在 P&T 委員會中經歷與我們幾年前最初推出產品時相同的流程。

And so until those P&T committees have taken place and the rules have been amended following the new label, that we are just seeing that they might take a longer period of time to actually convert enrollments into revenues as there might be some market access friction during that period of time.

因此，在這些 P&T 委員會成立並根據新標籤修改規則之前，我們只是看到他們可能需要更長的時間才能將註冊人數真正轉化為收入，因為在此期間可能會出現一些市場准入摩擦一段的時間。

In terms of the -- we're also, obviously, we're very excited about TARPEYO being selected as a potential blockbuster drug to watch by clarity.

顯然，我們也對 TARPEYO 被選為值得關注的潛在重磅藥物感到非常興奮。

And we believe that the disease modifying profile of TARPEYO will continue to drive significant demand from nephrologists and become a fundamental part of standard of care in IgAN.

我們相信，TARPEYO 的疾病緩解特性將繼續推動腎臟病專家的巨大需求，並成為 IgAN 護理標準的基本組成部分。

We're also looking forward to actually a potential full EMA approval of Kinpeygo in the first half of this year.

我們也期待今年上半年 Kinpeygo 可能會獲得 EMA 的全面批准。

And obviously, we know that our partner, STADA, is working on rolling out the product in across other kind of geographies in Europe as we speak.

顯然，我們知道我們的合作夥伴 STADA 正在努力在歐洲其他地區推出該產品。

And with regards to other ex US markets, where, as I've already mentioned, we are looking forward to our partner, Everest Medicines, rolling out their commercial launch, which they have targeted for Q2 of this year.

至於美國以外的其他市場，正如我已經提到的，我們期待我們的合作夥伴 Everest Medicines 推出其商業產品，他們的目標是今年第二季。

Next page, please.

請下一頁。

So some post-period events.

所以一些後期事件。

So as I already mentioned, we received a notice of allowance for any pain for TARPEYO.

正如我已經提到的，我們收到了一份關於 TARPEYO 任何疼痛的津貼通知。

This was subsequently issued and entered into the Orange Book in February of this year, and we believe that this significantly enhances product protection for TARPEYO beyond 2029.

隨後於今年 2 月發布並進入橙皮書，我們相信這將顯著增強 2029 年以後對 TARPEYO 的產品保護。

We also appointed Maria Törnsén as President, North America.

我們也任命 Maria Törnsén 為北美區總裁。

She brings very strong commercial rare disease experience to this position with a background from Shire, Sanofi, Genzyme and Sarepta.

她擁有 Shire、Sanofi、Genzyme 和 Sarepta 的背景，為該職位帶來了非常豐富的罕見疾病商業經驗。

We are very excited to welcoming her to the team and I'm sure that you will hear more from her over the year as she settles into the position.

我們非常高興地歡迎她加入團隊，我相信在她適應這個職位的這一年裡，您會聽到更多關於她的消息。

Next page, please.

請下一頁。

So obviously, we are covering Q4, but actually 2023 as a whole has really been an incredibly eventful and successful year, which saw so many pivotal events for the company.

顯然，我們正在報導第四季度，但實際上 2023 年作為一個整體確實是非常重要和成功的一年，公司發生了許多關鍵事件。

This obviously included the successful readout of NeflgArd Phase 3 clinical trial, the filing for approval with both FDA and EMA, the publication of the data in The Lancet, the interim readout of setanaxib data from head and neck cancer where we're hoping to readout that full dataset in the first half of this year, as I mentioned, obviously, the patents and the China conditional approval and ultimately, obviously, the full approval of TARPEYO by the FDA.

這顯然包括 NeflgArd 3 期臨床試驗的成功讀出、向 FDA 和 EMA 提交批准申請、在《柳葉刀》上發表數據、臨時讀出頭頸癌的 setanaxib 數據，我們希望讀出這些數據今年上半年的完整數據集，正如我所提到的，顯然，專利和中國有條件批准，以及最終TARPEYO 獲得FDA 的全面批准。

So we are extremely excited of what we have achieved this year, and we are looking forward to an equally exciting, if not more exciting 2024 when we will see -- we bring -- we started the year with a full approval in the IgAN population at risk of disease progression with a new indication reflecting the strong eGFR data.

因此，我們對今年所取得的成就感到非常興奮，我們期待 2024 年同樣令人興奮，甚至更令人興奮，屆時我們將看到——我們帶來——我們在新年伊始獲得 IgAN 人群的全面認可處於疾病進展風險的新適應症反映了強大的eGFR 數據。

So with that, I'm going to hand over to Richard Philipson, our CMO.

因此，我將把工作交給我們的首席行銷長理查德·菲利普森 (Richard Philipson)。

Thanks very much, Renée.

非常感謝，蕾妮。

So I'd like to take a moment just to look back to the end of last year.

所以我想花點時間回顧去年年底。

And we're delighted to have had a strong presence at the American Society of Nephrology Annual Meeting in Philadelphia in November 2023.

我們很高興能夠在 2023 年 11 月在費城舉行的美國腎臟病學會年會上強勢亮相。

We had a total of seven posters and an oral presentation.

我們總共有七張海報和一個口頭報告。

And additionally, a commercially sponsored product theater presented by Dr. Jim Tomlin.

此外，吉姆·湯姆林博士也舉辦了商業贊助的產品劇場。

And this together demonstrates our commitment to IgAN nephropathy and rare kidney diseases.

這共同體現了我們對 IgAN 腎病和罕見腎病的承諾。

So I'd now like to take a moment to highlight some of the data and analyses that were presented at ASN.

因此，我現在想花點時間重點介紹 ASN 上展示的一些數據和分析。

Next slide.

下一張投影片。

So firstly, Professor Richard Lafayette presents the analyses on NeflgArd Phase 3 trial, that's ASN.

首先，Richard Lafayette 教授介紹了 NeflgArd 3 期試驗的分析，即 ASN。

The focus of the presentation was the time to 30% reduction in eGFR or kidney failure, which was the secondary endpoints of the trial.

演示的重點是 eGFR 降低 30% 或腎衰竭的時間，這是該試驗的次要終點。

The time to this composite endpoint was significantly delayed with a 55% reduction in the risk of achieving this event in patients treated with Nefecon compared to placebo.

與安慰劑相比，接受 Nefecon 治療的患者達到此複合終點的時間顯著延遲，而實現此事件的風險降低了 55%。

It's particularly noteworthy that this outcome was consistent irrespective of baseline UPCR.

特別值得注意的是，無論 UPCR 基線如何，這一結果都是一致的。

Next slide.

下一張投影片。

Another presentation at ASN was a modeled analysis of clinical outcomes in patients in the NeflgArd trial compared with a matched registry cohort receiving supportive care only.

ASN 上的另一個演講是對 NeflgArd 試驗中患者的臨床結果與僅接受支持性護理的匹配註冊隊列進行比較的模型分析。

We used the NeflgArd two-year eGFR total slope outcome to calculate a hazard ratio for the clinical outcome of kidney failure, eGFR less than 15 mils per minute all sustained doubling a serum [craftness] using the income meta-analysis as reference.

我們使用 NeflgArd 兩年 eGFR 總斜率結果來計算腎衰竭臨床結果的風險比，eGFR 低於每分鐘 15 密耳，均持續使血清加倍[製程]，並使用收入薈萃分析作為參考。

This modeled analysis showed a predicted median delayed the clinical outcomes of 12.8 years when comparing Nefecon with placebo.

此模型分析顯示，將 Nefecon 與安慰劑進行比較時，預測的中位數臨床結果延遲了 12.8 年。

Furthermore, the model's analysis predicted that approximately 50% fewer patients would reach the clinical outcome within 10 years, again, when comparing Nefecon with placebo.

此外，該模型的分析預測，在將 Nefecon 與安慰劑進行比較時，10 年內達到臨床結果的患者數量將減少約 50%。

Next slide.

下一張投影片。

We also presented biomarker analyses confirming previous findings from the Phase 2b Nefecon trial.

我們也提供了生物標記分析，證實了 Nefecon 2b 期試驗的先前發現。

As you know, circulating immune complexes containing poorly (inaudible) IgA when deposited in the (inaudible) elicits an inflammatory response and drives the decline in kidney function seen in patients with IgA nephropathy.

如您所知，含有不良（聽不清楚）IgA 的循環免疫複合物沉積在（聽不清楚）中時會引發發炎反應，並導致 IgA 腎病患者的腎功能下降。

We have shown in samples taken from 160 patients in NeflgArd trial that Nefecon significantly reduced levels of circulating immune complexes throughout the treatment period compared to placebos, supporting the disease-modifying effect of the treatment.

我們在 NeflgArd 試驗中從 160 名患者採集的樣本中發現，與安慰劑相比，Nefecon 在整個治療期間顯著降低了循環免疫複合物的水平，支持了該治療的疾病緩解作用。

These biomarker observations are in line with what we saw clinically with respect to microhematuria by significantly fewer patients treated with Nefecon had microhematuria during observational follow-up compared to patients who had received placebo.

這些生物標記觀察結果與我們在微量血尿方面的臨床觀察結果一致，與接受安慰劑的患者相比，接受 Nefecon 治療的患者在觀察追蹤期間出現微量血尿的患者明顯較少。

So I'd now like to hand over to Maria, our President of North America.

現在我想將會議交給我們的北美總裁瑪麗亞。

Thank you very much, Richard.

非常感謝你，理查德。

Next slide, please.

請下一張投影片。

So as Renée mentioned earlier, our Q4 represented a very strong performance in terms of enrollment forms.

正如 Renée 之前提到的，我們的第四季在報名表方面表現非常強勁。

We had our best quarter since launch and saw a significant increase in number of new enrollments received by our patient services hub TARPEYO touch points.

我們經歷了自推出以來最好的季度，我們的患者服務中心 TARPEYO 接觸點收到的新註冊人數顯著增加。

During the quarter, we had 555 new enrollments, bringing the total for 2023 to over 1,700.

本季度，我們新增了 555 名註冊學生，使 2023 年的註冊總數超過 1,700 名。

During the quarter, we also had more than 300 new prescribers who made the decision to prescribe TARPEYO for the first time.

本季度，我們還有 300 多名新處方醫生首次決定開立 TARPEYO 處方。

Since launch, we now have over 1,600 health care providers who have prescribed TARPEYO.

自推出以來，我們現在已經有超過 1,600 名醫療保健提供者開出了 TARPEYO 處方。

As we have communicated in previous quarters, we have very good payer coverage and more than 90% of US lives are covered.

正如我們在前幾個季度所傳達的那樣，我們擁有非常好的付款人覆蓋範圍，超過 90% 的美國人的生活都得到了覆蓋。

And we are also reporting quarterly net sales of USD32.6 million.

我們也報告季度淨銷售額為 3260 萬美元。

Next slide, please.

請下一張投影片。

The fourth quarter contained some significant events for Calliditas.

第四季對卡利迪塔斯來說發生了一些重大事件。

As noted earlier, on December 20, we received full approval for TARPEYO from the FDA.

如前所述，12 月 20 日，我們獲得了 FDA 對 TARPEYO 的全面批准。

Our full approval label reflects the reduction of kidney loss in adults with IgAN at risk of disease progression.

我們的全面批准標籤反映了患有 IgAN 且有疾病進展風險的成人患者腎丟失的減少。

TARPEYO is the first and only product to receive this indication for the treatment of IgAN and our new label is based on the data that was published earlier in 2023 in the Lancet.

TARPEYO 是第一個也是唯一一個獲得 IgAN 治療適應症的產品，我們的新標籤是基於 2023 年早些時候在《柳葉刀》上發表的數據。

As a reminder, our Phase 3 trial met the primary eGFR endpoint and demonstrated highly statistical significance.

提醒一下，我們的 3 期試驗達到了主要 eGFR 終點，並表現出高度的統計顯著性。

Having a full approval label increases our addressable market and in order to meet the growing market opportunity, we also made the decision to expand our commercial and medical organizations in Q3.

擁有完整的核准標籤可以增加我們的潛在市場，為了滿足不斷成長的市場機會，我們也決定在第三季擴大我們的商業和醫療組織。

Today, we have over -- we have 70 rare disease account managers who are responsible for the sales of TARPEYO.

今天，我們有超過 70 位罕見疾病客戶經理負責 TARPEYO 的銷售。

And we have also expanded other field functions such as reimbursement managers and thought leader liaisons, bringing our total field-based organization to around 100 employees.

我們也擴展了其他現場職能，例如報銷經理和思想領袖聯絡人，使我們的現場組織總數達到約 100 名員工。

Already prior to the full approval, we had 90% payer coverage for TARPEYO.

在獲得全面批准之前，我們的 TARPEYO 付款人覆蓋率已達 90%。

And with the new label in hand, our expanded payer and reimbursement team are engaging with US payers to ensure policies are updated to reflect the new indication.

隨著新標籤的推出，我們擴大的付款人和報銷團隊正在與美國付款人合作，以確保更新政策以反映新的適應症。

Next slide, please.

請下一張投影片。

We are very excited about the opportunity ahead of us.

我們對擺在我們面前的機會感到非常興奮。

We have already seen the very positive reaction the Phase 3 data has had on nephrologists when introduced to the strong clinical results of TARPEYO.

當腎臟科醫師了解到 TARPEYO 的強大臨床結果時，我們已經看到了 3 期數據引起的非常積極的反應。

We now have an opportunity to promote our full approval label with an increased presence across sales, reimbursement, marketing, and medical affairs.

我們現在有機會推廣我們的全面批准標籤，增加銷售、報銷、行銷和醫療事務領域的影響力。

While we anticipate the strong data to result in more enrollments, we do expect it will take some time for payers to update their policies, so the impact of the new label will be fully realized in the second half of 2024.

雖然我們預計強勁的數據將帶來更多的註冊人數，但我們確實預計付款人需要一些時間來更新其政策，因此新標籤的影響將在 2024 年下半年充分體現。

We are also anticipating a seasonal impact to Q1 due to the open enrollment process, which is typical for this time of the year.

我們也預計，由於開放註冊流程（每年這個時候很常見）會對第一季產生季節性影響。

In 2024, we are also expecting an update to the KDIGO treatment practice guidelines.

2024 年，我們也期待 KDIGO 治療實務指引的更新。

These guidelines have the potential to broaden the definition of the at-risk population and also support the use of TARPEYO as the only fully approved drug with impact on eGFR.

這些指南有可能擴大高風險族群的定義，並支持使用 TARPEYO 作為唯一完全批准的對 eGFR 產生影響的藥物。

Today, we are already seeing that the majority of patients who reached nine-month treatment continue on TARPEYO.

今天，我們已經看到大多數接受九個月治療的患者繼續接受 TARPEYO 治療。

And in the first half of 2024, we're expecting new data from our open label expansion call.

在 2024 年上半年，我們預計會從我們的開放標籤擴展呼叫中獲得新資料。

The open label expansion dataset will provide us with additional clinical information on the potential benefit of a repeat course of nine months of treatment with TARPEYO.

開放標籤擴展資料集將為我們提供更多臨床信息，說明 TARPEYO 重複 9 個月療程的潛在益處。

And with that, I will hand it over to our CFO, Fredrik Johansson, for the financials.

接下來，我將把財務事宜交給我們的財務長弗雷德里克·約翰遜 (Fredrik Johansson)。

Thank you, Maria, and good afternoon and good morning, everyone.

謝謝瑪麗亞，大家下午好，早安。

I will now present to you the financial review for the fourth quarter of 2023.

我現在向大家介紹2023年第四季的財務回顧。

And as always, all numbers presented to you are in million SEK, unless otherwise stated.

像往常一樣，除非另有說明，否則向您提供的所有數字均以百萬瑞典克朗為單位。

To start with, we report SEK451.6 million in net revenues for the quarter.

首先，我們報告本季淨收入為 4.516 億瑞典克朗。

For the same quarter last year, we reported net revenues of SEK429 million

去年同一季度，我們報告的淨收入為 4.29 億瑞典克朗

Please note that in the correct comparison quarter last year, milestones of SEK257.9 million were included, predominantly from the out-license of Nefecon to doctors for Japan.

請注意，在去年的正確比較季度中，包括了 2.579 億瑞典克朗的里程碑，主要來自 Nefecon 向日本醫生的向外許可。

For 2023, we report SEK1,206.9 million in net revenues for the full year.

2023 年，我們報告全年淨收入為 12.069 億瑞典克朗。

For last year, we reported net revenues of SEK802.9 million.

去年，我們報告的淨收入為 8.029 億瑞典克朗。

TARPEYO on net product sales for the quarter amounted to SEK347.3 million or $32.6 million, which is a reported increase of 108% from the same quarter previous year and over 20% growth quarter over quarter.

TARPEYO 本季產品淨銷售額達 3.473 億瑞典克朗（3,260 萬美元），據報導比去年同期成長 108%，較上季成長超過 20%。

For the full year of '23, TARPEYO net product sales amounted to SEK1,075 million or $101.4 million, which is a reported increase of 189% from the full year of '22.

2023 年全年，TARPEYO 產品淨銷售額達到 10.75 億瑞典克朗或 1.014 億美元，報告道比 22 年全年成長 189%。

The remaining SEK104.3 million in revenues in the quarter are related to partnerships, primarily from milestone fees from Everest Medicines in connection with the China approval and also with contribution from royalties from STADA for Europe.

本季剩餘的 1.043 億瑞典克朗收入與合作夥伴關係有關，主要來自 Everest Medicines 與中國批准相關的里程碑費用，以及歐洲 STADA 的特許權使用費。

Our total operating expenses for the quarter amounted to SEK387.5 million compared to SEK388.7 million for the same quarter last year.

本季我們的總營運費用為 3.875 億瑞典克朗，去年同期為 3.887 億瑞典克朗。

For the full year of '23, our total operating expenses amounted to SEK1,519.5 million compared to SEK1,209.6 million for the full year of '22.

23 年全年，我們的總營運費用為 15.195 億瑞典克朗，而 22 年全年為 12.096 億瑞典克朗。

The cost for research and development increased by SEK4.4 million in the quarter to SEK106.7 million compared with SEK102.2 million for the same quarter previous year.

本季研發成本增加了 440 萬瑞典克朗，達到 1.067 億瑞典克朗，去年同期為 1.022 億瑞典克朗。

And we continue to primarily invest in our pipeline where we have three expected data readouts this year, including the readout in head and neck Phase 2 trial, which is expected in the first half of this year.

我們繼續主要投資於我們的管道，今年我們將有三個預期的數據讀數，包括預計今年上半年的頭頸二期試驗的讀數。

The cost for sales and marketing increased by SEK6.7 million in the quarter to SEK198.5 million compared to SEK191.9 million for the same quarter previous year.

本季銷售和行銷成本增加了 670 萬瑞典克朗，達到 1.985 億瑞典克朗，去年同期為 1.919 億瑞典克朗。

The increase is primarily related to sales and marketing of TARPEYO in the US where we, during the quarter, continued our preparations to be prepared for the TARPEYO full approval that we received in the end of the quarter.

這一成長主要與 TARPEYO 在美國的銷售和行銷有關，我們在本季繼續為本季末獲得 TARPEYO 的全面批准做好準備。

We are very pleased that we made an operating profit in the quarter of SEK41.8 million compared to SEK32.5 million for the same quarter last year.

我們很高興本季實現營業利潤 4,180 萬瑞典克朗，去年同期為 3,250 萬瑞典克朗。

We are also very pleased that we were cash flow positive from operating activities in the quarter, where cash from operating activities was SEK22.8 million compared to SEK230 million for the same quarter previous year.

我們也非常高興的是，本季經營活動產生的現金流量為正，其中經營活動產生的現金為 2,280 萬瑞典克朗，去年同期為 2.3 億瑞典克朗。

In the fourth quarter, we refinanced our credit facility with a EUR92 million loan from material capital to extend the interest-only period to the end of 2026, we paid back the EUR68 million Kreos loan whilst the new credit was agreed and the cash flow from financing activities in the quarter was SEK208.5 million and already originates from the net of the loan activities.

第四季度，我們用物質資本提供的9,200 萬歐元貸款為我們的信貸融資進行了再融資，將只付利息期限延長至2026 年底，我們償還了6,800 萬歐元的Kreos 貸款，同時新的信貸已達成一致，現金流來自本季的融資活動為 2.085 億瑞典克朗，已來自貸款活動淨額。

This leaves us with a net increase in cash in the quarter of SEK229 million.

這使得我們本季的現金淨增加 2.29 億瑞典克朗。

And we continue to have a healthy cash position of SEK973.7 million were approximately $93.6 million at the end of the quarter.

截至本季末，我們仍擁有 9.737 億瑞典克朗的健康現金狀況，約 9,360 萬美元。

In our year-end report today, we also provide an outlook for total net sales for this year.

在今天的年終報告中，我們也提供了今年總淨銷售額的展望。

We expect continued revenue growth this year, and we estimate our total net sales for 2024 to be between $150 million and $180 million.

我們預計今年營收將持續成長，預計 2024 年淨銷售額總額將在 1.5 億美元至 1.8 億美元之間。

As the commercial revenue over time, we'll incorporate growing sales from both Europe and China.

隨著時間的推移，商業收入將包括歐洲和中國不斷增長的銷售額。

We will provide an outlook on this basis going forward.

我們將在此基礎上提供未來的展望。

TARPEYO revenues will obviously make up the vast majority of the sales also this year.

TARPEYO 的收入顯然也將佔今年銷售額的絕大多數。

And we do not expect potential milestone revenues from our partners to be material in comparison to product sales.

與產品銷售相比，我們預期合作夥伴的潛在里程碑收入不會很大。

That was all from me.

這都是我說的。

And now back to you, Renée.

現在回到你身上，蕾妮。

Thank you very much.

非常感謝。

Next page, here we go.

下一頁，我們開始吧。

So some key takeaways for the quarter.

本季度的一些關鍵要點。

So obviously, the full approval of TARPEYO in the US, reflecting a new label incorporating eGFR and with a much broader patient population was obviously the key event for this quarter.

顯然，TARPEYO 在美國獲得全面批准，反映出納入 eGFR 的新標籤以及更廣泛的患者群體，顯然是本季的關鍵事件。

Data supporting this disease modification profile, the local mode of action, a long-term patient benefits of treatment with TARPEYO was, as you heard, shared in a recent nephrology conference.

正如您所聽到的，支持這種疾病改變概況、局部作用模式、TARPEYO 治療的長期患者益處的數據在最近的腎臟科會議上分享了。

Q4 net TARPEYO revenues of SEK347 million, equivalent to $32.6 million and total net product revenues in excess of $100 million for the year.

第四季 TARPEYO 淨收入為 3.47 億瑞典克朗，相當於 3,260 萬美元，全年產品淨收入總額超過 1 億美元。

And we also saw record enrollment numbers in the quarter, increasing quarter over quarter by more than 50%.

我們也看到本季的入學人數創歷史新高，較上季成長超過 50%。

Fredrik mentioned the positive cash flow from operations and the strong cash position of $94 million.

Fredrik 提到了來自營運的正現金流和 9,400 萬美元的強勁現金狀況。

And obviously, we've seen the positive momentum from the nephrology market focused on eGFR data, increased awareness of longitudinal data related to progression of IgAN patients and positive patient experiences, including the ability, obviously, for patients to have intermittent treatments rather than being forced into chronic medication.

顯然，我們已經看到腎病學市場的積極勢頭，重點關注 eGFR 數據、對與 IgAN 患者進展相關的縱向數據的認識提高以及積極的患者體驗，包括患者接受間歇性治療而不是長期接受治療的能力。被迫長期服藥。

And we believe that this will be -- this disease -- profile TARPEYO will continue to drive significant demand from nephrologists and become the cornerstone of standard of care in IgAN.

我們相信，這種疾病的概況 TARPEYO 將繼續推動腎臟病專家的巨大需求，並成為 IgAN 護理標準的基石。

The total revenue guidance for 2024 and reflecting strong growth expectations of the range of $150 million to $180 million really concludes the events of this quarter and obviously, looking into -- to this year, 2024.

2024 年的總營收指引反映了 1.5 億至 1.8 億美元的強勁成長預期，這確實是本季事件的總結，顯然也是對今年 2024 年的展望。

So I want to just close out this Q4 presentation saying that we are super excited about what 2024 brings as being the category leader in a growing market with a patient-centric message.

因此，我想在第四季度的演講結束時說，我們對 2024 年將成為不斷增長的市場中的類別領導者感到非常興奮，並傳達以患者為中心的信息。

And we believe that the new label will certainly continue to drive demand and clear patient benefits.

我們相信，新標籤肯定會繼續推動需求並為患者帶來明顯的好處。

And so with that, I'd like to open up questions.

因此，我想提出一些問題。

(Operator Instructions)

（操作員說明）

Maury Raycroft, Jefferies.

莫里‧雷克羅夫特，傑弗里斯。

Hi, good morning.

早安.

Thanks for taking my question and congrats on the progress.

感謝您提出我的問題並祝賀我的進展。

I was wondering if you can talk about assumptions and key drivers behind your revenue guidance of $150 million to $180 million for the year and how the 555 patient start forms in Q4?

我想知道您是否可以談談您今年 1.5 億至 1.8 億美元收入指引背後的假設和關鍵驅動因素，以及 555 名患者如何在第四季度開始形成？

And what you are seeing so far in the first quarter, how those numbers are factoring into your 2024 guidance?

到目前為止，您在第一季看到了什麼，這些數字如何納入您的 2024 年指引？

Sure.

當然。

So in terms of what we've done is we've kind of triangulated a couple of different ways to look at this.

因此，就我們所做的而言，我們已經透過幾種不同的方式來看待這個問題。

Obviously, in terms of what we're expecting to see is basically kind of a little bit of a year of two halves, right?

顯然，就我們期望看到的情況而言，基本上是一年分為兩半，對嗎？

So we are not -- we're not sure of how really kind of how quickly we can get through the kind of P&T committees of the payers and how quickly they will change the rules to really kind of comply with the -- to be aligned with the new label.

因此，我們不確定我們能夠以多快的速度通過付款人的 P&T 委員會，以及他們將多快地改變規則以真正遵守 - 保持一致與新標籤。

So obviously, what we are expecting is that we might see some of that market access friction where actually physicians are writing prescriptions as per the label, but obviously, where payers are still applying the rules of the old label.

顯然，我們期望的是，我們可能會看到一些市場准入摩擦，實際上醫生是按照標籤開處方的，但顯然，付款人仍在應用舊標籤的規則。

So that is something where I think that we are expecting to see strong growth in enrollments.

因此，我認為我們預計入學人數將強勁增長。

But we are expecting that that might take a longer period of time to actually convert those enrollments into revenues.

但我們預計可能需要更長的時間才能將這些註冊人數真正轉化為收入。

And this is something that is just a little bit of an unknown to us.

這對我們來說有點未知。

I think the second half, we are expecting the second half to be strong.

我認為下半場我們預計下半場會很強勁。

I think that -- and where these some of those market access switches should be resolved.

我認為——以及其中一些市場准入轉換應該在哪裡解決。

I think that in terms of another item that is a bit unknown for this year is obviously when the KDIGO guidelines are going to be available.

我認為今年另一個有點未知的項目顯然是 KDIGO 指南何時發布。

So our assumption really here has been that there's been quite a lot of delays, it's unclear when they will actually be coming out.

因此，我們的假設是存在相當多的延遲，目前還不清楚它們何時會真正發布。

And so our assumption really is that the KDIGO guidelines will not actually kind of come out until probably the second half of this year and maybe even in a fairly late in the year.

因此，我們的假設是，KDIGO 指南實際上可能要到今年下半年甚至今年相當晚的時候才會發布。

So on that basis, we've also assumed that we're not going to really see any benefit necessarily from the new KDIGO guidelines coming out this year.

因此，在此基礎上，我們也假設今年發布的新 KDIGO 指南不會真正帶來任何好處。

In terms of the -- the other thing that we've looked at is just really also looking at other launches and consensus expectations for other products in terms of the renal space.

就腎臟領域而言，我們關注的另一件事實際上也在關注其他產品的發布和對其他產品的共識期望。

And so we think that this kind of guidance and particularly considering that, obviously, those other renal launches also involve chronic treatment that this type of kind of span that we're in is very consistent with where those other launches either have taken place or where expectations are with regards to consensus for some of those other treatments this year.

因此，我們認為這種指導，特別是考慮到，顯然，那些其他腎臟發射也涉及長期治療，我們所處的這種類型的跨度與其他發射發生的地點或地點非常一致人們期望今年就其他一些治療方法達成共識。

So this is really kind of where we've taken our -- yes, the input for some of this guidance.

因此，這確實是我們為某些指南提供的意見。

And so I think that we really want to make sure that we're on a very stable footing as to any kind of guidance that we're providing with regards to the franchise this year.

因此，我認為我們確實希望確保我們今年提供的有關特許經營權的任何指導都處於非常穩定的基礎上。

Got it.

知道了。

And is there anything more you're saying about first quarter so far?

到目前為止，您對第一季還有什麼要說的嗎？

Is it as expected?

是不是如預想的呢？

Or I guess any more color you can provide on that?

或者我想你還能提供更多的顏色嗎？

So I think what we're seeing is and we're expecting this is we are going to have that kind of first quarter seasonality in terms, but I would not expect kind of the Q1 to be particularly strong because of that, because of that impact that we saw last year.

因此，我認為我們所看到的是，我們預計第一季將會出現這種季節性，但我不認為第一季會因此而特別強勁。我們去年看到的影響。

And I think we're seeing it so far this year as well.

我認為今年到目前為止我們也看到了這一點。

I think enrollments continue to be very encouraging.

我認為入學人數仍非常令人鼓舞。

And so again, I think we're seeing a lot of demand, and I think it's more of that structural issues with the US payer system, et cetera, and changing of insurance plans, et cetera.

再說一次，我認為我們看到了很多需求，而且我認為這更多的是美國支付系統等的結構性問題，以及保險計劃的變化等。

That seems to be impacting some of that conversion.

這似乎影響了部分轉換。

But that's probably what I can say so far about the quarter.

但這可能就是到目前為止我對本季所能說的。

Okay.

好的。

And maybe one other question for me and then I'll hop back in the queue.

也許還有一個問題要問我，然後我會跳回隊列。

For the P&T committees, to get the updated label through that process, is there anything you're doing to expedite the process?

對於 P&T 委員會來說，為了透過這個流程獲得更新的標籤，你們正在採取哪些措施來加快這項流程？

And how do you assess progress along the way?

您如何評估一路走來的進展？

So yes, I mean, we, obviously, we started already to tried to communicate with a lot of the P&T committees just based on the publication in the Lancet.

所以，是的，我的意思是，我們顯然已經開始嘗試根據《柳葉刀》上的出版物與許多 P&T 委員會進行溝通。

But in reality, obviously, no one is really going to schedule any kind of P&T committees until they know what the label looks like and that there is truly a new label to discuss.

但實際上，顯然，在知道廠牌是什麼樣子並且真正有一個新廠牌可供討論之前，沒有人會真正安排任何類型的 P&T 委員會。

So obviously, there has been quite a lot of interactions prior to this to try to prepare for those meetings.

顯然，在此之前已經進行了大量的互動，試圖為這些會議做準備。

But none of these plans really have to kind of take meetings or do anything or plan anything until you actually have a final label in hand.

但這些計劃都不需要召開會議或做任何事情或計劃任何事情，直到您真正掌握最終標籤為止。

So obviously, we have, as Maria mentioned, we've added some resources in this area, and it's obviously something that we are considering to be a kind of a high importance for the organization, obviously, these first six months.

顯然，正如瑪麗亞所提到的，我們在這個領域增加了一些資源，顯然，我們認為這對組織來說是非常重要的，顯然，在前六個月。

Got it.

知道了。

Okay.

好的。

Thanks for taking my questions.

感謝您回答我的問題。

I'll hop back in the queue.

我會跳回到隊列中。

Vamil Divan, Guggenheim Securities.

瓦米爾·迪萬，古根漢證券公司。

Great.

偉大的。

Thank you so much for taking my questions.

非常感謝您回答我的問題。

So like I have two.

就像我有兩個一樣。

Just about the broader IgAN market and I'm wondering if you have any sort of updated thoughts, you obviously mentioned all the excitement at ASN.

關於更廣泛的 IgAN 市場，我想知道您是否有任何更新的想法，您顯然提到了 ASN 上的所有興奮。

And I think just broadly speaking about more patients getting diagnosed and treated for IgAN now.

我認為，從廣義上講，現在有更多的患者被診斷並接受 IgAN 治療。

So I'm curious if you have any sort of updated views on sort of the potential market size especially in the US or you want to speak globally for IgAN?

因此，我很好奇您對潛在市場規模（尤其是美國）是否有任何最新看法，或者您想為 IgAN 在全球範圍內發言？

And then second, there's obviously noise from the emerging competition, sort of mid- to late-stage pipeline, specifically from the April Bath inhibitors.

其次，明顯存在來自新興競爭的噪音，某種中後期管道，特別是來自 April Bath 抑制劑。

So I'm curious sort of if those are make it to the market over the next two to three years, how you see those sort of impacting TARPEYO's placement treatment paradigm, if at all?

所以我很好奇，如果這些產品在未來兩到三年內進入市場，您如何看待這些影響 TARPEYO 的安置治療模式（如果有的話）？

Thank you.

謝謝。

Yes, sure.

是的，當然。

So I think we are consistently just -- a little bit of a kind of a repeated message really, I guess, from our perspective.

所以我認為，從我們的角度來看，我想，我們一直只是——確實有點重複的訊息。

But I think what we've seen consistently is that this obviously is not an acute disease, right?

但我認為我們一直看到的是，這顯然不是一種急性疾病，對吧？

It is a progressive disease and it does develop over a reasonably kind of a long period of time, doesn't have any kind of immediate mortality risks.

它是一種進行性疾病，確實會在相當長的一段時間內發展，不存在任何直接的死亡風險。

So I think on that basis, I think a large part of that kind of IgAN population has probably not been treated particularly aggressively or potentially not at all apart from really with ACEs and ARBs and other blood pressure related medications.

因此，我認為在此基礎上，我認為除了 ACE 和 ARB 以及其他與血壓相關的藥物外，這類 IgAN 人群中的很大一部分可能沒有接受過特別積極的治療，或者可能根本沒有接受過治療。

So I do think that the longitudinal data as well as some of the clinical trial data showing placebo group deterioration, all the patients that actually have, that are on kind of blood pressure related medication or have already had reductions in proteinuria, which clearly do not seem to translate into kind of eGFR stabilization, I think that that data is continuing to kind of make its way through the nephrology community.

因此，我確實認為，縱向數據以及一些臨床試驗數據顯示安慰劑組病情惡化，所有實際服用血壓相關藥物或蛋白尿已經減少的患者，這顯然並沒有減少。似乎轉化為eGFR 穩定，我認為該數據正在繼續在腎臟病學界傳播。

And I think there is a really kind of active dialogue in terms of how should this kind of potentially impact the treatment paradigm.

我認為，就這種可能如何影響治療範式而言，確實存在著一種正面的對話。

So I think that we are seeing a growing part of that market.

所以我認為我們看到這個市場的份額正在不斷增長。

But again, I think this will probably be a market that will develop and grow -- continue to grow reach over time as some of these kind of -- as more data really kind of makes its way into kind of peer review journals.

但我再次認為，隨著更多數據真正進入同行評審期刊，這可能是一個會發展和成長的市場——隨著時間的推移，其中一些市場的影響力將繼續擴大。

And as I think nephrologists ultimately use some of these available medications and see actually what impact do these medications really have in real life.

我認為腎臟科醫生最終會使用其中一些可用的藥物，並看看這些藥物在現實生活中真正產生什麼影響。

So I think that it is a growing kind of market opportunity for sure.

所以我認為這肯定是一個不斷增長的市場機會。

But I think we still have a little bit of time until that's reached its peak, kind of potential.

但我認為我們還有一點時間才能達到其潛力的頂峰。

In terms of the pipeline, so I guess it's always a little bit difficult to kind of make a lot of statements really on a small population in Phase 2b.

就管道而言，我想在第 2b 階段針對少數群體做出大量聲明總是有點困難。

But I think that, obviously from a kind of mechanistic perspective, assuming that everything lines up and actually some of these results are reproducible.

但我認為，顯然從某種機械的角度來看，假設一切都一致，並且實際上其中一些結果是可重現的。

And also obviously, safety data is critical for this.

顯然，安全資料對此至關重要。

I think that without really having that kind of whole picture of understanding what the product profile really looks like and therefore, not really understanding which patient population might be appropriate for that treatment.

我認為，如果沒有真正了解產品概況的整體情況，因此就沒有真正了解哪些患者群體可能適合該治療。

It's quite a difficult question to answer.

這是一個很難回答的問題。

But obviously, as part of your first question, it's also very difficult to know as these kind of treatments that are already available today, continue to penetrate the population.

但顯然，作為你的第一個問題的一部分，也很難知道這些目前已經可用的治療方法是否會繼續滲透到人群中。

It's also very difficult to know actually what is actually the unmet medical need going to be in this patient population in 2027.

實際上也很難知道 2027 年該患者族群中未滿足的醫療需求到底是什麼。

But I think from a mechanistic perspective, I'm going to hand over to Richard to give his view from that perspective.

但我認為從機械的角度來看，我將交給理查從這個角度給出他的觀點。

Sure.

當然。

Thanks, Renée.

謝謝，蕾妮。

So I think -- it's some interesting question, but with Nefecon TARPEYO as we've spoken about many times, the treatment has been designed to target the past patches in the distal [ilium], and it's a B-cell modulator in that region.

所以我認為——這是一個有趣的問題，但是正如我們多次談到的那樣，Nefecon TARPEYO 的治療旨在針對遠端 [髂骨] 中過去的斑塊，它是該區域的 B 細胞調節劑。

And it has low systemic bioavailability, around 90% of Nefecon is removed by the liver on first pass metabolism.

且其全身性生物利用度較低，約90%的Nefecon在首過代謝中被肝臟清除。

When we look at these other treatments, you mentioned the April Bliss mechanism.

當我們研究這些其他治療方法時，您提到了四月極樂機制。

I mean, these are systemic treatments which are acting on a difference hit, if you like, within the pathogenesis of IgA nephropathy.

我的意思是，如果您願意的話，這些是全身性治療，可以在 IgA 腎病的發病機制中發揮作用。

So taking those kinds of considerations into account and also noticing what Renée has already said about that we need to understand more about these treatments, they need to build up a greater understanding of the safety, et cetera.

因此，考慮到這些因素，並注意蕾妮已經說過的，我們需要更多地了解這些治療方法，他們需要對安全性等有更深入的了解。

But all of those things being equal, there isn't a fundamental reason why these treatments couldn't be given together given that they are acting different places at different levels within the pathogenesis of the disease.

但在所有這些條件相同的情況下，考慮到這些治療方法在疾病發病機制的不同層面上發揮不同的作用，因此沒有根本原因不能同時給予這些治療方法。

Okay.

好的。

Thank you very much for your insights.

非常感謝您的見解。

Yigal Nochomovitz, Citi.

伊格爾·諾霍莫維茨，花旗銀行。

I think this is Carly on for Yigal.

我認為這是伊格爾的卡莉。

Thanks so much for taking our questions.

非常感謝您回答我們的問題。

Maybe just a follow-up on some of your prior comments.

也許只是您之前的一些評論的後續行動。

Curious if you can talk a little bit more about the characteristics of patients being prescribed TARPEYO with respect to baseline proteinuria.

很好奇您能否多談談接受 TARPEYO 治療的患者在基線蛋白尿方面的特徵。

I know you mentioned the market access piece that you're working through, but curious if you're seeing any shift towards increasing intent to prescribe to patients with lower baseline proteinuria with the updated label?

我知道您提到了您正在研究的市場准入部分，但很好奇您是否發現有任何轉變，越來越傾向於使用更新後的標籤向基線蛋白尿較低的患者開處方？

Sure.

當然。

So I think in terms of what we've seen to date, I would say that obviously because of the label that we had up until December, clearly the language in the label said, generally, 1.5. So clearly doesn't -- it wasn't a cutoff.

所以我認為，就我們迄今為止所看到的情況而言，我想說，這顯然是因為我們直到 12 月才擁有的標籤，標籤中的語言顯然通常是 1.5。顯然不是——這不是一個截止點。

And so clearly, we had prescribers and successfully also kind of obviously getting to patients below 1.5. But because of label, obviously, the overall -- there has clearly been a shift to the more kind of advanced patient population, more serious patient populations.

很明顯，我們有處方者，也成功地為低於 1.5 的患者提供治療。但顯然，由於標籤的原因，總體而言，顯然已經轉向更高級的患者群體、更嚴重的患者群體。

I don't have a specific kind of breakdown of how that kind of works.

我沒有具體說明這種方式是如何運作的。

But I do know that obviously, it's a -- overall, it has been had that impact of having the shift.

但我確實知道，顯然，總的來說，這種轉變已經產生了影響。

The label, obviously, just became available in December.

顯然，該標籤於 12 月才上市。

And so actually, we have internally -- obviously produced material, trained our sales force, et cetera.

事實上，我們顯然在內部製作了材料，培訓了我們的銷售人員等等。

So we're really just kind of have rolled that out fairly recently into the market.

所以我們實際上只是最近才將其推向市場。

So it's a bit early to kind of know to what extent, if at all, there has been any real impact from the label at this point in time.

因此，現在要知道該品牌在多大程度上（如果有的話）有任何真正的影響還為時過早。

Okay.

好的。

Got it.

知道了。

That's helpful.

這很有幫助。

And then we wanted to ask about the Phase 2 data coming up for setanaxib in head and neck cancer.

然後我們想詢問 setanaxib 在頭頸癌的 2 期數據。

Just curious to know a little bit more about what you're looking to see in that dataset and what you think would be an attractive profile for potential partners for that program?

只是想更多地了解您希望在該數據集中看到的內容以及您認為對該計劃的潛在合作夥伴有吸引力的個人資料是什麼？

Thank you.

謝謝。

So I'm going to hand over to Richard to just describe a little bit about what we what the data readout is going to contain.

因此，我將讓理查德來描述一下資料讀出將包含的內容。

And then I'll give you a sense of what I think might be helpful.

然後我會給你一些我認為可能有幫助的感覺。

So just as a reminder, this is a double-blind, randomized controlled trial where we're doing setanaxib or placebo on top of pembrolizumab in patients with sort of recurrent or metastatic head and neck cancer.

提醒一下，這是一項雙盲、隨機對照試驗，我們在帕博利珠單抗的基礎上對患有某種復發或轉移性頭頸癌的患者進行塞塔那昔布或安慰劑治療。

And we expect to have the results, as Renée said, a little later in this half.

正如蕾妮所說，我們預計會在下半年晚些時候得到結果。

And the primary endpoint in that study is change in tumor size.

研究的主要終點是腫瘤大小的變化。

And we think this is a most important endpoint in this study that this stage of development, it's a little bit more sensitive than just looking at response rates, for example.

我們認為這是本研究中最重要的終點，例如，在這個發展階段，它比僅僅查看回應率更敏感。

Although we will also be looking at response rates, we will have data on progression-free survival and we also hope to have transcriptomic data available at the same time as well.

儘管我們也會關注緩解率，但我們將獲得無惡化存活期的數據，我們也希望同時獲得轉錄組數據。

So that will give us a very comprehensive view of the impacts -- of the clinical impacts of the treatment and also the impact of the treatment at a tumor biology level.

因此，這將使我們對治療的臨床影響以及治療在腫瘤生物學層面的影響有一個非常全面的了解。

And clearly, what we want to see, a significant reduction in tumor size in patients who are receiving setanaxib on top of pembrolizumab as patients who are receiving placebo on top of pembrolizumab.

顯然，我們希望看到的是，在帕博利珠單抗基礎上接受塞塔那昔治療的患者，與在帕博利珠單抗基礎上接受安慰劑的患者相比，腫瘤大小顯著減少。

But -- we're going to -- it's not -- we think it's a well-designed trial.

但是 - 我們將 - 它不是 - 我們認為這是一個精心設計的試驗。

There's an appropriate number of patients in the study.

研究中有適當數量的患者。

I think we need to take also -- I've talked about the primary endpoint, but we really need to take all of the endpoints to account and look at the impact of the treatment on the tumor biology as well when we're understanding the benefits of the treatment.

我認為我們還需要考慮——我已經討論過主要終點，但當我們了解治療方法時，我們確實需要考慮所有終點並研究治療對腫瘤生物學的影響。治療的好處。

Yes.

是的。

And I would just add to that, obviously, this patient population has a very poor outlook.

我想補充一點，顯然，這些患者群體的前景非常糟糕。

I mean, these are kind of relapse metastatic kind of patients with head and neck cancer.

我的意思是，這些是復發轉移性頭頸癌患者。

And first-line treatment, really pembrolizumab has a very, very limited response rate of 15% to 20%.

作為一線治療，帕博利珠單抗的緩解率非常非常有限，只有 15% 到 20%。

So in terms of talking to KOLs and getting some input from them, obviously, even kind of an increase of up to the kind of high 20s would certainly be considered clinically very relevant.

因此，在與 KOL 交談並從他們那裡獲得一些意見方面，顯然，即使是增加到 20 多歲，也肯定會被認為在臨床上非常相關。

So I think that the -- so I think both, as Richard mentioned as well as kind of progression free survival, I think that would kind of be the taken together is really I think what people would be looking for in terms of this being kind of a highly successful study.

所以我認為，所以我認為，正如理查德所提到的，以及無進展生存，我認為這實際上是我認為人們會在這種善良方面尋求的東西一項非常成功的研究。

Okay, great.

好的，太好了。

Thanks very much.

非常感謝。

Rami Katkhuda, LifeSci Capital.

Rami Katkhuda，生命科學資本。

Hey, guys, congrats on the updates and thanks for taking my questions as well.

嘿，夥計們，恭喜更新，也感謝您回答我的問題。

Two quick ones from me.

我的兩個快的。

First, the language on the label for Kinpeygo is a bit more strict than what we saw with the accelerated approval of the asset in the States.

首先，Kinpeygo 標籤上的語言比我們在美國加速批准該資產時看到的語言要嚴格一些。

I guess, do you expect there to be a difference in label language for a full approval as well?

我想，您是否希望獲得完全批准時標籤語言也會有所不同？

So you're absolutely correct.

所以你是完全正確的。

And I think it's always difficult to know how the regulators are going to kind of actually assess the same data.

我認為總是很難知道監管機構將如何實際評估相同的數據。

They don't always see eye to eye, they don't always agree.

他們並不總是意見一致，也不總是意見一致。

But certainly, our our hope would clearly be that the label in Kinpeygo is very much -- very similar to, if not the same, as the label in the US.

但當然，我們顯然希望 Kinpeygo 的標籤與美國的標籤非常相似，甚至非常相似。

Got it.

知道了。

Got it.

知道了。

And then I guess, if the open-label extension data is positive as well, is there potential for the recommended duration of therapy language to kind of be removed from the TARPEYO label?

然後我想，如果開放標籤擴展資料也是正面的，那麼建議的治療持續時間語言是否有可能從 TARPEYO 標籤中刪除？

So I think that obviously is something that we have been discussing and I think we'll continue to discuss, I mean, when we know when the right time is to maybe kind of go and have some interactions with the regulators, both based on kind of real-world data that we are observing as well as some of the data from our clinical trials and potential data in other kind of Phase 4 studies.

因此，我認為這顯然是我們一直在討論的事情，我認為我們將繼續討論，我的意思是，當我們知道什麼時候是合適的時機時，可能會與監管機構進行一些互動，兩者都基於類型我們正在觀察的真實世界數據以及我們的臨床試驗的一些數據和其他類型的 4 期研究的潛在數據。

So there is certainly something that we are keeping in mind as to when we have the appropriate amount of data or the type of data we think is relevant, we certainly intend to go and have additional interactions with the regulator.

因此，我們肯定會牢記當我們擁有適當數量的數據或我們認為相關的數據類型時，我們當然打算與監管機構進行額外的互動。

Got it.

知道了。

I guess do you guys know what percentage of patients currently are on treatment for less than or greater than nine months?

我想你們知道目前接受治療少於或超過九個月的患者的百分比是多少嗎？

No.

不。

You mean, line in -- like, overall?

你的意思是，整體來說，排隊？

No, I don't actually.

不，我實際上不是。

No.

不。

Okay.

好的。

No worries.

不用擔心。

Thank you again.

再次感謝你。

Thank you.

謝謝。

Annabel Samimy, Stifel.

安娜貝爾·薩米米，斯蒂菲爾。

Hi, thanks for taking my question.

您好，感謝您提出我的問題。

I had a couple here.

我這裡有一對。

In terms of enrollments you saw, a nice pickup.

就您所看到的註冊人數而言，這是一個不錯的成長。

Do you have any sense, the extent to which, you know, the pickup in enrollments was from the new prescribers versus your older prescribers who had just seen the eGFR data?

您是否知道，新處方醫生與剛看到 eGFR 數據的舊處方醫生相比，註冊人數的增加在多大程度上？

And I guess, with the data, how much can we see the enrollments pickup from there?

我想，根據這些數據，我們可以看到入學人數的增加有多少？

I understand that it may not necessarily translate into sales, but perhaps enrollments continue.

我知道這不一定會轉化為銷量，但註冊人數可能會繼續。

So that's our first question.

這是我們的第一個問題。

And then the second question is related to the magnitude of KDIGO guidelines.

第二個問題與 KDIGO 指南的重要性有關。

Are there any analogs that you can sort of more quantify what the impact of KDIGO could have on an uptick in sales there?

是否有任何類比可以更量化 KDIGO 對那裡銷售成長的影響？

Is it just still primarily -- the payers that are the gatekeepers here, and that's pretty much it, who we have to count on.

仍然主要是——付款人是這裡的看門人，僅此而已，我們必須依靠他們。

So I guess those are my questions and I have a follow-up after that also.

所以我想這些都是我的問題，之後我也會跟進。

Okay.

好的。

So I actually don't have at hand the kind of breakdown of the enrollments in terms of new kind of prescribers versus existing.

因此，我其實手邊沒有新型處方醫師與現有處方醫師的註冊情況明細。

But because obviously, there's always the possibility that new prescribers would have prescribed for more than one patient.

但因為顯然，新的處方醫生總是有可能為不只一位患者開出處方。

So obviously that this is -- but I guess the best estimate really would be that out of 555 enrollments, at least, if there were 300 of those, would be kind of from new prescribers.

顯然，這是——但我想最好的估計是，在 555 名註冊患者中，至少，如果有 300 名，將來自新的處方醫生。

The remaining kind of 200, the easy assumption is that these are kind of repeat prescribers.

剩下的 200 種，簡單的假設就是這些都是重複開處方的人。

But again, I can't guarantee that.

但同樣，我不能保證這一點。

But I think that would kind of be my best estimate at this point in time.

但我認為這將是我目前最好的估計。

In terms of the magnitude impact that KDIGO, I mean, I think that that obviously could be quite sizable because obviously today, what's been discussed or at least the different conferences, the podiums, et cetera, is, and it's based on this longitudinal data is, is one gram an appropriate definition to use in the guidelines to define patients at risk of disease progression.

就 KDIGO 的影響程度而言，我的意思是，我認為這顯然可能相當大，因為顯然今天所討論的內容或至少是不同的會議、講台等，並且它基於這些縱向數據是，一克是否是指南中用於定義處於疾病進展風險的患者的適當定義。

And I think what's been discussed and debated again in this forum is that maybe that should be reduced.

我認為本次論壇再次討論和辯論的是也許應該減少這種情況。

So if that level is reduced to 0.75 or 0.5, then obviously, that would have a very significant potential impact on the addressable population, that would be on-label.

因此，如果該水平降低到 0.75 或 0.5，那麼顯然，這將對可尋址人群產生非常重大的潛在影響，這將是標籤上的。

So I do think that it is a kind of a very -- it could be a very significant trigger.

所以我確實認為這可能是一個非常重要的觸發因素。

Again, probably not an immediate impact again, but certainly, it could it could have a very significant impact on the overall addressable market.

同樣，可能不會再次產生即時的影響，但可以肯定的是，它可能會對整個潛在市場產生非常重大的影響。

Okay.

好的。

And if I can get a little bit more into the week.

如果我這週能多做一點事的話。

So I guess we've spoken to a couple of KOLs.

所以我想我們已經和幾位 KOL 進行了交談。

One of the things that stood out is that the way they selected some patients were the ones that had clear inflammation or inflammatory markers where the ones that were more suitable for TARPEYO treatment versus any of the [Ros] inhibitor.

值得注意的事情之一是，他們選擇一些具有明確發炎或發炎標記的患者的方式，其中與任何 [Ros] 抑制劑相比，這些患者更適合 TARPEYO 治療。

Do you have a sense of how many patients that have UPCRs below 1.5 or in an inflammatory state?

您知道有多少患者 UPCR 低於 1.5 或處於發炎狀態嗎？

And the extent to which expanding that is going to really tap into that entire market or just a portion of the market or more inflammatory?

擴大這一規模將在多大程度上真正進入整個市場、或只是市場的一部分，或更具煽動性？

So maybe you can sort of address that a little bit.

所以也許你可以稍微解決一下這個問題。

I think that's actually a very kind of difficult question to kind of answer appropriately, actually, based on the information we have.

我認為，根據我們掌握的信息，這實際上是一個非常難以正確回答的問題。

I mean, I would say that we know that's a very heterogeneous disease.

我的意思是，我想說我們知道這是一種非常異質的疾病。

You can have patients that actually have decline of eGFR with virtually no proteinuria.

患者的 eGFR 確實下降，但幾乎沒有蛋白尿。

And you can -- I think the only -- I mean, the relevant way, I guess of looking at this would probably be a biopsy.

你可以——我認為唯一的——我的意思是，相關的方式，我想觀察這個可能是活檢。

But Richard, do you have any comments on that?

但是理查德，你對此有什麼評論嗎？

Well, I think that -- and also I don't think in the sort of commercial prescriber setting, will not necessarily going to have available to us all the information relating to their kind of aspects of the patient's condition that you're referring to relating to kind of inflammatory status, et cetera.

嗯，我認為，而且我認為在商業處方環境中，不一定會向我們提供與您所指的患者病情各方面相關的所有資訊與發炎狀態的種類等有關。

So inflammatory biomarkers or levels of microhematuria, et cetera, that's not necessarily going to be information that we're collecting and have available to us.

因此，發炎生物標記或微量血尿水平等，不一定是我們正在收集和提供的資訊。

So I think it would be difficult to really comment on that.

所以我認為很難對此做出真正的評論。

Okay.

好的。

And I guess one one last simple question.

我想還有最後一個簡單的問題。

Just to clarify, when you have discussions with payers, you said, they like the label in hand.

只是澄清一下，當您與付款人討論時，您說他們喜歡手上的標籤。

Do they not have access to this label at this point?

他們目前無法存取此標籤嗎？

Is there another label out there they need to physically put in their hands to pay attention?

是否還有其他標籤需要他們實際放在手中才能引起注意？

So I mean, obviously, the label language is now available, but obviously, they do not have to see anyone or meet anyone or have any meetings with regards to anything around the label unless you have a new label, which obviously they have to go through a new kind of P&T committee.

所以我的意思是，顯然，標籤語言現在已經可用，但顯然，他們不必見任何人或會見任何人或就標籤周圍的任何事情舉行任何會議，除非你有一個新標籤，顯然他們必須去通過一種新型的P&T 委員會。

So it's really more of a matter of they have their own process that they go through, whether this is in new drug or a new label update or anything else that would drive them to have a P&T committee.

因此，更重要的是他們有自己的流程，無論是新藥、新標籤更新或其他任何會促使他們成立 P&T 委員會的流程。

So it's really more a matter of -- they obviously have other things that they are also scheduled.

所以這實際上更多的是——他們顯然還安排了其他事情。

So when can they -- when will they agree to put this on their schedules.

那麼他們什麼時候可以——他們什麼時候同意把這件事列入他們的日程安排。

So when will they actually agree to go through this.

那麼他們什麼時候才能真正同意經歷這件事呢？

Because there is a requirement for them to go through this kind of formal process and therefore, also then issue any kind of potential update or change of the rules that they apply based on this new label.

因為他們需要經歷這種正式流程，因此，然後還要根據這個新標籤發布他們所應用的規則的任何潛在更新或更改。

So it's really kind of the same as when we originally started is that you can always do things on a medical exception basis, right?

所以這真的和我們最初開始時一樣，你總是可以在醫療例外的基礎上做事，對嗎？

But obviously, it gets easier when you actually have gone through the P&T committees and there is a more standardized way for the payers to address a certain drug.

但顯然，當您真正通過 P&T 委員會並且付款人有更標準化的方式來處理某種藥物時，事情就會變得更容易。

So which is why you can certainly always -- I mean, this will also depend a lot on on kind of how much energy and persistence do the in-treating physician have to go through potentially these kind of appeals processes until those rules have been amended, and that is just difficult to say.

所以這就是為什麼你總是可以——我的意思是，這在很大程度上取決於治療醫生必須有多少精力和毅力來經歷這些潛在的上訴程序，直到這些規則被修改為止。 ，這很難說。

Okay.

好的。

Okay, great.

好的，太好了。

Thank you.

謝謝。

Arthur He, H.C. Wainwright.

何亞瑟，H.C.溫賴特。

Hello, good morning -- hey, Renée and team.

你好，早安——嘿，Renee 和團隊。

Congrats on progress.

祝賀你取得了進步。

Thanks for taking my question.

感謝您提出我的問題。

So regarding this launch in China, could you give us some update or the preparedness on that part and remind us what's the Calliditas' role to support a launch?

那麼關於這次在中國的發射，您能否給我們一些最新情況或這方面的準備情況，並提醒我們 Calliditas 在支持發射方面發揮什麼作用？

Sure.

當然。

So obviously, the commercial launch will be carried out by Everest Medicines.

顯然，商業發行將由 Everest Medicines 進行。

And actually, as you may be aware, I mean, they -- the CEO there actually has a very kind of substantial and significant experience from other commercial companies in China.

事實上，正如你可能知道的，我的意思是，他們——那裡的執行長實際上擁有來自中國其他商業公司的非常豐富和重要的經驗。

And so I think actually that the team that's been brought on board is actually quite impressive and seems to have a lot of experience in terms of launching products in China.

所以我認為事實上，所引入的團隊實際上非常令人印象深刻，並且似乎在中國推出產品方面擁有豐富的經驗。

In terms of the the actual kind of activity, obviously, I think they have had -- they have been preparing for this for quite a long time.

就實際活動而言，顯然，我認為他們已經為此準備了相當長的時間。

And obviously, as we know, this is a much, much larger population than what we have here in Europe and the US.

顯然，正如我們所知，這個人口比歐洲和美國的人口多得多。

I guess my best kind of view, went to went to Shanghai to kind of visit some of the nephrology units and some of the hospitals there, I mean, it's clear that a lot of these hospitals have large numbers of patients that they actually just kind of have on their roster.

我想我最好的看法是，去上海參觀了一些腎臟科單位和那裡的一些醫院，我的意思是，很明顯，很多這些醫院都有大量的患者，他們實際上只是友善他們的名單上有。

And they're very well aware of this kind of the potential arrival of this medication.

他們非常清楚這種藥物的潛在到來。

So I think that it's really kind of a -- it seems to have a good expectation, I think.

所以我認為這確實是一種——我認為這似乎有一個很好的期望。

The early-access program was very successful.

搶先體驗計畫非常成功。

And as far as I'm aware, the company is really targeting a launch in Q2 of this year.

據我所知，該公司確實計劃在今年第二季推出。

So obviously, we will not have any kind of direct involvement in that commercial launch.

顯然，我們不會以任何形式直接參與該商業發布。

Thanks for that color.

謝謝那個顏色。

And just a quick follow-up on the open-label study.

這只是開放標籤研究的快速跟進。

Could you give us more color on what exactly the dataset look like regarding the size and the data point?

您能給我們更多關於資料集的大小和資料點的具體情況嗎？

Thanks.

謝謝。

So I guess that my understanding really isn't -- Richard, you can correct me if I'm wrong, but this really is just -- it's an open label study.

所以我想我的理解確實不是——理查德，如果我錯了你可以糾正我，但這確實是——這是一項開放標籤研究。

So everyone obviously is going to be on drug and inclusion criteria, we're very similar to the inclusion criteria for the Phase 3.

所以顯然每個人都會注意藥物和納入標準，我們與第三階段的納入標準非常相似。

So slightly lower kind of eGFR levels, but actually, the proteinuria cutoff was the same.

eGFR 水平略低，但實際上，蛋白尿截止值是相同的。

And so I believe it's about 120 -- 119 exact patients that have been enrolled into the trial.

因此，我相信大約有 120 至 119 名患者已被納入該試驗。

And our expectation is obviously, because this data obviously has not been unblinded.

而我們的預期是顯而易見的，因為這個數據顯然還沒有被揭盲。

So even if it's an open label study, obviously, we do not know what kind of treatment the patients had prior to entering this open label.

因此，即使這是一項開放標籤研究，顯然我們也不知道患者在進入該開放標籤之前接受過什麼樣的治療。

But we would expect that the majority of these patients would be placebo patients as they still qualified as being kind of at risk.

但我們預計這些患者中的大多數將是安慰劑患者，因為他們仍然有資格處於危險之中。

But we would also expect that there is a group of patients who will have -- who will be retreated.

但我們也預計有一群患者將會接受治療。

And our assumption is that that would be skewed towards those patients that probably had a more severe disease coming into the Phase 3 since, obviously, they might have had very significant improvements, both of kind of eGFR and proteinuria potentially.

我們的假設是，這將偏向那些可能患有更嚴重疾病進入第三階段的患者，因為顯然，他們可能在 eGFR 和蛋白尿方面都有非常顯著的改善。

But obviously, we're still qualifying as being at risk after that kind of two-year period have been spending that in the Phase 3.

但顯然，在第三階段度過了兩年的時間後，我們仍然有資格面臨風險。

So that is real.

所以這是真的。

And in terms of the data, it's really kind of very similar data.

就數據而言，這確實是非常相似的數據。

So it's really proteinuria, eGFR safety.

所以這確實是蛋白尿、eGFR 安全性。

I mean, it's all kind of the similar dataset from that perspective.

我的意思是，從這個角度來看，這些資料集都是相似的。

Thank you very much for taking my questions.

非常感謝您回答我的問題。

I will talk to you guys soon.

我很快就會和你們談談。

Christopher Uhde, SEB Enskilda.

Christopher Uhde，SEB 恩斯基爾達。

Hello.

你好。

Thanks for taking my questions.

感謝您回答我的問題。

I just have a few follow-ups.

我只有一些後續行動。

So I think in terms of average duration of therapy, I think previously, I believe you said, it was around six to seven months, so far, people are more prescribing along the lines of systemic steroids in terms of that, are you seeing now that starting to improve since the data was presented and approval?

所以我認為就平均治療持續時間而言，我想以前，我相信你說過，大約是六到七個月，到目前為止，人們更多地按照全身類固醇的方式開處方，你現在看到了嗎自從資料提交和批准以來，情況開始改善嗎？

And then my second question, you gave a little bit of a flavor on retreatment for those who are already going nine months.

然後是我的第二個問題，您對那些已經接受九個月治療的人進行了一些再治療。

But do you have any indication so far on the average frequency for the patients overall who've been getting TARPEYO?

但到目前為止，您是否有關於接受 TARPEYO 治療的患者整體平均頻率的任何跡象？

And I guess, then my third question is, so in terms of the returning prescribers, I'm not sure how much you can say given what you've said earlier, but are you getting a sense of whether the prescribers who prescribed previously are getting better at converting enrollments to treatments quickly, like navigating the reimbursement sort of [mays] better, if you will?

我想，那麼我的第三個問題是，就返回的處方者而言，鑑於您之前所說的，我不確定您能說多少，但是您是否了解以前開處方的處方者是否是更好地快速將註冊轉化為治療，例如在報銷方面[可能]更好，如果你願意的話？

Thank you.

謝謝。

Thanks.

謝謝。

So in terms of average duration, what we did is we followed this kind of patient cohort.

因此，就平均持續時間而言，我們所做的是追蹤此類患者群。

And I think we reported this, I think, in Q2 of last year.

我想我們在去年第二季就報告了這一點。

That actually showed it at that point in time that the average treatment duration was about eight months.

這實際上表明當時的平均治療持續時間約為八個月。

And so what we would be expecting, and I think we'll probably follow a cohort shortly and try and see what that looks like maybe towards the end of the year, a really -- kind of we would expect that to kind of be increasing at this point.

所以我們會期待什麼，我想我們可能會很快跟踪一批人，並嘗試看看可能在今年年底會是什麼樣子，我們真的希望這種情況會增加在此刻。

And the reason why would be increasing is obviously partly as you say there is that kind of habit, that kind of still sits.

增加的原因顯然部分是因為你說有那種習慣，那種習慣仍然存在。

And actually, I think it goes for almost all drugs.

事實上，我認為它幾乎適用於所有藥物。

And there is a sense of nephrologists that you tried something for six months and then see kind of what happens.

腎臟科醫生有一種感覺，你嘗試了六個月的方法，然後看看會發生什麼。

So I think that we would expect that to kind of continue to improve based on additional education, medical affairs, intervention, et cetera, to really explain the difference in terms of the local action, et cetera, of this particular drug.

因此，我認為我們期望在額外的教育、醫療事務、幹預等的基礎上繼續改進，以真正解釋這種特定藥物在局部作用等方面的差異。

So that would be our expectation.

這就是我們的期望。

In terms of retreatment, I think it is too early for us to kind of comment and integrate kind of detail on that.

在重新處理方面，我認為我們現在發表評論並整合相關細節還為時過早。

We have seen kind of retreatment happening, but I think we're going to wait in terms of collecting some more information on that before we really comment on it.

我們已經看到了某種程度的重新對待的發生，但我認為在我們真正對此發表評論之前，我們將等待收集更多相關資訊。

In terms of returning prescribers, I wish that I could tell you that these kind of prescribers who prescribe before are getting better at it.

就返回處方者而言，我希望我能告訴你，這些以前開過處方的處方者正在變得越來越擅長。

Unfortunately, I'm not sure that that's the case.

不幸的是，我不確定情況是否如此。

I think it just comes from the fact that this is a rare disease.

我認為這只是因為這是一種罕見疾病。

And so it might have been three or four months between them kind of prescribing it before and prescribing it now.

因此，他們之前開藥和現在開藥之間可能需要三、四個月的時間。

And unfortunately, there's been hundreds of patients in between that period of time for these nephrologists.

不幸的是，在這段時間裡，這些腎臟科醫師已經接診了數百名患者。

So I do -- I think it's unclear at this point in time how much better they're getting actually trying to submitting complete prescriptions.

所以我這樣做了——我認為目前還不清楚他們在嘗試提交完整處方方面實際上取得了多大的進展。

But we are still hopeful that we're going to get there.

但我們仍然希望能夠實現這一目標。

Thank you so much.

太感謝了。

Johan Unnérus, Redeye.

約翰烏內魯斯，《紅眼》。

Great.

偉大的。

Thanks for taking our questions.

感謝您回答我們的問題。

The first one, considering the enrollment and the unique subscribers and also the price increase, it seems like the guide is rather conservative.

第一個，考慮到註冊人數和獨立訂閱者以及價格上漲，該指南似乎相當保守。

Should we expect you to take a rather proactive approach during '24 and perhaps update the guide more actively?

我們是否應該期望您在 24 年期間採取相當主動的方法，或許更積極地更新指南？

Yes, that wouldn't be an impossibility.

是的，這並非不可能。

I think that obviously, as we -- as some of these things become clear, both in terms of how quickly we can get through P&T committees, when the KDIGO guidelines may or may not kind of become available, et cetera.

我認為，顯然，隨著我們 - 隨著其中一些事情變得清晰，無論是我們能夠以多快的速度通過 P&T 委員會，KDIGO 指南何時可能會或可能不會變得可用，等等。

And when it becomes a little bit more clear, then I think that could certainly imply that we would kind of provide more and more accurate guidance as time goes on.

當它變得更加清晰時，我認為這肯定意味著隨著時間的推移我們將提供越來越準確的指導。

Great.

偉大的。

And that leads us to the second question.

這就引出了第二個問題。

What about the irregularities and time that these P&T committees tend to meet?

這些 P&T 委員會開會的違規行為和時間又如何呢？

And will that happened several times here or when something is needed to be handled?

這種情況會不會在這裡發生好幾次，或是需要處理什麼事情的時候？

It does vary actually plan to plan.

實際計劃與計劃確實有所不同。

I mean, some of the bigger plans are more kind of structured.

我的意思是，一些更大的計劃更加結構化。

They may have like a quarterly meeting, et cetera, otherwise might have monthly meetings.

他們可能會召開季度會議等，否則可能會召開每月會議。

But yes, there is a certain cadence that they all have that, in which case, they will obviously do more than just one drug.

但是，是的，他們都有一定的節奏，在這種情況下，他們顯然會不僅僅使用一種藥物。

We will have several kind of cases that they will kind of address in one meeting, but it's not necessary, it's unusual that it would be ad hoc.

我們將有幾種情況，他們將在一次會議上解決，但這不是必要的，這是不尋常的，這是臨時的。

It's more kind of a structured process that is -- that they have agenda for either then on a kind of mainly kind of quarterly basis.

這更像是一個結構化的流程——他們主要是按季度製定議程。

So later in the first part -- during the first half, you should have some insight into this dynamic already?

那麼在第一部分的後面部分──在上半部中，你應該已經對這種動態有了一些了解了？

Absolutely.

絕對地。

And as I said, this is clearly something that within the organization, we are very focused on.

正如我所說，這顯然是我們組織內非常關注的事情。

And this is clearly something where we are working very actively at driving that process as much as we possibly can from the outside, but there's a limit of 52 to how much we can impact that, but there certainly is a lot of focus on it.

顯然，我們正在非常積極地努力從外部盡可能地推動這一進程，但我們可以影響的程度有限，但肯定有很多關注。

And regarding the backlog relating to the private commercial pay.

以及與私人商業支付相關的積壓問題。

As you said, this is not an acute illness, but it is a chronic illness and specialist will continue to monitor the patients.

正如你所說，這不是急性疾病，而是慢性疾病，專家將繼續監測患者。

The backlog is unlikely to disappear.

積壓的情況不太可能消失。

There are few, very few alternatives.

替代品很少，非常少。

Certainly, yes, there are kind of -- there are few alternatives.

當然，是的，有一些——幾乎沒有其他選擇。

I think what you might find is that physicians get frustrated, they cancel it.

我想你可能會發現醫生感到沮喪，他們取消了它。

They kind of meet their patient the next time, a couple of months, they kind of submit again to try and have better better luck this time.

他們下次見到他們的病人，幾個月後，他們再次提交，嘗試這次有更好的運氣。

So I think it'll be a mixture of those physicians who will have it -- be a little bit more patient and be willing to kind of go through the authorization process and some of those other prescribers who then may kind of come back when they think that actually the rules have been updated.

因此，我認為這將是那些擁有這種藥物的醫生的混合體——要有更多的耐心，願意完成授權過程，以及其他一些處方者，他們可能會在他們收到授權後回來。認為實際上規則已更新。

So they don't have to kind of go through -- jump through the same hoops.

所以他們不必經歷同樣的困境。

So I think it'll probably be a mix of those.

所以我認為它可能是這些的混合。

Great.

偉大的。

And finally, if I may, regarding the OP study, some of these patients will be repeat patients as you clarified earlier, some of them will be slightly more severe stage.

最後，請允許我介紹 OP 研究，正如您之前澄清的那樣，其中一些患者將是重複患者，其中一些患者的病情會稍微嚴重一些。

And earlier in this study, it's being noted the [consistence] that during the active period, the eGFR has been stabilized, what can we expect from this early study?

在這項研究的早期，人們注意到[一致性]，在活躍期，eGFR 已經穩定，我們可以從這項早期研究中期待什麼？

Of course, we have to wait for the actual results, but what should we expect?

當然，我們還要等待實際結果，但是我們該期待什麼呢？

I think from a mechanistic perspective, I mean, we wouldn't expect it to be any different in the open-label extension that we've seen, both in our Phase 2b and our Phase 3.

我認為從機制的角度來看，我們不希望它在我們所看到的開放標籤擴展中有任何不同，無論是在我們的 2b 階段還是在我們的 3 階段。

So yes, we would expect to see a very similar outcome where actually when patients are on treatment, it does stabilize their kidney function.

所以，是的，我們期望看到非常相似的結果，實際上當患者接受治療時，它確實穩定了他們的腎功能。

Very good.

非常好。

Thank you.

謝謝。

Thank you.

謝謝。

Suzanne van Voorthuizen, VLK.

蘇珊娜‧範‧福爾特赫伊森 (Suzanne van Voorthuizen)，VLK。

Hi, team.

大家好。

This is Suzanne.

這是蘇珊娜。

Thanks for taking my question.

感謝您提出我的問題。

A small follow-up regarding the access friction that you mentioned faced in the first half.

關於您提到的上半場遇到的訪問摩擦的一個小後續行動。

Should we expect you to update the market on the progress that you make with the payers as part of the quarterly earnings update or given its importance, could there be some communication about that separately on important milestones?

作為季度收益更新的一部分，我們是否應該期望您向市場通報您與付款人取得的進展，或者考慮到其重要性，是否可以就重要里程碑單獨進行一些溝通？

And then I have another question after this one.

繼這個問題之後我還有另一個問題。

I think we'll probably report as part of the quarterly updates.

我想我們可能會作為季度更新的一部分進行報告。

I think obviously, I mean, if there is something that we consider as being very important, then we can always -- I mean, we could always consider doing something, I hope.

我認為顯然，我的意思是，如果我們認為某件事非常重要，那麼我們總是可以——我的意思是，我希望我們總是可以考慮做某事。

But I guess my assumption would be that we would report on a quarterly basis as we have been.

但我想我的假設是我們將像以前一樣按季度報告。

Got it.

知道了。

All right.

好的。

And then maybe on Europe, can you provide some color on what the sales development look like for Kinpeygo and what was the 2023 sales in the following year?

然後，也許在歐洲，您能否提供一些有關 Kinpeygo 的銷售發展以及下一年 2023 年銷售額的資訊？

So I think we have our royalty numbers, but I don't know if we have anything.

所以我認為我們有我們的版稅號碼，但我不知道我們是否有任何東西。

Frederic, would we -- on a kind of

弗雷德里克，我們可以——以某種方式

--

--

Yes, we have the royalty number which we're separately reporting.

是的，我們有單獨申報的版稅號碼。

And overall for the full year, we reported approximately SEK40 million in royalties from Europe.

全年總體而言，我們報告來自歐洲的特許權使用費約為 4000 萬瑞典克朗。

Yes, I actually laid out -- STADA is obviously a very large company.

是的，我確實說過－ STADA 顯然是一家非常大的公司。

They don't necessarily break this out or kind of disclose any of these details.

他們不一定會打破這一點或披露任何這些細節。

So therefore, we don't really have access to those type of numbers.

因此，我們實際上無法存取這些類型的數字。

But obviously, we are aware of the fact that they are they are gaining kind of approval and acceptances from a variety of European countries, UK obviously being the most recent one.

但顯然，我們知道這樣一個事實，即他們正在獲得許多歐洲國家的認可和接受，英國顯然是最近的一個。

And it's my understanding that they're in kind of negotiations with at least four other geographic regions in Europe with the hope to obviously reach a Conclusion there also fairly shortly.

據我了解，他們正在與歐洲至少四個其他地理區域進行談判，希望很快就能在那裡達成結論。

But that is the kind of insight that I have this time.

但這就是我這次的見解。

All right.

好的。

Thank you.

謝謝。

There are no more questions at this time.

目前沒有更多問題。

So I hand the conference back to the speakers for any closing comments.

因此，我將會議交還給發言人以徵求結束意見。

Thank you very much, and thank you very much for listening to this Q4 report from 2023, and we look forward to meeting you again and when we get to report our Q1, which is due in May of this year.

非常感謝您，也非常感謝您收聽 2023 年第四季報告，我們期待再次與您見面，並期待我們報告第一季報告（預計將於今年 5 月發布）。

Thank you very much.

非常感謝。