使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Good morning, ladies and gentlemen, and thank you for standing by. Welcome to Theratechnologies' earnings conference call for the first quarter of 2018. (Operator Instructions) I would like to remind everyone that this conference call is being recorded today, Thursday, April 5, at 8:30 a.m. Eastern Time.
早上好,女士們,先生們,感謝你們的支持。歡迎參加 Theratechnologies 2018 年第一季度的收益電話會議。(操作員說明)我想提醒大家,今天,即 4 月 5 日,星期四,上午 8:30 正在錄製此電話會議。東部時間。
I would now like to turn the conference over to Denis Boucher. Mr. Boucher, please go ahead.
我現在想將會議轉交給 Denis Boucher。布歇先生,請繼續。
Denis Boucher - VP of Communications & Corporate Affairs
Denis Boucher - VP of Communications & Corporate Affairs
Thank you, and welcome. Mr. Luc Tanguay, President and Chief Executive Officer of Theratechnologies; as well as Mr. Philippe Dubuc, Senior Vice President and Chief Financial Officer, will be the speakers on today's call. A Q&A period open exclusively to financial analysts will follow their presentation.
謝謝,歡迎。Theratechnologies 總裁兼首席執行官 Luc Tanguay 先生;以及高級副總裁兼首席財務官 Philippe Dubuc 先生將在今天的電話會議上發言。在他們的演講之後,將有一個專門向金融分析師開放的問答環節。
Before Mr. Tanguay begins his remarks, I have been asked by Theratechnologies to read the following message regarding forward-looking statements. I would like to remind everyone that Theratechnologies' remarks today contain forward-looking statements about its current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements or other future events or developments.
在 Tanguay 先生開始發言之前,Theratechnologies 要求我閱讀以下有關前瞻性陳述的信息。我想提醒大家,Theratechnologies 今天的言論包含有關其當前和未來計劃、預期和意圖、結果、活動水平、績效、目標或成就或其他未來事件或發展的前瞻性陳述。
In preparing these forward-looking statements, several assumptions were made by Theratechnologies, and there are risks that results actually obtained by the company will differ materially from those statements. As a consequence, the company cannot guarantee that any forward-looking statement will materialize, and you are cautioned not to place undue reliance on them.
在準備這些前瞻性陳述時,Theratechnologies 做出了多項假設,並且存在公司實際獲得的結果與這些陳述存在重大差異的風險。因此,公司不能保證任何前瞻性陳述都會實現,請注意不要過分依賴它們。
Theratechnologies refer current and potential investors to the forward-looking information section of its press release issued this morning and to its Annual Information Form dated February 6, 2018, and the Risk Factors section therein available at www.sedar.com under Theratechnologies' public filings.
Theratechnologies 向當前和潛在投資者推薦其今天上午發布的新聞稿的前瞻性信息部分和日期為 2018 年 2 月 6 日的年度信息表,以及其中的風險因素部分,可在 www.sedar.com 的 Theratechnologies 公開文件中找到.
Forward-looking statements represent Theratechnologies' expectations as of April 5, 2018. Except as may be required by securities laws, Theratechnologies does not undertake any obligation to update any forward-looking statement whether as a result of new information, future events or otherwise.
前瞻性陳述代表 Theratechnologies 截至 2018 年 4 月 5 日的預期。除非證券法可能要求,否則 Theratechnologies 不承擔任何義務更新任何前瞻性陳述,無論是由於新信息、未來事件或其他原因。
I would now like to turn the conference over to Luc.
我現在想把會議轉交給呂克。
Luc Tanguay - CEO, President and Non-Independent Director
Luc Tanguay - CEO, President and Non-Independent Director
Okay. Thank you, Denis. Good morning, everyone, and thank you for being with us today.
好的。謝謝你,丹尼斯。大家早上好,感謝你們今天和我們在一起。
I'm pretty sure that not so long ago, I spoke to the vast majority of people on the call today. Although it seems like months have already gone by given the level of activity here, it's only a month ago that we received the much-anticipated approval of Trogarzo by the Food and Drug Administration in the U.S.
我敢肯定,就在不久前,我今天在電話會議上與絕大多數人進行了交談。儘管鑑於這裡的活動水平似乎已經過去了幾個月,但就在一個月前,我們才收到美國食品和藥物管理局對 Trogarzo 的期待已久的批准。
In essence, the approval cannot have come at a better time. Indeed, it was announced as the 25th Conference on Retroviruses and other Opportunistic Infection, known as CROI, was taking place in Boston. CROI is among the most important medical conferences on HIV.
從本質上講,批准來得正是時候。事實上,它是在第 25 屆逆轉錄病毒和其他機會性感染會議(稱為 CROI)在波士頓召開時宣布的。CROI 是最重要的 HIV 醫學會議之一。
As we were presenting a poster session on Trogarzo, we received a great deal of attention, and we fielded questions from specialists from around the world. This was a great opportunity to communicate the fact that Trogarzo had been approved for the treatment of patients with multidrug resistant HIV.
當我們展示關於 Trogarzo 的海報會議時,我們受到了極大的關注,並且我們回答了來自世界各地的專家的問題。這是一個很好的機會來傳達 Trogarzo 已被批准用於治療多重耐藥 HIV 患者的事實。
Furthermore, we were able to underline some unique features of Trogarzo, such as being the first monoclonal antibody used in the treatment of HIV, the first HIV treatment with a new mechanism of action approved in more than 10 years and the first non-daily treatment for HIV.
此外,我們能夠強調 Trogarzo 的一些獨特之處,例如它是第一個用於治療 HIV 的單克隆抗體、10 多年來第一個具有新作用機制的 HIV 治療獲得批准以及第一個非日常治療對於艾滋病毒。
We are also quite pleased with the indication approved by the FDA. In fact, the indication reflects the patient population of 20,000 to 25,000 that we have been talking about ever since our Investor Day in March 2017.
我們也對 FDA 批准的適應症感到非常滿意。事實上,該適應症反映了自 2017 年 3 月投資者日以來我們一直在談論的 20,000 至 25,000 名患者。
Getting the approval was one thing. We are now concentrating on making sure that we have product available to physicians and patients. I can tell you that the first commercial vials are being packaged by TaiMed, supplier in the U.S., and as soon as they are ready, the vial will be shipped to our distributor to fill our supply chain.
獲得批准是一回事。我們現在專注於確保我們的產品可供醫生和患者使用。我可以告訴你,第一批商業藥瓶正在由美國供應商 TaiMed 包裝,一旦準備就緒,藥瓶將被運送到我們的分銷商以填補我們的供應鏈。
Our target for the commercialization -- commercial availability of Trogarzo remains around the end of April. Based on the level of activity at our call center THERA patient support, I can also tell you that things are shaping up quite well.
我們的商業化目標——Trogarzo 的商業可用性保持在 4 月底左右。根據我們呼叫中心 THERA 患者支持的活動水平,我還可以告訴您,事情進展順利。
Of course, as I mentioned during the analyst call on approval day, we expect sales to gather momentum, as we obtain reimbursement from public and private payers. But I'm very pleased with the reports I'm getting from our managed market team.
當然,正如我在批准日的分析師電話會議上提到的那樣,隨著我們從公共和私人付款人那裡獲得報銷,我們預計銷售會增長勢頭。但我對從我們的管理市場團隊那裡得到的報告感到非常滿意。
There is definitely enthusiasm for the product. In fact, shortly after the approval and even before any active promotion, we started receiving requests for enrollment forms from across the U.S. Enrollment forms are used by physicians to prepare prescriptions for patients. And as of today, we have provided forms to close to 200 clinics, and we even have received some prescription at our call centers.
對產品肯定有熱情。事實上,在獲得批准後不久,甚至在任何積極推廣之前,我們就開始收到來自美國各地的註冊表格請求。醫生使用註冊表格為患者準備處方。截至今天,我們已經為近 200 家診所提供了表格,我們甚至在呼叫中心收到了一些處方。
While this is already impressive, we expect that we should see even more movement as our complete U.S. team of sales representative, medical science liaison and reimbursement professionals received comprehensive training last week here in Montréal.
雖然這已經令人印象深刻,但我們預計我們應該看到更多的變化,因為我們完整的美國銷售代表、醫學科學聯絡和報銷專業人員團隊上週在蒙特利爾接受了全面培訓。
So as such, the product has been officially launched since Monday of this week, and a full contingent of representatives is now calling on 5,000 physicians. This means that we should start seeing even more traction in the coming weeks and months.
因此,該產品從本週一開始正式上市,目前已經有 5000 名醫生參加了完整的代表隊伍。這意味著我們應該在未來幾周和幾個月內開始看到更多的牽引力。
As far as reimbursement is concerned, we are already seeing positive developments. In fact, the reimbursement of Trogarzo was quickly approved on an individual basis for some patients.
就報銷而言,我們已經看到了積極的發展。事實上,Trogarzo 的報銷很快就在一些患者的個人基礎上得到了批准。
On top of this, some payers have already developed their reimbursement policy, which is quite encouraging as it's extremely rare for plans to have medical policy developed this soon after approvals. Consequently, we will start to record and to report sales revenue from Trogarzo in our second quarter.
最重要的是,一些付款人已經制定了他們的報銷政策,這非常令人鼓舞,因為在批准後很快制定醫療政策的計劃極為罕見。因此,我們將在第二季度開始記錄和報告 Trogarzo 的銷售收入。
It's a very exciting time for Trogarzo and also for Theratechnologies. That does not mean that we will lose sight of the importance of EGRIFTA for our business.
對於 Trogarzo 和 Theratechnologies 來說,這是一個非常激動人心的時刻。這並不意味著我們會忽視 EGRIFTA 對我們業務的重要性。
Quite the contrary, EGRIFTA is and will be a key element in our strategic plan, as it generates solid cash flow to sustain our operations and has proven to be a pivotal tool in our development. Indeed, it enabled us to sign the agreement with TaiMed.
恰恰相反,EGRIFTA 是並將成為我們戰略計劃的關鍵要素,因為它產生穩定的現金流來維持我們的運營,並已被證明是我們發展的關鍵工具。事實上,它使我們能夠與 TaiMed 簽署協議。
As we build the Trogarzo franchise in the U.S., it's certain that we will remain committed to continue growing EGRIFTA sales. On that front, I'm quite pleased with what I have been seeing ever since we expanded our sales force in the U.S.
當我們在美國建立 Trogarzo 特許經營權時,可以肯定的是,我們將繼續致力於繼續增加 EGRIFTA 的銷售額。在這方面,我對自從我們擴大在美國的銷售隊伍以來所看到的情況感到非常滿意。
In simple terms, EGRIFTA is benefiting from our investment in Trogarzo. The impact of our larger sales force combined to additional marketing activities has been translating into sales increases compared to last year.
簡而言之,EGRIFTA 受益於我們對 Trogarzo 的投資。與去年相比,我們更大的銷售隊伍與更多營銷活動相結合的影響已經轉化為銷售額增長。
The new F4 formulation could also eventually support sales growth. On that front, the necessary bioequivalence study has now been completed. Result obtained show bioequivalence to the current 1 milligram formulation. And as a result, we expect to submit the supplemental new drug application, or sNDA, to the FDA in the third quarter of 2018 as previously mentioned.
新的 F4 配方也可能最終支持銷售增長。在這方面,必要的生物等效性研究現已完成。獲得的結果顯示與當前 1 毫克製劑的生物等效性。因此,如前所述,我們預計將在 2018 年第三季度向 FDA 提交補充新藥申請或 sNDA。
On the financial front, Philippe will give you all the details in a moment, but I can already tell you that we had our best first quarter ever in terms of revenues. Of course, you will not be surprised that our expenses were also higher compared to the same quarter last year, but they were, in fact, slightly lower than in Q4 2017. And this is in line with what we have previously alluded to in terms of expenses reaching a plateau.
在財務方面,Philippe 稍後會為您提供所有詳細信息,但我已經可以告訴您,就收入而言,我們的第一季度是有史以來最好的。當然,與去年同期相比,我們的支出也有所增加,您不會對此感到驚訝,但實際上略低於 2017 年第四季度。這與我們之前提到的費用達到穩定水平是一致的。
This goes to show that we have been managing expenses closely even as we were preparing to launch Trogarzo in the U.S. and speeding up our preparatory work in Europe. As a matter fact, in a few days from now, we will be meeting with representatives from rapporteur and co-rapporteur countries assigned to review our file.
這表明,即使我們準備在美國推出 Trogarzo 並加快我們在歐洲的準備工作,我們也一直在密切管理費用。事實上,幾天后,我們將與指定審查我們文件的報告國和聯合報告國的代表會面。
As you may recall, the 2 countries are the Netherlands and Italy. This technical meeting will be very, very helpful to finalize our regulatory strategy and to ensure that we can file in Europe as soon as we possibly can.
您可能還記得,這兩個國家是荷蘭和意大利。這次技術會議將非常非常有助於最終確定我們的監管策略,並確保我們能夠盡快在歐洲提交申請。
So that being said, it's still too early to provide the potential timeline for filing in Europe, but we will have a much more precise idea once the meeting with the rapporteurs has taken place.
話雖這麼說,現在提供在歐洲提交申請的潛在時間表還為時過早,但一旦與報告員會面,我們就會有一個更準確的想法。
So on that note, I will let Philippe present our results for the first quarter 2018, and I will come back after. Philippe?
因此,關於這一點,我將讓 Philippe 介紹我們 2018 年第一季度的業績,之後我會回來。菲利普?
Philippe Dubuc - Senior VP & CFO
Philippe Dubuc - Senior VP & CFO
Thank you, Luc, and good morning, everyone.
謝謝你,呂克,大家早上好。
As Luc mentioned a minute ago, this was our best first quarter ever in terms of revenues. In U.S. dollars, we saw 18% growth compared to the same quarter last year. In Canadian dollars, net sales of EGRIFTA came in at $10.2 million compared to $9 million last year, representing 13% growth.
正如 Luc 一分鐘前提到的那樣,就收入而言,這是我們有史以來最好的第一季度。以美元計算,我們看到與去年同期相比增長了 18%。以加元計算,EGRIFTA 的淨銷售額為 1020 萬美元,而去年為 900 萬美元,增長了 13%。
Increased revenues were recorded due to higher unit sales and prices. The revenue increase was somewhat offset by higher discounts in patients' assistance costs as well as unfavorable exchange rate fluctuation.
由於更高的單位銷售額和價格,收入增加。收入增長在一定程度上被患者援助費用的更高折扣以及不利的匯率波動所抵消。
We expect that our expanded sales force will continue to have a positive impact on EGRIFTA sales in the coming quarters, as our 35 sales representatives will call on more than 5,000 key physicians in the field of HIV.
我們預計,我們擴大後的銷售隊伍將在未來幾個季度繼續對 EGRIFTA 的銷售產生積極影響,因為我們的 35 名銷售代表將拜訪 HIV 領域的 5,000 多名主要醫生。
Nevertheless, the investment made towards the launch of Trogarzo obviously had an impact on our bottom line. In Q1 2018, we recorded a negative EBITDA of $2,021,000 compared to a positive EBITDA of $725,000 during the first quarter of 2017.
儘管如此,為推出 Trogarzo 所做的投資顯然對我們的利潤產生了影響。2018 年第一季度,我們錄得 2,021,000 美元的負 EBITDA,而 2017 年第一季度為 725,000 美元的正 EBITDA。
In Q1 of this year, cost of sales, which includes cost of goods sold, production-related costs and royalties to EMD Serono, was $2.1 million or approximately $100,000 more than in Q1 2017. In more detail, cost of goods were up slightly, increasing to $1.2 million in Q1 2018 from $1.1 million last year.
今年第一季度,銷售成本(包括銷售成本、生產相關成本和 EMD Serono 的特許權使用費)為 210 萬美元,比 2017 年第一季度增加約 100,000 美元。更詳細地說,商品成本略有上升,從去年的 110 萬美元增加到 2018 年第一季度的 120 萬美元。
As for royalties, they reached $1.1 million in Q1 2018 compared to slightly less than $800,000 for the same period last year. Due to the reversal of a loss provision taken in Q4 2017, production costs in Q1 2018 were actually favorable in the amount of $160,000. This compares to an expense of $178,000 in Q1 of last year.
至於特許權使用費,2018 年第一季度達到 110 萬美元,而去年同期略低於 80 萬美元。由於 2017 年第四季度虧損準備金的逆轉,2018 年第一季度的生產成本實際上有利,為 160,000 美元。相比之下,去年第一季度的支出為 178,000 美元。
As for research and development expenses, we also recorded an increase in Q1 2018 when compared to Q1 of last year. More precisely, it increased to $2.4 million from $2 million last year. Notably, R&D expenses were down by almost $600,000 from Q4 2017. The increase in spending compared to last year was, of course, related in great part to the anticipated launch of Trogarzo.
至於研發費用,與去年第一季度相比,我們在 2018 年第一季度也有所增加。更準確地說,它從去年的 200 萬美元增加到 240 萬美元。值得注意的是,研發費用比 2017 年第四季度減少了近 600,000 美元。當然,與去年相比支出的增加在很大程度上與 Trogarzo 的預期推出有關。
The same can be said regarding selling and market development expenses. Indeed, they were up to about $6.7 million in Q1 2018 compared to $3.8 million in Q1 last year. But again, they were down compared to Q4 2017 when they were close to $8 million. The increase compared to last year is largely due to the expansion of the sales force, which started to occur in Q2 of last year and was fully implemented in Q3.
銷售和市場開發費用也是如此。事實上,與去年第一季度的 380 萬美元相比,它們在 2018 年第一季度高達約 670 萬美元。但同樣,與 2017 年第四季度接近 800 萬美元時相比,它們有所下降。與去年相比的增長主要是由於銷售隊伍的擴張,從去年第二季度開始,並在第三季度全面實施。
G&A expenses reached $1.5 million in Q1 2018 compared to $1.2 million last year, reflecting the general development of the business, including the preparation of our European entry strategy.
G&A 費用在 2018 年第一季度達到 150 萬美元,而去年為 120 萬美元,反映了業務的總體發展,包括我們歐洲進入戰略的準備。
Finance costs amounted to $195,000 compared to $2.3 million for the same quarter last year. The fair value of the warrant liability does not affect our reporting anymore, as all warrants have now been exercised. As a result, we recorded a net loss of $2.6 million or $0.04 per share in Q1 2018 compared to a net loss of $2.2 million or $0.03 per share last year.
財務成本為 195,000 美元,而去年同期為 230 萬美元。認股權證負債的公允價值不再影響我們的報告,因為所有認股權證現已行使。因此,我們在 2018 年第一季度錄得淨虧損 260 萬美元或每股 0.04 美元,而去年淨虧損為 220 萬美元或每股 0.03 美元。
Operating activities in Q1 2018 generated a negative cash flow of about $1.1 million compared to a positive one of $2.5 million in Q1 2017. Operations led to a negative impact of $2.6 million, which was offset by changes in operating assets and liabilities, which generated over $1.5 million.
2018 年第一季度的經營活動產生了約 110 萬美元的負現金流,而 2017 年第一季度為 250 萬美元的正現金流。運營產生了 260 萬美元的負面影響,但被產生超過 150 萬美元的運營資產和負債的變化所抵消。
The exchange rate from American to Canadian dollars positively impacted our cash balance. As a result, the company retained a strong cash position at the end of its first quarter of 2018 with $32.5 million in cash and equivalents compared to $33 million at the end of our last fiscal year.
美元兌加元的匯率對我們的現金餘額產生了積極影響。因此,公司在 2018 年第一季度末保持了強勁的現金狀況,現金及等價物為 3250 萬美元,而上一財年末為 3300 萬美元。
And given the cash flow generated by EGRIFTA alone and the fact that we should start recording sales of Trogarzo in our second quarter, we currently have a comfortable cash position that gives us enough room to aggressively pursue the European filing for Trogarzo as well as to continue to look for other opportunities that would be a great fit for our company.
考慮到僅由 EGRIFTA 產生的現金流量以及我們應該在第二季度開始記錄 Trogarzo 銷售額的事實,我們目前擁有一個舒適的現金狀況,這讓我們有足夠的空間積極尋求 Trogarzo 的歐洲申請並繼續尋找其他適合我們公司的機會。
So on that note, I will turn it back over to Luc, who has some closing remarks.
因此,關於這一點,我將把它轉回給 Luc,他有一些結束語。
Luc Tanguay - CEO, President and Non-Independent Director
Luc Tanguay - CEO, President and Non-Independent Director
Thanks, Philippe. It's fair to say that our company has never been in a better position. This was our best first quarter ever in terms of revenues, and EGRIFTA sales are still growing and generating significant gross margin.
謝謝,菲利普。可以公平地說,我們公司處於前所未有的有利地位。就收入而言,這是我們有史以來最好的第一季度,EGRIFTA 的銷售額仍在增長,並產生了可觀的毛利率。
Trogarzo is now approved, and we can feel a high level of interest from physicians, patients and importantly, from payers. It's only a matter of a week before we start recording revenues from Trogarzo, and of course, sales will pick up momentum as reimbursement is being confirmed by more and more private and public payers.
Trogarzo 現已獲得批准,我們可以感受到醫生、患者以及付款人的高度興趣。距離我們開始記錄 Trogarzo 的收入只有一周的時間,當然,隨著越來越多的私人和公共付款人確認報銷,銷售將會加快勢頭。
To that end, our managed market team is very active and will continue to be over the next 6 months. Definitely, things are going in the right direction. While this is happening, we're also ensuring to move the European file as fast as we can. This is a significant market, and we want to be there in the shortest timeframe possible.
為此,我們的管理市場團隊非常活躍,並將在未來 6 個月內繼續保持活躍。毫無疑問,事情正在朝著正確的方向發展。在這種情況發生的同時,我們也在確保盡快移動歐洲文件。這是一個重要的市場,我們希望在盡可能短的時間內到達那裡。
Finally, from a cash point of view, we still have $32 million in liquidities, which is a great position to be in. We are at the pivotal point in our history, and I invite you to stay with us for what could be a very exciting journey.
最後,從現金的角度來看,我們還有 3200 萬美元的流動資金,這是一個很好的位置。我們正處於我們歷史上的關鍵時刻,我邀請您與我們一起度過一段激動人心的旅程。
So on that, we -- I want to thank you all for being on the call today. And we will now take questions from the financial analysts.
因此,關於這一點,我們——我要感謝大家今天的電話會議。我們現在將回答金融分析師的問題。
Operator
Operator
(Operator Instructions) Your first question comes from the line of Prakash Gowd from CIBC.
(操作員說明)您的第一個問題來自 CIBC 的 Prakash Gowd。
Prakash Gowd - Executive Director of Institutional Equity Research
Prakash Gowd - Executive Director of Institutional Equity Research
I just had a couple of questions. First on reimbursement for Trogarzo. You mentioned that you've already received some prescriptions at your THERA patient support call centers. And it sounds like you're probably trying to get some exception authorization for these patients. Can you quantify at all how many prescriptions we're speaking about here? And then what it really entails to get the exception authorization and the likelihood of success?
我只是有幾個問題。首先是 Trogarzo 的報銷。您提到您已經在 THERA 患者支持呼叫中心收到了一些處方。聽起來您可能正在嘗試為這些患者獲得一些例外授權。你能量化我們在這裡談論的處方數量嗎?那麼獲得例外授權和成功的可能性究竟需要什麼?
Luc Tanguay - CEO, President and Non-Independent Director
Luc Tanguay - CEO, President and Non-Independent Director
We prefer not to. And same thing in the future, maybe not provide exactly how many prescription we receive. What you have to understand, Prakash, is that we just launched actually the product. In fact, this week, we were in training the whole week last week. So no promotion has been done before Monday of this week. So even without that, we have sent over 200 or close to 200 enrollment forms to clinics. So there is interest for the product from those physicians and clinics, and we already received some prescriptions. So I imagine it's between 0 and 200.
我們寧願不這樣做。將來也一樣,可能不會提供我們收到的處方的確切數量。Prakash,您必須了解的是,我們實際上剛剛推出了該產品。事實上,這週,我們上週整整一周都在訓練。所以在本周星期一之前沒有進行任何促銷活動。因此,即使沒有,我們也向診所發送了 200 多份或將近 200 份登記表。所以這些醫生和診所對該產品很感興趣,我們已經收到了一些處方。所以我想它在 0 到 200 之間。
But the point is that even at so early in the process, it's very rare to see this kind of process and even having some insurance company approve on an individual basis those prescription or reimbursement for those patients. So all that put together, I think it shows that there is interest from physicians, from patients and also by the insurance company. And I think it will be a very -- it won't be fair -- a fair guideline if I was telling you what is the number. But we are very excited about the fact that this -- we have this kind of interest so early in the process. I don't know, Lyne, if you want to add on the (inaudible).
但關鍵是,即使在這個過程的早期,也很少看到這種過程,甚至讓一些保險公司單獨批准這些患者的處方或報銷。所以所有這些放在一起,我認為這表明醫生、患者和保險公司都有興趣。如果我告訴你數字是多少,我認為這將是一個非常——這不公平——公平的指導方針。但我們對此感到非常興奮——我們在這個過程的早期就產生了這種興趣。我不知道,Lyne,你是否想添加(聽不清)。
Lyne Fortin - Senior VP & Chief Commercial Officer
Lyne Fortin - Senior VP & Chief Commercial Officer
Yes, Prakash, I just wanted to add that, actually, you are right. The exception process is what is working now until the coverage criteria are loaded in the payer system. But I must say that the exception process is working very well, and that entails the physician justifying the medical necessity of getting Trogarzo to their patients. So this is what led to the approval of patients already into that process.
是的,普拉卡什,我只是想補充一點,實際上,你是對的。例外流程現在正在運行,直到覆蓋標準加載到付款人系統中。但我必須說,例外程序運作良好,這需要醫生證明將 Trogarzo 帶給患者的醫療必要性。所以這就是導致患者批准進入該過程的原因。
Prakash Gowd - Executive Director of Institutional Equity Research
Prakash Gowd - Executive Director of Institutional Equity Research
Okay. So Lyne, just a follow-up on that then. For the market access team and in their discussions with payers, are the payers sticking very much to the label requirements for Trogarzo? Or are they requiring any additional steps or administrative hurdles?
好的。所以 Lyne,只是關於那個的後續行動。對於市場准入團隊以及在與付款人的討論中,付款人是否非常遵守 Trogarzo 的標籤要求?或者他們是否需要任何額外的步驟或管理障礙?
Lyne Fortin - Senior VP & Chief Commercial Officer
Lyne Fortin - Senior VP & Chief Commercial Officer
Well, it is very early because, as I mentioned, the exception process is what's working now until the established payer policy. But I can say that the payer policies that are in development right now are looking very positive and aligned with the FDA approved indication. So we are very enthusiastic about the responsiveness of the payers on that front for the patients who are in the difficult situation of needing Trogarzo.
好吧,現在還為時過早,因為正如我所提到的,例外流程現在一直有效,直到製定付款人政策。但我可以說,目前正在製定的付款人政策看起來非常積極,並且符合 FDA 批准的適應症。因此,我們非常熱衷於付款人在這方面對處於需要 Trogarzo 的困境中的患者的反應。
Prakash Gowd - Executive Director of Institutional Equity Research
Prakash Gowd - Executive Director of Institutional Equity Research
Okay. That's great. That's a good sign. Then just on EGRIFTA. Can you talk a little bit about your expectations for the momentum to continue throughout the course of this year? Or are you potentially expecting maybe sales to plateau a bit as the sales force priority now shifts to Trogarzo?
好的。那太棒了。這是一個好兆頭。然後就在 EGRIFTA 上。你能談談你對這一勢頭在今年全年持續的期望嗎?或者您是否可能期望隨著銷售人員的優先權現在轉移到 Trogarzo,銷售可能會有所平穩?
Luc Tanguay - CEO, President and Non-Independent Director
Luc Tanguay - CEO, President and Non-Independent Director
No, we -- it's a very good question, Prakash. We're still in line with our guidance on sales of Trogarzo. We believe that we will have between 10% to 15% growth in EGRIFTA this year. And to make sure that the whole sales force will not shift solely on Trogarzo, we make sure that the incentive plan will cover both EGRIFTA and Trogarzo. So it's very important for us to continue the growth of EGRIFTA. Of course, we won't have the same growth in Trogarzo. But it's a product that generates good gross margin, and it's a very important asset for us. So we're still seeing some growth in EGRIFTA for the rest of the year. We don't think we're going to get the plateau this year. Yes.
不,我們——這是一個很好的問題,Prakash。我們仍然符合我們對 Trogarzo 銷售的指導。我們相信今年 EGRIFTA 的增長率將在 10% 到 15% 之間。為了確保整個銷售團隊不會只轉向 Trogarzo,我們確保激勵計劃將涵蓋 EGRIFTA 和 Trogarzo。因此,繼續發展 EGRIFTA 對我們來說非常重要。當然,我們不會在 Trogarzo 有同樣的增長。但它是一種產生良好毛利率的產品,對我們來說是一項非常重要的資產。因此,在今年餘下的時間裡,我們仍然看到 EGRIFTA 有所增長。我們認為今年不會達到平穩期。是的。
Lyne Fortin - Senior VP & Chief Commercial Officer
Lyne Fortin - Senior VP & Chief Commercial Officer
And if I can add as well is that promoting Trogarzo is opening up new doors for EGRIFTA as well, because ID specialists who are interested in treating HIV may not have been so interested in talking about the co-morbidity conditions associated with HIV care. But now having our representative present Trogarzo is opening up those new avenues to discuss EGRIFTA in physicians who may have not been that accessible in the past.
如果我還可以補充一點,推廣 Trogarzo 也為 EGRIFTA 打開了新的大門,因為對治療 HIV 感興趣的 ID 專家可能對談論與 HIV 護理相關的合併症不太感興趣。但現在我們的代表 Trogarzo 正在開闢新的途徑,在過去可能無法接觸到的醫生中討論 EGRIFTA。
Prakash Gowd - Executive Director of Institutional Equity Research
Prakash Gowd - Executive Director of Institutional Equity Research
Okay. That's great. And for the -- for EGRIFTA sales, you mentioned that the growth was offset by increased discounting and slightly negative changes in payer mix. Now is this kind of a onetime thing? Or is this something you're likely to see going forward, the discounts and payer mix changes?
好的。那太棒了。對於 EGRIFTA 銷售,您提到增長被折扣增加和付款人組合的輕微負面變化所抵消。現在這是一次性的事情嗎?或者這是您可能會看到的東西,折扣和付款人組合會發生變化嗎?
Luc Tanguay - CEO, President and Non-Independent Director
Luc Tanguay - CEO, President and Non-Independent Director
In fact, Prakash, it was partially offset discount -- offset, hopefully. It's just that our gross to net has diminished maybe by 1 or 2 points because we're getting more and more Medicaid patients where the discount is high -- the rebates is higher. So it's just that we're getting more patient. Our patient base is growing. And some patient are coming from Medicaid, and this is normal. I think it just is not that big of a change. Maybe a couple of points -- basis points. Yes.
事實上,普拉卡什,它部分抵消了折扣——希望抵消。只是我們的淨利潤率可能減少了 1 或 2 個百分點,因為我們越來越多的醫療補助患者享受高折扣——回扣更高。所以只是我們變得更有耐心了。我們的患者群正在增長。有些病人來自醫療補助計劃,這是正常的。我認為這並沒有那麼大的變化。也許有幾個點——基點。是的。
Prakash Gowd - Executive Director of Institutional Equity Research
Prakash Gowd - Executive Director of Institutional Equity Research
Last question. Just on the F4 formulation. You're filing the sNDA Q3. I know it's early, but in terms of commercial strategy, is it -- would it be your goal to transition all of the business to the F4 formulation in advance of patent expiry?
最後一個問題。就在 F4 公式上。您正在提交 sNDA Q3。我知道現在還早,但就商業戰略而言,你的目標是在專利到期前將所有業務轉變為 F4 製劑嗎?
Luc Tanguay - CEO, President and Non-Independent Director
Luc Tanguay - CEO, President and Non-Independent Director
We're going to -- once we know how it's going with the FDA in the, let's say, in the second half of this year, we're going to prepare our transition plan for the F4. We think the F4 will capture more -- most of the business. At this point, I would say that we intend to keep the current presentation on the market, that could be for Canada or for some patients that will not like to transit to the new formulation. But most of our business will probably be on the F4 eventually, yes.
我們將——一旦我們知道 FDA 在今年下半年的進展情況,比方說,我們將為 F4 準備過渡計劃。我們認為 F4 將獲得更多——大部分業務。在這一點上,我想說我們打算在市場上保留目前的介紹,這可能適用於加拿大或一些不喜歡過渡到新配方的患者。但我們的大部分業務最終可能會在 F4 上,是的。
Lyne Fortin - Senior VP & Chief Commercial Officer
Lyne Fortin - Senior VP & Chief Commercial Officer
We will have actual plans to make that very attractive in terms of the 1 vial reconstitution instead of 2, the no refrigeration, the smaller needle size. So there's a lot of good commercial, promotional spin that we will be using to leverage that new formulation.
我們將製定實際計劃,使其在 1 瓶重組而不是 2 瓶、無需冷藏、針頭尺寸更小方面非常有吸引力。因此,我們將使用很多好的商業、促銷手段來利用新的配方。
Operator
Operator
(Operator Instructions) Your next question comes from the line of Endri Leno from National Bank.
(操作員說明)您的下一個問題來自國家銀行的 Endri Leno。
Endri Leno - Associate
Endri Leno - Associate
Just a quick one from me for Trogarzo. I was wondering if you can please provide, what do you expect the public/private payer mix composition to be when it's all said and done? And then as perhaps a follow-up a little bit to that, I mean, what -- or when do you expect Medicare, Medicaid approval or inclusion to come?
我為 Trogarzo 快速地寫了一封信。我想知道您是否可以提供,當一切都說完之後,您期望公共/私人付款人的組合構成如何?然後作為對此的一點後續行動,我的意思是,什麼——或者你預計醫療保險、醫療補助計劃何時會獲得批准或納入?
Luc Tanguay - CEO, President and Non-Independent Director
Luc Tanguay - CEO, President and Non-Independent Director
In general, Medicaid, Medicare and private, we expect to have more and more approved between 3 to 6 months. That is our target. As our -- as I mentioned in my speech, we already have some -- that has put Trogarzo on their policy, both from private and public payers at this point. So it's already started, but we're going to get momentum between 3 to 6 months. That's where we think we're going to have the most of them for that part. In terms of proportion, we believe that -- what's the percentage, Lyne, maybe 1/3 each from that?
一般來說,Medicaid、Medicare 和私人,我們預計在 3 到 6 個月之間會有越來越多的批准。那是我們的目標。正如我們——正如我在演講中提到的那樣,我們已經有一些——已經將 Trogarzo 納入了他們的政策,目前來自私人和公共支付者。所以它已經開始了,但我們將在 3 到 6 個月之間獲得動力。這就是我們認為我們將在該部分擁有最多的地方。就比例而言,我們認為 - 百分比是多少,Lyne,每個人可能佔 1/3?
Lyne Fortin - Senior VP & Chief Commercial Officer
Lyne Fortin - Senior VP & Chief Commercial Officer
Yes, probably 1/3 each commercial, Medicare and Medicaid and ADAP.
是的,每個商業廣告、醫療保險、醫療補助和 ADAP 可能各佔 1/3。
Operator
Operator
There are no further questions at this time. Mr. Boucher, I turn the call back over to you.
目前沒有其他問題。鮑徹先生,我把電話轉給你。
Denis Boucher - VP of Communications & Corporate Affairs
Denis Boucher - VP of Communications & Corporate Affairs
Well, thank you. On behalf of everyone here, I would like to thank you for being on the call today. Have a great day.
嗯,謝謝。我代表在座的每一個人,感謝你們今天的來電。祝你有美好的一天。
Operator
Operator
This concludes today's conference call. You may now disconnect.
今天的電話會議到此結束。您現在可以斷開連接。