Theratechnologies Inc.(THERF) 首席执行官 Luc Tanguay 在 2019年 第二季度业绩 - 收益电话会议记录

[机器翻译] 电话会议 · 2019年07月12日 · 116 次阅读

Theratechnologies Inc. (OTCPK:THERF) Q2 2019 Results Earnings Conference Call July 11, 2019 8:30 AM ET

Theratechnologies Inc.([OTCPK:THERF])2019年第二季度业绩收益电话会议2019年7月11日美国东部时间上午8:30

公司参与者

Denis Boucher - Vice President, Communications and Corporate Affairs
Luc Tanguay - President and Chief Executive Officer
Philippe Dubuc - Senior Vice President and Chief Financial Officer
Christian Marsolais - Senior Vice President and Chief Medical Officer
Jovan Antunovic - Senior Vice President and Chief Commercial Officer

  • Denis Boucher - 通信和公司事务副总裁
  • Luc Tanguay - 总裁兼首席执行官
  • Philippe Dubuc - 高级副总裁兼首席财务官
  • Christian Marsolais - 高级副总裁兼首席医疗官
  • Jovan Antunovic - 高级副总裁兼首席商务官

电话会议参与者

Bryan Abrahams - RBC Capital Markets
André Uddin - Mackie Research Capital Corporation

  • 布莱恩亚伯拉罕 - 加拿大皇家银行资本市场
  • AndréUddin - Mackie Research Capital Corporation

会议主持员

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to this Theratechnologies Earnings Conference Call. At this time, all participants are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. Instructions will be provided at that time for you to queue up for questions. [Operator Instructions].
I would like to remind everyone that this conference call is being recorded today, July 11, 2019 at 8:30 AM Eastern Time.
I would now like to turn the conference over to Mr. Denis Boucher, Vice President, Communications and Corporate Affairs. Monsieur Boucher, please go ahead.

女士们,先生们,早上好,谢谢你们的支持。 欢迎参加本次Theratechnologies收益电话会议。 此时,所有参与者都处于只听模式。 演讲结束后,我们将进行问答环节。 当时将提供说明,供您排队提问。 [操作员说明]。

我想提醒大家,这个电话会议正在记录,即2019年7月11日美国东部时间上午8:30。

我现在想把会议转交给通讯和公司事务副总裁Denis Boucher先生。 鲍彻先生,请继续。

丹尼斯鲍彻

Thank you very much. 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.
Before Luc 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.
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.
Theratechnologies refers current and potential investors to the Forward-Looking Information section of its Management's Discussion and Analysis issued this morning and to its annual information form dated February 20, 2019, and the Risk Factors section therein available at www.sedar.com under Theratechnologies' public filings.
Forward-looking statements represent Theratechnologies' expectations as of the 1, 2019. 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.
I would now like to turn the conference over to Luc.

非常感谢你。谢谢你,欢迎你。 Theratechnologies总裁兼首席执行官Luc Tanguay先生以及高级副总裁兼首席财务官Philippe Dubuc先生将在今天的电话会议上发言。专门针对金融分析师的问答时段将在他们的演讲之后进行。

在Luc开始发言之前,Theratechnologies要求我阅读以下关于前瞻性陈述的信息。我想提醒大家,Theratechnologies今天的言论包含有关其当前和未来计划,期望和意图,结果,活动水平,绩效,目标或成就或其他未来事件或发展的前瞻性陈述。

在准备这些前瞻性陈述时,Theratechnologies做出了若干假设,并且公司实际获得的结果与这些陈述存在重大差异。因此,公司无法保证任何前瞻性陈述将会实现,并且警告您不要过度依赖它们。

Theratechnologies将当前和潜在投资者引入其今天上午发布的管理层讨论和分析的前瞻性信息部分以及2019年2月20日的年度信息表格,其中的风险因素部分可在www.sedar.com的Theratechnologies下获得。公开文件。

前瞻性陈述代表Theratechnologies截至2019年1月的预期。除证券法可能要求外,Theratechnologies不承担更新任何前瞻性陈述的义务,无论是否出现新信息,未来事件或其他情况。

我现在想把会议转交给吕克。

Luc Tanguay

Thank you, Denis. Good morning, everyone, and thank you for being on the call today.
Summer is finally here, but it certainly won't be a slow season for us. We have many irons on the fire and each and every one of them represent an important piece of what we want to accomplish for this company.
May I remind you that our vision and our goal are to become a significant player in the pharmaceutical industry by making a difference in the lives of patients with special medical needs.
Of course, the cornerstone towards achieving this vision is, in the short term, to make the most of what EGRIFTA and Trogarzo have to give in terms of sales.
In Q2, our sales were up substantially compared to the same quarter last year, thanks to the increase in contribution of Trogarzo to our revenue. In fact, we have reached $15.6 million in sales in the last quarter, up from $9.6 million for the same quarter last year, representing over 60% growth.
So, I'd like to talk first about Trogarzo. Last quarter, sales of Trogarzo increased by 13.6% from the previous quarter. Things are evolving quite well for Trogarzo as net sales in June were in line with those of EGRIFTA. We are happy to have reached this milestone.
More importantly, sales of Trogarzo have kept gaining momentum recently. In fact, sales for the first five weeks of Q3 are over 20% higher than those of the first five weeks of Q2 2019.
More than ever, we are confident that peak sales of Trogarzo in the US alone could at least be five times the current sales of EGRIFTA. This has been our target from the start. And a year after lunch, it still is.
To ensure that we reach this rather ambitious objective, we're constantly implementing new initiatives. For example, we started a direct-to-consumer campaign in two key regions in the US, and that could eventually be expanded.
We have revamped our product websites and have hired key account managers in key markets. We are actively building a relationship with patient associations across the US. We will be represented at the next AIDS Walk in San Francisco and we have refined our messaging to align it to the overarching goal of bringing viral loads to undetectable levels. We believe that these initiatives, among many others, will continue to generate momentum from Trogarzo in the US.
Of course, we shall now target about Europe. As you know, we're just a few weeks away from a recommendation from the CHMP for Trogarzo. If positive, it should pave the way for an approval by the European Union.
Once approved, we'll be ready to launch within a few months in Germany, which is one of the main markets in terms of patient population, but also in terms of setting the price point for Trogarzo elsewhere in Europe.
As I said before, Europe represents a sizable market and we have been working diligently for the last few months in order to build a strong [indiscernible 0:06:01] supporting the best pricing possible.
Once we have launched in Germany, we'll turn our attention the other four most important markets, namely France, Italy, Spain and the UK. These markets should be coming online towards the end of 2020.

谢谢你,丹尼斯。大家早上好,谢谢你今天的来电。

夏天终于来了,但对我们来说肯定不会是一个缓慢的季节。我们有许多铁杆,每一个铁杆都代表着我们想要为这家公司完成的重要部分。

请允许我提醒您,我们的愿景和目标是通过改变具有特殊医疗需求的患者的生活,成为制药行业的重要参与者。

当然,实现这一愿景的基石是,在短期内,要充分利用EGRIFTA和Trogarzo在销售方面的贡献。

在第二季度,由于Trogarzo对我们收入的贡献增加,我们的销售额与去年同期相比大幅增长。事实上,上一季度我们的销售额已达到1560万美元,高于去年同期的960万美元,增幅超过60%。

所以,我想首先谈谈Trogarzo。上个季度,Trogarzo的销售额比上一季度增长了13.6%。由于6月份的净销售额与EGRIFTA的净销售额一致,Trogarzo的情况也在不断发展。我们很高兴达到这一里程碑。

更重要的是,Trogarzo的销售最近一直在增长。事实上,第三季度前五周的销售额比2019年第二季度的前五周高出20%以上。

我们比以往任何时候都更有信心仅在美国Trogarzo的销售峰值至少可以达到当前EGRIFTA销量的五倍。这从一开始就是我们的目标。午餐后一年,它仍然是。

为了确保我们实现这一雄心勃勃的目标,我们不断实施新举措。例如,我们在美国的两个主要地区开展了直接面向消费者的活动,最终可能会扩大。

我们改进了产品网站,并在主要市场聘请了大客户经理。我们正积极与美国各地的患者协会建立关系。我们将参加旧金山的下一次艾滋病步行活动,我们已经完善了我们的信息,使其与将病毒载量降至不可检测水平的总体目标相一致。我们相信,这些举措以及其他许多举措将继续在美国的特罗加佐产生动力。

当然,我们现在将以欧洲为目标。如您所知,我们距离CHMP对Trogarzo的推荐只有几周的时间。如果是积极的,它应该为欧盟的批准铺平道路。

一旦获得批准,我们将准备在几个月内在德国推出,这是患者人数方面的主要市场之一,同时也为Trogarzo在欧洲其他地方设定价格点。

正如我之前所说,欧洲代表了一个相当大的市场,我们在过去的几个月里一直在努力工作,以便建立一个强大的[音频不清晰0:06:01]来支持最好的定价。

一旦我们在德国推出,我们将把注意力转移到其他四个最重要的市场,即法国,意大利,西班牙和英国。这些市场应该在2020年底上线。

We now have the key people in place to prepare the market prior to an approval by the European Union. Our recent interaction with key opinion leaders as well as a market study we commissioned confirmed our earlier expectation that Europe will represent a market approximately half the size of the US.
I think anyone would be hard-pressed not to be excited about the future of Trogarzo. Already, it's having a profound impact on our company, but we are more than ever convinced that it will be the game changer that we thought it would be for Theratechnologies in due course based on the fact that we have made and keep making the right moves.
Of course, and like many other things in life, success comes when you remain focused on the task at hand and show patience.
Moving to EGRIFTA, we're just a few months away from the launch of EGRIFTA SV, a new and more user-friendly formulation. In fact, we expect to launch this exciting new product in the US at the end of September, giving the product features we think that it will help to give renewed interest in EGRIFTA.
As you know, when we regained commercial rights to EGRIFTA, the goal was to generate the leverage to bring Theratechnologies to the next level. This is exactly what happened, but this is far from being the end of the story.
As you know, we just announced our intention to develop a new and patented formulation of EGRIFTA for an indication in HIV patients with NASH.
Our decision became fairly obvious once data from a study conducted by Dr. Steve Grinspoon of the MGH was released. The effect of tesamorelin on liver fat and liver fibrosis is significant.
Tesamorelin reduced liver fat by 37% compared to placebo. It was also shown that 35% of the patients returned to normal liver value compared to only 5% in the placebo group. And both results were statistically significant.
Furthermore, only 10.5% of tesamorelin patients experienced progression of liver fibrosis compared to 37.5% in patients receiving a placebo, a result which was also statistically significant even if the number of patients was relatively limited.
This clearly shows that tesamorelin is a serious contender to become a promising option for the treatment of NASH in HIV patients.
EGRIFTA is the only product in late-stage development for the treatment of NASH in HIV patients. And in addition, we have accumulated several years of actual clinical experience with tesamorelin in close to 6,500 patients.. In fact, our product was deemed to be safe enough for the FDA to lift post-approval commitments when it approves EGRIFTA.
Based on our preliminary market research, we estimate that this new indication could target anywhere between 100,000 to 300,000 patients in the US only, and we also estimate that this could represent for us a market potential that could generate sales 8 to 8.5 [ph] times higher than the current indication of EGRIFTA. Further market research is ongoing, but already you can appreciate the massive potential it holds for EGRIFTA.

在获得欧盟批准之前,我们现在有关键人员准备市场。我们最近与主要意见领袖的互动以及我们委托进行的市场研究证实了我们早先的预期,即欧洲将代表市场规模约为美国的一半。

我想任何人都会很难不对Trogarzo的未来感到兴奋。它已经对我们公司产生了深远的影响,但我们比以往任何时候都更加确信它会成为游戏规则改变者,我们认为它将适用于Theratechnologies,因为我们已经制定并继续做出正确的行动。

当然,就像生活中的许多其他事情一样,当你专注于手头的任务并表现出耐心时,就会取得成功。

转向EGRIFTA,我们距离推出EGRIFTA SV还有几个月的时间,这是一种新的,更加用户友好的配方。事实上,我们预计将于9月底在美国推出这款令人兴奋的新产品,我们认为这将有助于重新引起对EGRIFTA的兴趣。

如您所知,当我们重新获得EGRIFTA的商业权利时,目标是产生杠杆作用,使Theratechnologies更上一层楼。这正是发生的事情,但这远不是故事的结局。

如您所知,我们刚刚宣布打算开发一种新的专利EGRIFTA配方,用于治疗HIV患者的NASH。

一旦MGH的Steve Grinspoon博士进行的研究数据公布,我们的决定就变得相当明显。特沙莫瑞对肝脏脂肪和肝纤维化的作用是显着的。

与安慰剂相比,Tesamorelin使肝脏脂肪减少了37%。研究还表明,35%的患者恢复正常肝脏值,而安慰剂组仅为5%。两项结果均具有统计学意义。

此外,只有10.5%的tesamorelin患者出现肝纤维化进展,而接受安慰剂的患者只有37.5%,即使患者数量相对有限,结果也具有统计学意义。

这清楚地表明,tesamorelin是一种有力的竞争者,成为治疗HIV患者NASH的有希望的选择。

EGRIFTA是治疗HIV患者NASH的后期开发中唯一的产品。此外,我们已经在接近6,500名患者中积累了几年的tesamorelin实际临床经验。事实上,我们的产品被认为足够安全,FDA在批准EGRIFTA时可以解除批准后的承诺。

根据我们的初步市场调查,我们估计这一新指标仅针对美国100,000至300,000名患者,我们还估计这可能代表我们的市场潜力可以产生8至8.5 [ph]次的销售额高于EGRIFTA的当前指示。进一步的市场研究正在进行中,但您已经意识到它对EGRIFTA的巨大潜力。

As for the non-HIV market, we will make a decision by year-end. The non-HIV market may seem like an obvious choice because of its size, but we must take as many factors into consideration.
Among them, we must consider the competition, the product profile, the cost of development, and reflect on the potential partnership for this particular indication. We need to answer these questions, and that's why we need a little bit more time to establish our approach in that market segment.
In HIV patients, though, the situation is quite different, given that the product is already marketed for lipodystrophy in HIV patients. It will not require such a large Phase III trial and tesamorelin is the only product in late-stage development for NASH in HIV patients.
In addition, NASH HIV could become the entry door for EGRIFTA in Europe, which could be yet another significant growth generator for Theratechnologies.
In conclusion, this is a great opportunity for Theratechnologies. The reward could be significant in the fairly short term as this is not a 10-year development program.
But to give you even more reason to be excited about Theratechnologies, let me come back on the unique oncology treatment platform.
While huge progress has been made in the treatment of various forms of cancers, a lot remains to be done in terms of efficacy and tolerability. Existing cancer treatments are notorious for their less-than-desirable side effects.
This is where our targeted oncology platform comes in. Currently, existing treatment can be compared to carpet bombing, which in the process of reaching the villain also attack the innocent.
Our technology could potentially change this by using a peptide that could ensure that cancer cells are targeted while healthy cells are left alone. In vitro and in vivo data release at ASCO demonstrated just how much potential there is in this new approach to cancer treatment.
The beauty of it all is that we use already-approved anticancer agent to attach to our peptide technology. This means that rather than developing completely new investigational agents like a gene therapy or immunotherapy, we are working on making already-effective agents even better in terms of efficacy and safety.
Our goal is to initiate the clinical trial in 2020 and complete a proof-of-concept in patients in the second half of 2021, which is just around the corner.
I believe that you can appreciate just how much and how quickly things are changing for the better at Theratechnologies and this is a sign of our focus on the task at hand and our commitment to deliver on our vision.
So, on that note, I will now let Philippe present our results and I will come back after for a few closing remarks.

至于非HIV市场,我们将在年底前作出决定。由于其规模,非艾滋病病毒市场似乎是一个明显的选择,但我们必须考虑到许多因素。

其中,我们必须考虑竞争,产品概况,发展成本,并反思这一特定指标的潜在伙伴关系。我们需要回答这些问题,这就是我们需要更多时间在该细分市场中建立我们的方法的原因。

然而,在HIV患者中,情况完全不同,因为该产品已经在HIV患者中销售用于脂肪代谢障碍。它不需要如此大规模的III期试验,而tesamorelin是HIV患者NASH后期开发的唯一产品。

此外,NASH HIV可能成为欧洲EGRIFTA的入口,这可能是Theratechnologies的另一个重要增长发生器。

总之,这对Theratechnologies来说是一个很好的机会。奖励在相当短的时间内可能很重要,因为这不是一个10年的发展计划。

但是为了让你更有理由对Theratechnologies感到兴奋,让我回到独特的肿瘤治疗平台。

虽然在治疗各种形式的癌症方面取得了巨大进步,但在功效和耐受性方面仍有许多工作要做。现有的癌症治疗因其不太理想的副作用而臭名昭着。

这就是我们的目标肿瘤学平台的用武之地。目前,现有的治疗方法可以与地毯式爆炸相比,后者在到达恶棍的过程中也会攻击无辜者。

我们的技术可能通过使用一种肽来改变这一点,该肽可确保靶向癌细胞,同时保留健康细胞。 ASCO的体外和体内数据发布证明了这种新的癌症治疗方法有多大潜力。

这一切的美妙之处在于我们使用已经批准的抗癌剂来附加我们的肽技术。这意味着我们不是开发全新的研究药物,如基因疗法或免疫疗法,而是在功效和安全性方面努力使已经有效的药物更好。

我们的目标是在2020年启动临床试验,并在2021年下半年完成对患者的概念验证,即将到来。

我相信您可以在Theratechnologies中了解事情的变化有多快和多快,这表明我们专注于手头的任务以及我们对实现愿景的承诺。

所以,就此而言,我现在让Philippe介绍我们的结果,之后我会回来几句结束语。

Philippe Dubuc

Thank you, Luc. And good morning, everyone. As Luc had just mentioned, our second quarter results are again setting a new record for us. Our second quarter consolidated revenues were up 63% compared to the same quarter last year and they reached $15.6 million.
Looking at sales by product, EGRIFTA net sales were $8.6 million, basically unchanged from Q2 of last year. One of the reasons for this was a shift in patient mix towards more publicly-insured patients than in the same period last year. And as you know, we offer greater rebates for these payers. The EGRIFTA sales are expected to resume growing in the latter part of this year as we launch EGRIFTA SV which we used to refer to as the F4 formulation.
Increased compliance and adherence are expected with EGRIFTA SV due to the product's more patient-friendly attributes. Also, as EGRIFTA SV is considered a new product by public payers in the US, rebates with these groups will be reset and renegotiated before launch.
In practice, this means that our rebates offered, which in some cases reach 80%, will be reduced substantially. This is important since a growing number of EGRIFTA patients are currently eligible for rebates.
As for Trogarzo, unit sales were up 14.5% and reached $7 million in the second quarter of 2019, up 13% in dollar terms from the first quarter of 2019 and compared to $924,000 for the second quarter of last year.
Reaching this level of sales has triggered the first commercial milestone, having reached $20 million over the past four quarters. As such, we will be paying the first half of the $7 million milestone or $3.5 million in the coming days to TaiMed.
Given all the recent efforts and the activities that we're launching, we expect that sales will keep growing strongly in the future. Again, as Luc mentioned, unit sales to pharmacies for the first five weeks of Q3 show strong growth of 20% over the first five weeks of Q2 2019.
Cost of goods sold in the second quarter of 2019 amounted to $5.4 million, up from $1.6 million for the same quarter last year. This is due in large part to the introduction of Trogarzo and to overall increased sales in the US.
As for R&D expenses, they increased to $2.6 million in Q2 2019 compared to $1.9 million for the same quarter last year. The increase is largely due to regulatory and prelaunch activities in Europe, which are mostly nonrecurring, as well as our increased activity due to our acquisition of Katana Biopharma in February of this year. Again, the FDA's decision to release Theratechnologies from the EGRIFTA postapproval commitments helped to offset the increase.
Selling and market development expenses increased to $7 million compared to $6 million last year. This is a reflection of increased activities in the United States and Europe.
General and administrative expenses grew to $1.8 million in the second quarter of 2019 compared to $1.3 million for the same quarter last year. Again, the increase comes as a result of our growing presence in Europe.

谢谢你,吕克。大家早上好。正如吕克刚刚提到的,我们的第二季度业绩再次为我们创造了新纪录。我们的第二季度综合收入与去年同期相比增长了63%,达到了1560万美元。

从产品销售情况看,EGRIFTA净销售额为860万美元,与去年第二季度基本持平。造成这种情况的原因之一是患者组合向更多公开保险患者转移,与去年同期相比。如您所知,我们为这些付款人提供更高的回扣。预计今年下半年EGRIFTA的销量将恢复增长,因为我们推出了EGRIFTA SV,我们曾将其称为F4配方。

由于该产品具有更加耐心的特性,因此EGRIFTA SV有望提高合规性和依从性。此外,由于EGRIFTA SV被美国的公共付款人视为新产品,因此在启动之前将重置和重新协商这些组的回扣。

在实践中,这意味着我们提供的折扣(在某些情况下达到80%)将大幅减少。这很重要,因为越来越多的EGRIFTA患者目前有资格获得回扣。

至于Trogarzo,2019年第二季度的单位销售额增长14.5%,达到700万美元,按美元计算比2019年第一季度增长13%,而去年第二季度为924,000美元。

达到这一销售水平已经引发了第一个商业里程碑,在过去的四个季度中达到了2000万美元。因此,我们将在未来几天向TaiMed支付700万美元里程碑的上半年或350万美元。

鉴于我们最近的努力和我们正在推出的活动,我们预计未来销售将继续强劲增长。 Luc再次提到,第三季度前五周药房的单位销售额在2019年第二季度的前五周强劲增长了20%。

2019年第二季度的销售成本为540万美元,高于去年同期的160万美元。这在很大程度上归功于Trogarzo的引入以及美国整体销售额的增长。

至于研发费用,它们在2019年第二季度增加到260万美元,而去年同期为190万美元。这一增长主要是由于欧洲的监管和发布前活动(主要是非经常性的)以及由于我们在今年2月收购Katana Biopharma而增加的活动。同样,FDA决定从EGRIFTA批准后的承诺中释放Theratechnologies,这有助于抵消这一增长。

与去年的600万美元相比,销售和市场开发费用增加到700万美元。这反映了美国和欧洲活动的增加。

2019年第二季度的一般管理费用增加到180万美元,而去年同期为130万美元。此外,由于我们在欧洲的业务增长,这一增长也随之而来。

We recorded a positive adjusted EBITDA of $453,000 in Q2 2019 compared to a negative adjusted EBITDA of $819,000 in Q2 of 2018. Of course, our EBITDA is being impacted by the investments being made on several fronts, including preparation work in Europe, the preparation for the launch of EGRIFTA SV and the development of the oncology platform.
In Q2 2019, finance costs came to $1.45 million compared to $283,000 in Q2 of 2018. Most of the increase is associated with the interest on the convertible notes, which were issued in June 2018.
Finance costs were somewhat offset by finance income of $292,000 due to the higher cash and cash equivalents balances for the quarter.
For the second quarter of 2019, we recorded a net loss of $3.2 million or $0.04 per share compared to a net loss of $1.9 million or $0.03 per share for the same period last year.
While our operations were largely breakeven in terms of cash use for the quarter, a combination of higher receivables and inventories, coupled with a decrease in our accounts payable, contributed to the use of $10 million in the quarter.
Higher receivables were related to higher sales, but also to the timing of orders within the quarter. Higher inventories are again related to higher sales activity, but also inventory buildup in preparation for the launch of EGRIFTA SV, while lower payables are mostly related to the timing of various payments to suppliers. We consider this level of change in working capital as being exceptional and expect more normal variations going forward.
Our financial position remains strong, with $43 million in cash and bonds at the end of the second quarter.
Before I turn it over to Luc for some closing remarks, I would like to announce that our board has formally authorized management to prepare and file an application to list our shares on NASDAQ. A listing on a US-based exchange will help us gain wider recognition, increase the liquidity of our stock, expand our shareholder base and better reflect the value of Theratechnologies. My team and I are actively working on the required documentation and we expect to file the application within the next few weeks.
Luc?

我们在2019年第二季度录得的正调整EBITDA为453,000美元,而2018年第二季度的调整后EBITDA为819,000美元。当然,我们的EBITDA受到多个方面的投资影响,包括欧洲的准备工作,准备工作EGRIFTA SV的推出和肿瘤学平台的发展。

2019年第二季度,融资成本为145万美元,而2018年第二季度为283,000美元。大部分增长与2018年6月发行的可转换票据利息相关。

由于本季度现金和现金等价物余额较高,财务费用在一定程度上被财务收入292,000美元抵消。

对于2019年第二季度,我们录得净亏损320万美元或每股0.04美元,而去年同期净亏损190万美元或每股0.03美元。

虽然我们的业务在本季度的现金使用方面基本保持盈亏平衡,但应收账款和存货增加以及应付账款减少的组合导致本季度使用1000万美元。

较高的应收账款与销售额增加有关,也与本季度的订单时间有关。较高的库存再次与较高的销售活动有关,但也与库存积累有关,为EGRIFTA SV的推出做准备,而较低的应付款主要与向供应商支付各种款项的时间有关。我们将营运资本的这种变化水平视为特殊情况,并期待更多正常变化。

我们的财务状况依然强劲,第二季度末的现金和债券为4300万美元。

在我将其转交给Luc的一些结束语之前,我想宣布我们的董事会已经正式授权管理层准备并提交申请以在纳斯达克上市我们的股票。在美国交易所上市将有助于我们获得更广泛的认可,增加我们股票的流动性,扩大我们的股东基础并更好地反映Theratechnologies的价值。我和我的团队正在积极处理所需的文档,我们希望在接下来的几周内提交申请。

吕克?

Luc Tanguay

Thank you, Philippe. As you can appreciate, our company keeps going in the right direction with sales moving up and several initiatives that are designed to support our growth.
The bottom line is that we have a company built on solid footing with potential to grow rapidly in the short, mid and long-term. In the short-term, Trogarzo keeps gathering momentum, while EGRIFTA should get renewed interest with the launch of EGRIFTA SV early in the fall.
Europe also holds great potential for Trogarzo. And if we receive an approval around the end of September, we should be in a position to start recording sales in Germany by the end of this year.
Over the mid and long-term, slow push version of Trogarzo, the NASH indication for EGRIFTA and our oncology platform represent huge opportunities that could bring us to the level we envision for this company.
I want to thank you all for being on the call today and we will now take questions from financial analysts.

谢谢Philippe。 正如您所欣赏的那样,我们公司一直朝着正确的方向前进,销售额不断上升,并且还有一些旨在支持我们发展的举措。

最重要的是,我们拥有一家建立在稳固基础上的公司,并有可能在短期,中期和长期内迅速发展。 在短期内,Trogarzo不断积聚动力,而EGRIFTA应该会在秋季初推出EGRIFTA SV时重新受到关注。

欧洲也拥有Trogarzo的巨大潜力。 如果我们在9月底前获得批准,我们应该能够在今年年底之前开始在德国销售。

在中长期,缓慢推进的Trogarzo版本中,EGRIF的NASH指示和我们的肿瘤平台代表了巨大的机会,可以将我们带到我们为这家公司设想的水平。

我想感谢大家今天的来电,我们现在将向金融分析师提问。

问答环节

Thank you. [Operator Instructions]. Your first question comes from the line of Bryan Abrahams from RBC Capital markets. Please go ahead.

谢谢。 [操作员说明]。 你的第一个问题来自RBC Capital市场的Bryan Abrahams。 请继续。

布莱恩亚伯拉罕

Hi there. Thanks very much for taking my questions. On Trogarzo in Europe, I guess, first, on the regulatory side, can you talk about where you stand with respect to the registry there, your confidence you'll have sufficient sites and patient numbers and whether or not you might expect oral arguments prior to CHMP's decision?
And then, maybe on the commercial front, it sounds like there could be a potentially robust opportunity based on your latest market research. I was wondering if you could drill down on that a little bit more in terms of your expectations for – what you're learning about what the treatment dynamics could look like in Europe and maybe some similarities and differences to the US. Thanks.

嗨,您好。 非常感谢您提出我的问题。 在欧洲的Trogarzo,我想,首先,在监管方面,你能谈谈你对那里的注册表的立场,你有信心,你将有足够的网站和患者数量,以及你是否可能期望口头辩论 CHMP的决定?

然后,也许在商业方面,听起来根据您的最新市场研究可能存在潜在的强大机会。 我想知道你是否可以根据自己的期望进一步深入了解 - 你在了解欧洲的治疗动态可能是什么,以及与美国的某些相似之处和不同之处。 谢谢。

Luc Tanguay

Okay. So, I have a few of my colleagues in the room with me. So, Jovan for commercial and Christian for medical. So, I'll ask Christian to answer the question on the regulatory.

好的。 所以,我和我的房间里有几个同事。 因此,Jovan用于商业和基督教用于医疗。 所以,我会请克里斯蒂安回答关于监管的问题。

Christian Marsolais

Yeah. Bryan, regarding the regulatory for Trogarzo in Europe, it's going very well. As for any file, we had a number of questions. Those questions were addressed. We recently also announced that we were taking a bit more time to address some of the questions and we're quite confident in our responses that we have put forward for the EMA and we're expecting responses towards the end of July on the file.

是啊。 布莱恩,关于Trogarzo在欧洲的监管,它进展顺利。 至于任何文件,我们都有很多问题。 这些问题得到了解决。 我们最近还宣布,我们花了一些时间来解决一些问题,我们对我们针对EMA提出的回复非常有信心,我们期待7月底对该文件的回复。

Jovan Antunovic

Yeah. On the commercial side, what we see is that, from the research is that actual market size is similar to the United States. We also see similarities in some of the markets. For example, Germany is structured in a similar way to the US whereby we have a mix of hospital usage as well as community usage, whereas the other markets are more hospital-based. One thing of interest is that, although we haven't launched in Europe yet, we have quite a high awareness for the drug already, and that is going to grow as we get the approval and moving to more commercial activities once we get approval.

是啊。 在商业方面,我们看到的是,从研究中看,实际市场规模与美国相似。 我们也看到一些市场的相似之处。 例如,德国的结构与美国类似,我们将医院用量和社区用量混合在一起,而其他市场则更多地以医院为基础。 有一点值得关注的是,尽管我们还没有在欧洲推出,但我们已经对这种药物有了很高的认识,并且随着我们获得批准并且一旦获得批准就转向更多商业活动,这种情况将会增长。

布莱恩亚伯拉罕

Got it. That's really helpful. And then, I was wondering if you could maybe – shifting gears to Trogarzo's US launch and uptake, can you talk a bit about maybe the breadth of the prescribing base, how that's evolving and how the DTC campaign might potentially impact adoption patterns? Do you think the data you presented on those – on the latest five weeks and some of the uptick you're seeing there, do you think that's pulled through from the DTC campaign and any other early signals you can speak of apart from that? Thanks.

得到它了。 这真的很有帮助。 然后,我想知道你是否可以 - 转向Trogarzo在美国的发布和采用,你能否谈谈处方基础的广度,如何发展以及DTC活动可能如何影响采用模式? 你是否认为你提供的数据 - 最近五周以及你在那里看到的一些上涨,你认为这是从DTC活动和你可以说除此之外的任何其他早期信号中得到的吗? 谢谢。

Jovan Antunovic

It's very difficult to get the impact measured as quickly as that from the DTC, but we are getting quite a bit of qualitative feedback from the field about the positive impact that we're having on the – as a result of the DTC for both EGRIFTA and Trogarzo. So, we're still very early in this DTC and we will get results moving forward, but we're very optimistic that it will have an impact on our ability to accelerate Trogarzo and EGRIFTA.

很难像DTC那样快速地测量到影响,但是我们从现场获得了相当多的定性反馈,关于我们对它的积极影响 - 由于两个EGR场的DTC 和特罗加佐。 所以,我们在这个DTC中还很早,我们将会取得进展,但我们非常乐观地认为它会对我们加速Trogarzo和EGRIFTA的能力产生影响。

布莱恩亚伯拉罕

Great. Thanks so much.

非常好。 非常感谢。

会议主持员

[Operator Instructions]. Your next question comes from the line of André Uddin from Mackie Research Capital. Please go ahead.

[操作员说明]。 您的下一个问题来自Mackie Research Capital的AndréUddin。 请继续。

安德烈·乌丁

Good morning, everyone. Just actually wanted to ask, when do you expect to meet with the FDA to discuss your pivotal trial and also will you need to an F8 bioequivalency trial with EGRIFTA? Thanks.

大家,早安。 实际上,您想问一下,您希望何时与FDA会面以讨论您的关键试验?您还需要进行一项针对EGRIFTA的F8生物等效性试验吗? 谢谢。

Luc Tanguay

André, I will address your first question, but I need a clarification for the second one. You're asking for bioequivalence? Can you clarify that part of the question?

安德烈,我将解决你的第一个问题,但我需要澄清第二个问题。 你要求生物等效性? 你能澄清一下这部分问题吗?

安德烈·乌丁

Just wanted to see if you actually had to do any bioequivalence studies with your F8 formulation.

只是想看看你是否真的必须用你的F8配方进行任何生物等效性研究。

Luc Tanguay

Okay, okay. Maybe I'll start with the BS [ph], yes, we're working on this at the moment and is progressing very well. Then we will have to do a bioequivalence similar as the one that we have done for the F4. It is fairly similar in terms of volume of administration versus what we have done between the F1 and the F4. Therefore, we are quite confident that we'll be able to demonstrate bioequivalence.
For the NASH, the file is progressing extremely well. We're working with regulatory consultants, we're working with physicians with expertise in the field of NASH, and we're planning to meet with the FDA and the EMA because we'd like to have one global plan for US and for Europe towards the end of this year. But the file is moving extremely well.

好吧好吧。 也许我会从BS [ph]开始,是的,我们目前正在研究这个问题并且进展顺利。 然后我们将不得不做一个类似于我们为F4所做的生物等效性。 在管理量方面与我们在F1和F4之间所做的相比,它非常相似。 因此,我们相信我们能够证明生物等效性。

对于NASH,文件进展非常顺利。 我们正与监管顾问合作,我们正与拥有NASH领域专业知识的医生合作,我们计划与FDA和EMA会面,因为我们希望为美国和欧洲制定一个全球计划 到今年年底。 但文件移动得非常好。

安德烈·乌丁

Okay, all right. Thank you.

好的,好的。 谢谢。

会议主持员

There are no further questions at this time. I turn the call back over to management for closing remarks.

目前没有其他问题。 我将电话转回管理层以结束评论。

Luc Tanguay

Well, thank you very much. I want to thank everyone for being on the call today. There are no further questions at this time. We will conclude today's conference call. Hope you have a great day and a great summer. Thank you very much. Bye-bye.

好的,谢谢。 我要感谢大家今天的来电。 目前没有其他问题。 我们将结束今天的电话会议。 希望你有一个美好的一天和一个美好的夏天。 非常感谢你。 再见。

会议主持员

Thank you. This concludes today's conference call. You may now disconnect.

谢谢。 今天的电话会议结束了。 您现在可以断开连接。

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