新西兰制药公司 (ZEAL) 首席执行官 Emmanuel Dulac 对 2019年 上半年业绩 - 收益电话成绩单

Zealand Pharma A/S (NASDAQ:ZEAL) First Half 2019 Results Earnings Conference Call August 15, 2019 10:00 AM ET

新西兰制药A / S(纳斯达克股票代码:[ZEAL])2019年上半年业绩收益电话会议2019年8月15日美国东部时间上午10:00


Lani Morvan - Head of Investor Relations and Communications
Emmanuel Dulac - CEO
Adam Steensberg - Chief Medical and Development Officer
Marino Garcia - SVP, Corporation & Business Development

  • Lani Morvan - 投资者关系与传播部主管
  • Emmanuel Dulac - 首席执行官
  • Adam Steensberg - 首席医疗和发展官
  • Marino Garcia - 高级副总裁,公司和业务发展部


David Lebowitz - Morgan Stanley
Graig Suvannavejh - Goldman Sachs
Alan Carr - Needham
Thomas Bowers - Danske Bank
Lucy Codrington - Jefferies
Peter Sehested - Handelsbanken

  • David Lebowitz - 摩根士丹利
  • Graig Suvannavejh - 高盛
  • 艾伦卡尔 - 李约瑟
  • 托马斯鲍尔斯 - 丹麦银行
  • Lucy Codrington - Jefferies
  • Peter Sehested - Handelsbanken


Ladies and gentlemen, thank you for standing by and welcome to the Zealand Pharma Results for the First Half of 2019 Conference Call. At this time, all participants are in a listen-only mode. There will be a presentation, followed by question-and-answer session. [Operator Instructions] I must advise you that this conference is being recorded today, Thursday, 15 of August, 2019.
I would now like to hand the conference over to your first speaker today, Lani Morvan, Head of Investor Relations and Communications. Thank you. Please go ahead.,

女士们,先生们,感谢您的支持,并欢迎参加2019年上半年电话会议的西兰制药业绩。 此时,所有参与者都处于只听模式。 将有一个演示文稿,然后是问答环节。 [操作员说明]我必须告知您,本次会议将于今天,即2019年8月15日星期四举行。

我现在想把这次会议交给你的第一位发言人,投资者关系和传播负责人Lani Morvan。 谢谢。 请继续。,

Lani Morvan

Thank you and welcome to Zealand Pharma’s conference call for the first half of fiscal year 2019. Leading today's call are Zealand’s CEO, Emmanuel Dulac and Chief Medical and Development Officer, Adam Steensberg. Emmanuel will provide financial highlights to the first half of the year, as well as business highlights from the second quarter and the period thereafter. Adam, will follow with highlights from our research and development programs. After their prepared remarks, we will open to take your questions and joining for the Q&A will be the rest of the full corporate management team.
You can find the company announcement containing the first half interim report and additional supporting information on our corporate website as at zealandpharma.com. As the company headquartered in Denmark our financials are reported in Danish crowns, also referred to as kroner. Key figures may have been converted to US dollars for convenience.
On page one, I will point out that we will be making forward-looking statements that are subject to risks and uncertainties. These statements are valid only as of today and the company assumes no obligation to update them unless as required by law. Please refer to recent filings for a more complete picture of risks and other factors.
And as we advance to page two, I will now turn the call over to Emmanuel.

感谢并欢迎来到2019财政年度上半年的西兰制药公司电话会议。今天的电话会议是西兰首席执行官Emmanuel Dulac和首席医疗和发展官Adam Steensberg。 Emmanuel将在今年上半年提供财务亮点,以及第二季度及之后的业务亮点。亚当,将遵循我们的研发计划的亮点。在他们准备好的评论之后,我们将开始接受您的问题,加入问答将是整个公司管理团队的其余部分。




Emmanuel Dulac

Thank you, Lani and thanks to everyone for joining the call today. In the second quarter of 2019 we continued strong execution across all our company objectives. For me it's been now four exciting and busy months since starting at Zealand. I remain honored by the opportunity to grow these leading biotech and impressive team, with a strong track record. And I look forward to building upon the relationship that we have established with all key stakeholders and investors.
Turning to page three. Over the last 20 years Zealand Pharma has proven that our peptide therapeutics platform and know-how is providing us a competitive advantage on the discovery side. We have one of the most predictive and promising platform in biotech.
Over the last 10 years we have proven that we can take multiple programs through the clinics and execute on them according to industry benchmarks. To harvest the benefits of these years of investments and efforts, we are not preparing to take our own products through registration and commercialization. We have retained the full commercial rights for our late-stage programs, and assuming we get approval for glepaglutide and dasiglucagon in all indications, we are contemplating four launches in three years, starting in 2021.
After a score assessment of market potential and partnerships we concluded that building our own commercial presence in the US to market all of the products coming from our fully own programs is the best way for Zealand Pharma to maximize the value of our company and grow our assets.
Of course, right now all eyes are on the dasiglucagon, HypoPal rescue pen. We have strong reasons to be encouraged by about dasiglucagon based on the consistent promising results that we have seen from the rescue pen throughout the clinical studies, as well as from our older programs with dasiglucagon.
The unmet medical need and expansion potential of our hypoglycaemia rescue market is further validated by the recent approval of the nasal glucagon from Navy [ph] The dasiglucagon rescue pen is now expected to be the first product commercialized by our own organization. If all indications are approved as plan, we will enter the market with a rescue pen, gain further momentum with dasiglucagon to treat CHI and culminate our efforts with the significant potential of transforming life with diabetes, with use of the dual hormone artificial pancreas.
To fulfill our ambition of becoming a fully integrated biotech company that we’ve added strategic decision to realize the full value of the combined dasiglucagon opportunity, we are accelerating the buildup of our U.S. operations and preparing for transition into a commercial stage company in 2020. This is an exciting and pivotal time for our company history. We will update you in the coming quarters on our commercial readiness efforts in much more detail.
Moving ahead to page four. You will see key financial metrics and business insights from the first half of 2019. Beginning with financial results through the period ending June 30, Zealand recognized just under DKK20 million in revenue, attributable to our agreement with Alexion.


转到第三页。在过去的20年里,Zealand Pharma已经证明我们的肽疗法平台和专有技术为我们在发现方面提供了竞争优势。我们拥有生物技术领域最具预测性和前景的平台之一。


在对市场潜力和合作伙伴关系进行评分后,我们得出结论,在美国建立自己的商业存在以推销来自我们完全​​自己的计划的所有产品,这是西兰制药最大化公司价值和发展资产的最佳途径。 。





We have net operating expenses of DKK292 million. We ended the house with a net operating loss of DKK272 million. We are taking the opportunity to adjust our guidance on net operating expenses for the year, now expected to be within DKK580 million to DKK600 million changed from previous DKK550 million to DKK570 million.
Change in guidance is mainly related to strong clinical progress, resulting in additional spend on ZP7570 and dasiglucagon CHI programs, as well as accelerated build up in the US to prepare for commercialization of the dasiglucagon HypoPal rescue pen.
For business highlights, we saw overall strong progress and solid results made across our pipeline. Adam will go through the details shortly. I will simply point to the encouraging results delivered by two dasiglucagon program and the extended development of potential novel treatment for short bowel syndrome by advancing both glepaglutide and ZP7570 in clinical studies.
This leads me to discuss further organization on page five. We are now recruiting for two of our top management position. The candidate choices for CFO have been narrowed to finalist, recruitment for a CSO has been initiated as Andy Parker will be departing Zealand’s Chief Scientific Officer. During his time at Zealand, Andy has contributed greatly to advancing our peptide platform and research organization and on behalf of all Zealand Pharma, I want to thank Andy for his hard work and wish him the best in his next endeavor.
In line with the progress of a pipeline, our organization has grown by 16% this year, at 172 employees. We have more resource to support growth in both research and development, while continuing to be a lean and agile organization.
This quarter, I have accelerated the first steps for building commercial operations in the US. We are recruiting for the top leadership roles and started executing on our medical and commercial launch strategy. I look forward to welcoming new team members into these critical roles and to establishing a footprint in the most important markets for potential products.
On page six, we have a visual for our financial position, which remains strong. The chart on the left has been adjusted to reflect the update guidance on net operating expenses, which remains in line with our ambitions, to bring several fleet own programs to the market. And on the right, you can see that our cash position also remained strong with about DKK1.14 billion after the first out of the year.
Moving to page seven. I ask that you please hold the questions until the Q&A later during the call and I will now ask Adam to update on our development programs. Adam?


指导的变化主要与强大的临床进展有关,导致ZP7570和dasiglucagon CHI计划的额外支出,以及美国加速建立以准备商业化dasiglucagon HypoPal救援笔。







Adam Steensberg

Thank you, Emmanuel. So page eight is an overview of Zealand’s extremely robust pipeline. Each of these late stage programs will be covered on the next slides, but notably that is an advancement of ZP7570 into clinical testing, as well as the completion of Phase 2 for the dual hormone pump with dasiglucagon in this last quarter.
The stage clinical programs with Boehringer Ingelheim continue without changes. We expect BI to conclude this year Phase 1 for their once weekly dual glucagon agonist for treatment of obesity and diabetes and we further await their decision regarding Phase 1 initiation for the other once weekly amylin analog also for the treatment of obesity and diabetes. The work has begun with Alexion and they complement inhibitor program and is progressing according to plans.
So on page nine. Glepaglutide, is long-acting GLP-2 analog being developed for treatment of short of short bowel syndrome in an auto injector with potential convenient weekly administration. In 2018 we initiated a pivotal Phase 3 study which remains on track to announce results in 2020. We look forward to the continued steady enrollment of patients throughout the remainder of the year.
Moving to page 10. Dasiglucagon is a potential first in class, stable glucagon analog invented and developed by Zealand and related use HypoPal rescue pen for easy, fast and effective treatment of severe hypoglycemia.
Last quarter we recorded top line results from a conservatory Phase 3 study with median time to glucose recovery of only 10 minutes from injection. This study was important because it was conducted with the auto injector that is intended for the market and it demonstrated similar results to the previous [indiscernible] studies used previous studies.
Results are expected in September from the ongoing Phase 3 pediatric trial using the same dose as administered to adults and thus we remain on track for submitting the NDA to the US FDA in early 2020.
Please turn to page 11. In June, we were extremely pleased to see the results from the Phase 2 trial in patients with Type 1 diabetes with dasiglucagon in the iLet bionic pancreas. This was the first ever outpatient home used clinical study of a true dual artificial pancreas using both insulin and dasiglucagon. And we believe that this study demonstrated unprecedented glycemic control.
We are excited by the disruptive innovation and believe it holds the potential to transform the lives of people burdened with type 1 diabetes. As a next step in the development, we look forward to the pivotal Phase 3 trial that is set to begin in 2020.
Page 12 provides an update on our dasiglucagon program focused on treating congenital hyperinsulinism. A chat with CHI is born with a genetic defect in the pancreas causing continuous high levels of insulin and thus, consistent episodes of dangerous low blood glucose. The burden of this disease on the children and their families is immense and they must constantly battle against the low blood glucose with EG nasogastric feeding and frequent feeding during sleep et cetera.


与Boehringer Ingelheim的阶段临床项目继续没有变化。我们预计BI将在今年第1阶段结束他们每周一次的双重胰高血糖素激动剂治疗肥胖症和糖尿病,我们进一步等待他们决定第1阶段每周一次的胰岛淀粉样多肽类似物用于治疗肥胖症和糖尿病。这项工作已经从Alexion开始,他们补充了抑制剂计划,并且正在按计划进行。

所以在第九页。 Glepaglutide是一种长效GLP-2类似物,用于治疗自动注射器中的短肠综合征短期,可能方便每周给药。在2018年,我们启动了一项关键的第3阶段研究,该研究有望在2020年公布结果。我们期待在今年剩余时间内持续稳定的患者入组率。







Therefore we were very pleased to see during summer increased traction in the - movement into our first Phase 3 study evaluating dasiglucagon prevent - potential to prevent their episodes of hypoglycemia and CHI children aged 3 months to 12 years and we now expect to have the results of this study in 2020. The second Phase 3 trial enrolled 12 children with CHI, some newborns after one year. And that study remains on track for initiation later this year.
Now on page 13, I will return the call to Emmanuel for his concluding remarks.

因此,我们非常高兴地看到在夏季增加牵引力 - 进入我们的第一阶段3研究评估dasiglucagon预防 - 可能预防他们的低血糖发作和3个月至12岁的CHI儿童,我们现在期望得到的结果 这项研究是在2020年进行的。第二期3期试验招募了12名患有CHI的儿童,其中一些是新生儿,一年后。 这项研究有望在今年晚些时候启动。


Emmanuel Dulac

Thank you, Adam for this overview and congratulations for the progress. Very good to see the program advancing as planned.
Page 14 shows the objectives for 2019. Halfway through the year and with updates just provided, you can see that Zealand Pharma is well on track to deliver. On page 15, shows the accomplishments already made in 2019 and the upcoming news items we anticipate for the rest of the year. We believe there are significant opportunities on the horizon to create further value for shareholders and Zealand continues on the clear path for 2019 and we all remain enthusiastic about the progress being made.

感谢Adam,对此进行了总结,并祝贺他取得了进展。 非常高兴看到该计划按计划推进。

第14页显示了2019年的目标。在今年中期和刚刚提供的更新中,您可以看到,西兰制药公司正在按计划进行交付。 在第15页,显示了2019年已经取得的成就以及我们预计今年剩余时间内即将发布的新闻。 我们相信,为股东创造更多价值有很多机会,而且西兰继续走上2019年的明确道路,我们都对正在取得的进展保持热情。

Lani Morvan

Thank you, Emmanuel and Adam. This concludes our prepared remarks. So thank you all for your attention thus far. Tom, we're now ready to take questions. So please open the line.

谢谢Emmanuel和Adam。 以上是我们准备的评论。 所以到目前为止,感谢大家的关注。 汤姆,我们现在准备回答问题了。 所以请打开线。


[Operator Instructions] And we have questions on the line. The first one comes from the line of David Lebowitz [Morgan Stanley]. Your line is now open.

[操作员说明]我们在线上有疑问。 第一个来自David Lebowitz [摩根士丹利]。 你的生产线现已开放。

David Lebowitz

Thank you very much for taking my question. A competitive product [indiscernible] with nasal treatment for hypoglycaemia was just approved I guess, how do you see the competitive dynamic shifting up in the space given the convenience that a nasal approach might offer?

非常感谢您提出我的问题。 对于低血糖的鼻腔治疗而言,一种有竞争力的产品[音频不清晰]刚被批准,我认为,鉴于鼻腔方法可能提供的便利性,您如何看待在空间中竞争性的动态变化?

Emmanuel Dulac

Yes. Well, I think I mean first of all, I think it's a very good news for patients, that's a new drug approved in the sales. It shows as well the largely unmet medical need to several companies are coming up with solutions to these patients. I think as you know the price is kind of set in this market already from increased existing treatments. So I think the pricing of vaccine doesn't necessary change anything for the rest of us. We still believe that there were actually no real promotion for these products in the past, so now having an active compound and injecting in newness in this market will actually rehelp transform this market.
There's a vast potential as patients are not necessarily equipping themselves with these solutions. And because there would be several solutions, there will be actually potential to differentiation between the products. We believe that speed of response will be a very major differentiation points in the future.

是。 嗯,我想我的意思首先,我认为对患者来说这是一个非常好的消息,这是一种在销售中批准的新药。 它还显示,几家公司的医疗需求基本未得到满足,正在为这些患者提供解决方案。 我想如你所知,这个市场的价格已经从增加的现有治疗方法中得到了确定。 所以我认为疫苗的价格没有必要改变我们其他人的任何东西。 我们仍然认为,过去这些产品实际上并没有真正的推广,所以现在拥有一个活跃的化合物,并在这个市场注入新的东西,实际上将重新改造这个市场。

由于患者不一定能够配备这些解决方案,因此潜力巨大。 而且因为会有几种解决方案,实际上可能会区分产品。 我们相信,应对速度将是未来非常重要的差异化点。

David Lebowitz

Thanks for taking my question.



And the next question comes from the line of Graig Suvannavejh [Goldman Sachs]. Your line is now open.

接下来的问题来自Graig Suvannavejh [Goldman Sachs]。 你的生产线现已开放。

Graig Suvannavejh

Great. Good afternoon and good morning and congrats on the progress. I've got a few questions, if you don't mind. My first question just has to do with your decision to now go ahead and formally launch dasiglucagon hypo power as well as the rest of the franchise. Could you just may be give us a little bit more color around that decision? And what was the partnership interest that was generated around the product and in those discussions? And was that the reason why you decided to launch on your own? And I've got a few follow-ups. Thank you.

非常好。 下午好,早上好,祝贺进展。 如果你不介意,我有几个问题。 我的第一个问题就是你决定现在继续正式推出dasiglucagon hyp power以及其他特许经营权。 你能否就这个决定给我们一点颜色? 围绕产品和那些讨论产生的合作关系是什么? 那是你决定自己推出的原因吗? 我有一些后续行动。 谢谢。

Emmanuel Dulac

That's good. I will try to answer all these in one answer actually. But first of all, we saw earlier this year fantastic results from the dual hormone pump. The long-term prospects of the dasiglucagon franchise significantly increased based on these results. So since I started after conducting a thorough assessment of market potential and partnerships, we came to the conclusion that building our own commercial presence in the U.S. is the best way to maximize the value of our company and grow all of our assets. So while we remain open to dialogue with partners and especially, for example, rest of the world, we are preparing to build and launch our assets, which actually fulfills on 1 side our long-term strategic become like a fully integrated research, development and commercial company as well as maximizing the value of our assets. Does that answer your question?

非常好。 我会尽力在一个答案中回答所有这些问题。 但首先,我们今年早些时候看到了双激素泵的奇妙结果。 基于这些结果,dasiglucagon特许经营的长期前景显着增加。 因此,在我对市场潜力和合作伙伴关系进行全面评估后开始,我们得出的结论是,在美国建立自己的商业存在是实现公司价值最大化和增长所有资产的最佳途径。 因此,虽然我们仍然愿意与合作伙伴,特别是世界其他地区进行对话,但我们正在准备建立和启动我们的资产,这实际上实现了我们的长期战略,就像一个完全一体化的研究,开发和 商业公司以及最大化我们资产的价值。 这是否回答你的问题?

Graig Suvannavejh

Yes. It does. Also just on the topic of business development, the company has been fairly vocal about business development opportunities. And obviously, it's hard to predict the outcome of any discussions you're having. But my question is, are you still expecting or hoping for additional business development activities in the second half of the year? And are they more around out licensing or in licensing opportunities?

是。 确实如此。 此外,就业务发展而言,该公司一直在谈论业务发展机会。 显然,很难预测你所进行的任何讨论的结果。 但我的问题是,您是否仍然期望或希望在下半年进行额外的业务开发活动? 他们是在更多的许可或许可机会?

Emmanuel Dulac

That's very efficient. I'm going to pass actually this question to our Chief Business Officer, Marino Garcia.

这非常有效。 我将把这个问题实际传递给我们的首席商务官Marino Garcia。


Hi. As you mentioned, I mean, it's always difficult to predict what transactions you're working on may actually come to fruition and get announced. But what I - what I'm confident or comfortable saying is that we have multiple initiatives going on both from licensing and acquisitions, in and out licensing I should say, as well as potential acquisitions to enhance our pipeline and we're looking at other options as well to help us with our ongoing strategy that Emanuel has highlighted, for example and building in the U.S.
So that we have a - the mandate is very clear, the support from Emanuel and the executives and the board is very clear and we hope to have some announcements of more news in the coming weeks, months ahead.

你好。 正如你所提到的,我的意思是,总是很难预测你正在进行的交易实际上可能会实现并得到宣布。 但是我 - 我有信心或者更自在地说,我们在许可和收购方面都有多项举措,我应该说进出许可,以及为了增强我们的管道而进行的潜在收购,我们正在寻找其他方面。 选项以及帮助我们实现伊曼纽尔强调的持续战略,例如在美国建设

所以我们有一个 - 任务非常明确,伊曼纽尔和高管以及董事会的支持非常明确,我们希望在未来几周,未来几个月内发布更多新闻。

Graig Suvannavejh

Okay. Thank you very much. And then maybe a last question before, maybe I'll jump back into the queue. I'm intrigued about the once weekly GLP-1 glucagon combination, as well as the once weekly amylin analog for obesity IN Type 2 diabetes. And I'm trying to just get a better sense around that opportunity, especially relative to potential positioning versus say like an oral semaglutide? Thanks.

好的。 非常感谢你。 然后可能是最后一个问题,也许我会跳回队列。 我对每周一次的GLP-1胰高血糖素组合,以及每周一次的胰岛淀粉样多肽类似物对2型糖尿病肥胖感兴趣。 而我正试图更好地理解这个机会,特别是相对于潜在的定位,而不是像口服semaglutide? 谢谢。

Adam Steensberg

Thanks, Graig. This is Adam. Maybe I can comment on that. So far from the point of view, we have the to build our assumptions around and then maybe answer that companies will also be ensuring a similar targets. But we have seen both that the GLP-1 and actually the amylin analog is the weight loss potential that exceeds what we have otherwise seen with other compounds. So very promising on that end. And then at the same time, providing very good glycemic control. The modality is such an especially for the Tier 1, I think some scientific point of view, also very attracting in the sense that and the liver, which is a major problem for these patients. Of course, we are in a dialogue with BI and what we can say is that they continue to committed to these programs and see and has potential regardless of the oral compounds that you mentioned, and I think what we alluded here is molecules that we provide efficacy beyond what we're seeing in clinical development with some data so far. So we look very much forward to the next steps. And BI made the decisions on the next steps and of course we'll inform the market when we have that information.

谢谢,格雷格。这是亚当。也许我可以对此发表评论。从目前的角度来看,我们必须围绕这个假设,然后回答公司也将确保类似的目标。但我们已经看到GLP-1和实际上胰岛淀粉样多肽类似物的重量损失潜力超过了我们在其他化合物中看到的。因此在这方面很有希望。然后同时提供非常好的血糖控制。对于方法1来说,这种方式是特别的,我认为有些科学观点,在某种意义上也非常吸引人和肝脏,这对这些患者来说是一个主要问题。当然,我们正在与商务智能进行对话,我们可以说他们继续致力于这些计划并看到并且有潜力,无论您提到的口服化合物如何,我认为我们在此提到的是我们提供的分子到目前为止,我们在临床开发中看到的效果超出了一些数据。所以我们非常期待接下来的步骤。 BI在接下来的步骤中做出了决定,当然我们会在获得这些信息时通知市场。

Graig Suvannavejh

Okay, great. Thank you very much and congratulations again on the progress.

好,太棒了。 非常感谢,并再次祝贺进展。


And the next question comes from the line of Alan Carr [Needham] Your line is now open. You may ask your question.

接下来的问题来自Alan Carr [Needham],你的生产线现已开放。 你可以问你的问题。


Hi, thanks for taking my questions. Somewhere around your plans to close your commercial operations. Is this something that focus just in the U.S.? Or do you plan to also build in Europe? You're going to be expanding effort in Europe, too. And then is it -- coming back to a question earlier, is this more of -- is the decision more of a function in the change in management or strategy? Or is it issues with finding the potential partner? And then also, if you can talk about what's next for the dual pump program for dasiglucagon? Do you need to meet with the FDA for a pre-Phase III meeting? Where does that stand? And where do you think this -- the nature of the scale and nature of the space can be? Thanks.

嗨,谢谢你接受我的问题。 你计划关闭商业运营的地方。 这件事只关注美国吗? 或者你打算在欧洲建造? 你也将在欧洲扩大努力。 然后是它 - 更早回到一个问题,更多的是 - 在管理或战略变革中更多地决定一个功能吗? 或者是找到潜在合作伙伴的问题? 还有,如果你能谈谈dasiglucagon的双泵程序的下一步是什么? 您是否需要与FDA会面以进行第III阶段会议? 那站在哪里? 你认为这个 - 空间的规模和性质的性质是什么? 谢谢。

Emmanuel Dulac

Thank you, Alan. I'm going to respond to the first one, I’ll pass the next two to Adam. On the first one, we are right now only focusing our attention on the US markets and deploying our commercial operations in the US. At the same time and you know especially on the revenue side we will actually try to make our products available on a per patient basis or even in per country basis if we find an avenue there, with the commercial deployment of you know patient services, sales force, medical affair, market access, people will be mostly in the US and the goal is to support the rest of the world on an opportunity basis from people that we have here based in Copenhagen. And for the next two questions, I'm going to give them to Adam.

谢谢,艾伦。 我要回应第一个,我将把接下来的两个传给亚当。 在第一个方面,我们现在只关注美国市场并在美国部署我们的商业运营。 与此同时,您尤其了解收入方面,如果我们在那里找到一条途径,我们将实际尝试按照每位患者或甚至每个国家/地区提供我们的产品,并通过商业部署了解患者服务,销售情况 力量,医疗,市场准入,人们将主要在美国,目标是在哥本哈根的人们的机会基础上支持世界其他地方。 接下来的两个问题,我要把它们交给亚当。

Adam Steensberg

Okay. Maybe on the first one, I think and you asked about kind of a focus on balancing the also, the reasons behind that and perhaps, Emmanuel, he will follow again the few things here, but I think as Emmanuel also included, we have some fantastic data we continue to artificial pancreas release just before ADA, which in our mind demonstrates the potential of changes of using dasiglucagon to really achieve something that has never been achieved before in Type 1 diabetes and that is close to full control without engagement all the time.
So with those data set, you can say the confidence that we have had in the dual hormone opportunity for some time just grew even larger. And of course, in this context, the value of the full franchise, the dasiglucagon goes far beyond the HypoPal rescue pen. So that of course changed a little bit the dynamics of how we look at this and then as Emmanuel also said, he can with his background from U.S. I mean, of course, we a chance to look at our portfolio.
Emmanuel will provide further details just with regards to your last question, these next steps that we have. So already last year, we had a very positive interaction with the FDA, and we have been writing as we have also communicated to the market that they actually do consider growth cost and our partner based on our next phase to engage in Phase III development.
Since then, we have conducted a study, we just discussed and furthermore, earnings has raised significant amount, so we are fully funded to actually going that product that sufficient pancreas to the last stages of development and also engaged in commercialization and have a parts of that.
Our next steps with the FDA is that we will have a meeting with them to discuss the Phase III program. We actually believe it will be a program that is limited, and you can say in size compared to what you would normally expect for these kind of indications, but we would not comment on the complete detail before we are in a meeting with the FDA.
But in the sense of size of the study, we are actually very, very positive. Some of the aspects of the study has already been discussed, but we would like to have it a little bit more firm with the FDA before we put more flavor into this. What I will say is that with the team and the Zealand team is fully engaged and fully in preparation mode to get to the Phase III study to out the next year. So we are working diligently towards that milestone, and we will have meetings with FDA later this year to finalize the plans. And Emmanuel, do you want to add more to that?







Emmanuel Dulac

Alan, do you need more information about the franchise because again, I think dasiglucagon is seen as a franchise. It's not - even though we have you know the rescue pen and the CHI and the dual hormone pump, its I would say - you should look at it from a birds view and it's a Type 1 diabetes market, patient group you know in which there are subgroups in it.
And so we believe that there is real synergies that you know taking this approach as a whole, as a franchise and we will benefit a lot from the experience of marketing and commercializing the first two indications before bringing the dual hormone pump. But you know on the basis of the latest results we definitely wanted to retain.

艾伦,你是否需要更多有关特许经营权的信息,因为我认为dasiglucagon被视为特许经营权。 它不是 - 即使我们让你知道救援笔和CHI以及双激素泵,我会说 - 你应该从鸟类的角度来看它,它是一个1型糖尿病市场,你知道的患者群体在那里 是其中的子组。

因此,我们相信,作为一个整体,你知道采用这种方法存在真正的协同效应,我们将从带来双激素泵之前的前两种适应症的营销和商业化经验中获益良多。 但是你知道在最新结果的基础上我们肯定想保留。


Okay. So with respect to the dual pump, will you be making an announcement after you've confirmed a Phase 3 trial design or we need to wait until you start the trial next year?

好的。 那么对于双泵,您是否会在确认第3阶段试验设计后发布公告,或者我们需要等到明年开始试用?

Emmanuel Dulac

I'm sure we'll talk about, we'll be more specific once I've had the meeting and the does mean that we have planned, as we have also said before and we will make some announcements maybe that is to be seen if it's going to be announcement or just product quarterly that we would be getting at the time on the Montel stand on this once we have the meeting.

我相信我们会谈论,一旦我参加了会议,我们会更加具体,这意味着我们已经计划好了,正如我们之前所说的那样,我们会发表一些声明,或许有待观察 如果它是公告或只是季度产品,那么一旦我们召开会议,我们就会在Montel展位上获得这一点。


And the next question comes from the line of Thomas Bowers from Danske Bank.

接下来的问题来自Danske Bank的Thomas Bowers。

Thomas Bowers

A lot of follow-up questions from me. Just to get a clear view on how you think of commercialization in Europe. Did I understand correctly that you will not build any sales force or anything in Europe? And how should we see or not even going to file for approvals for in Europe? Or will you sort of basically -- are you planning on doing in an inpatient program and then partner with the program in Europe? And I guess that also goes for the rescue pen.
And then secondly, I mean, what's your exact plans on when you enter the U.S. market? I mean, for me, for rescue pen, it does reflect that you need quite a significant sales force. So how do you plan to attack and address the U.S. market? I mean, you have just DKK 1 billion in cash so it is quite large investment that you need to do for 2021. So are you still in negotiations for doing some out licensing outside the U.S. that would cause the balance sheet? Or how should we see that?

我提出了很多后续问题。 只是为了清楚地了解您对欧洲商业化的看法。 我是否正确理解您不会在欧洲建立任何销售人员或任何东西? 我们应该如何看待甚至不在欧洲申请批准? 或者你会基本上 - 你打算在住院计划中做什么,然后与欧洲的计划合作? 我想这也适用于救援笔。

其次,我的意思是,当你进入美国市场时,你的确切计划是什么? 我的意思是,对我来说,对于救援笔来说,它确实反映出你需要相当大的销售力量。 那么你打算如何攻击和解决美国市场? 我的意思是,你现在只有10亿丹麦克朗的现金,所以你需要为2021年做一笔相当大的投资。所以,你是否仍在谈判在美国境外做一些可能导致资产负债表的许可? 或者我们应该怎么看?

Emmanuel Dulac

Thanks, Thomas. So regarding your first question about your Europe commercial presence, you're right. But it's not Europe, it's I would say the rest of the world, it's wider than Europe. So we will not deploy commercial presence in rest of the world per se. But we will actually try to provide through the existing channels and there's a lot actually especially in yield, but not for the dasiglucagon approach. What we are, and we stated this as well, we remain open to dialogue in terms of partnerships for rest of the world.
And so I think this could be -- I mean, a matter for updating the future. We are definitely going to find in Europe in the, so we will do that as the next that. But again, we we're taking the U.S. first approach. And related to your financing questions, we are continuously evaluating financial options to support the ambition and our ambitions and development plan. If the need arise for additional funding, we will actually formally announce such opportunity to the market.
Of course we're not guiding on it, but you can be sure that with the ambition plan we have, we will have to go back to the market one day. But we have 2 years actually of financing right now in the bank, so we're very comfortable with the situation. And that supports us easily for the next 2 years.


所以我认为这可能是 - 我的意思是,更新未来的问题。我们肯定会在欧洲找到,所以我们将把它作为下一个。但同样,我们采取美国的第一种方法。与您的融资问题相关,我们不断评估财务方案,以支持雄心壮志和雄心壮志以及发展计划。如果需要额外的资金,我们实际上会正式向市场宣布这样的机会。


Thomas Bowers

Okay. And just on what size sales force do you think you need for the U.S. market maybe also going to take some [indiscernible] maybe.

好的。 对于美国市场而言,您认为自己需要的销售力量大小可能也会带来一些[音频不清晰]。

Emmanuel Dulac

Yes. So again, we don't have -- we don't communicate firm numbers right now. But I can tell you that when we look at the dasiglucagon rescue pen and CHI and even the dual pump, we're talking about a market today that doesn't really exists in terms of active promotion. It's in very big potential markets. We see diabetes but at the same time, we're not competing against the insulin. So we have to look at this market in a way that it's I would say a niche within a very large market. And we have -- we're going to take ways to actually size our efforts accordingly to maximize the return investments for this opportunity. So we don't have to compete against all the insulin makers.
We have to actually appropriately position our products in the largest opportunity areas. And to just to guide you, one, if you look right now this market, which again hasn't developed as a promoted market but as naturally developed. Around 70% of the users of existing kits today are kids. So it's family with Type 1 diabetes kids who are buying around 70% of these kits. As you could actually definitely launch within like a very niched approach. And it actually aligns very well with our CHI indication that is coming behind because CHI is again is in this field of pediatric diabetes and endocrinology.
And I think it prepares us really were for the dual-hormone pump, which is where we say over and over that's where we want to go. So I would only guide the market to actually say that basically, we will not provide revenue and target, and we have do actually still define what type of KPIs we will provide the market with. But I think I would say that I would lower your short term expectation and I would increase your long-term expectations on the company based on the dual-hormone pump potential.

是。再说一次,我们没有 - 我们现在不沟通公司数字。但我可以告诉你,当我们看到dasiglucagon救生笔和CHI甚至双泵时,我们谈论的是今天的市场,在积极推广方面并不存在。这是一个非常大的潜在市场。我们看到糖尿病,但与此同时,我们并没有与胰岛素竞争。因此,我们必须以一种非常大的市场中的利基方式来看待这个市场。我们已经 - 我们将采取相应的方法来实际调整我们的工作量,以最大限度地为这个机会提供回报投资。因此,我们不必与所有胰岛素制造商竞争。




And the next question comes from the line of Lucy Codrington of Jefferies.

接下来的问题来自Jefferies的Lucy Codrington。

Lucy Codrington

Just a couple. I just wondered if you could comment a bit more on the rate of today glepaglutide trial and CHI trial. Are you happy with the current rate? And should we therefore be thinking about late October the second half of next year for those trials? And then I appreciate if the competitive product, but I just 1 for the nasal approach for the glucagon rescue, do you know if the Lilly device requires the patient to actively inhale? Or is it a case of just squirting the glucagon out the patients there via I guess with somebody who's with the patient?

只是一对。 我只是想知道你是否可以对今天的glepaglutide试验和CHI试验的比率进行更多评论。 你对目前的费率感到满意吗? 因此,我们是否应该考虑在明年下半年10月下旬进行这些试验? 然后我很欣赏这个有竞争力的产品,但我只是为了胰高血糖症救援的鼻腔方法,你知道礼来设备是否需要患者主动吸气吗? 或者只是通过与患者同在的患者将胰高血糖素喷射到患者身上的情况?

Adam Steensberg

Yes. Lucy, I think I'm the best equipped to ask question first maybe our understanding is that it will not require the patients to inhale, that you just have to spray up into the nose the Lilly device. So that the answer. With regard to recruitment, if I start with CHI, which is actually where we have seen a significant ramp-up in recruitment and also screening some we are actually also as you noticed that we actually start to guide more results in 2020. So here we have managed to have running now that participating in this study, and we see it out of excitement.
And of course one thing is the randomized number of patients, but we also have more importantly, the number of screen patients for anticipate to enter the studies. So that's where we would have I would say a much higher confidence in the speed of recruitment that we have just a quarter ago. And glepaglutide is a little bit similar story in the sense that we have now managed to get most if not all of the size activated over the summer.
We also have a number of patient in the screening and it's a study, which takes actually after a few months some screening on till we randomize running phases, and so on. So here we are also very confident that we will reach the target that we are guiding on with regard to recruitment and expect the numbers to grow as you see state of over the next month. And definitely, I think that's also what we guided last quarter. The results would be expected in the second half of 2020 and not the first because it's a 6 months study.


当然,有一点是随机数量的患者,但我们也更重要的是,预计进入研究的筛查患者数量。这就是我们应该拥有的地方,我会说我们在四分之一前的招聘速度上有更高的信心。 glepaglutide在某种意义上讲是一个类似的故事,我们现在已经设法获得了大部分(如果不是全部)在夏天激活的尺寸。



And the next question comes from the line of Peter Sehested from Handelsbanken.

接下来的问题来自Handelsbanken的Peter Sehested。

Peter Sehested

It's Peter from Handelsbanken. I have 4 and I apologize if they have been asked before during the conference call. The first one...

这是来自Handelsbanken的Peter。 我有4个人,如果他们在电话会议之前被问过,我会道歉。 第一个...

Emmanuel Dulac

Peter, can you speak closer to the phone? We can't hear you.

彼得,你能接近电话吗? 我们听不到你的声音。

Peter Sehested

Is it better now?


Emmanuel Dulac

Yes. It's slightly better, yes.

是。 它好一点,是的。

Peter Sehested

Okay. So my first question relates to your backup counts for short bowel syndrome of ZP7570. Could you give us an overview of what kind of data you would have on that compound when you announce the Phase III data for glepaglutide? That is my first question. My second question relates to where pricing for the year for glucagon in the dual-hormone pump. How -- what is your strategy for demonstrating the added value of glucagon in that pump relative to payor discussions? That is my third question -- sorry, second question. And my third question relates to peak sales prognosis for dasiglucagon in the rescue pen setting. And finally, my fourth question relates to your commercial infrastructure in the U.S. I guess you need 2 different infrastructure setups to market, dasiglucagon and glepaglutide. Could you be so kind just to briefly highlight what kind of -- might not give some guidance on numbers, but just to give us a sense where is the overlap here? And where do you need some different say resources the market of those 2 products?

好的。所以我的第一个问题涉及您对ZP7570短肠综合征的备用计数。当您宣布glepaglutide的III期数据时,您能否概述一下您对该化合物的数据类型?这是我的第一个问题。我的第二个问题涉及双激素泵中胰高血糖素年份的定价。如何 - 相对于付款人讨论,您在该泵中展示胰高血糖素增值的策略是什么?这是我的第三个问题 - 抱歉,第二个问题。我的第三个问题涉及救援笔设置中dasiglucagon的销售预测峰值。最后,我的第四个问题与您在美国的商业基础设施有关。我猜您需要两种不同的基础设施设置,即dasiglucagon和glepaglutide。你能不能只是简单地强调什么样的 - 可能不会对数字给出一些指导,但只是为了让我们知道这里的重叠在哪里?那些2种产品的市场需要哪些不同的资源呢?

Adam Steensberg

Thank you, Peter. This is Adam. Maybe I can start answering the first 2 questions. So the 2 compounds, ZP7570 also in the short bowel syndrome, what data we have available once we have the Phase III data from. So we initiated a Phase I study, which is a classical study in helping balances safety and tolerability dose escalation study and here in June and across we expect to conclude that and then also hopefully getting to the multiple-ascending dose so have the full safety Phase I study is concluded at a time when we have the date.
And we also -- I mean based on this data and how the dose escalation goes. I mean we, as a company, would have to start when and how to do the Phase II and how it relates to the liver Phase III outcome. On the versus insulin only, I think we have only released top line results from the study that we announced in June. But if I just look there into some of the key glycemic parameters, then it was short term study, but one of the main things I would focus on is that in that study, if you just kind of model how that would look, in a longer term study, then we could actually get 90% subjects on the hormone system into the range of glycemic control that is recommended by American Diabetes Association versus only 50% in the insulin-only system, which is also by assisting.
So there is a system that actually allow stations to achieve the glycemic levels that ADA recommends. And we did that with actually having lower incidence of hypoglycemia and also half the number of dangerous low blood glucose. So you can see glycemic results with less hypoglycemia. And because it's are dual hormones system, it will also require us efforts by the patients and families because the system itself corrects the dose and insulin only systems, patients will have snack and intervene in order to correct the dose, which will happen now and again, in the insulin-only system.
So that's why we are super excited. It's not just a question of getting into target comments actually a person were getting into target with less efforts and much, much less hypoglycemia. So we see this as a tool to truly disrupt the technology, which would actually place the opportunity in a very different level than the existing systems, which all provide I will say great pinnacle results in clinical studies. But once you release the products into real life, it's such a struggle for patients to be and also as seen by real life evidence data.


我们也 - 我的意思是基于这些数据以及剂量递增的方式。我的意思是,作为一家公司,我们必须开始何时以及如何进行第二阶段及其与肝脏III期结果的关系。仅针对胰岛素,我认为我们只发布了6月份宣布的研究的最高结果。但是,如果我只是查看一些关键的血糖参数,那么这是短期研究,但我要关注的主要事情之一是,在那项研究中,如果你只是模型的样子,那么长期研究,那么我们实际上可以让90%的激素系统受试者进入美国糖尿病协会推荐的血糖控制范围,而仅使用胰岛素系统只有50%,这也是通过协助。



Emmanuel Dulac

Yes. And I will take your last 2 questions, Peter. The sales prognosis with our rescue pen. I just wanted to point you to the size of the market today. Today, there is about 1 million kit, existing kits sold annually in the U.S. And there's around 7.2 million insulin-dependent patients.
The predictions from various analysts and as well from Lilly and from other companies is that this market will likely triple and reach around 1 billion in the coming years simply because there will be actually several products that will offer valuable solutions for patients whereas versus the existing kits. There will be active promotion from potentially 3 companies in this yield, and they will be actually product differentiation between these products. So again, we believe we have the compound that has a very strong differentiation profile by being really fast and effective.
And so I won't guide you on this sales prognosis on our own rescue pen, but we think we have potentially a drug that could establish some of the care. On the fourth question, which is your sales force structure in the U.S. There are synergies between the different indications. One of the big synergy I want to point out is for remedies, you had to deploy very active and elaborated patient services team and patients true. And I think it would be very innovative to use some of these experts to help with very specific cases of diabetes management, whether it's the rescue pen or the dual-hormone pump.
But I think it's not used right now because there's a very -- there's somewhat a separation between management, the way it's being done and rest of the market in U.S. market. But I think there's a big value in learning and trying to implement best practice from one side to the other. Again, I told you there will be synergies as well in the plan. I mean some of these experts are crossing over. But ultimately, the bulk of the sales force will be deployed in terms of number of people deployed on the diabetes side.
They don't have the same profile as the rare disease folks. You don't need experts like you need in remedies. But in remedies, you can achieve very good promotional efforts in the U.S. with a handful number of people. You don't need an army, and you can figure very targeted approach based on some situations of patients in key centers, excellent centers.
We have a product on the market in SBS. So there's a lot of information, market information available right now knowing where these patients are and where these key centers are. So I think we can build from that knowledge and get to market really fast. Again, assuming we have a differentiated product and with a superior profile. Does it answer your question?







Peter Sehested




And we have no further questions at this time. You may continue.

我们目前没有其他问题。 你可以继续。

Lani Morvan

Thank you, everybody, for participating in joining us today. If there are no more questions, I think we will go ahead and end the call.

感谢大家今天参加我们的活动。 如果没有其他问题,我想我们会继续并结束通话。

Emmanuel Dulac

Thank you, everyone. Thank you for participating.

谢谢大家。 感谢您的参与。


Thank you. And that does conclude our conference for today. Thank you all for participating. You may all disconnect.

谢谢。 这确实结束了我们今天的会议。 谢谢大家的参与。 你可能都断开了。


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