Cassava Sciences Inc (SAVA) 2014 Q2 法說會逐字稿

Greetings and welcome to the Pain Therapeutics second-quarter 2014 financial results conference call. At this time all participants are in a listen-only mode. (Operator Instructions)

您好，歡迎您參加 Pain Therapeutics 2014 年第二季財務業績電話會議。此時所有參與者都處於只聽模式。 （操作員說明）

As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Peter Roddy, Vice President and Chief Financial Officer for Pain Therapeutics. Thank you, Mr. Roddy; you may begin.

提醒一下，本次會議正在錄製中。現在我想將會議交給主持人彼得·羅迪（Peter Roddy），他是疼痛治療公司的副總裁兼財務長。謝謝你，羅迪先生；你可以開始了。

Thank you. Welcome to our earnings call for the second-quarter 2014. And thank you very much for being with us today. On the call with me is Remi Barbier, Chairman, President, and CEO.

謝謝。歡迎參加我們 2014 年第二季的財報電話會議。與我通話的是董事長、總裁兼執行長雷米·巴比爾 (Remi Barbier)。

Here is our agenda for this call. After the traditional reminder regarding forward-looking statements, I'll touch on some of the financial highlights of the second quarter. Remi will then provide an update on our business, and we'll have time for questions after Remi's comments.

這是我們本次電話會議的議程。在對前瞻性陳述進行傳統提醒之後，我將談談第二季的一些財務亮點。然後，雷米將提供我們業務的最新情況，雷米發表評論後，我們將有時間回答問題。

Please keep in mind that during the course of this call, we will make forward-looking statements, including statements about some of our product candidates and our finances. These forward-looking statements involve risks and uncertainties. Actual results may differ materially from our forward-looking statements. Further information about these and other risks are included in our annual report on Form 10-K, our 10-Q for the first quarter of 2014, and our other filings with the Securities and Exchange Commission.

請記住，在本次電話會議期間，我們將做出前瞻性聲明，包括有關我們的一些產品候選人和我們的財務狀況的聲明。這些前瞻性陳述涉及風險和不確定性。實際結果可能與我們的前瞻性陳述有重大差異。有關這些風險和其他風險的更多資訊包含在我們的 10-K 表格年度報告、2014 年第一季的 10-Q 報告以及我們向美國證券交易委員會提交的其他文件中。

Now I'll comment on the financial highlights for the second quarter. We started the quarter with $47.1 million; used $2.3 million in the second quarter; and at June 30, we had about $45 million. That translates to between four and five years of cash. Be it four or five years, it's a strong balance sheet, and we'll continue to exert discipline over the use of our cash.

現在我將評論第二季的財務亮點。本季初我們的營收為 4,710 萬美元；第二季使用了230萬美元；截至 6 月 30 日，我們的資金約為 4,500 萬美元。這相當於四到五年的現金。無論是四年還是五年，這都是一個強大的資產負債表，我們將繼續對現金的使用施加紀律。

Our guidance for cash usage for 2014 continues to be about $12 million. With our guidance focused on cash, I'll ask you to please recall that our revenue in the second-quarter 2013 and for the first half of 2013 was not cash revenue and came from the accounting for up-front payment from Pfizer in years past.

我們對 2014 年現金使用的指導仍然是 1200 萬美元左右。由於我們的指導重點是現金，請您記住，我們 2013 年第二季和 2013 年上半年的收入不是現金收入，而是來自過去幾年輝瑞預付款的會計處理。

We finished up the accounting for those payments in the fourth quarter of 2013. You won't see this non-cash revenue in 2014. We increased our R&D spending in Q2 2014, primarily on third-party activities on our early-stage assets, up to $1.9 million from $1.1 million in the second quarter of 2013.

我們在2013 年第四季完成了這些付款的會計處理。活動，從 2013 年第二季的 110 萬美元增加到 190 萬美元。

As I mentioned on our last call -- off of the financial statement, onto another subject -- we had some insider stock option exercise activity in 2014. Some of these option exercises were so-called net exercises, and given how net exercises are reported to the Securities and Exchange Commission, people might confuse net exercises with sales of stock. They are not. There have been no insider sales in PTI stock this year; and, again, we aren't aware of any plans for insiders to do so.

正如我在上次電話會議中提到的（從財務報表轉向另一個主題），我們在2014 年進行了一些內部股票選擇權行使活動。行權的報告方式對於證券交易委員會來說，人們可能會將淨行使與股票銷售混淆。他們不是。今年以來，PTI 股票沒有發生內線交易；而且，我們不知道內部人士有任何這樣做的計劃。

Remi will take it from here.

雷米將從這裡拿走它。

Okay. Thanks, Pete. I'd like to discuss a couple of things, but before we go there, I'd like to say that overall I feel great about REMOXY and where we stand. Based on a couple of contacts I've had with Pfizer in the past week, I can affirm that Pfizer is moving full speed ahead with REMOXY and that the plan continues to be to refile the NDA for REMOXY in 2015.

好的。謝謝，皮特。我想討論一些事情，但在我們討論之前，我想說的是，總的來說，我對 REMOXY 和我們的立場感覺很好。根據過去一周我與輝瑞的幾次接觸，我可以肯定輝瑞正在全速推進 REMOXY，並且計劃繼續在 2015 年重新提交 REMOXY 的 NDA。

This being the midyear point, I think it kind of pays to step back and see: what did we tell shareholders we would do? What did we actually do? Where could we improve?

這是年中的時刻，我認為退一步看看是值得的：我們告訴股東我們會做什麼？我們實際上做了什麼？我們可以在哪些方面改進？

Overall, the three goals for this year have been to stay in close contact with Pfizer, with the understanding that anything we can do to help REMOXY move forward, we would do this. The second goal has been to expand the pipeline of pain assets while still maintaining fiscal discipline.

總體而言，今年的三個目標是與輝瑞保持密切聯繫，並了解我們可以做任何事情來幫助 REMOXY 前進，我們都會這樣做。第二個目標是擴大痛苦資產的管道，同時仍保持財務紀律。

And the third overall overarching goal here has been to build awareness of Pain Therapeutics. Those have been the three themes for 2014, and I think on all three themes we have done very well.

這裡的第三個總體目標是建立對疼痛治療的認識。這是2014年的三個主題，我認為在這三個主題上我們都做得很好。

Let me take each one apart. Without going back into history, I want to remind shareholders that REMOXY is, I believe, extremely well partnered. We understand that shareholders have a choice. Last time I looked, there were something like, I think, 200 public biotech companies. And 90% of them of these public biotech companies are, I would say, in the infancy stage. So are we.

讓我把每一個都拆開。在不回顧歷史的情況下，我想提醒股東，我相信 REMOXY 是非常好的合作夥伴。我們知道股東有選擇。上次我查看時，我認為大約有 200 家上市生物技術公司。我想說，這些上市生技公司中 90% 都處於起步階段。我們也是。

While Pain Therapeutics is in its infancy stage, we think we have a well-laid-out, rational plan to get to our walking legs in a relatively short amount of time, which is to say a year or a year and a half. The cornerstone for Pain Therapeutics, of course, is REMOXY.

雖然疼痛治療還處於起步階段，但我們認為我們有一個周密、合理的計劃，可以在相對較短的時間內（即一年或一年半）實現雙腿行走。當然，疼痛治療的基石是 REMOXY。

I want to remind shareholders that the royalty on -- postapproval, our royalty starts at 15% and goes up to 20% after cumulative net sales of $1 billion. And on approval we receive a $15 million cash milestone payment from Pfizer.

我想提醒股東，批准後的特許權使用費從 15% 開始，在累計淨銷售額達到 10 億美元後升至 20%。獲得批准後，我們將收到輝瑞 (Pfizer) 提供的 1500 萬美元現金里程碑付款。

The patent life is fairly long. I believe at this point it goes beyond 2030. As far as Pfizer is concerned, we stay in very close communication. Like I said, I've had two communications with them in the past week alone.

專利壽命相當長。我相信現在已經超過 2030 年了。就像我說的，僅在過去一周我就與他們進行了兩次溝通。

I'm not aware of any delays. Everything I hear is full speed ahead, and everything is on track for an NDA refiling in 2015 per Pfizer. So I've always said, with REMOXY, no news is good news. And the only good news I have here is, again, everything is on track, and I feel great about where REMOXY is headed.

我不知道有任何延誤。我聽到的一切都在全速推進，輝瑞公司將於 2015 年重新提交新藥申請 (NDA)，一切都按計劃進行。所以我一直說，對於 REMOXY，沒有消息就是好消息。我在這裡得到的唯一好消息是，一切都步入正軌，我對 REMOXY 的發展方向感覺很好。

One thing we did tell our shareholders is that we would complete a strategic review of all of our assets. We did this. We completed this exercise in the second half of pretty much not that long ago, a few weeks ago. And the grand conclusion is a rather simple conclusion, which is that we have specific expertise in developing pain assets, and that's really where we want to focus.

我們確實告訴股東的一件事是，我們將完成對所有資產的策略審查。我們這樣做了。我們在不久前（幾週前）的下半年完成了這項練習。最重要的結論是一個相當簡單的結論，那就是我們在開發痛點資產方面擁有特定的專業知識，這才是我們真正想要關注的地方。

To that end, our vision continues to be to have at least one, possibly two, products in Phase III by the time REMOXY is approved. The asset that we have committed to is hydromorphone -- and, I should say, an abuse-resistant version of hydromorphone.

為此，我們的願景仍然是在 REMOXY 獲得批准時至少有一種（可能是兩種）產品處於 III 期階段。我們致力於開發的資產是氫嗎啡酮——我應該說，是氫嗎啡酮的抗濫用版本。

This is the hydromorphone product that was returned to us by Pfizer some time ago, because they feel it doesn't meet their minimum market size. Hydromorphone, I think, in a good year is probably somewhere between $200 million and $500 million in annual sales.

這是輝瑞前段時間退回給我們的氫嗎啡酮產品，因為他們覺得不符合他們的最低市場規模。我認為，在好的年份，氫嗎啡酮的年銷售額可能在 2 億至 5 億美元之間。

We think for a small company such as we are, that type of market size is more than adequate for us. So we are pursuing its development. We plan to initiate a Phase I very shortly, followed by an FDA meeting. And we expect to be in a Phase III trial with abuse-resistant hydromorphone in 2015.

我們認為對於像我們這樣的小公司來說，這種市場規模對我們來說已經足夠了。所以我們正在追求它的發展。我們計劃很快啟動第一階段，隨後召開 FDA 會議。我們預計 2015 年進行抗濫用氫嗎啡酮的 III 期試驗。

I also want to say that the hydromorphone that we have under development -- it is not exactly what Pfizer gave back. It is actually a reformulated version, if you will. With our partners we reformulated hydromorphone, taking into account everything we've learned about REMOXY.

我還想說，我們正在開發的氫嗎啡酮——它並不完全是輝瑞所回饋的。如果你願意的話，它實際上是一個重新制定的版本。我們與合作夥伴一起重新配製氫嗎啡酮，並考慮到我們對 REMOXY 的了解。

The other drug asset that we are committed to unfortunately remains undisclosed. And it remains undisclosed for very good reasons, for a very simple reason. The IP is just getting wrapped up as we speak. I'm actually spending a fair amount of my time, and so are a lot of us, on the intellectual property.

不幸的是，我們致力於的其他藥物資產仍未披露。出於非常充分的理由，它仍然沒有被公開，原因非常簡單。在我們說話的時候，IP 剛剛結束。事實上，我和我們很多人都在智慧財產權上花了相當多的時間。

We expect the patents to be written very shortly and filed shortly thereafter. And at this point we are actually looking for a good conference to announce the product this fall. We may announce it at the BioCentury conference or one other conference that we are invited to -- Wall Street-type conference.

我們預計專利將很快撰寫並隨後提交。目前，我們實際上正在尋找一個好的會議來在今年秋天宣布該產品。我們可能會在 BioCentury 會議或我們受邀參加的其他會議——華爾街類型的會議上宣布這一點。

On the abuse resistance front, I think what we are seeing at the FDA is that abuse resistance remains and absolute top priority, as evidenced by their approval of a potential competitor's drug. I also want to say that there is still quite a bit of hype around abuse resistance. And the hype really is generated -- in my opinion, at least -- by a rather small number of companies that are trying, that are attempting to develop abuse-resistant products.

在抗濫用方面，我認為我們在 FDA 看到的是，抗濫用仍然是絕對的首要任務，他們對潛在競爭對手藥物的批准就證明了這一點。我還想說，關於抗虐待仍然存在相當多的炒作。至少在我看來，這種炒作確實是由一小部分正在嘗試開發防濫用產品的公司發起的。

But despite the hype, what the FDA has said and what they have been very consistent about is that they want to see abuse resistance programs -- they want to make sure that these programs are grounded in real science. And what that means in practice is that companies, in order to get any type of abuse-resistant claim, will need to show two types of abuse resistance data, both in vivo, which is to say drug-like ability studies; as well as in vitro, which is to say, laboratory work.

但儘管大肆宣傳，FDA 所說的以及他們一直以來非常一致的說法是，他們希望看到抗濫用計劃——他們希望確保這些計劃以真正的科學為基礎。這在實踐中意味著，公司為了獲得任何類型的抗濫用聲明，需要提供兩種類型的抗濫用數據，兩者都是體內的，即類藥物能力研究；以及體內的抗濫用數據。以及體外，即實驗室工作。

The overall vision for Pain Therapeutics, the long-term vision, has not changed. I still maintain that we have a once-in-a-lifetime opportunity to position this Company for profit on the other side of an approval for REMOXY. That is the direction we're headed.

疼痛治療的整體願景，即長期願景，沒有改變。我仍然認為，在 REMOXY 獲得批准的另一邊，我們有一個千載難逢的機會將公司定位為盈利。這就是我們前進的方向。

And, again, given the 15% to 20% royalty and given Pfizer's experience and expertise in sales and marketing, I do maintain that we do have potentially a very nice opportunity to build a profitable company -- while at the same time, of course, having the depth and breadth of a pain pipeline.

而且，考慮到15% 到20% 的特許權使用費以及輝瑞在銷售和行銷方面的經驗和專業知識，我確實認為我們確實有可能有一個非常好的機會來建立一家盈利的公司——當然，同時， ，具有疼痛管道的深度和廣度。

At this time I'd like to close the Pete-and-Remi session and perhaps open it up for investor questions. Operator?

這次我想結束皮特和雷米的會議，或許可以開始回答投資人的問題。操作員？

(Operator Instructions) Kevin Kedra, Gabelli & Co.

（操作員說明）Kevin Kedra，Gabelli & Co.

To ask maybe first -- maybe this is a bit of semantics, but I know before we have talked about sort of a mid-2015 filing for REMOXY. Now you're saying 2015, not necessarily mid-2015. So should we be reading that more as sort of a later 2015 timeframe? Is that mid-2015 time frame still reasonable?

也許首先要問——也許這有點語義，但我知道我們之前討論過 2015 年中期的 REMOXY 申請。現在你說的是 2015 年，不一定是 2015 年中期。那麼我們是否應該更多地將其視為 2015 年稍後的時間框架？ 2015 年中期的時間框架還合理嗎？

No, there's no slippage in the time frame; it's a matter of semantics. Again, I'm not aware of any delays. There are no delays. Everything is moving full speed ahead. There's nothing to indicate a slippage from the filing date.

不，時間範圍內沒有任何延誤；這是語義問題。再說一次，我不知道有任何延誤。沒有任何延誤。一切都在全速前進。沒有任何跡象表明申請日期有所延誤。

Secondly, maybe on the hydromorphone product, I'm just wondering why you choose to move forward with that asset as opposed to some of the other ones in your pipeline? And then how should we be thinking about the pathway for that product in Phase III? Would we be looking at a similar Phase III program as what we saw for REMOXY, or could it possibly be a bit more expedited -- smaller trials, shorter time frame? What's the right sort of way to think about that?

其次，也許在氫嗎啡酮產品上，我只是想知道為什麼您選擇推進該資產而不是管道中的其他一些資​​產？那我們該如何考慮該產品第三階段的發展路徑呢？我們是否會考慮與 REMOXY 類似的 III 期項目，或者可能會更快一點——試驗規模更小、時間更短？正確的思考方式是什麼？

I will tell you the way we think about hydromorphone, which is a very nice kind of midmarket-type product. Again, $200 million to $500 million in potential revenues per year on the other side of an approval. And as far as the clinical pathway, I believe it should be fairly straightforward, which is to say the Phase I that's ongoing or that will be ongoing very shortly in order to nail down the final formulation; followed by an FDA meeting in 2015; followed by Phase III 2015, as well.

我將告訴您我們對氫嗎啡酮的看法，這是一個非常好的中端市場類型產品。同樣，獲得批准後，每年的潛在收入可達 2 億至 5 億美元。就臨床路徑而言，我認為它應該相當簡單，也就是說，第一階段正在進行或很快就會進行，以便確定最終的配方；隨後於 2015 年召開 FDA 會議；其次是 2015 年第三階段。

Again, it's a little bit early to be precise about what the Phase III could look like. But in our experience, what we did on the clinical front with REMOXY is a pretty good carbon copy for what can be done with strong opioids, such as oxycodone or hydromorphone. In fact, if you actually look at what competitors are doing, they are very typically following what we did with REMOXY, which is to say it's where we type our studies. You know, randomized, placebo-controlled, etc., etc. Does that help?

同樣，現在要準確判斷第三階段的情況還為時過早。但根據我們的經驗，我們在臨床方面使用 REMOXY 所做的工作是對強阿片類藥物（如羥考酮或氫嗎啡酮）所做的工作的一個很好的複製。事實上，如果你真正看看競爭對手在做什麼，他們通常會遵循我們對 REMOXY 所做的事情，也就是說，這就是我們研究的地方。你知道，隨機的、安慰劑對照的等等，這有幫助嗎？

And then maybe if I can squeeze one last one in, just wondering, some of your competitors have been more vocal about getting into the space. One recently said they planned to be a top player in the space; they have a pipeline of a few abuse-deterrent assets.

然後，也許我可以擠出最後一個，只是想知道，你們的一些競爭對手對於進入這個領域更加直言不諱。最近有人表示，他們計劃成為該領域的頂級玩家；他們擁有一些防止濫用的資產。

What do you think it means for REMOXY and your follow-on compounds as you see more companies getting into this space? Is this good, because it's going to grow the pie for everybody? Or do we have to start thinking about how the market share is going to be carved up in a few years?

當您看到越來越多的公司進入這一領域時，您認為這對 REMOXY 和您的後續化合物意味著什麼？這很好嗎，因為它會為每個人都做大蛋糕嗎？還是我們必須開始思考幾年後市佔率將如何分割？

Well, it's an interesting question, Kevin. When we were the only game in town, certain shareholders were saying, well, it's not a real market, because no one else is playing in it. Now that a number of different companies are jumping on the bandwagon, I'm kind of hearing the same thing, which is maybe it's not a good thing.

嗯，這是一個有趣的問題，凱文。當我們是城裡唯一的遊戲時，某些股東說，好吧，這不是一個真正的市場，因為沒有其他人參與其中。現在許多不同的公司都在加入這個潮流，我聽到了同樣的說法，這也許不是一件好事。

I actually -- I'm in the position where the more the players, the merrier. But having said that, there are two key, strategic imperatives in order to win in this market. Remember, this is a very, very easy game to play, but a very difficult game to win.

事實上，我所處的位置是，玩家越多，就越快樂。但話雖如此，要贏得這個市場，有兩個關鍵的策略要務。請記住，這是一款非常非常容易玩的遊戲，但卻是一款很難獲勝的遊戲。

In order to win, I maintain that you need two things. One is: you need sales and marketing. And what better company out there for sales and marketing than Pfizer?

為了獲勝，我認為你需要兩件事。一是：你需要銷售和行銷。還有哪家公司在銷售和行銷方面比輝瑞更好呢？

The second thing you need is a drug, an abuse-resistant drug that can really resist an entire basket, an entire portfolio, of methods of abuse. It's not sufficient to come up with an abuse-resistant product that can only prevent snorting, or that can only prevent injecting, or even both.

你需要的第二件事是一種藥物，一種抗濫用藥物，能夠真正抵抗整個籃子、整個組合的濫用方法。僅僅發展出一種只能防止吸食、或只能防止注射、甚至兩者兼而有之的防濫用產品是不夠的。

I think what we've seen in the marketplace is that abusers are very clever. And depending on how you count, there are somewhere between 9 and 12 different methods of abusing -- common methods of abusing these drugs. And to the extent that we believe REMOXY can prevent or defer the abuse on many if not all of these 9 to 12 methods and routes of administration, I think we are in a great position.

我認為我們在市場上看到的是濫用者非常聰明。根據您的統計方式，有 9 到 12 種不同的濫用方法——濫用這些藥物的常見方法。如果我們相信 REMOXY 可以預防或推遲對這 9 至 12 種給藥方法和途徑中的許多（如果不是全部）的濫用，我認為我們處於有利地位。

Thanks.

謝謝。

Thank you. There are no further questions at this time. I'd like to turn the floor back over to management for closing comments.

謝謝。目前沒有其他問題。我想將發言權交還給管理層以徵求結束意見。

Remi, do you want to close this up, or shall I?

雷米，你想結束這一切嗎？

Sure, I'm happy to close it up. Kevin, also, on your last point, I just want to reiterate that eventually the entire market, which is -- what, something like a $9 billion to $10 billion market -- the entire market will need to convert to abuse-resistant.

當然，我很高興關閉它。凱文，關於你的最後一點，我只想重申，最終整個市場，也就是 90 億到 100 億美元的市場，整個市場將需要轉變為抗濫用的。

So, again, I think there's plenty of room for more than one player. But I still maintain that in order to win, you need abuse-resistant data against many different routes of abuse. And it has to result in a clear label differentiation. And you need a partner to sell.

所以，我再次認為有足夠的空間容納不只一名球員。但我仍然認為，為了獲勝，您需要針對許多不同濫用途徑的防濫用數據。它必須產生明顯的標籤差異化。你需要一個合作夥伴來銷售。

I think on that note, since there are no more questions, we would like to close the conference call. Thank you for your time today, and we look forward to reporting more progress in second half of this year.

我認為，鑑於沒有更多問題，我們想結束電話會議。感謝您今天抽出寶貴時間，我們期待在今年下半年報告更多進展。

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

今天的電話會議到此結束。此時您可以斷開線路。感謝您的參與。