Earnings Labs

Arrowhead Pharmaceuticals, Inc. (ARWR)

Q1 2017 Earnings Call· Tue, Feb 7, 2017

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Transcript

Operator

Operator

Ladies and gentlemen, welcome to the Arrowhead Pharmaceutical's Conference Call. Throughout today's recorded presentation all participants will be in a listen-only mode. After the presentation, there will be an opportunity to ask questions. I will now hand the conference over to Vincent Anzalone, Vice President of Investor Relations for Arrowhead. Please go ahead, Vince.

Vincent Anzalone

President

Good afternoon, everyone. Thank you for joining us today to discuss Arrowhead's results for its fiscal 2017 first quarter ended December 31, 2016. With us today from Management are President and CEO, Dr. Christopher Anzalone, who will provide an overview of the quarter; Dr. Bruce Given, our Chief Operating Officer and Head of R&D who will discuss our late stage research programs and Ken Myszkowski, our Chief Financial Officer who will give a review of the financials. Before we begin, I'd like to remind you that comments made during today's call contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. All statements, other than statements of historical fact, including without limitation those with respect to Arrowhead's goals, plans and strategies, are forward-looking statements. These include statements regarding our expectations around the development, safety and efficacy of our drug candidates, projected cash runway and expected future development activities. These statements represent management's current expectations and are inherently uncertain. Thus, actual results may differ materially. Arrowhead disclaims any intent and undertakes no duty to update any of the forward-looking statements discussed on today's call. You should refer to the discussions under Risk Factors in Arrowhead's annual report on Form 10-K and the company's subsequent quarterly reports on Form 10-Q for additional matters to be considered in this regard, including risks and other considerations that could cause actual results to vary from those presently expected results expressed in today’s call. With that said, I'd like to turn the call over to Dr. Christopher Anzalone, President and CEO of the company. Chris?

Christopher Anzalone

President and CEO

Thanks Vince. Good afternoon, everyone. And thank you for joining us today. Drug development rarely moves in a straight line. We saw this clearly last year when we were forced to make the difficult decision to halt the ARC-520, ARC-521 and ARC-AAT clinical programs that utilize the EX1 delivery vehicle. Our job is to navigate these unexpected turns and focus on our primary purpose as a company, bringing new medicines to patients who need them. While these candidates will not make it to the market, they have advanced our ability to eventually help patients. These programs substantially expanded our understanding of the underlying diseases and provided key insights into how they could be treated. Importantly, we are now even better positioned to design high quality RNAi therapeutics against HBV and AAT liver disease, design and prosecute focus clinical studies quickly and ultimately provide treatment for patients with few options. We have good options and opportunities because we've always thought broadly about treating HBV AAT liver disease and other important unmet medical needs. We have never been content with current standards even when they were the best the world had to offer and we have always pushed science for better solutions. When we purchased the Roche RNAi assets just over five years ago, delivery was the greatest challenge in the field and the difficulty of getting intact RNAi triggers out of the endosome and into the cytoplasm had stymied most efforts. Our intravenously delivered DPC technology turned out to be the most powerful approach to this question and demonstrated what was possible to accomplish with our RNAi in humans. This was quite an accomplishment, but we're not finished innovating. Our research team was hard at work at follow-on next-generation approach. This involve sophisticated RNA chemistry modifications that held the promise of…

Bruce Given

COO

Thanks Chris. As Chris described, we considered the DPC delivery technology to have been a great breakthrough that raised the bar significantly for what could be expected in the field of RNA interference. Our progress has pushed everyone else in the field to work harder to show the level of knockdown that we achieved. Which the animal toxicology data at the end of last year brought an abrupt and unexpected end to our DPC technology, despite good tolerability in humans, we have seen the requirement for IV dosing to be a limitation in the longer-term from a clinical perspective and had already pivoted in our research labs. Because of this pivot, while the loss for our clinical programs was unfortunate, we think the setback will be shorter than most observers probably expect. I would like to talk a bit about some of our announced programs and help explain why we are enthusiastic despite last year's events. ARO-HBV and ARO-AAT, build upon Arrowhead's clinical experience in these diseases with previous generation candidates ARC-520, ARC-521 and ARC-AAT. Those programs validated the potential of using RNAi and HBV and AATD and what we learned over multiple clinical studies is helping to inform and potentially accelerate the development path of our ARO-HBV and ARO-AAT. First regarding ARO-HBV, we will have abstracts at EASL in April, describing our clinical work with ARC-520 and ARC-521. I'm not going to front run the data but I'll say that we remain convinced that RNAi will join Nukes as centerpieces in combination regimens going forward in HBV. We also presented important data regarding ARC-AAT in the liver disease associated with AAT last fall at AASLD. One of our scientists, Dr. Chris Wooddell presented compelling data from the transgenic mouse model in an oral session, demonstrating normalization of fibrosis gene…

Ken Myszkowski

Chief Financial Officer

Thank you, Bruce and good afternoon, everyone. As we reported today, our net loss for the three months ended December 31, 2016 was $12.1 million or $0.17 per share based on $71.4 million weighted average shares outstanding. This compares with a net loss of $19.3 million or $0.32 per share based on $59.5 million weighted shares outstanding for the three months ended December 31, 2015. Revenue for the three months ended December 31, 2016 was $4.4 million compared to $43,750 for the three months ended December 31, 2015. This increase is driven by the upfront payments received from our collaboration agreements with Amgen and these payments will be recognized as revenue over the next one to two years. Total operating expenses for the three months ended December 31, 2016, were $19.3 million compared to $19.4 million in the three months ended December 31, 2015. Net cash provided by operating activities during the three months ended December 31, 2016 was $10 million compared with net cash used of $21.2 million during the three months ended December 31, 2015. The key driver of this change was the $30 million upfront payment received from Amgen associated with ARO-LPA collaboration agreement. Turning to our balance sheet, our cash was $102.1 million at December 31, 2016 compared to $85.4 million at September 30, 2016. The increase in our cash was primarily driven by the upfront payment and equity investment totaling $42.5 million during the quarter. This was offset by cash used for operating activities. Our common shares outstanding at December 31, 2016 was 74.4 million. This includes the preferred shares that were converted during the quarter and preferred shares were outstanding at December 31, 2016. With that overview, I'll turn the call back to Chris.

Christopher Anzalone

President and CEO

Thanks Ken. Everything we do at Arrowhead is driven by a desire to bring important new medicines to patients without adequate treatment options that has not changed. Our disappointment about having to halt the development of prior generation candidates last year has become a renewed drive this year to make potentially better solutions for patients and to get back in the clinic as quickly as possible. Our current resources provide operating runway into 2019 and we believe this is sufficient to reach several medical readouts across multiple programs. Simply put, we have the technology experience and capital to make important strides in multiple disease areas. I began today's call with a concept that drug development rarely moves in a straight line and I will end on the same note. In this complicated business, we try to control that which can be controlled, we create contingencies for challenges we can imagine, we build capabilities to address challenges we may not imagine and we continue to push science toward better solutions. We do all this to arrive at a single destination, creation of new medicines for people who need them. The route to get there will have twists and turns but at the end of the day, the route is not important, the outcome is what matters. We are creating great new medicines right now and look forward to sharing our progress along the way and ultimately helping patients. I would now like to open the call to questions and actually before I do, let me just clarify one thing. I think that when I was talking about the HIF2 Alpha program, I mistakenly once or twice, mistakenly referred to the candidates as ARC-HIF2 when that was ARO-HIF2. Our current candidate in that program is ARO-HIF2, not ARC-HIF2. So, I apologize for that confusion. With that, I'll open the call to questions. Operator?

Operator

Operator

[Operator instructions] Our first question comes from Ted Tenthoff with Piper Jaffrey. Your line is now open.

Ted Tenthoff

Analyst · Piper Jaffrey. Your line is now open

Great. Thank you very much. Just wanted to check, at this point, what do you think is the most likely of the subQ assets to enter into the clinic first and is the AAT program still -- are you still working with the Alpha-1 Antitrypsin Association?

Christopher Anzalone

President and CEO

I'll let Bruce handle that.

Bruce Given

COO

I'll take your second question first. Sure, we still have a good relationship with the Alpha-1 foundation and I don't expect that will change at all. We remain good friends and that will be important when we get that sure. As for which drug will get into the clinic first, it's kind of a horse race at this point and I think there are several candidates and which candidate is going to finish first I think internally we could probably place bets as well.

Ted Tenthoff

Analyst · Piper Jaffrey. Your line is now open

Okay. Will keep posted. Thanks.

Bruce Given

COO

Thanks Ted.

Operator

Operator

Thank you. Our next question comes from Katherine Xu with William Blair. Your line is now open.

Katherine Xu

Analyst · William Blair. Your line is now open

Yes, good afternoon. Sorry if I missed it; did you mention whether there is going to be candidates entering the clinic in 2017?

Christopher Anzalone

President and CEO

We've not mentioned that. We're going to wait until our Analyst Day sometime this year where we can give you more granular guidance on when to expect candidates into the clinic. Part of that is really to as Bruce says, it's not clear to us which program is going to make to the clinic first. I think we're moving pretty well on multiple fronts and so we're not yet compared to give guidance on that. We'll do that at the Analyst Day.

Katherine Xu

Analyst · William Blair. Your line is now open

Can you comment on the stake Silence Therapeutics takes to you?

Christopher Anzalone

President and CEO

I am sorry. Can you repeat that?

Katherine Xu

Analyst · William Blair. Your line is now open

The Silence Therapeutics took some stakes in Arrowhead…

Christopher Anzalone

President and CEO

There is not much we know about that. So, we do know that the silence has taken a position in Arrowhead. They bought stock in the open market. There are no current discussions about any sort of transactions about any -- even license agreement. There is nothing really going on right now. Again, we understand that they acquired some stock and that's sort of as much as we know right now.

Katherine Xu

Analyst · William Blair. Your line is now open

I guess we will see the data of course at EASL, but I'm just curious, in your last press release, you talked about with either ARC-520 or ARC-521, you actually saw some significant knockdown of s-antigen, and also some patients were on track to clearance. Can you just explain that a little bit -- what you mean by that, to the extent that you can?

Christopher Anzalone

President and CEO

Yes, I don't want to front run the data presentation at EASL, but we saw patients that had quite low levels of s-antigen that looked like they were moving in the right direction. So obviously, that was a prospective statement of what we thought could happen, but the reality is zero clearance is something that is individual patient response and even as a field, we don't understand very well what happens to patients with zero clear versus those that don't. It's one of the things I think we'll learn about the next few years, but not that we're going to have agents I think that are going to make zero clearance and more frequent events at some point in the future, but that statement I think does represent what we thought, certainly represents what we felt. That doesn't necessarily mean that any of those patients will seroclear.

Katherine Xu

Analyst · William Blair. Your line is now open

Thank you.

Christopher Anzalone

President and CEO

Sure. And our next question comes from Carmen Augustine with Jefferies. Your line is now open.

Carmen Augustine

Analyst · William Blair. Your line is now open

Hi there. thanks for taking the question. So, when do you think we could expect the next update on the Amgen partnership? And do you expect to announce additional partnerships this year?

Christopher Anzalone

President and CEO

Unfortunately, I can't answer you those questions. We really can't give any guidance on the Amgen partnership because A, our visibility on that is incomplete of course. We're working diligently with them and it's not clear how fast either of those programs are going to move, but more importantly, we don't know what Amgen wants to talk, wants to include publicly on that. So, we really have nothing to offer at this point. With respect to new partnerships, we certainly think that we are a good partner and we think we've got an awful lot to offer the partners and we would -- we believe we're in a good position to held companies who want to one create RNAi Therapeutics against certain indications. And so, it is our hope that we enter into new partnerships. We've not given any guidance on when that may be of course in large part because we can't control that, but we certainly hope that the Amgen partnership in not our last partnership.

Carmen Augustine

Analyst · William Blair. Your line is now open

Okay. Got it. And then in light of the recent workforce reduction and redeployment of resources, what do you expect the cash runway to be through 2017? And on a related note, of the potential $617 million in milestone and equity payments from Amgen, how much is allocated to preclinical, clinical, and regulatory milestones?

Christopher Anzalone

President and CEO

We haven’t given any granular guidance on the breakdown of those milestone payments. With respect to cash forecast, we've also not giving guidance on cash burn in 2017. We have said now on a couple occasions that we have plenty of runway right now and plenty of our sources right now without any additional Amgen milestone payments without any additional partnerships, we've enough cash right now to operate into 2019 and we think that that is a good long runway given where we are with our various programs, but we've not given more granular financial guidance beyond that at this point.

Carmen Augustine

Analyst · William Blair. Your line is now open

Okay. Thanks.

Christopher Anzalone

President and CEO

You're welcome.

Operator

Operator

[Operator instructions] Our next question comes from Madhu Kumar with Chardan. Your line is now open.

Madhu Kumar

Analyst · Chardan. Your line is now open

Good afternoon, guys. So, what is the latest with the Spring Bank collaboration?

Christopher Anzalone

President and CEO

Bruce, do you want to address that?

Bruce Given

COO

So, that collaboration had two parts. So, a preclinical part and a clinical part. The preclinical part is still moving along. The clinical part was to join MONARCH and be in conjunction with ARC-520 and of course ARC-520 has left the clinic now. So ultimately, we think there would still be a place for doing work, combining the Spring Bank compound with ARO-HBV, but whether or not that will continue to that point is a little bit hard to see at this time, but they continue to be supportive. We continue to feel that they are intriguing compound from combination with RNAi and it would still be I think our intention too at some point see what the combination does in the clinic.

Madhu Kumar

Analyst · Chardan. Your line is now open

Okay. Thanks guys.

Bruce Given

COO

Sure. You're welcome.

Operator

Operator

And I am showing no further questions. I would now like to turn the call back over to Chris Anzalone for any further remarks.

Christopher Anzalone

President and CEO

Thanks everyone for your attention and we'll see you next quarter.

Operator

Operator

Ladies and gentlemen, thank you for participating in today's conference. You may all disconnect. Everyone have a great day.