Earnings Labs

Arrowhead Pharmaceuticals, Inc. (ARWR)

Q1 2018 Earnings Call· Sat, Feb 10, 2018

$70.41

+0.40%

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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 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.

Vincent Anzalone

President

Thanks, Amanda. Good afternoon, everyone. Thank you for joining us today to discuss Arrowhead’s results for its fiscal 2018 first quarter ended December 31, 2017. 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; and Ken Myszkowski, our Chief Financial Officer, who will give a review of the financials. We will then open up the call to your questions. Before we begin, I would 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 provide any – sorry, 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 the 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. It’s been a short time since we held our last earnings call for fiscal 2017 year-end, but we have already made substantial progress toward our goals for 2018. It is gratifying to see how far we’ve come in the last 12 months and exciting to see what we are expecting to accomplish in 2018. We’re positioned to go from zero to five clinical programs in 12 months, and I want to applaud the hard work of all the smart, talented and driven folks at Arrowhead who are making this possible. Let’s begin with the primary goals we have for calendar 2018. They are, one, complete dosing of our Phase 1/2 study of ARO-HBV; two, complete dosing our Phase 1 study of ARO-AAT; three, organizing R&D Day to discuss the new pulmonary platform; four, execute a business development collaboration; five, file a CTA for ARO-APOC3; six, file a CTA for ARO-ANG3; seven, file a CTA for our first inhaled pulmonary program, ARO-Lung1; and eight, present data at appropriate scientific conferences. All our programs are based on our TRiM platform, which utilizes ligand-mediated delivery and is designed to enable multiple tissue targeting while being structurally straightforward. It is a product of more than a decade of research at Arrowhead, using targeted drug delivery vehicles for RNAi. TRiM technology enables Arrowhead’s RNAi therapeutics to retain the maximal activity achieved with prior generation technologies, but with a more structurally straightforward molecule that offer several potential advantages. These include simplified manufacturing and therefore, reduce costs; multiple routes of administration, including subcutaneous injection and inhaled administration; potential for improved safety; and the promise to bring RNAi to tissues outside the liver, which would represent a big leap forward for the field and a substantial…

Ken Myszkowski

Chief Financial Officer

Thank you, Chris, and good afternoon, everyone. As we reported today, our net loss for the quarter ended December 31, 2017 was $13.2 million, or $0.18 per share based on $74.8 million weighted average shares outstanding. This compares with a net loss of $12.1 million, or $0.17 per share based on $71.4 million weighted average shares outstanding for the quarter ended December 31, 2016. Revenue for the quarter ended December 31, 2017 was $3.5 million, compared to $4.4 million for the quarter ended December 31, 2016. Revenue in each period relates to the recognition of the upfront payments received from our collaboration and license agreements with Amgen. Of the total upfront payments of $35 million, all but $1.9 million has been recognized as revenue to date, and the remainder is anticipated to be recognized over the next nine months. Total operating expenses for the quarter ended December 31, 2017 were $17.3 million compared to $19.3 million for the quarter ended December 31, 2016. This decrease is primarily due to the discontinuation of our previous clinical trials in late 2016. Net cash used in operating activities during the quarter ended December 31, 2017 was $14.7 million compared with net cash provided from operating activities of $10 million during the quarter ended December 31, 2016. The key driver of this change was the $30 million upfront payment received from Amgen in 2016, associated with our ARO-LPA collaboration and licensing agreement. Turning to our balance sheet. Our cash and short-term investments totaled $50.7 million at December 31, 2017, compared to $65.6 million at September 30, 2017. The decrease in our cash was primarily driven by cash used in operating activities. In January 2018, we completed an equity financing issuing 11.5 million shares, which resulted in $56.8 million of net cash proceeds to the company. This financing along with our existing cash and short-term investments provided us with more than $100 million of liquid assets, which will allow us to continue to advance our pipeline through the clinic for many quarters. Our common shares outstanding at December 31, 2017 was $74.9 million. With that brief overview, I’ll turn the call back to Chris.

Christopher Anzalone

Operator

Thanks, Ken. We have great expectations for 2018, and believe that the company you will see this time next year will be substantially different than the one you see today. We believe that we are the fastest and most innovative company in the field, and because of this, we’re at the door of disruptive opportunity to change medicine and public health in a variety of areas. To both new and existing investors, we think we can accomplish a lot together. We sincerely thank you for joining us. I would now like to open the call to questions. Operator?

Operator

Operator

Thank you. [Operator Instructions] And the first question comes from the line of Katherine Xu of William Blair. Your line is open.

Katherine Xu

Analyst · William Blair. Your line is open

Yes. Hi, good afternoon. Well, congrats on the rapid progress. But I just want to ask maybe if you could elaborate how come the – you can beat your guidance by that much with the CTA filing, and also how the tox studies have been going, including this GLP tox apparently that’s a very important part, which is safety on the new – on the TRiM platform that people are concerned about?

Christopher Anzalone

Operator

Thanks. Bruce, do you want to take that?

Bruce Given

Analyst

Sure. Hi, Katherine. We certainly had to play perfect baseball, so everything had to go kind of flawlessly with the tax program, everything had to go flawlessly with the manufacturing program. And because of that, I think, we in the end, we had to set guidance not necessarily expecting perfection. We, of course, internally most people when they give guidance, they necessarily mean kind of the end of the quarter, I think, with our AAT guidance, we were thinking that maybe we would be submitting our CTA sometime in January or so and with HBV, we were thinking maybe in the April timeframe. And we just were able to execute in such a way that we were – we’re able to beat those guidances with both of those CTAs going in essentially between the middle and the last-half of December of last year. But we pushed hard to get those in early, because we wanted to get into the queue for evaluation early in 2018. We felt that even delayed into January, we ran the risk of not making it into the first set of evaluations by the IRBs and regulatory authorities. So it was worth it to us to really push people very hard and do a lot of work in parallel with instead of in series and by doing that, we were able to achieve pretty extraordinary results.

Katherine Xu

Analyst · William Blair. Your line is open

Then the tox observation so far?

Bruce Given

Analyst

Well, we’re comfortable with them, that the final arbiters of tox are always the IRBs and the reviewers from a regulatory perspective. But we felt comfortable with our submissions and we continue to feel comfortable. But we tend not to give detailed review of our GLP tox and that’s pretty true usually in industry as well, I think.

Christopher Anzalone

Operator

But we can tell you broadly, look, our confidence in these drugs weren’t changed by the GLP tox findings. It was consistent with what we expected.

Bruce Given

Analyst

Yes, we weren’t surprised.

Katherine Xu

Analyst · William Blair. Your line is open

Okay. And then is it fair to expect some proof of concept data from both the AAT and HBV program as far as the end of the year and potential partnership deal for the – for some other programs during 2018?

Christopher Anzalone

Operator

Yes. So we’re not prepared to give guidance on proof of concept data yet, because we still have not yet started dosing patients. Let’s get final approval by the IRBs and final approval by the regulatory agencies and we’ll start dosing patients at that point. I think, we can – we’ll be better positioned to give good firm guidance. It is our hope, as I mentioned, early in the prepared remarks that we can finish dosing both of those studies into – in calendar 2018. And so just give us some time on listen once – and we’ll provide guidance once we start dosing. Sorry, what was the other question?

Bruce Given

Analyst

Partnerships?

Christopher Anzalone

Operator

Partnership, yes. Similar – similarly there, look, I think that we have a good chance of getting an important collaboration done this year. But you really can’t give guidance on that, because that’s out of our control. I think, what is within our control, building up this TRiM platform, demonstrating that it is active and that it appears to be well tolerated. We’re doing all those things and we feel good about it. And I think that we have some targets that are potentially interesting to partners. And so everything we can do we’re doing. And now, we’ll just see, if we can bear some fruit this year. It is certainly our hope that we can do that.

Katherine Xu

Analyst · William Blair. Your line is open

All right. Thank you.

Christopher Anzalone

Operator

Sure.

Operator

Operator

Thank you. And our next question is from the line of Keay Nakae of Chardan. Your line is open.

Keay Nakae

Analyst · Keay Nakae of Chardan. Your line is open

Yes, thanks. With respect to potential partnerships, especially for the cardiovascular [indiscernible] patients, is the numbers you’ve disclosed from the Amgen partnership, is that what we should be thinking about if you’re able to partner those given the fact that you expect to file the CTAs around the end of this year?

Christopher Anzalone

Operator

Yes. I appreciate that question. Thanks very much, but not one that I can answer. A, I don’t – here’s is what I think. I think that APOC3 and ANGPTL3 are good targets, I think, they’re good validated targets that should be of interest to a big pharma – to big pharma and that they could be attractive targets for partners, I believe that. When can we get a partnership done? Can we get a partnership done? I don’t know the answer to that. And so, speculating on timing of that is just – is not something that I’m going to do at this point. Similarly, I really can’t speculate on should that happen, I really can’t speculate on what the economics would be. Some of that will depend upon the time of partnership, of course, the longer we hold onto these potentially, the more valuable they could be. So there are just too many variables there unfortunately to really speculate on.

Keay Nakae

Analyst · Keay Nakae of Chardan. Your line is open

Okay. That’s all I have. Thanks.

Christopher Anzalone

Operator

Okay. Thank you.

Operator

Operator

Thank you. [Operator Instructions] Our next question is from the line of Madhu Kumar of B. Riley FBR. Your line is open.

Madhu Kumar

Analyst · Madhu Kumar of B. Riley FBR. Your line is open

Hey, guys, thanks for taking my questions. So my first question relates to the APOC3 program. So looking at the indication space for APOC3, how much do you think you would pursue to kind of orphan indication just so your competitors have gone pretty far down the development pipeline in right now versus the kind of bigger ticket cardiovascular indications?

Christopher Anzalone

Operator

Yes. So let me take a first crack at that. One of the things we like about APOC3 is that, it gives us multiple regulatory pathways. If we were to hold onto this for ourselves, it clearly make more sense for us to focus on orphan indications. Whereas, if a partner were to take this, it may make more sense to go after large cardiovascular markets and go ahead and invest in a large outcome study. So I think, ultimately, which route we take will depend upon who takes us forward, I think.

Madhu Kumar

Analyst · Madhu Kumar of B. Riley FBR. Your line is open

Okay, thanks. And remind me, did Amgen – were they – was – were they shown C3 and angiopoietin-like 3 as part of the partnership?

Christopher Anzalone

Operator

No. So we started talking to Amgen quite some time ago about Lp little a and about the undisclosed target, that was before we had any program in ANGPTL3 or APOC3. So these are relatively new.

Madhu Kumar

Analyst · Madhu Kumar of B. Riley FBR. Your line is open

And one last. Will there – remind me if I missed this. Will there be 520 or 521 data kind of follow-on data diesel?

Bruce Given

Analyst

Yes. I think, we may see some 520 data. I don’t think we’re going to see 521 data just because that that study really got stopped so early. What data we had got presented, I think, it must have been Easter last year when we presented what data we had, but it was quite sparse. Enough to be very tantalizing, but we don’t have more of 521 data sort of hiding out some place. We pretty much showed everything we had.

Madhu Kumar

Analyst · Madhu Kumar of B. Riley FBR. Your line is open

Okay, great. Thanks for taking my question. Let’s have a great weekend, guys.

Bruce Given

Analyst

Thanks very much. You too.

Christopher Anzalone

Operator

Take care.

Operator

Operator

Thank you. And at this time, I’m showing no further questions. I’d like to turn the conference back over to Chris Anzalone for closing remarks.

Christopher Anzalone

Operator

Thanks very much, everyone. Thank you for joining us on our call today, and we will see you next quarter.

Operator

Operator

Ladies and gentlemen, thank you for your participation in today’s conference. This does conclude the program. You may now disconnect. Everyone, have a great day.